    [Senate Hearing 108-844]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 108-844

                           CLONING: A RISK TO WOMEN?

    =======================================================================

                                    HEARING

                                   before the

                 SUBCOMMITTEE ON SCIENCE, TECHNOLOGY AND SPACE

                                     OF THE

                             COMMITTEE ON COMMERCE,
                          SCIENCE, AND TRANSPORTATION
                              UNITED STATES SENATE

                          ONE HUNDRED EIGHTH CONGRESS

                                 FIRST SESSION

                                   __________

                                 MARCH 27, 2003

                                   __________

        Printed for the use of the Committee on Commerce, Science, and
                                 Transportation

                         U.S. GOVERNMENT PRINTING OFFICE
                                 WASHINGTON: 2006

    96-697 PDF

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           SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION

                          ONE HUNDRED EIGHTH CONGRESS

                                 FIRST SESSION

                         JOHN McCAIN, Arizona, Chairman
    TED STEVENS, Alaska                  ERNEST F. HOLLINGS, South Carolina
    CONRAD BURNS, Montana                DANIEL K. INOUYE, Hawaii
    TRENT LOTT, Mississippi              JOHN D. ROCKEFELLER IV, West
    KAY BAILEY HUTCHISON, Texas              Virginia
    OLYMPIA J. SNOWE, Maine              JOHN F. KERRY, Massachusetts
    SAM BROWNBACK, Kansas                JOHN B. BREAUX, Louisiana
    GORDON SMITH, Oregon                 BYRON L. DORGAN, North Dakota
    PETER G. FITZGERALD, Illinois        RON WYDEN, Oregon
    JOHN ENSIGN, Nevada                  BARBARA BOXER, California
    GEORGE ALLEN, Virginia               BILL NELSON, Florida
    JOHN E. SUNUNU, New Hampshire        MARIA CANTWELL, Washington
                                         FRANK LAUTENBERG, New Jersey

          Jeanne Bumpus, Republican Staff Director and General Counsel
                 Robert W. Chamberlin, Republican Chief Counsel
          Kevin D. Kayes, Democratic Staff Director and Chief Counsel
                    Gregg Elias, Democratic General Counsel

                                     ------

                 SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND SPACE

                        SAM BROWNBACK, Kansas, Chairman
    TED STEVENS, Alaska                  JOHN B. BREAUX, Louisiana
    CONRAD BURNS, Montana                JOHN D. ROCKEFELLER IV, West
    TRENT LOTT, Mississippi                  Virginia
    KAY BAILEY HUTCHISON, Texas          JOHN F. KERRY, Massachusetts
    JOHN ENSIGN, Nevada                  BYRON L. DORGAN, North Dakota
    GEORGE ALLEN, Virginia               RON WYDEN, Oregon
    JOHN E. SUNUNU, New Hampshire        BILL NELSON, Florida
                                         FRANK LAUTENBERG, New Jersey

                                C O N T E N T S

                                  ----------
                                                                       Page
    Hearing held on March 27, 2003...................................     1
    Statement of Senator Brownback...................................     1

                                   Witnesses

    Bruchalski, Dr. John T., Obstetrician and Gynecologist, Fairfax,
      Virginia.......................................................     3
        Prepared statement...........................................     7
    Bustillo, Dr. Maria, Director, Assisted Reproductive
      Technologies, South Florida Institute for Reproductive Medicine     9
        Prepared statement...........................................    12
    Charo, R. Alta, J.D., Associate Dean, Professor of Law and
      Bioethics, University of Wisconsin Law and Medical Schools.....    25
        Prepared statement...........................................    27
    Doerflinger, Richard M., Deputy Director, Secretariat for Pro-
      Life Activities, U.S. Conference of Catholic Bishops...........    36
        Prepared statement...........................................    40
    Kimbrell, Andrew, Executive Director, International Center for
      Technology Assessment..........................................    29
        Prepared statement...........................................    33
    Landrieu, Hon. Mary L., U.S. Senator from Louisiana..............    18
    Millican, Lynne, R.N., B.S.N., Paralegal, Boston, Massachusetts..    48
        Prepared statement...........................................    50

                                    Appendix

    Wyden, Hon. Ron, U.S. Senator from Oregon, prepared statement....    99
    Response to written questions submitted by Hon. Frank Lautenberg
      to Richard M. Doerflinger......................................    99
    Prepared statements on the risks of Lupron usage:
        Kimberly Bradford............................................   100
        Melody Hampton...............................................   106
        Susan Hayward................................................   106
        Lisa A. Plante...............................................   110
        Melanie Waldman..............................................   110
        J. Wolf......................................................   111

                           CLONING: A RISK TO WOMEN?

                                  ----------

                            THURSDAY, MARCH 27, 2003

                                           U.S. Senate,
                Subcommittee on Science, Technology, and Space,
            Committee on Commerce, Science, and Transportation,
                                                        Washington, DC.
        The Subcommittee met, pursuant to notice, at 9:35 a.m. in
    room SR-253, Russell Senate Office Building, Hon. Sam
    Brownback, Chairman of the Subcommittee, presiding.

               OPENING STATEMENT OF HON. SAM BROWNBACK,
                        U.S. SENATOR FROM KANSAS

        Senator Brownback. Good morning. The hearing will come to
    order. Today, we will conduct our second hearing in this
    Subcommittee on the issue of human cloning. We particularly
    want to try and better understand whether or not human cloning
    for so-called ``therapeutic purposes'' poses a risk to women's
    health. That will be the question we will examine today.
        Many of the proponents of human cloning claim that a cure
    to many of the diseases that plague humanity lies just around
    the corner. In this hearing, we will examine some of these
    claims and also what would have to happen in order for these
    claims to be realized.
        First, we should start with a few definitions. The
    bipartisan Human Cloning Prohibition Act of 2003, S. 245,
    sponsored by myself and Senator Landrieu, defines ``human
    cloning'' as human asexual reproduction that is accomplished by
    introducing nuclear material from one or more human somatic
    cells into a fertilized or unfertilized oocyte, or human egg,
    whose nuclear material has been removed or inactivated so as to
    produce a living organism at any stage of development that is
    genetically virtually identical to an existing or previously
    existing human organism.
        The definition is very important. The fusion of the somatic
    cell and the oocyte creates a human embryo that is genetically
    identical to the somatic cell donor. This genetic match is what
    proponents of human cloning claim will solve the immune-
    response rejection problem and will provide treatment to
    millions of people.
        This hearing will examine what would be necessary in order
    to realize the promise held out to those suffering by those who
    are advocating human cloning as a means to cure the diseases
    that plague humanity. And clearly, we all want to see a cure
    for these horrible diseases.
        However, it is clear that in order to be effective,
    ``therapeutic'' cloning must rely on the collection of a vast
    number of human eggs. In order to conduct so-called
    ``therapeutic cloning'' on the scale that would yield just a
    portion of the benefit that the advocates promise, one would
    need to harvest a vast number of human eggs from women of
    childbearing age. Dr. David Stevens estimates that--and this is
    a quote from him--``To get enough eggs to seek clone cures for
    these four diseases''--just four diseases--``ALS, Parkinson's,
    Alzheimer's, and diabetes, every woman in the U.S. aged 18 to
    44--that is approximately 55 million--would have to endure two
    cycles of ovarian hormone hyperstimulation and then undergo
    surgery.''
        The ``egg dearth'' is a mathematical certainty. It is one
    reason why some researchers say that therapeutic cloning will
    not be generally available as a medical treatment.
        Recently, biotech researchers, John Odorico, Dan Kaufman,
    and James Thompson, admitted the following in the research
    journal, Stem Cells, and stated this, ``The poor availability
    of human oocytes, or eggs, the low efficiency of the nuclear
    cell procedure, and the long population doubling time of human
    ES cells make it difficult to envision this--therapeutic
    cloning--becoming a routine clinical procedure, even if ethical
    considerations were not a significant point of contention.''
        Perhaps this is what led Dr. Thomas Okarma, Chief Executive
    of Geron Corporation, to state that it would take, quote,
    ``thousands of human eggs on an assembly line'' to produce a
    custom therapy for a single person. He then goes on, ``This
    process is a nonstarter, commercially.''
        Concerns such as these, as well as others, have led a group
    of progressive activists, many of whom support abortion rights,
    to state in their letter of support for a ban on all human
    cloning that, ``Although we may differ in our views regarding
    reproductive issues, we agree that a human embryo should not be
    cloned for the specific intention of using it as a resource for
    medical experimentation or for producing a baby. Moreover, we
    believe that the market for eggs, women's eggs, that would be
    created by this research will provide unethical incentives for
    women to undergo health-threatening hormone treatment and
    surgery. We are also concerned about the increasing bio-
    industrialization of life by the scientific community and life
    science companies, and shocked and dismayed that clonal human
    embryos have been patented and declared to be human,
    `inventions.' ''
        As I am sure many of our witnesses are already aware, and
    as many in this audience already know, the typical in vitro
    fertilization procedure involves the collection of eggs from
    women who seek to become pregnant in this manner. The market
    for these eggs is already developing. In fact, it is now known
    that Advanced Cell Technology of Massachusetts, the pioneers in
    human cloning, paid women up to $4,000 per egg donation. Such a
    market for women's eggs will clearly be a threat to the health
    of many women. That women undergo the health risks associated
    with egg donation for the purpose of having children is one
    thing; but that they would be induced by some to undergo this
    health risk for money is another matter.
        I am hopeful that we can use this hearing to better
    understand the threats posed to women and whether or not this
    is a route we should even consider. But more importantly, I am
    growing increasingly concerned that some of the proponents of
    human cloning are holding out the hope for a cure as a tool to
    build support for a morally dubious enterprise.
        In the past, we have heard that fetal tissue research held
    the cure to the whole host of dread diseases that plague
    humanity. To date, we have met only with failure upon failure
    from fetal tissue research. Almost five years ago, we heard
    that human embryonic stem cell research held the cure. In fact,
    at one hearing Senator Specter asked Dr. James Thompson,
    ``Illustrative for Parkinson's now, for Parkinson's, how long
    for a cure?'' And Dr. Thompson's response, ``Parkinson's? I am
    going to say five to ten years more. It will be one of the
    first ones.'' This December marks five years since he made that
    statement, and, to date, there is no cure for Parkinson's from
    human embryonic stem cells in sight.
        I want to fight for a cure to Parkinson's disease. I want
    to see cures. I want to see us going routes and ways that we
    can get there. I want to get to the bottom of this, but we
    cannot continue to play with people's hopes.
        Finally, I would like to note, with some satisfaction, that
    we are making some clear progress on the issue of human
    cloning. The Governor of Arkansas signed a bill very similar to
    S. 245, the bipartisan Human Cloning Prohibition Act of 2003,
    into law earlier this week. The State Senate of North Dakota
    voted, 46 to zero, yesterday to approve similar legislation,
    the State House in North Dakota having already voted, 90 to
    one, to approve the same legislation. There is a movement
    taking place across the board in a number of states.
        We want to examine this, in particular, regarding women's
    health. And with that, I want to call up the first panel to
    testify here today. And if you would come forward. I think
    Senator Landrieu may be coming up later on. But the first panel
    of Dr. John Bruchalski, from Fairfax, Virginia, Dr. Maria del
    Carmen Bustillo, from Miami, Florida, and I think Lynne
    Millican called in earlier, sick, so I do not know if she has
    been able to arrive yet or not, apparently not. So we'll
    proceed with the two of you as the first panel.
        I very much appreciate your attendance and your
    presentations. I will be happy to take your full written
    statement into the record and allow you to summarize, if you
    would like to; or if you would like to present that full
    statement, that would be fine, as well.
        Dr. Bruchalski, I am sure I butchered your name. Would you
    give me the correct pronunciation?
        Dr. Bruchalski. Bruchalski.
        Senator Brownback. Bruchalski. I was making too much of it.
    I apologize for that.
        Dr. Bruchalski, the floor is yours. Thank you very much for
    joining us here today.

         STATEMENT OF DR. JOHN T. BRUCHALSKI, OBSTETRICIAN AND
                    GYNECOLOGIST, FAIRFAX, VIRGINIA

        Dr. Bruchalski. Thank you, Senator, and good morning.
        The tragic human backdrop to this Senate hearing is the
    very real and painful reality that one in six women of
    reproductive age will seek professional help during their
    lifetimes because of infertility.
        I come before you today because of my personal experience
    as an obstetrical and gynecologic resident from 1987 to 1991 at
    the Norfolk Medical Program, the home of the Jones Institute
    for Reproductive Medicine. It is the American infertility
    center that not only successfully produced America's first in
    vitro child, but was also the center that coined the term
    ``pre-embryo'' while I was there.
        And because of what I have learned in the last dozen years
    as a practicing obstetrician and gynecologist, I want to focus
    my remarks to the very real issues of egg donation in the
    cloning process, otherwise termed ``human somatic cell nuclear
    transfer,'' and their detrimental impact on women.
        To appreciate this deleterious effect and the massive scope
    of this risk to women, I would just like to briefly review the
    cloning process. An egg is surgically, usually transvaginally,
    taken from the hormonally treated woman's ovary. The nucleus is
    removed from that egg, and a somatic nucleus from the
    individual to be cloned is transferred into an empty egg and
    fused with electric current. Then development occurs through
    the morula stage when the pre-embryo is screened for gene
    expression and imprinting defects. This is done until the
    blastocyst stage, when it is implanted into the woman's uterus.
        However, this process is quite fragile, that despite having
    cloned five animal species, we hypothesize the need for
    hundreds, if not thousands, of eggs to be obtained for each
    clone to be used to treat the mentioned diseases of
    Parkinson's, Alzheimer's, and diabetes, to name a few.
        Where and how and from whom are these eggs to be obtained?
    We need look no further than our present IVF data. If IVF
    donors average 10 to 15 eggs retrieved per hyper-stimulated
    cycle and each patient with Parkinson's disease needs 50 to a
    hundred eggs to clone to obtain stem cells, for the 1 million
    people with Parkinson's disease, 50 million eggs would be
    required to be retrieved from possibly 5 million egg donors.
    For the 17 million people with diabetes, 850 million eggs would
    be required, and, subsequently, 85 million egg donors needed.
        To obtain these eggs, we must turn to drugs and/or to
    donors. But remember, the success of cloning in the IVF process
    used rests literally on the bodies of the women experimented
    on. IVF was successful in humans before it was successful in
    animals. ICSI, intracytoplasmic sperm injection, an assisted
    reproductive technology used in up to 40 percent of all cycles
    now was successful in humans before it was successful in
    animals. There appears to be a fuzzy boundary between research
    and treatment when it comes to those women undergoing these
    processes.
        Our reproductive industry is not enveloped by a coherent,
    whole, regulatory framework. The drugs are regulated by the FDA
    without long-term data, and the process of mixing sperm and egg
    together in any way in combination is not regulated at all. The
    natural progression of research is to do experiments in cell
    cultures in animal models to look at safety issues first and
    whether these experiments are effective. Then, after you have
    this data, you move on to humans, specifically women in the
    case of this reproductive technology. This has not happened
    with the reproductive technologies up until now, and this is my
    concern.
        Institution review boards that are found in hospitals are
    only required for research in federally backed institutions or
    for FDA-regulated products. And ART has been largely privately
    funded.
        The Genetics and Public Policy Center at Johns Hopkins
    Hospital University is beginning to look into this travesty.
    Women have borne the positive and negative effects of being
    experimented on through the years of IVF, and now it appears
    the same with cloning.
        Kathy Hudson, who is the director of the above-mentioned
    institute at Hopkins said, ``Scientifically, there are some
    unanswered questions about the long-term consequences those
    drugs might have on women. There are questions about whether
    they lead to the production of unhealthy eggs and whether they
    pose a cancer risk to the mother. That is an area that we, at
    the center, hope to examine.''
        Drugs such as Fertinex, Gonal-F, Pergonal, Cetrotide, and
    Lupron are all to be under review. Significant headaches,
    abdominal swelling, abdominal pain are some of the more common
    side effects. And since we have now had a plateau in the
    success of IVF procedures, we are now beginning to look into
    other user-friendly protocols that have fewer side effects.
        In 2002, alone, at least 12 studies in articles in peer-
    review journals suggest a potential link between these
    reproductive technologies and birth defects, like heart defects
    and genetic diseases, childhood cancers, decreased cognition,
    and others. We truly do not know whether it is due to the
    nature of the problems of infertility or due to the drugs and
    the procedures of assisted reproduction.
        The fertility drug-cancer link refers to ovarian
    stimulation in ovarian cancer. The initial Whittemore study, a
    meta-analysis of 12 case-controlled studies on ovulation
    induction seemed to show a 27-fold increased odds ratio for
    developing ovarian cancer, even though some of the analysis was
    determined to be flawed. Later, the Rossing study reported a
    similar association between the drugs of ovulation and ovarian
    cancer.
        This alleged increased risk of ovarian cancer in patients
    using ovulation-inducing agents is very disturbing, and a
    consensus among our American Fertility Society recommends that
    women who are considering the use of fertility drugs should be
    told that there is a possibility of increased risk and should
    be given alternatives. But at this point, there is no data
    overall to support discontinuing or changing these ovulation-
    induction procedures. Two small numbers, detection bias and
    recall bias, were all used to statistically support their
    conclusions.
        These drugs also have spurred the profound rise in multiple
    births--twins, triplets, and above. In the year 2000, 35
    percent of ART births were multiples, and their higher risks
    for birth defects and low birth weight and added healthcare
    costs are a significant psychological burden for women, not to
    mention the process of selection reduction where the infertile
    woman is faced with the decision to terminate one of her
    fetuses to improve outcome.
        Now, the other approach to obtain eggs is to seek a donor,
    a woman who is willing to donate her eggs for the cloning
    process. Again, we can look to in vitro experience for what to
    expect in the cloning scenario. Last month, experts in the
    United Kingdom publicly questioned whether such selfless acts
    are justified given the health risks they may face in later
    life. These women are paid between 1,500 to 3,500 American
    dollars, or 4,000 to 5,000 British pounds, oftentimes going to
    the highest bidder over the Internet.
        A prominent physician at a London IVF clinic, citing the
    unknown long-term effects and the possible cancer risks, says
    that they cannot duck this issue any longer for their donor egg
    patients. However, the British Human Fertilization and
    Embryology Authority says it has no plans to review the system
    for egg donation.
        On this side of the Atlantic, it is illegal to buy or sell
    human body parts, except eggs. In 1999, we transferred more
    than 8,000 embryos produced from fresh or frozen donated eggs
    into the uteri of women, according to the American Society for
    Reproductive Medicine. Ads placed in campus newspapers dangling
    tens of thousands of dollars before women with the right
    pedigree of looks, talent, and SAT scores is the method for
    attracting these precise donors. For a month, the woman turns
    over her body to the process of superovulation with the above-
    mentioned agents and the harvesting procedure of transvaginal
    aspiration. One out of a hundred will develop the
    hyperstimulation syndrome, which includes ascites, pulmonary
    overload, and sometimes hospitalization. One Stanford woman
    recently even had a stroke while being treated for egg
    donation.
        The psychological component of this process is being
    questioned. ``Are we leading them to make a decision that later
    in life they may regret? The money will be spent, and, in the
    end, she will have given up her genetic child forever. We have
    to really care about these women.''
        So, in conclusion, I agree that the problem of infertility
    is quite enormous and that we have made great strides since the
    late 1970s and early 1980s. However, my profession has recently
    seen the data on the benefits of menopausal hormonal therapy
    crumble in less than a year while listening to all the angst
    and betrayal spoken of by my older patients who have taken
    these hormonal therapies.
        After considerable pressure, my alma mater, despite private
    funding, decided to stop creating human embryos specifically
    for stem cell research this past January. That is the Jones
    Institute. They were the first institute in the world to make
    human embryos for research and then to destroy them after
    harvesting the stem cells. We perfected ART in humans before we
    did it in animals, using women as research subjects and
    treatment end points. There was no animal data before IVF and
    ICSI were done in humans.
        In 1993, the award-winning prized paper at the conjoined
    meeting of the American and Canadian Fertility Societies came
    out of George Washington University and Dr. Hall. Seventeen
    abnormal human embryos were taken and multiplied to obtain 48
    embryos. Two embryo clones developed to the 32-cell stage
    before the procedure was stopped. This was done in 1993 and
    presented at that conference and received the top prize.
        I come before this Committee, and I urge this Subcommittee
    to see cloning as another risk to women.
        Thank you very much.
        [The prepared statement of Dr. Bruchalski follows:]

        Prepared Statement of Dr. John T. Bruchalski, Obstetrician and
                        Gynecologist, Fairfax, Virginia
    Introduction
        Good morning. The tragic human backdrop to this Senate hearing is
    the very real and painful reality that one in six women of reproductive
    age will seek professional help during their lifetimes because of
    infertility. \1\ I come before you today because of my personal
    experiences as an obstetrical and gynecologic resident from 1987 to
    1991 at the Norfolk medical program that houses the Jones Institute for
    Reproductive Medicine, the preeminent, American infertility Center that
    not only successfully produced America's first in vitro child, but also
    the Center that coined the term ``pre-embryo'' while I was there; and
    because of what I have learned in the last dozen years as a practicing
    obstetrician and gynecologist I want to focus my remarks to the very
    real issues of egg donation in the cloning process, (human somatic cell
    nuclear transfer), and their detrimental impact on women.
    Cloning's Abuse of Women: Issues With Egg Donation
        To appreciate the deleterious effects and the massive scope of this
    risk to women, let's briefly review the cloning process. An egg is
    surgically, usually transvaginally, taken from the hormonally treated
    woman's ovary. The nucleus is removed from the egg, and a somatic
    nucleus from the individual to be cloned is transferred into the empty
    egg and fused with electric current. Then development occurs through
    the morula stage when the pre-embryo is screened for gene expression
    and imprinting defects, until the blastocyst stage (64 to 200 cell
    stage) when it is implanted into the woman's uterus. \2\
        However, this process is so fragile that despite having already
    cloned five animal species, we hypothesize the need for hundreds, if
    not thousands of eggs to be obtained for each clone to be used to treat
    the mentioned diseases of ALS, Parkinson's, Alzheimer's and diabetes.
    Where and how and from whom are these eggs to be obtained? We need look
    no further than our present IVF data. If IVF donors average 10 to 15
    eggs retrieved per hyper-stimulated cycle presently, and each patient
    with Parkinson's Disease need 50 to 100 eggs to clone, to obtain stem
    cells; for the one million Parkinson patients, 50 million eggs would be
    required to be retrieved, from possibly 5 million egg donors. For the
    17 million with diabetes, 850 million eggs would be required, and
    subsequently, 85 million egg donors needed. \3\
        To obtain these eggs we must turn to drugs and/or to donors, but
    remember, the success of cloning and the IVF processes used rests
    literally on the bodies of the women experimented on. IVF was
    successful in humans before it was successful in animals. ICSI, an
    assisted reproductive technology, used in up to 40 percent of all
    cycles, was successful in humans before it was successful in animals.
    There is a fuzzy boundary between research and treatment when it comes
    to those women undergoing these processes. \4\ Our reproductive
    industry is not enveloped by a coherent, whole regulatory framework.
    The drugs are regulated by the Food and Drug Administration without
    long term data, and the process of mixing sperm and egg together in any
    way and combination is not regulated at all. The natural progression of
    research is to do experiments in cell culture or animal models, to look
    at safety issues first, and whether these experiments are effective.
    Then after you have a lot of animal data, you move into humans,
    specifically women in the case of reproduction. This hasn't happened
    with ART and this is my concern. Institutional Review Boards are only
    required for research if federally backed institutions, or for FDA
    regulated products, and ART has been largely privately funded. The
    Genetics and Public Policy Center at Johns Hopkins University is
    beginning to look into this travesty. Women have born the positive and
    negative effects of being experimented on through the years of IVF and
    now it appears the same with cloning.
    Drugs
        Kathy Hudson, the director of the above mentioned new institute at
    Hopkins said, ``Scientifically, there are some unanswered questions
    about the long term consequences those drugs might have on women. There
    are questions about whether they lead to the production of unhealthy
    eggs, and whether they pose a cancer risk to the mother. That's an area
    that we at the Center hope to examine''. \5\ Fertinex, purified FSH
    from urine; Gonal F, FSH engineered from recombinant DNA; Pergonal, a
    mixture of FSH and LH collected from postmenopausal women; Cetrotide, a
    GnRH antagonist; and Lupron, the initial GnRH agonist mainstay are all
    to be under review. Significant headaches, abdominal bloating changing
    clothes size, and abdominal pain are some of the more common side
    effects. \6\
        In 2002 alone, at least 12 studies and articles in peer-reviewed
    journals suggest a potential link between ART and birth defects like
    heart defects and genetic diseases; childhood cancer; decreased
    cognition and more. We do not know whether it is due to the nature of
    the problems of infertility or due to the drugs and the procedures of
    assisted reproduction. \7\,}\8\
        The fertility drug/cancer link refers to ovarian stimulation and
    ovarian cancer. The initial Whittemore study, a metaanalysis of 12 case
    controlled studies on ovulation induction seemed to show a 27 fold
    increased odds ratio for developing ovarian cancer even though some of
    the analysis was determined to be flawed. \9\ Later, the Rossing study
    reported a similar association between the drugs of ovulation and
    ovarian cancer. \10\ This alleged increased risk of ovarian cancer in
    patients using ovulation inducing drugs is very disturbing, and a
    consensus among our American Fertility Society recommends that women
    who are considering the use of fertility drugs should be told that
    there is a possibility of increased risk and should be given
    alternatives, but there is no data to support discontinuing or changing
    ovulation induction, follicular stimulation, or in-vitro fertilization.
    \11\ Too small numbers, detection bias, and recall bias were used to
    support their conclusion.
        These drugs also have spurred the profound rise in multiple births;
    twins, triplets, and above. In 2000, 35 percent of all ART births were
    multiples, and their higher risk for birth defects and low birth weight
    and added health care costs are a significant psychological burden for
    women, not to mention the process of selective reduction where the
    infertile woman is faced with the decision to terminate one of her
    fetuses to improve outcome. \12\
    Egg Donors
        The other approach to obtain eggs is to seek a donor, a woman who
    is willing to donate her eggs for the cloning process. Again, we can
    look to the in-vitro experience for what to expect in the cloning
    cases.
        Last month, experts in the United Kingdom publicly questioned
    whether such selfless acts are justified given the health risks they
    may face in later life. These women are paid from $1,500 to $3,500 in
    America to 4,000 to 5,000 pounds in the UK, oftentimes going to the
    highest bidder over the internet. \13\ A prominent physician at a
    London IVF clinic citing the unknown long term effects, and the
    possible cancer risks says they can not duck this issue any longer for
    their donor egg patients. However, the British Human Fertilization and
    Embryology Authority says it has no plans to review the system for egg
    donation. \13\
        On this side of the Atlantic it is illegal to buy or sell human
    body parts, except for eggs. In 1999, we transferred more than 8,000
    embryos produced from fresh or frozen donated eggs into the wombs of
    women according to the American Society for Reproductive Medicine. \14\
    Ads placed in campus newspapers, dangling tens of thousands of dollars
    before women with the right pedigree of looks, talent and SAT scores is
    the method for attracting the precise donor. \15\ For a month, the
    woman turns over her body to the process of superovulation with the
    above mentioned drugs and the harvesting procedure of transvaginal
    aspiration. One out of hundred will develop the ``hyperstimulation''
    condition that includes: fluid shifts, ascites, pulmonary overload and
    sometimes hospitalization. One Stanford woman even had a stroke while
    being treated for egg donation. The American Society for Reproductive
    Medicine developed guidelines that place a $5,000 limit on donor
    compensation, and calling for independent medical and psychological
    evaluations of the donors. The guidelines seem to be on target but not
    all centers adhere to them. \15\
        The psychological component of this process is being questioned,
    ``Are we leading them to make a decision that later in life they may
    regret? The money will be spent and, in the end, she has given up her
    genetic child forever. We have to really care about these women.'' \16\
    Conclusion
        We have to really care about these women. My profession has seen
    the data on the benefits of menopausal hormonal therapy crumble in less
    than a year, while listening to all the angst and betrayal spoken by my
    elder patients.
        After considerable pressure, my alma mater, despite private
    funding, decided to stop creating human embryos specifically for stem
    cell research this past January. They were the first institute in the
    world to make human embryos for research and then to destroy them after
    harvesting the stem cells. \17\
        We perfected ART in humans before we did it in animals, using women
    as research subjects and treatment endpoints. There was no animal data
    before IVF and ICSI were done in humans. With this as background and
    fact, I urge this Subcommittee to see cloning as another risk to women.
                                  Bibliography
        \1\ Abma, JC et.al. Centers for Disease Control and Prevention,
    National Center for Health Statistics. Fertility, family planning and
    women's health: new data from the 1995 National Survey of Family
    Growth, Report No. 19; Series 23, 1997.
        \2\ Geron Inc. Advanced Cell Technology.
        \3\ David Stevens, MD, private communication, 7 May 2002.
        \4\ www.popsci.com/popsci/medicine/article/0,12543,419326-2,00.html
        \5\ www.popsci.com/popsci/medicine/article/0,12543,419326,00.html
        \6\ Physicians' Desk Reference 2003, Thompson, 3119-3136.
        \7\ www.popsci.com/popsci/medicine/article/0,12543,411770-2,00.html
        \8\ www.popsci.com/popsci/medicine/article/0,12543,411770-3,00.html
        \9\ Am. J. Epidemiol. 136:1175-1220, 1992.
        \10\ N. Engl. J. Med. 331:771-6, 1994.
        \11\ Ob.Gyn. News October 15, 1993, 12, 13.
        \12\ Blickenstein I, Keith LG, eds. Iatrogenic Multiple Pregnancy:
    Clinical Implications. London: Parthenon Publishing; 2000.
        \13\ //society.guardian.co.uk/publichealth/story/
    0,11098,892559,00.html
        \14\ //seattletimes.nwsource.com/cgi-bin/
    PrintStory.pl?document_id=134568946&zsection
    _id=268448406&slug=egg04m&date=20021104
        \15\ www.usnews.com/usnews/issue/030113/health/13donor.b.htm
        \16\ Martha Frase-Blunt, Ova-Compensating? Women Who Donate Eggs To
    Infertile Couples Earn a Reward--But Pay A Price, Washington Post,
    Tuesday, December 4, 2001; page HE01.
        \17\ Carol Morello, Center Shifts Stem Cell Approach, Washington
    Post, Friday, January 18, 2002, page A14.

        Senator Brownback. Thank you, Dr. Bruchalski. I appreciate
    that.
        Dr. Bustillo, thank you very much for joining us here
    today. We look forward to your testimony.

          STATEMENT OF DR. MARIA BUSTILLO, DIRECTOR, ASSISTED
               REPRODUCTIVE TECHNOLOGIES, SOUTH FLORIDA
                  INSTITUTE FOR REPRODUCTIVE MEDICINE

        Dr. Bustillo. Thank you very much. Good morning, Mr.
    Chairman.
        I am Dr. Maria Bustillo. I am the director of Assisted
    Reproductive Technologies, or ART, at the South Florida
    Institute for Reproductive Medicine in Miami, Florida. However,
    today I am representing the Coalition for the Advancement of
    Medical Research. It is a group of more than 75 patient
    advocacy, scientific, and research organizations dedicated to
    stem cell research.
        Since 1981, I have been involved in ART working to assist
    women and their families to bring children into this world. I
    have worked in human reproduction since the earliest days of in
    vitro fertilization and its related technologies. The field,
    which, like embryonic stem cell research and somatic cell
    nuclear transfer today, was filled with controversy.
        Over the last 20 years, the science and clinical practice
    of ART has improved dramatically. To date, more than 150,000
    children have been born in the United States thanks to these
    treatments.
        Over the past two decades, I have advocated for the
    adequate inclusion of women in clinical trials. Early on in
    this debate, some individuals were concerned about the
    exploitation of women, but the Institute of Medicine of the
    National Academy of Sciences, in its landmark 1994 report,
    concluded that both justice and science were best served by the
    adequate inclusion of women in well designed scientific
    research.
        Similarly, today, as we view this new area of science,
    regenerative medicine, individuals again have expressed
    concerns about the exploitation of women. I believe that this
    relatively new area of science, properly regulated, potentially
    holds more hope for treatments and cures for diseases for which
    women and men suffer than it poses risks to their health. In
    this belief about therapeutic cloning I am in agreement with 40
    Nobel Prize winners and the former First Lady, Nancy Reagan.
        Today's discussion relates to research to improve the
    health of millions of patients, many of whom are women, while
    preventing the specter of human reproductive cloning in an area
    which I believe is unethical and unsafe. Categorically, I am
    against the cloning of a new human being, and I believe that
    most Americans, including scientists and physicians, would
    agree.
        Opponents of therapeutic cloning protest that women will
    become egg-producing factories endangering themselves and
    deepening the divide between socioeconomic classes, because
    poor women will be more willing to sell their eggs. Donating
    eggs is far more complicated than contributing sperm, but women
    are smart enough to make informed choices about their bodies,
    including what they want to do with their eggs.
        It is important that we deal with facts, not speculation
    and not rhetoric. We have a great deal of experience with egg
    donation. It is a vital therapeutic option which has been used
    to help more than 15,000 American families to have children.
        I was a member of the American team that performed the
    first egg donation in 1983, and I have personally treated many
    egg donors over the last 20 years. I can assure you that I
    would not do that if it were not safe. All potential egg donors
    first undergo extensive medical and psychological screening.
    Ordinarily, a woman matures and releases only one egg in a
    menstrual cycle. In our techniques, including egg donation,
    medications are given to achieve the development of multiple
    eggs. Over that time period, the woman is monitored. And after
    the development is deemed appropriate, the eggs are retrieved
    transvaginally using ultrasound guidance.
        The American Society for Reproductive Medicine and the
    Society for Assisted Reproductive Technology have guidelines
    which they have promulgated extensively that are both clinical
    and ethical guidelines for gamete donation. And all its member
    clinics, 370 member clinics of SART, are required to adhere to
    these guidelines.
        I would like to ask that these reports and statement be
    entered into the record.
        Senator Brownback. Without objection, they will be in the
    record. *
    ---------------------------------------------------------------------------
        * The information referred to has been retained in Committee files.
    ---------------------------------------------------------------------------
        Dr. Bustillo. Many of the standards the profession has had
    in place for a number of years will now be enforced by the FDA
    as they make final the regulations of reproductive tissues
    within the next year.
        In sum, there is a long history of egg donations for
    reproductive uses. Protections and safeguards for both the
    donor and the recipient are in place and, I think, could be
    easily modified to accommodate egg donation for research or
    clinical applications of embryonic stem cells.
        As a scientist and long-time women's health advocate, I
    also find a complete ban on research troubling. About 25 years
    ago, because of similar religious and ethical considerations,
    there was a call for a ban on research involving recombinant
    DNA. Today, hundreds of thousands of people are healthier or
    alive because of the use of recombinant DNA to produce insulin,
    interferons, and other therapeutic recombinant molecules.
        This leads me to discuss why I believe women, as well as
    men, have tremendous potential to benefit from therapeutic
    cloning. Regenerative medicine, including using cloning
    techniques to create new cells more like a patient's own cells
    holds the promise to treat and cure numerous debilitating and
    deadly diseases like cancer, autoimmune diseases like lupus,
    multiple sclerosis, and early-onset diabetes, cardiovascular
    disease, and neurological diseases like Alzheimer's and
    Parkinson's. Annually, these diseases strike more than a
    hundred million individuals, a large proportion of whom are
    women. This field of research holds the potential to restore
    normal, healthy functions to cells and replace those that no
    longer function.
        Therapeutic cloning using somatic cell nuclear transfer
    holds great promise to develop new and innovative treatments
    for numerous diseases. For instance, let us discuss breast
    cancer. Using somatic cell nuclear transfer, scientists could
    take a cell from a patient with breast cancer and reprogram the
    cell to its earliest stage of development. Then they can
    compare the diseased cell's development to the healthy cell's
    development. In so doing, scientists could learn about the
    trigger mechanisms that lead to that disease. These fundamental
    insights offer tremendous potential for the development of
    interventions to treat or prevent disease. This is an example
    of why extracting stem cells from in vitro fertilized embryos
    is inadequate in tackling certain research.
        Women are affected not only by the diseases that attack
    them, but also by the diseases contracted by other family
    members, as they, women, are routinely their families'
    predominant caretakers. Women's, wives', mothers', daughters'
    lives quickly become subsumed by the illnesses within their
    families.
        I realize that embryonic stem cell research is in its
    infancy and an enormous amount of research must be performed
    before it can be translated into medical treatments, but we
    must carefully weigh the implications of any roadblocks that
    might halt this research. As with any technology, procedures
    become more efficient in time, so fewer eggs will be required.
    Researchers in therapeutic cloning also are hopeful that in the
    future they will know how to generate stem cells without
    needing eggs.
        Senate bill 303, the Hatch-Feinstein bill, strictly
    punishes unlawful conduct by providing criminal and civil
    penalties for violating the law while at the same time allowing
    physician and patient access to potential life-saving therapies
    without the fear of reprisal.
        I thank you for your time.
        [The prepared statement of Dr. Bustillo follows:]

         Prepared Statement of Dr. Maria Bustillo, Director, Assisted
      Reproductive Technologies, South Florida Institute for Reproductive
                                    Medicine
        Good morning, Mr. Chairman and Members of the Subcommittee. I am
    Dr. Maria Bustillo, Director of the ART at the South Florida Institute
    for Reproductive Medicine in Miami, Florida. I also am a founding
    member and former board member and vice president of the Society for
    Women's Health Research; past President of the Society for Assisted
    Reproductive Technology and former board member of the American Society
    of Reproductive Medicine. Today I am representing the Coalition for the
    Advancement of Medical Research, a group of more than 75 patient
    advocacy, scientific and research organizations dedicated to stem cell
    research.
        Since 1981, 1 have been involved in assisted reproductive
    technology, working to assist women and their families to bring
    children into this world. I have worked since the earliest days of In-
    Vitro Fertilization and related Assisted Reproductive Technologies, a
    field which like embryonic stem cell research and somatic cell nuclear
    transfer today, was filled with controversy. Over the last twenty
    years, the science and clinical practice of ART has improved
    dramatically. To date, more than 150,000 children have been born in the
    United States thanks to these treatments.
        Throughout my career I also have worked to advance research on
    women's health and supported work to alleviate their suffering and
    improve the quality and longevity of their lives. With the Society,
    over the past decade, I have advocated for the adequate inclusion of
    women in clinical trials and the subsequent analysis of resultant data
    so that scientific conclusions take into account any differences
    between women and men. Early on, in this debate, some individuals were
    concerned about the exploitation of women. But, the Institute of
    Medicine (of the National Academy of Sciences) in its landmark 1994
    report concluded that both justice and science were best served by the
    adequate inclusion of women in well-designed scientific research.
        Similarly, today as we view this new area of science, regenerative
    medicine, individuals again have expressed concerns about the
    exploitation of women. Once again, I am in agreement with the National
    Academy of Sciences. Two of its recently published reports support the
    exploration of the potential of regenerative medicine and therapeutic
    cloning. I believe that this relatively new area of science, properly
    regulated, potentially holds more hope for treatments and cures for
    diseases from which women and men suffer than it poses risks to their
    health.
        Today's discussion relates to research to improve the health of
    millions of patients, many of whom are women, while preventing the
    specter of human reproductive cloning--an area which I believe is
    unethical and unsafe. Categorically, I am against the cloning of a new
    human being, and I believe that most Americans, including scientists
    and physicians, would agree. Just this month, in a poll commissioned by
    the Coalition for the Advancement of Medical Research, more than two
    thirds of Americans support therapeutic cloning research to produce
    stem cells for treating life-threatening diseases and conditions and
    want the government to allow it to proceed. I agree with them and the
    National Academy of Sciences, 40 Nobel Prize winners, and former First
    Lady Nancy Reagan in my support for therapeutic cloning.
        Initially, I would like to counter opposition to therapeutic
    cloning as it relates to women. First, opponents of cloning protest
    that women will become egg-producing factories, endangering themselves
    and deepening the divide between socioeconomic classes because poor
    women will be more willing to sell their eggs.
        It is true that donating eggs is far more complicated than
    contributing sperm. But women are smart enough to make informed choices
    about their bodies, including what they want to do with their eggs.
    Women who believe that they can help an ailing family member or even
    help women like themselves who have a history of, say, Alzheimer's
    disease, should be allowed to make these choices.
        It is important that we deal with facts, not speculation and not
    rhetoric. We have a great deal of experience with egg donation. It is a
    vital therapeutic option which has been used to help more than 15,000
    American families have children. Twenty years ago, I was on the team
    that performed the first egg donation and I have personally treated
    many egg donors over the past 20 years. I can assure you I would not do
    that if it were not safe.
        All potential egg donors first undergo extensive medical and
    psychological screening. Women who are deemed as suitable donors enter
    a pool of potential donors who are then matched with recipient couples.
    The donor undergoes what is known as controlled superovulation.
    Ordinarily a woman matures and releases only one egg in each menstrual
    cycle. In ART techniques, including egg donating, the physician
    administers a combination of hormonal medications for about two to
    three weeks to trigger the development of many eggs. Over that time
    period, the patient is monitored using ultra sound technology and
    diagnostic blood tests. Finally the eggs are retrieved using
    transvaginal aspiration, using an ultrasound guided needle and
    intravenous sedation.
        As with any medical procedure, there are some potential risks to
    the patient/donor. There is a slight risk (less than 1 percent) of
    ovarian hyper stimulation, though even this risk is thought to be lower
    in donors than in normal ART patients. There have also been some
    studies reporting a link between some of the medicines used in ART
    procedures and ovarian cancer, which caused some initial concern.
    However further research has led us to conclude that there may well be
    an underlying medical problem which may be associated with both
    infertility and ovarian cancer. That is, it is not the medicines which
    lead to a higher cancer rate.
        The American Society for Reproductive Medicine and the Society for
    Assisted Reproductive Technology have promulgated extensive clinical
    and ethical guidelines on gamete donation, and all 370 member clinics
    of SART are required to adhere to these standards. I would like to ask
    that these reports and statement be entered into the record.
        These standards include the extensive screening I described early,
    a limitation on the number of times any one woman can donate, and a cap
    on compensation to the donor. The ASRM ethics committee has determined
    that sperm and egg donors can be compensated for the time and trouble
    associated with the donation, but that compensation should not vary
    according to the traits of the donor.
        Many of the standards the profession has had in place for a number
    of years will now be enforced by the FDA as they make final their
    regulations of reproductive tissues next year.
        In sum, there is a long history of egg donation for reproductive
    uses. Protections and safeguards for both donor and recipient are in
    place and could easily be modified to accommodate egg donation for
    research or clinical applications of embryonic stem cells.
        As a scientist and longtime women's health advocate, I also find a
    complete ban on research troubling. I am aware that the word
    ``moratorium'' is used in Senator Brownback's legislation, but I view a
    ``moratorium'' the same as a ban because after a hiatus in an area of
    scientific research, trained scientists are no longer available, the
    field diminishes, and the United States would have to play catch-up
    with other nation's research achievements. About 25 years ago, because
    of similar religious and ethical considerations, there was a call for a
    ban on research involving recombinant DNA. Today hundreds of thousands
    of people are healthier or alive because of the use of recombinant DNA
    to produce insulin, interferons, and other therapeutic recombinant
    molecules.
        This leads me to discuss why I believe women, as well as men, have
    tremendous potential to benefit from therapeutic cloning. Regenerative
    medicine, including using cloning techniques to create new cells more
    like a patient's own cells, holds the promise to treat and cure
    numerous debilitating and deadly diseases, like cancer, autoimmune
    diseases like lupus erythematosus (lupus), multiple sclerosis, and
    early onset diabetes, cardiovascular disease and neurological diseases
    like Alzheimer's and Parkinson's disease. Annually, these diseases
    strike more than 100 million individuals, a large proportion of whom
    are women. This field of research holds the potential to restore normal
    healthy functions to cells and replace those that no longer function.
        Therapeutic cloning, using Somatic Cell Nuclear Transplantation
    (SCNT) holds great promise to develop new and innovative treatments for
    numerous diseases. For instance, let us discuss breast cancer. Using
    SCNT, scientists can take the cell of a patient with breast cancer and
    reprogram the cell to its earliest stage of development. Then, they can
    compare the diseased cell's development to the healthy cell's
    development. In so doing, scientists can learn about the trigger
    mechanisms that lead to disease. These fundamental insights offer
    tremendous potential for the development of interventions to treat or
    prevent disease. This is an example of why extracting stem cells from
    In-Vitro Fertilization (IVF) embryos is inadequate for tackling certain
    research.
        Cardiovascular disease, including heart attacks and congestive
    heart failure, is the nation's number one killer of both women and men.
    Annually, approximately one-half million more women than men die of
    this dreaded disease. Restoring the function of damaged heart cells is
    a daunting challenge. The National Institutes of Health reports that
    recent research provides early evidence that adult and embryonic stem
    cells may be able to replace damaged heart muscle cells and establish
    new blood vessels to supply them. Scientists believe that embryonic
    stem cells in contrast to adult stem cells hold greater potential
    because they have the ability to be come any type of cell in the human
    body and hold virtually unlimited ability to replicate.
        Many autoimmune diseases like lupus, multiple sclerosis, rheumatoid
    arthritis, and Sjogren's disease, strike women disproportionately.
    Lupus and Sjogren's are nine times more frequent in women; rheumatoid
    arthritis is four times more frequent in women; and multiple sclerosis
    strikes women twice as frequently as men. (Other autoimmune diseases
    like early onset diabetes are more evenly distributed among the
    population.) For all autoimmune diseases, complex biological questions
    remain unanswered about why the body's immune system fails to protect
    the body against disease and allows it to turn against itself. Research
    on stem cells is providing new ways to remove errant immune cells and
    restore normal immune cells to the body. However, obstacles to some
    type of adult stem cells are the limited number that can be harvested
    and the difficulties in propagating them in the laboratories.
        Women also are affected not only by the diseases that attack them
    but also by the diseases contracted by other members of their family,
    as they routinely are their family's predominant caretakers. Wives',
    mothers', and daughters' lives quickly become subsumed by the illnesses
    within their families.
        I realize that embryonic stem cell research is in its infancy, and
    an enormous amount of research must he performed before it can be
    translated into medical treatments. But we must carefully weigh the
    implications of any roadblocks that might halt this scientific
    research.
        S. 245, the Human Cloning Prohibition Act, legislation introduced
    by Senator Brownback, to my knowledge, for the first time in U.S.
    history, dead ends a promising new avenue of research, perhaps sending
    it underground, or at the least, sending it overseas along with our
    most promising scientists. It outlaws research that scientists believe
    could play a critical role in curing and alleviating the suffering of
    millions of patients, including women. This bill also makes criminals
    of anyone who would bring into this country the potential products of
    this research.
        The Coalition for the Advancement for Medical Research believes
    that S. 303, the Human Cloning Ban and Stem Cell Research Protection
    Act, the legislation introduced by Senators Hatch, Feinstein, Specter,
    Kennedy, Harkin, and Miller strikes the appropriate balance between
    preventing unsafe and unethical research on human reproductive cloning
    and permitting scientific research endorsed by the National Academy of
    Sciences, 40 Nobel laureates, former First Lady Nancy Reagan, and
    former Presidents Gerald Ford and Jimmy Carter.
        S. 303 applies the Common Rule, the law governing federal ethical
    standards, to SCNT research so that institutional review boards already
    in place at universities and hospitals would ensure that women
    participating in research are fully informed about the procedures and
    risks involved in donating eggs. As in all areas of research, stringent
    safeguards must be in place to protect people against coersion.
    Otherwise informed consent is not truly informed consent. As I already
    discussed, egg donation in all circumstances must be conducted with
    rigorous informed-consent procedures. (As with any technology,
    procedures become more efficient in time, so fewer eggs will be
    required. Researchers in therapeutic cloning also are hopeful that in
    the future they will know how to generate stem cells without needing
    eggs.) S. 303 also strictly penalizes unlawful conduct by providing for
    criminal and civil penalties for violating the law while allowing
    physician and patient access to potentially life-saving therapies
    without fear of reprisal.
        Thank you.

