[House Hearing, 108 Congress]
[From the U.S. Government Printing Office]





BALANCING ACT: THE HEALTH ADVANTAGES OF NATURALLY-OCCURRING HORMONES IN 
                      HORMONE REPLACEMENT THERAPY

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

                                HEARING

                               before the

               SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS

                                 of the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION

                               __________

                             JULY 22, 2004

                               __________

                           Serial No. 108-249

                               __________

       Printed for the use of the Committee on Government Reform


  Available via the World Wide Web: http://www.gpo.gov/congress/house
                      http://www.house.gov/reform


                                 ______

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                     COMMITTEE ON GOVERNMENT REFORM

                     TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana                  HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut       TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana              CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California                 DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky                  DANNY K. DAVIS, Illinois
JO ANN DAVIS, Virginia               JOHN F. TIERNEY, Massachusetts
TODD RUSSELL PLATTS, Pennsylvania    WM. LACY CLAY, Missouri
CHRIS CANNON, Utah                   DIANE E. WATSON, California
ADAM H. PUTNAM, Florida              STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia          CHRIS VAN HOLLEN, Maryland
JOHN J. DUNCAN, Jr., Tennessee       LINDA T. SANCHEZ, California
NATHAN DEAL, Georgia                 C.A. ``DUTCH'' RUPPERSBERGER, 
CANDICE S. MILLER, Michigan              Maryland
TIM MURPHY, Pennsylvania             ELEANOR HOLMES NORTON, District of 
MICHAEL R. TURNER, Ohio                  Columbia
JOHN R. CARTER, Texas                JIM COOPER, Tennessee
MARSHA BLACKBURN, Tennessee          BETTY McCOLLUM, Minnesota
PATRICK J. TIBERI, Ohio                          ------
KATHERINE HARRIS, Florida            BERNARD SANDERS, Vermont 
                                         (Independent)

                    Melissa Wojciak, Staff Director
       David Marin, Deputy Staff Director/Communications Director
                      Rob Borden, Parliamentarian
                       Teresa Austin, Chief Clerk
           Phil Barnet, Minority Chief of Staff/Chief Counsel

               Subcommittee on Human Rights and Wellness

                     DAN BURTON, Indiana, Chairman
CHRIS CANNON, Utah                   DIANE E. WATSON, California
CHRISTOPHER SHAYS, Connecticut       BERNARD SANDERS, Vermont 
ILEANA ROS-LEHTINEN, Florida             (Independent)
                                     ELIJAH E. CUMMINGS, Maryland

                               Ex Officio

TOM DAVIS, Virginia                  HENRY A. WAXMAN, California
                      Mark Walker, Chief of Staff
                Mindi Walker, Professional Staff Member
                        Danielle Perraut, Clerk
          Richard Butcher, Minority Professional Staff Member


                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on July 22, 2004....................................     1
Statement of:
    Alving, Barbara, M.D., Acting Director, National Heart, Lung, 
      and Blood Institute, National Institutes of Health, U.S. 
      Department of Health and Human Services....................    10
    Fugh-Berman, Adriane, M.D., associate professor, Department 
      of Physiology and Biophysics, Georgetown University School 
      of Medicine; David Brownstein, M.D., Center for Holistic 
      Medicine; Carol Petersen, managing pharmacist, Women's 
      International Pharmacy; Vicki Reynolds, owner, Texas 
      Reliant Air-Conditioning and Heating, Inc.; and Steven F. 
      Hotze, M.D., Hotze Health and Wellness Center..............    29
Letters, statements, etc., submitted for the record by:
    Alving, Barbara, M.D., Acting Director, National Heart, Lung, 
      and Blood Institute, National Institutes of Health, U.S. 
      Department of Health and Human Services, prepared statement 
      of.........................................................    14
    Brownstein, David, M.D., Center for Holistic Medicine, 
      prepared statement of......................................    41
    Burton, Hon. Dan, a Representative in Congress from the State 
      of Indiana, prepared statement of..........................     5
    Fugh-Berman, Adriane, M.D., associate professor, Department 
      of Physiology and Biophysics, Georgetown University School 
      of Medicine, prepared statement of.........................    32
    Hotze, Steven F., M.D., Hotze Health and Wellness Center, 
      prepared statement of......................................    69
    Petersen, Carol, managing pharmacist, Women's International 
      Pharmacy, prepared statement of............................    57
    Reynolds, Vicki, owner, Texas Reliant Air-Conditioning and 
      Heating, Inc., prepared statement of.......................    62

