[Senate Hearing 108-844]
[From the U.S. Government Printing Office]
S. Hrg. 108-844
CLONING: A RISK TO WOMEN?
SUBCOMMITTEE ON SCIENCE, TECHNOLOGY AND SPACE
COMMITTEE ON COMMERCE,
SCIENCE, AND TRANSPORTATION
UNITED STATES SENATE
ONE HUNDRED EIGHTH CONGRESS
MARCH 27, 2003
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SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
ONE HUNDRED EIGHTH CONGRESS
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
Hearing held on March 27, 2003................................... 1
Statement of Senator Brownback................................... 1
Bruchalski, Dr. John T., Obstetrician and Gynecologist, Fairfax,
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
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
Subcommittee on Science, Technology, and Space,
Committee on Commerce, Science, and Transportation,
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
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,
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
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
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
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
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
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
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
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.
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
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\
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
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
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\
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
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.
\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.
\6\ Physicians' Desk Reference 2003, Thompson, 3119-3136.
\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.
\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
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.
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
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
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
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
I would like to ask that these reports and statement be
entered into the record.
Senator Brownback. Without objection, they will be in the
* 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
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
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
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
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
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
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
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
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
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
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
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.
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
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
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
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----
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
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
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,
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
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----
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----
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
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. 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----
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,
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
Senator Brownback. I understand, but do we not normally----
Dr. Bustillo. Yes, and I----
Senator Brownback. We are talking about therapeutic cloning
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
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
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
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
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
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
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
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
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----
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
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
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
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
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
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
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----
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
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
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
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
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
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
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
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
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
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
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
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.
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
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
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
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
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
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
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
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-
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
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
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
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
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
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;
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.
Senator Brownback. Thank you, Mr. Kimbrell.
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
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
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
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 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
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
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
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
\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
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
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
\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''
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,
\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
\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
(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
\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
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
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
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
\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
(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
\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/
\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/
\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
\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
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
3. Effectively attacks the threat of ``reproductive cloning''
at its root, by preventing the production of cloned human
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
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
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,
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
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
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
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,
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--
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--
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
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
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
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;
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
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
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,
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,
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, 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.''
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,
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.''
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
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,
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
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
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.''
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
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.''
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
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
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
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
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
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''
``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-
``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
``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 . . .
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,
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
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;
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
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
M:male contraception; `male' factor infertility (female is
treated--male is not); Meniere's Disease; menstrual migraines; motility
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
U:urinary retention in prostate cancer; ureteral obstruction caused
by endometriosis; urinary retention due to benign prostatic
W:with or without medroxyprogesterone in treatment of fibroids.
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
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
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
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,
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
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
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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
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
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,
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.
Ms. Charo. But putting that aside--and I say that with
respect and affection, because Richard and I have dealt with
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
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
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
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,
Senator Brownback. What is the----
Ms. Charo. This would be one----
Senator Brownback. What is the patient population going to
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
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
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
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
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
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
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!
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
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.
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. . .
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
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
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
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
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
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
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
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
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
Prepared Statement of Lisa A. Plante, former U.S. Congressional staff
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
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
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!
PS: Please be advised I have my test results and all records
proving everything said in above statement.