        Senator Brownback. Thank you. Thank you for your testimony.
    Dr. Bustillo? Am I----
        Dr. Bustillo. Bustillo, uh-huh.
        Senator Brownback. Bustillo. There a number of diabetes
    cases in the country, how many people suffer from diabetes in
    the U.S.?
        Dr. Bustillo. Well, there are two different kinds of
    diabetes, but the majority of patients with diabetes have
    adult-onset diabetes. But juvenile-onset diabetes affects
    millions of young people, as well.
        Senator Brownback. Just walk me through the numbers of what
    it would take if human cloning were allowed for treatment just
    in diabetes, of how many----
        Dr. Bustillo. I think what we----
        Senator Brownback.--eggs it would take to provide this as a
    broad-scale treatment across the country.
        Dr. Bustillo. I think what we need to remember is that
    those numbers seem huge, but the issue is that I think we need
    to do some very basic research that would allow us to generate,
    for instance, stem cell lines that would divide themselves and
    that would need, as the technology gets more efficient, fewer
    and fewer eggs to treat the patients. But we are at the stage
    where we really are just beginning to learn about this.
        So, yes, it will take hundreds and thousands of eggs to do
    this.
        Senator Brownback. Where will we come up with those eggs?
        Dr. Bustillo. Well, I think there are a number of ways to
    come up with those eggs. The one is what the folks at Norfolk
    did, which is actually to recruit women, under review,
    institutional review board, screened, paid to do this as they
    would otherwise do it, as most women who do egg donation do get
    paid in the United States and are often anonymous to the
    recipient couple, and would provide these eggs for the purpose
    of research either because they have a family member that might
    in the future benefit from this research or because they are
    interested in helping humanity.
        Senator Brownback. Should we be paying women for eggs?
        Dr. Bustillo. I think the position of the Fertility Society
    or the Society of Reproductive Medicine is that we should pay
    women for their time and trouble. This is a procedure not as
    easy as just giving a sperm sample. And as my colleague here
    stated, it does take several weeks, several medications, so we
    are really paying them for time off, babysitting, the things
    that they need. So we have determined what a reasonable cost is
    to them.
        Senator Brownback. So you would put a cap on how much we
    could pay women for eggs?
        Dr. Bustillo. Yes.
        Senator Brownback. Have you come up with a----
        Dr. Bustillo. I think----
        Senator Brownback.--position of what that----
        Dr. Bustillo.--as he mentioned it----
        Senator Brownback.--price----
        Dr. Bustillo.--in the United States, it is somewhere
    between 1,500, and in states like New Jersey and New York it is
    a lot higher. So it varies, depending on the part of the
    country that you are with. But I think, no, not more than
    5,000, 6,000 would be a very reasonable amount.
        Senator Brownback. To put a national upper price tag on
    women's eggs?
        Dr. Bustillo. I think it would be dangerous to do that,
    because--again, hopefully, as we get more efficient with new
    medications, new protocols, it may involve less trouble, less
    time, et cetera, so to put a national cap which may actually be
    higher than you might need in the future would not be wise.
        Senator Brownback. But you agree that now some women are
    being recruited and paid very high prices based upon their
    mental capacity, their physical nature, is that correct?
        Dr. Bustillo. Well, they are being recruited. I do not know
    how widespread that is. And again, the American Society for
    Reproductive Medicine, the Fertility Society, is definitely
    opposed to that and encourages its members not to proceed in
    that fashion.
        Senator Brownback. But you would encourage women to be
    recruited for egg donation for human cloning.
        Dr. Bustillo. For therapeutic cloning, yes.
        Senator Brownback. And you would----
        Dr. Bustillo. For the generation of stem cells, yes, sir.
        Senator Brownback. Okay, so you would. And you do agree
    that that--if we were to go with this on a broad-scale effort
    to try to cure a number of these diseases, we are talking of,
    you said, hundreds of thousands of eggs.
        Dr. Bustillo. Yes, sir.
        Senator Brownback. And that is going to involve at least
    hundreds of thousands of women, is that correct, or millions?
        Dr. Bustillo. Well, also another source of eggs would be
    infertility patients. We cannot forget them. And especially as
    infertility patients, if we get the younger infertility
    patient--if we should provide insurance coverage, for instance,
    for in vitro and make it amenable to the younger patient, they
    generally would produce more eggs than they require to generate
    their own, to solve their own fertility problem.
        Senator Brownback. But how many women are you envisioning?
    Let us say we just said therapeutic cloning is fabulous, we are
    going to go full scale with therapeutic cloning, start
    recruiting women. We have got a hundred million people, in your
    testimony, that suffer from these debilitating diseases. Are we
    not talking about millions of women donating----
        Dr. Bustillo. No, because----
        Senator Brownback.--their eggs?
        Dr. Bustillo.--again, I think as the research gets better,
    hopefully we will not even need eggs at some point once--I
    mean, we will still need some eggs for some of the cell-
    development studies that I mentioned, with breast cancer and
    other diseases, but as we get more efficient and we learn how
    to replicate and keep stem cell lines going, et cetera, I think
    we are going to need fewer and fewer fresh donated eggs.
        Senator Brownback. Well, let us say we really get good at
    this and you only need five eggs per patient. I mean, that is a
    fabulous number relative to--I think Dolly was 300 tries,
    something like that, to get----
        Dr. Bustillo. Two hundred and almost forty experiments,
    yes.
        Senator Brownback. So let us say we get it to a five to one
    ratio, that you only need five eggs for the try, which would be
    a--that would be a great technological move forward.
        Dr. Bustillo. Uh-huh.
        Senator Brownback. Are you not truly still talking about
    millions of women who are going to have to sell their eggs for
    this process----
        Dr. Bustillo. Again----
        Senator Brownback.--to really be engaged?
        Dr. Bustillo. Again, it would be--you know, there are
    probably close to 50,000 women undergoing in vitro for
    therapeutic reasons for their own infertility, so that would
    also add to the pool of the donation.
        Senator Brownback. Okay. All right, 50,000, and we get
    five--let us say--how many eggs do we get per those----
        Dr. Bustillo. It is----
        Senator Brownback.--50,000?
        Dr. Bustillo.--age related, and you can--in donors, in
    general, we get 15 to 20, 25 eggs. In----
        Senator Brownback. Say we get 20.
        Dr. Bustillo.--patients, we get fewer.
        Senator Brownback. What if we--can we get 20 eggs from
    those 50,000 women? Twenty eggs----
        Dr. Bustillo. We could----
        Senator Brownback.--each?
        Dr. Bustillo.--we could get 15 eggs from each, right. But I
    think what we have to do to make it much more efficient is not
    each time get the egg, but obtain stem cells from the initial
    few women who would donate eggs for research purposes, obtain
    these stem cells, do the research, do the work, keep them
    going, and then this would be much more effective than having
    to do the therapeutic cloning each time you want to treat a
    patient.
        Senator Brownback. Okay, so you are saying you just do not
    think we are going to be needing therapeutic cloning in the
    future. You think we need it now, but we are not going to need
    it in the future. Is that----
        Dr. Bustillo. That's very----
        Senator Brownback.--correct?
        Dr. Bustillo.--possible.
        Senator Brownback. But, now, you base that on----
        Dr. Bustillo. Just----
        Senator Brownback.--nothing but hope at this point----
        Dr. Bustillo. No, I think----
        Senator Brownback.--in time.
        Dr. Bustillo.--I base that on some of the things we are
    learning about what to do, how to treat these cells to make
    them go in certain tissues, like, you know, pancreatic tissue,
    et cetera; and if we can learn the mechanisms of how these
    cells go from undifferentiated cells to these specific cells,
    then I think we will be able to reproduce those and need them
    less and less.
        Senator Brownback. Okay, then why do we not do that in
    animals first and than take that to humans? Why do we not
    perfect what you are saying first in animals before we go to--
    --
        Dr. Bustillo. Well----
        Senator Brownback.--humans?
        Dr. Bustillo.--always, animals are wonderful, but they are
    not necessarily humans.
        Senator Brownback. But do we not normally, in this country,
    start with animal----
        Dr. Bustillo. And we----
        Senator Brownback.--models and----
        Dr. Bustillo.--do, and we have, and there are some
    wonderful animal models and some recent data on the model for
    Parkinson's disease in the mouse. And work has been done in
    that area which shows very promising results in the mouse now
    being mobile after transferring of cells generated from stem
    cells from mouse embryos.
        Senator Brownback. No, I understand, but why would you not
    perfect your technique that you are hoping we get to so we do
    not need the millions of women's eggs? Why do we not perfect
    that first in animals and then take it to humans?
        Dr. Bustillo. No, I think we have been doing that. However,
    the animal is never a perfect model for the human.
        Senator Brownback. Well, have we developed what you have
    said in animals yet and perfected it and the technique so we do
    not have to do the cloning, which you are saying we----
        Dr. Bustillo. I think----
        Senator Brownback.--should need to in the future?
        Dr. Bustillo. I think we are in the process of doing that,
    yes, sir.
        Senator Brownback. But it has not been done yet.
        Dr. Bustillo. Not perfected for every cell type.
        Senator Brownback. It is not even close, is it?
        Dr. Bustillo. I do not think so.
        Senator Brownback. So you are basing this, that we are
    going to do this in humans, off of what you hope will take
    place but what we have not produced in animal models even yet,
    is that correct?
        Dr. Bustillo. I think so. You have to remember that the
    isolation of stem cells in animals has only been around for
    about 10, 15 years, so the work is just beginning. Things in
    science often take a long time. So we are at a very early stage
    of this kind of research.
        Senator Brownback. Do we normally, then, in early stages of
    research, do that on humans?
        Dr. Bustillo. In this country, we have done that--for
    instance, as my colleague mentioned, in vitro fertilization--
    because often there is absolutely no financing for this kind of
    work, particularly from the Federal Government. So, oftentimes,
    this research is advocated and driven by the patients affected
    by the disease, such as----
        Senator Brownback. But is it not normally true we develop
    our animal models first; and then, when we perfect it, we take
    it to humans?
        Dr. Bustillo. Again, that was not done in in vitro
    fertilization.
        Senator Brownback. I understand, but do we not normally----
        Dr. Bustillo. Yes, and I----
        Senator Brownback. We are talking about therapeutic cloning
    here, correct?
        Dr. Bustillo. Right.
        Senator Brownback. Okay.
        Senator Landrieu has arrived and is limited on her time.
    Would you mind if we have her testify now, and you can stay
    seated there, and we will receive her testimony?
        Senator Landrieu, thank you very much for joining us. I
    appreciate you being here, a cosponsor of the bill, and I am
    happy to receive your testimony.

                  STATEMENT OF HON. MARY L. LANDRIEU,
                      U.S. SENATOR FROM LOUISIANA

        Senator Landrieu. Thank you, Mr. Chairman. I am going to
    submit a more detailed statement for the record. * I would like
    to thank our witnesses for being a part of this very important
    hearing. I also wanted to thank you, Mr. Chairman, and to show
    my support for your efforts to try to help the public better
    understand that the alternative to a ban on human cloning is
    actually the licensing of a brand-new industry. I think this
    hearing is very important in trying to communicate to the
    public what that industry would look like.
    ---------------------------------------------------------------------------
        * The information referred to was not available at the time this
    hearing went to press.
    ---------------------------------------------------------------------------
        What the witnesses have just described, I think, would be
    very upsetting to many, many people in this country. The level
    of experimentation that would have to go on, the numbers of
    women that would be needed for these types of experiments, and
    the lack of fine-tuning of the procedures is concerning. I
    think that your point about the normal course of scientific
    work in this country is to perfect some of these techniques on
    animals before we move to the human population is a good one.
        I applaud your efforts this morning to help focus on the
    shortcomings of this Feinstein-Kennedy proposal, and force us
    to consider how licensing a brand-new industry, crosses the
    ethical line, as well as the line of common sense.
        I also want to note for the record that as the weeks and
    months go on with many legislatures in session around the
    country, two legislatures have recently passed a ban in North
    Dakota and Arkansas. Many people in my State of Louisiana, are
    very concerned about this issue, not because they are against
    research, or because they oppose science or finding cures for
    the terrible diseases that our children and our grandchildren
    suffer from, but because we have grave concerns about opening
    up an industry where the marketplace dictates or moves women to
    donate hundreds and thousands of the--what is to prevent the
    situation arising where the smarter you are, ``prettier'' you
    are, the ``more attractive'' you are, you get paid more for
    your egg than someone else, who is ``less attractive'' or
    ``less smart,'' to have an industry that virtually is, in many
    ways, unregulated. Even if it were regulated with our best
    attempts here, I am not sure that we could eliminate some of
    the more gruesome aspects of what is being discussed here
    today.
        I thank the scientists here for their work and their
    efforts. I appreciate we have different views. But again, it is
    important to be clear what Congress is debating. The issue is
    whether to license a new industry that would use women as
    manufacturers and eggs as commodities. Do we want to be setting
    prices on eggs and injecting hormones into women to produce
    eggs for the benefit of experimentation? I think this is too
    far for where the American people want to go at this time.
        Thank you, Mr. Chairman.
        Senator Brownback. Thank you for submitting the statement
    for the record, and thank you for coming by, Senator Landrieu.
        Dr. Bruchalski, what would happen if you took just a
    hundred thousand women and collected their eggs for therapeutic
    cloning? What is the likely impact on that hundred-thousand
    women? Do we have any notion of studies of how many would be
    impacted negatively, physically, by just that many going
    through? Not a million, but just a hundred thousand.
        Dr. Bruchalski. At a hundred thousand people undergoing
    this process----
        Senator Brownback. Pull that microphone a little closer.
        Dr. Bruchalski. For a hundred thousand women undergoing
    this process, there would be the effects of hyperstimulation on
    all these women, including abdominal bloating, tenderness so
    significant that we are now trying to perform or have newer
    protocols to decrease these side effects that are so pervasive.
    We believe that it is close to 1 percent of these women would
    undergo the hyperstimulation syndrome, so whatever 1 percent of
    a hundred thousand--it is in this small subset where you have a
    fluid overload situation, where the abdomen is filled with
    fluid, and it is called ascites. You can develop pulmonary
    edema, and you have to hospitalize this group of patients to
    prevent further decompensation. And so that occurs in 1 percent
    of the present--almost 1 percent of the present-day cycles. So
    you are looking at a sizeable number of women who would undergo
    serious side effects in order to obtain the outcomes desired.
    And at a hundred thousand, that is, relatively, a very, very,
    very conservative estimate for any of the diseases mentioned.
        Senator Brownback. Well, what if we extend that to a
    million women? I would gather we are going to get a broader
    cross-section of women to donate--or sell eggs, rather--at that
    point in time, a broader cross-section of health potential
    difficulties if you are going at a million women. What
    potential health side-effects could we have with that large of
    a pool?
        Dr. Bruchalski. Well, you would still be looking at the
    numbers that I suggested, but it would be, you know, multiplied
    by a factor of ten. You would have still that 1 percent of a
    million having to be hospitalized, and the vast majority of
    those other women having to often take time off through that
    month's therapy to deal with not only the procedures itself,
    but many of the side effects, which I just mentioned, which
    include headache, abdominal tenderness, abdominal pain, pelvic
    pain.
        Senator Brownback. Do we have any idea of the price we
    would have to pay to get women to do this, where it is not for
    a child for themselves, which I would think--you know, a number
    of women, if this is for a child, their child, they are willing
    to go through a lot of things to do that, and I am so grateful,
    but if this is to sell eggs, do we have any notion of price
    that you are going to have to bid to to be able to get a
    million women to donate eggs and go through this process?
        Dr. Bruchalski. No, we do not know exactly the amount. The
    guidelines that are given are--how can I say? They are
    encouraged. They are not really required; they are encouraged
    for the various centers to follow. And I appreciate my
    colleague's hopeful optimism in regard to this, how possibly we
    can try to decrease that number over time so we do not have
    this impact.
        But I still keep coming back to the reality that in in-
    vitro fertilization cycles today, we still are able to get 10
    to 15 eggs per cycle. We have not improved on our efficiency in
    20-plus years of in vitro fertilization work in this country.
    We have made incredible strides. We have helped many centers,
    instead of placing six, seven, eight, nine, ten embryos back
    into uteri, we are now recommending only three to four, in many
    cases, because of the horrors and the difficulties with
    multiple births. We have made many strides.
        But I do not know the exact top-dollar amount that would
    have to be placed, because right now, as you mentioned, that
    number is quite high, in some cases.
        Senator Brownback. Dr. Bustillo, do we have any idea of how
    many women now sell their eggs, not for their own childbearing
    for themselves, but for somebody else? Do we have any notion of
    what that market is now?
        Dr. Bustillo. Well, we have----
        Senator Brownback. The total number?
        Dr. Bustillo. Right. We have data, the American Society of
    Reproductive Medicine, actually under the--the CDC collects
    that data from these member clinics of the American Society for
    Reproductive Medicine, and the last--we collect the data after
    birth, so we have numbers, and I believe the 2000 data, which
    he mentioned was the last data, and I believe it was around 8-,
    9,000 cycles of egg donation. Now, those women do not
    necessarily all sell their eggs, because some women who donate
    their eggs are actually relatives--i.e., sisters, friends--of
    the women who need the eggs.
        Senator Brownback. Okay.
        Dr. Bustillo. So we do not have a hard number on how many
    are actually paid. But I would suspect that the majority of egg
    donation is done with paying the donors. And again, just for
    the----
        Senator Brownback. Somewhere 8- to 9,000?
        Dr. Bustillo. No, sir.
        Senator Brownback. 8- to 9,000 that----
        Dr. Bustillo. Yes.
        Senator Brownback.--did not----
        Dr. Bustillo. That----
        Senator Brownback.--this is not for their own child.
        Dr. Bustillo. Right, that is correct.
        Senator Brownback. Okay. So let us say we have got to
    increase that number up to a hundred thousand, which I think is
    dreadfully low. I mean, for what we have of current technology,
    you are really looking at the millions to make this broadly
    available for people. But let us say it is just a hundred
    thousand women that we want to pay to give eggs so that we
    could go on some scale of therapeutic cloning across the United
    States, just a hundred thousand women. So these are not going
    to be for a baby for themselves; this is going to be for
    research purposes, this is going to be for trying to develop
    health cures. How much of a market bid-up are we going to have
    to do to get a hundred thousand women to donate eggs?
        Dr. Bustillo. Again, you are assuming that those eggs will
    only come from women who are volunteering for the research,
    because I still think that some women who are going through in
    vitro fertilization for their own benefit, again, as we--and I
    disagree with my colleague; we have made great strides in the
    success rate of IVF.
        Senator Brownback. How much would we have to pay to get a
    hundred thousand women to donate eggs?
        Dr. Bustillo. How much do we have to pay them? Again, it
    depends on what they have to go through, and----
        Senator Brownback. Well, you know what they have to go
    through.
        Dr. Bustillo. Well, I know what they have to go through
    today. I know what they had to go through 20 years ago, which
    is much more than they have to go----
        Senator Brownback. Well, how much----
        Dr. Bustillo.--through today.
        Senator Brownback.--what they'll have to go through next
    year.
        Dr. Bustillo. Next year? They----
        Senator Brownback. Are we just going to open it up----
        Dr. Bustillo. Yes.
        Senator Brownback. So the technology is basically----
        Dr. Bustillo. I would say----
        Senator Brownback.--what you have today.
        Dr. Bustillo.--you'd have to pay about $3,000.
        Senator Brownback. You think we can get a hundred thousand
    women for $3,000 each to donate eggs, go through the process
    that we're involved in.
        Dr. Bustillo. I mean, it's not going to be easy. They need
    to be motivated, you know, for the betterment of humanity, for
    the relative with diabetes.
        Senator Brownback. Well----
        Dr. Bustillo. It's going to be----
        Senator Brownback.--if you were asked to do this, could do
    this, or had a daughter that wanted to do this, would you do
    this for $3,000?
        Dr. Bustillo. Yes, sir.
        Senator Brownback. And you would recommend your daughter to
    do it for----
        Dr. Bustillo. I would----
        Senator Brownback.--3,000.
        Dr. Bustillo.--if she was comfortable with it. She would
    have to be screened medically, psychologically, all the
    implications of that, yes.
        Senator Brownback. What all is the screening that's going
    to need to take place?
        Dr. Bustillo. Well, we have been doing this for a number of
    years, but you would have to screen them for--and the screening
    may be different, because the screening we do now is because
    they're going to hopefully produce babies, so we screen them
    genetically, a number of tests, routine tests, that we do for
    cystic fibrosis, et cetera. We screen them to make sure they
    have no other medical illnesses. We screen them for their
    family history. They meet with psychologists. They have a
    number of visits to make sure they understand the implication
    of their eggs going either to someone else or to research, so
    they have to be very comfortable with it.
        Senator Brownback. So----
        Dr. Bustillo. I would say, in my practice, we screen ten
    women to have one accepted, just--and this is for----
        Senator Brownback. So we're talking about a million women
    needing to come forward to get a hundred thousand to----
        Dr. Bustillo. It's very possible.
        Senator Brownback. Wow.
        Dr. Bustillo. But, again, you are assuming that you're
    going to need this sort of generation of fresh eggs on a
    continuing basis.
        Senator Brownback. Well, if we start this right now, we
    obviously are going to need that.
        Dr. Bustillo. No, because you're talking about treating
    everyone at once. All research, you know, doesn't start by
    application to a hundred million people that are affected by
    these diseases. We're talking about beginning slowly and
    hopefully perfecting it so we need fewer eggs, you know,
    because we're going to create stem cell lines, et cetera.
        Senator Brownback. We are going to perfect it amongst
    people as we go along.
        Dr. Bustillo. Because, again, animal models are being
    worked on, but I think they are not perfect. And eventually you
    will have to jump from animals to people.
        Senator Brownback. It would be nice if we knew it worked in
    animals first before we tried it in people, do you not think?
        Dr. Bustillo. I think it would, and I think we have some
    very encouraging new data coming out that it does for certain
    diseases, like Parkinson's.
        Senator Brownback. With therapeutic cloning, we are--
    talking about therapeutic cloning at this point. Do you think
    we are----
        Dr. Bustillo. We are talking----
        Senator Brownback.--perfected enough on the----
        Dr. Bustillo. We are talking----
        Senator Brownback.--cloning process to take that from
    animals to humans and move this on forward?
        Dr. Bustillo. I am talking about the generation of stem
    cells that then can be directed to make tissues that would
    treat diseases like Parkinson's, diabetes, et cetera.
        Senator Brownback. Now, have you studied the cloning
    research in animals and whether or not we have any health
    problems in those animals. If we have----
        Dr. Bustillo. Not----
        Senator Brownback.--perfected the cloning process in
    animals.
        Dr. Bustillo. You are now talking, sir, about reproductive
    cloning, and I am adamantly opposed to that.
        Senator Brownback. But would you agree that there are
    health problems in reproductive clones?
        Dr. Bustillo. In reproductive cloning, yes, sir.
        Senator Brownback. Where would they carry those health
    problems from? Do they get them from the very first genetic
    pool that they are in or not?
        Dr. Bustillo. We do not know what the problems are--I mean,
    how the problems start. And as you said, there were over 200
    experiments to generate Dolly. But----
        Senator Brownback. Dolly----
        Dr. Bustillo.--we are confusing the issue a little bit
    that----
        Senator Brownback. Well----
        Dr. Bustillo.--we are talking now about----
        Senator Brownback.--but let me ask you----
        Dr. Bustillo.--reproductive cloning.
        Senator Brownback. Then correct me as I go through this.
    Dolly was just put to sleep.
        Dr. Bustillo. Yes.
        Senator Brownback. Aged prematurely, I believe. Did she
    have lung and liver problems?
        Dr. Bustillo. Yes.
        Senator Brownback. Okay.
        Dr. Bustillo. Lung problems, I believe.
        Senator Brownback. Do we think any of these, or do we know,
    if these were genetic problems that she had?
        Dr. Bustillo. We do not know for sure.
        Senator Brownback. Is it a good chance they were----
        Dr. Bustillo. But again, sir----
        Senator Brownback.--genetic problems?
        Dr. Bustillo.--we are talking about reproductive cloning. I
    am not in----
        Senator Brownback. I understand.
        Dr. Bustillo.--favor of----
        Senator Brownback. I understand.
        Dr. Bustillo.--reproductive cloning.
        Senator Brownback. I understand we are talking about
    reproductive cloning. But when does gene imprinting occur?
        Dr. Bustillo. It depends on the gene, but I think usually
    very early.
        Senator Brownback. Are you not given the very first gene
    pool as what you start with? And does it change----
        Dr. Bustillo. That is----
        Senator Brownback.--at a very----
        Dr. Bustillo.--correct. But again, when we are talking
    about stem cells, we are talking about a cell that is
    undifferentiated----
        Senator Brownback. I understand, but----
        Dr. Bustillo.--not imprinted----
        Senator Brownback. Well, then maybe I just need to be much
    more clear with you on my question. If Dolly has genetic
    problems--she is given a genetic pool from the very outset that
    does not change, so if she has genetic problems, she has them
    as a therapeutic clone or as a reproductive clone if she has a
    genetic defect in this system. Is that correct?
        Dr. Bustillo. No, sir, because it is a----
        Senator Brownback. Okay, but----
        Dr. Bustillo.--different----
        Senator Brownback.--when does the gene change?
        Dr. Bustillo. It is one cell versus an organism, so it is a
    very different situation.
        Senator Brownback. Is the gene pool any different?
        Dr. Bustillo. Well, yes, it is different in that it does
    not--in some cases, it does not have, you know, the immunologic
    signals, et cetera, so it depends on the cell. Yes, it is very
    different.
        Senator Brownback. So the gene pool that Dolly had as a
    one-cell embryo is different from what she has as an adult.
        Dr. Bustillo. No, but the gene pool of Dolly as an organism
    and the interaction between the genes and the different cells
    between the different organ systems is a whole different
    situation from taking a few cells from a five day old embryo
    and generating stem cells that are undifferentiated.
        Senator Brownback. Is it possible that Dolly had genetic
    defects as a one-cell embryo?
        Dr. Bustillo. Yes, it is very possible.
        Senator Brownback. Isn't it even likely?
        Dr. Bustillo. It is likely, because, again, Dolly, again,
    was generated from an adult somatic cell, and we are not
    talking about doing that with therapeutic cloning utilizing
    stem cell generation from normally in vitro fertilized embryos.
    It is a different experiment.
        Senator Brownback. Are you comfortable with the level of
    knowledge we have of therapeutic cloning amongst animals
    today----
        Dr. Bustillo. I think----
        Senator Brownback.--that this is a technology to be
    transferred to humans?
        Dr. Bustillo. I think, in certain areas, I think it is very
    promising and probably ready for some early human experiments,
    like Parkinson's disease.
        Senator Brownback. And you are comfortable with what we
    know in the animal to transfer it into the human model today?
        Dr. Bustillo. I am not an expert on Parkinson's disease or
    in this area, but I think it is, again, promising, and I think
    what we need is more research utilizing human tissues. I know
    we are not ready to institute medical therapy utilizing
    therapeutic cloning today.
        Senator Brownback. Okay.
        Thank you, panelists, very much for your interest and your
    information, and we appreciate very much your coming here and
    testifying today.
        I would call up our next panel, Ms. Alta Charo, Associate
    Dean for Research and Faculty Development, University of
    Wisconsin Law School, Mr. Andrew Kimbrell, International Center
    for Technology Assessment, and Mr. Richard Doerflinger,
    Associate Director for Policy Development, U.S. Conference of
    Catholic Bishops.
        I was just informed that a witness in that first panel,
    Lynne Millican, is in at Union Station, so we may add her to
    you as a panel when she comes on forward.
        Ms. Charo, thank you very much for joining us today, and
    the floor is yours.

           STATEMENT OF R. ALTA CHARO, J.D., ASSOCIATE DEAN,
             PROFESSOR OF LAW AND BIOETHICS, UNIVERSITY OF
                   WISCONSIN LAW AND MEDICAL SCHOOLS

        Ms. Charo. Thank you very much, Senator Brownback, and
    thank you for the opportunity to discuss with you a shared goal
    of preventing irresponsible efforts to use cloning to produce
    children.
        As you know, Congress has repeatedly tried to bolster the
    FDA's already successful efforts to prohibit reproductive
    cloning, but each effort has become bogged down in a related,
    but distinctly separate, debate concerning the use of cloning
    for nonreproductive research or therapeutic purposes, and I
    urge you today to separate those two debates.
        S. 303 bans reproductive cloning with stiff penalties for
    those scientists and doctors who might dare to make such an
    attempt by transferring a cloned embryo into a woman's body,
    and it builds on the extensive existing regulation of cloning
    research by adding even further regulatory safeguards.
        Now, if and when cloning research is done in humans for
    therapeutic ends--that is, to produce embryos whose stem cells
    will be transplanted back into the donor to repair damaged
    organs--it is clearly and indisputably covered by the FDA
    regulations on cell-based therapy and transplantation,
    regulations that already apply to privately funded activity and
    that, by virtue of the congressional delegation of power to
    FDA, answers some of the very questions raised earlier today
    about the appropriate transition from animal to human research
    and the scaling of human research under close monitoring.
        FDA's regulations cover myriad aspects of the work, from
    the labs where it is done to the collection of the eggs, the
    nuclear transfer procedure, the derivation of stem cells, and,
    finally, the transplant back to the donor. The regulations also
    require that every aspect of the work be carried out under the
    strict oversight of an institutional review board. Those IRBs
    ensure that reimbursement to egg donors is reasonable and poses
    no risk of donors being tempted to abandon their own good
    judgment. The IRBs also review the scientific basis for
    determining the risks and benefits that will be described to
    these women and the actual documents that will embody the
    information for their use when they give their informed
    consent. IRBs also monitor the research while it goes on, with
    periodic updates to guard against unexpected side effects. This
    is the same comprehensive scheme of protections used generally
    for human subjects research in the United States.
        Now, S. 303 would build on this very extensive set of
    current regulations that governs all publicly or privately
    transplant-related work by extending the common rule to even
    privately funded work that does not involve transplantation as
    an end point. Under S. 303, even basic research that involves
    only developing stem cell lines for work in the laboratory
    would still require informed consent from egg donors and
    oversight by IRBs so that no aspect of cloning work, whether
    for therapeutic or purely research purposes, could proceed
    unmonitored.
        Now, given the extensive existing and proposed regulation,
    I believe that prohibiting all cloning research is unduly
    burdensome and, in addition, subject to constitutional
    challenge. For 30 years, courts and scholars have discussed the
    scope of the First Amendment and its protection of scientific
    research as part of the freedom of thought, inquiry, and
    dissemination of knowledge that is at the core of that aspect
    of the Bill of Rights. Thought and the testing of thoughts
    through science facilitates the dissemination of ideas just as
    much as monetary contributions to political campaigns
    facilitates the expression of political ideas. And indeed, in
    many cases, research is, in and of itself, a form of political
    expression.
        In other places and other times, governments have sought to
    ban the dissection of the human body because it would interfere
    with deeply felt notions of the body as a reflection of the
    divine order; or sought to ban investigation of the orbits of
    the planets, as it would interfere with essential views about
    the place of humankind in the universe. So, too, does
    investigation of the origins of life, of the secrets of
    conception and development, threaten our deepest views
    concerning the sources of life. But the First Amendment exists
    precisely to protect the development and dissemination of
    knowledge and truth and opinion so that it may be tested and
    retested over time in the marketplace of ideas.
        Certainly, of course, protected activities are still
    subject to reasonable regulation; but where prohibitions are
    designed merely to guard against the development of knowledge
    for fear it might someday be used in controversial ways, it
    runs afoul of the very basis of the First Amendment protection
    of inquiry.
        And where prohibitions are designed to guard against
    violating the rights of embryos, they run athwart of the legal
    reality that federal law does not grant embryos the same rights
    as live born children. Indeed, the Supreme Court has repeatedly
    reiterated its view that even while science and theology and
    philosophy continue to debate the biological and moral status
    of the embryo, the Constitution does not grant them the rights
    of persons under the law. Any federal law that goes beyond
    reasonable regulation and instead entirely bans nonreproductive
    research and therapeutic cloning applications, therefore, is
    vulnerable to challenges in interference in the First Amendment
    rights of patients, doctors, and scientists, a challenge that
    might well result in an injunction on the enforcement of the
    entire federal law during the many years that judicial review
    runs its course.
        I, therefore, urge the Congress to focus on legislation
    that prevents the unsafe practice of reproductive cloning. I
    also urge it to adopt the additional regulatory protections for
    nonreproductive research uses of cloning, as proposed in S.
    303, so the public is reassured that every measure has been
    taken to guide the research in a responsible way.
        A debate on embryo research, generally, or on
    nonreproductive cloning research, in particular, can always
    proceed separately, to be debated on its own merits and
    ultimately to be tested on its own terms before the
    constitutional authorities of the Nation.
        Thank you very much, Senator Brownback.
        [The prepared statement of Ms. Charo follows:]

    Prepared Statement of R. Alta Charo, J.D., Associate Dean, Professor of
       Law and Bioethics, University of Wisconsin Law and Medical Schools
        Mr. Chairman and Members of the Committee,
        My name is Alta Charo, and I am a professor of law and bioethics at
    the University of Wisconsin. Thank you for this opportunity to discuss
    with you a shared goal, the goal of preventing irresponsible
    experimentation that involves the use of somatic cell nuclear transfer
    (that is, cloning) to produce a live-born child.
        Because cloning is not, and may well never be, a safe method for
    conceiving children, there is virtually perfect consensus that such
    attempts ought to be discouraged. The Federal Food and Drug
    Administration has already taken a first and definitive step toward
    this goal, by announcing that it views attempts to use somatic cell
    nuclear transfer to create a child to fall within the scope of its
    regulatory authority, and by further announcing that this technique may
    not legally be used in the United States for this purpose.
        While scholars may argue about the precise statutory language
    behind this action, it is a fact that FDA has already enforced its
    authority, by investigating alleged attempts to use cloning to produce
    a live-born child, and by issuing warning letters to those suspected of
    being most likely to try this unsafe experiment. The small number of
    eccentric scientists who claim an interest in pursuing this effort have
    reacted by moving their activities to other countries, and by
    acknowledging in the press that they understand that cloning to produce
    a live-born child is illegal in the United States, thus confirming the
    effectiveness of FDA's enforcement efforts.
        The Congress has repeatedly demonstrated its interest in bolstering
    FDA's already successful efforts, whether by re-affirming and
    particularizing its jurisdiction over this activity or by banning the
    practice directly by legislative action. In each effort, however,
    Congress has become bogged down in a related but distinctly separate
    debate concerning the use of cloning for research or therapeutic
    purposes.
        I urge you today to separate these two debates, both to protect the
    valuable scientific and medical advances that may emerge from non-
    reproductive cloning research, and to pave the way to effective action
    to discourage attempts to use this technique to produce children.
        S. 303, introduced and co-sponsored in the Senate by Members such
    as Senators Hatch, Feinstein, Kennedy, and Specter would prohibit all
    efforts to use cloning to produce children. Stiff penalties are applied
    to those who would dare to make such an attempt. The simple act of
    transferring a cloned embryo into a woman's womb becomes definitive
    proof of the attempt and triggers criminal penalties for those doctors
    or scientists who make the attempt.
        Critics of this approach express concern that such legislation
    would be difficult to enforce, and urge Congress to ban basic research
    lest it lead to the prohibited act of transferring a cloned embryo into
    a womb for development. But criminal law is almost always grounded in a
    theory of deterrence. We do not prohibit the manufacture of guns in
    order to guard against the possibility of their future misuse in
    homicide. Rather, we criminalize misuse of guns and prosecute the
    offenders accordingly.
        Critics of this approach also worry that this leaves other, non-
    reproductive forms of research unregulated, and fear it may lead to
    exploitation of egg donors or the diversion of this research toward
    eugenic ends. But these critics overlook both the extensive existing
    regulation of cloning research and the additional regulatory safeguards
    that have been proposed in new legislation before the Senate.
        If and when cloning research is done for therapeutic ends, that is,
    when it is done to produce embryos whose stem cells will be
    transplanted back into the donor in an effort to repair or regrow
    damaged tissues of the brain, the heart and other organs, it is clearly
    and indisputably covered by the FDA regulations on cell-based therapy
    and transplantation. These regulations cover all such research, even
    when it is done with private funding.
        FDA's regulations cover myriad aspects of the research, from the
    laboratories where it may be done, to the collection of eggs, to the
    nuclear transfer procedure, to the derivation of stem cells, to the
    final transplant back to the donor. And FDA regulation also requires
    that every aspect of the work be carried out under the strict oversight
    of an Institutional Review Board (IRB), whose job is to guarantee that
    eggs are donated only after voluntary and fully informed consent.
        IRBs ensure that reimbursement to egg donors for their time and
    inconvenience is reasonable and poses no risk of donors being tempted
    to abandon their own good judgement. And IRBs review the scientific
    basis for the information given to egg donors about the risks
    associated with egg donation, as well as the actual documents they will
    be given to ensure that their consent is genuinely informed. IRBs also
    monitor research, with periodic updates to guard against unexpected
    side-effects in donors or unexpected problems in the laboratory
    management of the cloned materials and stem cells. This is the same,
    comprehensive scheme of protections used generally for human subjects
    research, and our experience in the United States demonstrates that
    research with human subjects, is not only extremely safe, it is far
    safer than the ordinary practice of medicine.
        This system of protections is supplemented with an extra layer of
    safeguards whenever genetic engineering is introduced into research. If
    and when cloning research comes to involve genetic manipulation of any
    sort involving the embryo or its stem cells, it will also be screened
    by the Federal Recombinant DNA Advisory Committee, which has long
    functioned as the gatekeeper to gene therapy. This Committee's charge
    is broad, and it is empowered to examine every aspect of research to
    ensure its safety for all participants.
        S. 303 would extend this comprehensive system of protections to all
    cloning research, by extending the Common Rule for human research
    protections even to privately funded research that does not involve
    transplanting the resulting stem cells back into the donor. Unique to
    cloning research is the possibility of cloning tissue from women who
    suffer from breast cancer or autoimmune diseases, so that specialized
    stem cell lines that exhibit these diseases can be grown in the
    laboratory for further research and testing. No other source of stem
    cells, neither those from surplus IVF embryos at infertility clinics
    nor those from bone marrow or other sources of adult stem cells can be
    used for this crucial research. Here, S. 303 would require informed
    consent from egg donors and oversight by IRBs, so that no aspect of
    cloning work, whether for therapeutic or purely research purposes,
    would proceed unmonitored.
        Given the extensive regulation that already exists, and the
    proposals for extending that regulation even further, outright
    prohibitions or moratoria on cloning research are unduly burdensome and
    subject to constitutional challenge.
        For thirty years, federal courts and nationally recognized scholars
    have discussed the scope of the First Amendment and its protection of
    scientific research as part of the freedom of thought, inquiry, and
    dissemination of knowledge that is at the core of that aspect of the
    Bill of Rights. Research is an integral part of the scientific method,
    a form of inquiry that fits uniquely within the purposes, histories,
    and structures of the First Amendment. Thought and the testing of
    thoughts through science facilitates the dissemination of ideas just as
    much as monetary contributions to political candidates facilitates the
    expression of political ideas.
        Indeed, in many cases, research is in and of itself a form of
    challenging political ideas. In other places and other times,
    governments have sought to ban the dissection of human bodies, because
    it would interfere with deeply felt notions of the body as a reflection
    of the divine order, or have sought to ban investigation of the orbits
    of the planets, as it would interfere with essential views about the
    place of humankind in the universe. So, too, does investigation of the
    origins of life, of the secrets of conception and development, threaten
    our deepest views concerning the sources of life. But the First
    Amendment exists precisely to protect the development and dissemination
    of knowledge and truth and opinion, so that they may be tested and re-
    tested over time in the marketplace of ideas.
        Certainly, even protected activities are subject to reasonable
    regulation to avoid interfering with the rights of others. But where
    prohibitions are designed merely to guard against the development of
    knowledge, for fear it might someday lead to new and controversial ways
    to manipulate cells and genes, they run afoul of the very basis of the
    First Amendment protection of inquiry, association, and dissemination.
        And where prohibitions are designed to guard against violating the
    rights of embryos, they run athwart of the legal reality that federal
    law does not grant embryos the same rights as live-born children.
    Indeed, the Supreme Court has repeatedly reiterated its view that even
    while science, theology and philosophy continue to debate the
    biological and moral status of the embryo, the Constitution does not
    grant them the rights of other persons under the law.
        Any federal law that goes beyond reasonable regulation of cloning
    research and enacts a temporary or permanent ban on this form of
    scientific inquiry is thus vulnerable to challenge in court as an
    interference with the First Amendment rights of patients and
    researchers. Such challenges might well result in an injunction to
    forbid enforcement of the federal law until judicial review has been
    completed, a process that can take years. During such a hiatus, the
    federal law is inoperative, thus thwarting Congressional efforts to use
    legislation to prevent reproductive uses of cloning.
        If the Congress wishes to take action with regard to reproductive
    cloning, I urge it to focus on legislation that prevents that unsafe
    practice.
        I also urge it to adopt the additional regulatory protections
    proposed in S. 303 for research and therapeutic applications of
    cloning, so that the public can be reassured that every measure has
    been taken to guide this research along a responsible path.
        A separate debate, on embryo research generally or non-reproductive
    cloning research in particular, can always proceed separately, to be
    debated on its own merits, and ultimately to be tested on its own terms
    before the constitutional authorities of the nation.

        Senator Brownback. Thank you very much.
        Mr. Kimbrell.

           STATEMENT OF ANDREW KIMBRELL, EXECUTIVE DIRECTOR,
             INTERNATIONAL CENTER FOR TECHNOLOGY ASSESSMENT

        Mr. Kimbrell. Thank you very much, Mr. Chairman, for the
    opportunity to speak today, and I also thank you for having a
    hearing on this very important subject that I think too often
    has been ignored in the multiyear debate now that we have had
    in Congress on cloning, the very crucial issue of the women's
    health implications of both research and reproductive cloning.
        I am an attorney and the executive director of the
    International Center for Technology Assessment. But also, for
    ten years I served as the chairman of the National Coalition
    Against Surrogacy, where I, firsthand, litigated on behalf of
    dozens of women across the country who were victimized by
    commercialized childbearing. And so I saw firsthand what these
    fertility drugs can do and what this process can do, both
    physically and psychologically, to women around the country.
        Now, I have submitted a more detailed statement for the
    record, Mr. Chairman. I would like to just summarize and
    perhaps focus on a couple of the points that have been made and
    see if I can be of some help on this.
        Senator Brownback. Your statement will be in the record.
        Mr. Kimbrell. Thank you.
        Perhaps, first, in that there seems to be, sort of, a cost-
    benefit analysis going on here, I wonder how many Senators
    would answer a certain pop quiz correctly, Mr. Chairman, and
    that would be, ``How many stem cells have been garnered from
    cloned human embryos as we sit here today?'' And this is by
    peer-reviewed studies, which show how many. And the answer, Mr.
    Chairman, is zero. Zero. With all the testimony I have heard in
    five years, and I've testified myself, about all these cures--I
    have heard scientists come here for five years--the number of
    stem cells that have been garnered from cloned human embryos is
    zero.
        And I think this is essential for a couple of reasons as we
    look toward this, because I think that we are seeing recent
    science that suggests that--exactly as you were suggesting, Mr.
    Chairman, in that Dolly was the 277th try and the horrible
    birth defects that were testified in the Senate about--that
    research is showing that something happens during the cloning
    process.
        Dr. Yenich has a recent study, peer reviewed, that says
    there is silencing of certain genes once a cell, an embryo, is
    cloned. And I think we may be looking, in the future, at a
    scenario where it is understood that cloning harms embryos in a
    way that will never allow them--never allow them--to be a
    consistent source of stem cells.
        So at the outset, I would suggest that we separate these
    two debates. I am here representing a coalition of
    environmentalists and feminists and over a hundred others who
    have signed on for a ban on reproductive cloning and a
    moratorium on research cloning. Many of them support expanded
    stem cell research. But to confuse the stem cell debate with
    the cloning debate, when right now we have zero stem cells
    coming from embryo cloning, to me is disingenuous at best, and
    it has been done time and time again.
        There are a couple of other points that I think are very,
    very important to make here, and one has to do with the
    enforcement. The Hatch bill, S. 303, seeks to both halt
    reproductive cloning and encourage research cloning. And if you
    look at that bill and the definitions of that bill, there is a
    definition of a ``cloned embryo'' as an unfertilized
    blastocyst.
        And let us consider this term for a moment, an
    ``unfertilized blastocyst.'' This appears to me to be
    intentionally misleading. ``Unfertilized'' seems to me that it
    would be unviable, or could never become a child. We know that
    is not true. If that ``unfertilized blastocyst'' were
    transplanted into a woman's womb, it, indeed, would grow into a
    child--perhaps not a healthy child, as we have learned from the
    Dolly experience, but it would become a child. And second of
    all, there seems to be the idea that because it is a
    blastocyst, it is not an embryo, and that is not correct. Of
    course it is an embryo.
        As a matter of fact, and this is absolutely critical--and
    before the Senate, the Department of Justice testified last
    year that once a cloned embryo has been created, it is
    indistinguishable, biologically, from a normal fertilized
    embryo. All right? Once the cloned embryo is created, it is
    indistinguishable from a fertilized embryo.
        Now, think about the enforcement issues this raises once,
    as in the Hatch bill, thousands, perhaps millions, of these
    cloned embryos are created, once they are out there, once they
    are in an IVF clinic, once they are transported, shipped,
    frozen, which this bill allows, 303. They will be
    indistinguishable from other embryos, biologically. That is an
    enforcement nightmare. Imagine trying to enforce firearms or
    drugs if once they were created, they became literally
    invisible and were allowed to be shipped, transported, frozen.
        So the question is, in S. 303, where they try and enforce
    their ban on reproductive cloning by basically saying that the
    illegal act is the transferring of this embryo into a woman,
    how are we going to know which kind of embryos are being
    transferred into a woman? At that late stage, how do you even
    know whether it is a cloned embryo or a conventional fertilized
    embryo? There is no way to know.
        Additionally, the idea of having a police force that is
    going into doctors' offices around the country to try and find
    out whether the transfer to a woman was from a cloned or a
    fertilized embryo is not only a huge invasion of privacy, but
    is obviously, from an enforcement standpoint, ridiculous. But
    even if you had that police force, they would not be able to
    tell, right? Because they would not be able to distinguish that
    embryo from a normal embryo.
        So this term ``unfertilized blastocyst'' hides the fact
    that these embryos, indeed, are identical, and that the only
    way--the only way--you can have responsible legislation in this
    area is at the supply level. In that once they are created,
    they are indistinguishable from other embryos, clearly the only
    way to stop this is at the supply level; in other words, to
    either ban the process of creating cloned embryos or to have it
    so restricted and so monitored that we have custody of each and
    every embryo created. Otherwise, no one--you, me, no one in
    this room, no scientist--can tell us which embryos are out
    there and what is being done with them. As such, the
    enforcement scheme, as laid out in 303, is legally incoherent,
    scientifically incoherent, and will do nothing to halt
    reproductive cloning.
        Now, adding insult to injury, 303 then has a provision that
    seems to admit that there are some enforcement problems here
    and says one year after the bill has been passed, they want a
    report on exactly what enforcement is happening or not
    happening.
        Mr. Chairman, I would suggest that the time to do studies
    on enforcement is not after a harmful practice has been allowed
    to be disseminated and perhaps creating its harm in this
    invisible way throughout the country, but before we allow a
    harmful practice to ever be sanctioned by law. The idea of
    having a bill that says, ``Let's look at enforcement a year
    after we allow this process,'' again, is legally incoherent,
    and I cannot understand it.
        Now, Ms. Charo mentioned that the--correctly, I think--that
    303 relies on these institutional review boards for a case by
    case study and approval of research cloning. Let me read you a
    1998 report by the HHS office, the Inspector General's report
    to the HHS, on the efficacy of institutional review boards in
    monitoring and reviewing these kinds of human subject
    experiments. In this report, the Inspector General found,
    ``that the IRBs reviewed too much, too quickly, with too little
    expertise, that they conducted minimal continuing review of
    approval research, that they faced conflicts of interest that
    threatened their independence, provided far too little training
    for investigators and board members.'' A 2000 report looking at
    how these reforms were possibly carried out, they basically
    said, ``minor changes, but these problems still exist, are
    endemic to these IRBs and have not been cured.''
        Well, I find it very troubling, Mr. Chairman, that the
    core, the backbone, of regulations, S. 303, is these IRBs that
    HHS, for the last five years, has been saying are not working.
        A couple of final points. One of the first opportunities I
    had in Washington many, many years ago, was working with then-
    Representative Al Gore to help create and then pass the Organ
    Transplant Act. This, as you know, is the act that prohibits
    the sale of organs in the United States. And as such, we faced
    a very difficult question about what kind of reasonable
    compensation people should be given for organ donation. One of
    the considerations we had at that time was whether ``time and
    inconvenience,'' those terms, should be used for something that
    you could recompense people who had donated their organs. We
    rejected it at that time, because we viewed it as I think it
    is, a loophole for virtually any kind of payments you want to
    give.
        Now, a couple of years ago, a spokesman for the infertility
    industry admitted that time and inconvenience was simply,
    ``semantics.'' It means ``payment.''
        So the fact that we are talking about--in S. 303, the fact
    that they are saying you cannot have valuable consideration to
    these egg donors, but you can pay them for their time and
    inconvenience, according to the infertility industry, itself,
    is semantics. ``Payment'' and ``time and inconvenience'' are
    the same thing.
        And let me read you from the marvelous legal scholar,
    George Annas on this, on the term ``inconvenience'' as used in
    this valuable consideration for paying for women's eggs. This
    is George Annas now, ``Of course, you're not really buying a
    woman's inconvenience. It's a bogus argument that you're not
    actually selling these eggs. Clearly, donors are selling their
    reproductive capacity. And if you can sell your egg, then
    shouldn't you sell your child, too?''
        Again, in contrast to this, I urge the Committee to look at
    the Organ Transplant Act, where we do not allow this huge
    loophole that has been allowed in this bill.
        A couple of final points, if I could. One is this idea that
    we are restricting science and that that is a possible offense
    to the First Amendment. One of my privileges as an attorney has
    been to do numerous litigations under the Animal Welfare Act.
    In order to protect animals from cruel experiments, experiments
    that offend both their dignity and their physical and
    psychological wellbeing, we have numerous restrictions on
    experiments that can be conducted in virtually every area of
    medicine. Numerous. None of those has ever been subjected, to
    my knowledge, to any kind of constitutional attack, and I think
    anybody who thought that they could do that would not be taken
    seriously, legally. If, to protect animals, we can have
    significant restrictions on research, I do not know why we
    cannot do the same thing for women's health.
        Thank you, Mr. Chairman.
        [The prepared statement of Mr. Kimbrell follows:]

          Prepared Statement of Andrew Kimbrell, Executive Director,
                 International Center for Technology Assessment
        Mr. Chairman and Members of the Committee:
        My name is Andrew Kimbrell. I am the Executive Director of the
    international Center for Technology Assessment, an attorney and author
    of The Human Body Shop: the engineering and marketing of life (Harper
    Collins 1991, 3rd Edition 1998). I am here today as part of a broad
    coalition of progressive environmental, consumer and women's health
    groups who agree that responsible policy on the matter of human cloning
    requires a ban on reproductive cloning and a moratorium on human
    cloning for research. The potential impacts to women of human
    reproductive cloning, but especially, human research cloning have
    received insufficient attention in the cloning debate, and I'm grateful
    to the Committee both for recognizing the importance of this issue and
    providing me the opportunity to testify today. I'd like to begin by
    summarizing the physical and psychological risks to women posed by
    human reproductive and research cloning. I will then provide a brief
    analysis of S. 303, introduced by Senators Hatch and Feinstein and
    explain why, as currently written, this bill would neither effectively
    ban human reproductive cloning nor provide adequate protection to
    women.
    The Impacts of Human Cloning to Women
        Human cloning is a process in which a nucleus from a human somatic
    cell is fused with an enucleated human egg cell to produce a cloned
    embryo. The technical term for this process is ``somatic cell nuclear
    transfer.'' There are two potential uses of cloned embryos produced by
    nuclear transfer, each of which pose significant risks to women. In the
    case of human reproductive cloning, cloned embryos would be transferred
    into a woman's uterus, and, if brought to term, would result in a child
    that would be a genetic duplicate of the nuclear donor. In the case of
    human cloning for research purposes, these cloned embryos would be used
    to develop stem cell lines for regenerative tissue research. The
    following describes the risks to women posed by each of these two types
    of human cloning.
    Human Reproductive Cloning
        Human reproductive cloning is widely condemned and has been
    outlawed by more than 30 countries. Many scientists agree that
    reproductive cloning is an inherently unsafe procedure that could only
    he made ``safe'' by carrying out extensive, unethical experimentation
    on women. The physical risks associated with this procedure cannot be
    overstated. Almost all cloning experiments in mammals have resulted in
    miscarriages, stillbirths, and deformities. Many efforts to clone
    mammals have resulted in abnormally large fetuses, often up to twice
    the average size. In humans, ``large offspring syndrome'' of this
    magnitude could be fatal to a surrogate mother as well as to the fetus.
    Finally, experiments in mammals have been highly inconsistent and
    unpredictable. As such, endless experimentation with mice, sheep, cats,
    even monkeys may never provide us the level of confidence required to
    attempt this procedure in humans.
        As many scientists, health professionals, ethicists and others have
    noted, these insurmountable risks, alone, warrant a permanent ban on
    human reproductive cloning. In addition, reproductive cloning poses
    significant psychological and social risks to women. Surrogate mothers
    who would have to undergo the stillbirths and miscarriages and witness
    the deformities involved in attempting to create a successful clone
    would suffer an enormous emotional and psychological toll. In addition,
    if reproductive cloning were allowed, an increase in demand for
    surrogate mothers would exacerbate an already coercive market in the
    buying and selling of women's wombs. That demand would likely be met by
    low-income women, pressured into selling their bodies as ``mother
    machines'' to those who can afford the price.
    Human Embryo Cloning for Research
        The impacts to women (and social consequences, generally) posed by
    human research cloning have been less widely discussed, but are
    nonetheless compelling. They include the following:

       Research cloning is a highly inefficient process, which
            would require an unlimited supply of human eggs. It has been
            estimated that research cloning might be able to provide up to
            1.7 million therapies per year. Assuming a highly optimistic
            success rate of 1 stem cell culture per 5 cloned embryos, and
            one cloned embryo per 10 eggs, these therapies would require 85
            million eggs, or 8.5 million egg donors.

       Egg donation is a burdensome, risky, and painful procedure.
            Egg donation is not a simple process; it lasts several weeks,
            and includes repeated injections of fertility hormones and
            super-ovulatory drugs and finally, surgery. Risks associated
            with egg extraction include a potential link to ovarian cysts
            and cancers, severe pelvic pain, abdominal bleeding, and
            ovarian hyperstimulation syndrome, a potentially life-
            threatening condition.

       An explosion in demand for human eggs would exacerbate the
            coercive nature of the lucrative egg donation industry.
            Currently, compensation to women for egg ``donation'' is
            uncapped, and ranges from an average payment of $5,000-$6,000
            to as high as $80,000. The increase in egg demand created by
            research cloning is likely to increase the price of eggs and
            coercive potential of the egg market.

       The burden of egg supply will likely fall on underprivileged
            women. There are no federal standards concerning limitations on
            the number of times a woman can donate eggs. Low-income women
            may feel obliged to choose repeated egg donation as a source of
            income.

       Research cloning will result in a loss of choice for women.
            Researchers can clone embryos from any number of body cells. A
            woman's cells could be removed for the creation of any number
            of cloned embryos without her knowledge or choice.

       The perfection of techniques to create cloned human embryos
            through research cloning would make it far more likely that
            reproductive cloning will occur. The major barrier to
            successful reproductive cloning lies not in implantation, but
            in the development of the ability to clone embryos free of
            reprogramming errors. Allowing the creation of cloned embryos
            would encourage the perfection of this technical barrier, after
            which uterine implantation would be a trivial step. As such,
            research cloning is the gateway for eventual reproductive
            cloning and its profound impacts on women's health described
            above.

       Perfection of research cloning techniques will also open the
            door to creating ``designer babies.'' Inheritable genetic
            modification, or germline engineering, is a process that
            involves changing genes that are passed on to future children.
            This technique has been used to create ``transgenic'' animals
            for commercial and research purposes, and some scientists and
            others are advocating its acceptance and use in humans.
            Perfection of research cloning techniques is necessary for
            ``designer babies'' to become commercially practicable.
            Allowing genetic ``enhancements'' in humans would unleash a
            powerful new eugenics, and could lead to unacceptable forms of
            genetic discrimination and inequality, not unlike those that
            many advocates for women's health and rights have worked so
            hard to overcome.