 
BALANCING ACT: THE HEALTH ADVANTAGES OF NATURALLY-OCCURRING HORMONES IN 
                      HORMONE REPLACEMENT THERAPY

                              ----------                              


                        THURSDAY, JULY 22, 2004

                  House of Representatives,
         Subcommittee on Human Rights and Wellness,
                            Committee on Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2:30 p.m., in 
room 2154, Rayburn House Office Building, Hon. Dan Burton 
(chairman of the subcommittee) presiding.
    Present: Representatives Burton and Watson.
    Staff present: Mark Walker, chief of staff; Mindi Walker, 
Brian Fauls, and Dan Getz, professional staff members; Nick 
Mutton, press secretary; Danielle Perraut, clerk; Sarah 
Despres, minority counsel; Richard Butcher, minority 
professional staff member; and Cecelia Morton, minority office 
manager.
    Mr. Burton. First of all, I want to apologize for my 
tardiness. We were supposed to start at 2:30, but we've had a 
very involved, contentious hearing down in the committee room. 
And I've learned something after 22 years, and that is that the 
last week of the session before we go out on the August break, 
you shouldn't have a hearing. Because it's absolutely a 
madhouse around here. We've got a lot of votes and a lot of 
things going on.
    Good afternoon. A quorum being present, the Subcommittee on 
Human Rights and Wellness will come to order.
    I ask unanimous consent that all Members and witnesses' 
written and opening statements be included in the record. 
Without objection, so ordered.
    I ask unanimous consent that all articles, exhibits and 
extraneous or tabular materials referred to be included in the 
record, and without objection, so ordered.
    And in the event that other Members attend the hearing that 
are not on the committee, I ask unanimous consent that they be 
permitted to serve as a member of the subcommittee for today's 
hearing. And without objection, so ordered.
    We're convening today to examine the health benefits of 
using natural hormones in hormone replacement therapy.
    As you might know, millions of American women are 
prescribed synthetic hormones by their doctors to assist with 
the decreasing levels of estrogen and progesterone in their 
bodies experienced during menopause as well as other hormonal 
fluctuations that might occur. It might be surprising to note 
that many men in the United States are administered 
testosterone for similar decreases in hormonal levels during 
the aging process, which progresses at a similar rate as 
menopause, called andropause.
    While the declining concentrations of hormones in the body 
is entirely normal, hormone replacement therapy should not be 
undervalued as a highly effective medical treatment. It not 
only balances the hormone level within a patient, but it also 
serves as a preventative measure to ward off potential health 
risks associated with imbalanced hormones such as osteoporosis 
and the No. 1 cause of death in the United States, heart 
disease.
    Because naturally occurring substances cannot be patented 
in the United States, pharmaceutical companies must somehow 
manipulate hormones with additional chemicals in order to be 
able to hold the manufacturing rights of these formulas.
    Since pharmaceutical companies must mass produce these 
synthetic hormones according to the formulations covered by a 
patent, they are only offered in certain doses as a ``one size 
fits all'' solution to hormonal imbalances. This results in 
many American women and men being administered either too much 
or too little of the hormones they need to properly address 
their wellness needs, thus creating the potential for further 
health complications.
    Even more concerning is the nature of the synthetic 
hormones. Because natural hormones must be manipulated by 
chemicals in order to be patented, the body does not recognize 
some of the components of the synthetic hormones, which causes 
some serious and potentially life-threatening side effects.
    In 1991, the National Institutes of Health [NIH], launched 
the ``Women's Health Initiative,'' one of the largest studies 
on hormone replacement therapy ever initiated in the United 
States. This clinical trial observed 16,608 postmenopausal 
women who received estrogen and progestin therapy or a placebo, 
as well as 10,739 women who had a hysterectomy and were given 
estrogen alone or a placebo. This study was supposed to 
continue until 2005; however, it was ceased in July 2002 
because the NIH's Data and Safety Monitoring Board found an 
increased risk of breast cancer, heart attacks, strokes and 
total blood clots.
    This information is especially sobering to me, as it has 
devastated my family forever. Barbara, my wife, was taking 
synthetic hormones when she contracted breast cancer that 
eventually, at least in part, took her life. And I firmly 
believe that her overall health and quality of life 
deteriorated because she was taking those doctor-prescribed 
hormones. Of course, at the time, we didn't know that.
    There is an alternative to the mass produced and chemically 
altered hormones, and these are called biologically identical 
or natural hormones. Essentially, there are entities known as 
compounding pharmacies that are smaller scale operations to 
pharmaceutical companies that produce medicines more 
specialized to accommodate a wide variety of patients, rather 
than the one size fits all approach to manufacturing hormones.
    These compounding pharmacies are located around the country 
and have the capacity to concoct natural, plant-based hormone 
medications for use in hormone replacement therapy. Because 
these biologically identical hormones are the same chemical 
structure as the hormones created in the body, the body does 
not have the same harmful reactions as it does when the 
synthetic hormones are administered.
    To better explain the health benefits of naturally 
occurring hormones, as well as the operation of compounding 
pharmacies, the subcommittee will have the pleasure of hearing 
from Dr. Steven Hotze, a physician and founder of the Hotze 
Health and Wellness Center located in Houston, TX. Dr. Hotze's 
practice specializes in using biologically identical hormones 
to assist both men and women correct hormonal imbalances. To 
gain a better perspective into the benefits of natural hormones 
in hormone replacement therapy, Ms. Vicki Reynolds, a patient 
of Dr. Hotze's, is here with us today to share her personal 
experience.
    In addition, the subcommittee will hear testimony from Ms. 
Carol Petersen with the Women's International Pharmacy, to 
discuss the operations of compounding pharmacies in the United 
States.
    Dr. David Brownstein is with us as well to discuss the 
further benefits of using natural hormonal therapy to combat 
hypothyroidism. Dr. Brownstein has written a number of books on 
this subject and is considered one of the foremost experts in 
the field of holistic medicine. The doctor also serves as the 
medical director at the Center for Holistic Medicine.
    While many physicians believe that administering their 
patients hormones, whether synthetic or natural, is a 
beneficial tool to assist with hormonal transitions, there are 
some doctors who contend that scientific literature shows that 
these tactics are not necessarily the healthiest option for 
patients. In order to explain this viewpoint, the subcommittee 
will hear testimony from Dr. Adriane Fugh-Berman, an associate 
professor with the Department of Physiology and Biophysics at 
Georgetown University. Dr. Fugh-Berman is internationally known 
as an expert in the scientific evaluation of alternative 
medicine, as well as nationally recognized expert on the topic 
of women's health.
    The U.S. Federal Government has produced many studies and 
has approved various drugs to assist in hormone replacement 
therapy. The subcommittee has the distinct pleasure of hearing 
from Dr. Barbara Alving, who is married to a Hoosier, is that 
what you told me?
    Dr. Alving. No, I'm the Hoosier.
    Mr. Burton. You're the Hoosier? Where are you from?
    Dr. Alving. Fort Wayne, IN.
    Mr. Burton. That's right on the edge of my district, so God 
bless you, my child. [Laughter.]
    Dr. Alving. My brother lives in Indianapolis.
    Mr. Burton. What part?
    Dr. Alving. The south part.
    Mr. Burton. Oh, well, he may not be able to vote for me, so 
I'll have to pass on him. [Laughter.]
    She's the Acting Director of the National Heart, Lung and 
Blood Institute at the Department of HHS, and she will give an 
overview of the Department's activities in regard to this 
issue.
    I look forward to hearing from all of you today. And once 
again, since we started late, we'll get started right away with 
you, Dr. Alving. We appreciate your being here.
    [The prepared statement of Hon. Dan Burton follows:]