    A Misguided Legislative Approach: S. 303
        On February 5, 2003, Senators Hatch (R-UT), Feinstein (D-CA),
    Specter (R-PA), Kennedy (D-MA), Harkin (D-IA), and Miller (D-GA)
    announced the introduction of S. 303, a new bill to address the issue
    of human cloning. At a hearing held by the Senate Committee on the
    Judiciary on March 19, Senator Hatch stated that the purpose of the
    bill is twofold: (1) To stop any attempts to facilitate the birth of a
    cloned baby; and (2) to allow a promising form of stem cell research to
    go forward under ``strict ethical guidelines.'' A closer examination of
    S. 303 reveals that neither of these goals will be accomplished by this
    bill. In particular, the bill, as currently written, will not
    effectively prevent human reproductive cloning, nor will it adequately
    protect women. CTA is preparing a thorough, in-depth analysis of this
    deeply flawed and misguided legislation, which it will provide the
    Committee in the near future. However, today I would like to focus on
    just a few of the more egregious failings of S. 303.
    S. 303 Fails To Effectively Prevent Human Reproductive Cloning:
        Among the changes from last year's incarnation of this bill is its
    use of the term ``unfertilized blastocyst'' to describe a cloned human
    embryo. The use of this term appears to be intentionally misleading. It
    suggests that, once created, clonal embryos (i.e., ``unfertilized
    blastocysts'') could he distinguished from ``fertilized'' embryos,
    namely those created from the union of an egg and a sperm. Additionally
    it seems to suggest that the ``unfertilized blastocyst'' is in some way
    not viable, that if it were transferred to a woman's womb it would not
    result in a child. It is true that a cloned embryo is not fertilized in
    the traditional sense, by way of the union of an egg and sperm. However
    a cloned embryo is potentially as viable as a conventional embryo and
    if implanted in a womb could result in a cloned child. Moreover, and
    very importantly, once created a cloned embryo (``unfertilized
    blastocyst'') cannot be distinguished from a ``fertilized'' embryo. To
    repeat once an embryo is cloned it is biologically identical to a
    fertilized embryo and cannot be distinguished from a fertilized embryo
    nor identified as a cloned embryo.
        This important fact, purposely obscured by S. 303, underscores the
    enormous challenge in enforcing any restriction on the sale or use of
    cloned embryos after they have been created. The bill allows for the
    production of an endless supply of cloned human embryos without
    acknowledging that once they are produced they are biologically
    identical to conventional embryos and will be virtually impossible to
    find. This simple fact demonstrates that any attempt to regulate the
    use of cloned embryos after they have been created is legislating the
    impossible. Imagine trying to regulate the use of drugs or firearms if
    they became invisible once they were created and you get the scope of
    the difficulty in enforcing the ban on reproductive cloning attempted
    by S. 303.
        Clearly the only coherent approach to halting reproductive cloning
    is at the supply level, that is to either ban or significantly restrict
    the creation of cloned embryos. S. 303 does the reverse. it encourages
    the creation of cloned embryos but does not in any way provide direct
    oversight of the number of facilities creating human cloned embryos,
    limit the number of clonal embryos created, or create a strict chain of
    custody requirement for each individual cloned human embryo produced
    for research purposes. As such, there is no way to ensure that cloned
    embryos purportedly produced for research purposes are not subsequently
    transferred to a woman's uterus. This potential that these embryos will
    be used for reproductive cloning is exponentially increased because the
    bill explicitly allows for: (1) Freezing; (2) transport; and (3) export
    of cloned human embryos. Without either a ban on the production of
    cloned embryos or a highly restricted production of cloned embryos that
    is subject to a rigorously enforced system of monitoring that tracks
    the chain of custody of each and every cloned human embryo produced,
    there can be no way to ensure that attempts to clone human beings are
    not being undertaken. S. 303 provides for neither of these alternatives
    and therefore will completely fail in its stated purpose of halting
    human reproductive cloning and will also fail in preventing the serious
    impacts on women's health which reproductive cloning will bring.
        Rather than addressing this enforcement issue directly, S. 303
    calls for a series of reports on enforcement mechanisms found in state
    or international laws to be completed one year after the bill has been
    passed. This is incomprehensible. Allowing human cloning to proceed for
    a year, or potentially several years, while various enforcement schemes
    are reviewed and studied in order to arrive at adequate enforcement is
    legally incoherent. The whole point of regulatory legislation is to
    develop an effective enforcement regime before allowing a certain
    potentially harmful activity to proceed, not after it has been
    disseminated and creates the harm the legislation was intended to
    avoid.
    S. 303 Fails to Provide Adequate Protection to Women Egg Donors:
        The bill assigns the primary load of protecting women in research
    cloning to existing human subject protection regulations. Yet it is
    probable that these regulations would not even apply to egg donors or
    somatic cell donors. This is because these donors would not be
    ``research subjects'' as contemplated under the regulations; instead,
    they are ``donors'' of biological material, not a class currently
    covered under the regulations. Even if these regulations did apply,
    companies involved in cloning embryos could avoid these requirements by
    obtaining human eggs and cells from outside sources and not directly
    from the donors. In addition, standards of Investigational Review Board
    (IRB) review are not the most efficient or practical way to provide
    consistent protection to these participants. Decisions about the
    appropriate process for extracting and using human eggs and somatic
    cells in research should not be made on an individual, case-by-case
    basis, or left to the whim of a given IRB. Instead, federal standards
    should be developed that are specific to women's health concerns.
        I would add that the bill's reliance on IRBs as the primary means
    to monitor and control human cloning activity also ignores serious
    issues that have been raised about these Boards. A number of recent
    major failures in human research protection have led me, and many in
    the scientific community, to believe that most of the important issues
    raised in the 1998 HHS Office of Inspector General Report
    ``Institutional Review Boards: A Time for Reform'' have yet to be
    effectively addressed.
        In this 1998 report the Inspector General found that IRBs:

       reviewed too much, too quickly, with too little expertise;
       conducted minimal continuing review of approved research;
       faced conflicts that threatened their independence; and
       provided too little training for investigators and board
            members.

        They also found that neither IRBs nor HHS devoted much attention to
    evaluating IRB effectiveness.
        In a follow up investigation in 2000, the OIG found that while
    several promising steps had been taken by NIH and FDA, few of the
    recommended reforms had been enacted. Of particular continuing concern
    to the IG were the areas of:

       flexibility and accountability;
       oversight and human protections;
       board and investigator education;
       conflicts of interest;
       workload; and
       federal oversight.

        Virtually the same list as in 1998. Given these findings, if we are
    serious about ensuring that reproductive cloning cannot occur, and that
    women's health be protected IRBs are not any kind of answer for at
    least the foreseeable future.
        Let me conclude with S. 303's handling of the exploitation of women
    in the egg donation process. There can be no doubt that the endorsement
    of research cloning in S. 303 would stimulate a major expansion in the
    market for women's eggs. At the same time, the bill does not adequately
    address the coercive aspects of the egg donation industry, which would
    be exacerbated by a massive increase in the demand for women's eggs.
    While the bill prohibits the purchase or sale of human eggs for use in
    embryo cloning research ``for valuable consideration'', it does so with
    a large loophole. While ``valuable consideration'' is prohibited the
    bill does allow for payment to egg donors for the ``time or
    inconvenience'' associated with the donation. This vague provision has
    been used for years by institutions around the country to allow them to
    pay tens of thousands of dollars to egg donors. Ultimately, there is
    little real difference between paying for eggs or for the ``time and
    inconvenience'' of their removal. ``It's almost a matter of
    semantics,'' admits Joyce Zeitz, former public relations coordinator
    for the American Fertility Society. Legal scholar George Annas sees the
    term ``inconvenience'' as nothing more than a ruse: ``Of course, you're
    not really buying a woman's inconvenience. It's a bogus argument that
    your not actually selling these eggs. Clearly, donors are selling their
    reproductive capacity. And if you can sell your egg, then why shouldn't
    you sell your child too?'' In contrast to S. 303 language, I would
    point out that the U.S. Organ Transplant Act prohibiting sale of organs
    does not have the ``time and inconvenience'' loophole. I would further
    note that S. 303 contains no caps on the number of times a woman can
    donate/sell eggs. As such, economically disenfranchised women are
    likely to become repeat donors.
        In sum, if passed S. 303, will encourage unlimited production of
    unidentifiable cloned embryos. This will not halt but rather facilitate
    human reproductive cloning and thus will completely fail to adequately
    protect women's health from the dangers of all forms of human cloning.
    The bill is deeply flawed both in concept and in its specifics. It is
    simply irresponsible legislation.
        Thank you.

        Senator Brownback. Thank you, Mr. Kimbrell.
        Mr. Doerflinger?

              STATEMENT OF RICHARD M. DOERFLINGER, DEPUTY
          DIRECTOR, SECRETARIAT FOR PRO-LIFE ACTIVITIES, U.S.
                     CONFERENCE OF CATHOLIC BISHOPS

        Mr. Doerflinger. Thank you, Mr. Chairman.
        Human cloning is an unethical and dehumanizing procedure;
    and, ironically, the most startling evidence of its
    dehumanizing aspects can be found in some proposals ostensibly
    aimed at preventing human cloning. A case in point, in my view,
    is the Hatch-Feinstein Human Cloning Ban and Stem Cell Research
    Protection Act, S. 303. The bill is gravely deficient in at
    least eight ways. I say ``at least,'' because I had one day to
    write the testimony. I will find 20 more tomorrow.
        Very briefly, first, the bill is offered under false
    pretenses. In fact, it does not ban human cloning at all, for
    any purpose. ``Human cloning'' is defined by the National
    Academy of Sciences as the production of an organism that has
    the same nuclear genome as another organism. And contrary to
    the fertility doctor who testified earlier, there is a
    virtually unanimous consensus among Congress, the NIH, the
    National Bioethics Advisory Commission, and many others that
    the embryo, even at the earliest stage, is an organism of the
    human species. That is not a moral or political statement; it
    is simply basic science. In fact, there is a great deal of law
    on stem cell research right now that is based on the legal
    opinion that a stem cell is not an organism, but an embryo is.
    When you produce that embryo, you have done human cloning. S.
    303 does nothing whatever to place any limits on cloning, for
    any purpose or no purpose.
        Two, what it does ban is embryo transfer, which is a
    distinct procedure also defined by the National Academy of
    Sciences. And that creates a great many problems, some of which
    Mr. Kimbrell has just gone over. The bill's penalties are
    directed not at irresponsible cloning researchers, but at
    anyone engaged in trying to implant such an embryo in a woman's
    womb--presumably, by the language of the bill, including the
    woman herself. In fact, everyone else could simply evade
    penalties under the law by training the woman to transfer the
    embryos to her own womb. If the woman is exempt from penalties,
    then the law simply evaporates. It is simply a regulation on
    who can do human cloning, rather than on whether you can do it
    at all, even reproductive cloning.
        S. 303 recognizes the enforcement problem here that, as Mr.
    Kimbrell said, you simply cannot tell, even if you were
    standing right over the shoulder of the fertility physician,
    whether any given embryo about to be transferred to a woman is
    from cloning or fertilization. You cannot even do it with all
    the prenatal diagnostic tests that we have now--because we do
    not have a test, for example, for the disorderly gene
    imprinting and gene expression that are found in cloned
    embryos. And so the Act tries to resolve this by forbidding
    researchers to conduct human cloning research in the same place
    where IVF is done in assisted reproduction.
        That only confirms what the Justice Department has said in
    its House testimony some time ago. You cannot enforce this bill
    without placing new and unprecedented restrictions on assisted
    reproduction techniques that are widely accepted. Whether you
    are banning the location of an IVF clinic, or banning the
    location of a cloning research facility, is simply going to
    depend on which one got there first. You cannot operate the
    second one in the same place as the first one. This would be
    the first federal law in history that bans the location of IVF
    clinics in certain places.
        Third, the bill allows research that will facilitate what
    its sponsors claim to oppose--that is, cloning to produce
    children. My longer statement has quotes from people who favor
    research cloning, confirming that, of course, if you allow
    cloning for research it will facilitate and bring closer the
    day when this procedure is refined and people can conduct it
    for reproductive purposes. In fact, some of the organizations
    supporting S. 303 have exactly that view themselves--that when
    research cloning is allowed to make the procedure, ``safer,''
    they might then support reproductive cloning as well.
        Fourth, the bill allows--and this is a very odd clause--it
    allows exporting of cloned embryos to other countries, but only
    if they do not--I have to read this, because the double
    negatives are a little odd--it forbids exporting of cloned
    embryos, called unfertilized blastocysts, to a foreign country
    only if such country does not prohibit human cloning. So the
    only circumstance in which you can export cloned embryos to
    another country is where they will be used for illegal
    activity. We are pretending to ban even reproductive cloning,
    and then facilitating it in violation of other countries' laws
    elsewhere. I do not think that will increase our standing
    abroad.
        Fifth, the bill has a number of careless and incoherent
    passages that end up potentially restricting activities that
    are not human cloning at all. One I would like to mention
    briefly is this ``unfertilized blastocyst'' term which is
    defined in such a way that it fails even to make the
    distinction between an embryo and a stem cell. ``Any intact
    cellular structure,'' made by nuclear transfer is covered. And
    so the very sort of things that some people have talked about
    to bypass the moral problem of cloning, ways of adapting the
    procedure so that, from the outset, it only makes stem cells
    instead of an organism, an embryo, that then has to be killed
    for its stem cells, would be as restricted by this bill as
    actually making an embryo is. This is not a defect in the
    Brownback bill.
        Sixth, regarding protection of women, this bill is really a
    Potemkin Village. It is very carefully crafted so that it takes
    the whole body of current law and regulation on human subjects
    research, finds the areas that would actually have some
    relevance to cloning research, and then makes sure they are not
    applied. The only regulations it does apply are rather vague
    and general provisions that, in fact, do not have much of
    anything to do with cloning, for reproduction or research. It
    does not apply, for example, the protections for unborn
    children in pregnant women. It does not apply the current
    federal law that has been in place for six years on embryo
    research. It only applies these vague informed consent
    standards, and these provisions on compensation for time or
    inconvenience. I have a hard time with the idea of the
    ``inconvenience'' of getting ovarian cancer.
        Here is something that the National Bioethics Advisory
    Commission said about the IRB system. Professor Charo was a
    member of the commission at the time. ``In our view, IRBs
    should appreciate that, for some components of a study,
    participants might incur risks with no personal potential
    benefit. For these elements''--and that is what happens with
    egg donation for cloning research--``For these elements, there
    should be some limitation on the amount of social and physical
    risk that can be imposed, regardless of the participant's
    willingness to participate or the monetary or other enticement
    being offered.'' That is the advice that this bill ignores. It
    thinks that if you throw in some compensation and have people
    sign a form, then this inherently ethically questionable
    practice of having women undergo the risks of these egg
    donation practices for no possible benefit to themselves is
    perfectly all right.
        The bill's reference to FDA oversight is even more
    unpersuasive, because it requires you to treat the cloned
    embryo as a biological product, as a commodity to be regulated,
    presumably in order to prevent harm to others. So it has
    nothing to do with the ostensible purpose of the bill in terms
    of its stance against reproductive cloning, which was to
    protect the safety of the child who is going to be receiving
    birth defects and miscarrying from being cloned. You cannot
    call the child a dangerous biological product, and say it is
    the person to be protected from risk at the same time.
        There are many other defects here, but I want to end with
    just this one, because it is not widely known here. This bill
    is already obsolete. The biotechnology movement has moved on.
    There are eight states now where state biotechnology alliances
    are supporting bills that have language like the following.
    ``It is the public policy of this state to promote research
    involving the derivation and use of human embryonic stem cells,
    human embryonic germ cells''--those can only be obtained from
    fetuses eight weeks old--``and human adult stem cells from any
    source, including somatic cell nuclear transplantation.'' Now,
    that language is no accident. It has been simultaneously
    introduced in eight states in the last couple of months.
        The researchers have looked at the field, and they have
    found what anyone can find by looking at the medical
    literature. There are only two studies in all the vast sea of
    medical literature that showed any therapeutic benefit from
    cloning in animals; and one of them required taking the clone
    to the fetal stage, and the other required taking it to the
    newborn stage.
        They are already moving on past this bill, the 14-day limit
    on maintaining embryos--morally reprehensible though that is
    because, for the first time in history, the Federal Government
    would actually define a class of humanity it is a crime not to
    destroy at a certain stage. That limit is going to be
    infinitely flexible, because tomorrow the researchers will come
    back and say, ``We need 20 days, we need 30, we need a
    hundred.'' They are already saying it in the laboratory of the
    states, and we should beware of something that is far too much
    of a free fall even to be called a ``slippery slope.'' We are
    already there. They are already taking these animal studies,
    and saying that the human model for therapeutic cloning may
    have to exploit human beings into much later stages than the
    embryonic.
        Embryonic stem cells have been found to have many serious
    problems in terms of integrating with tissues, in terms of
    tumor formation and overproliferation. And the logical way,
    unfortunately, for the researchers to get more usable cells is
    to grow those cells to a later stage in the original organism,
    and then destroy that organism.
        Mr. Chairman, we should ban human cloning, but we should do
    it by banning human cloning. Legislation which allows the
    practice, and then seeks to destroy the humans thus produced so
    that we can pretend we have banned cloning, is worse than doing
    nothing.
        I urge Congress to oppose S. 303 and to approve the
    Brownback-Landrieu bill, S. 245. Thank you.
        [The prepared statement of Mr. Doerflinger follows:]

        Prepared Statement of Richard M. Doerflinger, Deputy Director,
       Secretariat for Pro-Life Activities, U.S. Conference of Catholic
                                    Bishops
        I am Richard M. Doerflinger, Deputy Director of the Secretariat for
    Pro-Life Activities at the U.S. Conference of Catholic Bishops. I also
    serve as Adjunct Fellow in Bioethics and Public Policy at the National
    Catholic Bioethics Center. It is on behalf of the bishops' conference
    that I wish to speak to you today about the moral challenge presented
    by radically different congressional proposals on human cloning.
        The sanctity and dignity of human life is a cornerstone of Catholic
    moral reflection and social teaching. We believe a society can be
    judged by the respect it shows for human life, especially in its most
    vulnerable stages and conditions.
        Human cloning is sometimes presented as a means for creating life,
    not destroying it. Yet it shows disrespect toward human life in the
    very act of generating it. Cloning completely divorces human
    reproduction from the context of a loving union between man and woman,
    producing children with no ``parents'' in the ordinary sense. Here
    human life does not arise from an act of love, but is manufactured to
    predetermined specifications. A developing human being is treated as an
    object, not as an individual with his or her own identity and rights.
    As one group of scientific and other experts advising the Holy See has
    written:

            In the cloning process the basic relationships of the human
            person are perverted: filiation, consanguinity, kinship,
            parenthood. A woman can be the twin sister of her mother, lack
            a biological father and be the daughter of her grandmother. In
            vitro fertilization has already led to the confusion of
            parentage, but cloning will mean the radical rupture of these
            bonds. \1\
    ---------------------------------------------------------------------------
        \1\ Reflections from the Pontifical Academy for Life, ``Human
    Cloning Is Immoral'' (July 9, 1997), in The Pope Speaks, vol. 43, no. 1
    (January/February 1998), p. 29. Also see: Congregation for the Doctrine
    of the Faith, Donum Vitae (Instruction on Respect for Human Life in its
    Origin and on the Dignity of Procreation) (March 10, 1987), I.6 and
    II.B.

        Such moral concern transcends denominational bounds and has been
    eloquently expressed by some of our country's most respected
    philosophers and ethicists. Writes Professor Leon Kass of the
    University of Chicago, now chairman of the President's Council on
    ---------------------------------------------------------------------------
    Bioethics:

            Human cloning would . . . represent a giant step toward turning
            begetting into making, procreation into manufacture (literally,
            something ``handmade'') . . . [W]e here would be taking a major
            step into making man himself simply another one of the man-made
            things. \2\
    ---------------------------------------------------------------------------
        \2\ Leon R. Kass, ``The Wisdom on Repugnance,'' in The New
    Republic, June 2, 1997, p. 23.

        From the dehumanizing nature of this technique flow many disturbing
    consequences. Because cloned humans are produced by a means more suited
    to more primitive forms of life--a means which involves no loving
    relationship, no personal investment or responsibility for a new life,
    but only laboratory technique--they would be uniquely at risk of being
    treated as ``second-class'' human beings.
        The very scenarios often cited as justifications for human cloning
    are actually symptoms of the moral problem it creates. It has been said
    that cloning could be used to create ``copies'' of illustrious people,
    to replace a deceased loved one, or even to provide a source of spare
    tissues or organs for the person whose genetic material was used for
    the procedure. In each proposal we see a utilitarian view of human
    life, in which a human being is treated as a means to someone else's
    ends instead of as a person with his or her own inherent dignity. This
    same attitude lies at the root of human slavery.
        Let me be perfectly clear. In reality a cloned human being would
    not be, in any sense, an ``object'' or a substandard human being.
    Whatever the circumstances of his or her origin, he or she deserves to
    be treated as a human person with an individual identity. But the
    depersonalized technique of manufacture known as cloning disregards
    this dignity and sets the stage for further exploitation. Cloning is
    not wrong because cloned human beings lack human dignity--it is wrong
    because they have human dignity, and deserve to come into the world in
    ways that respect this dignity. Each child has a right to be conceived
    and born as the fruit of a loving union between husband and wife, to be
    loved and accepted as a new and distinct individual.
        Ironically, the most startling evidence of the dehumanizing aspects
    of cloning is found in some proposals ostensibly aimed at preventing
    human cloning. Some Members of Congress favor legislation that would
    not ban human cloning at all--but would simply ban any effort to allow
    cloned human beings to survive. In these proposals, researchers are
    allowed to use cloning for the unlimited mass production of human
    embryos for experimentation--after which they are required to destroy
    them. Enactment of such a proposal would mark the first time in history
    that the U.S. government defined a class of human beings that it is a
    crime not to destroy.
        Specifically I have been asked to comment on the two pending
    federal bills now offered as a response to human cloning: the Hatch/
    Feinstein ``Human Cloning Ban and Stem Cell Research Protection Act''
    (S. 303), and the Brownback/Landrieu ``Human Cloning Prohibition Act''
    (S. 245).
        Let me begin with the bill that is, in my view, offered under false
    pretenses--the bill that, despite its title, is not a ban on human
    cloning at all.
    S. 303 (Hatch/Feinstein)
        This bill is gravely deficient in at least eight ways.
        1. It does not, in fact, ban human cloning at all. The National
    Academy of Sciences (NAS) has defined ``cloning'' as the production of
    ``an organism that has the same nuclear genome as another organism.''
    \3\ As Congress has formally acknowledged since 1996, the early embryo
    produced by fertilization or cloning is an organism of the human
    species.\4\ The National Institutes of Health (NIH), and President
    Clinton's National Bioethics Advisory Commission (NBAC), have
    acknowledged the same fact.\5\ To produce that embryo--using, for
    example, the somatic cell nuclear transfer procedure used to make Dolly
    the sheep--is to conduct human cloning, whatever else one may plan to
    do with that embryo afterwards. This is scientific fact, not ethics or
    politics. It was, in fact, a unanimous point of agreement in the recent
    report on cloning by the President's Council on Bioethics, whose
    Members otherwise disagreed sharply on moral and policy issues.\6\ S.
    303 does nothing whatever to ban the use of the cloning procedure to
    create human embryos, for any purpose (or even to restrict someone's
    ability to create them for no discernible purpose at all).
    ---------------------------------------------------------------------------
        \3\ National Academy of Sciences, Scientific and Medical Aspects of
    Human Reproductive Cloning (National Academy Press 2002), p. E-4.
        \4\ See the Dickey amendment enacted as part of the annual Labor/
    HHS appropriations bills since 1996: `` `human embryo or embryos'
    includes any organism, not protected as a human subject under 45 CFR 46
    as of the date of the enactment of this Act, that is derived by
    fertilization, parthenogenesis, cloning, or any other means from one or
    more human gametes or human diploid cells.'' The current version of
    this amendment is Sec. 510 of Pub. L. 108-7, the Omnibus Appropriations
    Act of 2003 (enacted Feb. 20, 2003).
        \5\ NBAC defined ``embryo'' as ``the developing organism from the
    time of fertilization until significant differentiation has occurred .
    . .'' NBAC, Cloning Human Beings (Rockville, MD: June 1997), Vol. I, p.
    A-2. This term encompasses the cloned embryo: ``The Commission began
    its discussions fully recognizing that any effort in humans to transfer
    a somatic cell nucleus into an enucleated egg involves the creation of
    an embryo, with the apparent potential to be implanted in utero and
    developed to term.'' Id., p. 3. Similarly, the NIH defines ``embryo''
    as follows: ``In humans, the developing organism from the time of
    fertilization until the end of the eighth week of gestation.'' NIH,
    Stem Cells: Scientific Progress and Future Research Directions (U.S.
    Department of Health and Human Services: June 2001), p. F-3.
        \6\ The President's Council on Bioethics, Human Cloning and Human
    Dignity (Washington, DC: July 2002), pp. 54-55.
    ---------------------------------------------------------------------------
        2. What it does ban is ``embryo transfer,'' a distinct procedure
    already in use by fertility clinics across the world for many years;
    and this creates serious legal and enforcement problems. The NAS
    defines ``embryo transfer'' as ``the introduction of a preimplantation
    embryo into the uterus for growth and development.'' \7\ S. 303 bans
    this procedure, if it involves an embryo produced earlier by cloning
    (page 2 lines 10-13). This has certain consequences:
    ---------------------------------------------------------------------------
        \7\NAS, note 3 supra, p. A-2.
    ---------------------------------------------------------------------------
        (A) The bill's penalties are directed not against irresponsible
    researchers engaged in human cloning, but against those engaged in
    implanting or attempting to implant the cloned embryo in a womb--
    presumably including the woman herself. (If the penalty did not apply
    to the woman, of course, this would create an enormous loophole--the
    law could be completely evaded by having the woman herself conduct the
    embryo transfer, a realistic possibility if she has any training as a
    fertility doctor or technician.)

        (B) Such a law is inherently almost impossible to enforce, because
    at this stage of embryonic development there is no reliable way for law
    enforcement to distinguish cloned embryos from fertilized embryos.\8\
    Even to initiate such scrutiny would require delaying embryo transfer
    until the results of all relevant tests were obtained, at which time
    the embryo in question (whether cloned or fertilized) would most likely
    be dead. In this context it is important to note that while cloned
    animal embryos seem much more likely to suffer from serious problems of
    disorderly gene expression than embryos created by union of sperm and
    egg, these problems are not detectable by any prenatal diagnostic test
    in current use.\9\
    ---------------------------------------------------------------------------
        \8\ See Written Statement of Daniel J. Bryant, Assistant Attorney
    General, before the Subcommittee on Criminal Justice, Drug Policy and
    Human Resources of the House Committee on Government Reform, May 15,
    2002 (www.house.gov/weldon/issues/doj.htm).
        \9\ For example, see: Testimony of Dr. Mark E. Westhusin before the
    House Energy and Commerce Subcommittee on Oversight and Investigations,
    March 28, 2001; R. Jaenisch and I. Wilmut, ``Don't Clone Humans!'', 291
    Science (30 March 2001), p. 2552.

        (C) The bill recognizes this problem, and tries to resolve it by
    forbidding researchers to conduct human cloning research at the same
    laboratory where ``assisted reproduction'' occurs (page 10 lines 19-
    24). But of course this begs the question, which is: How do you tell
    which of the two is being done at any given time? And how would you
    create a closed system to prevent cloned embryos from being brought
    from one laboratory to the one next door? \10\
    ---------------------------------------------------------------------------
        \10\ This provision illustrates the truth of the Justice
    Department's testimony: One cannot enforce this ban without imposing
    new and unprecedented restrictions on fertility procedures already
    widely practiced in this country. For the provision is double-edged:
    Its text says that one may not conduct cloning research in a laboratory
    where eggs are subjected to assisted reproduction procedures (page 10
    lines 21-24); but its heading calls for ``separation of in vitro
    fertilization laboratories'' from locations where cloning research is
    conducted (page 10 lines 19-21). If a laboratory started conducting
    cloning research first, in vitro fertilization is banned there. This
    would be the first federal law to restrict where one may establish a
    private fertility clinic.
    ---------------------------------------------------------------------------
        3. This bill allows cloning research that will facilitate what its
    sponsors claim to oppose--that is, cloning to produce born children.
    Again, this is widely acknowledged by experts who support cloning for
    research in general and S. 303 in particular. For example, researchers
    and ethicists who support cloning for research purposes (which they
    call CRNT for ``cell replacement through nuclear transfer'') admit that
    ``the techniques developed in CRNT research can prepare the way
    scientifically and technically for efforts at reproductive cloning.''
    \11\ Similarly, the ethics committee of the American Society for
    Reproductive Medicine (ASRM), which supports S. 303, has stated
    regarding human cloning for research purposes:
    ---------------------------------------------------------------------------
        \11\ Lanza et al., ``The ethical validity of using nuclear transfer
    in human transplantation,'' 284 (24) Journal of the American Medical
    Association (Dec. 27, 2000), pp. 3175-9 at p. 3178.

            If undertaken, the development of SCNT [somatic cell nuclear
            transfer] for such therapeutic purposes, in which embryos are
            not transferred for pregnancy, is likely to produce knowledge
            that could be used to achieve reproductive SCNT.\12\
    ---------------------------------------------------------------------------
        \12\ Ethics Committee of the American Society for Reproductive
    Medicine, ``Human somatic cell nuclear transfer (cloning),'' 74 (5)
    Fertility and Sterility (Nov. 2000), pp. 873-6 at p. 873.

        To be sure, this does not create an intractable conflict for ASRM
    itself in terms of supporting S. 303, because ASRM does not support a
    permanent ban on (even) ``reproductive'' cloning.\13\ The conflict is
    between the public statements of the bill's supporters in Congress, and
    the real-world impact of the legislation they support.
    ---------------------------------------------------------------------------
        \13\ ``There is not yet clear consensus that reproductive SCNT in
    cases of infertility serves a compelling need . . . Nor is there clear
    consensus on a compelling need to bar the technique.'' Id., p. 875.
    ASRM can support S. 303, consistent with its own policy, because the
    bill's authorization for research cloning will help make its ban on
    ``reproductive cloning'' a temporary one.
    ---------------------------------------------------------------------------
        4. The bill allows exporting of cloned embryos to facilitate
    violations of other countries' laws. Incredibly, the bill forbids
    exporting of cloned embryos (``unfertilized blastocysts'') to a foreign
    country only ``if such country does not prohibit human cloning'' (page
    3 lines 19-21). Under S. 303, cloned embryos can be exported to foreign
    countries that do prohibit ``human cloning'' as defined by the bill,
    where they will be used in illegal efforts to initiate pregnancies with
    cloned embryos. Thus the bill would facilitate abroad what it purports
    to make illegal here.
        5. Through careless and incoherent drafting, the bill potentially
    restricts activities that are not human cloning. To mention only a few:
        (A) ``human somatic cell''--defined to include ``any human cell
    other than a haploid germ cell'' (page 2 lines 14-16), so that it
    includes even the one-celled embryo. It will be a crime to implant in a
    uterus any embryo produced by transferring the nucleus from one single-
    celled embryo into another embryo or an unfertilized egg. By most
    definitions this is not cloning; it is a nuclear transfer technique
    used in some fertility clinics in an effort to circumvent mitochondrial
    disease (by replacing the defective mitochondrial DNA found in the
    protoplasm of the woman's own egg), to allow women with this disease to
    have healthy children. S. 303 bans this nuclear transfer procedure
    itself (page 9 line 23 to page 10 line 2), and also bans transferring
    any of these repaired embryos to a woman's womb (page 3 lines 13-14, in
    light of the definitions on page 2).
        (B) ``unfertilized blastocyst'' (page 3 lines 3-9)--This is
    apparently intended as a demeaning reference to cloned embryos, but the
    word ``blastocyst'' is inaccurately used here to refer to the one-
    celled embryo initially produced by cloning, and even to the 14-day-old
    cloned embryo (whose further survival is made illegal by S. 303).\14\
    More broadly, ``unfertilized blastocyst'' is defined as any ``intact
    cellular structure'' produced by somatic cell nuclear transfer, so the
    bill bans transferring this product to a woman's womb whether it is an
    embryo or not. For example, if researchers develop a way to modify the
    egg or the somatic cell in advance, so that the initial product of this
    technique is not a living organism but a culture of stem cells (as some
    researchers say they may be able to do), this would be covered by the
    ban. Placing, say, endothelial stem cells produced by this hypothetical
    technique into a woman's womb to help heal her endometrial tissue would
    not be forbidden by any moral principle of which I am aware--but under
    a literal reading of this bill, it could provoke a ten-year prison
    sentence.
    ---------------------------------------------------------------------------
        \14\ In embryology the ``blastocyst'' is the embryo from four to
    around seven days old.
    ---------------------------------------------------------------------------
        (C) ``the functional equivalent of a uterus'' (page 2 line 13)--
    This odd phrase is not defined, leaving room for much confusion. For
    example, S. 303's prime sponsor has repeatedly said there is no such
    thing as the functional equivalent of a uterus, because the function of
    a uterus is to turn the new embryo into a ``human life'' and no
    artificial environment can fulfill this task:

            After many conversations with scientists, ethicists, patient
            advocates, and religious leaders and many hours of thought,
            reflection, and prayer, I reached the conclusion that human
            life does not begin in the petri dish. I believe that human
            life requires and begins in a mother's nurturing womb.\15\
    ---------------------------------------------------------------------------
        \15\ Statement of Senator Orrin Hatch before the Senate Commerce
    Subcommittee on Science, Technology and Space, January 29, 2003.

        If, on the other hand, the phrase ``functional equivalent'' is to
    have any application, one can only guess how effective an artificial
    environment must be to qualify as a ``functional equivalent'' of a
    uterus. Certainly a Petri dish itself does not qualify, for then even
    cloning for research (which requires developing the cloned embryo to
    the blastocyst stage in that dish) would be banned. Perhaps a
    ``functional equivalent'' is an environment that could sustain the
    cloned embryo to live birth, because any womb that fails to do so would
    not fulfill the usual ``function'' of a womb. In that case, one may
    transfer the embryo to any artificial environment that would fall short
    of this function to any extent--in other words, at present one may
    transfer the embryo to any and all artificial environments. This will
    be important in the likely event (discussed below) that the bill's
    ``14-day rule'' for maintaining a cloned embryo is later changed.
        6. The bill erects a Potemkin village, a mere facade, of protection
    against research risks for human subjects involved in cloning research.
    Title II of the bill (page 8 ff.) claims to expand current regulations
    on federally funded research involving human subjects (Subpart A of 45
    CFR Part 46), so they will now apply to all ``research involving
    nuclear transplantation'' (even if privately funded). This one-sentence
    expansion of federal regulations into the private sphere raises a
    number of serious legal and jurisdictional issues that cannot be
    explored in depth here.\16\
    ---------------------------------------------------------------------------
        \16\ One threshold question would be: What activities involving
    nuclear transplantation will count as ``research''? The question is now
    easily answered operationally in the case of federally funded research,
    because each research proposal must be submitted to the Federal
    Government in the form of a grant request. Potential grantees have an
    interest in arguing that what they wish to do is research. Is any
    current federal definition of ``research'' clear and specific enough to
    be applied to those conducting privately funded activities, even when
    the researchers will have an interest in denying that they are
    conducting ``research'' (so they can exempt themselves from this Title
    of the bill)? Does this bill really intend to say that if a project is
    not research--if cloning is used to produce human embryos simply for
    sport, or in order to ``farm'' them for strictly commercial purposes,
    such activity is exempt from these restrictions?
    ---------------------------------------------------------------------------
        However, assuming that the goal here is to place real ethical
    limits on human cloning for biomedical research, that goal is not met
    at all. Three distinct classes of humans may be involved in cloning
    research--the embryos created by cloning, the women solicited for their
    eggs, and the patients who donate body cells in the hope of receiving a
    genetically compatible stem cell treatment--and this Title lets them
    all down:
        (A) There is no ethical limit on what one may do to cloned embryos
    outside the womb, because there are no such limits in federal human
    subjects regulations. To be sure, there are limits--in fact, there is
    an absolute ban--on federally funded research that harms or destroys
    human embryos, specifically including cloned embryos.\17\ However, that
    is statutory language, not part of the Code of Federal Regulations, so
    it will not apply. This is, of course, by design--if S. 303 did extend
    Congress's policy on federally funded human embryo research to the
    private sector, the research favored by supporters of S. 303 would be
    illegal. This raises a very odd contradiction: Congress will enshrine
    as permanent law whatever regulatory language happens to have been
    written by the staff of the Executive branch up to the moment when this
    bill is enacted (page 9 lines 15-22)--but Congress will ignore its own
    statutory language that has been duly enacted and signed into law by
    Democratic and Republican presidents every year for the past six years,
    although it is the only federal policy that directly relates to the
    issue at hand. The only relevant provision that S. 303 itself provides
    on this point is in direct contradiction to current federal policy on
    embryo research--that is, the provision requiring all cloned embryos to
    be destroyed at the age of 14 days (page 10 lines 3-7). In federally
    funded projects, of course, Congress forbids researchers to destroy or
    harm cloned human embryos.
    ---------------------------------------------------------------------------
        \17\ See the Dickey amendment, note 4 supra.
    ---------------------------------------------------------------------------
        (B) Title II places no ethical limits on what may be done to human
    subjects who may be the recipients of stem cells from cloned embryos.
    The bill's expansion of federal human subjects regulations into the
    private sector applies only to ``research involving nuclear
    transplantation'' (that is, the act of creating cloned embryos). Since
    1999, the law on federally funded research involving human embryos has
    been construed not to apply to activities using stem cells derived from
    those embryos.\18\ The sponsors of S. 303 certainly agree with this
    legal opinion, which allows the Federal Government to fund embryonic
    stem cell research even when it cannot fund the research in which the
    embryos are created or destroyed. S. 303 actually reinforces this
    distinction, by explicitly defining the ``unfertilized blastocyst''
    produced by nuclear transplantation to exclude any stem cells derived
    from this blastocyst (page 3 lines 6-9). So the considerable risks
    involved in placing embryonic stem cells from cloned embryos into
    patients--an activity that in animals can produce tissue rejection,
    overproliferation, and tumor formation--are completely unaddressed by
    this bill.\19\
    ---------------------------------------------------------------------------
        \18\ HHS General Counsel Harriet S. Rabb, Memorandum to NIH
    Director Harold Varmus on ``Federal Funding for Research Involving
    Human Pluripotent Stem Cells,'' Jan. 15, 1999.
        \19\ The NIH notes: ``The potential disadvantages of the use of
    human ES cells for transplant therapy include the propensity of
    undifferentiated ES cells to induce the formation of tumors
    (teratomas).'' NIH, note 5 supra, p. 17. In short, ``undifferentiated
    embryonic stem cells are not considered as suitable for transplantation
    due to the risk of unregulated growth.'' Id., p. 97. Also see S.
    Wakitani et al., ``Embryonic stem cells injected into the mouse knee
    joint form teratomas and subsequently destroy the joint,'' 42
    Rheumatology (2003), pp. 162-5. And recent studies indicate that even
    stem cells from cloned embryos, supposedly a genetic match, may be
    rejected by recipients' bodies. See Y.L. Tsai et al., ``Plasticity,
    Niches, and the Use of Stem Cells,'' 2 Developmental Cell (June 2002),
    pp. 707-712 at p. 710.
    ---------------------------------------------------------------------------
        (C) Title II places only the vaguest and most inadequate limits on
    what can be done to women selected as ``donors'' of eggs. Again,
    current federal regulations contain no specific guidance on the
    standards for donating eggs to make embryos, for the obvious reason
    that it has been a de facto federal policy for 23 years not to fund
    human in vitro fertilization research. The regulations contain some
    vague and general guidelines regarding risks, informed consent, and
    approval by institutional review boards (IRBs). But egg donation for
    the purpose of creating embryos for research is one of those practices
    that the entire IRB system is supposedly designed to discourage--that
    is, the practice of involving human subjects in research that imposes
    significant risks upon them but can be of no benefit to them as
    individuals. S. 303 wrongly seems to assume that a signature on a
    consent form (page 10 lines 9-13) and compensation for ``time or
    inconvenience'' (page 9 lines 12-14) will justify researchers in
    subjecting women to serious risks, including a potentially increased
    risk of ovarian cancer, in the name of progress. This approach ignores
    what Professor Alta Charo and the other members of the National
    Bioethics Advisory Commission warned in 2001, when they issued a report
    on the inadequacy of current safeguards against such exploitation of
    human subjects:

            No matter what potential benefit is offered to individual
            participants or society at large, the possibility of benefit
            from one element of a study should not be used to justify
            otherwise unacceptable elements . . . In our view, IRBs should
            appreciate that for some components of a study, participants
            might incur risks with no personal potential benefit . . . For
            these elements, there should be some limitation on the amount
            of social and physical risk that can be imposed, regardless of
            the participants' willingness to participate or the monetary
            (or other) enticement being offered.\20\
    ---------------------------------------------------------------------------
        \20\ NBAC, Ethical and Policy Issues in Research Involving Human
    Participants (Bethesda, Maryland: August 2001), p. iii (emphasis
    added).
    ---------------------------------------------------------------------------
        This NBAC report also called attention to serious deficiencies in
    the IRB system itself as it currently exists, including the conflicts
    of interest that often allow IRBs to represent the interests of their
    own research institution rather than those of vulnerable human
    subjects:

            In recent years, increasing strains on the system have
            undermined the practice of independent review. IRBs are
            overburdened by the volume of research coming before them, a
            strain that is compounded by concerns about training of IRB
            members and possible conflicts of interest. In addition, the
            constantly changing nature of research challenges existing
            notions about what constitutes risks and potential benefits . .
            . Today, investigators and IRBs are rightly confused over
            issues as basic as which areas of inquiry should be reviewed
            and who constitutes a human participant.\21\
    ---------------------------------------------------------------------------
        \21\ Id. p. iii, vii (emphasis added). For an extreme recent case
    of ``conflict of interest,'' see the findings of Maryland's highest
    court in Grimes v. Kennedy Krieger Institute, 782 A.2d 807 (Md. 2001).
    The court found that the IRB at Johns Hopkins University had
    ``abdicated'' its responsibility to protect children from research
    risks, and had shown itself ``willing to aid researchers in getting
    around federal regulations designed to protect children used as
    subjects in nontherapeutic research'' (that is, research that would not
    benefit those particular children). No one who has read this decision
    will want to entrust all ethically controversial research decisions
    solely to IRBs.

        The Commission even noted with concern that ``there are no clear
    criteria for IRBs to use in judging whether the risks of research are
    reasonable in terms of what might be gained by the individual or
    society.'' \22\
    ---------------------------------------------------------------------------
        \22\ Id., p. xvi (emphasis added).
    ---------------------------------------------------------------------------
        It is difficult to reconcile this pointed and well-deserved
    critique of the current system with the enthusiastic endorsement given
    to it by Professor Charo in her testimony before this Subcommittee
    today. How can this new, complex and ethically controversial field of
    human cloning research--research that may endanger women and
    desperately sick patients as well as embryonic humans--be adequately
    addressed by a system so often found incapable even of meeting its
    current obligations to protect human subjects in traditional medical
    research?
        (D) Title II's reference to FDA oversight is confusing,
    unpersuasive and incoherent. At an earlier hearing before the House of
    Representatives, Members of Congress of both parties found the claim of
    FDA jurisdiction over human cloning to be unpersuasive.\23\ At the very
    least, any such claim must address a very basic threshold question. In
    order to claim that FDA regulations can be applied to research
    involving ``nuclear transplantation'' (page 9 lines 19-20), what kind
    of entity does the cloned embryo have to be? These regulations do not
    cover medical techniques or procedures as such, but relate to
    ``products'' such as ``foods, including dietary supplements, that bear
    a nutrient content claim or a health claim, infant formulas, food and
    color additives, drugs for human use, medical devices for human use,
    biological products for human use, and electronic products'' (21 CFR
    Sec. 56.101(a)). Assuming that the cloned embryo is not a food additive
    or a drug, he or she must be a ``biological product''--a commodity to
    be tested for its dangers to others. Not only is this a false,
    demeaning and dehumanizing label for a fellow member of the human
    species, but it directly contradicts the sponsors' alleged rationale
    for banning ``reproductive'' cloning--that is, the risks to the child,
    including the massive risk of miscarriage and birth defects. One and
    the same entity cannot be the innocent victim of the experiment, and at
    the same time be the dangerous ``biological product'' from whom others
    must be protected by the Food and Drug Administration.
    ---------------------------------------------------------------------------
        \23\ Hearing before the House Energy and Commerce Subcommittee on
    Oversight and Investigations, March 28, 2001. The opening remarks by
    Committee Chairman Rep. Billy Tauzin were characteristic of Members'
    reactions: ``The FDA argues these old federal laws regulating new drugs
    cover a human cell or a human fetus. I frankly do not find it obvious
    that a human fetus is a drug.''
    ---------------------------------------------------------------------------
        (E) The bill's policy on research involving the cloned child in the
    womb raises especially disturbing moral and legal issues. While current
    federal regulations on protection of human subjects do not cover the
    embryo outside the womb, they do protect the embryo and fetus implanted
    in the womb as well as the pregnant woman (45 CFR Sec. Sec. 46.201 to
    46.207). However, S. 303 refuses to expand to the private sector these
    specific protections for the cloned unborn child or the woman who may
    bear him or her--for these are found in Subpart B of Part 46, and Title
    II expands the reach only of Subpart A (see page 9 line 18).\24\
    Researchers who were not themselves involved in the illegal act of
    transferring the cloned embryo to a uterus would surely be interested
    in observing any special risks or other developments arising from the
    first human clonal pregnancy. Apparently S. 303 refuses to expand
    protections for pregnant women and their cloned unborn children in
    order to avoid a direct contradiction: The existing federal regulations
    forbid federally funded researchers to impose significant risks of harm
    and death on the unborn human subject (see 45 CFR Sec. 46.204), but
    sponsors of S. 303 want to ban ``maintaining'' the cloned unborn child
    for more than 14 days in any environment except a deep freezer (page 10
    lines 3-7). It seems this latter requirement can only be obeyed by
    forcing an abortion about one week after implantation (which usually
    occurs about six days after the embryo is formed). This raises a moral
    and perhaps even constitutional nightmare, and directly contradicts
    federal policies that have sought to protect fetuses and pregnant women
    from harmful research since 1975.
    ---------------------------------------------------------------------------
        \24\ Transferring such an embryo to the womb is of course illegal
    under S. 303, and those who perform this activity would be prosecuted
    and imprisoned. If the woman is not herself punished, she will still be
    potentially available as a subject for observational research on human
    clonal pregnancies (research conducted by researchers other than the
    original felons). If she, too, is imprisoned, however, she might be
    protected by the federal regulations providing additional protections
    for prisoners subjected to research (Subpart C, 45 CFR Sec. Sec. 46.301
    to 306)--if not for the fact that S. 303 excludes Subpart C as well.
    ---------------------------------------------------------------------------
        7. Most generally, this bill's policy on the human embryo ratifies
    one gravely demeaning view that lies at an extreme end of the spectrum
    in our divided and pluralistic society: The embryo as commodity, as
    nothing more than disposable property to be manufactured and discarded
    to suit the desires of others. It is important to note this, because
    supporters of cloning for research have wrongly applied this
    ``pluralistic society'' argument against the Brownback bill.\25\ The
    fact is that a complete ban on cloning, already approved by a number of
    states as well as foreign countries, can be supported and is supported
    by Americans with a wide array of views on the moral status of the
    embryo--those who, like myself, hold that each and every member of the
    human species deserves to be protected as a human person; those who,
    like some ethicists, columnists and others, hold that the embryo (if
    not a ``full'' person) is at least a developing human life that
    deserves respect and should not be created solely to be destroyed; \26\
    and those who are agnostic on the status of the embryo but recognize
    that a complete ban on cloning is the only effective and enforceable
    way to prevent cloning for babymaking as well as further assaults on
    human dignity.\27\ By contrast, the enactment of S. 303 would assume,
    and seek to promote, a national consensus that the cloned embryo has no
    moral status whatever, or has the status of a being whose survival is
    an active threat to the public good. No other view is consistent with a
    policy that this embryo may be created at will, but that government can
    mandate its destruction at a certain stage.
    ---------------------------------------------------------------------------
        \25\ See Testimony by Dr. Paul Berg (``We take considerable pride
    in being a pluralistic society''), Dr. Harold Varmus (``(W)ho has such
    moral standing that they [sic] would impose on our multi-ethnic,
    pluralistic society an ethical standard that only a minority would
    endorse?''); and Dr. Thomas Murray (``Respecting the diversity of
    beliefs about families, about women, men, children--and embryos--honors
    our most noble traditions'') before the Senate Judiciary Committee,
    March 19, 2003.
        \26\ ``We can debate all day whether an embryo is or isn't a
    person. But it is unquestionably human life, complete with its own
    unique set of human genes that inform and drive its own development.
    The idea of the manufacture of such a magnificent thing as a human life
    purely for the purpose of conducting research is grotesque, at best.''
    Editorial, ``Embryo Research Is Inhuman,'' Chicago Sun-Times, October
    10, 1994, p. 25.
        \27\ See ``Statement of Dr. Krauthammer,'' in The President's
    Council on Bioethics, note 6 supra, pp. 277-285.
    ---------------------------------------------------------------------------
        Under S. 303 it would be a federal offense to let such an embryo
    survive, or to show this fellow human being any degree of respect. Dr.
    Charles Krauthammer has observed:

            Creating a human embryo just so it can be used and then
            destroyed undermines the very foundation of the moral prudence
            that informs the entire enterprise of genetic research: the
            idea that, while a human embryo may not be a person, it is not
            nothing. Because if it is nothing, then everything is
            permitted. And if everything is permitted, then there are no
            fences, no safeguards, no bottom.\28\
    ---------------------------------------------------------------------------
        \28\ Id., p. 285.

        I am confident that Congress will not enact such a gravely immoral
    policy and that President Bush would refuse to sign it.
        8. Finally, this bill as written cannot achieve its stated
    objective of advancing therapies, and the biotechnology lobby has
    already moved on to broader policies for exploiting cloned humans at
    the fetal and newborn stages. The sponsors of this bill have apparently
    failed to notice that only two animal studies have claimed to show any
    ``therapeutic'' benefits from cloning for research. One study, seeking
    to provide kidney tissue for cows, found it necessary to develop the
    cloned cow embryos to the fetal stage so they could be aborted for
    their partly formed kidney tissue.\29\ The other, seeking to remedy an
    immune deficiency in mice, found it necessary to produce a newborn
    mouse whose adult stem cells could be transplanted into the original
    mouse.\30\ These and other studies have found embryonic stem cells to
    be enormously difficult to culture, to control, and to develop into
    usable cells that will integrate with the host animals' cells; they
    have found these cells to have a disturbing tendency to form lethal
    tumors in recipients' bodies; and they have found that even embryonic
    cells from cloning can be rejected by the recipients' bodies, perhaps
    because of inherent differences between embryonic and adult cells.\31\
    Reading the handwriting on the wall, state biotechnology alliances have
    conducted simultaneous campaigns in several states to pass legislation
    authorizing
    ---------------------------------------------------------------------------
        \29\ R. Lanza et al., ``Generation of histocompatible tissues using
    nuclear transplantation,'' 20 Nature Biotechnology (July 2002), pp.
    689-96. The authors wrote: ``Because the cloned cells were derived from
    early-stage fetuses, this approach is not an example of therapeutic
    cloning and would not be undertaken in humans.'' Id, p. 689. Now lead
    researcher Robert Lanza has reversed his stand, insisting that this
    study is indeed a model for ``therapeutic cloning.'' See Do No Harm:
    The Coalition for Research Ethics, ``Reality Check: Proof of
    `Therapeutic' Cloning?'', March 10, 2003 (www.stemcellresearch.org/pr/
    pr20030310.htm).
        \30\ W. Rideout et al., ``Correction of a Genetic Defect by Nuclear
    Transplantation and Combined Cell and Gene Therapy,'' 109 Cell (April
    15, 2002), pp. 17-27. For a critique of this study see Americans to Ban
    Cloning, ``Why the `Successful' Mouse `Therapeutic' Cloning Really
    Didn't Work,'' April 2002 (http://cloninginformation.org/info/
    unsuccessful_mouse_therapy.htm).
        \31\ See note 19 supra.

            research involving the derivation and use of human embryonic
            stem cells, human embryonic germ cells, and human adult stem
            cells from any source, including somatic cell nuclear
            transplantation.\32\
    ---------------------------------------------------------------------------
        \32\ Such language was enacted into law in California in September
    2002. Virtually identical language has been proposed in: Illinois (HB
    3589, introduced February 2003), Maryland (HB 482, introduced February
    2003), New Jersey (S. 1909, introduced September 2002), New York (A.
    1819, introduced January 2003), Pennsylvania (HB 422, introduced
    February 2003), Texas (SB 1034, introduced March 2003), Vermont (H.
    326, introduced in 2003), and Washington (SB 5466, approved by
    Committee March 2003).