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 STATEMENT OF BARBARA ALVING, M.D., ACTING DIRECTOR, NATIONAL 
   HEART, LUNG, AND BLOOD INSTITUTE, NATIONAL INSTITUTES OF 
      HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Alving. Thank you, Mr. Chairman. I'm pleased to appear 
before this committee in my capacity not only as the Acting 
Director of the National Heart, Lung and Blood Institute, but 
also Director of the NIH's Women's Health Initiative. I have 
been the Director of this since 2002. This was after the first 
paper was released on the role of Prempro in protection against 
heart disease. The Women's Health Initiative, however, has been 
administered by my institute since 1997.
    So I'm first here to tell you what we've learned from the 
WHI, with regard to hormone therapy, using conjugated equine 
estrogen, and second, to comment on alternative therapies that 
are now receiving attention. The WHI began in 1991 and the 
purpose was to really investigate approaches that might be 
helpful to older women in preventing common chronic diseases, 
particularly coronary heart disease and also to determine if 
this would increase the risk for breast cancer, alter the risk 
for colorectal cancers and have an effect on osteoporosis.
    Estrogen replacement was just one such approach. For much 
of the 20th century, popular thinking was that restoring the 
levels of estrogen which ebb during middle age would enable 
women to remain forever young. And we're still trying on that 
end. Although estrogen was initially prescribed to alleviate 
troublesome menopausal symptoms, a number of observational or 
epidemiologic studies really suggested that women who took 
estrogen experienced a lower incidence of chronic diseases, 
particularly heart disease, and enjoyed better health overall 
than women who did not take prolonged hormone therapy. And data 
from many basic science investigations really provided 
explanations for how this might occur.
    But we really didn't have actual proof that this was the 
case. So in 1991, a very bold woman, Dr. Bernadine Healy, said 
it's time to really initiate a very large scale study. So the 
Women's Health Initiative hormone trial was designed to answer 
these questions. And remember, this was before the era of 
statins and other therapies that have been widely accepted in 
this current era.
    So as you've said, the Women's Health Initiative recruited 
about 27,000 healthy postmenopausal women of 50 to 79 years of 
age. This age group was recruited because this is the age at 
which one would begin to see cardiovascular events and other 
adverse effects. And these women were divided into one of two 
groups, depending on whether or not they had undergone a 
hysterectomy. Those who still had a uterus were assigned to 
take a pill containing estrogen and progestin. This was 0.625 
milligrams of conjugated equine estrogen, plus 2.5 milligrams 
of medroxyprogesterone acetate, also known as Prempro, or a 
placebo. And those who had undergone a hysterectomy took 
Premarin, 0.625 milligrams of conjugated equine estrogen or a 
placebo.
    And you may say, well, why those drugs? Why those doses? 
These drugs were the most widely used at this time in the 
United States. So it was decided that not all doses and not all 
different combinations could be studied. So this was the one 
that was accepted for study.
    It's worth noting that there was a lot of controversy at 
the beginning of this trial. Many interested parties said the 
trial should not be done, it's obvious that hormone therapy is 
beneficial, it's a foregone conclusion. Some even said it was 
not ethical to do, because it would take half of the 
participating women to take placebos and thereby deny them the 
positive effect of hormones.
    Nonetheless, the arguments in favor of a randomized placebo 
controlled clinical trial prevailed, so now as we know, we've 
seen results. The WHI trial of estrogen plus progestin was 
halted in 2002, as you have said, Mr. Chairman, after an 
average followup of 5.2 years. Compared with women who took a 
placebo, women taking the hormones of Prempro or estrogen plus 
progestin experienced an increased risk of breast cancer and 
more episodes of heart attacks, strokes and blood clots. 
However, they also had lower rates of colo-rectal cancer and 
fractures. But it was felt that overall, this did not merit 