        Embryonic germ cells, of course, are harvested at the fetal stage
    (at around 8 weeks' gestation), while adult stem cells are harvested
    from infants and children. In this new generation of cloning
    legislation, the old distinction between ``therapeutic'' cloning and
    ``reproductive'' cloning has been obliterated: Researchers will conduct
    ``reproductive'' cloning (developing cloned embryos to at least the
    fetal stage) to achieve ``therapeutic'' cloning (producing usable stem
    cells for supposed therapies).
        At present S. 303 punishes efforts to maintain the cloned embryo
    past the 14th day. But this is an arbitrary limit, and Congress will be
    hard pressed to find a principled reason not to extend this to 20 days,
    or 30, or 100, if (as now seems more than likely) researchers report
    that such an extension is necessary to fulfill the ``promise'' of
    ``therapeutic cloning.'' In the laboratory of the states, this broader
    agenda has already been launched.
        S. 245 (Brownback/Landrieu)
        By contrast, S. 245 has none of the serious problems outlined
    above. Very briefly, this bill:

            1. Does ban human cloning, as that is accurately and
            scientifically defined.

            2. Imposes its penalties on irresponsible researchers, not on
            vulnerable women, and avoids the moral, legal and
            constitutional problems raised by efforts to ``ban'' pregnancy
            and birth.

            3. Effectively attacks the threat of ``reproductive cloning''
            at its root, by preventing the production of cloned human
            embryos.

            4. Bans shipping, receiving or importing of cloned human
            embryos for any purpose, preventing any collusion by the U.S.
            Government with those who wish to violate other countries' laws
            against cloning.

            5. Is carefully crafted to avoid interference with any activity
            other than human cloning.

            6. Directly protects all humans who would be harmed by the
            practice of human cloning (embryos, patients, and women who
            might be exploited for their eggs), by banning the practice for
            any purpose.

            7. Respects the diversity of American views on the human
            embryo, by enacting only those provisions necessary to ban
            human cloning and leaving other research (including embryonic
            stem cell research that does not involve cloning) to be
            addressed by other proposals.

            8. Prevents future ``slippery slopes'' that would require us to
            demean and exploit ever wider classes of our fellow humans as
            sources of body parts.

        This is a case in which how we achieve an important goal is at
    least as important as whether we achieve it. We should ban human
    cloning--by banning the use of the cloning procedure to create new
    developing humans in the first place, as in the Brownback/Landrieu
    cloning ban (S. 245). Legislation which allows the practice, and then
    seeks to dehumanize and destroy the humans thus produced so we can
    pretend we have banned cloning, is worse than doing nothing. I urge
    Congress to oppose S. 303, and to approve the genuine ban on human
    cloning offered by S. 245.

        Senator Brownback. Thank you very much, Mr. Doerflinger.
        We have now been joined by Ms. Lynne Millican. She is a
    patient/advocate, had difficulty getting in this morning, and,
    I think, was not feeling quite the best, and we are very
    appreciative of your willingness to come and testify this
    morning in spite of how you have been feeling. Thank you for
    joining us, and the floor is yours.

     STATEMENT OF LYNNE MILLICAN, R.N., B.S.N., PARALEGAL, BOSTON,
                             MASSACHUSETTS

        Ms. Millican. Well, I am honored to be here, and I did have
    great difficulty in getting here.
        I actually should not have to be here. I underwent
    fertility treatment to have a baby. However, I think I am more
    like egg donors than anybody else, because the extent of my
    disease was such that I needed a hysterectomy. I never expected
    to have children. I just wanted to make sure that I would not
    be 40 years old and look back and think, ``What if I had
    tried?''
        So that is the context that I underwent this treatment, and
    I was given the drugs Lupron and Pergonal. Before I took these
    drugs, I had endometriosis, misdiagnosed which resulted in
    infertility, a knee injury, colds, flus, and usual childhood
    illnesses. Since Lupron, it has been a nightmare. Everybody
    wants to promote research, but who is looking out for the harm
    that is being caused by this? I am just one--there are
    thousands of Lupron victims, and they are one of the reasons
    why I am here today, because when I was vomiting at 5 o'clock
    this morning, all I could think of is if I do not come here and
    tell you people about all of these sick women out there, I
    would never be able to live with myself.
        I am a registered nurse, but I cannot help these people. I
    have had difficulty getting help myself. In 1995, after six
    years of going through this, I testified at the Massachusetts
    Health Care Committee, because when I realized, in 1990, that
    there were no regulations, no laws, no protections, no nothing,
    no consumer advocacy, no governmental assistance, no state
    assistance, no consumer agency assistance, I wound up getting
    involved in drafting a piece of legislation, a first-in-the-
    Nation bill in Massachusetts that would require fertility
    clinics to have a license to operate. I provided written and
    oral testimony every year.
        In 1995, at that time, I sat down at my computer and I
    typed in single space on continuous computer paper every
    doctor's office visit, surgery test, lab, procedure that I had,
    and this is just to 1995. This paper is seven and a half feet
    tall. And I am just one victim.
        If you go on the National Lupron Victims Network, yesterday
    morning there were over 2 million hits, and the counter just
    started January 1st, 2000. Lupron is not FDA approved for
    fertility treatment. It is a pregnancy category-X drug,
    according to the FDA. It is a hazardous drug according to NIH
    and OSHA. It is a reproductive and developmental teratogen. It
    has been referred to as a toxicant. I was told it was safe and
    effective and used successfully throughout the world. I run
    into women who never heard this risk information. This is
    unacceptable.
        The Boston Globe, in August of 1996, quoted the Nation's
    largest volume fertility clinic, a physician, as stating,
    ``Women do not need to know that Lupron is not FDA-approved for
    fertility treatment.'' I disagree.
        I have had adenoma, breast cysts, cardiac arrhythmias,
    dizziness, edema, fatigue, gastritis, gastroesophageal reflux
    disease, hyperlipidemia, immune system abnormalities, joint
    pain, knee pain, lymphadenopathy, myalgia, neuralgia,
    osteopenia, now I have severe osteoporosis. My dentist said my
    jaw is dissolving. I have lost one tooth, and the rest of them
    are loosened.
        I am not alone. Initially, I did think I was alone. I would
    ask all the doctors, ``I just took Lupron. Is this related to
    Lupron?'' They'd say: ``No, nothing to do with it. Just
    coincidence. It is just your time.'' Well, it is not my time.
        Candice Hedin, of Marlboro, Mass., seven years ago took
    Lupron for fertility treatment, with Clomid. She suffered
    multiple unexplained serious illnesses. She has been
    hospitalized for unexplained chest pain, inability to breathe,
    about 15 times. She has hives inside her mouth and throat, open
    sores. She cannot eat or drink anything. She gets hospitalized.
        Wendy Camacho, Cherry Hill, New Jersey, took Lupron for IVF
    years ago. As she puts it, ``my IVF baby is now nine and my
    health is a mess. It has been downhill since. I have seen
    neurologists, rheumatologists, orthopedists. None of them have
    any answers for me. I have severe fatigue, fibromyalgia,
    trouble sleeping, nightmares, gross motor skills are
    disintegrating fast.'' I could go on and on, and these are just
    a few people----
        Senator Brownback. Would you----
        Ms. Millican.--that I put in.
        Senator Brownback.--would you submit those for the record?
        Ms. Millican. I have.
        Senator Brownback. Okay, I just want to make sure that we
    have those in the record, those of other people, other
    statements from individuals.
        Ms. Millican. I included them within my own statement.
        Senator Brownback. Good.
        Ms. Millican. There is much more that I could have put in
    my statement. Time did not permit.
        I do not feel that any victim should ever have to do what I
    have had to do. I brought this just simply as a display.
        I had to file my own lawsuit without a lawyer. I am not a
    lawyer. There is nobody to help these people. Although I do
    have to say now--you know, I started this in 1989--now there
    are lawsuits that are being filed.
        TAP has been sued for product liability. They are being
    settled. I do know that cases are being consolidated, and I do
    foresee a class action looming large. TAP has been declared a
    criminal enterprise based upon its scheme with physicians and
    billing fraud and kickbacks and--they just paid the largest
    fine in history at the time, $875 million. They allegedly have
    been maintaining a registry of babies exposed, inadvertently
    exposed, to Lupron, and they have a registry of over a hundred
    babies. That data is as of 1992. Somebody needs to find out how
    these babies are. TAP Pharmaceuticals maintains that there are
    no birth defects attributable to the drug.
        I know women myself with adverse pregnancy: birth outcomes
    after Lupron, and there are women on the Internet who report
    similar problems. There are problems with all of these drugs. I
    am especially concerned about Lupron, because I do believe that
    it is an especially toxic drug. But I have concerns about other
    drugs, as well. There has been no long-term epidemiologically
    sound research looking into the long-term health effects of any
    of these drugs.
        And where are you going to get these eggs from? You are
    going to get them from women who think they are doing a good
    thing, maybe who need some money. I have seen egg donor ads in
    Boston, ``We're on the T.'' Poor women who do not have cars,
    who need money, who are going to be going for this, and they
    need to know about the risks. And where are they going to hear
    it from? Only from somebody like me or other victims. And I do
    not get an opportunity to do this, because I am sick a lot of
    the time. But where are these women going to hear about this?
    The fertility industry is not telling them. I call them a bunch
    of ``reproductive endo-criminologists.''
        There is a lot more that I have to say, but----
        [The prepared statement of Ms. Millican follows:]

    Prepared Statement of Lynne Millican, R.N., B.S.N., Paralegal, Boston,
                                 Massachusetts
        Mr. Chairman, and Members of the Committee:
        I am honored for the invitation to speak to you today on this very
    important issue. And although I am a registered nurse, I am here before
    you because of personal experiences as a patient undergoing
    superovulation during in vitro fertilization (IVF) attempts at several
    Boston fertility clinics over a decade ago--and because of what I've
    learned in the interim. My focus will be upon the adverse effects to
    the eggs, embryos, fetuses and women from one particular and commonly
    used drug, Lupron (leuprolide acetate), which is not FDA approved for
    fertility treatment; as well as addressing the risks from other
    fertility drugs and the assisted reproductive technology (ART)
    procedures in general.
        For ease of reading and reference, this paper will be arranged
    under the following 13 headings:

            1. Preliminary Comments
            2. Dead Women Don't Talk--p.4
            3. On The Count Of Eggs And Money--p. 5
            4. A Brief Overview of the ``Hazardous'', ``Commonly
            Prescribed'' Agent Lupron--p.12
            5. Impact of Lupron Upon Women's Brains, Bodies, and Bones--
            p.14
            6. Known Effects Of Lupron On Eggs, Embryos, and Babies--p.16
            7. Examples of Iatrogenic Illnesses Induced By Exposure--p.19
            8. Rita Abend, D.D.S.--Her Story & The Inception Of The NLVN--
            p.29
            9. The State of the ART, And The ART of Stating--p.32
            10. The Check is in the Fe/male--p.33
            11. Considering Cloning? Consider the Myths of Hype, and The
            Realities of Scientific Misconduct--p.36
            12. The Marginalization Of Victims And Lack Of Medico-legal
            Advocacy--p.39
            13. A Request To Congress Asking For An Investigation Into
            Lupron and ART--p.44

    1. Preliminary Comments
        The drugs and fertility agents and the processes used in
    superovulation regimes for fertility treatments are exactly the same as
    that used to obtain women's eggs for cloning research (although
    numerous variations of the protocols exist within the core group of
    `fertility drugs'). Cloning cannot take place without women's eggs, and
    therefore the information I have to offer concerning the risks of
    fertility treatment have direct application to the process of
    therapeutic cloning. It has been estimated that some 8 million eggs per
    year may be necessary to sustain therapeutic cloning research--how many
    women would that entail? My research into the medical literature
    revealed the maximum top three reports of numbers of eggs retrieved at
    one time as being: 91 eggs from one woman at one time (Source, 1995),
    71 eggs from one woman at one time (Lewit, 1995), and 56 eggs from one
    woman at one time (Lim, 1995). Since this research will require
    millions of eggs, this demand translates into the need to obtain as
    many eggs as possible from each woman per attempt. To quote from the
    consent form for egg donation for purposes of stem cell research at
    Advanced Cell Technology: ``The idea is that the greater number of
    fully mature eggs, the greater the chance of successfully utilizing
    them in this research.'' (ACT)
        A dozen years ago, an article examined ``[t]he risks associated
    with ovulation induction'', identifying that ``epidemiologic studies
    are needed to determine the true risks associated with exposure'' to
    the older, `traditional' fertility drugs (St. Clair Stephenson, 1991).
    More than a decade later, the question is still being asked: `Are we
    ignoring potential dangers of in vitro fertilization and related
    treatments?' (Winston, 2002). Costly complications from ART were, in
    part: a high incidence of first and second trimester bleeding,
    spontaneous abortion, toxemia, fetal growth restriction, anemia,
    anesthetic complications, ovarian hyperstimulation syndrome, culture
    medium infections (hepatitis and AIDS), visceral and vascular injuries,
    pathogenic infections, and breast and ovarian cancer. (Schenker, 1994).
    I believe it was Mirabella's August 1993 issue which carried `A
    Doctor's Story', about a physician who took Clomid and was diagnosed
    with breast cancer. Large scale, epidemiological sound studies remain
    lacking on these earlier drugs, and yet in the interim years, the newer
    fertility `agents' have been added and have themselves become
    `traditional', standard, chemicals used in ovulation induction--but
    again, this standard has developed without any epidemiologically sound,
    long-term, safety data. It is noteworthy that while Lupron has become
    `standard' within superovulation regimes, it is administered at various
    doses for various times, varying even within the various patients, and
    has varying effects.
        There have been a number of past, as well as a flurry of recent,
    published reports of birth defects in babies born from superovulation,
    IVF and other variants of ART, and it is widely acknowledged that
    critical long-term studies of the risks of ART are lacking (i.e., among
    others: Kola, 1988; Fischel, 1989; Saunders, 1989; Tanbo, 1995; Silver,
    1999; Aboulghar, 2001; Mitchell, 2002; BBC, 2002; Sutcliffe, 2002;
    Skloot, 2003). Titles often tell the story: ``Ocular Manifestations in
    Children Born After In Vitro Fertilization' (Anteby, 2001), `Congenital
    malformations in infants born after IVF: a population-based study'
    (Ericson, 2001), `Hormone and Fertility Drug Use and the Risk of
    Neuroblastoma: A Report from the Children's Cancer Group and the
    Pediatric Oncology Group' (Olshan, 1999), `Congenital malformations in
    infants born after IVF: a population-based study' (Ericson, 2001),
    `Brain worry over IVF children' (Health, 2002), `Low and very low birth
    weight in infants conceived with use of assisted reproductive
    technology' (Schieve, 2002), `The Risk of Major Birth Defects after
    Intracytoplasmic Sperm Injection and in Vitro Fertilization' (Hansen,
    2002), `In Vitro Fertilization May Be Linked To Bladder Defects'
    (Trock, 2003), `Some Studies Sees Ills for In Vitro Children' (Mestel,
    2003), `Incidence of retinoblastoma in children born after in-vitro
    fertilisation' (Moll, 2003). March 2002 brought headline news that the
    highly promoted and touted low incidence of birth defects from IVF
    (always stated as ``similar to the general population, about 2-3
    percent'') was now being reported as 9 percent--much higher than the
    general population. And now March 2003 brings news that IVF babies are
    at increased risk for urologic birth defects (Wood, 2003).
        The American Society for Reproductive Medicine, in its Annual
    Meeting in 2002, released the following statement on October 14, 2002:
    ``Studies Show Children of ART Develop Normally'' (ASRM, 2002--note
    link of `kidsareallright'). Figures don't lie, but liars figure. (In
    1990, the Federal Trade Commission brought complaints against 4
    fertility providers for false claims in fertility treatment success
    rates [FTC, 1990]). To quote the New York Times: ``Since the 1970's,
    fertility clinics have created almost a million children through
    experimental technologies. They've used untested and unregulated
    procedures . . . Where is Washington in all of this?'' (Skloot, 2003).
        Online transcripts from the FDA's Reproductive Health Drugs
    Advisory Committee Public Meeting, held October 18, 1999, identified
    ``the need for pregnancy registries of babies born resulting from such
    [ART] treatment. These drugs include GnRH agonists and antagonists,
    human menopausal gonadotropins, purified urofillitropin, recombinant
    follicle stimulating, chorionic gonadotropin, and progesterone''. The
    United Kingdom recently announced plans to study 68,000 people born as
    a result of ART (Kaiser, 2002). Will the percentage of birth defects
    from ART continue to climb in the U.K., and the U.S., with further
    study? Do human embryos really need to be grown in human ovarian cancer
    cell lines (see Ben-Chetrit, 1996)? ``Abnormal embryos'' have been
    implanted into women (Munne, 1995)--what kind of consent did that
    experiment entail? One treatment, using intravenous immunoglobulin
    (IVIG), has raised questions about the ``ability to screen for any
    diseases that could crop up 20 or 30 years down the road. Some doctors
    have even gone so far as to denounce [the] practice not as medicine,
    but witchcraft.'' (Arnot, 2000).
        Children have been born from co-culture with animal sera that could
    potentially contain prions, viruses, and/or unknown infectious agents--
    and my questions from the mid 1990's about risks from such co-cultures
    to embryos, children, and women went unanswered. In 2002, the FDA sent
    a `Dear Colleague' letter, announcing that the transfer of such co-
    cultured embryos ``constitute[d] a clinical investigation involving
    xenotransplantation'' (Letter, 2002), but no enforcement action would
    be based on already existing embryos; and FDA and U.S. Public Health
    Service guidance documents recommend, among others, ``follow patients
    for their lifetimes and counsel them to be alert to any unusual
    symptoms . . . [and] they and their intimate contacts should defer from
    donation of blood and other tissues.'' (CBER, 2002). Vero cells, from
    African green monkey kidney cells, have been used frequently in human
    embryo co-culture (i.e., see Veiga, 1999). In an online 1994 report of
    ART practices, it was stated that ``[a]lthough the firm of Merieux
    refuses to accept any responsibility for the use of these [Vero] cells
    for the culture of human embryos, they are already widely used for this
    purpose by many specialists in medically assisted procreation . . .''
    (Report, 1994). Who is minding this store?
        The nation's highest volume clinic was one of 10 participating
    clinics in a 1988 national study that attempted to look at the long-
    term health consequences of ART and drugs on the women and offspring--
    however the study made no mention of GnRHa's--the results were touted
    as `reassuring', yet results were inconclusive (although ``warrant[ing]
    epidemiologic study''), and with too few study subjects (NICHHD, 1992).
    Of note, this writer, who developed multiple health problems, was a
    fertility patient at this clinic during this study--but was never asked
    to participate in this study. More significantly, another patient who
    was asked and did participate in this study (and shared her study
    documents with me) was subsequently dropped from the study following
    her hospitalization for severe ovarian hyperstimulation syndrome during
    her fertility treatment--in which she went into kidney failure and
    nearly died.
        Many follow-up studies I've read of ART children do not identify
    the specific drugs received. My own experiences highlight the lack of
    informed consent that women experience when they ``agree'' to take
    fertility drugs. The best illustration of this is found in the Boston
    Globe's quote of the Director from Boston IVF, the `nation's largest
    volume fertility clinic' (one of the two clinics I attended) who
    proclaimed ``women do not need to know about the lack of FDA approval
    [of Lupron for fertility treatment] . . .'' (Kong, 1996) Years later,
    this clinic would receive ``$180,000 over two years to cover the cost
    of providing the embryos'' ``to Harvard University scientists for stem
    cell research. . . . Harvard researchers plan to offer the new stem
    cells to any interested scientist at no cost, with no commercial
    restrictions. . . .'' (Mishra, 2001)
        The profit within the fertility industry that exists today, as well
    as the hyped potential profit of therapeutic cloning tomorrow, along
    with lack of informed consent, the risks, and inherent exploitation all
    point to this issue having very serious ramifications upon many lives.
        A recent Popular Science article unintentionally highlights the
    issue of consent: in the March 2003 series, the McNamara's were
    featured as they had undergone experimental fertility treatment using
    cow uterus to grow their embryos. This Popular Science piece examined
    the risks of ART, and the McNamara's conclusion at the end of this
    article was ``Yeah, there is [a possibility of long-term effects] . . .
    But . . . we would still have done it.'' (Skloot, 2003). However,
    Popular Science held a Popular Science Infertility Chat on America
    Online, and, in fact, the McNamara's stated in the chat--after they had
    read the article--that ``I think it's important to point out that the
    information in the article wasn't available when we made our decisions.
    . . . Honestly, if it was presented in a way that it would cause trauma
    to our offspring, we probably wouldn't have done it.'' (Chat, 2003)
     2. Dead Women Don't Talk
        Not until long after my fertility treatment did I learn that,
    before my treatment, there were questions raised and warning given
    regarding the fertility industry's use of lack of informed consent,
    deceptive advertising and manipulated statistics. The first survey in
    the world of IVF clinics was done by two journalist/authors, Gena Corea
    and Susan Ince, and this survey revealed that while half of responding
    clinics had claimed high success rates, they had, in fact, produced not
    one baby (Corea, 1987). In 1992 I had begun legal action against my
    fertility treatment providers, and in 1997, Gena Corea (see also Corea,
    1985) provided a statement to me intended for inclusion into the Offer
    of Proof for my medical malpractice tribunal (Millican v. Harvard
    Community Health Plan, Boston IVF, Natalie Schultz M.D., Brian Walsh
    M.D., Mahmood Niaraki M.D., Selwyn Oskowitz M.D., Michael Alper M.D.)
    The following 5 paragraphs are from that statement:
        `` . . . A lack of informed consent to IVF has been a constant and
    continuing problem with IVF from its earliest days when Lesley Brown,
    pregnant with the first IVF baby, Louise, was under the misapprehension
    that hundreds of such babies had already been born. She had no idea
    that she was in such an experimental program. . . .''
        `` . . . The exact number of women who have died in in vitro
    fertilization programs is not known. However I have information on the
    deaths of ten women: in Germany, Brazil, Israel, Spain, and Martinique
    (in all these countries, I have tape-recorded interviews with the
    physicians and/or relatives of the dead women), and in Australia, New
    Zealand and Canada. Women entering IVF programs do not know of these
    deaths. Even physicians practicing IVF do not know of most of the
    deaths or their causes. With the exception of the Israelis, the IVF
    teams involved are not writing reports on the deaths for their
    professional publications nor are they delivering papers on the deaths
    at international meetings . . . No professional or governmental
    organization is recording the deaths in a data bank.''
        ``Some Brazilians know of the first death--of a woman named Zenaide
    Maria Bernardo, whose daughter and physician I interviewed in,
    respectively, Araraquara and Sao Paulo, Brazil. They know of her death
    because it occurred during a course on IVF for physicians and the
    course was a huge media event, covered by Globo, a national television
    station and the fourth largest in the world. The death could hardly be
    covered up when the television cameras were rolling. But aside from
    these Brazilian citizens, few in the public know of any IVF deaths.''
        ``To date, IVF deaths are known to have occurred due to
    hyperstimulation of the ovaries through the administration of hormones;
    anesthesia for laparoscopy; infection following laparoscopy; bleeding
    following laparoscopy; bleeding following ultrasonically-guided
    puncture of egg follicles; and ectopic pregnancy.''
        ``Physicians and the public relations firms hired by the IVF
    industry often give women the impression that IVF is a low-risk
    procedure. How do they know it is low-risk? I have interviewed
    physicians around the world on IVF deaths and without exception, I have
    known of, and had documentation on, more IVF deaths than any of them
    claimed to. Why is that? If scientists doing IVF do not know of the
    deaths their programs are causing, why don't they? What are the
    mechanisms by which this information has been obscured? Through their
    journals and conferences, physicians share information on every slight
    change in drug protocol for inducing artificial ovulation. Shouldn't
    information on deaths, injuries, psychotic breaks, lengthy recoveries
    also be shared? It's not. . . .''
    3. On The Count of Eggs and Money
        Early articles describe Lupron's application in ovulation induction
    regimes as ``in special situations'' (Blankstein, 1988), yet Lupron
    ``began to be widely used for IVF in 1989'' (Martin, 1994). By 1990
    fertility industry figures, GnRHa's were utilized in 97 percent of
    reported assisted reproductive technology cycles (MRI, 1992), with
    Lupron identified as the ``prevalent choice'' and most frequently
    prescribed GnRHa in this country (Keenan, 1991; Martin, 1994). The
    fertility industry had already achieved the recognition of being more
    than a billion dollar industry by 1990 (Talan, 1990), and sounding like
    a trumpet, a 1991 publication proclaimed ``Chronic indications for GnRH
    agonist therapy among IVF/GIFT patients are likely to increase
    significantly in the immediate future.'' (Gordon, 1991). Early on,
    Lupron's use had been described as increasing the use/purchase of
    Pergonal (manufactured by Serono) by 50 percent (Keenan, 1991), and it
    was known that ``[t]he direct financial cost of cycles incorporating
    adjunctive leuprolide therapy was 40 percent greater than the cost of
    cycles in which no leuprolide therapy was used.'' (Dodson, 1991). At
    this time, the failure rates for IVF were around 80-85 percent:
    ``rarely has a technology that has had such dismal success rates been
    so quickly accepted.'' (Raymond, 1993).
        When I complained to my Harvard HMO about their use of this
    experimental drug, their response was an illustration in how
    definitions can easily be changed; they state that institutional review
    board (IRB) review was unnecessary because Lupron was not being used in
    ``research'', but rather Lupron was being used in a ``therapeutic''
    manner. The Office for Protection from Research Risks has received
    reports from major research institutions of ``startling ignorance'' of
    IRB policies regarding informed consent in reproductive research
    (Ellis, 1995).
        Because of my nightmare experiences as a fertility consumer, I
    became involved in drafting a first in the nation bill which would have
    required fertility clinics to have a license to operate, and which
    would have mandated informed consent of ART risks (Millican (2), 1992;
    Lasalandra, 1995). My collaborator in drafting this bill, Linda
    DeBenedictis, had also attended Boston IVF and had also been mandated
    to switch to Lupron--and her story was told over a 3 part series on
    Boston TV news. Doctors from Boston IVF told the DeBenedictis' that 3
    eggs had fertilized and 3 embryos were ready for implantation the next
    morning. Upon arrival at the clinic the next morning, there were not 3
    embryos for implantation--there were no embryos for implantation. The
    clinic maintained there had been an ``error in communication'', and
    that no embryos had fertilized (WHDH, 1989).
        From 1992-1999, I provided verbal and written testimony to the MA.
    Health Care Committee in support of this bill (MA. H. 3308), and these
    documents are a testament to my experiences, my learning curve, and the
    mounting evidence against Lupron. My 1992 written testimony states: ``
    . . . nearly every IVF clinic has mandated that women take Lupron--or
    they will not be allowed to cycle  . . . Women are told that Lupron
    results in better quality and better quantity of eggs.'' In 1995, my
    testimony states I was told that I ``must use Lupron'' if I wanted to
    undergo IVF. Women reported successful IVF births without Lupron, yet
    were made to use Lupron nonetheless, and reported subsequent failure in
    these switched cycles. Other women using Lupron complain of failure to
    suppress and canceled IVF cycles, premature leutinization, and poor
    quality eggs with Lupron (see Chetkowski, 1989; Schoolcraft, 1991). The
    internet posts of women identify the badgering, and coercion, and
    manipulation, and threats used to convince women into taking Lupron for
    a variety of indications--many refer to their doctor as trying to
    ``shove it down [their] throat''.
        Later I would learn that the first survey in the world of IVF
    clinics was conducted in 1986 (Raymond, 1993), revealing deceptive
    success rate claims and manipulated figures (Corea, 1987). As a result,
    the 101st Congress held hearings in the Subcommittee on Regulation,
    Business Opportunities, and Energy, House of Representatives, in which
    data from 191 fertility clinics was published. This clinic specific
    information shows a significant number of these reporting fertility
    clinics had recently ``switched'' and/or ``began to use'' Lupron in
    their superovulation regimes--without any IRB review (Hearing, 1989).
    One reporting clinic provided testimony identifying Lupron as ``a
    costly, experimental medicine  . . .'' (Kemmann, 1989).
        One of the fertility clinics that I attended in 1990, Brigham &
    Womens, had as its protocol in its IVF brochure that ``Lupron is only
    used in certain diagnosis'', but in 1991 this clinic changed its
    brochure to read ``Lupron is widely prescribed''. I would later learn
    that the director of this IVF clinic, Dr. Andrew Friedman, had been a
    lead Lupron investigator, had received numerous grants and funds from
    Lupron's manufacturer, Takeda Abbott Pharmaceuticals (TAP), and had
    published extensively on Lupron. Dr. Friedman was ultimately found
    guilty of falsifying and fabricating approximately 80 percent of the
    data in four Lupron studies, two of which had been published and were
    subsequently retracted. Friedman had ``altered and fabricated
    information in patient medical records, falsified research notes by
    changing dates and changing and adding text'', and fabricated notes and
    fabricated patients for clinical visits that had not taken place.
    (Federal Register, 1996; see also Lasalandra, 1998; Millican, 1998;
    Kong, 1999).
        My 1995 written testimony in support of MA. H 3308 identified
    ``manipulated figures'' in a fifth Friedman Lupron study (Millican,
    1995). To the best of my knowledge, while confidential Harvard
    documents state further investigation into other Friedman Lupron data
    should be explored, no investigation has been conducted beyond the
    four, identified, fraudulent Friedman Lupron studies. Two years after
    the Federal Register publication of Friedman's fraud, the MA. Board of
    Registration `acted' by temporarily suspending his medical license,
    however the published and cited bogus data is irretrievable. And in
    fact, one fraudulent and retracted Friedman Lupron study was cited as a
    credible reference and data source in an article published on Medscape
    (Women's Health) in August 2001 (Data, 2001). In a similar faux pas,
    FDA Consumer magazine recently had to provide a correction to an
    article in which it erroneously stated GnRHa's would ``shrink
    fibroids''--a statement told repeatedly to women despite the fact
    Lupron has only been approved for ``the anemia associated with
    fibroids, when iron therapy alone has been ineffective''. The
    indication of Lupron's use to ``shrink fibroids'' received the FDA's
    rejection in the past, and no FDA approval has ever been granted for
    this indication. (FDA, 2002)
        NBC Dateline did a story January 2, 2000 about severe side effects
    experienced by women taking Lupron for endometriosis (adverse events
    such as joint pain, numbness, memory loss, irregular heart beat,
    suicidal depression, whole body swelling, grand-mal seizures). Quoting
    from the Dateline story transcript: ``[Dateline] asked TAP about the
    complaints of these women, given TAP's marketing of Lupron as ``perhaps
    making miracles possible.'' While the company declined an on-camera
    interview, [Dateline] met with several top executives, who told
    [Dateline] the preponderance of evidence suggests that Lupron works,
    otherwise women wouldn't continue to use it.'' Dateline's story
    concluded with ``[Lupron] is also widely and routinely used for women
    going through fertility treatments.'' (Dateline, 2000).
        In 2001, the U.S. Attorney's office in Boston would land the
    largest fine in history--$875 million--from TAP for its lucrative,
    unethical, illegal, conspiratorial scheme involving urologists and
    kickbacks, gifts, trips, TV's, computers, VCR's, as well as gifts of
    free samples of Lupron which were then billed to Medicare. Confidential
    documents of Lupron's ``return to practice'' scheme were revealed
    during Chairman Bliley's hearings (Oversight Hearings). This
    prosecution resulted in TAP officially earning the title of ``a
    criminal enterprise'', and a decade earlier TAP had profitably
    tarnished itself with receipt of Notices of Adverse Findings from the
    FDA due to its incessant and ``deliberate campaign to promote this
    product [Lupron] for a wide range of unapproved uses.'' (FDA, FDC;
    1990). ``In addition to offering inducements to hospitals and doctors,
    TAP was encouraging its salespeople to approach patients in support
    groups.'' (Pitchmen, 2002). And I aware of one gynecologist who TAP
    approached and indicated he could clear $98,000 to his income by
    prescribing Lupron.
        Government documents of the TAP prosecution reveal that TAP also
    attempted to make deals involving the costs of gynecological uses of
    Lupron. And, incredulously, these government documents state that
    ``Lupron depot 3.75 mg is indicated for treatment of . . .
    infertility''. This statement contradicts the FDA's lack of approval of
    Lupron for the indication of infertility, but the presence of this
    erroneous and promotional language within these government documents
    well illustrates the extent of pervasive influence of the industrial
    mantra that `Lupron is standard in fertility treatment' (U.S.A., 1998).
    The rationale for so many unreasonable heated decrees of ``you must
    take Lupron if you want IVF (to get good quantity and quality eggs)'',
    ``you must take Lupron for your endometriosis (if you ever want to get
    pregnant)'', ``you must take Lupron for your fibroids (or you'll bleed
    to death or have to have a hysterectomy)'' was now as clear as a solid
    gold bell struck with a silver spoon.
        Fertility clinics have been generating in the multi-million dollar
    annual surplus range, and years ago claimed a 37.5 percent profit
    margin and physician salaries up to one million (Gabriel, 1996). For
    quite some time, reproductive endocriminology has enjoyed the label of
    a multi-billion dollar industry. In such an area of `obscene
    profiteering', every attempt at regulation has met with stiff
    opposition. The MA. bill (H. #3308) has habitually died and been
    refiled each session, although it has not been refiled this year to
    date. And I understand a recent provision by Senator Frist to study the
    adverse health effects of ART on women and babies was also defeated
    (Skloot, 2003). Patient protections are nowhere to be found, while
    patent and industry protections abound--and market/ing forces rather
    than science dictate the `standard of care'.
        When discussions of the lack of regulation within the fertility
    industry arise, the industry refers to the Federal bill, the `Fertility
    Clinic Success Rate and Certification Act of 1992', as the answer. Yet
    this Act, Public Law 102-493 (signed into law by President George H.W.
    Bush on October 24, 1992), does not contain any language whatsoever to
    address or mandate informed consent to the risks of the drugs and
    procedures. And, in H.R. 4772 (which directs the Secretary of the
    Department of Health and Human Services to develop a model embryo
    laboratory certification program for the states), there are
    ``Limitations'' (in `Section 3:i') which declare: ``(1) In developing
    the certification program, the Secretary may not establish any
    regulation, standard, or requirement which has the effect of exercising
    supervision or control over the practice of medicine in assisted
    reproductive technology programs; [and] (2) In adopting the
    certification program, a state may not establish any regulation,
    standard, or requirement which has the effect of exercising supervision
    or control over the practice of medicine in assisted reproductive
    technology programs.
        This language, which was crafted at the behest of the industry
    (Lawrence, 1993), appears from my vantage point to illustrate the
    Lupron loophole well--`you can tell us what to do, as long as you don't
    tell us what we can't do  . . . including patentable, profitable,
    ventures involving injecting hazardous drugs without informed consent.'
    What we have here is unconscionable stealthcare: an entire `profession'
    and industry utilizing hazardous and untested drugs and procedures upon
    vulnerable women attempting to conceive, without informed consent,
    under the guise of ``science'' and ``under the law''. For a preyed upon
    victim to have to try to sort this out without advocacy, and to have to
    learn how and then search applicable law to try to make sense of this
    outrageousness, is patently absurd. Judge Learned Hand precisely
    captured the essence of this matter: `` . . . there are precautions so
    imperative that even their universal disregard will not excuse their
    omission'' (T.J. Hooper, 1932).
        Of critical note is the increasing number of states that have
    passed legislation that mandates insurance coverage for fertility
    treatment--in essence, promoting further use of experimental agents
    such as Lupron (and in the case of MA., it would appear that the state
    has become complicitous in the advancement of human experimentation in
    light of failure to pass informed consent legislation). These states
    have been, and/or are being, lobbied heavily by RESOLVE, Inc., an
    organization that alleges to ``educate, support, and advocate'' for the
    infertile, yet was taking thousands of dollars from TAP Pharmaceuticals
    as early as 1989 (before any female indication had ever been FDA
    approved for Lupron). RESOLVE, Inc. admits to receiving hundreds of
    thousands of dollars from numerous fertility drug manufacturers in its
    itemizations in Annual Report disclosures, however RESOLVE claims in
    published Boston reports that RESOLVE ``does not receive any funding
    from drug companies'' (Seiffert, 2000).
        RESOLVE has a history of opposing regulation of the fertility
    industry, including MA. H #3308 (Millican (1), 1992), and of ``mov[ing]
    quickly to downplay'' information pertaining to risks from fertility
    drugs and treatment (Dezell, 1994). And, in similar fashion, the
    Endometriosis Association (EA), which testified at the FDA on behalf
    of, and claims an active role in the approval of, Synarel, the first
    GnRHa FDA approved for use in women with endometriosis--with the EA
    providing testimony to the FDA on behalf of Lupron as well . . . yet
    the EA has also received thousands upon thousands upon thousands of
    dollars from GnRHa manufacturers, including TAP (see
    www.lupronvictims.com, `Endometriosis', for partial list of specific
    years, companies, and dollar donation amounts). Another younger
    endometriosis association, founded in 1997, the Endometriosis Research
    Center (ERC), like the EA, publicizes clinical drug trials for
    endometriosis. The ``ERC March 2000'' was ``presented by the ERC and
    Amgen Praecis'' (manufacturer of a GnRH antagonist) (ERC, 2001); and an
    ERC Board Member and Director of Operations is also the ``co-ordinator
    of the AstraZeneca [manufacturer of Zoladex] Pharmaceutical Corporation
    website, the Endometriosis Zone'' (Operations, 2003). While the disease
    of endometriosis and the havoc it wreaks needs as much attention as
    possible, the eternal presence of conflicts is quite troubling.
        For years the FDA has been making annual seizures at ports of
    unlabeled and illegal fertility medications, including Lupron. I have
    also seen a publicly posted note on a fertility message board
    advertizing an ultrasound machine, and media reports have been made in
    the past of `black market' Lupron and sales. Just what type of
    underground market exists out there? Just how many people are lining
    their plush pockets while their victims simply line and pile up?
        `Follow the money' is an apt adage for this unregulated billion-
    dollar industry and all its associates groups. The value of eggs and
    embryos for research was clearly identified in the transcripts of the
    National Institutes of Health's 1994 Human Embryo Research Panel
    Hearings, wherein the profit from human embryo research in the form of
    vaccines, hormones, proteins, stem cells, gene therapy, cell lines,
    organogenesis, ectogenesis, parthenogenesis, chimeras, patents, etc.
    was amply highlighted. There were a few voices of caution: i.e., Dr.
    Van Blerkom stated ``The [medical] literature is the quality of the
    science in the field, and without offending anybody who might have a
    vested interest, I think the quality of science in this field has been
    awful, in this country at least, from the very beginning, awful because
    there are reports that get into journals based on handfuls of
    patients.'' And C.A. Tauer stated ``I think the fact that the research
    enterprise has gone on out there without peer review and without the
    appropriate safeguards is something very bad that has happened.'' (NIH,
    1994)
        One patent relating to assessing eggs and pre-implantation embryos
    noted that ``[s]ignificant improvements in ovulation induction, oocyte
    retrieval, and in vitro culture techniques have resulted in an
    abundance of embryos per patient or experimental animal.'' (Assignee,
    1996). One gross eggsample of commercialism at its highest level of
    crass was the website auction of the eggs of ``beautiful young models
    for as much as $150,000 a pop'' (Oldenburg, 1999). Hundreds of ``egg
    donor wanted'' ads litter the nation's newspapers and college campuses,
    with financial enticement as high as $50,000 for Ivy league eggs
    (Padawer, 2002) and $100,000 for the preference of `proven college-
    level athletic ability' (Enge, 2000)--and the industry proclaims the
    ``shortage of egg donors''--yet it would seem that the published
    medical literature tells a different story.
        In curiosity, I added the number of human oocytes and embryos
    identified in a mere, random, 20 pages in just one of the numerous
    relevant medical journal publications available, and arrived at a total
    of 7,845 human oocytes [eggs] and 266 human embryos used in research in
    these few pages. These 20 pages contained roughly 80 abstracts,
    published in just one supplement of this one journal, from just one
    month, in just one year (Journal, 1995). This genetic `research
    material' is described in the published medical literature as ``coming
    from the IVF program'', ``surplus'', ``left-over'', ``discarded'',
    ``extra'', ``spare'', ``clinic'', ``donated'', ``research'',
    ``abnormal'', ``fertilized'', ``unfertilized'', ``nontransferable'',
    ``suboptimal'', ``nonviable'', and ``aspirated''. In Britain's The
    Times, an article entitled `Scientists pillaging foreign embryos'
    qualified that ``the stem cells are derived from an anonymous embryo in
    the United States, left over from an IVF procedure.'' (Hawkes, 2000).
    And, again for curiousity, I tallied the incidence of `egg donor
    wanted' ads published in the Boston Globe for the month of February
    2001; and found `egg donor wanted' ads published on February 4th, 6th,
    7th, 8th, 11th, 14th, 18th, 20th (twice), 21st, 22nd, 25th, and 27th.
        The Washington Post reported in 1998 on `Experimenting with eggs':
    `` . . . No one was paying attention . . . The research required many
    eggs to practice on, said [][one] clinic's director, so doctors there
    turned to women who were donating eggs to infertile women and used some
    of the leftover eggs for their research. `We call it sharing with the
    lab' he said.'' (Weiss, 1998). And there are few embryologists who
    admit to ``hav[ing] played around with embryos after hours.'' (Rogers,
    2001).
        The same researcher who recruited egg donors for Advanced Cell
    Technology's human embryo cloning endeavors has a mobile embryology
    lab--``a conventional-looking recreation vehicle with a connected
    trailer. Inside is nearly all the gear needed for in-vitro
    fertilization.'' (MSNBC, 2002). Currently this mobile embryology lab is
    utilized to serve HIV+ clients who wish IVF, but it is noted that such
    a traveling lab ``could potentially provide location-flexible ART for
    under served populations'' (Foundation, 2002). In the matter presently
    before Congress, there is discussion that if therapeutic cloning were
    allowed, it should be removed from the fertility clinic setting. Are
    traveling embryology vans, pulling trailers and driving throughout the
    streets of the country, the answer? With the value of human eggs as
    research material increasing, imagine the obscene profit that an
    unscrupulous scientist could envision with a mobile IVF unit traveling
    the country, trafficking in underground egg sales.
        The profoundly significant and despicable thefts (``conversion'',
    ``sharing'') of women's ova and embryos by Drs. Ricardo Asch, Sergio
    Stone and Jose Balmaceda at the University of California at Irvine
    (Regents; Press; 1995) should be a serious reminder to the utter (and
    anesthetized) ease with which such menacing maneuvers can be executed.
    (And Dr. Asch had co-authored studies of Lupron, ``which was kindly
    provided by Abbott'' [Guerrero, 1993]). The contemptible violations of
    stealing women's eggs and embryos should highlight the profitability of
    schemes to procure women's eggs and embryos for use in research and/or
    covert `re-sale'. Dr. Asch reportedly `left his office daily with
    briefcase stuffed with thousands of dollars'. And attention should be
    directed to the drug protocol(s) used--medications administered
    ``deliberately'' ``so there would be a surplus of eggs'' (Challender,
    1995). Who is exerting any oversight over the field of reproductivity?
    Who would exert oversight over therapeutic cloning--this same industry?
        The conflicts within this arena are excessive and have had a
    tremendously negative impact upon care. For one example, I pursued
    initial rheumatology work up for bone pain post-Lupron at the renowned
    hospital which had first prescribed Lupron to me, and during the course
    of my visits I was met with the standard ``(pain) has no connection to
    Lupron''. Years later I would read that the head of this department had
    been a long-term highly paid consultant and scientific advisor for
    Lupron's manufacturer (with compensations rising each of the many years
    displayed)--and I've seen this doctor's signature on the contract where
    the pledge is taken to `defend the company's products at all times in
    all ways'. In retrospect, I'm able to say `no wonder no one there
    wanted to even hear about any connection between Lupron and problems'--
    but how many other patients know of conflicts of interest in their
    circumstance(s) . . . and who will tell them?
    4. A Brief Overview of the ``Hazardous'', ``Commonly Prescribed'' Agent
            Lupron
        Lupron, referred to as a GnRHa (gonadotropin releasing hormone
    analog/agonist [and also previously referred to as LHRH]), will be the
    focus of my comments as it is one of the most commonly used agents, but
    it should be recognized that numerous other GnRHa's as well as the
    newer GnRH antagonists are being used in superovulation of women--and
    the risks from all of these agents should be taken into consideration.
    Thousands of women have become seriously ill after taking Lupron (and
    there have also been complaints about other GnRHa's, such as Buserelin,
    Synarel and Zoladex); and the alleged safety and mechanism of action of
    these drugs needs attention. A National Lupron Victims Network (NLVN)
    was founded in 1993, and when I learned of their existence in 1994,
    they were the only entity who was interested in the results of my
    searches into the medical literature; and this information, along with
    many other sources of information, continues to serve as the
    `clearinghouse' of information on the risks of Lupron at their website,
    www.lupronvictims.com. The NLVN began a visit counter on January 1,
    2000: as of 3/25/03 there were 2,119,422 hits made to this site. While
    the NLVN provides detailed information on Lupron, other internet sites
    contain public message boards about problems after Lupron, i.e., Delphi
    message boards such as `Julie's After Lupron Page' (Julie's Page), and
    AOL message boards, among many others.
        The initial patent filed for Lupron involved ovulation induction
    (Patent #4,005,063), and Lupron has been used in drug company funded
    studies to induce ovulation (i.e., Segal, 1992). Lupron has become the
    ``standard of care'' for some 15 years, for a variety of reasons,
    including to maximize number of eggs produced. A multitude of many,
    including numerous Internet pharmacy websites, hawk Lupron as a
    ``fertility medication'' . . . yet the FDA has never approved Lupron
    for infertility, or fertility treatment, or IVF treatment, or any
    variant of IVF or ART. According to the Physician's Desk Reference, the
    FDA classifies Lupron as a Pregnancy Category X drug, meaning any woman
    who is or who may become pregnant should not use. Lupron is a known
    teratogen (Shephard, 1992), and Lupron is a known developmental and
    reproductive toxicant (Scorecard). NIH and OSHA place Lupron
    (leuprolide) on its list of hazardous drugs (NIH, OSHA). Yet,
    inexplicably, medical literature reports Lupron to be the most commonly
    prescribed and ``prevalent choice'' of GnRHa used in fertility
    treatment (Keenan, 1991; Martin, 1994).
        Medical literature regularly refers to Lupron as an antineoplastic
    and chemotherapy, with some references characterizing Lupron as an
    antineoplastic hormone. Yet, according to deHaen modified American
    Hospital Formulary System, Lupron is not listed in the antineoplastic/
    hormone category (Classification No. 10:00.10, as are the drugs
    Tamoxifen, Megestrol, Flutamide)--but rather Lupron is listed in the
    antineoplastic/OTHER category (Classification No. 10:00.12, listed
    along with Interferon) (deHaen, 1995). No one seems to know what the
    ``other'' in Lupron is! But it is known that Lupron was originally
    approved out of the FDA's Office of Biologics Research and Review. (NDA
    [New Drug Application] 19-010).
        Clinical studies conducted by the manufacturer to evaluate Lupron's
    efficacy (and `not' safety) in fertility treatment and in IVF occurred
    between 1988 through 1992, according to Abbott Annual Reports (see also
    FDC, 1988). The ``IVF clinical trials'' and ``fertility treatment
    clinical trials'' using Lupron ``were discontinued'', according to the
    manufacturer (Abbott correspondence, 1995), and I've been unable to
    learn whether these Lupron IVF and Lupron fertility trials were
    discontinued because of efficacy reasons, safety reasons, both reasons,
    or other reasons.
        Lupron has never gained FDA approval for any type of fertility
    treatment, however, Lupron did gain FDA approval for use in women for
    pain management of endometriosis in 1990--yet the clinical studies for
    these approvals are a joke--conducted on a handful of women, by paid
    investigators, and with an endpoint of establishing Lupron's efficacy
    in pain management of endometriosis while the women in these studies
    were simultaneously allowed to take narcotics, including Dilaudid and
    parenteral narcotics. These women were also expected to `recall and
    record their adverse events at the end of the study month', yet were
    not informed that Lupron was known to affect memory (NDA 19-010; see
    also Newton, 1996). Problems with this trial alone could fill this
    document--never mind attempting to address the numerous and gross
    problems evident within other Lupron NDA's.
        Lupron is alleged to cause menopausal symptoms such as hot flashes
    and headaches, and Lupron's categorization as a ``hormone'' is an
    allusion that is frequently conveyed to women. Women are often told by
    the physician, and TAP continues to state, that side effects to Lupron
    disappear after the `drug' is stopped. Yet FDA documents for the
    endometriosis NDA identify that the majority of hot flashes occurred
    after stop of study (NDA 20-011). One clinical trial evaluating memory
    loss and cognitive effects of Lupron in young women undergoing IVF
    showed that ``[72 percent] showed difficulty with memory while on
    leuprolide'' and there was ``no correlation between estradiol levels
    and tests results on any test'' (Varney, 1993); and another study
    showed 11 percent continued with memory complaints 6 months after stop
    of study (Newton, 1996). In the March 1984 FDA's toxicological reviews
    of Lupron, it is stated that ``[rat] testes showed various degrees of
    testicular degeneration which were detectable within 2 days. The
    severity of the lesions were greater in the testes of rats sacrificed 7
    days after cessation of treatment indicating that the effects continued
    after drug withdrawal. . . .'' (Jordan, 1984).
        Women are told that Lupron will ``shut down their system'',
    allowing ``control'' over their system, and that the side effects are
    related to menopausal symptoms. But in fact, it was known prior to my
    `treatment' with Lupron (but not disclosed to me) that Lupron causes a
    ``hypophysectomy'' (Holmes, 1988)--which, by definition, is
    ``destruction or removal of the pituitary''; and it was known (but not
    disclosed to me) that ``sustained treatment with GnRH agonists most
    likely abolishes pituitary function'' (Bischof, 1988). I would also
    later learn that in the original rat studies submitted to the FDA for
    Lupron's initial approval of palliative prostate cancer, all rats at
    all doses developed pituitary adenomas (tumors)--and it was stated that
    ``there is no obvious reason to suggest that the same process could not
    occur in humans'' (NDA 19-010).
        Years following these Lupron animal studies, it would be reported
    ``[w]e cannot exclude that [GnRHa] may cause not only adenomas in rat
    pituitary glands as reported previously, but also a (nodular)
    hyperplasia of the pituitary gland in man.'' (Radner, 1991) While the
    industry maintains that the hot flashes from Lupron are due to lack of
    estrogen, women complain of hot flashes while on Lupron but not
    achieving `suppression' (termed ``Lupron escape''), and women complain
    of hot flashes while on Lupron plus estrogen, and women complain of hot
    flashes after stopping Lupron that do not go away. Years later, I'd
    read that it is the ``interference with the pulsatile pattern of GnRH
    that causes flushes'' (van Leusden, 1994)--thus, the alteration,
    impairment, destruction, of the pituitary (as never explained to me or
    others). To quote one investigator: ``GnRH analogs are not like any
    other medication currently available for treatment of disease. As we
    continue to learn more about these analogs' mechanisms of action, it is
    increasingly apparent that they do not just affect the gonadal [sex]
    hormones, but are powerful modulators of autonomic neural function.''
    (Mathias, 1995)
    5. Impact Of Lupron Upon Women's Brains, Bodies, and Bones
        By way of understanding the significance of this information, the
    hypothalamus and pituitary are considered the master glands of the
    body, and both are directly connected to each other by neurons and
    blood supply; and are responsible and required for proper functioning
    of the autonomic nervous system (involving hunger, thirst, temperature,
    heart rate, blood pressure), and the production of numerous hormones
    necessary for life. GnRH, gonadotropin releasing hormone, which is made
    by only around 1000 neurons in the hypothalamus (Wierman, 1995), is
    sent to the pituitary and causes the secretion of (among others) the
    hormones necessary for normal ovulation (leutenizing hormone [LH] and
    follicle stimulating hormone [FSH]). Lupron is a synthetic copy of the
    GnRH found in pig and sheep, except that Lupron has an added, unnatural
    amino acid substitution inserted into the structure of the molecule,
    causing it to become an `analog' of GnRH and far more potent than the
    original molecular structure. Which brings me to several pertinent
    comments made by the FDA that sum up some of the problems and concerns
    with the use of such a new molecular entity:
        One year prior to Lupron's initial FDA approval for palliative
    treatment of prostate cancer, members of the FDA's Center for Drugs and
    Biologics wrote an article entitled `Trends in Drug Development with
    Special Reference to the Testing of LHRH [GnRH] Analogues'--stating
    ``[c]onceivably, LHRH analogues may be antigenic . . . [and] may even
    cause immune-related disorders. . . . The long-term safety of LHRH
    analogues have not yet been fully investigated, especially when we are
    dealing with structures drifting farther and farther from the original
    molecule.'' (Gueriguian, 1984).
        Lupron's structure indeed differs from the original structure in
    that it contains an UN-natural amino acid, making the `drift' of
    Lupron, in my opinion, far from the original `natural' (pig/sheep)
    structure. Bear in mind that other GnRHa's have modifications of the
    original GnRH molecule with their own unnatural substitutions at
    different and differing places along the structure of the original GnRH
    molecule--and the newest `models', the GnRH antagonists, are even
    further modified. It would seem that there was recognition by these FDA
    members that `tinkering' with this molecule raised long-term safety
    issues for human health.
        Five years following the publication of `Trends in Drug Development
    with Special Reference to the Testing of LHRH Analogues', prior to any
    FDA approval of any GnRH analog use in women, the FDA Medical Review
    Officer of GnRH drugs for gynecology closed her comments at a public
    hearing with her ``experience in observing the course of GnRH analog
    research over the past year.'' These were Dr. Ragavan's comments in
    1989: ``Most of the studies that have been presented for [GnRH] analog
    research are presently being conducted in young women for benign
    indications. . . . The number of studies trying to use these drugs has
    by no means slowed down recently. Industrial sponsors have been quick
    to fund these studies on the drugs seeing a potential market. . . .
    [The Committee] may wish to consider the ethical issues of continued
    intellectual searches for the use of analogs and the possible risks
    associated with such studies in this study population. We have always
    used with extreme caution in our abilities to render men hypogonadal
    albeit for different reasons. And have reserved this treatment for life
    threatening conditions in the male, such as prostate cancer. Should we
    use the same caution in women, especially when we treat benign chronic
    non-life threatening conditions such as endometriosis? In fact, I
    propose for you an even more caution in this population who must live
    with the consequences of treatment for a very long time.'' (Ragavan,
    1989)
        In 1994, the FDA issued recommendations (authored by FDA Medical
    Officer Reviewers of either Lupron's prostate or endometriosis NDA's)
    that ``only pertain to GnRH analogs and should not be considered as
    guidance for the testing of any drug classes''; and with acknowledgment
    of ``unpublished work'' from TAP Pharmaceuticals, these Reviewers
    recommended: ``At necropsy, special attention should be given to the
    anterior pituitary, adrenal, pancreas, testes, and ovaries, since an
    increased incidence of neoplasia in these organs has been associated
    with GnRH agonist treatment. . . . Following restoration of fertility
    after cessation of treatment, the possibility exists that some germ
    cells may have been permanently affected by drug treatment. It is
    therefore important to investigate the effects of fetal morphology
    (teratogenicity) and on postnatal development of the offspring.''
    (Raheja, 1994).
        An FDA Medical Officer, in reviewing a proposed study for Lupron in
    high risk breast cancer patients stated the ``[d]evelopment of this
    drug as a general contraceptive should meet with substantial
    reservations . . . it is an adventure into the unknown'', and a
    Committee Chairman recommended ``find out what its [Lupron plus oral
    contraceptives] long-term effects were, and then consider it for a
    larger population.'' (FDC, 1994)
        Medical literature reports that the use of GnRHa's in IVF has
    caused neurological symptoms--migraines, numbness and tingling,
    paresthesia and weaknesses and sensory ataxia--``Transient cerebral
    ischemia is one possibility that may explain the symptoms . . . a
    direct effect of potent GnRHa on the central nervous system resulting
    in neurological effects independent of the hypothalamic-pituitary-
    gonadal axis is possible . . . [and] it is quite possible that mild
    cases with minor symptoms have escaped notice; thus, the occurrence of
    this type of complication may be far more common that we realize.''
    (Ashkenazi, 1990). Of note within the latter article's Medline abstract
    on PubMed is the mesh heading: ``Nervous System Diseases/chemically
    induced''.
        Another study using Lupron and Synarel, for endometriosis alone or
    with infertility, was titled ``Memory complaints associated with the
    use of gonadotropin-releasing hormone agonists: a preliminary study''
    (Newton, 1996). ``Profound luteinizing hormone suppression after
    stopping the gonadotropin-releasing hormone-agonist leuprolide
    acetate'' is another study's title (Sungurtekin, 1995).
        In 1995, the first bone biopsy was done on the bones of young women
    receiving GnRHa therapy for endometriosis, and results showed that
    after 6 months of GnRH use in young women, there was ``severe
    disruption of the cancellous microstructure'' of the bone, and the
    ``results suggest that bone loss induced by GnRH analogs may be
    associated with adverse effects on cancellous microstructure which are
    unlikely to be reversed following cessation of therapy.'' (Compston,
    1995; See reprint of bone biopsy results before and after GnRHa at
    www.lupronvictims.com--`Effects on bone').
        Ovarian enlargement and development of ovarian cysts frequently
    occurs during superovulation, with ovarian cyst formation ``occur[ring]
    in up to 35 percent of women receiving leuprolide acetate'' (Serafini,
    1988; Gocze, 1993). And during clinical trials of Lupron's use in
    endometriosis, it is noted that no difference in ovarian enlargement/
    decrease was noted compared to control patients (NDA 20-011), yet in a
    separate study (co-authored by a Lupron endometriosis clinical trial
    investigator) it was noted that ``significant changes were noted'' and
    ``the identifiability of the ovaries [by MRI] was significantly poorer
    . . . The effects of [Lupron] therapy on the normal uterus and the
    ovaries were statistically significant'', predicting an ``experienced
    radiologist should expect to be able to identify the ovaries on only 70
    percent of the images.'' (Zawin, 1990)
        In the Journal of American Medical Association, a letter reported
    ``[p]ossible ocular adverse effects associated with leuprolide
    injections'', and noted ``11 reported cases of pseudotumor cerebri''
    (Fraunfelder, 1995) Thousands of women (and men as well) have contacted
    the NLVN, filled out surveys detailing their medical complaints after
    Lupron, and continue to report adverse events post-Lupron to the FDA,
    to TAP, to doctors, to lawyers, to legislators, to federal, state, and
    consumer agencies, and to the media). The FDA and TAP continue to
    receive these reports, and women continue to receive Lupron, without
    receiving informed consent.
    6. Known Effects Of Lupron On Eggs, Embryos, and Babies
        Ovarian cyst formation ``occurs in up to 35 percent of women
    receiving leuprolide'' (Serafini, 1988). Even though Lupron is
    allegedly prescribed to prevent ovarian hyperstimulation syndrome, the
    use of Lupron (including the sole use of Lupron alone, with no other
    fertility drugs) has caused the life threatening condition of `severe
    ovarian hyperstimulation syndrome' (Yeh, 1989; Barbieri, 1991; Hampton,
    1991; Droesch, 1994; Weissman, 1998). ``[U]nacceptable level[s] and
    variability of stimulation prior to suppression'' was encountered early
    with Lupron's use in ovulation induction regimes (Meldrum, 1988), and
    aberrant estradiol flares and an inability of Lupron to establish ``any
    ovarian response'' were noted elsewhere (i.e., Chetkowski, 1989;
    Penzias, 1992, 1994). Lupron is commonly used during the superovulation
    regime prior to egg aspiration/donation, and one study using Lupron in
    an egg donor program concluded that ``continuous postaspiration GnRHa
    [Lupron] may be beneficial for oocyte donors whose ovaries are
    hyperstimulated''. In this latter egg donor study utilizing Lupron, 1
    of 6 patients required hospitalization. (Ng, 1995). ``Fertility clinics
    will not be informing their patients that in Collingswood N.J. there
    flourishes a National Lupron Victims Network.'' (Millican (3), 1995)
        Published medical reports have noted the occurrence of abnormal
    human pregnancy outcomes associated with the use of Lupron--43.5
    percent in one 1996 study (Karande, 1996). Another report, using the
    `long Lupron protocol', showed a 38 percent abortion rate (Shanis,
    1995), and a study of `low responders' using Lupron showed a 66.6
    percent spontaneous first trimester abortion rate (Droesch, 1989). In
    `healthy women undergoing ovarian stimulation' using Lupron in another
    study, another 66.6 percent abortion rate was noted (Minaretzis, 1995).
    Another study's title states ``Exposure to [Lupron] in Early Pregnancy
    is Associated With High Pregnancy Wastage That Could be Related to the
    Length of Exposure'' (Sasy, 1997).
        What are the known effects of Lupron upon eggs? In a 1994 study of
    chickens using Lupron, 1 out of 25 of the hens died, and at the end of
    the 30-day experiment, all egg shells had thinned (Burke, 1994). A
    study using two GnRHa's (including Lupron) involving rabbit ovaries,
    concluded ``GnRHa act directly in the rabbit ovary . . . increasing
    oocyte [egg] degeneration'' (Yoshimura, 1991). In studies involving
    Lupron in human fertility cycles, it was reported that ``some retrieved
    oocytes exhibit incomplete nuclear and cytoplasmic maturation after the
    use of this agonist [Lupron]'' (Racowsky, 1997) as well as
    ``maturational asynchrony between oocyte cumulus-coronal morphology and
    nuclear maturity'' (Hammitt, 1993). In `Designs on Life', by Robert Lee
    Hotz, it was revealed that ``[s]cientists . . . noticed that Lupron
    embryos were different. They grew faster, developed more rapidly. They
    were more fragile when frozen and less likely to survive thawing.
    Nobody knew why or what it meant for the long-term health of the woman
    or any resulting child.'' (Hotz, 1991)
        According to the 1998 text, `Drugs in Pregnancy and Lactation', TAP
    communicated in 1992 that it was ``maintaining a registry of
    inadvertent human exposure during pregnancy to leuprolide and currently
    has over 100 such cases. No cases of congenital defects attributable to
    the drug have been reported . . .'' (Briggs, 1994). And ``[f]etal
    growth retardation was observed with increased frequency among the
    offspring of rats or rabbits treated during pregnancy with subcutaneous
    doses of leuprolide similar to those used in humans.'' (Friedman JM,
    1994). In a study using Lupron and other GnRHa's on rabbit eggs,
    ``[t]he rates of normal fertilization and early embryonic development
    were significantly reduced in the oocytes matured by GnRHa'', and it
    was noted that ``one cannot exclude the possibility that GnRHa in
    pharmacological dosages may be cytotoxic against oocytes.'' (Yoshimura,
    1992)
        In a patent for embryo culture composition, it is noted that
    ``culture of primate embryos in the presence of a GnRH agonist . . .
    unexpectedly dramatically reduces the rate of embryo attachment and
    cell differentiation.'' (Hearn, 2000). Using Lupron in fertility
    cycles, ``some retrieved oocytes exhibit incomplete nuclear and
    cytoplasmic maturation after the use of this agonist'' (Racowsky,
    1997). Growth retardation has been noted in young monkeys given Lupron
    (Golub, 1997).
        But TAP has maintained a registry from over a decade ago of more
    than 100 Lupron exposed babies in which no ``attributable'' defect has
    allegedly been found Perhaps someone needs to investigate the veracity
    of this data. There have been accounts by women, including on the
    internet, reporting birth defects in babies conceived on or after
    stopping Lupron--including Lupron use for fertility as well as use for
    endometriosis. It is not uncommon to see an internet infertility
    message board note stating ``I have one Lupron 2-week kit for sale. I
    just lost my third baby and can't go through this any more''. Public
    posts have described babies conceived spontaneously within several
    months of stopping Lupron, and born with birth defects such as Total
    Anomalous Pulmonary Venous Return, a heart defect. I personally know
    women who conceived babies from IVF using Lupron whose children have
    anatomic anomalies and developmental delays, and I know women who
    conceived babies after using Lupron for endometriosis who've
    experienced loss of child, developmental delays, esophageal stricture,
    attention deficit, and serious seizure disorders. I personally know 3
    women, with 5 children (conceived on Lupron either through IVF or
    unintentionally during Lupron for endometriosis) who have serious
    seizure disorders, and I have heard of other similar cases. Internet
    message boards about parenting problems with ART children show notes of
    ART children undergoing a variety of tests (i.e., CAT scans) and
    surgeries (i.e., open heart) and being prescribed a variety of drugs
    for a variety of ailments including poor muscle tone, jerkiness,
    choking, esophageal stricture, spinal cord abnormalities, GERD
    (gastroesophageal reflux disease).
        The first published long-term study of babies born after accidental
    exposure to GnRHa's revealed that 4 out of 6 babies have severe
    neurodevelopmental abnormalities, and the conclusion of this study was
    that ``[t]his observation . . . justifies the need for long-term
    follow-up of more children previously exposed to GnRHa'' (Lahat, 1999).
    When Lupron is used in superovulation regimes, upwards of 1 mg/day will
    be injected for several weeks to one month or more, and to within days
    of egg retrieval. Women are given both the daily Lupron and depot
    Lupron (monthly formulation) for superovulation regimes (i.e.,
    Ruhlmann, 1993)--yet Lupron depot brochures for endometriosis and
    fibroids state barrier contraception should be used during depot Lupron
    and that pregnancy should not be attempted until 2 months after therapy
    (meaning 3 months from the last injection). Again--TAP Lupron depot
    brochures advise barrier contraception during Lupron and recommend
    pregnancy not be attempted until 3 months after last injection, yet TAP
    has funded studies using Lupron depot and Lupron daily in infertility
    and IVF. Regardless of daily or depot Lupron use, women are told that
    Lupron will be out of their system before any fertilized egg is
    implanted--yet published medical literature by, among others, a TAP
    Medical Director, identified that detectable levels of Lupron remained
    after 11 weeks following the last injection. (Miller, 1990)
        Women are prescribed anywhere from 10-45 days of Lupron during one
    superovulation regime (see, i.e., Nader, 1988), often being put on
    prolonged Lupron--a ``delay''. (Damario, 1997). And women are
    frequently prescribed birth control pills before Lupron to prevent
    Lupron-induced ovarian cysts that are known to develop. One woman from
    the `Surrogates' Corner', having already given birth twice to twins in
    the past as a surrogate, describes how she's working with a new couple:
    `` . . . I have been on Lupron since May 26 . . . I can't take much
    more Lupron!''--the date of her note was July 28th (Surrogate, 2000). A
    woman could receive a range of 5-22.5 mgs in one `fertility' cycle with
    Lupron if using Lupron 0.5 mg per day, or she could receive a range of
    10-45 mgs in one `fertility' cycle if using Lupron 1 mg per day. Some
    women are prescribed more, some less, in a superovulation regime. Women
    receiving Lupron for endometriosis receive 3.75 mg per month in one
    injection--for a total of 22.5 mgs in 6 months of treatment (a limit
    recommended by the FDA due to occurrence of bone loss). The woman who
    undergoes one ``controlled ovarian hyperstimulation'' regimen may be
    very well be exposed to more Lupron than a woman undergoing six months
    of treatment for endometriosis.
        While the endometriosis patient may undergo more than 6 months of
    Lupron `treatment', women who undergo fertility treatment are well
    known to be `frequent fliers' (given the failure rate and need for
    repeated IVF trials to attempt `success'). One published study reported
    a woman undergoing superovulation 18 times (Check, 1988). Women who
    take Lupron for fibroids use 3.75 mgs per month for 3 months--although
    variations in dose and duration are often reported. Consider that men
    in the final stages of prostate cancer are currently prescribed Lupron
    7.5 mg per month (depot), and not the daily Lupron, yet the daily
    Lupron was the initial form of Lupron first approved by the FDA (for
    palliative treatment of prostate cancer). Currently, daily Lupron is
    rarely used in prostate cancer, but it is this daily Lupron that is
    most frequently prescribed in superovulation regimes, despite
    discontinued clinical trials and despite never having gained FDA
    approval for fertility or IVF.
    7. Examples of Iatrogenic Illnesses Induced By Exposure
        In 1999, the FDA reported on their review of MedWatch Reports for
    adverse events from Lupron. The FDA reviewed more than 6000 reports,
    concluding ``there were high prevalence rates for serious side
    effects''. The FDA's action was to reexamine the product label, ``to
    ensure that these events are adequately addressed.'' (Lazar, 1999). It
    is my understanding that the FDA was to undertake another review. In
    the meantime, what, if anything, has been done ``to ensure that these
    events are [] addressed''? After FOX 25's 2 part series on the adverse
    effects of Lupron, FOX informed Senator Kennedy of their series and
    quoted the Senator as stating he found their ``report on possible side
    effects of Lupron was troubling. Physicians have an obligation to
    inform patients of the risks of drugs they prescribe, and promotion of
    potentially risky `off-label' uses of products by manufacturers is
    illegal and unethical.'' (Kennedy, 1999)
        The medical literature offers numerous examples of iatrogenic
    illnesses following exposure to GnRHa's. For example, in a 1990 study
    utilizing GnRHa in IVF treatment, one of a group of women who had
    developed severe ovarian hyperstimulation syndrome and liver function
    abnormalities, had a liver biopsy performed (at the end of surgical
    removal of conceptus due to intrauterine death 2 months into the
    pregnancy). This liver biopsy showed ``a striking abnormality
    consisting of macrovesicular fatty infiltration around and linking the
    portal tracts. This appearance could not be classified into any well-
    recognized clinical entity.'' (Forman, 1990).
        These, and other, clinical reports are disturbing, especially as
    they pile on top of one another. Case report or study titles often tell
    the story: `Adverse effects of leuprolide acetate depot treatment'
    (Friedman, 1993), `Neuropsychologic Dysfunction in Women Following
    Leuprolide Acetate Induction of Hypoestrogenism' (Varney, 1993),
    `Angina and myocardial infarction with use of leuprolide acetate'
    (McCoy, 1994), `Memory complaints associated with the use of
    gonadotropin-releasing hormone agonists: a preliminary study' (Newton,
    1996), `Leuprolide Causes Pure Red Cell Aplasia' (Maeda, 1998),
    `Transient thyrotoxicosis and hypothyroidism following administration
    of the GnRH agonist leuprolide acetate' (Kasayama, 2000), `A case of
    atypical absence seizures induced by leuprolide acetate' (Akaboshi,
    2000). Case reports of Lupron-treated fibroids having ``striking
    vascular changes and histologic features of vasculitis and
    atherosclerosis'' note that ``[t]he florid and rapid development of
    vascular inflammation, fibrinoid deposits, and thrombosis after
    leuprolide acetate therapy [``rarely seen in non-leuprolide treated
    (fibroids)''] suggest an immune-mediated process. . . . these
    observations are significant and worrisome if such changes affect other
    organs.'' (Mesia, 1997). Lupron has been listed among those medications
    that may cause lupus. (Greenberg, 1999).
        Problems associated with Lupron are also identified in the titles
    of male uses of Lupron as well, i.e. `Leuprolide therapy for prostate
    cancer. An association with scintigraphic ``flare'' on bone scan'
    (Johns, 1990), `Sudden death due to disease flare with luteinizing
    hormone-releasing hormone agonist therapy for carcinoma of the
    prostate' (Thompson, 1990), `Possible Ocular Adverse Effects Associated
    With Leuprolide Injections' (Fraunfelder, 1995), `Pituitary apoplexy
    after leuprolide administration for carcinoma of the prostate' (Morsi,
    1996; multiple other similar case reports have been published),
    `Localized Amyloidosis of the Seminal Vesicle: Possible Association
    With Hormonally Treated Prostatic Adenocarcinoma' (Unger, 1997),
    `Incidence of bone fracture in patients receiving luteinizing hormone-
    releasing hormone agonists for prostate cancer' (Hatano, 2000),
    `Altered cognitive function in men treated for prostate cancer with
    luteinizing hormone-releasing analogues and cyproterone acetate: a
    randomized controlled trial' (Green, 2002).
        In the animal testing data submitted for Lupron's initial approval,
    the FDA Review and Evaluation of Pharmacology and Toxicology Data
    states, among others: `` . . . There are other, inconsistent, effects
    of Leuprolide in the various toxicology studies but potentially the
    most serious effect of Leuprolide, in my view, is its effect on spinal
    column bone marrow. This increased fat deposition and subsequent
    hypocellularity was explained as a physiological response to the drug.
    . . .'' (Jordan, 1984). Years later, other animal testing would reveal
    ``[a]lterations in thymic and bone marrow lymphocyte subpopulations in
    GnRH agonist [Lupron] treated prepubertal female mice'' (Rao, 1993).
        Many, many relevant studies and case reports are left unmentioned
    here. Many effects of Lupron, such as upon the bone, heart, immune, and
    other systems, have barely, if at all, been touched upon. But it is the
    people with real names, real faces, and real pain that is most
    upsetting. Many women, and sometimes family of these women, have
    contacted me over the years with varied complaints following Lupron--
    always looking for help. It is extremely difficult for me to hear these
    horror `stories'.
        As a former full-time career R.N. who has been able to effectively
    advocate for any patient, and did so for many patients in the past,
    after Lupron I suddenly found myself in a land somewhere beyond the
    upper level of nowhere--and all rules had changed. It was an awful
    moment when I realized that I was not alone and there were many other
    Lupron victims--comforted by company, but horrified at the scope
    involved. All other victims were echoing my words that ``after lupron''
    thus and such started. And all other victims have interesting doctor
    `stories' to tell. My experiences were simply inexplicable at times,
    and I quickly learned (but fiercely resisted) the fact that Lupron was
    not open for substantive discussion. I would self-triage my own various
    symptoms and prioritize before arriving at the doctor's office,
    otherwise s/he would be overwhelmed. One physician replied after I
    reported dizziness, pedal edema (swelling in feet), and gastric pain,
    that ``those are bullshit symptoms''. That atrocious answer and
    behavior is never a correct response to any patient, and after I
    changed doctors a small gastric bleed was diagnosed. These few personal
    details barely convey the level of destruction this drug and the
    subsequent unmerry-go-round has had upon my life and the lives of
    countless others. Here is a glimpse into the experiences of some other
    women who want you to know that they're hurt and they want attention
    paid to this public health issue.
        Candace Hedin, of Marlboro MA., was told seven years ago, at age
    25, that she'd need Lupron prior to undergoing fertility treatment with
    Clomid. Candace was put on Lupron for six monthly shots, and has
    suffered with multiple, unexplained, serious illnesses since. She's
    been hospitalized for unexplained chest pain and inability to breath
    about 15 times, and each time it just ``goes away after 3 or 4 days''
    until the next time ``it'' returns. Candace also has extensive and
    extreme hives, including inside her mouth and throat, which become open
    sores and she cannot eat or drink anything--resulting in
    hospitalizations for dehydration. She also reports continued vaginal
    bleeding despite having undergone a total hysterectomy and a battery of
    tests (including full body CAT scan) to establish the reason(s) for
    this bleeding, and all tests have been inconclusive. In addition, her
    mammogram is normal, her prolactin level is normal, but she lactates
    daily. ``Nobody's even looking at any of this--I can't get any
    diagnoses! All they tell me is my immune system stinks--I'm allergic to
    my own body is the diagnosis. My toenails are coming out and now my
    fingernails are coming out too!'' Candace's husband says ``How can you
    take a girl, at 25, who'd never had any medical problems, and suddenly
    become so sick and debilitated--we've gone to 5000 medical doctors and
    they say `think of something that might have caused all these things to
    suddenly come about' and I tell them `Ya!--she took lupron and she's
    been sick ever since'--but they say Lupron doesn't have anything to do
    with it. I think I'm watching my wife die in front of my eyes and no
    one wants to do a thing about it.'' (personal communications)
        Wendy Camacho of Cherry Hill NJ took Lupron for IVF years ago, and
    as she puts it ``my IVF baby is now 9 and my health is a mess . . . it
    has been downhill since.'' Wendy writes ``I have seen neurologists,
    rheumatologists and orthopedists, and none of them have any answers for
    me. I have been experiencing severe fatigue (diagnosed as
    fibromyalgia), trouble sleeping, nightmares, gross motor skills are
    disintegrating fast. I am unable to work as a waitress anymore because
    my arms can't balance anything, and my legs give out from under me at
    will. I also have severe osteoarthritis. During a routine eye exam, at
    which I was diagnosed with cataracts (rare at age 38), I was asked by
    the doctor if I ever took fertility drugs. When I said yes, I was told
    I was one of many, but she said she didn't know enough about it to go
    into detail. . . . I now have the corneas of a 6 year old boy. . . . I
    was diagnosed with MS, benign remittent, Thank God. I awoke one morning
    with a very weakened left side. EMG showed I have only 35 percent
    strength on that side. I have spent ages going to doctors. . . . I
    would tell everyone--RUN in the opposite direction from Lupron.''
    (personal correspondence)
        Linda DeBenedictis, a teacher from MA., mandated to use Lupron
    without rationale, has testified at the MA. Health Care Committee
    regarding the health problems she's experienced. At the 1995 hearings
    for MA. H #3308, at the close of her testimony, Linda stood up, faced
    the crowd, and removed her wig. She is totally bald, and has lost every
    single hair on her entire body (FOX News, 1999). [Unlike other
    chemotherapy/antineoplastics, hair growth had not returned years after
    Lupron.]
        Gilda Radner posthumously is associated with ovarian cancer
    awareness, however little focus has been placed upon her fertility
    treatment. In her book `Its Always Something', Gilda questioned red
    meat and hair dyes, among other potential causes for her ovarian
    cancer--but never questioned her use of fertility drugs.
        And Barbara Mays, and her offspring, are two others whom I believe
    deserve consideration as victims of fertility treatment: Barbara Mays
    was infertile for 10 years, underwent fertility treatment, and
    ultimately gave birth to a baby born with a heart defect. The Mays baby
    was intentionally switched in the hospital nursery, and the Mays went
    home with a healthy baby (named Kimberly `Mays') who had been born to
    the Twiggs. The baby that the Twiggs took home, the biological child of
    the Mays, died at age 9 from congenital heart problems. Several years
    ago, a national news broadcast aired an interview with the dying LPN
    who admitted she was instructed to switch the babies and remained
    silent for fear of losing her job, but no rationale was offered for the
    switch. Based upon historical fact and my observations of the
    machinations of this industry, the field of reproductive
    endocriminology can be characterized as utilizing a multitude of slick
    maneuvers to deny, disinform, mislead, discount, dismiss, diminish, and
    suppress risks. The U.S. investigation of TAP's billing practices
    revealed that a computer program given by TAP to many doctors in the
    country (some 10,000 urologists received gifts from TAP), which
    computated the amount of money per Lupron prescription the doctor could
    earn, also harbored a `secret key'--and in the event the secret
    computer program was in danger of discovery, a secret key was struck
    and !presto! all incriminating information disappeared. Given the
    history of the fertility industry, it appears plausible that !presto!
    any incriminating association between the use of fertility treatment
    and congenital birth defects could disappear if you `remove' the
    association by `simply' switching babies.
        In a 1996 Boston Globe story, available industry figures (for 1993)
    showed that more than 50,000 assisted reproduction procedures were
    performed, and about 8,500 came home with babies--noting that
    ``thousands of others bring home only disappointment and a lingering
    anxiety about the aftereffects of treatment.'' Susan McCarthy,
    attending Boston IVF, had 34 eggs ripen at once--which ``led to kidney
    failure, and she developed a massive, life-threatening infection. She
    was hospitalized for days, connected to tubes delivering intravenous
    antibiotics and draining the fluid that was swelling her abdomen,
    making her look four months pregnant. `I felt terrible for the longest
    time . . . And it's not just that. I don't have anything to show for
    it. . . . ' [Susan] recalls ``ovarian hyperstimulation was mentioned by
    the clinic staff. But the risk was dismissed with the comment `it never
    happens' ''(Kong, 1996).
        The story also described an egg donor, Debra Christensen of Divide,
    CO., who took Lupron, and suffered ovarian hyperstimulation, ripening
    30 eggs, and experiencing a lot of pain. Following soon after Debra's
    egg donation, she became pregnant and experienced problems with this,
    her 3rd child, that she hadn't experienced before--``The placenta grew
    into her uterine lining, huge uterine cysts developed and her son had
    to be delivered two months prematurely. Nine months later, when the
    cysts had swollen her uterus to about six times normal size,
    Christensen--at 32--had to have her uterus and ovaries removed.''
    (Kong, 1996)
        According to Stanford Magazine, Calla Papademas, a 22-year old
    Stanford graduate ``slipped in and out of a coma in the intensive care
    unit at Stanford Hospital'' after responding to an egg donor ad
    ``promising $25,000 or more'' and agreeing to donate her eggs for a
    $15,000 fee. . . . A few days after Calla began the drug regimen
    [Lupron], a benign, undetected tumor on her pituitary gland--which
    Calla's doctors believe was stimulated by the Lupron--grew at a furious
    rate and ultimately ruptured, causing a massive stroke. Calla suffered
    brain damage and lasting weakness on her left side. Her academic and
    career plans were derailed, and she and her family incurred $100,000 in
    uninsured medical bills. . . .'' (Hamilton, 2001)
        In my own situation, within months of stopping Lupron I began to
    experience a variety of ailments, was unable to work for 3 years (and
    have yet to be able to return to full-time employment since Lupron),
    lost my job and home, and slowly came to the terrifying realization
    that I was in for the fight of my life at a time in which I had never
    felt sicker or had so many health problems. Six years later, in 1995,
    in preparation for written testimony in support of MA. H #3308, I
    audited my health records and compiled a chronological list. All
    doctors visits, surgeries, labs, tests, procedures, ultrasounds, etc.
    were typed, in single space, on continuous computer paper--and the end
    product was 7\1/2\ feet tall. This sheet of paper represented: adenoma
    (tumor), breast cysts, cardiac arrhythmias, dizziness, edema
    (swelling), fatigue, gastritis, gastro-esophageal reflux disease
    (GERD), hyperlipidemia, immune system abnormalities, joint pain, knee
    pain (exacerbated), lymphadenopathy (swollen glands), myalgia (muscle
    pain), neuralgia (nerve pain), osteopenia, and spasms, to name a few.
    And, most importantly, knowing the many serious health problems of so
    many other very sick women post-Lupron, I consider myself to be one of
    the `luckier' and `healthier' victims--causing me to fight even more.
        All my symptoms/diagnoses/diseases have been acknowledged as
    adverse events reported to the FDA following Lupron, yet none of my
    symptoms or diagnoses or diseases have ever been reported to the FDA as
    adverse events from Lupron. Since 1995 this list has grown: arthritis,
    ascites (abnormal collection of fluid in abdomen), adrenal problems
    (abnormal cortisol and ACTH levels--workup ongoing), degenerative disk
    disease, ``dissolving jaw'' per dentist, enlarged liver (pre-Lupron
    operative reports indicate normal liver), fibromyalgia-like syndrome,
    lesions in nerves in arms, lesions on skin, scoliosis (presently
    ``mild'', and childhood screenings and pre-Lupron X-Rays evidence
    normal spinal curvature), the osteopenia has now progressed to severe
    osteoporosis, telemetry monitoring of cardiac status (pulse noted at
    38, blood pressure roughly 60/42) raised the specter of a pacemaker
    should I become symptomatic, and a few other problems I can't recall at
    the moment. In the last seven months, I've been hospitalized twice, and
    officially rang in this spring at the endocrinologists office,
    reviewing recent abnormal cortisol and ACTH levels, and heard orders
    I've never heard in my life: ``[I] need to avoid stress''.
        For `fun' during recent hospitalizations for gastritis, I'd ask the
    nurses to explain the following: at times (not always) when they'd
    check my resting pulse and the machine would register a heart rate of,
    say, 41--I'd ask ``do you know how I can make my pulse go down?'' I'd
    get out of bed and momentarily jog in place and the pulse oximeter
    would go down to 38. When they'd wonder what would make that happen,
    Lupron and autonomic nervous system dysfunction becomes the topic.
    Invariably, I've met nurses, phlebotomists, ultrasonographers, and
    fellow patients who've been prescribed Lupron without informed consent
    of the risks. And I've met a number of doctors who report seeing
    patients in their own practice with similar ``bone, gastric, and
    cardiac problems after Lupron''.
        Nurses are also not informed, despite OSHA recommendations, to use
    two pair of chemotherapy gloves and a chemotherapy gown (among other
    precautions) when handling and administering Lupron. And any healthcare
    worker who is planning on conceiving or fathering a child is advised to
    avoid handling the hazardous drug Lupron at least 3 months prior to
    conception attempts (AHFS, 1999). Three years ago, I conducted a survey
    of random U.S. healthcare institutions, inquiring what policy and
    procedure they had for the administration of Lupron by healthcare
    workers. 100 percent of the respondents stated they had no such policy
    or procedure (unpublished data). I've met, talked to, and read online
    plenty of women complaining about Lupron, and I've never once seen
    anyone say their doctor or nurse was gowned and double-gloved during
    their injection. TAP states in its product literature that there are no
    hazardous components to Lupron. Would you consent to an injection of a
    hazardous agent for a benign condition from a gowned and double-gloved
    health worker?
        Many women undergoing 3 months of treatment for fibroids or 6
    months of treatment for endometriosis with Lupron have been complaining
    about post-Lupron problems for years, and again, sometimes these women
    can receive less Lupron than someone undergoing repeated IVF or egg
    donation. Some women use Lupron for endometriosis and IVF, as in my
    situation. And some women have also been maintained on Lupron for years
    on end. Dr. Mercola states Lupron for endometriosis ``could be the Kiss
    of Death . . . Lupron is a disaster drug that in no way shape or form
    treats the cause of the problem. I have seen it absolutely devastate
    many women's lives. It is one of the few drugs that I actually cringe
    when patients tell me that they have taken it. It is my experience and
    belief that this drug causes permanent neurological damage. This drug
    needs to be avoided at all costs.'' (Mercola, 2002)
        Paula Andrade, an R.N. from Methuen MA., provided a statement of
    her experiences as supportive testimony for my 1997 Offer of Proof for
    my medical malpractice tribunal: ``Four years ago I took a GnRH
    analogue [Lupron and Synarel] for problems with endometriosis. I took
    the medication for 5\3/4\ months. The week before I was due to
    discontinue the medication I became ill. I experienced flu like
    symptoms with severe muscle pain, paresthesias, and bone crushing
    fatigue. Four weeks later I developed a host of neurological problems
    including vertigo, nausea, loss of balance, blurred vision, muscle
    twitching, and fasciculations with difficulty walking and constant
    muscle stiffness. Since then I have been seen by several neurologists
    and rheumatologists who remain baffled by my condition. I haven't been
    able to receive any help within the medical community. Prior to taking
    the medication I was an active and healthy individual who had worked as
    an RN for many years. I took care of my home and family. Since the
    medication I have been unable to work and have difficulty performing
    daily activities. I have spoken with other women from around the United
    States who have taken this medication and are now suffering with
    similar problems and whose lives have been drastically altered. I swear
    under the pains and penalty of law that the above statements are
    true.'' Today Paula says she hasn't seen a doctor in years--``For
    what--they can't find out what's wrong and nothing they did changes the
    way I am, so what good is it to keep going?'' (personal correspondence
    and communications)
        Lisa Plante, Fall River, MA., was a former congressional staffer
    who was prescribed Lupron for presumed endometriosis--and Lisa and I
    traveled to Washington together last year to speak to Senate staff on
    the issue of Lupron and its connection to cloning. Lisa experienced
    extreme and unbearable bone and joint pain from the time of her first
    of three injections, and this pain has gradually worsened. Eight years
    later Lisa says ``I now have arthritic bones, very bad bone loss,
    constant bone pain and joint pain, and basically feel like I have aged
    30 years since Lupron. I have not been able to live a normal life with
    my family because of this bone pain and want others to be fully
    informed of the dangers of Lupron. Women must not be put at risk like
    this and MUST NOT be used as guinea pigs!'' Lisa recently went on a
    long promised overseas vacation with her family, fearing that her
    future might prevent her from ever going--and during this trip Lisa
    spent 50 percent of her time in the hotel bed, in pain. Lisa is not
    able to travel here today. (personal correspondence and communications)
        Paulette Wilson, Newport News, VA, took two monthly injections of
    Lupron for endometriosis, and after the second shot she ``woke up with
    chest pain and needed to go to the emergency room.'' She was told she
    had `reflux disease', a gastrointestinal disorder. ``I never had any
    problem like that before. . . . Tests showed that I had acid burns from
    my esophagus to my rectum.'' Paulette now lives with severe pain, which
    sometimes affects her entire body. Paulette also has been diagnosed
    with fibromyalgia (Regush, 2002) and liver problems (personal
    correspondence).
        Jeanne Wolf, from Orange County, NY, had to have her gallbladder
    removed after Lupron, and was diagnosed with gastritis for years until
    stomach testing showed that she had gastroparesis--her stomach was
    paralyzed and was not emptying food. ``I am waiting for these bastards
    to pay for what they poisoned me with. Funny thing is I was given the
    poison because they said I had endometriosis, well I obtained my
    laparoscopy biopsy results and no endo was ever found! My body and mind
    will never be the same.'' (personal correspondence)
        Melanie Waldman Lloyd, Corvallis, OR, took Synarel to treat her
    endometriosis prior to attempting pregnancy, and subsequently developed
    immune problems, suffered 8 miscarriages due to antibody formation, has
    developed thyroid problems, eye problems affecting eye muscles and
    seeing double, and now takes an IV treatment every 2 months (which runs
    at cost some $600 per dose). Melanie writes ``My health is ruined from
    this drug. . . . No one should take this drug without knowing the
    risks.'' (personal correspondance)
        Melody Hampton, Mt. Victory, OH, more than 7 years after Lupron,
    continues to experience tremendous headaches, rash, joint pain, nausea,
    heart palpitations, high white cell count, bone loss, high blood
    pressure, blood in urine, atrophy of muscles, leg swelling--all
    beginning shortly after her first Lupron injection. (personal
    correspondance; Regush, 2002)
        Kimberly Bradford of FL, also started complaining right after her
    first injection, and continues with complaints a decade later. Kimberly
    suffered a miscarriage following her use of Lupron, experienced intense
    migraines, and has neuropathy and Adie syndrome in her right eye. She
    started to trip over everything and began to notice a smell of
    ``burning'' which led to an MRI of her brain. An MRI ``showed lesions
    on my brain. There was a question of ``demyelinating lesions'' or MS,
    and Kimberly has come to call this ``my spot''--``it's in the white
    matter, in the middle, near the pituitary gland, but not in an area
    they can biopsy without causing more injury.'' When Kimberly's doctor
    was filling out her Family Medical Leave Act paperwork, he stated that
    ``this all started when [Kimberly] unknowingly got [her]self involved
    with the FDA's phase IV clinical trial of Lupron.'' Kimberly says: ``I
    did not know until my own research that I was part of a clinical trial.
    I never signed a consent for this.'' (Bradford, 2002). [Kimberly is not
    the only patient with a diagnosis of brain lesions following Lupron
    use].
        Diane DeFeo, a teacher from Yonkers, NY, lost two teaching jobs as
    a result of being on Lupron. Diane writes ``This was disabling. I was
    exhausted and still experiencing pain, had migraines, mood swings, bone
    and muscle aches and pains, not to mention that I gained 35 pounds. I
    have lapses of memory I call ``lupron moments.'' I was constantly
    dizzy. And I waited for the symptoms of Lupron poisoning to diminish.
    Seven years later I still experience effects from this drug. And TAP
    Pharmaceuticals, the company that manufacturers this poison, simply--
    this is evil at work. The physicians that continue to prescribe this
    drug knowing the possible repercussions are the most evil of all. I
    pray for the day when people will take us seriously and that women do
    not need to suffer permanent illness and damage. (personal
    correspondance).
        Julie Johnson, Chicago, IL., relates how her doctor told her ``its
    lupron or hysterectomy, so I agreed to the lupron. I had my first shot
    at the end of October 1996, and I was fine--for about 20 hours. Then I
    developed a terrible pain at the injection site and I could not move,
    walk, or sit, but my doctor said it was not the Lupron and I probably
    hurt my back and it eventually eased with a dull ache remaining at that
    site.'' She received a second shot and experienced achiness but
    attributed it to the flu and received her third shot, to awake the next
    day with hives. ``And then my knees started to ache, and every morning
    for the next week I woke up with pain in another part of my body. By
    New Years I hurt very badly--even wiggling my toes to slip on shoes was
    excruciating. The pain went on for months and months and I noticed that
    I was losing strength in my legs.'' Julie continues to suffer from
    fibromyalgia, has lost her libido and has dealt with chronic depression
    since Lupron. She tells of her phone calls to TAP, in which ``he
    refused to listen to me--I've often wondered, if they refuse to listen
    or take this type of information from the women who have taken lupron--
    how will they know what type of problems lupron causes?'' (personal
    correspondance). Julie is the founder of `Julie's After Lupron Page',
    on Delphi.com, a public internet message board where Lupron victims
    share information and experiences. (Julie's Page).
        Susan Hayward, Lake Havasu City, AZ, says ``I would rather suffer
    with my initial diagnosis, endometriosis, than what this drug has done
    to the rest of my body and life''. Susan relates how, in attempts to
    maintain her career amidst endometriosis, 2 doctors administered a
    total of either 19 or 20 Lupron injections over a five year period.
    ``When I first started using the drug I had to purchase it like any
    other prescription. Later, both doctors had me skip going to the
    pharmacy and they obtained the drug for me. I believe I was sold
    prescription samples. The kickback schemes involved with TAP and
    physicians are well documented . . .''. Since Lupron, Susan reports
    experiencing ``vertebrae bone loss diagnosed as degenerative disk
    disease, arthritis, myalgia, bone pain, fatigue, swelling in hands and
    feet, severe allergies, nausea, weight increase, severe memory loss,
    vision changes, sleep changes, rapid heart beat, and abdominal pain.  .
    . . After taking Lupron, I don't go a day without pain and am under
    constant doctor care to control pain and autoimmune problems. I left my
    home and moved to Arizona where I didn't know a soul so I could get
    relief from the arthritis problems. . . . The total lack of support
    from the medical profession is appalling, and all lawyers say `without
    a doctor saying your problems are related to Lupron you don't have a
    case'.  . . . I lost my career and am disabled, but more than that it
    has robbed me of any faith in our system of justice and what is
    right.'' Susan points out that her disability has resulted in
    ``approximately $900,000 disability costs being paid by Social Security
    and the Federal Retirement Program, plus factor in the increased
    insurance premiums from hundreds of thousands in medical bills from
    hospitalizations, surgeries and tests.'' (personal correspondence; see
    also Lazar, 1999).
        Judy Norsigian, Co-director of the Boston Women's Health Book
    Collective, also provided a statement for my 1997 Offer of Proof in my
    medical malpractice tribunal: `` . . . No fewer than 15-20 women have
    called our Women's Health Information Center over the past 5-6 years
    about totally debilitating and frightening reactions to this drug  . .
    .''.
        In 1995 Donna Kuha, of MA., entered one of Dr. Andrew Friedman's
    Lupron clinical trials for fibroids--``The doctor told me it would be
    good for me.  . . . He didn't tell me of any possible danger.  . . . I
    sure didn't expect a stroke.'' Donna Kuha, ``who lost the use of a hand
    and most of the use of one leg, is one of a disturbing number of
    patients who have been harmed by clinical trials.'' (Lasalandra (2),
    1998; personal communications, 1998). Publicly available court records
    in Kuha's medical malpractice trial, containing medical records,
    indicate Donna suffered her first stroke while in the Lupron clinical
    trial, and she suffered another stroke subsequent to Lupron
    discontinuation, as well as developing a seizure disorder. In my
    professional opinion, the medical records within these court documents
    compel one to entertain `the magic clot theory' and are deserving of a
    close and critical review. According to the public records, Donna's
    expert medical witness concluded that a drug other than Lupron caused
    her stroke, and twenty-one pages into this plaintiff's medical expert's
    curriculum vitae it is learned that he's been an Abbott consultant
    since ``1987 through present'', and had served on Abbott Young
    Investigator Award Advisory Board in 4 previous years. (Kuha, 1997).
    Donna suffered her first stroke in March, 1995--just prior to Lupron's
    FDA approval for `anemia associated with fibroids when iron therapy
    alone is ineffective'. (NDA 19-943)
        The Boston Herald did a 3-part series on Lupron, the second part
    entitled `Women seek answers on drug's suspected side effects'. A dozen
    women were interviewed for this story, which began ``Hundreds of women
    nationwide, with nowhere else to turn, are forging a campaign against a
    drug they believe has ruined their health and their lives.'' Quoting
    one victim in the series: ``My knees tremble a lot and get very weak,
    and I have to use a cane now to go up and down the stairs,'' says
    Kimberly Savino, 17, of Easton, who was prescribed Lupron last year for
    a gynecological problem. Before taking the drug, Savino said she often
    rode horses and jogged. Today, three months after stopping Lupron, the
    teenager has trouble even walking and has been diagnosed with a
    degenerative arthritis, which usually develops over many years. Her
    mother is worried--and suspects Kimberly's strange bone problems were
    triggered by Lupron. ``It's very hard to see her, all of a sudden,
    moving around like an old lady with a cane,'' said Susan Savino. ``Now
    we don't know if she is going to end up in a wheelchair. This shouldn't
    be happening to someone who is 17.'' (Lazar, 1999)
        This shouldn't happen to anyone at any age. And problems with
    Lupron appear throughout all ages and all indications. For example, a
    public internet post from another mother about her 15 year old daughter
    who at age 5\1/2\ was treated with Lupron for 3\1/2\ years. The mother
    reports her daughter had no problems on Lupron, but writes that ``her
    period has never been real regular  . . . she has been having severe
    pains in her leg joints. Started in the knees and have moved to the
    hips.  . . . Now she is having similar pains in her elbows and
    shoulders. She was always a small girl until about the same time as the
    pain started, she gained almost 50 pounds and can't seem to get it off.
    Does anyone out there know if this could be some long term affects of
    Lupron???? We have had her to 2 different doctors and they can't seem
    to figure out what is going on. . . .''
        Numerous men have reported a multitude of adverse events following
    their use of Lupron for palliative treatment of prostate cancer (Abend,
    personal communication, 1994). Zoladex (goserelin) is another GnRHa
    used in prostate cancer, as well as used in endometriosis and
    infertility. Lupron, Zoladex, and Synarel are all advertised as
    ``fertility medications'' (Fertilitext, 2003; Members, 2003), yet no
    GnRH analog has been approved for fertility treatment or IVF or any
    variant of infertility treatment. In an overseas IVF study using
    GnRHa's Zoladex and Buserelin with clomiphene (CC) and hMG, ``[i]f no
    selection against chromosomally abnormal oocytes takes place at the
    time of fertilization, more abnormal oocytes are harvested with GnRHa/
    hMG protocols than with CC/hMG.'' (DeSutter, 1992). Studies in pregnant
    baboons using Zoladex resulted in numerous abortions and stillbirths
    and neonatal death (Kang, 1989).
        Debbie Arnason wants you to know about her husband's experience
    with Zoladex treatment: ``Arne Arnason of Naples FL was diagnosed with
    prostate cancer about 18 months ago and was put on Zoladex 3-month
    depots with resulting side effects of debilitating hot flashes, extreme
    weakness, breathing difficulties, irritability, bone mineral density
    loss, hip, back and joint pain as well as muscle pain. He was unable to
    work. With each successive treatment, the symptoms became worse. We
    truly believe the 3rd and last shot was unnecessary--this treatment
    aged him 20 years in 9 months, requiring 2 ER visits, one for
    arrhythmia and one for a retinal tear. Arne continues to have symptoms
    related to the calcium imbalances the Zoladex created--he was referred
    for surgery of the neck to remove his parathyroid gland. It's just been
    one scary thing after another. No one warned us of any of this!! I had
    to do all my own research. We feel for people who don't know the awful
    consequences of the use of this goserelin acetate drug, Zoladex by
    AstraZeneca (similar to Lupron)''. (Arnason, personal communications
    and correspondence) [AstraZeneca ``is in negotiations with U.S. state
    and federal authorities over the potential settlement'' involving
    ``improper claims for its prostate cancer treatment Zoladex, in a ruse
    similar to that of TAP  . . .'' (Pharmafocus, 2003; Church, 2002)].
    8. Rita Abend, D.D.S.--Her Story & The Inception Of The NLVN
        The following is testimony of Linda Abend, D.D.S., dated December
    5, 1997, and submitted into the public record as expert witness
    testimony within my Offer of Proof in my medical malpractice tribunal
    (Millican v. Harvard Community Health Plan, Boston IVF, Natalie Schultz
    M.D., Brian Walsh M.D., Mahmood Niaraki M.D., Selwyn Oskowitz M.D.,
    Michael Alper M.D.; No. 92-2140A). At that time, in 1997, there was no
    medical expert that I could locate who was willing to publicly address
    Lupron's causality to adverse health problems. Linda Abend's testimony
    is reprinted below in its entirety:
        ``Dear Tribunal Members: Many years ago I founded The National
    Lupron Victims Network to inform people about the risks involved in
    taking the drug Lupron. The network does not accept any money from
    either victims or external sources. All of our information is available
    for free on the internet. I hope that the information I have found in
    my years of research will help other people so that they are fully
    informed of the risks involved in taking Lupron.''
        ``Women and men from all over the world have contacted the network.
    Nearly all of the people I have spoken to were not informed of the
    risks involved in taking Lupron. The majority of the people who
    continue to have medical problems after taking Lupron are finding that
    they are having an unusually hard time getting adequate medical care.''
        ``The individual case that I have the greatest knowledge of is that
    of my sister, Dr. Rita Abend. Before Rita took Lupron, difficulty in
    obtaining medical care was something neither Rita nor I could
    comprehend. Once she took Lupron everything changed. While on Lupron
    Rita experienced horrendous side-effects. Doctors had never informed
    Rita of any risks. Ultimately, we realized that she probably would
    never receive the medical care that she so desperately needed.''
        ``Since taking Lupron, Rita has been diagnosed with seizures,
    autonomic nervous system dysfunction and myeloma/plasmacytomas (a rare
    form of bone marrow cancer). All of these diagnoses were given and then
    rescinded at one time or another. Results on her blood laboratory
    reports and numerous pages of medical documents were whited-out, and
    vials of blood lost by a physician before they even left his office.
    Doctor after doctor has refused to treat her including one who plainly
    stated that it would not be in his best interest to do so. Rita went
    all over the country in search of medical care after taking Lupron.
    Rita, like many others who took Lupron, could not get honest medical
    care after taking Lupron. And without honest medical care and doctors
    to testify, due process in the courts is an impossibility.''
        ``In one instance, Rita had to obtain a court order in order to get
    her medical records from one doctor, Orin Devinsky. Devinsky had
    threatened to ``destroy'' the continuous audio-visual video tapes that
    he had made of her electroencephalograms (EEGs) during a 9 day hospital
    stay in a specialized epilepsy unit, approximately two weeks after
    stopping Lupron. (Rita spent three of these days in intensive care).
    Despite the fact that these tapes had over 600 computerized ``events''
    (alerting the viewer to abnormal brain activity) Devinsky wanted to
    destroy them. During the hospital stay Devinsky learned that Rita's IQ
    had dropped to 97 on an IQ test and her manual dexterity was in the
    bottom 8 percent of the nation. Instead of informing us of this drastic
    decline after taking Lupron, he informed us that the tests came back
    ``normal''. Although Devinsky's admitting diagnosis was ``convulsions''
    (based on an EEG), he claimed that this was all a mistake and in the
    end nothing was wrong with Rita. Even with the court order Devinsky did
    not turn over all of the medical records. He claims to have ``lost''
    some tapes.''
        ``Instead of offering Rita anti-seizure medication, Devinsky tried
    to coax Rita into taking a derivative of pentamethylenetetrazole (PTZ),
    insisting that it was perfectly safe and that no one had ever been hurt
    by it. Rita refused the PTZ. After researching PTZ I discovered that
    PTZ is no longer given to humans since it is not safe. It has been
    found to cause seizures and effects the autonomic nervous system. It is
    used in the laboratory to make animals epileptic for experimentation
    purposes. When Rita finally found a doctor to monitor her seizure
    condition caused by Lupron, she was offered not one, but four anti-
    seizure medications.''
        ``In another instance, Rita was experiencing extreme pain in her
    hip. An x-ray revealed that she had lost 30-50 percent of her bone
    density at the head of her femur. Lupron is known to cause bone loss at
    the head of the femur. Rita was instructed to use a walker because her
    hip could fracture from the loss of bone. Rita was referred to a
    specialist. He refused to treat her. He refused to run a single test,
    not even a blood test. Rita was left in bed suffering with excruciating
    pain for one year, unable to get up without the use of a walker.''
        ``Today, my sister, a once actively employed, vital, energetic and
    intelligent woman who graduated from New York University Dental School,
    is now totally and permanently disabled. It is hard to say which is
    most difficult for Rita; relinquishing her dental license,
    relinquishing her drivers license, accepting the fact that
    comprehensive medical care (no testing, no answers) will always be
    denied because she took Lupron, or that justice will probably not
    prevail if one has been injured by Lupron.''
        ``Doctors who prescribe Lupron are denying people the accurate
    information they need in order to make an informed decision. Once
    people become ill on Lupron, these physicians are denying the temporal
    relationship between Lupron and the onset of symptoms. They even deny
    information in respected peer-reviewed medical journals. For example,
    two studies reported memory loss with Lupron occurring in 72 percent
    and 75 percent of the studied populations. Both studies were published
    in the Journal of Assisted Reproduction and Genetics, and Fertility &
    Sterility, respectively. The percentages reported are quite high. In
    fact, if an individual does not experience memory loss with Lupron that
    individual is in the minority. Yet, doctors who prescribe Lupron are
    continuing to deny that Lupron causes memory loss. Doctors who
    prescribe Lupron are also denying that Lupron can cause other side-
    effects that have already been ackowledged in the medical literature
    and printed in the package insert. They deny the correlation of side-
    effects while on Lupron. They deny the correlation when one stops
    taking Lupron and the side-effects persist.''
        ``I certainly do not want to leave you with the impression that I
    believe all physicians are bad. There are many good, caring physicians
    out there treating people with all kinds of medical problems. But when
    Lupron victims turn to physicians for help and answers they get a deaf
    ear and the run-around. Lupron victims are not victims of Lupron alone,
    but are also victims of a medical system that has failed them. And
    without medical care and doctors to testify, they are unable to obtain
    justice in the courts. If you have any questions, please feel free to
    contact me. Respectfully, Linda Abend, D.D.S., Founder, The National
    Lupron Victims Network.''
        Although Linda Abend closed this 1997 statement with an invitation
    for contact, attempts to contact the NLVN (by myself, other victims,
    lawyers, and media) have been in vain. Phone calls go unanswered and
    certified mail to their long-held address returned ``unk''. No new
    information has been posted at the NLVN website for years, and the
    private NLVN message group (where there had been postings by hundreds
    of members) has long been inaccessible. Thousands of women contacted
    the NLVN and had filled out the detailed questionnaire that the NLVN
    had mailed out, and was processing, in the 1990's. Now, the question is
    not only what happened to all that information--but what has happened
    to Rita, Linda, and the NLVN?
    9. The State Of The ART, And The Art Of Stating
        In February 1995 I noticed a surrogate ad running in a college
    newspaper, offering $17,000 plus expenses to carry the gift of life for
    an infertile couple, and I called the ad. A Dr. Radecki answered the
    phone, and I heard all about the wonders of IVF and ``there were no
    long-lasting risks'' and ``no one ever suffered serious harm from the
    drugs.'' On March 21, 1995, I was surprised to see CBS Evening News
    interviewing this Dr. Radecki--and became even more surprised to learn
    that Dr. Radecki was not a fertility doctor--he was a psychiatrist who
    had lost his license for sexually abusing his patients. By the end of
    March 1995, Dr. Radecki had closed shop--the telephone number for the
    surrogate ads was disconnected, the ads were gone, and he was under
    siege for misrepresentation.
        A TAP advertisement in a fertility journal gives a glimpse into the
    sly canvas upon which the industry paints its picture: This TAP Lupron
    ad read: ``Remote Control: Your patient with endometriosis doesn't have
    to remember her daily therapy--Lupron Depot 3.75 mg remembers it for
    her.  . . . She only needs to remember six monthly visits.'' (Ad,
    1992). Nowhere does the consumer learn that memory loss has been known
    to be ``a commonly observed'' side effect to Lupron, or that patient
    noncompliance with daily Lupron could likely have been related to a
    memory disorder (listed as a known adverse event to Lupron), or that
    clinical trials conducted for Lupron depot approval utilized
    methodologically flawed study design that was conducive to subjects
    forgetting adverse events (surveyed every 30 days).
        In 1990, several Brigham & Womens physicians (including the lead
    author who would later admit to falsifying and fabricating
    approximately 80 percent of 4 Lupron studies) would write ``not since
    the development of oral contraceptives has there been so much
    excitement and enthusiasm among basic scientists, clinical
    investigators, and practitioners of reproductive medicine.'' (Friedman,
    1990). A coauthor in the latter article, Robert Barbieri M.D., has also
    been a lead investigator for Lupron, authoring or co-authoring
    (including with Friedman) many Lupron or GnRHa studies and books, and
    has received TAP funds for numerous studies, and serves also as a
    Medical Advisor on TAP's Lupron endometriosis website.
        In 1997, Dr. Barbieri, representing the industry, testified in
    opposition to the MA. bill which would have mandated state regulation
    and informed consent of the risks of ART. Following the hearing, when I
    asked Dr. Barbieri why memory loss, along with all of the other
    hundreds of reported side effects, was not included in their IVF
    Clinic's consent form, he subsequently forwarded their consent form
    with an attached, handwritten note stating: ``Here is a copy of our
    current Lupron consent form for IVF. I am going to ask Dr. Hornstein to
    add memory loss as a potential side effect. I don't think we can add
    300 side effects. Do you have 3 or 4 others that would be important to
    add?'' That such a lead and allegedly prestigious Lupron investigator
    should query me as to what adverse events are important to include
    within their Lupron informed consent document (presumably approved by
    an IRB) is troubling, disgraceful, and the epitome of the `state of
    this art'.
        ``Inclusion of patients with a poor response to GnRHa therapy has
    not always occurred in outcome analysis in the published medical
    literature.'' (Redwine, 1994). Conflicts of interest are extensive,
    troubling, and have far reaching consequences upon standards of care
    and the state of science. Two cases in point: Another lead Lupron
    investigator alleged in a study that reduced bone mass was associated
    with endometriosis (Comite, 1989), yet another investigator with
    contrasting findings reported that ``One explanation for the difference
    between the results of this study and those of Comite et al. is that
    they included women who previously had been treated with GnRH agonists
    and these agonists are associated with bone loss.'' (Dochi, 1994). (See
    www.lupronvictims.com, `Endometriosis' for further elaboration on these
    studies). Claims of the disease endometriosis being associated with
    bone loss, while deliberately omitting patient's prior use of GnRHa
    (which is known to causes bone loss), is a perilous concept of
    manipulating iatrogenic, adverse, drug effects into a disease-related
    non-tort phenomenon--and deserves attention.
        A 2002 Human Reproduction article, `High rates of autoimmune and
    endocrine disorders, fibromyalgia, chronic fatigue syndrome and atopic
    diseases among women with endometriosis: a survey analysis', co-
    authored by the President of the Endometriosis Association, failed to
    mention GnRHa's within the article (Sinaii, 2002). The survey upon
    which the article is based, which was sponsored by Zeneca (1998), does
    contain reference to GnRHa use in survey participants. Despite the
    presence of a National Lupron Victims Network, with many women
    complaining of autoimmune and endocrine disorders, fibromyalgia,
    chronic fatigue syndrome, etc. post-Lupron, this article makes no
    mention of these adverse advents.
        I do not think any of this is funny--but if there were ever a game
    involving Lupron and/or GnRHa titled something like `Patent--Conflict
    . . .Yea or Nay', I'd participate. For example: Issue--Person involved
    with the testing of animals and Lupron and FDA approval submission  . .
    . Yea Patent! Yea Conflict! Issue--Person heading major reproductive
    research unit and member of RESOLVE's Advisory Board  . . . Yea Patent!
    Yea Conflict! Issue--Member of major Institutional Review Board, who
    has performed numerous TAP-sponsored Lupron studies, and published
    numerous articles on Lupron  . . . Yea Patent! Yea Conflict! Issue--
    Individuals promoting awareness of risks of Lupron and ART  . . .
    Patently NayNay!
    10. The Check Is In The Fe/male
        ``GnRH and its analogs have led to exciting new avenues of therapy
    in virtually every subspecialty of internal medicine as well as in
    gynecology, pediatrics, and urology  . . . virtually every subspecialty
    of medicine will be touched by the GnRH analogues  . . .'' (Conn,
    Crowley; 1994).
        The following is a fairly comprehensive, alphabetical, list of
    clinical uses, case reports, or studies involving Lupron's use in
    unapproved and off-label indications. These uses were mostly found
    within published medical literature, although some were noted within
    patents, or advertisements for clinical trials, and one was a personal
    clinical observation. Citations have been omitted for brevity, but are
    available upon request.
        A:adjuncts for IVF; adjunct to fibroid surgery; anovulation; autism
    [management of sexual behaviors]; acute intermittent porphyria;
    Alzheimer; adenomyosis; severe adenomyosis; adhesions; amenorrhea
    [functional]; angiomyxoma of vulva; autoimmune disease; autonomic
    neuropathies; `add-back' regimen [estrogen/progestin with lupron];
    advanced breast cancer.
        B:before hysterectomy for leiomyomas; benign prostatic hyperplasia;
    benign prostatic hypertrophy; birth control; breast cancer; breast
    cancer prevention; bioavailability following nasal and inhalation
    delivery to healthy humans.
        C:catamenial insulin reaction; catamenial pneumothorax; chronic
    intestinal pseudo obstruction [in patient with heart-lung transplant];
    cluster headaches; colorectal cancer, congenital adrenal hyperplasia
    with oligomenorrhea; contraception; cryptorchidism; controlled ovarian
    hyperstimulation in normal, abnormal and poor responders; combination
    therapy with flutamide and castration; colonic endometriosis;
    comparison of suppressive capacity of different GnRHa's in women;
    comparison of hCG versus lupron for releasing oocytes.
        D:dysfunctional uterine bleeding prior to hysterectomy.
        E:egg donation; endometrial ablation; endometrial cancer,
    endometrial glandular hyperplasia; endometrial hyperplasia without
    atypia; endometrial cancer; endometrial stromal sarcoma; epithelial
    ovarian cancer; exhibitionism; effect of very high dose in prostate
    cancer; effects in animal and man; effect on embryos (``accelerated
    development''); endometrial preparation for transfer of frozen-thawed
    pre-embryos in patients with anovulatory or irregular cycles; effects
    on follicular fluid hormone composition at oocyte retrieval for IVF;
    effect on hair growth and hormone levels in hirsute women; effects on
    glucose metabolism in a diabetic patient; equivalency of hMG and FSH
    stimulation following suppression; effect on LH surge; effect on
    adrenocorticotropin and cortisol secretion in premenopausal women;
    effect on seminal vesicles; effects of lupron on luteal-phase
    hyperprolactinemia during ovarian stimulation.
        F:fallopian tube obstruction; functional ovarian hyperandrogenism,
    functional abdominal pain from functional bowel disease; fibrocystic
    breast disease; first cycles of IVF/GIFT; follicular development and
    oocyte maturation.
        G:GIFT.
        H: Headache, Huntington's Disease (for exhibitionism),
    hyperandrogenism, hysteroscopic surgery; hilus cell hyperplasia within
    ovarian cyst wall; hypermenorrhea in premenopausal women with acute
    leukemia; hypermenorrhea with severe thrombocytopenia;
    hypergonadotropic hypogonadism; hypergonadotropic amenorrhea;
    hypothalamic-pituitary axis disease; hypothalamic hamartomas and sexual
    precocity; hirsutism; moderate and severe hirsutism; hysteroscopic
    surgery; benign symptomatic hyperandrogenism in a postmenopausal woman;
    hidradenitis suppurativa.
        I: infertility; IUI; IVF; IVF-ET in insulin-dependent diabetics;
    irritable bowel syndrome; intravenous leiomyomatosis with cardiac
    extension; intranasal lupron for endometriosis; intranasal/sc lupron
    for fibroids.
        K:Kallmann syndrome.
        L: leuprolide flare regime for IVF/GIFT & embryo cryopreservation;
    lupron screening test for IVF; luteal phase lupron flare protocol;
    luteinized unruptured follicle syndrome; leiomyosarcoma; leiomyomatosis
    peritonealis disseminata.
        M:male contraception; `male' factor infertility (female is
    treated--male is not); Meniere's Disease; menstrual migraines; motility
    disorders.
        O:ovarian cysts; ovarian cysts after ovarian transposition; ovarian
    epithelial tumors; ovarian granulosa cell tumor; ovarian hyperthecosis;
    advanced epithelial ovarian carcinoma; ovulation induction; ovarian
    stimulation; ovarian stimulation with lupron and norethindrone in IVF/
    GIFT; ovarian hyperstimulation; oocyte release; ovarian
    hyperstimulation syndrome; severe ovarian hyperstimulation; oocyte
    donation, oocyte donation [post-menopausal]; operable breast cancer;
    ovarian carcinoma [refractory]; ovarian remnant syndrome [diagnostic].
        P:pancreatic cancer; paraphilias; Parkinson's Disease symptoms,
    pedophilia, pelvic pain not associated with endometriosis; pituitary
    metastatic mass; polycystic ovarian disease; PMS; protection against
    chemotherapy-induced testicular damage; postpartum depression;
    premenopausal breast cancer; post-menopausal breast cancer [advanced];
    pre-implantation [embryonic] diagnosis; prevention of hypermenorrhea in
    premenopausal women undergoing bone marrow transplantation; prostate
    cancer (Stage C adenocarcinoma]; endometroid adenocarcinoma of
    prostate; pseudo intestinal blockage, psychosis in PMS, resistant
    paraphilia, pulmonary endometriosis; pulmonary tuberous sclerosis;
    pulmonary delivery of leuprolide in health male volunteers; pre-
    myomectomy; poor prognosis patients for IVF/poor responders;
    preservation of fertility in a woman with menorrhagia; pharmacokinetic
    studies in humans [iv and sc]; preoperative treatment of complicated
    myomata; pre-surgical treatment of fibroids.
        R:resectoscopic endometrial ablation; rectal endometriosis; routine
    pituitary suppression before ovarian stimulation.
        S:sexual offenders; sexual precocity; Sickle-cell anemia associated
    priapism; surrogacy, SUZI; steroid-cell tumor (advanced); systemic
    lupron erythematosis; submucous myomas; sexual behavior disorders;
    syndrome of familial virilization, insulin resistance, and acanthosis
    nigricans; stimulation test in Tourette's syndrome; small cell
    carcinoma of prostate.
        T:transgender adjunct, testicular function effects; transdermal vs.
    subcutaneous leuprolide--a comparison; triggering follicular
    maturation.
        U:urinary retention in prostate cancer; ureteral obstruction caused
    by endometriosis; urinary retention due to benign prostatic
    hyperplasia.
        W:with or without medroxyprogesterone in treatment of fibroids.
        Z:ZIFT
        And the following list is simply an odd collection of TAP-funded
    Lupron studies that were jotted down along the way. This list should
    not be construed as any formal, complete, or even partial, audit of the
    numbers of published TAP funded Lupron studies. Even if the total tally
    of TAP funded Lurpron grants and investigators could be counted today,
    that figure would be obsolete with the next publication of TAP funded
    Lupron studies. But here's a few examples, with duplicative years
    indicating separate studies.
        In Alabama, there was one of 13 investigative sites conducting TAP
    funded research; in Arizona, TAP funded a symposium; in California,
    numerous investigators for numerous indications; in Colorado, 5
    physicians received TAP funds; in Connecticut, another one of the 13
    investigative sites conducting TAP funded Lupron research; in Florida,
    another one of the 13 investigative sites conducting TAP funded Lupron
    research, and in Florida, a TAP sponsored educational program at Walt
    Disney for unapproved female uses (FDA memo by David Banks, 1990); in
    Illinois, numerous investigators supported by grants from either Abbott
    or TAP or both, in 1988, 1989, 1991, and another one of the 13
    investigative sites conducting TAP funded Lupron research; in Kansas,
    another one of the 13 investigative sites conducting TAP funded Lupron
    research; in Massachusetts, another one of the 13 investigative sites
    conducting TAP funded Lupron research, and in Massachusetts in 1987
    numerous investigators conducted TAP funded Lupron research, and in
    Massachusetts in 1988 numerous investigators conducted TAP funded
    Lupron research, and in Massachusetts in 1989 numerous investigators
    conducted TAP funded Lupron research, and in Massachusetts in 1989
    numerous investigators conducted TAP funded Lupron research, and in
    Massachusetts in 1990 numerous investigators conducted TAP funded
    Lupron research, and in Massachusetts in 1991 numerous investigators
    conducted TAP funded Lupron research, and in Massachusetts in 1995
    numerous investigators conducted TAP funded Lupron research, and in
    Massachusetts in 1997 Brigham & Women's website identified two grants
    were funded by TAP; in Maryland, another one of the 13 investigative
    sites conducing TAP funded Lupron research; in North Carolina, numerous
    investigators (including an FDA Advisory Committee member) received
    funding from TAP, and had Lupron ``generously provided'' by TAP for a
    study involving ovulation induction; in New York, another one of the 13
    investigative sites conducting TAP funded Lupron research; in
    Pennsylvania, another one of the 13 investigative sites conducting TAP
    funded Lupron research; in Tennessee, one physician was on TAP's
    Speaker's Bureau and is an ``active contributor'' to the EA (personal
    correspondence, 1998); in Texas, another one of the 13 investigative
    sites conducting TAP funded Lupron research; and in Texas an
    educational grant from TAP to numerous investigators; and in
    Washington, another one of the 13 investigative sites conducting TAP
    funded Lupron research.
    11. Considering Cloning? Consider The Myths of Hype & The Realities of
            Scientific Misconduct
        It is outrageous to hype cloning research, which will involve
    superovulation with drugs such as Lupron, as probable cures for
    diabetes, Parkinson disease, Alzheimer, etc.--when women who've
    received Lupron have now iatrogenically DEVELOPED these and other
    diseases. It is appalling that this debate has not centered on the
    adverse health effects of superovulation and Lupron upon the women, and
    especially the reports of adverse pregnancy and birth outcomes
    associated with treatment.
        Without proper long-term follow-up study of the reports of adverse
    health outcomes to the superovulated women and without proper long-term
    follow-up of the adverse pregnancy and adverse birth outcomes in the
    babies conceived and exposed to drugs such as Lupron, how can you
    propel recklessly forward to create a massive demand for more
    superovulation of women for research eggs?
        The message of research and biotech has resulted in the impression
    of hope, promise, cure, and benefit. My personal experience can be
    summed up by the words hype, myth, research fraud, conflicts of
    interest, and injury  . . . and all without any medicolegal advocacy
    for the injured victim. It is a myth that public safety is being
    protected by the FDA, evidenced by the fact that some 20 million people
    have taken drugs that have been recalled--drugs that were initially
    deemed `safe and effective during study', only to later learn that data
    identifying serious problems, including deaths, had been suppressed.
        Somewhere it is written that it was a ``comforting but erroneous
    myth'' that research involving drugs and devices still serves medicine.
    Time magazine's 4/22/02 cover, of a woman crouched within a laboratory
    cage, epitomized the story within, depicting yet another research
    debacle in which data identifying adverse side effects was kept
    secret--and only revealed by a whistleblower (Lemonick, 2002). Time
    also noted that there were more than 60 institutions that ``failed to
    protect human subjects adequately.'' Other recent articles have
    identified the dramatic disparity in research results and reporting,
    depending on who is paying for the research--with contracts allowing
    pharmaceutical companies control over disclosure of bad data.
    Furthermore, large sums of money in the form of grants, stock options,
    company ownership, patents, consulting agreements, scientific
    agreements, speaking engagements, symposiums, trips, gifts, etc. (which
    are disclosed in less than \1/2\ of 1 percent [Stolberg, 2001]), have
    created an environment conducive to suppressing bad data and inducing
    outright fabrication of data. It would be nice to think that ethical
    behavior is the norm, but a review of recent news compels one to notice
    the increasingly rampant unethical machinations of research medicine.
        To date there have been a number of renowned reproductive
    physicians/surgeons who have been found to have fabricated and/or
    falsified data: Dr. Andrew J. Friedman, a lead investigator for Lupron,
    recipient of many TAP grants to study Lupron, and director of Brigham &
    Women's IVF Program (where this writer was mandated to use Lupron), was
    found to have falsified and fabricated approximately 80 percent of the
    data in 2 published, and 2 unpublished Lupron journal articles (Federal
    Register, 1996). Is it any wonder that during the time Dr. Friedman was
    director of Brigham & Women's IVF Program, the criteria for the
    administration of Lupron with IVF changed from ``Lupron is only used in
    certain diagnoses'' to ``Lupron is widely prescribed''? Where is the
    data to justify such widespread application of a hazardous,
    reproductive and developmental toxicant?
        There has also been the brothers Drs. Nezhat (one of whom serves as
    a Scientific Advisor for the EA, according to the EA website) who have
    been found to have fabricated research involving laparoscopic surgery
    for endometriosis, resulting in the retraction of two published journal
    articles (Nezhat; 1991, 1992). An attorney, as a result of litigation
    (on behalf of a client who believed she had signed an informed consent
    form to authorize surgery but had instead signed a waiver of right to
    receive informed consent), doggedly pursued to have this bogus
    published surgical procedure data examined--and only after 6 years was
    the data finally produced, examined, and retracted. In one study, more
    than half of the patients were used for pre-market testing of a new,
    non-FDA approved, circular stapling device. ``The Doctors Nezhats'
    retracted bowel surgery articles are included in Ethicon's coursebook
    for surgeons.  . . . While the Doctors Nezhat reported no ``short or
    long term ill effects'' with this new technique, there were significant
    complications in these subjects, some severe. A portion of one woman's
    bowel died during surgery, another's anastomosis (where bowel is
    rejoined) massively hemorrhaged a few days post-op requiring repair,
    one patient's bowels fell into the toilet post-operatively, several
    patients had bowel leaks in the staple line, several patients were
    incontinent of feces, some could no longer evacuate normally, etc. Yet,
    the operation was promoted for 185,000 women by Johnson and Johnson
    based on the Doctors Nezhats' research'' (Attorney James J. Neal, 2003:
    www.mdjdfraud.com; see also Neal, 2002).
        The father of GIFT, gamete intrafallopian transfer, Dr. Cecil
    Jackobson, rounded off his accomplishments with 52 convictions of
    perjury and fraud. He had been substituting his own sperm for that of
    some 75 women's husbands' sperm resulting in these women (initially)
    unknowingly giving birth to children fathered by this `expert'. To
    quote USA Today, `` . . . His case taught a valuable lesson about the
    fertility industry: Self-regulation is not enough.  . . . Many of his
    most offensive acts were legal--like donating his own sperm. The only
    way Jacobson was stopped was on federal wire, mail fraud and perjury
    charges.  . . .'' (USA Today, 1992).
        The ``Dyno Gyno'', Dr. Niels Lauersen (and a cohort) were convicted
    of billing fraud, ``falsif[ying] bills to get $2.5 million in payments
    from insurers for a variety of fertility procedures'' (Barrett, January
    2001), and Dr. Lauersen was ``jailed as flight risk'' (Barrett, March
    2001). Dyno Gyno loyalists attempted to assign this fraudulent billing
    as nothing but `an attempt to provide otherwise denied procedures',
    causing ``prosecutors [to] fume that the case is not about health-care
    policy, but a thief with a medical degree and a lab coat.'' (Barrett,
    2000). Of note is an aside mentioned in the latter article, which
    relates one loyal Lauersen patient's position that women's health
    issues don't get enough insurance coverage. The aside is a description
    of this patient, ``whose three children all needed special attention
    from the doctor due to different complications at birth.'' (Ibid). No
    further elaboration is made on these ``birth complications'', and the
    implications of such ``complications'' appear to be unrecognized.
        And the story of Dr. Asch, et al. is well known: Dr. Asch, who was
    overdosing women in superovulation to steal their eggs and then sell
    them to researchers and other unsuspecting women, reportedly often left
    his office with a briefcase stuffed with thousands of dollars in cash--
    while he was also preaching and publishing on the psychological effect
    of egg donation on women (Lessor, 1993).
        A renowned group of fertility experts published a study, a report
    of ``the first case of human germline genetic modification resulting in
    normal healthy children'' (Barritt, 2001), however the expert group
    ``failed to disclose that along with 15 healthy babies it produced two
    fetuses with a rare genetic disorder. Experts are horrified because the
    fault can be passed to future generations'' (Hill, 2001). The fertility
    clinic and fertility experts report published claims of healthy
    children from their procedure  . . . yet the Washington Post reported
    ``[i]nternal documents from Saint Barnabas explicitly acknowledge that
    the novel technique may be causing the problem  . . .'' (Weiss, 2001).
    The `Birth Defects Research for Children' points out that ``the two
    cases of Turner's syndrome should have been mentioned in the report so
    that doctors and others would be aware of all the facts'' (Birth
    Defects, 2001). The group would later report that the ``children born
    after IVF with cytoplasmic transfer have been carefully evaluated and
    one 18-month-old child was recently diagnosed with a pervasive
    development disorder  . . . a broad spectrum of disorders with mixed
    prognosis.  . . . . Because the procedure is experimental, protocols
    have been supervised and re-evaluated in 1999 and 2001. . . . However,
    this research has been suspended since early July 2001, pending
    clarification of new requirements suggested by the Federal Food and
    Drug Administration.'' (Institute, 2001). Six years prior, in an
    abstract published by one of this group, 4 abnormal embryos were
    implanted into women--and this act brought little, if any, attention
    from anyone or anywhere. (Munne, 1995). At St. Barnabas' webpage on egg
    donation (in which Lupron is used), the question of ``What are the
    risks of being an egg donor'' is answered  . . . ``Donors may risk
    psychological distress if they are rejected from the program  . . .''
    (St. Barnabas, 2001).
        Falsified and suppressed data (which can set, alter, and impact
    standards of care), along with conflicts of interest and abuses of
    human subjects in research endeavors are poisoning medicine
    systemically. Shouldn't you begin to address the forces that result in
    profit via dictation of data and spin and to-hell-with `first do no
    harm'? And should you really open the reproductive research doors wider
    to the inevitable abuses in human embryo cloning research? The criminal
    penalties of jail and fines of at least $1 million that President Bush
    has proposed should be applied not just to the use or importation of
    cloning technology, but rather should be applied like a heavy wet
    blanket over every research discipline in medicine in attempts to quash
    this destructive slow burn.
    12. The Marginalization of Victims and Lack of Medico-Legal Advocacy
        The consumer who has been victimized by the fertility industry and/
    or Lupron has no recourse. Consumer protections are woefully lacking in
    the fertility research enterprises today--and there is no reason to
    assume that adequate `measures' will take place or be enforced in the
    cloning arena. Start cleaning up the mess in today's fertility clinic
    before you create nightmares at the human embryo farms.
        Who or what is in place now to assist the injured egg donor, or the
    harmed fertility patient--and whomever or whatever is offered as an
    answer to that question, please then answer what are they doing now
    about Lupron victims? My complaints to the FDA about Lupron and lack of
    informed consent promulgate the mantra that the FDA has no supervision
    over the practice of medicine, which falls to state Boards of Medicine.
    State Boards of Medicine state a doctor can prescribe any drug they
    want off-label, and drugs are under the purview of the FDA. The
    Department of Public Health has no jurisdiction over fertility clinics,
    so refers one to the Board of Registration in Medicine. The FTC round-
    robins the consumer to the FDA. And there you go, round and round  . .
    . no informed consent, no advocacy, no accountability, no protection.
    The consumer is left stranded, while profits and abuses exponentiate,
    and her medical needs, costs, tests, and doctor/hospital visits
    accumulate.
        Fiscal prudence would seem to imply that insurance companies would
    audit their costs of members 5 years prior to and then 5 years post
    Lupron, for expenditure comparison. My medical bills, and the medical
    bills of others, both before and after Lupron, speak for themselves.
    After enjoying a full-time salary for many years, it would be 8 years
    post-Lupron before I had earned a total of my formerly annual years
    salary. Illnesses, medical costs, inability to work, no medical or
    legal advocacy--all are extreme hindrance to the effort, energy and
    time necessary to mobilize for survival. Eggs donors, et al. beware! My
    advice to those considering undergoing superovulation and Lupron is:
    first, establish independent wealth in the event you become disabled;
    second, you will not be able to recognize lack of informed consent or
    be able to rely on the information or advice given to you, therefore
    some type of healthcare degree, preferably M.D., is necessary; third,
    having advanced chemistry will be especially helpful, so bone up there
    also; fourth, you may need to become quite familiar with the legal
    system and you might be on your own--so prepare yourself beforehand to
    save yourself a lot of grief; fifth, make sure you have family and
    friends available who can help you as you may find you are in need;
    sixth, make sure you can type real fast as you may find yourself having
    to write thousands of letters; and seventh, buy a head-phone because
    you will need to talk to as many people as you can.
        It is ``very bad'', indeed, that reproductive experimentation has
    been conducted without informed consent, and with `treatment' using
    hazardous agents propagandized as safe and as science--but is neither.
    ``It no longer appears possible to consider the marketing of new drugs
    for stimulating the gonadicpituitary axis unless they have been tested
    within the framework of IVF'' (Buvat-Laborie, 1988). The Health,
    Education, and Welfare Department, in 1979, advised that a global study
    be undertaken to establish the safety of IVF, and although no such
    undertaking was done, it was proclaimed at the 1994 Human Embryo
    Research Panel Hearings that former concerns about IVF's safety had
    been abated. The March 2000 study indicating a 9 percent rate of major
    birth defects from IVF represents a substantial increase from former
    reports. Dolly, the cloned sheep, became lame and was euthenized. And
    there are thousands of Lupron victims who appear to have no voice, and
    are crying out for medical care and legal representation.
        The FDA has had a ``fatal erosion of integrity'' (Horton, 2001),
    and conflicts of interest on 18 FDA Advisory Committees were revealed
    several years ago. (Cauchon, 2000; Mercola(2), 2000). The protections
    allegedly in place for federal research subjects were recently shown to
    have failed--and in private research enterprise the consumer is just
    plain out of luck. Conflicts of interest abound in clinical trials--
    ``Let's be realistic'' said [the] commissioner of the FDA, ``Profits do
    drive this business'' (Agnew, 2000). Where are the consumer
    protections?
        While there has been some litigation recently, in the early 1990's
    there was little legal recourse available, and I am aware of 2 other
    women who attempted to bring their own lawsuit involving Lupron pro se
    because they couldn't find an attorney. I searched high and low, east
    and west, north and south, individual and firm and agency alike. Never
    having been inside a law library and needing to know everything about a
    foreboding and alien process with requirements and deadlines I'd yet to
    learn creates a most precarious and unfortunate position. Having to
    learn how to draft a complaint, and having to figure out the problem in
    terms of legal issues, identify the law and find other case law, file
    motions to compel, file answers and promulgate interrogatories and
    requests for production of documents, undergo 7 motions for summary
    judgment and a medical malpractice tribunal--without any attorney or
    real guidance beyond cursory advice by attorneys over the phone. I was
    told by numerous attorneys ``you most definitely have a case, but
    without laws and standards--its a legal vacuum'' and then years later,
    ``if you can find the expert, I'll take the case''.
        Not until my case approached the MA. Appellate level did I pursue
    obtaining a paralegal certificate, but clearly, without counsel, and
    without laws and regulations, I understood that I had limited abilities
    to do justice to the case or the issue. I tried over and over, again
    and again, to find an attorney, each attempt to no avail--and it was
    very unnerving to try to prepare an appeal to the MA. Supreme Judicial
    Court pro se. Incredibly, a final online internet plea for some legal
    guidance was seen by an appellate attorney with endometriosis, Barbara
    Sosin, from Chicago IL. Barbara's reproductive endocrinologist ``fired
    [her] because [she] refused to take Lupron''. This doctor told her
    ``I've been so patient with your irrational refusal to take this
    medication, and there's nothing more that I have to offer you''.
    Therefore, through just a few phone calls of my presenting the legal
    issues, cases, and facts, Attorney Sosin was able to help me assemble
    this information in the most appropriate format, and I was very
    grateful for that last minute support. But, nonetheless, from start to
    almost finish (some 8 years), traveling that road alone is
    unacceptable; and was not the way for such an important matter to have
    had to be handled. Filing a case pro se is something that no victim
    should ever have to do.
        Many product liability cases have been filed against TAP regarding
    adverse events to women following Lupron--and quietly settled. Through
    the grapevine, I became aware of 5 cases in the latter 1990's, and
    obtained court records for Villarreal v. TAP (Sacramento County, CA.,
    No 528453; 1993), and Gantner v. TAP (Cook County, Il, No. 96L11379;
    1997)--and have since become aware of a separate, additional settled
    case, and there are many potential-plaintiffs searching for counsel. I
    am aware that cases are being consolidated, and do foresee a class
    action suit looming on the horizon. But it has taken a very long time
    to get to that point, and an awful lot of wonderful, innocent, misled
    people have been hurt. My lawsuit was initially filed in 1992, and was
    terminated at the MA. Supreme Court level in 2000, the day Boston
    papers broke the Lupron urology kickback scam story--but I left nearly
    1000 pages of medical, scientific, pharmaceutical, and governmental
    documents involving Lupron's risks for the next victim/case.
        Since then, and after 11 years of seeing untold numbers of doctors
    and specialists, I finally received documentation that my ``multiple
    medical problems [are] consistent with case reports following Lupron
    exposure  . . . [and have] an extremely complex, multifaceted,
    constellation of medical problems.'' I'd like to quote the final
    paragraph from my MA. Supreme Judicial Court appeal: ``Moreover,
    Defendants claims of lupron's `menopausal' action does not correlate
    with known science. (Appendix p. 290 & 293). And studies for lupron's
    use in IVF were ``discontinued''. (Appendix p. 358). Therefore, her IVF
    treatment with lupron was not grounded in reliable scientific
    methodology. The opinions of the Defendants, as well as the accepted
    `standard of care' regarding the use of lupron, cannot meet the
    threshold requirements of Daubert and is ``junk science'', creating a
    genuine issue of material fact for a jury. (Daubert v. Merrell Dow
    Pharmaceuticals . . .)'' (Millican vs. Harvard Community Health Plan,
    Boston IVF, Natalie Schultz MD, Brian Walsh MD, Mahmood Niaraki MD,
    Selwyn Oskowitz MD, Michael Alper MD. Docket No. 98-P-1472.)
        An online investigation of Lupron (www.redflagsweekly.com), as well
    as the NLVN, myself, other victims, and media such as FOX News and
    Dateline, have challenged TAP to produce data and to answer questions--
    but there has been no response from TAP. The FDA was to take another
    look at its damaging 1999 review, but no word has been heard. The NIH
    just conducts more Lupron studies, while shielding consumers from its
    webpages for its Hazardous Drug List and Material Data Safety Sheets
    (MSDS). The MSDS for Lupron, available to all hospitals and healthcare
    institutions, states that leuprolide acetate is ``hazardous per OSHA
    criteria'', and identifies that ``women of childbearing potential must
    be excluded from working directly with product.'' This is information
    necessary for consumers to make an informed decision about `treatment'
    with a hazardous, toxic substance. Questions were posed to several NIH
    Lupron investigators inquiring whether their Lupron trials followed NIH
    and OSHA guidelines in use of protective gear for healthworkers
    administering Lupron, and these questions were responded to by several
    NIH investigators--however, the replies do not answer the question as
    to whether NIH Lupron clinical trials follow NIH guidelines (personal
    communications). More than thirty years after the debacle of DES, the
    CDC (in 2003) began a campaign to inform people about the potential
    health effects of DES (www.cdc.gov/DES). The CDC's annual report of
    fertility clinic data has been questioned in the past, and issues
    regarding its reliability have again been raised, pointing out its
    ``lack of reliable information'', citing data that is up to 3 years
    old, and clinic success rates that are ``too easy to fudge'' (Report,
    2002).
        In one aspect of my `fertility treatment nightmare', the dates and
    details of an office visit were deliberately altered in the computer
    through collusion and deliberative machinations by several of the
    defendants in my case--and my HMO had steadfastly denied that I had
    ever received treatment or prescriptions on that date (Millican v.
    Harvard Community Health Plan, Boston IVF, Natalie Schultz M.D., Brian
    Walsh M.D., Mahmood Niaraki M.D., Selwyn Oskowitz M.D., Michael Alper
    M.D.; see also Donahue, 1996). Given the ease with which my computer
    record data was deleted and altered, along with numerous other
    experiences, as well as the known fraudulent Lupron data, and recent
    newsreports on fraudulent research elsewhere, ``data'' coming from
    self-interested parties should always be viewed as potentially
    unreliable, to say the least.
        A few more comments from Gena Corea's supportive statement for my
    lawsuit are pertinent here: ``After discussing the death of a woman in
    the IVF program in a Seville clinic with Dr. Francesca Martinez of the
    IVF program at Instituto Dexeus in Barcelona, Spain, I said to her: If
    it's so difficult for you, who are practicing IVF, to find information
    on women who died of IVF, how can you say what the risks of IVF are?
    She replied that she and her colleagues knew what happened in their own
    center and they had many cases--2,000. So she is telling potential IVF
    candidates what the risks of IVF are based on her own clinic's
    experience. This is a pitiful situation.'' And Gena concludes by saying
    ``I don't know what will happen with Ms. Millican's complaint. What
    often occurs in such situations is that women, with only their own
    limited financial resources, without even an attorney, doing the labor
    themselves when they come home tired from their jobs, seek justice. Few
    can do it. Few can break silence on the abuse to which they have been
    subjected. But it is vital to talk back, to insist one's reality into
    the fictional never-never land of miracle babies and ecstatic, unharmed
    mothers. I applaud [those women] for speaking [t]he[i]r truth.''
        The answers do not lie in continued exposure to Lupron, which would
    definitely occur should the Senate pass any bill allowing therapeutic
    cloning research. Does Lupron sound like the kind of drug you want to
    give to young healthy women who are `offering' to donate eggs? Does
    Lupron sound like the kind of drug you would want to take for any
    benign condition, without informed consent? It appears that the
    majority of women whose eggs are harvested used Lupron. How many women
    know Lupron has never been approved for fertility? How many women know
    the facts and the tragedies mentioned in these pages? If millions of
    women are needed to meet the demand for research `material', what will
    these women be told? My advice to them is--instead of asking questions
    to the Industry  . . . read the Congressional Record.
    13. A Request To Congress Asking For An Investigation Into Lupron and
            ART
        In closing, the data in this paper barely scratches the surface of
    problems associated with Lupron and ART, and Committee Members should
    know that there are unknowns and redflags beyond those described in
    this submission. Time limits did not prevent further detail or
    elaboration, and wish to add that any references or further information
    are available upon request.
        For all of the above stated reasons, I would respectfully urge the
    Committee to ban reproductive and therapeutic cloning.
        And I would like to also respectfully urge the Committee and
    Congress to undertake a formal investigation into Lupron and its
    victims, as well as investigating the long and short term safety of ART
    drugs and procedures on women and offspring.
        Respectfully submitted.
                                  References:
        Aboulgar H, Aboulghar M, Mansour R, Serour G, Amin Y, Al-Inany H.
    2001. A Prospective Controlled Study of Karyotyping for 430 Consecutive
    Babies Conceived Through Intracytoplasmic Sperm Injection. Fertility
    and Steriliy, 76:249.
        ACT. Duncan Holly Biomedical and Advanced Cell Technology. Consent
    to Participate in a Study Involving Egg Donation for Stem Cell
    Research. Undated.
        Ad: TAP Lupron Depot Advertisement. i.e.; September 1992. Remote
    Control. Fertility and Sterility, 58(3).
        Agnew B. August 25, 2000. Financial Conflicts Get More Scrutiny in
    Clinical Trials. Science.
        AHFS. American Hospital Formulary Service. AHFS Drug Information
    1999. ASHP Technical Assistance Bulletin on Handling Cytotoxic and
    Hazardous Drugs. p.1030/1.
        Akaboshi S, Takeshita K. September 2000. A case of a typical
    absence seizure induced by leuprolide acetate. Pediatric Neurology,
    23(3):266.
        Anteby I, Cohen E, Anteby E, BenEzra D. October 2001. Ocular
    Manifestations in Children Born After In Vitro Fertilization. Archives
    of Ophthalmology, 119:1525.
        Arnot, Bob Dr. December 18, 2000. The miracle of life. MSNBC.COM.
    Accessed 2000; no longer accessible.
        Ashkenazi J, Goldman JA, Dicker D, Feldberg D, Goldman G. April
    1990. Adverse neurological symptoms after gonadotropin-releasing
    hormone analog therapy for in vitro fertilization cycles. Fertility and
    Sterility, 53(4):738.
        ASRM Press Release. October 14, 2002. Highlights from ASRM 2002:
    Studies Show Children of ART Develop Normally, citing Neri Q. et. al--
    Abstract P-406. http://www.asrm.org/Media/Press/kidsareallright.html.
    Accessed 10/17/02.
        Assignees: Hardy RI, Golan DE, Biggers JD. Patent 5,541,081.
    Assignee, President and Fellows of Harvard College, Brigham & Women's
    Hospital, Inc. Process for assessing oocyte and embryo quality. Filed
    March 22, 1994, Granted July 30, 1996.
        Barbieri R, Yeh J, Ravnikar VA. August 1991. Letter. GnRH agonists
    and ovarian hyperstimulation. Fertility and Sterility, 56(2):376.
        Barrett D. November 12, 2000. `Dyno Gyno' Retrial Set In Med-Bill
    `Doctoring'. New York Post.
        Barrett D. January 10, 2001. `Dyno Gyno' Convicted of Billing
    Fraud. New York Post.
        Barret D. March 24, 2001. Dyno Gyno' Jailed As Flight Risk. New
    York Post.
        Barritt JA, Brenner CA, Malter HE, Cohen J. March 2001.
    Mitochondria in human offspring derived from ooplasmic transplantation:
    Brief communication. Human Reproduction, 16(3):513.
        BBC News Online. March 7, 2002. http://news.bbc.co.uk/2/low/health/
    1860492.stm. Accessed 11/23/02.
        Ben-Chetrit A, Jurisicova A, Casper RF. March 1996. Coculture with
    ovarian cancer cell enhances human blastocyst formation in vitro.
    Fertility and Sterility, 65(3):664.
        Birth Defects: Birth Defects Research for Children. July 2001.
    Milestone Fertility Therapy May Have Fatal Flaw. http://
    www.birthdefects.org/archives/News_jul01.htm. Accessed 4/13/03.
        Bischof P, Herrmann WL. 1988. Absence of Immunoreactive Luteinizing
    Hormone following Gonadotropin--Releasing Hormone Agonist Therapy in
    Women with Endometriosis. Gynecologic Obstetric Investigation,25:130.
        Blankstein J, Quigley MM. April 1988. The anovulatory patient. An
    orderly approach to evaluation and treatment. Postgraduate Medicine,
    83(5):97.
        Bradford, Kimberly: http://www.geocities.com/lupronfacts/
    lupronstories.html
        Briggs GG, Freeman RK, Yaffee SS. Drugs in Pregnancy and Lactation,
    4th Ed. Williams and Wilkins, Baltimore. 1994. p. 481/1.
        Burke WH, Attia YA. 1994. Molting single comb white leghorns with
    the use of the Lupron depot formulation of leuprolide acetate. Poultry
    Science, 73:1226.
        Buvat-Laborie: In Buvat J and Bringer J (eds), 1986, Induction et
    Stimulation de L'Ovulation: Progres en gynecologie I, Paris. ``The
    sentence[] quoted here [is] in Chapter 4, by B. Hedon et al. As cited
    by Laborie F. 1988. New Reproductive Technologies: News from France and
    Elsewhere. Reproductive and Genetic Engineering, 1(1):77.
        Cauchon D. September 25, 2000. FDA Advisers Tied to Industry/Number
    of drug experts available is limited. USA Today.
        CBER, FDA: Information and Recommendations for Physicians Involved
    in the Co-Culture of Human Embryos with NonHuman Animal Cells. March 8,
    2002. http://www.fda.gov/cber/infosheets/humembclin.htm.
        Challender D, Littwin S. December 1995. Fertility Fraud: Why One
    Mother May Never Know Her Babies. Redbook. p.84.
        Chat. February 11, 2002. Popular Science Infertility Chat on
    America Online. Transcript: http://www.popsci.com/popsci/medicine/
    article/0,12543,429819,00.html. Accessed 3/11/03.
        Check JH, Wu CH, Check ML. March 1988. The effect of leuprolide
    acetate in aiding induction of ovulation in hypergonadotropic
    hypogonadism: a case report. Fertility and Sterility, 49(3):542.
        Chetkowski RJ, Kruse LR, Nass TE. August 1989. Improvized pregnancy
    outcome with the addition of leuprolide acetate to gonadotropins for in
    vitro fertilization. Fertility and Sterility, 52(2):250.
        Church S. September 18, 2002. Doctor pleads guilty in scam
    involving AstraZeneca drug. Local News from TheNewsJournal. Accessed
    10/11/02. http://www.delawareonline.com/newsjournal/local/2002/02/18pm-
    astra.html.
        Comite F, Delman M, Hutchinson-Williams K, DeCherney AH, Jensen P.
    1989. Reduced Bone Mass in Reproductive-Aged Women With Endometriosis.
    Journal of Clinical Endocrinology and Metabolism, 69(4):837.
        Compston JE, Yamaguchi K, Croucher PI, Garrahan NJ, Lindsay PC,
    Shaw RW. February 1995. The Effects of Gonadotropin-Releasing Hormone
    Agonists on Iliac Crest Cancellous Bone Structure in Women With
    Endometriosis. Bone, 16(2):261.
        Conn PM, Crowley WF Jr. 1994. Gonadotropin-releasing hormone and
    its analogs. Annual Review of Medicine, 45:391.
        Corea G. The Mother Machine: Reproductive Technologies from
    Artificial Insemination to Artificial Wombs. Harper and Row. 1985.
        Corea G, Ince S. 1987. Report of a survey of IVF clinics in the
    U.S. In Patricia Spallone and Deborah Lynn Steinberg (eds). Made To
    Order: The Myth of Reproductive and Genetic Progress. Pergamon Press.
    Oxford.
        Data, 2001: Medscape, Women's Health. Managing Uterine Fibroids, by
    M. Davidson. http://womenshealth.medscape.com/41240.rhtml?srcmp=wh-
    080301. Clinician Reviews, 11(6):79-85. http://www.medscape.com/CPG/
    ClinReviews/2001/v11.n06/c1106.04.davi/c1106.04.davi-01.html. Accessed
    8/4/01. Both sites no longer accessible.
        Dateline. January 2, 2000. ``The Painful Truth?''. NBC News
    Dateline. Transcript by Burrelle's, Box 7, Livingston, N.J. 07039.
    Number 1048.
        deHaen International Inc. Drug Information Systems & Services.
    1985. deHaen's Drug Product Index USA--Section III. New Drug Analysis.
    Europe and Japan. p.16.
        Demario MA, Moomjy M, Tortoriello D, Moy F, Davis OK, Rosenwaks Z.
    December 1997. Delay of gonadotropin stimulation in patients receiving
    gonadotropin-releasing hormone agonist (GnRH-a) therapy permits
    increase clinic efficiency and may enhance in vitro fertilization (IVF)
    pregnancy rates. Fertility and Sterility, 68(6):1004.
        DeSutter P, Dhont M, Vandekerckhove D. 1992. Hormonal Stimulation
    for in Vitro Fertilization: A Comparison of Fertilization Rates and
    Cytogenetic Findings in Unfertilized Oocytes. Journal of Assisted
    Reproduction and Genetics, 9(3):254.
        Dezell, M. April 15, 1994. Uncertain miracle. Boston Phoenix. p.20.
        Dochi T, Lees B, Sidhu M, Stevenson JC. 1994. Bone density and
    endometriosis. Fertility and Sterility, 61(1):175.
        Dodson WC, Walmer DK, Hughes CL, Yancy SE, Haney AF. 1991.
    Adjunctive leuprolide therapy does not improve cycle fecundity in
    controlled ovarian hyperstimulation and intrauterine insemination of
    subfertile women. Obstetrical Gynecology, 78(2):187.
        Donahue: The Phil Donahue Show. ``Watch Out! Private Information
    May Not Be Private''. Air date August 8, 1996. Panelists: Senator
    Patrick Leahy (via satellite), Lynne Millican, Ram Avrahami, Stephen
    Shaw, Evan Hendricks, Connie Hetling, Daniel (a Skip Tracer). Record
    date December 12, 1995.
        Droesch K, Barbieri RL. July 1994. Ovarian hyperstimulation
    syndrome associated with the use of the gonadotropin-releasing hormone
    agonist leuprolide acetate. Fertility and Sterility, 62(1):189.
        Droesch K, Muasher SJ, Brzyski RG, Jones GS, Simonetti S, Liu HC,
    Rosenwaks Z. February 1989. Value of suppression with a gonadotropin-
    releasing hormone agonist prior to gonadotropin stimulation for in
    vitro fertilization. Fertility and Sterility, 51(2):292.
        Ellis, GB. 1995. Fertility and Sterility, 64(6):1063.
        Enge, M. February 10, 2000. Couple offers $100,000 for egg donor:
    Infertile pair's solicitation may be the highest price yet. The Denver
    Post. http://platforum.tripod.com/eggmoney.htm. Accessed 3/25/03.
        ERC. March 2000. ``ERC and Amgen Praecis Present `ERC MARCH 2000
    Petition For A Cure'''.
        Ericson A, Kallen B. March 2001. Congenital malformations in
    infants born after IVF: a population-based study. Human Reproduction,
    16(3):504.
        FDA Notice of Adverse Findings sent to TAP President by Acting
    Director of the FDA on March 21, 1990 (5 pages).
        FDA, 2002: March-April 2002. FDA Consumer Magazine. Letters:
    Correction to November-December 2001 FDA Consumer. See http://
    www.fda.gov/fdac/features/2001/601_tech.html; and: www.fda.gov/fdac/
    departs/2002/202--ltrs.html. Both accessed 9/8/02.
        FDC Reports. December 5, 1988. TAP Lupron: U.S. Sales Expected to
    Double in 1988; Gynecological Indications Planned for Future Expand
    LHRH Analog's Market Potential to $100 Million Level. p.4.
        FDC Reports. April 2, 1990. Takeda-Abbott Lupron Promotions Will
    Have To Be Precleared By FDA Under Letter Of Adverse Finding; Agency
    Chides Firm For Promoting Unapproved Uses. The Pink Sheet, 52(14):11.
        FDC Reports. July 4, 1994. Gonadotropin Releasing Hormone Low Dose
    Steroids Not Appropriate for Study in Breast Cancer High Risks. The
    Pink Sheet; 56(27):13.
        Fertilitext: Understanding Fertility Medication. http://
    www.fertilitext.org/p3_pharmacy/medication.html. Accessed 4/7/03.
        Federal Register, May 1, 1996. Findings of Scientific Misconduct.
    Vol 61(85):19295-6.
        Fischel, Jackson. September 1989. Follicular stimulation and
    ovarian cancer. British Medical Journal.
        Forman RG, Frydman R, Egan D, Ross C, Barlow DH. March 1990. Severe
    ovarian hyperstimulation syndrome using agonists of gonadotropin-
    releasing hormone for in vitro fertilization: a European series and a
    proposal for prevention. Fertility and Sterility, 53(3):502.
        Foundation. http://www.reproduction.org/foundation/
    development.html. Accessed 2002.
        FOX News: FOX 25 TV News. May 24, 1999. Risk or Remedy. Dedham, MA.
    Reporter, Tory Ryden. See also Risk or Remedy, Part 2; November 29,
    1999.
        Fraunfelder FT, Edwards R. March 8, 1995. Letters. Possible Ocular
    Adverse Effects Associated With Leuprolide Injections. Journal of
    American Medical Association, 273(10):773.
        Friedman AJ, Lobel SM, Rein MS, Barbieri RL. October 190. Efficacy
    and safety considerations in women with uterine leiomyomas treated with
    gonadotropin-releasing hormone agonists: The estrogen threshhold
    hypothesis. American Journal of Obstetrics and Gynecology, 163:1114.
        Friedman AJ, Juneau-Norcross M, Rein MS. February 1993. Adverse
    effects of leuprolide acetate depot treatment. Fertility and Sterility,
    59(2):448.
        Friedman JM, Polifka JE (Eds). Teratogenic Effects of drugs: A
    Resource for Clinicians. Johns Hopkins University Press, Baltimore,
    1994. p.333.
        FTC. (1) In the Matter of IVF Australia, Ltd, IVF Australia, NY,
    and IVF Australia, MA (Docket No. C-3319) [IVF Australia subsequently
    changed names to `IVF America'], (2) In the Matter of NME Hospitals,
    dba West Boca Medical Center (Docket no. C-3317), (3) In the Matter of
    Fertility Institute of Western Massachusetts and Ronald K. Burke
    (Docket No. C-3318), (4) In the Matter of Reproductive Genetics In
    Vitro and George P. Henry (Docket No. C-3357).
        Gabriel T. January 7, 1996. Eggs and Egos: Cornell Staff Clashed
    Over Issue of Safety. The New York Times.
        Gocze PM, Freeman DA, Arany A, Garadnay B. May 22, 1993. Letter.
    Lancet, 341:1346.
        Golub MS, Styne DM, Wheeler MD, Keen CL, Hendrick AG, Moran F,
    Gershwin ME. October 1997. Growth retardation in premenarchial female
    rhesus monkeys during chronic administration of GnRH agonist
    (leuprolide acetate). Journal Med Primatology, 26(5):248.
        Gordon K, Hodgen GD. 1991. GnRH Analogues in Ovarian Stimulation.
    In Frontiers in Human Reproduction, Eds Seppala M, Hamberger L. Annals
    of New York Academy of Sciences, 626;238.
        Green HJ, Pakenham KI, Headley BC, Yaxley J, Nicol DL, Mactaggart
    PN, Swanson C, Watson RB, Gardiner RA. September 2002. Altered
    cognitive function in men treated for prostate cancer with luteinizing-
    releasing hormone analogues and cyproterone acetate: a randomized
    controlled trial. BJU International, 90(4):427.
        Greenberg B, Michalska M. November 1999. Systemic lupron
    erythematosus. Postgraduate Medicine, 106(6):213.
        Gueriguian JL, Schaffenburg CA, Chiu, Berliner. 1984. Trends in
    Drug Development with Special Reference to the Testing of LHRH
    Analogues: LHRH and its Analogues. Elsevier Science Publishers. p.507-
    16.
        Guerrero HE, Stein P, Asch RH, de Fried EP, Tesone M. April 1993.
    Effect of a gonadotropin-releasing hormone agonist on luteinizing
    hormone receptors and steroidogenesis in ovarian cells. Fertility and
    Sterility, 59(4):803.
        Hamilton, JO'C. November/December 2001. Egg Donors. What are the
    Costs? http://www.stanfordalumni.org/news/magazine/2000/novdec/
    articles/eggdonor.html. Accessed 2/14/03.
        Hammitt DG, Syrop CH, Van Voorhis BJ, Walker DL, Miller TM, Barud
    KM. February 1993. Maturational asynchrony between oocyte cumulus-
    coronal morphology and nuclear maturity in gonadotropin-releasing
    hormone agonist stimulations. Fertility and Sterility, 59(2):375.
        Hampton HL, Whitworth NS, Cowan BD. 1991. Gonadotropin-releasing
    hormone agonist (leuprolide acetate) induced ovarian hyperstimulation
    syndrome in a woman undergoing intermittent hemodialysis. Fertility and
    Sterility, 55:429.
        Hatano T, Oishi Y, Furuta A, Iwamuro S, Tashiro K. 2000. BJU
    Internation, 86:449.
        Hawkes N. July 8, 2000. Scientists `pillaging foreign embryos'. The
    Times, Britain. http://www.the-times.co.uk/news/pages/tim/2000/07/08/
    timnwsnws01005.html. Accessed 2000.
        Health: Anonymous. February 8, 2002. Brain Worry Over IVF Children.
    BBC News. http://news.bbc.co.uk/hi/english/health/newsid--1807000/
    1807351.stm. Accessed 7/1/02.
        Hearing before the Subcommittee on Regulation, Business
    Opportunities, and Energy of the Committee on Small Business, House of
    Representatives, 101st Congress, First Session, March 9, 1980.
    Publication Serial No. 101-5.
        Hearn, JP. Patent #6,110,741. Gonadotropin releasor hormone-
    containing composition for embryo culture and method for in vitro
    fertilization. August 29, 2000.
        Hill A. May 20, 2001. Horror at `three parent foetus' gene
    disorders. The Observer, United Kingdom. http://www.observer.co.uk/
    international/story/0,6903,493303,00.html. Accessed 5/01.
        Holmes, HB. September 1988. In Vitro Fertilization: Reflections on
    the State of the Art. Birth,15(3):134.
        Horton R. May 19, 2001. Commentary: Lotronex and the FDA: a fatal
    erosion of integrity. The Lancet, 357:1544.
        Hotz, RL. Designs on Life. Pocket Books, New York. 1991. p.67.
        Hotz, RL. October 27, 1991. A Risky Fertility Revolution: Drugs may
    bear long-term danger for moms, babies. Atlanta Constitution, p.1.
        Institute: The Institute for Reproductive Medicine and Science of
    Saint Barnabas. http://www.sbivf.com/science/art_serv_cyto.htm.
    Accessed 4/13/03.
        Johns WD, Garnick MB, Kaplan WD. July 1990. Leuprolide therapy for
    prostate cancer. An association with scintigraphic ``flare'' on bone
    scan. Clinical Nuclear Medicine, 15(7):485.
        Jordan, A. March 1, 1984. FDA Review and Evaluation of Pharmacology
    and Toxicology Data. NDA 19-010.
        Journal, 1995. Supplement. Journal of Assisted Reproduction and
    Genetics, 12(3):123S-143S.
        Julie's After Lupron Page. Delphi Forums.
        http://forums.delphiforums.com/afterlupron/
        Kaiser Network Daily Reproductive Health Report. October 23, 2002.
    United Kingdom to Study Health, Birth Defects Among People Born as a
    Result of Fertility Treatment. http://www.kaisernetwork.org/daily--
    rep--index.cfm?DR=14197. Accessed 11/23/02.
        Kang IS, Kuehl TJ, Siler-Khodr TM. November 1989. Effect of
    treatment with gonadotropin-releasing hormone analogues on pregnancy
    outcome in the baboon. Fertility and Sterility, 52(5):846.
        Karande VC, Rinehart JS, Pratt DE, Gleicher N. 1996. Abstract P-34.
    Is the inadvertent administration of leuprolide acetate in early human
    pregnancy truly associated with normal outcomes? Fertility and
    Sterility, Supplement, p. A27.
        Kasayama S, Miyake S, Samejima Y. December 2000. Transient
    thyrotoxicosis and hypothyroidism following administration of the GnRH
    agonist leuprolide acetate. Endocr J, 47(6):783.
        Keenan D, Cohen J, Suzman M, Wright G, Kort H, Massey J. April
    1991. Stimulation cycles suppressed with gonadotropin-releasing hormone
    analog yield accelerated embryos. Fertility and Sterility, 55(4):792.
        Kemmann E. March 21, 1989. Letter from Department of Obstetrics &
    Gynecology to Rep. Ron Wyden. Hearing before the Subcommittee on
    Regulation, Business Opportunities, and Energy of the Committee on
    Small Business, House of Representatives, 101st Congress, First
    Session, March 9, 1980. Publication Serial No. 101-5, p. 850-2.
        Kennedy, Senator Edward: FOX 25 News Interview. November 24, 1999.
    Dedham, MA. Reporter Tory Ryden.
        Kola I. September 1988. Commentary: Embryo and Fetal Abnormalities
    in IVF. Birth, 15(3):145.
        Kong D. August 4, 1996. The painful quest for fertility. Costs,
    Effects of Treatment Questioned. Boston Globe, p. 1. (Part two
    published 8/5/96).
        Kong D. August 4, 1996. The painful quest for fertility. What Price
    Pregnancy? Consumer Advocates Question Donations. Boston Sunday Globe,
    p. 35.
        Kong D. April 7, 1999. Convictions Missing From Doctor Profiles:
    Medical Board Calls Omissions `A Glitch'. Boston Globe. p. B1.
        Kuha v. Andrew J. Friedman M.D., Brigham and Women's Hospital.
    Superior Court, Suffolk County, MA. Docket No. 97-3725.
        Lahat E, Raziel A, Friedler S, Schieber-Kazir M, Ron-El R. October
    1999. Long-term follow-up of children born after inadvertent
    administration of a gonadotrophin-releasing hormone agonist in early
    pregnancy. Human Reproduction, 14(10):2656. See also Human
    Reproduction, 15(6):1412.
        Lasalandra M. March 18, 1995. Bill proposed to regulate fertility
    clinics. Boston Herald. p.11.
        Lasalandra M. June 2, 1998. Noted doc loses license for falsifying
    med data. Boston Herald.
        Lasalandra M (2). June 9, 1998. Feds to better monitor human tests.
    Boston Herald.
        Lawrence LD, Rosenwaks Z. February 1993. Implications of the
    Fertility Clinic Success Rate and Certification Act of 1992. Fertility
    and Sterility, 59(2):288.
        Lazar, K. August 22, 1999. Wonder Drug For Men Alleged To Cause
    Harm In Women. Boston Herald. http://www.bostonherald.com/bostonherald/
    nat/drug08221999.htm. Accessed 4/4/00.
        Lazar, K. August 23, 1999. Women Seek Answers On Drug's Suspected
    Side Effects. Boston Herald. http://www.bostonherald.com/bostonherald/
    nat/drug08231999.htm. Accessed 4/4/00.
        Lazar, K. August 24, 1999. Women Outraged Over Drug's Ill Effects.
    Boston Herald. See: http://www.bostonherald.com/bostonherald/nat/
    drug08231999.htm. Accessed 4/4/00.
        Lemonick MD, Goldstein A. April 22, 2002. Human Guinea Pigs: At
    Your Own Risk. Time.
        Lessor R, Cervantes N, O'Connor N, Balmaceda J, Asch RH. January
    1993. An analysis of social and psychological characteristics of women
    volunteering to become oocyte donors. Fertility and Sterility,
    59(1):65.
        Letter. March 8, 2002. From Director, Office of Therapeutics
    Research and Review, Center for Biologics Evaluation and Research, FDA,
    to `Dear Colleague'.
    http://www.fda.gov/cber/ltr/humemb.pdf. Accessed 3/11/02.
        Lewit N, Manor D, Itskovitz-Eldor. 1995. Supplement, Abstract OC-
    55: Prevention of ovarian hyperstimulation syndrome in high risk
    patients by using GnRH agonist for the induction of LH surge. Journal
    of Assisted Reproduction and Genetics, 12(3):40S.
        Lim LH, Lee WD, Lee HK, Kim SK, Yoon SH, Yoon HG. 1995. A program
    of IVF-ET without hormone monitoring: simple, effective and economic.
    Abstract PP-115. Journal of Assisted Reproduction and Genetics, 12(3);
    Supplement.
        Maeda H, Arai Y, Aoki Y, Okubo K, Okada T, Ueda Y. August 1998.
    Leuprolide Causes Pure Red Cell Aplasia. The Journal of Urology,
    160:501.
        Martin MC, Givens CR, Schriock ED, Glass RH, Dandekar PV. June
    1994. The choice of a gonadotropin-releasing hormone analog influences
    outcome of an in vitro fertilization treatment. American Journal of
    Obstetrics and Gynecology, 170(6):1629.
        Mathias JR, Clench MH. June 1995. Placebo Controlled Study
    Randomizing Leuprolide Acetate. Digestive Diseases and Sciences,
    40(6):1405.
        McCoy MJ. 1994. Angina and myocardial infarction with use of
    leuprolide acetate. American Journal of Obstetrics and Gynecology,
    171:275.
        Meldrum DR, Wisot A, Hamilton F, Gutlay AL, Huynh D, Kempton W.
    September 1988. Timing of initiation and dose schedule of leuprolide
    influence the time course of ovarian suppression. Fertility and
    Sterility, 50(2):400.
        Members. Fertility Drugs. Webmaster: Seth G. Derman, M.D.
    FertilMD@AOL.COM. http://members.aol.com/fertilmd/drugs.html. Accessed
    4/7/03.
        Mercola. http://www.mercola.com/2002/feb/9/lupron.htm. Accessed 2/
    10/02.
        Mercola. Mercola.com. February 20, 2002. Most Doctors Who Set
    Guidelines Have Industry Ties, citing Journal of American Medical
    Association, 287:612. http://www.mercola.com/2002/feb/20/
    doctor_guidelines.htm. Accessed 5/25/02.
        Mesia AF, Gahr D, Wild M, Mittal K, Demopoulos RI. May 1997.
    Immunohistochemistry of vascular changes in leuprolide acetate-treated
    leiomyomas. American Journal of Obstetrics and Gynecology, 176:1026.
        Mestel, R. January 24, 2003. Some Studies See Ills for In Vitro
    Children. Los Angeles Times. http://www.ourstolenfuture.org/Commentary/
    News/2003/2003-0124LAT-invitrorisks.htm. Accessed 3/11/03.
        Miller JD. 1990. Leuprolide Acetate for the Treatment of
    Endometriosis. Current Concepts in Endometriosis: 337.
        Millican (1), L; Judy Norsigian; Representative Gregory Sullivan.
    August 31, 1992. Letters to Editor. Supporters of infertility treatment
    regulation speak out. The Patriot Ledger.
        Millican, L. Testimony in Support of An Act Relative to the
    Treatment of Infertility, MA. Health Care Committee, MA. House of
    Representatives. Presented March 9, 1992.
        Millican (2), L. November 6, 1992. Letters. Fertility regulation
    long overdue. Boston Herald. p. 26.
        Millican, L. Testimony in Support of An Act Relative to the
    Treatment of Infertility, MA. House #1833. Health Care Committee, MA.
    House of Representatives. Presented March 28, 1995.
        Millican (2), L. February 21, 1995. Letters. Fertility drugs can
    cause harm. Boston Herald, p. 26.
        Millican, L. June 15, 1998. Letters. Taking doc's license only the
    first step. Boston Herald, p. 22.
        Minaretzis D, Alper MM, Oskowitz SP, Lobel SM, Mortola JF, Pavlou
    SN. May 1995. Gonadotropin-releasing hormone antagonist versus agonist
    administration in women undergoing controlled ovarian hyperstimulation:
    cycle performance and in vitro steroidogenesis of granulosa-lutein
    cells. American Journal of Obstetrics and Gynecology, 172(5):1518.
        Mishra R. August 24, 2001. Clinic To Give Embryos To Harvard For
    Stem Cell Research. Boston Globe. p.1.
        Mitchell AA. March 7, 2002. Editorial: Infertility Treatment--More
    Risks and Challenges. The New England Journal of Medicine, 346(10):769.
        Moll AC, Imhof SM, Cruysberg JRM, Schouten-Van Meeteren AYN, Boers
    M, Van Leeuwen FL. January 25, 2003. Incidence of retinoblastoma in
    children born after in-vitro fertilisation. The Lancet, 361(9354):309.
        Morsi A, Jamal S, Silverberg JDH. 1996. Case Report: Pituitary
    apoplexy after leuprolide administration for carcinoma of the prostate.
    Clinical Endocrinology, 44:121.
        MRI. Medical Research International, Society for Assisted
    Reproductive Technology, The American Fertility Society. January 1992.
    In vitro fertilization-embryo transfer (IVF-ET) in the United States:
    1990 results from the IVF-ET Registry. Fertility and Sterility,
    57(1):15.
        MSNBC News website. http://www.msnbc.com/news/161044.asp. Accessed
    2002.
        Munne S, Cohen J, Alikani M, Rosenwaks Z, Grifo J. 1995.
    Supplement. Abstract OC-248. First healthy delivery after
    preimplantation genetic diagnosis of aneuploidy. Journal of Assisted
    Reproduction and Genetics, 12(3):88S.
        Nader S, Berkowitz AS, Winkel CA. February 1988. Ovarian response
    to human menopausal gonadotropin after therapy with the gonadotropin-
    releasing horomone agonist leuprolide. American Journal of Obstetrics
    and Gynecology, 158:403.
        NDA 19-010. New Drug Application 19-010: Summary Basis of Approval.
    Lupron 1 mg daily SC for palliative treatment of advanced prostate
    cancer. Approved 1985.
        NDA 20-011. New Drug Application 20-011: Summary Basis of Approval.
    Lupron Depot 3.5 mg IM per month for pain management in endometriosis.
    Approved October 1990.
        Neal, J. June 8, 2002. Fraudulent Conduct That Takes Lives: Why
    Criminal Prosecution Of Medical Researchers With Financial Conflicts,
    Who Fabricate Safety Data, Has Become An Essential Component Of
    Regaining The Integrity Of Device And Drug Research In The United
    States. Part One. Redflagsweekly. http://www.redflagsweekly.com/
    new_frontiers/2002_june08P.html. Accessed 6/8/02
        Newton C, Slota D, Yuzpe AA, Tummon IS. June 1996. Memory
    complaints associated with the use of gonadotropin-releasing hormone
    agonists: a preliminary study. Fertility and Sterility, 65(6):1253.
        Nezhat C, Pennington E, Nezhat F, Silfen S. 1991. Laparoscopically
    Assisted Anterior Rectal Wall Resection and Reanastemosis for deeply
    infiltrating endometriosis. Surgical Laparoscopy and Endocscopy,
    1(2):106.
        Nezhat F, Nezhat C, Pennington E, Ambroze W. 1992. Laparoscopic
    Segmental Resection for infiltrating endometriosis of the rectosigmoid
    colon: a preliminary report. Surgical Laparoscopy and Endoscopy,
    2(3):212.
        Ng ST, Wu TC. Jan-Feb 1995. Use of gonadotropin-releasing hormone
    agonist following follicular aspiration in donor ooctye program--impact
    on subsequent menstruations. Int J Fertil Menopausal Stud, 40(1):29.
        NICHHD. Reports submitted by Medical Research International, in
    performance of the Contract ``Health Surveillance of Women Treated for
    Infertility by In Vitro Fertilizaiton'' (N01-HD-8-2910): Ovarian Cancer
    and Ovulatory Stimulants: Issues in Study Design, December 30, 1992;
    Adverse Effects of Ovulatory Stimulants, January 4, 1993; Reproductive
    Health Study: Characteristics of the Study Population, February 26,
    1993; Reproductive Health Study: Short-Term Adverse Events, April 16,
    1993; Final Report, August 3, 1993.
        NIH/OSHA: NIH page for hazardous drugs was available to the public
    in the past, but currently is available only to NIH employees. OSHA
    provides the same list: http://www.osha.gov/dts/osta/otm/otm_vi/
    otm_vi_2.html#app_vi:2_1
        NIH Human Embryo Research Panel Hearings. February 2, 1994, April
    12, 1994. Bethesda, MD.
        Oldenburg, D. November 18, 1999. Sperm Banks Online: Going Too Far?
    The Washington Post.
    http://platform.tripod.com/eggmoney.htm. Accessed 3/25/03.
        Olshan, AF, Smith J, Cook MN, Grufferman S, Pollock BH, Stram DO,
    Seeger RC, Look AT, Cohn SL, Castleberry RP, Bondy ML. 1999. Hormone
    and Fertility Drug Use and the Risk of Neuroblastoma: A Report from the
    Children's Cancer Group and the Pediatric Oncology Group. American
    Journal of Epidemiology, 150(9):930.
        Operations. ERC Staff: http://www.endocenter.org. ERC Staff/
    AstraZeneca: http://www.va4hire.com/g/guidone.html. Accessed 1/03.
        Oversight Hearings (A & B)--
        A: Chairman Bliley's letter to TAP:
        http://com-notes.house.gov/cchear/hearings106.nsf/
    8eaabcee30ee07ee852566f900700f0d/
    6f5b04a11873189e852568db0056da45?OpenDocument
        B: TAP--The Total Package:
        http://com.notes.house.gov/oversight/7.pdf
        http://com.notes.house.gov/oversight/8.pdf
        Padawer, R. 2002. Soaring egg donation prices causing ethical
    concerns. www.bergen.com/cgi-bin/page.pl?id=5105001. Accessed 10/8/02.
        Penzias AS, Lee G, DeCherney AH, Jones EE. 1992. Supplement.
    Abstract P-214. Aberrant Estradiol Flare Despite GnRH-Agonist Induced
    Suppression is Associated With Impaired Implantations. Fertility and
    Sterility:S170.
        Penzias AS, Lee G, Seifer DB, Shamma FN, DeCherney AH, Reindollar
    RH, Jones EE. March 1994. Aberrant estradiol flare despite
    gonadotropin-releasing hormone-agonist-induced suppression is
    associated with impaired implantation. Fertility and Sterility,
    61(3):558.
        Pharmafocus. February 3, 2002. AstraZeneca sets aside $350m in
    fraud case. Pharmafocus; InPharm.com. Accessed 4/11/03.http://
    www.inpharm.com/External/InpH/1,,1-4-5675-0-inp_intelligence_news_0-
    36647,00.html.
        Pitchmen. Boston Globe Editorial. November 11, 17, 2002. Pitchmen
    for drugs. Boston Globe, p. D10.
        Press Release, University of CA. Board of Regents' Meeting,
    November 16, 1995. Remarks of the Chancellor. http://www.uci.edu/fc/
    regents/1116.html.
        Racowsky C, Prather AL, Johnson MK, Olvera SP, Gelety TJ. May 1997.
    Prematurely condensed chromosomes and meiotic abnormalities in
    unfertilized human oocytes after ovarian stimulation with and without
    gonadotropin-releasing hormone agonist. Fertility and Sterility,
    67(5):932.
        Radner H, Pummer K, Lax S, Wandschneider G, Gofler H. 1991.
    Pituitary hyperplasia after goserelin (LHRH-analogue) therapy.
    Neuropathology and Applied Neuropathology, 17:75.
        Ragavan, Vanaja, M.D., F.D.A. Review of the new drug application
    for nafarelin acetate. Fertility and Maternal Health Committee. Hearing
    4/28/89. Transcript, p.47.
        Raheja KL, Jordan A. 1994. FDA Recommendations for Preclinical
    Testing of Gonadotropin Releasing Hormone (GnRH) Analgoues. Regulatory
    Toxicology and Pharmacology, 19:168.
        Rao LV, Cleveland RP, Ataya KM. 1993. Alterations in thymic and
    bone marrow lymphocte subpopulations in GnRH agonist treated
    prepubertal female mice. Journal of Reproductive Immunology, 25:167.
        Rao LV, Cleveland RP, Ataya KM. 1993. GnRH Agonist Induces
    Suppression of Lymphocyte Subpopulations in Secondary Lymphoid Tissues
    of Prepubertal Female Mice. American Journal of Reproductive
    Immunology, 30:15.
        Raymond JG. Women as Wombs. Reproductive Technologies And The
    Battle Over Women's Freedom. 1993. Harper, San Francisco; p.9.
        Redwine D. 1994. Letters. Pros and Cons of ``Add-Back'' Therapy.
    Fertility and Sterility, 61:2:404.
        Regents of the University of California v. Ricardo Asch, Sergio
    Stone, Jose Balmaceda. Case No. 747155. http://www.ocregister.com/
    clinic/external/0525suit.htm. Accessed 4/18/01.
        Regush, Nicholas. Redflagsdaily.com: Online Lupron Investigation.
    http://www.redflagsweekly.com/lupron.html.
        Report, 1994. Anonymous. March 30, 1994. Report No. 42: Opinion on
    the evolution of practices concerning medically assisted procreation.
    Current research in reproductive technologies. http://www.ccne-
    ethique.org/english/avis/a_042p02.htm. Accessed 9/9/01.
        Report, 2002. Kaisernetwork, citing Dockser Marcus, Wall Street
    Journal, December 11, 2002. Kaiser Daily Reproductive Health Report:
    CDC Fertility Facility Report Criticized As Inaccurate, Unreliable.
    December 11, 2002. http://www.kaisernetwork.org/daily_reports/
    rep_index.cfm?DR--ID=15038. Accessed 12/11/02.
        Rogers L, Lauria J. August 19, 2001. Lawyer in fresh fight to clone
    dead baby son. The Sunday Times. World News: United States. http://
    wwwsunday-times.co.uk/news/pages/sti/2001/08/19/stifgnusa03002.html.
    Accessed 4/18/01.
        Ruhlmann C, Chillik CF, Brugo Olmedo S, Nicholson RE, Rolla E,
    Kuperman MN, Nicholson RF. 1993. Abstract P-021. Leuprolide Acetate in
    a Long Protocol of Ovarian Hyperstimulation for ART: Depot Preparation
    Versus Daily Administration. Fertility and Sterility. Supplement, S90.
        Saunders DM, Lancaster P. April 1989. The Wider Perinatal
    Significance of the Australian In Vitro Fertilization Data Collection
    Program. American Journal of Perinatology, 6(2):252.
        Sasy M, Abuzeid M, Rizk B. 1997. Abstract. Exposure to
    Gonadotrophin Releasing Hormone Agonist in Early Pregnancy is
    Associated With High Pregnancy Wastage That Could be Related to the
    Length of Exposure. Fertility and Sterility, Supplement. Accessed
    online 1998, (abstract 19970188.htm).
        Schenker JG, Ezra Y. March 1994. Complications of assisted
    reproductive techniques. Fertility and Sterility, 61(3):411.
        Schieve LA, Meikle SF, Ferre C, Peterson HB, Jeng G, Wilcox LS.
    March 7, 2002. Low and very low birth weight in infants conceived with
    use of assisted reproductive technology. New England Journal of
    Medicine, 346(10):731.
        Schoolcraft W, Sinton E, Schlenker T, Huynh D, Hamilton F, Medlrum
    DR. March 1991. Lower pregnancy rate with premature luteinization
    during pituitary suppression with leuprolide acetate. Fertility and
    Sterility, 56(3):563.
        Scorecard: http://www.scorecard.org/chemical-profiles/
    summary.tcl?edf_substance_id=74381%2d53-2d6
        Segal S, Casper RF. June 1992. Gonadotropin-releasing hormone
    agonist versus human chorionic gonadotropin for triggering follicular
    maturatio in vitro fertilization. Fertility and Sterility, 57(6):1254.
        Seiffert, D. March 3, 2000. Are Fertility Drugs Safe? Boston TAB.
    p. 8.
        Serafini P, Batzofin J, Kerin J, Marrs R. August 1988. Pregnancy: a
    risk to initiation of leuprolide acetate during the luteal phase before
    controlled ovarian hyperstimulation. Fertility and Sterility,
    50(2):371.
        Shanis B, Summers D, Check JH, O'Shaughnesy A, Nazari A. 1995.
    Supplement. Abstract PP-126. An Ultra-Short Use of Leuprolide Acetate
    Works As Well As Longer Use To Prevent Premature Luteinization
    Following controlled Ovarian Hyperstimulation. Journal of Assisted
    Reproduction and Genetics, 12(3):154S.
        Shephard TH. Ed. Catalogue of Teratogenic Agents, 7th Edition.
    Johns Hopkins University Press, Baltimore. 1992. p. 233.
        Silver RI, Rodriguez R, Chang TSK, Gearhart JP. June 1999. In vitro
    fertilization is associated with an increased risk of hypospadias. The
    Journal of Urology, 161(6):1954.
        Sinaii N, Cleary SD, Ballweg ML, Nieman LK, Stratton P. October
    2002. High rates of autoimmune and endocrine disorders, fibromyalgia,
    chronic fatigue syndrome and atopic diseases among women with
    endometriosis: a survey analysis. Human Reproduction, 17(10):2715.
        Skloot RL. February 22, 2003. The Other Baby Experiment. New York
    Times.
    http://www.ourstolenfuture.org/Commentary/News/2003/2003-0222-NYT-
    fertilityrisks.htm. Accessed 3/11/03.
        Skloot R, March 2003. Sally has 2 Mommies and 1 Daddy. Popular
    Science.
    http://www.popsci.com/popsci/medicine/article/0,12543,411770,00.html.
    Accessed 3/11/03.
        Source. The citation for this source is unavailable--from memory, I
    believe that the published figure of 91 eggs per one woman was the
    maximum range given within an abstract published in a fertility
    journal, and found approximately prior to the year 1996.
        St. Barnabas IVF. Egg Donation: A Step By Step Guide for the
    Donor'.http://www.eggdonation.org/Donor/EggDonationInformation.htm.
    Accessed 2002, 4/15/03.
        St. Clair Stephenson PA. The risks associated with ovulation
    induction. Iatrogenics, 1:7.
        Stolberg SG. April 25, 2001. Scientists Often Mum About Ties To
    Industry. New York Times. p.17.
        Sungurtekin U, Jansen RPS. March 1995. Profound luteinizing hormone
    suppression after stopping the gonadotropin-releasing hormone-agonist
    leuprolide acetate. Fertility and Sterility, 63(3):663.
        Surrogate: Surrogates' Corner. Darlene. July 28, 2000. Lupron
    crazy! http://www.surrogacy.com/boards/surrogates.html. Accessed 4/9/
    03.
        Sutcliffe A, Bonduelle M, Taylor BW. October 31, 2002. Letter.
    Major birth defects after assisted reproduction. New England Journal of
    Medicine, 347(18):1449.
        Talan J. September 25, 1990. The `Test-Tube' Option; In-Vitro
    Fertilization has given the world 10,000 babies, but it works for only
    1 in 10 couples. Newsday. p.11.
        Tanbo T, Dale PO, Lunde O, Moe N, Abyholm T. August 1995. Obstetric
    Outcome in Singleton Pregnancies After Assisted Reproduction.
    Obstetrics & Gynecology, 86(2):188.
        Thompson IM, Zeidman EJ, Rodriguez FR. December 1990. Sudden death
    due to disease flare with luteinizing hormone-releasing hormone agonist
    therapy for carcinoma of the prostate. Journal of Urology, 144(6):1479.
        T.J. Hooper, 60 F.(2d)737 (1932).
        Trock BJ, Wood HM. March 18, 2003. In Vitro Fertilization May Be
    Linked To Bladder Defects. Press Release, Johns Hopkins Medical
    Institutions. http://www.hopkinsmedicine.org/press/2003/March/
    030318A.htm. Accessed 4/3/03.
        Unger PD, Wang Q, Gordon RE, Stock R, Stone N. December 1997.
    Localized amyloidosis of the Seminal Vesicle: Possible Association With
    Hormonally Treated Prostatic Adenocarcinoma. Archives of Pathology and
    Laboratory Medicine, 121:1265.
        United States of America, ex rel. Joseph Gerstein and Tufts
    Associated Health Maintenance Organization, Inc., Plaintiffs v. TAP
    Holdings, Inc. And TAP Pharmaceuticals, Inc., Defendants. Civil Action
    No. 98 CV10547GAO. U.S. District Court for the Eastern District of MA.
    March 26, 1998.
        USA Today. May 8, 1992. Today's Debate--Infertility Clinics. See:
    http://www.mit.edu/afs/net.mit.edu/user/tytso/usenet/usa-today/issues/
    72. Accessed 4/10/03.
        Van Leusdan HA. December 1994. The flush revisited. European
    Journal of Obstetrical Gynecology and Reproductive Biology, 57(3):137.
        Varney NR, Syrop C, Kubu CS, Struchen M, Hahn S, Franzen K. 1993.
    Neuropsychologic Dysfunction in Women Following Leuprolide Acetate
    Induction of Hypoestrogenism. Journal of Assisted Reproduction and
    Genetics, 10(1):53.
        Veiga A, Torello MJ, Menezo Y, Busquets A, Sarrias O, Coroleu B,
    Barri PN. December 1999. Use of co-culture of human embryos on Vero
    cells to improve clinical implantation rate. Human Reproduction, 14.
    Supplement; 2:112.
        Weiss R. February 9, 1998. Fertility Innovation or Exploitation?
    Washington Post, p. A1.
        Weiss R. May 18, 2001. Pioneering Fertility Technique Resulted in
    Abnormal Fetuses. Washington Post. p. A3. Accessed 4/3/03:http://
    www.washingtonpost.com/ac2/wp-dyn/A42037-2001May17?language=printer.
        Weissman A, Barash A, Shapiro H, Casper RF. 1998. Ovarian
    hyperstimulation following the sole administration of agonistic
    analogues of gonadotrophin releasing hormone. Human Reproduction,
    13(12):3421.
        WHDH. July 1989: ``Expecting a Miracle'', WHDH News, Channel 7,
    Boston, MA. Reporter, Hank Phillipi Ryan.
        Wierman ME, Bruder JM, Kepa JK. February 1995. Regulation of
    gonadotropin-releasing hormone (GnRH) gene expression in hypothalamic
    neuronal cells. Cellular Molecular Neurobiology, 15(1):79.
        Winston RM, Hardy K. 2002. Are we ignoring potential dangers of in
    vitro fertilization and related treatments? Nat Cell Biol, Supplement:
    s14.
        Wood HM, Trock BJ, Gearhart JP. April 2003. In Vitro Fertilization
    and the Cloacal-Bladder Exstrophy-Epispadias Complex: Is there an
    Association? The Journal of Urology, 169(4):1512.
        Yeh J, Barbieri RL, Ravnikar VA, 1989. Ovarian hyperstimulation
    associated with the sole use of leuprolide for ovarian suppression.
    Journal of In Vitro Fertilization and Embryo Transfer, 6:261.
        Yoshimura Y, Nakamura Y, Yamada H, Nanno T, Ubukata Y, Ando M,
    Suzuki M. January 1991. Gonadotropin-releasing hormone agonists induce
    meitic maturation and degeneration of oocytes in the in vitro perfused
    rabbit ovary. Fertility and Sterility, 55(1):177.
        Yoshimura Y, Nakamura Y, Ando M, Shiokawa S, Koyama N, Nanno T. May
    1992. Direct effect of gonadotropin-releasing hormoone agonists on the
    rabbit ovarian follicle. Fertility and Sterility, 57(5):1091.
        Zawin M, McCarthy S, Scoutt L, Lange R, Lavy G, Vulte J, Comite F.
    May 1990. Monitoring Therapy with a Gonadotropin-releasing Hormone
    Analog: Utility of MR Imaging. Radiology, 175(2):503.
        For further reading on pharmaceutical puppet groups, see New York
    Times `Drug Industry Has Ties to Groups With Many Different Voices',
    10/5/00.