using this drug as protection against chronic disease.
    And furthermore, an ancillary study, that is a study that 
really hadn't been included in the beginning but was sort of 
added on, well, which actually was funded by the manufacturer, 
Wyeth funded this study initially in women 65 years and older 
who were in this study were tested for cognitive effects of 
Prempro. Surprisingly enough, it was found that in these older 
women, there was an increased risk of dementia and no really 
improvement of cognitive impairment with the taking of Prempro. 
This too was a very big surprise because there had been papers 
suggesting that Prempro could actually be protective against 
cognitive impairment.
    Subsequently, in the spring of 2004, the estrogen alone 
trial, which the DSMB, or Data Safety Modern Board have said 
should be continued was halted, because the NIH, on looking 
over all of the data and in listening to the DSMB, felt that 
there was really no effect on coronary heart disease, that is, 
there was no benefit or risk but there was a continued 
increased risk for stroke. What was also interesting with the 
estrogen alone study was that there did not appear to be any 
increased risk for breast cancer during the time of this study. 
There was, however, an increased risk of deep venous 
thrombosis, and there was a reduced risk of hip and other 
fractures.
    And again, finding from the cognitive study in women taking 
estrogen alone revealed that really, estrogen did not reduce 
the incidence of dementia and really did not have any 
improvement, in fact had an adverse effect on cognitive 
function.
    So in light of the WHI findings and the findings from the 
dementia studies, the Food and Drug Administration provided the 
following update in April 2004. Estrogens and progestins should 
not be used to prevent chronic diseases, such as memory loss, 
heart disease, heart attacks or stroke. Estrogens provide 
valuable therapy for many women for menopausal hot flashes. But 
they do carry risks. And therefore, menopausal women who are 
considering using estrogen or estrogen with progestin should 
discuss with their physicians the benefits versus risks and for 
hot flashes and significant symptoms of vulvar and vaginal 
atrophy, the products are approved and effective therapies.
    There are also approved for women whose significant risk of 
osteoporosis outweighs the potential adverse effects and if 
they cannot other drugs that are approved for postmenopausal 
osteoporosis. And then the FDA said, estrogens and progestins 
should be used, when they're used, at the lowest doses for the 
shortest duration to reach treatment goals. Although we do not 
know at what dose there may be a less risk of serious side 
effects and that women indeed are encouraged to talk to their 
health care provider regularly about their ongoing treatment.
    There's also in women who take hormone therapy a higher 
incidence of abnormal mammograms which require medical 
attention and really need to be evaluated in greater detail 
when those abnormalities do occur. Therefore, each woman's 
individual medical situation needs to be carefully discussed 
with her health care provider to make the best decisions.
    Now, for prescription hormone formulations other than those 
studied in the WHI, the FDA advises, although other estrogens 
and progestins were not studied, it's important to tell 
postmenopausal women who take hormone therapy about the 
potential risks which are assumed to be the same for other 
products, and they have put these labels on those products.
    In the aftermath of the Women's Health Initiative finding, 
increased attention has been focused on the use of 
complementary and alternative medicine to manage symptoms 
associated with the menopausal transition. This includes 
dietary supplements, botanicals, which are probably the most 
commonly used. The National Center for Complementary and 
Alternative Medicine supports both basic and clinical research 
on the safety and efficacy of botanicals such as soy, black 
cohosh and red clover in alleviating hot flashes, osteoporosis 
and cognitive and affective problems.
    Other studies are generating laboratory data that are vital 
to the understanding of the mechanism of action and 
characterizing these botanicals to identify the active 