        Senator Brownback. Well, thank you for making it in and for
    coming here to give your personal testimony and also the
    statements of other people who have contacted you.
        You mentioned the National Lupron Victims Network on the
    Internet----
        Ms. Millican. Yes.
        Senator Brownback.--and that a number of suits have been
    filed against Lupron.
        Ms. Millican. Yes, they have.
        Senator Brownback. And those are being settled? Have any of
    them been tried yet? Do you know?
        Ms. Millican. To my knowledge, none have been tried, no.
        Senator Brownback. Okay.
        Ms. Millican. They are all settled.
        Senator Brownback. Mr. Kimbrell, this hearing is primarily
    about the issue of egg donation and an egg market and its
    impact on women. And as I have heard you speak over the years
    on this topic, that has been an area that your group has been
    as focused on as anybody in the starting of a new bio-
    industrialization. Have you done any studies, do you know of
    any economists who have looked at any studies, as to what price
    would need to be paid to get a million qualified women to be
    able to donate eggs? Do you know of anybody who has looked at
    that and the numbers associated with it?
        Mr. Kimbrell. You know, it is hard to say. And let me
    just--I have this in the record, but I will show it here. We
    talked about this earlier. I thought it might be good to have
    an example right in front of us. We got this last month from
    the Stanford Daily. This is an ad that was put in the
    newspaper, the Stanford Daily. It says, ``Special egg donor
    needed''--let's see here--``height approximately 5'9'' or
    taller, Caucasian, SAT score around 1250 or high ACT, college
    student or graduate, under 30, athletic, no genetic medical
    issues, compensation $80,000.''
        [The information referred to follows:]

        Senator Brownback. Wow.
        Mr. Kimbrell. ``Extra compensation available for someone
    who might be especially gifted in athletics, science,
    mathematics, or music.''
        So it is pretty hard, Senator, to really see what, you
    know, the price will be or will not be, but I will tell you,
    for whoever is tempted by these ads, and we know they are
    always targeted, as was surrogate motherhood, always targeted
    to poor women. You know, wealthy women do not sell their
    reproductive heritage. They do not sell their bodies. They do
    not sell their eggs. These are poor women. These are basically
    turning the poor women of this country and around the world
    into ``mother machines.''
        So what amount would actually be required, perhaps in an
    economy that is not that good, to encourage these women? I do
    not know. But I do wish that a part of the informed consent of
    these women will be to listen to Ms. Millican and what has
    happened to her. I think we should make that legislatively part
    of consent, because I think a great many women have come into
    this--and we interviewed numbers of them, both in the surrogate
    motherhood when we wrote our book and in reports on this and
    the egg donation, and they had no idea. They thought they were
    trying to do a good thing for somebody else, they desperately
    needed the money, and the screening that was talked about
    before is minimal, at best, and the real reason they are there,
    quite often, is because they are in desperate need of money,
    and so informed consent virtually never happens. And so I think
    that, again, a requirement that they hear the kind of health
    effects that they could suffer would be key.
        Senator Brownback. When you were doing the Organ Donor
    Bill, I was taken by your statement about no payments for the
    donations allowed, and it strikes me that that has worked just
    fine--I mean, that people continue to donate organs and they do
    not seek the compensation for it.
        Mr. Kimbrell. That is right. And then, of course, any of us
    who--and I hope all of us do--give blood know that that works
    just fine, too. It is an extraordinarily important thing we can
    all do.
        Yes, when we first passed that bill, Senator, there was a
    lot of discussion about black market organs in this country and
    that it would not work, and it has worked very, very well,
    indeed.
        And I think that, again, the important point here when
    we're looking at 303 is that second provision that says ``time
    and inconvenience.'' A number of States have that same
    provision, and they do not prevent ads like this. It is a
    loophole. ``Inconvenience,'' as George Annas, in the quote that
    I cited before, means virtually nothing. It means that you can
    pay anything you want for, ``inconvenience.''
        I certainly second Mr. Doerflinger's point that it is also
    hard to calculate, when you hear what Ms. Millican was saying
    and you know the cancer risks involved, exactly how far you
    take that term, ``inconvenience.''
        But, yes, I think it is very instructive to compare this
    with NOTA, the Organ Transplant Act, and note how this bill has
    been purposely changed to allow for this loophole.
        Senator Brownback. Ms. Charo, you have served on the
    National Bioethics Board previously, is that correct?
        Ms. Charo. That is correct.
        Senator Brownback. I am sure this has to be troubling to
    you about bidding for women's eggs. Was that issue handled by
    the National Bioethics Board when you were serving on it, and
    did it take a position against the compensation of women for
    the donation of eggs?
        Ms. Charo. First, before I answer, if I may, I would like
    to also indicate I did have a longer statement and ask that it
    be put in the record, if I may.
        Senator Brownback. Without objection.
        Ms. Charo. And one other quick clarification. With respect,
    I think Mr. Doerflinger lacks the anatomy that every woman in
    the room has to know that it is really not possible to transfer
    embryos into yourself.
        [Laughter.]
        Ms. Charo. But putting that aside--and I say that with
    respect and affection, because Richard and I have dealt with
    each other.
        With response to your question about egg donation,
    specifically, the National Bioethics Advisory Commission, which
    did do a report on stem cell policy--a report from which I
    recused myself due to the possible appearance of a conflict of
    interest, as I was at the University of Wisconsin--did not
    touch directly on the question of sale of human eggs. However,
    I would note that in many cases what we have been hearing today
    are descriptions of a market that takes place in the context of
    eggs being sought for reproductive purposes. That is,
    somebody--we do not know who--has the misguided belief that SAT
    scores are inheritable and, therefore, is offering a high price
    to somebody who they think could transmit that SAT score to an
    offspring. That is not the kind of incentive structure that
    would exist if you are looking for people to donate or provide
    eggs in other ways for a research context in which the eggs are
    not going to be used for reproductive purposes and there is no
    expectation of a long-term outcome, only be used for stem
    cells.
        Second, the American Society for Reproductive Medicine has
    set a $5,000 limit on what is expected to be a notion of
    ``reasonable compensation,'' a notion that is also reflected--
    --
        Senator Brownback. Is that----
        Ms. Charo.--in the National----
        Senator Brownback. Excuse me. Is that a hard limit? And
    that does not carry the weight of law, does it?
        Ms. Charo. It does not carry the weight of law. This is a
    professional society guideline----
        Senator Brownback. Just a recommendation.
        Ms. Charo.--as I understand it. And I will happily stand
    corrected by those who know it more precisely. But these
    guidelines have----
        Senator Brownback. I am sorry. If I could, I want to be----
        Ms. Charo. Sure.
        Senator Brownback.--clear on this. That is a recommendation
    of that group that the compensation not be above $5,000?
        Ms. Charo. That is correct. That is----
        Senator Brownback. Okay.
        Ms. Charo.--correct. And----
        Senator Brownback. Can I get to the very specific point?
    Because I really want to get--and then I will give you time----
        Ms. Charo. Sure.
        Senator Brownback.--to answer the rest of this. But have
    you seen any studies, anybody calibrate, saying if we want to
    get simply a million women to donate eggs--say, we are three,
    five years down the road, this has come along great, we want to
    do this for diabetes, for ALS or something, but we want to get
    a million women to donate eggs--what is the market? What are we
    going to have to pay to get--as I understand from the testimony
    earlier, you are going to probably have to go through 10
    million women to find 1 million who would be qualified if you
    have got this ten to one ratio.
        Ms. Charo. Well, actually----
        Senator Brownback. And you are going to have to----
        Ms. Charo. Right.
        Senator Brownback. I mean, there is going to have to be a
    pretty heavy recruitment, I think, if--the experience under
    anybody's scenario is a pretty difficult one to go through
    this, for a woman to go through it. Have you seen any numbers
    on this?
        Ms. Charo. There are no numbers, because the scenario is
    not realistic. I think the premise is the problem, Senator
    Brownback. I do not share the premise. And I think this is what
    Dr. Bustillo was trying to get at, as well.
        The way this research will proceed, first on the
    therapeutic arm and on the purely research laboratory study
    arm, is that it starts very small, with very small numbers of
    people under close control by the Food and Drug Administration,
    in which they are looking at the animal data, whether it's
    ready for laboratory work with human materials, and you start
    with very small numbers of people. And as you continue to do
    the work and slowly scale up as you perfect your techniques,
    you are simultaneously developing methods by which you no
    longer need as many eggs for the next stage, per procedure, as
    you did in the first stages of research.
        So the scenario of using millions of women----
        Senator Brownback. Then you paint----
        Ms. Charo.--at an early stage for all diseases, I do not
    think is realistic vision.
        Senator Brownback. Then you paint for me--we have got a
    hundred million people with these diseases we are going to cure
    with the cloning----
        Ms. Charo. No, I do not think a hundred million people are
    going to be the patient population for therapeutic cloning,
    either.
        Senator Brownback. What is the----
        Ms. Charo. This would be one----
        Senator Brownback. What is the patient population going to
    be?
        Ms. Charo. No, it is the patient population people with the
    diseases, but for each----
        Senator Brownback. Okay, well, what is it----
        Ms. Charo.--person, there are----
        Senator Brownback.--going to be? Please----
        Ms. Charo. There are many----
        Senator Brownback.--come up with the number, if you can, or
    a round figure for me, if you can. What is the patient
    population going to be?
        Ms. Charo. We do not know that yet, because the research is
    just beginning. The point is, for every disease, whether it is
    heart disease or Parkinson's, there are multiple therapies. It
    is not one therapy that is used for every person. Different
    things work in different people, and therapeutic cloning may
    work for some subset of that patient population.
        I do not think I have ever heard any responsible doctor or
    scientist suggest that this therapy will be used for every
    patient----
        Senator Brownback. Well, why----
        Ms. Charo.--with every one of these diseases, and that's
    another reason why the numbers----
        Senator Brownback.--do they keep saying, then----
        Ms. Charo.--can become misleadingly large.
        Senator Brownback.--we are going to--we have got all these
    cures for--and then they list a litany of diseases that are
    going to be cured by therapeutic cloning, the same list that
    was put forward in the fetal tissue debate that we are going to
    cure with that, the same list that was put forward in embryonic
    stem cell. I mean, at some point in time there has to be some
    coming up with, ''Here is the product of what we have done.''
        Ms. Charo. Oh, but I think it is unfair, with research
    aspects of human cloning, to ask for an actual approved, FDA-
    reviewed and -approved, therapy to emerge within five years.
        When Jamie Thompson said what he did about Parkinson's at
    that hearing, what he was talking about was, ``When would we be
    able to move into clinical trials for Parkinson's disease?''
    And he predicted five to ten years out. It is now five years
    out, as you correctly note.
        Senator Brownback. And there is no----
        Ms. Charo. And we are now at----
        Senator Brownback.--limitation on therapeutic cloning to
    date, is there?
        Ms. Charo. We are now at the stage at which we have
    successfully seen human embryonic stem cells--and, remember, he
    was not talking about cloning them; he was talking about stem
    cells from extra IVF embryos--so we have now seen those stem
    cells successfully differentiated into neurological tissue. And
    the next step is to see whether or not that tissue can be
    developed to the appropriate stage for transplant into a
    patient. That requires lab work, animal work, and, eventually,
    human trials. We still have another five years on his
    prediction to see if we can get that next stage of the work
    done to the point where the FDA would permit that work to go
    on.
        The FDA, remember, keeps a very tight lid on all of this.
    It requires licensing of establishments that do this kind of
    research. It has an extremely tight tracking and monitoring
    system so it can track viral transmissions as well as
    everything else in its comprehensive tissue action plan, and it
    has comprehensive donor suitability requirements. That is, it
    has already issued Federal regulations--proposed, interim, and
    finalized--that cover every aspect of this but keep it moving
    slowly and responsibly.
        Senator Brownback. I want to ask Mr. Doerflinger or Mr.
    Kimbrell about this issue. I think both of you were around
    Washington when the fetal tissue debate started going, and I
    believe fetal tissue was stated that it was going to cure a
    myriad of diseases at that time. And these are actually even
    cells that were further developed; they are less primitive than
    the embryonic, the therapeutic embryonic.
        These are a couple of quotes from New York Times of some
    extensive studies on fetal tissue impact in Parkinson's
    patients, which were, ``Disastrous side effects. Absolutely
    devastating. It was tragic. Catastrophic. It's a real
    nightmare, and we can't selectively turn it off,'' because the
    cells were, as I understand, uncontrollable. Instead of making
    brain cells, they make various different tissues or tumors.
        Were people saying, at this same time, we were going to do
    with fetal tissue what is being proposed with therapeutic
    cloning?
        Mr. Kimbrell. Yes, Senator. I was working with then-Senator
    Humphrey and Senator Kennedy to try and get adequate regulation
    at that time on fetal tissue research.
        To step back just a second, though, just so we can get some
    clarity on a prior issue, I would note that 18 months ago,
    Michael West, of Advanced Cell Technology, at a Senate hearing,
    predicted that within six months, his company would be ready to
    create stem cells from cloned human embryos that would save
    3,000 lives a day. And he warned that for those--and, Senator,
    you may be one of these that was suggesting a six month
    moratorium on this--that that would cause the loss of perhaps
    as many as a half million lives.
        So I did want to just clear the record that these claims
    have been made, and, at that time, Senator Harkin said, ``Thank
    you. Now at least we have some--I am quoting--real numbers.''
    So these claims have been made, and I just wanted to clear that
    piece of it up.
        And yes, indeed, I think one of the things we have to be
    very careful with here that I have seen in 15 years of working
    on these issues, and this includes fetal tissue research and
    somatic gene therapy research, is hype over healing. Quite
    often, what we have seen is, with a lot of hype, some early
    investment capital, and some sometimes overly ambitious
    researchers, the real victims have been those who are suffering
    from these diseases.
        And this happened with fetal tissue. The claims were
    extraordinary. We were talking about claims, at that time, or
    the researchers were, of a hundred million lives being saved by
    fetal tissue research. They pushed it through, despite the best
    efforts of many in this body. We were not able to get adequate
    regulation. We were not able to impose a moratorium. And you
    see what has happened. Approximately 15 to 20 percent of all
    patients that have been given these fetal tissue for
    Parkinson's have uncontrolled motion 24 hours a day. They
    cannot feed. They cannot speak properly. And that has led to
    this front page New York Times story saying, ``My God, what
    have we done?'' Many of these researchers are now saying we
    should never have done it.
        So, again, before we jump into these predictions such as
    the one that Dr. West made at a prior Senate hearing, we need
    to realize that the real victims, quite often, of this hype
    over healing turn out to be those who are suffering from those
    diseases, themselves, and I think that it is the responsibility
    of this body and every legislative body to look out after their
    interests and realize that those interests are not always being
    served by those who are pushing these technologies.
        Senator Brownback. Good. I want to thank--Mr. Doerflinger,
    yes, do you have a statement?
        Mr. Doerflinger. I wanted to say something about that
    issue, too. The fetal tissue did have very mixed and often
    devastating effects. I think what the federally funded research
    showed was that there seemed to be some benefits only in
    younger patients with Parkinson's. None of the patients over 60
    years old were really helped. And I think about 15 percent had
    these devastating side effects that made them worse.
        There was one study in the Journal of Neurology, May of
    1996, that may be an even more disturbing sign of what we may
    face with embryonic cells. That was the story of a man who went
    to China for his fetal tissue transplant for Parkinson's. He
    was dissatisfied with the slow pace of progress in this
    country. They seem to have implanted in him some cells that
    were somewhat earlier in gestational age than the usual eight
    weeks. What happened to him was that he seemed to get some
    benefit from it, but within a year he had mysteriously died.
    And on autopsy, what they found was that bone and skin and hair
    tissue had proliferated in the middle of his brain and filled
    up the ventricles of his brain and killed him, cut off his
    breathing reflex among other things.
        So having failed with fetal tissue, it does not seem
    logical to me to say, ``What we need is earlier cells,
    embryonic stem cells,'' that now, in animal trials, are proving
    to have a very disturbing tendency, when tried for Parkinson's,
    when tried for spinal cord injury in rats, for example, when
    tried in knee repair in mice--one of the studies quoted in my
    testimony--have the very disturbing tendency to form tumors,
    and even, in one of the rat experiments, to simply kill 20
    percent of the rats in the study.
        We are finding, at this point, almost an obsession with
    this as the Holy Grail for medical cures. And it is really
    tending to divert people away from things that are far less
    morally controversial that are far, far closer to actually
    helping human patients.
        There was almost no news in most news sources about the
    first clinical trial of a patient with Parkinson's disease
    using his own adult neural stem cells. But that man, three
    years later, has 83 percent reversal of his symptoms in a study
    by Dr. Michel Levesque, and they are trying for broader
    clinical trials and approval from the FDA for that.
        There are so many things moving forward that do not require
    having to worry about lethal tumor formation, having to worry
    about harvesting women's eggs, having to worry about
    overproliferation and uncontrolled growth in patients' bodies,
    that it is becoming increasingly clear this whole agenda of
    therapeutic cloning--in which as Mr. Kimbrell noted, they still
    have not managed to make a single cloned human embryo that
    survived long enough to get any embryonic stem cell--is
    becoming an enormous digression away from medical progress that
    we could otherwise have.
        Mr. Kimbrell. Mr. Chairman, just one quick note on that.
    Since I am here representing Friends of the Earth and
    Greenpeace and other environmental groups, let me note that as
    of this morning's E-mail, I saw a peer-reviewed study that
    associates Parkinson's with early exposure to pesticides. I
    would suggest that it might be reducing our exposure to
    pesticides might be a far better place to start than trying to
    harvest fetal tissue.
        Senator Brownback. Well, you are all very kind to come
    forward and to testify. Ms. Millican, in particular, I am
    appreciative of you fighting through your difficulties to be
    here today. We do all want to find cures, and we want to do it
    as best we possibly can for everybody who is involved.
        The record will stay open for the requisite number of days.
    I do appreciate all the witnesses for coming here.
        The hearing is adjourned.
        [Whereupon, at 11:30 a.m., the hearing was adjourned.]
                                A P P E N D I X

         Prepared Statement of Hon. Ron Wyden, U.S. Senator from Oregon
        Chairman Brownback, in any new field of research, it is important
    to oversee closely the clinical practices of researchers to assure that
    abuses do not occur. We have done this in the past with in vitro
    fertilization, and I think we can do it in the future to produce
    vitally important therapeutic nuclear transfer treatments safely.
        In 1992, when in vitro fertilization was a relatively new
    technology, I authored the Fertility Clinic Success Rate and
    Certification Act. This remains the only federal legislation regulating
    these clinics. My legislation provided women and their families the
    information that they needed to make educated choices about embryo
    clinics by requiring the publication of clinic success rates. In
    addition, individuals can now also learn who accredits the clinic they
    are considering. All this information is available on the U.S. Centers
    for Disease and Control website and the information is updated
    annually. My legislation also called for the creation of a state model
    regulatory program for certification of embryo laboratories. This was
    accomplished in 1999, when the U.S. Department of Health and Human
    Services published a state model regulatory program. Combining consumer
    information, the state model regulatory program and the guidelines that
    this medical field had developed for itself, I think IVF has been a
    clear success story for the treatment of women.
        We can continue this kind of successful oversight in therapeutic
    nuclear transfer research and its applications to the treatment of
    disease and injuries. As I stated clearly in this Subcommittee's
    January 29th hearing, I support the strong ethics requirements--which
    would be enforced by the Department of Health and Human Services--
    contained in the bipartisan legislation ``The Human Cloning Ban and
    Stem Cell Research Protection Act of 2003,'' S. 303. These provisions
    require informed consent, prohibit the purchase or sale of an egg cell,
    and apply all of the existing federal ethical research standards to
    nuclear transfer treatments. Tough penalties give this law teeth, but
    do not stand in the way of the many medical advances that can be made
    through nuclear transfer.
        It is important to remember that this research will help women.
    Nuclear transfer technology is crucial to treating diseases which
    affect women disproportionately or exclusively. By increasing our
    understanding of how cells predisposed toward diseases like ovarian
    cancer develop, we can learn how to fight these diseases. Promising
    treatments for osteoporosis, arthritis, and autoimmune diseases could
    be supplied by replacing damaged tissues with cells grown through
    nuclear transfer. Women would directly benefit from such advances, and
    would be helped as well as the primary care givers for those who suffer
    from chronic diseases.
        I hope we can work together to protect women's health at the same
    time that we allow for careful progress in nuclear transfer research.
                                     ______

      Response to Written Questions Submitted by Hon. Frank Lautenberg to
                             Richard M. Doerflinger
        Question. If the egg could be manipulated so that it could not
    implant and therefore would not have the potential to become a child,
    would you still oppose any research or therapeutic cloning?
        Answer. First, a clarification: No mere egg can implant in a womb.
    If we are discussing the new embryo created by human cloning, which is
    no longer simply an egg, then in our view that embryo deserves respect
    as a new developing member of the human species--a human life with
    potential, not only a potential life. The cloned human deserves that
    respect because he or she is already a human life here and now, not
    only because of what he or she may become in the future.

        An embryo with no ability to implant in the mother's womb will not
    survive very long. Nor will a newborn infant who has no ability to
    ingest his or her mother's milk or other nutrients. But we would not
    say of the infant that he or she is less than human due to the lack of
    potential to become an adult, and we should not say of the embryo that
    he or she is less than human due to the lack of potential to survive
    long enough to be born. In either case, deliberately manipulating these
    humans in order to deprive them of these abilities needed for survival
    would be gravely immoral in itself. So my answer to the question is in
    the affirmative.
        There may, in fact, be ways to modify the nuclear transfer
    procedure so that it produces stem cells without ever producing a
    living human organism (that is, an embryo) in the first place. The
    Brownback/Landrieu cloning ban (S. 245), which we support, explicitly
    allows for this, and bans only the use of the somatic cell nuclear
    transfer procedure to create a human embryo. But an embryo that has
    been unethically manipulated to be short-lived is still a human embryo.
                                     ______

           Prepared Statement of Kimberly Bradford, Orlando, Florida
        My name is Kimberly Bradford, I'm 34, the mother of one 7 year old
    son and have been very ill for the past 10 years due to the use of
    Lupron for Endometriosis. When we are younger, in our late teens, in
    high school and college we start thinking, dreaming about what our life
    is going to be like. We start setting goals. All of mine were cut
    short. Lupron robbed me of the good health I once had. It stole my
    ability to participate in most physical activities. It took my ability
    to think clearly and make rational decisions. At times it took my
    ability to move at all and left me paralyzed.
        I am very grateful for the one child I was able to have . . .I had
    some VERY good surgeons who made that possible. I had several
    operations that led to my ability to bear my one and only child.
        I lost my first child. I got pregnant four months after my last
    Lupron shot. I thought enough time had passed, I was wrong. The toxin
    was not gone, considering how sick I was I should have known but all I
    could see what the need to have a child. This is the same need that
    MANY women have when they undergo infertility treatment and agree to
    use Lupron, even though it is NOT approve for such use. How Lupron
    became used for this I can't imagine. It's toxin is so sickening. I
    know they use Lupron for superovulation, a procedure that Puts women's
    lives in jeopardy. The use of Lupron to gain eggs for stem cell
    research is wrong! The same diseases that they are trying to cure,
    Lupron is causing!
        It is risking the health of the women who innocently volunteer for
    this, not to mention possible passing on a toxin contained in the egg
    itself.
    My Whole Story:
        My diagnosis of Endo came in October of 92, but my ordeal started
    when I was 11. Like most of us I had the usual, painful period then
    painful ovulation. My period kept getting longer and longer despite
    being on birth control pills at age 16. I complained to my GYN for
    years about the pain, but it was not until I had a class II pap
    (Dyplasia) that she finally listened. She wanted to do a biopsy and
    laser my cervix so she agreed to do a Lap at the same time. I was 24 at
    the time of my lap. I worked in the same hospital as my doctor so she
    knew me by name. She was also my mothers doctor. Needless to say I
    trusted her. I think she agreed to do the lap to try and prove me
    wrong. I had been doing research on my pain and knew I had Endo. Well,
    I had it. It was covering my bladder. This explained why I always
    thought I had a bladder infection or UTI only to have the tests come
    back negative. It also explained why Sex hurt so much. She told my
    parents afterwards that she didn't remove any, she told us it was
    inoperable and wanted to put me on a drug called Lupron. I had to watch
    a video prior to getting an injection. It was made by TAP holdings, the
    pharmaceutical CO that makes Lupron. In the video was this very perky
    women spewing the benefits of Lupron and how you can find relief for up
    to a WHOLE YEAR. A year sounded like a long time then. . . . Little did
    I know. The only info I could find on Lupron was mostly for men with
    Prostate cancer. It was listed in the PDR but that doesn't really give
    you an idea on how ``real'' people react. I gave up my search and took
    the drug. I mean after all I trusted my doctor. I was told about the
    pseudo-menopause symptoms, hot flashes and such. She also told me to
    drink milk, but not to worry about it too much because of my age.
        I started complaining right after my first injection. The hot
    flashes were horrible. My poor mother felt so sorry for me she stopped
    taking her hormones so we could ``flash'' together. It was winter so at
    least we could just go outside and melt snow. But this was fun compared
    to the rest. . . . I started bruising really bad, like just from
    wearing shoes. No one could even touch me without an imprint of their
    finger or hand showing up on my skin. I called the doctor, the one I
    trusted, and was told ``don't go horseback riding'' She said it as if
    it was part of my daily routine.
        I felt like I was in a ``fog.'' I couldn't think. Decision's like
    what color sweater to wear became a major ordeal. When I looked in the
    mirror I always expected to see someone else. I felt 80. Everything
    hurt, like someone drained my blood and replaced it with acid.
        The shots were given by one of the nurses in her office. When I
    received my records in the mail a few months ago the notes were filled
    with stuff like ``Kim is very excited planning her wedding,'' NO
    complaints, nothing medical! Nothing I said was documented. I did
    complain!! About headaches, insomnia, joint pain, pain at the injection
    site for days, I was told that none of these things could be caused by
    Lupron and not to worry about them. I was left believing that I just
    had an overactive imagination. My doctor did only one exam during those
    6 months and it was really bad! I wanted to kick her in the face. I
    told her it hurt and she said ``what about sex?'' Was she kidding? I
    couldn't stand the Q-tip never mind actually having sex. She said
    ``everything looks great, you're going to be just fine.'' I was so
    naive. I wanted so badly to believe her. I tried to put it out of my
    mind, after all I had a wedding to plan. All my energy went to that and
    just trying to get thorough a week of work without missing too much
    time. I got married on June 5, 1993, one month after my last injection.
    400 invited guests, family, friends, members of his family I had not
    met yet . . .they all witnessed my total emotional breakdown. It was
    REALLY awful! I can't even bear to watch the video as all you see is my
    head bobbing as I cried, I should have bought stock in Kleenex. I must
    have gone through 4 boxes during the service. I could not even say my
    vows because I was crying so hard. My husband thought I wanted out. I
    did but only to put an end to the embarrassment. We could not kiss
    because I had to blow my nose, as if no one would notice. Somehow we
    got through the night. Next came the honeymoon and a week of
    unbelievable pain. I kept quiet, I was supposed to be OK, this was just
    in my head. . . .
        When we got back we moved from Maryland to Virginia, about 3 hrs
    away. By August I couldn't stand the pain anymore. I finally broke down
    and told my husband everything. I told him he could leave me if he
    wanted. I was not the same person he thought he had married and I was
    not sure if I would ever be the same. The pain was getting worse, not
    better as the doctor had promised. I called her, desperate for answers.
    Her reply ``there is nothing more I can do for you, find another
    doctor.'' I was devastated, but I needed help so I searched for a new
    doctor. I finally found one who specialized in high risk pregnancy and
    GYN disorders.
        She met with my husband and I for over an hour. She had lots of
    questions. The biggest being ``why was the Endo not removed''? Good
    Question!!! I was told it was inoperable. This was the beginning of an
    eye opening experience. I finally realized that my doctor of nine years
    had deceived me. Anyway, the new doctor wanted to do another lap. I had
    it in October 93. Almost exactly a year from the first one. Despite my
    old doctors promises of Lupron helping me, it actually made it worse!!!
    It had gone from just my bladder to my bladder, cul de sac, ovaries,
    and tubes. Basically there was a little bit everywhere and I would not
    have been able to have children without her intervention. She removed
    all she could and did a LUNA as well but could not get to as much of
    the nerve as she would have liked. We had no time to waste planning a
    pregnancy. My husband knew when we got married that our window of
    opportunity for children would be small. We got the green light and I
    was pregnant by January 94. Sadly, Our happiness did not last long. I
    miscarried in March.
        I shut myself off from the rest of the world for a while. That
    summer I drank . . . a lot . . . Looking back it wasn't fully out of
    depression it was also to hide my other problems. It was easier to hide
    my dizziness and stumbling and visual problems if I had a few drinks
    than to admit there was something else wrong with me. Somehow we got
    through it and by September I was pregnant again. This time I told no
    one until I was past the point of my last miscarriage. I was so fearful
    of losing this one I would wake up thinking I was in labor, pushing and
    everything. The pain was pretty intense the first couple of months, but
    it did give me an excuse again for my klutziness. Then around 3\1/2\
    months an amazing thing happened, I felt great!!!! For about 5 months I
    was almost pain free, symptom free, headache free. WOW! My son was born
    on May 11, 1995. I nursed for about 3 months then tried to go back on
    birth control pills. But surprise, I could not remember to take them
    everyday. I talked to my doctor and finally decided that Depo Provera
    may be the best choice. It offered me a chance to ``save'' my uterus
    until I was ready to have another one. I wouldn't get a period so the
    pain I had with them and ovulation would be gone. At the time it made
    sense. But with it I also lost my excuses for not facing the other
    problems my body was having. And just to prove it they started knocking
    me on my butt. I started to get sinus infections. I should say again,
    my VERY first sinus infection ever came after my second injection. I
    never had allergy problems before. After months of trying different
    antibiotics my doctor finally sent me to an allergy specialist. That's
    when I found out I now had an IGA deficiency. Which had been checked by
    the doctor I saw for the infections I got while on Lupron? My IGA at
    that time was low, but still in normal range. Basically your body has
    five different Ig's for different systems in your body. They are the
    ``brains'' behind your white blood cells and tell your white blood
    cells what to attack when you have an infection. I don't have enough to
    fight infections in my respiratory system. I also learned that when I
    get a sinus infection I am more susceptible to other infections like
    strep throat and bacterial laryngitis. They put me on Prednisone and a
    long course of Biaxin. Still it took months to get well. I was
    miserable and thought for sure I was going to lose my mind!!! When the
    infections finally settled down I went back to work for the Orthopedic
    practice I was with before I had my son. He was almost two and I
    thought he needed to be with children his age, rather than a mother who
    was sick all the time. It didn't take long for myself and others to
    realize something was wrong. I mean you can only walk into so many
    walls before someone asks if you're alright. My right foot has a
    tendency to ``disappear'' on me at times. I hardly noticed my tripping
    over it anymore, but others noticed. I started getting these intense
    migraines with an Olfactory aura. Everything smelled like it was
    burning. My PCP thought I should have an MRI of my brain. I had it on a
    Thursday. That evening I got a call from my doctor. They wanted to do
    more. I needed to go back to the hospital in the morning for more MRIs.
    Then when we got home I got another call. They still wanted more, so
    back we went. Since it was a Friday and I was scarred to death at this
    point my PCP gave me her home number to call if I needed anything. She
    also wanted to see me Monday morning. She didn't have the results but
    thought I should see a Neurologist. The one she had called in to read
    my MRI was not in my insurance plan, so she went through the book and
    found one that could see me right away. I can tell you this was the
    single most humiliating experience in my entire life!!!!! He came into
    the exam room abruptly, he did not even introduce himself. He picked up
    my chart and looked at me and said ``So you're feeling dizzy, what does
    that mean? Look at the wall, is the wall spinning or are you spinning''
    I was speechless!!! I was also very scared, I still didn't have the
    results of my MRI, but I had brought the films with me and he proceeded
    to read them by holding them up to the light above his head, no light
    board. The whole time he is looking at them he's saying ``Well you get
    headaches because, unfortunately, you are a women.'' I kid you not he
    really said this!!!! Then he looks at my eyes and asks if I had been
    checked for syphilis. I had enough and left. What a jerk!!!!!!!
        I took my MRI films back to the hospital and called my PCP to tell
    them what happened. That doctors name is no longer in their book!! They
    still had not received a report on my MRI. In the mean time I went to
    an ENT to rule out Menergies disease. The doctor was very nice and said
    I had classic vertigo but did not know why. He said maybe it was just a
    virus and would go away. At this point all I could do was hope and
    pray. I made an appointment to see him back in three weeks. He said he
    would run more tests if nothing had improved. About one week before my
    follow-up with him I got a call from my PCP. She said she really wanted
    me to see another Neurologist. I got nervous and told her I was willing
    to go out of my Insurance network if she could get me in. The best the
    Neuro's office could do was 2 months away. I took it and kept my
    appointment with the ENT. This is when I learned what everyone already
    knew. My MRI showed lesions on my brain. There was a question of
    ``demylinating lesions'' or M.S. I don't remember the drive back to my
    office that day. Only my supervisor driving me home. And the look on my
    husbands face when he came home and found me curled up on the kitchen
    floor. We had tried to convince ourselves that no news was good news. I
    kept thinking ``this is not real, this is not happening to me, to us.''
    I kept calling the Neurologists office in hopes of a cancellation or
    something. I was very angry, how could everyone just expect me to put
    my brain on hold?
        When I finally saw him he showed me the area everyone was fussing
    about. I have come to call it ``my spot.'' It is an area about the size
    of a quarter on the left side of my brain. It's in the white matter, in
    the middle, near the pituitary gland, but not in an area they can
    biopsy without causing more injury. He wanted to do a battery of tests,
    lab work, visual evoke potentials and a spinal tap. So far so good,
    then about four days after my spinal tap on a Saturday morning my
    husband tried to hand me the phone. It was my parents. I could hardly
    move the right side. I couldn't grip the phone with my right hand. I
    couldn't talk, just slur. My husband was scarred, I was worse. I tried
    to get up, the right side of my body felt like it weighed 300 lbs. We
    called the neurologist and he met us in the ER. He did some tests and
    seemed worried. He decided that I should stay in the hospital for a few
    days and take IV steroids, salumedrol. He also thought that I may still
    be leaking spinal fluid and should have a blood patch, and more MRIs.
    While I was in the hospital he got the results of my Spinal tap, No
    M.S. But that did not help tell us what was going on. They took me to
    the O.R. and did the blood patch, YUCK!!!! And then off to MRI to do
    more MRIs and a MRA to check for stroke. Lesions still there but
    nothing else. After four days I still did not have the use of my right
    hand. Two days after I got home I started to swell. I though I was
    having a reaction to something, but did not know to what. As I swelled
    it felt like every cell in my body was exploding. I called the Neuro
    just to have him refer me back to my PCP. They wanted to see me first
    thing in the morning, but that meant still getting through the night. I
    should have gone to the ER but instead just sat up all night. I felt
    like I had been hit by a Mac truck. When I woke in the morning I looked
    like I had the chicken pox, but I could finally move my hand. My
    stomach hurt pretty bad but I thought it was just from the swelling as
    everything else hurt as well. When I got to my PCP's office she did an
    exam, made an appointment for me with a dermatologist for the rash and
    to top it all off she explained that the stomach pain could possibly be
    from the steroids. I have stomach problems anyway and she was afraid it
    ripped a hole in my stomach. So back to the hospital for an Upper GI.
    That turned out OK, no holes. She gave me darvocet for pain. That to go
    along with the bag of Meds I already had from the Neurologist:
    Fiorocet, imitrex, erogot, Noratryptoline, Inderol, and midrin. I am a
    walking pharmacy. Now I add Zantac back to my list.
        My Neurologist thought it would be a good idea for me to get
    another opinion since he was still not sure what to pinpoint everything
    to. So I took my MRIs and records to The Medical College of Virginia
    (MCV), to the Neurology department. There I was examined by three
    students, one resident and one fully certified physician. After two
    hours of questions and following pen lights they finally looked at my
    MRIs. The doctor turned to everyone in the room and said ``Do you see
    it?'' I felt like a lab rat!! ``WELL'' he finally gets back to me ``The
    good news is you don't have M.S., the bad news is I think you have
    Lupus''? When will this nightmare ever end??????? It took a while to
    let this ``new'' diagnosis set in. Then to organize it in my mind as to
    how they could go from one end of the spectrum to another. I started to
    do some research and it seems that Lupus and M.S. have a lot of the
    same symptoms. Even the treatment is the same. Change your diet, get
    more exercise, take steroids when you have a ``flare.'' Someone at work
    recommended a Rheumotologist and I made an appointment. He is known for
    having the longest living Scleroderma patient and very well respected
    in our community. Unfortunately it made his ego quite large. He, like
    ALL the other doctors spent a great deal of time with me during the
    initial evaluation. He ordered his own round of blood work and checked
    all my joints and muscles. He told me to bring my husband with me for
    the follow-up because he wanted him to understand EVERYTHING that was
    happening. A month later we found ourselves in the exam room with the
    doctor telling us that as far as the question of Lupus goes my SED RATE
    was OK so we should talk about something else for now . . .
    Fibromyalgia. I sat there for a half hour and only heard about 3 words
    he said. Rub here, Rub there, get more exercise, see me in a month . .
    . Now this time I am sure I was losing my mind!! I have to be, that is
    the only explanation for what has been happening to me the past few
    years. I went back for the follow up and with a list of questions. None
    of which were answered. He seemed uninterested in the Neurological
    things that were happening. I was worried about this happening in
    public or while I was alone with my son, what would happen to him???
    Then it happened. I picked him up from pre-school and wanted to buy him
    a new pair of shoes. I was carrying him because it was a busy parking
    lot and he is very active. We had to walk up about 5 concrete steps to
    get into the shopping center. On the second step my right foot just
    ``disappeared'' and down we went. His back slammed into the concrete as
    did my right knee. He's screaming, I'm dazed and hurt and people are
    running at us, out from the stores. This has to be a nightmare. I shut
    my eyes and tried to wish it all away. It didn't work. We finally got
    up. His back was OK, just a little scrape and a lot of scared. I looked
    around and could not remember where I parked the car. Then I saw it but
    it kept getting farther and farther away. My heart raced and I felt
    cold sweat just pouring out of me. An anxiety attack on top of it all.
    The doctor heard none of this. He said ``perhaps you're not getting
    enough sleep . . . he handed me a prescription for Flexeril and Ambien
    . . . ``see me back in a month or two''. I wanted to scream! I finally
    sought out a counselor and saw her for about 6 months, once a week. It
    felt so good to be told that I wasn't crazy, I really needed to hear
    that. It also felt good to be treated like my problems were important.
    She never once said the old ``it could be worse, you could have X, Y or
    Z.'' She was just as appalled at the way I had been treated and
    shuffled around from doctor to doctor, none of them taking into account
    the other's findings. She helped me come to terms with things I already
    knew, but could not except. There is no going back, I can't turn back
    the clock and not take Lupron, it's already done. There most likely is
    no cure for what is wrong with me, but there can be peace. It's just
    finding a way to obtain it. She gave me the courage to do my own
    research and ways of reaching out to others who this has happened to.
    She helped me find my voice. Now I am able to share my story, this
    story, with others and possibly prevent this from happening to someone
    else. This is my path to peace. Through this search I have found that
    My illness is probably not M.S. or Lupus . . . but something else,
    something somewhere in-between. I have begun seeking out other doctors.
    Ones to help me deal with the pain I have daily. Most of my physical
    pain is on the right side. There are signs of Arthritis in my neck,
    right hand and elbow and right knee. I also still see the Neurologist
    to keep an eye on the lesions and help with headaches. I see a Neuro-
    opt, one of my Neuro's partners to keep track of the Neuropathy and
    Adie syndrome in my right eye. My husband has been VERY supportive. He
    bought me this computer to help me research. He has gone to the library
    with me and tries to find contacts who may be able to help us. He kept
    me grounded when I found the information on the NLVN. He was with me
    when we brought all this to the attention of my PCP and was told by
    them that ``the only way for the medical community to know these things
    is when a group of people search each other out and find that they have
    the same problems and the only common denominator is a certain drug . .
    . in this case LUPRON.'' He filled out my FMLA stating that this all
    started when I unknowingly got myself involved with the FDA's phase IV
    clinical trial of LUPRON. I did not know until my own research that I
    was part of a clinical trial. I never signed a consent for this. I am
    just a sure that the doctor who gave it to me NEVER filled out the
    MEDWATCH forms or reported any of my problems with this drug. I called
    TAP in the beginning just to see what they would say. I asked if they
    were going to do any long term studies on Lupron. They told me ``Maybe
    in another 20-25 years, look how long it took them to find out about
    DES.'' I can't wait that long. For now I will continue to spread this
    story to as many people as I can. I will continue to have a battery of
    tests done every couple of months. I will continue to try to find
    doctors who have some answers. I will continue to take various
    combinations of medications to try to keep my illness as stable as
    possible. I will try to continue to be the best mother and wife as I
    can be. I will continue my search for peace. . .
        To those of you who made it this far in this story and are facing
    problems from taking Lupron, please know that you are not alone in your
    fears or concerns about what this drug has done to you. There is a lot
    of information out there and a few very good sources of support. If
    there is anything I can do to help you, just ask!
        There is info available on Medscape and from the National Library
    of Medicine at pubmed. Dateline aired a show on Lupron on January 2,
    2000. They interviewed 9 women who all have permanent damage from
    taking Lupron. One of those women, started a website to offer support:
    Julie's After Lupron Forum I believe 8 of the 9 women post there as
    well as many, many others. There is also a petition: Lupron Petition.
    Kay Lazar, a reporter for the Boston Herald, wrote a 2 part article on
    our Lupron Damage in August 1999. If anyone would like the links or the
    articles, just ask. Until we find a lawyer who will take our case our
    own stories are the most powerful tool we have.
        If you have not taken Lupron yet and are trying to decide please do
    your research before you do anything that could alter your life
    forever. I know that Endometriosis is VERY painful. I still have it. I
    know that pain can cloud our judgment. The promises of a Painfree
    period of time. The HOPE it brings to be Painfree is a very persuasive
    reason for taking it. Please do not take what I have said lightly. I am
    not the only one. This is only one story, I am only one person. All I
    ask is that you search. Search your heart, your mind and weigh the
    price of your soul . . . .
        Good luck to all!
    Adendum
        It is now July of 1999 and some things have changed for me since I
    ended this story. But of course, there really is no end . . . My
    husband was offered a promotion that could not be turned down. We moved
    to Orlando, FL in February of this year. We are now settled in our new
    house and my son has started in Montessori school. Before we moved I
    asked for recommendations for a GYN and have found a really good one. I
    had stopped taking Depo Provera in January of 1998, in hopes of having
    another baby. It took 14 months for my period to return. And it came
    with vengeance!! My Endo pain has been increasing every month. I told
    my GYN at the first visit my problems from Lupron. He had me start
    taking Prenatal vitamins to boost my immune system. He also referred me
    to a Reproductive Endocrinologist. We have met with him once and his
    acknowledgment of my Lupron trouble has been the best I have received.
    He added more B-6 and evening primrose oil to my list of meds. The bad
    news is he has diagnosed me with secondary infertility. He does not
    think I am ovulating at all and when he did an internal sonogram he did
    not like the looks of my ovaries. I will have an HSG next month and
    possibly start fertility drugs. His biggest concern with these meds is
    that they DO make Endo worse. They are all high in estrogen, which most
    of you know feeds the endo. He is also concerned about what other
    antibodies Lupron may have caused me to develop, so I will be tested
    for those soon. My pregnancy, if it happens, must also be followed by a
    Neurologist. I have an appointment with one soon. Basically I am
    starting from ground 0. Being a ``new'' patient, filling out endless
    forms, explaining my condition(s) and it's cause, hoping they believe
    me or at least understand. Not to mention waiting MONTHS for that new
    patient slot to open up.
        It's now the end of August. I've had the HSG, it wasn't good and it
    hurt like Hell! He was able to force the Dye through. I emphasize
    ``force.'' Rob and I have talked and all this pressure to try and get
    pregnant has been wearing me down. It's felt like something I have to
    do, like having to do the laundry or dishes. The reality is we don't
    know if I am even healthy enough to have another child. My Endo pain is
    controlling me right now. I can feel it building up on my bladder. It
    hurts to pee and I feel like I have to go all the time. I went and had
    a check for a UTI, almost hoping that is all it was . . . no such luck.
    I am going to go with Lap #3 and see how I feel afterwards.
    November 10, 1999
        I am now almost 2 weeks post Laperoscopy. DR found more Endo and
    adhesions. Also said my uterus was VERY red and not the color of salmon
    it should be. He also said my right ovary spasms when he touched it. I
    know that sounds kinda gross . . . Well, I don't know what any of this
    means just yet. My follow up with him is on the 15th. I am not
    recovering as quickly as I should. I can't seem to shake the ``flu''
    like symptoms and fatigue. I had a few complications after surgery. My
    blood pressure dropped and heart rate dropped very low. They had to
    keep waking me up. Plus I had trouble peeing. Don't understand why it
    never occurred to them that I might have a UTI since I had a low grade
    fever and pain. The pain meds they were giving me came by the way of
    hip injection. Well, one struck a nerve and now my leg feels like I
    have a HUGE gaping wound in it. It hurts to shave. Supposedly this will
    slowly go away. I hope so!!! I am not feeling well today! I am nauseous
    and my stomach hurts, right around my uterus.
        I have received more published articles on Lupron. Two from the
    Boston globe from 1996. It details two women taking Lupron for
    infertility and it caused hyperstimulation of the ovaries. They both
    almost died. The others are from the HERS foundation from back in 1989-
    1990. The founder of this group had all the research info on Lupron
    prior to it's approval. She has proof to show that they knew of the
    dangers of this drug before it got approved. She also gives her strong
    opinion that Lupron will turn out to be worse than Thalidomide or DES
    ever was. For my son's sake (he is a post Lupron baby) I pray to GOD
    every night that he is spared! It is bad enough that he got me for a
    Mom.
    November 20, 1999
        Had my Post op on Monday. It didn't go so well. Since he was unsure
    about my uterus he took biopsies of it in different places. Turns out
    it is ALL Endo with the added probability that I now also have
    Adenomyosis. This is when Endometriosis is found embedded in the
    uterine muscle and the ligaments that attach it. He feels bad for
    second guessing and not removing what he could. I am still kinda numb
    and don't really know how to react to all this. He also showed me a
    cyst he ruptured and the ``redness'' where all the nerves are
    hyperstimulated from the endo and told me I have some PCS (pelvic
    congestion syndrome). This he explained is from an injury to the
    uterus. Most likely from delivering my son. I will start continuous BC
    Pills for now, try to buy some time while I sort through all this.
    June 2000
        Had another appointment with the GYN. I wanted to see the pictures
    again. UGH! All that endo still there. So far the Continuous Loestrin
    Fe has been helping. At least as far as no added ovulation or period
    pain. He brought up the ``H'' word. He wanted to tell me what his
    thoughts on it are. Wanted to tell me that he has turned women away
    because he did not feel a hyst was the right choice for them. He says
    he does NOT believe in just yanking out a women's organs. Then he said
    whenever I was ready, so was he. . .
    November 2000
        Here I am one year post op and all was going relatively well until
    I got home from a long summer vacation. Apparently at some point during
    my long trip up the east coast I got bit by a deer tick and developed
    Lymes disease. I have spent 5 of the last 8 weeks on antibiotics. I
    still have Lupron to thank for my poor immune system. It makes
    everything so much harder to fight. The lymes got into my joints and I
    have a stress fracture in my rt foot. That pain started 3 weeks ago.
    Then to top it all off the antibiotics weekend the pill enough to cause
    some severe pain. After being in bed for 2 days with a migraine my
    neurologist called in some vicodin. Rob picked it up for me and my plan
    was to take 2 and hop in the tub for a good long soak. Except that as
    soon as I actually go up the pain began. By the time I knelt to start
    the water I knew I was not going to get back up. The pain took my
    breathe away and I could not even yell to Rob for help. Zak found me on
    the bathroom floor whimpering. I HATE that he saw me like this. I hate
    even more that he had to come with us to the ER. Odd but in all my
    years with endo this was my first trip to the ER because of it. It took
    2 shots of demerol to calm me down and be able to tell them what was
    wrong. When someone came in to check my uterus, I think I could have
    kicked him into the next room! The pain was incredible. They gave me
    another shot before sending me on my way. Nothing they can do for me
    there. I went to see the GYN the next day and the word Hysterectomy was
    tossed around again. He gave me more pain med and told me to return in
    3 weeks. WELL I'm not going to make it to 3 weeks. Zak came into my
    room 2 nights ago looking for the dog and when I got up to help him the
    pain started again. This time the pain was alone. I made it to the
    bathroom in time to pass a few large clots and am still bleeding today.
    I have an appointment Friday morning. . . . If I can just make it
    through the holidays. . . .
        Jan 2001--Another Laperoscopy only reinforces Pelvic Congestion and
    Adenomyosis is worse. A hyst is unavoidable and Dr. doubts I will get
    much relief.
        November--Have Ovarian Vein Embolization. DO NOT Recommend!!!!
    AWFUL procedure! 7 hours, through Jugular, AWAKE no less. . . filling
    left ovarian veins with Coils, Balloons and glue. . .
        This procedure caused MAJOR pain and problems. Large Endometromas
    grew in left ovary. At scheduled Ultrasound in January they have
    ruptured. Talk about pain!!! Dr. does not know what to do. For the
    first time he is at a loss for a plan. My endo is beyond his
    capabilities. There is more to it but I'm running out of room.
        March 2002--Fly to California to see Dr. Andrew Cook. . . I
    honestly believe this man saved my life. I had a hysterectomy and Bowel
    resection. He FULLY understands all problems from Lupron and did a LOT
    of testing for problems he is aware of. Specifically Allergy related. .
    . I am allergic to ALL my hormones and 6 of 9 foods tested for.
        This Doctor was amazing! WWW.PELVICPAIN.COM. . . now if I can get
    the rest of my pain under control. . .If my hands could stop hurting
    for just one day. . . Or my head . . . That would be really nice! I am
    actually not sure what I would do with no pain in my life. I have lived
    with it for so long now . . .I do NOT remember what it is like to live
    without pain. Maybe someday. . .
                                     ______

                      Prepared Statement of Melody Hampton
        My name is Melody Hampton. My testamony is part of the testimony
    Lynne Millican gave to the Senate Subcommittee. I would like to add a
    few things. I am now 44 years old and I feel 94. I am sick all the time
    and a lot of days I just hardly can move due to the stiffness and pain
    in my body. I ask you to please do what ever you can to stop Lupron
    from being put into anyones body. I do not know what can be done for us
    who have the drug in our bodies already, but please don't let others be
    hurt like this. I will die knowing Lupron ruined my body and my life as
    I knew it. For me not to plead for others would be a sin. Thank you in
    advance for your efforts.
                                     ______

         Prepared Statement of Susan Hayward, Lake Havasu City, Arizona
        My name is Susan Hayward and I moved to Lake Havasu City, AZ two
    years ago from Massachusetts where I was born. In 1997 at the age of
    42, I became disabled from the U.S. Postal Service. I have been
    receiving Social Security Disability Payments and Disability from the
    Office of Personnel Management under the FERS program. I worked my
    entire life up until the point where I became disabled, 28 years
    straight, with the last 10 with the Federal Government. I had a great
    job with a private office making good wages. It was a career and I
    planned to work there until retirement in my 60s.
        The reason I am writing to you is because I want to offer my
    experience with the drug Lupron to bring awareness of the harmful side
    effects of this prescription drug. In my situation, I was administered
    19-20 injections of Lupron as treatment for endometriosis. The
    recommended dosage is 6. When you examine marketing techniques of the
    manufacturer, Abbott Laboratories and Takeda Pharmaceuticals, TAP, then
    you can understand why doctors continued to prescribe the drug. Samples
    were offered to physicians who were able to bill patients and insurance
    companies for hundreds of dollars. The total for my prescriptions is
    approximately $7,000 alone. Two doctors gave me my injections and they
    had something in common; both had me skip going to the pharmacy and
    they obtained the drug for me. When I first started using the drug I
    had to purchase it like any other prescription. Later, I believe I was
    sold prescription samples. The kickback schemes involved with TAP and
    physicians are well documented in the litigation resulting in the
    largest fine in U.S. History against a drug company. We are all paying
    the price for this so TAP and doctors could profit.
        Please think for a moment about the costs of lost productivity from
    my being disabled: approximately $900,000 disability costs being paid
    by Social Security and the Federal Retirement Program. Factor in the
    increased insurance premiums from hundreds of thousands in medical
    bills from hospitalizations, surgeries and tests. None of this
    considers the personal loss of my Thrift Savings Plan, the loss of
    contributions to the economy in commuting costs from using an
    automobile to buying lunches, or what this has done to me physically
    and emotionally.
        My motives are not monetary. I simply want to warn other
    individuals how dangerous Lupron is so they too don't become ill or
    disabled. I feel that my life has already been ruined, but perhaps I
    can help another person from having their life destroyed. Against the
    advice of lawyers I went public with my story in the Boston Herald in
    1999. By publishing my story I could compromise any future legal case,
    but it was too important for me to warn others.
        I have written to Hillary Clinton when she was in the White House,
    Senator Ted Kennedy, and my local State Representative in the past. My
    understanding of such abuses TAP makes is that individuals hide behind
    the guise of a corporation and are not accountable, all in the
    promotion of capitalism and profit. If one of those people at TAP
    thought they'd go to jail for selling poison to the public, they
    wouldn't be marketing this drug. There is a history in this country of
    exposing the public to dangerous drugs, pharmaceutical giants making
    huge profits with full knowledge of the harm they are causing, and by
    the time litigation catches up with the profiteers they have bailed out
    and reorganized. The paltry settlements offered through class actions
    are eaten up by lawyers and never truly compensate the victims for the
    amount of damage. The pharmaceutical lobby in Washington, DC is quite
    powerful and has strong influence over political voting. Understandable
    when you consider how much money they've made from all the profits. Who
    is watching out for the citizens when you have this dragon to slay? The
    FDA has done little to help claiming there is no other drug available
    that will do what Lupron does. My firsthand experience is that I would
    rather suffer with my initial diagnosis, endometriosis, than what this
    drug has done to the rest of my body and life. What I believe is that
    TAP will not stop selling Lupron until it no longer is profitable. The
    only way to make it unprofitable is through a barrage of litigation or
    a huge class action suit. But TAP has even found a way around that. All
    the successful lawsuits against TAP brought on behalf of victims for
    the damage it causes are SEALED with secrecy agreements. This makes it
    that much more difficult for victims to argue a new case and delaying a
    class action. If we can't find out what constitutes successful
    litigation then we get stalled, the statute of limitations runs out,
    lawyers don't have the resources to start a class action, and all these
    victims linger in silence. Unlike other pharmaceutical lawsuits where
    there is a direct cause and effect, i.e., Fen-Fen and heart disease,
    Lupron causes a syndrome with a host of symptoms that are very easy to
    blame on something else and difficult to prove. The ailments often
    don't show up in tests until much later if at all, so we get grouped
    into garbage diagnoses such as chronic fatigue, fibromyalgia, and
    degenerative disk disease. TAP continues to create more profits and
    victims with few obstacles.
        Please consider who the people are that are using Lupron and how
    TAP has consistently tried to find new ways to market it. Originally it
    was developed for men with late stage prostrate cancer. Any cry of foul
    play would be discounted by this group because ``they are dying
    anyway.'' Who knows how many of these men suffered more problems than
    they already had and nobody listened. Women desperate to have a baby
    were given Lupron for invitro fertilization. Many were so happy to
    finally have a child that they overlooked the health problems these
    children face. TAP decided they could use it for treatment of
    endometriosis. It doesn't cure it and causes a rapid regrowth once it's
    stopped. Like myself, most of these women are suffering with incredible
    pain and having to fight to receive the proper treatment, painkillers
    and surgical excision requiring a skilled surgeon. Fibroids temporarily
    shrink in some cases but still need to be removed. If they aren't there
    is rapid regrowth. Lupron only postpones the inevitable so why are they
    giving it to us? The FDA claims there is nothing else doctors can
    offer. TAP says we need it so they can profit. It doesn't make sense if
    it doesn't help, and it actually causes us harm. Precoscious puberty is
    being treated with Lupron with younger victims without the opportunity
    to gain an education before their memories are compromised. The memory
    problems can best be described as Swiss Cheese, neither long or short
    term, more like holes with total blanks. It is my understanding this is
    some form of seizure where thought processes are interrupted mid
    sentence and you draw a complete blank. Sex offenders are given
    probation if they take the drug as a form of chemical castration. The
    majority of the public hold sex offenders with disdain, so who is going
    to be looking out for their interests? Are there other markets for TAP
    to sell Lupron? I assume they are lobbying for cloning so they can sell
    more in IVF to harvest doner eggs. With each new group of users it
    lends credibility to the use of Lupron i.e., they've been using it for
    years to treat prostate cancer so it's safe for treatement of
    endometriosis. In reality, it should not be prescribed for anyone who
    isn't terminal, and then only as a last resort. That's what it was
    developed for and that's the only way it should be used.
        As a way to offer greater understanding of what Lupron can do to
    someone's life, I'd like to offer background on my situation and
    illustrate the difficulties this drug has caused.
        Like many people in this country, I was born into a lower middle
    class family. There were difficulties in my parents' marriage and I
    ended up being raised by my grandparents with 3 siblings with help from
    public assistance, or welfare. This humbled me a great deal and I
    learned a good work ethic early. We were raised with strong morals and
    religious background.
        My whole life I aspired to be a success and have a normal
    lifestyle. I knew education was important and had planned to attend
    college after high school, but the year I qualified for a free college
    education was in 1973 when Richard Nixon cut the welfare bill. A lot of
    hope went away when that happened but I started working and eventually
    went through college attaining my Bachelor's in Business 10 years later
    and even took a post graduate course at Harvard. I worked full time
    during those years with the exception of one when I was writing my
    thesis, and worked part time instead.
        Upon completion of college I decided on a career in the U.S. Postal
    Service. I was very proud to work in the largest mail processing
    facility in my area. We were voted #1 in the country for customer
    satisfaction and I met the Postmaster General. There was a tremendous
    sense of pride for all the employees but with me, it was even more so
    because I tied a lot of my sense of self esteem and worth in with my
    job and accomplishments.
        A few years into my career I applied for a managerial promotion and
    wasn't awarded it. The person who received the promotion had a high
    school diploma and military background as a prison guard in the Coast
    Guard. The next several years I endured extreme stress at the hands of
    this professionally jealous supervisor. I sought assistance from the
    American Postal Workers' Union, higher level management including the
    Plant Manager, EEO, and the Employee Assistance Program. By the time I
    was allowed to report to a different supervisor, I had developed
    endometriosis.
        What followed was years of pain and surgeries. I needed my job in
    order to support myself and lived in fear that I would not be able to
    maintain the schedule from illness. I sought treatment in Boston at
    University Hospital, now a part of Boston Medical Center. I assumed I
    would receive the best care with the newest techniques. The doctor who
    treated me was well known for his research and after a few months and
    diagnosis, placed me on Lupron. Between October 1992 and October 1997 I
    received 19-20 injections of the drug from my doctor in Boston and my
    local gynecologist. Both doctors knew of each other and the number of
    shots I was receiving. Instead of finding a solution for the pain the
    doctors would put me right back on Lupron until the bone loss was too
    great.
        People ask me how I could allow the doctors to give me so much
    Lupron. It's a multifaceted issue. From my background you can see that
    my sense of self worth directly correlated to my accomplishments at
    work. I struggled to get myself educated and gain a career. It took
    many years for me to attain the level I was at and I was in the career
    I chose to be. This was my lifelong plan and goals. How could I
    maintain that if I was always sick? I had to do everything I could in
    order to keep working for the financial and emotional benefits.
    Eventually it got to the point where I could no longer do it. Later on
    I was diagnosed with post traumatic stress disorder.
        The main symptoms that I attribute to my using Lupron are the
    vertibrae bone loss diagnosed as degenerative disk disease, arthritus,
    myalgia, bone pain, fatigue, swelling in hands and feet, severe
    allergies, nausea, weight increase, severe memory loss, vision changes,
    sleep changes, rapid heart beat, and abdominal pain. During the first
    doses of Lupron I developed panic attacks which I never had. The first
    few years after using Lupron I had horrendous migraines. Before I took
    Lupron I had none of these conditions; I was a normal woman in her 30s
    with endometriosis. After taking Lupron, I don't go a day without pain
    and am under constant doctor care to control pain and autoimmune
    problems. I left my home and moved to Arizona where I didn't know a
    sole so I could get relief from the arthritus problems. It was worth
    the chance that maybe I could gain my health back and be able to work
    again. That is all I've ever wanted when you consider where I came
    from.
        I'd like to outline the frustration we Lupron patients suffer at
    the hands of the medical establishment. The symptoms and diagnostic
    tests don't always show what we experience and often we have to be
    tactful in how we approach doctors. If you mention Lupron sometimes
    they brush us off because they know it's a bad situation and fear being
    dragged in a lawsuit. What's the alternative, not tell them? Others
    dismiss you like you are making the whole thing up in your head like a
    hypocondriac. In 6 years of dealing with my health problems post
    Lupron, I have yet to find an MD who believes my problems are caused by
    it. You don't take a healthy woman in her 30s to a woman with a host of
    medical issues in her 40s by endometriosis alone. Stress didn't cause
    my back to become herniated in 3 places. I didn't move to Arizona for
    arthritus relief because I don't have it, but that's what my tests say.
    The total lack of support from the medical profession is appauling, and
    there are thousands of people who need this documented. We need to know
    which tests to have, the proper pain relief medications, what we can do
    to help ourselves. Right now all we are doing is muddling along trying
    to help each other and most of us have no medical background. I attempt
    reading studies and biology reports that I struggle to understand
    because I know there are answers. Isn't that what we pay doctors to do?
    We don't all become doctors because we get sick, but that's what we are
    expected to do when it comes to Lupron.
        The other side of the equation is the legal establishment. I've
    contacted half a dozen lawyers and they all say the same thing; without
    a doctor saying your problems are directly related to the use of
    Lupron, you don't have a case. This is a need for an expert witness. It
    costs thousands to hire one. Most of us don't have the resources and
    law firms won't proceed without the guarantee of a positive outcome in
    the case. Another issue is the recommendation of only 6 doses of Lupron
    during the course of a lifetime. I had two doctors who ignored that and
    when presented to a lawyer they said it's a matter of opinion
    regardless of it being in the Physicians Desk Reference. That attitude
    has resulted in people like me with multiple injections over the course
    of years. Patients have no recourse and doctors don't face any
    consequences. With all the sealed verdicts and secrecy agreements, it
    makes it very difficult to obtain legal representation within the
    window of opportunity the statute of limitations allows. Once a class
    action does finally open up the lawyers will be looking for a
    percentage of ALL claims, probably a third of any settlement. Class
    actions are historically lower awards than a regular court case because
    there are so many litigants and often they drive the company into
    bankruptcy. As one lawyer put it, you are likely to receive a dime on a
    dollar. Class actions have administators too and they also take a
    portion. The true victims in these cases rarely get compensated for
    what they endure, while the tag-a-longs get rewarded handsomely. My
    feelings are to forget the money, let's stop poisoning new people, but
    that won't happen without TAP feeling the financial pinch.
        I have mentioned what this whole experience with Lupron has done to
    me physically and the frustrations I continue to endure with the legal
    and medical professionals, but I want to stress what this has done to
    me personally. Yes, I lost my career and am disabled, but more than
    that it has robbed me of any faith in our system of justice and what is
    right. How disheartening do you think it is for me knowing they are
    poisoning innocent teens because their bodies are developing too
    quickly? I worry so much about other people and what will happen to
    them knowing what this has done to me. How can everyone turn a blind
    eye to what is going on here? Do the lobbyists hold that much influence
    that people toss their morals out the window? Isn't that why people go
    into politics to begin with, to make a difference for the good of all?
    I know in my heart there are caring people in this world who just don't
    understand this situation with Lupron. I want as many people to know
    about it as possible so they can warn people not to take it, and
    hopefully someone will become motivated enough to do something to help
    the ones like myself who are just too sick to do anything about it.
        Also on a personal level, I enjoy travel more than any other
    passtime. Now I can no longer carry a bag or wheel a suitcase because
    my back can't sustain it. I was lucky enough to visit Europe before I
    stopped working and at the time, I kept thinking I better go now while
    I can. Thank goodness I had the insight to know to go when I did
    because I could never travel long distance again. This is the most
    enjoyable aspect of my life and now it's gone caused by the bone damage
    Lupron gave me.
        The most frustrating aspect of this whole situation is the fact
    that people have known about this for a very long time. I uncovered
    data published in 1990 warning about Lupron and feel it is important to
    incorporate it into this letter. It is obvious to me that the FDA is
    not protecting the public. TAP continues to find new ways to market
    this dangerous prescription drug and the doctors don't delve into it
    deeply enough to understand exactly what it does to our pituitary
    gland, hypothalmus, and adrenal systems that make us have problematic
    autoimmune responses. The economic costs will be catastrophic with
    millions of victims should this continue unbridled. It will make my
    loosing my Thrift Savings Plan look like a drop in the bucket.
        In closing I'd like to express my appreciation for you taking the
    time to listen and showing interest. We need caring individuals to take
    a stand against this multi-national corporation harming us so more
    people won't suffer. I am sincerely grateful for anything you can do to
    help.
                                     ______

                     Prepared Statement of Melanie Waldman
        I am one of the women named in the testimony about Lupron. I am not
    looking for a lawsuit, reparations, etc., I just beg that someone does
    something to stop this drug from being used without more information to
    all parties.
        Before taking the spray version of Lupron (synarel) I was an
    architect and able to work full time. Since my health was destroyed by
    this drug I have not been able to work. I am fortunate that I am
    married and that my husband is able to support us on his salary. I am
    also fortunate that his health insurance coverage allows no more than
    1,000 dollars out of pocket expenses because without that we would
    never be able to afford the IV treatments for the resulting joint pain
    that keep me functioning at all. I also know the drug is commonly used
    off label for people like me who suffer from endometriosis. (the ironic
    piece is that I'm used to it hoping to increase my chances to get
    pregnant and it destroyed my ability to carry a pregnancy, I am also
    lucky that we were able to afford to adopt a child) yet Doctors are not
    aware that so many of us have horrible permanent side effects. It seems
    like this issue falls throughout the regulatory cracks. The FDA has not
    approved it for this use, the manufacturer promotes it but is not
    responsible for its off label repercussions and the Doctors. have no
    way to find out the facts.
        In a time with more important issues like war and the economy, I am
    sure this issue doesn't seem pressing, but I ask that you do your best
    to see that something is done to prevent more woman from being
    needlessly harmed.
                                     ______

     Prepared Statement of Lisa A. Plante, former U.S. Congressional staff
                                     person
        My problems with Lupron started when I was wrongly diagnosed with
    endometriosis (all I had was adhesions) I was suffering from years of
    pain with adhesions attached to many internal organs. After many
    surgeries due to cysts I still experienced much pain.
        I asked a young doctor (OBGYN) to please make me better so I could
    live normally, enjoy my family and 2 children. This particular doctor
    said I would have to try Lupron before he did anything invasive. I was
    never properly diagnosed with endo before my injections of Lupron but
    was absolutely desperate to get better and decided to trust this
    doctor's advice.
        Immediately after having the first injection of Lupron I
    experienced terrible bone & joint pain, chest pain, depression,
    insomnia, foggy brain. . . etc., the doctor said it would be temporary
    and to stick with more monthly injections..
        I questioned doctor prior to Lupron injections on a pamphlet an
    organization (NLVN) was leaving in libraries that a friend had given
    me. The doctor asked to keep the pamphlet and told me not to worry that
    it was probably a competing drug company. I spoke with people who
    warned me of Lupron but thought they were spewing lies for one reason
    or another. I decided to trust my doctor in thinking he would never
    give me something that would harm me. I desperately wanted to work with
    him in getting me better and took 3 more injections of Lupron.
        I was encouraged to take more injections of Lupron but abdominal
    pain was unbearable plus the side effects . . . this was a nightmarish
    time. . .
        The doctor and his partner decided to take out my only remaining
    ovary plus the adhesions. After adhesion removal, I felt better in the
    abdomen but continued to have bad side effects from Lupron. After 8
    years, I still have bone and joint pain, foggy brain, chest pain,
    bloating . . . My teeth have thinned out tremendously, hips hurt, arms
    & joints are weak and sore. I do excercise a little, which helps some
    but feel like a very old lady at age 46.
        I don't think the doctor meant to cause me any harm and realize the
    constraints of many doctors these days but to give this drug out to
    just anybody is not a good idea. I especially don't think it's good to
    use in helping women's fertility! My gosh, where is the common sense?
        dates took Lupron:

            Lupron Depot 3.75 kit TAP--1/20/1995
            Lupron Depot 3.75 kit TAP--2/27/1995
            Lupron Depot 3.75 kit TAP--3/29/1995
            Lupron Depot 3.75 kit TAP--4/28/1995
                                     ______

                         Prepared Statement of J. Wolf
        Dear Senator,
        I was given your name by someone who is aggressively trying to help
    those of us who were poisoned by Lupron, I appreciate you reading this,
    my experience with this drug. I went to my doctor complaining of
    cramps, I was told to have an exploratory laparoscopy, when this was
    completed, I went back to the doctor and was told I had endometriosis.
    I was a little mystified since that is related to infertility and other
    symptoms that I did not have but he was my doctor and I had no reason
    to doubt his findings. He prescribed Lupron injections and told me it
    was a safe drug and I would only experience mild menopause symptoms
    with the loss of my menstrual cycle but all would return to normal as
    soon as the injections were stopped so I began them Sept. 1996. I
    returned to his office for monthly injections until Nov. 1996, when I
    began to complain of worsening pain, the injections were stopped and I
    became worse. I repeatedly went back to the doctor sometimes doubled
    over in pain (which was not there before Lupron). He did another
    laparoscopy with no findings and I was then sent to a gastroentologist
    for which he referred me also with no findings from the endoscopy and
    colonoscopy he performed, I kept going back in major pain (not present
    before Lupron) He then started to patronize me insinuating this was a
    women's problem and maybe in my head and suggested I go get the nerve
    in my gut cut, in other words, let's stop the pain without finding the
    cause, I began to doubt this doctor, I requested all my medical records
    from his office and to my shock found that the laparoscopy he performed
    before Lupron showed NO endometriosis and neither did the biopsy! By
    now it's the end of 1997 and I'm suffering to no end. I realized I may
    have been used for this experimental drug on women and I believe it was
    because of my insurance that I was placed on this drug, had I not been
    able to afford it I don't think I would be suffering right now. I took
    matters into my own hands and started all over again seeing a different
    set of doctors, I went through a series of tests all over again when a
    doctor suggested I get a nuclear stomach emptying test. This test
    showed an extremely delayed emptying (normal stomach is less then 60
    minutes and mine was 500 minutes!!). I finally had a diagnosis to go
    with the pain, I saw several doctors that took several more tests and I
    was told I had gastroparisis (a paralyzed stomach). With research and
    many questions I learned that this does not go away and I'd have it for
    the rest of my life, I knew Lupron did this to me because I never had
    stomach problems before Lupron so I requested the test again a few
    months later, my theory was since Lupron did this to me perhaps as it
    leaves my system I will improve, I was right 4 months later it was
    better, I repeated it a total of 4 times in two years each getting a
    little better as the Lupron was further from my system, I began to
    research Lupron and to my horror found it was used for prostate cancer
    and on sex offenders to castrate them, I was not told this by my doctor
    nor was I allowed to see the paper work accompanying this drug because
    it was giving to me at the doctors office. Given these facts I would
    have chose NOT to take this drug, I was deceived in the worse way
    possible first by a doctor who gave me a drug with no known medical
    diagnosis and then by the drug company for not disclosing the facts,
    side effects, uses, ect. . . , I am left with a stomach that will never
    be the same, my personality has changed, I have weight issues that I
    never had before, with a paralyzed stomach the food just sat there for
    days causing my gallbladder to become so infected I had to have it
    removed, I had doctors tell me I needed a hysterectomy and almost
    removed all my women parts for no reason, I had a doctor tell me to get
    the nerve in my stomach cut to ``shut me up'', my hair has fallen out,
    my menstrual cycle is now painful, I have fits of rage from my hormones
    being sent into overdrive and suffer from major depression, I was
    basically castrated myself because Lupron has murdered my sex drive. I
    am not the same person and know I will never get back the person I was
    before this poison, I want help, I need help, This drug is a danger and
    it shouldn't be given, The drug company needs to be held accountable
    for the pain it caused and will cause in the future. I only hope you
    can do something because as I understand a new generation of Lupron
    babies will be popping up soon as the gynecological field is pushing
    this drug to desperate infertile women without knowing the
    ramifications of it's use!
        Thank You,

            PS: Please be advised I have my test results and all records
            proving everything said in above statement.