ingredients in the botanicals so that standardized supplements 
can be prepared. For example, two ongoing basic studies are 
looking at the effect of black cohosh extract on human breast 
tissue and its role as a serotonin modulator and other research 
is looking at the effect of soy on breast and endometrial 
tissue, as well as on bone. In addition to individual research 
project grants, the National Center for Complementary and 
Alternative Medicine supports several research centers on 
women's health.
    The National Institute of Aging is supporting a 4-year 
randomized control trial to evaluate the efficacy and safety of 
phytoestrogen based approaches, such as black cohosh and multi-
botanical preparations given with and without soy diet 
counseling for treating vasomotor symptoms in premenopausal and 
in postmenopausal women. The toxicity of black cohosh and other 
herbals and phytoestrogens is being evaluated by the National 
Institute of Environmental Health Sciences as a part of an 
overall effect to establish the safety of herbal medicines.
    The scientific literature on complementary and alternative 
medicines is equivocal, due to problems of very small trials, 
short duration of treatment, very large placebo effects and 
very imprecise measures for measuring hot flashes. 
Investigations of the efficacy of soy to treat cognitive 
changes has produced conflicting results. Now, the NCCAM, 
National Center for Complementary and Alternative Medicine, has 
contracted with the Agency for Health Care Research and Quality 
to conduct and review and to assess the literature to provide a 
clearer idea of what is known about soy.
    Clearly, additional research will be needed to provide the 
safety and efficacy of the information on the range of these 
alternative modalities. And the NIH is working with other 
institutes all together in this area, as well as with the FDA 
and the women's health component of the Department of Health 
and Human Services. Also, there are studies on assessing hot 
flashes, what is the biology behind the hot flashes and in 
March 2005, the NCCAM, National Institute of Aging and other 
institutes will co-sponsor a state of the science meeting on 
the management of menopausal related symptoms.
    So women are eagerly awaiting the outcome of Federal 
efforts to uncover new approaches to address the menopausal 
symptoms. And in discussions with gynecologists, we know that 
women also are seeking natural or biologically identical 
hormone therapies via entities such as the Women's Health 
International Pharmacy. In addition, the FDA has been very 
proactive in the approval of additional hormone therapy since 
the ending of the Women's Health Initiative. For example, lower 
doses of Premarin are now available as well as Prempro. And 
most recently, a drug known as Menotestam has just been 
approved by the FDA. This is an estrogen patch.
    So some of what the FDA has approved is biologically 
identical and other components are not. I thought that all of 
this was very well laid out on the Web site of the Women's 
International Pharmacy.
    So I thank you for the opportunity to address you, and I'd 
be pleased to answer any questions.
    [The prepared statement of Dr. Alving follows:]

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    Mr. Burton. Thank you very much.
    I heard you mention there were studies on dementia.
    Dr. Alving. Yes.
    Mr. Burton. Who conducted those studies? Was that the FDA?
    Dr. Alving. No. The investigators in the Women's Health 
Initiative conducted those studies.
    Mr. Burton. What company sponsored those studies?
    Dr. Alving. Actually, one of the principal investigators 
received funding from Wyeth to do----
    Mr. Burton. OK, that's all I wanted to know. A 
pharmaceutical company. That's all I wanted to know.
    Dr. Alving. However, they switched the funding after that.
    Mr. Burton. I know. Did you know, Doctor, that they've been 
putting mercury in vaccines, which is another subject----
    Dr. Alving. Yes.
    Mr. Burton [continuing]. Since 1929. Do you know the FDA 
has never tested it, ever? And yet our kids are getting up to 
26 vaccinations before they start to school? And they've been 
containing mercury, and we've gone from 1 in 10,000 children 
that were autistic to 1 in 166? An absolutely epidemic. And the 
FDA never really tested it.
    What I'd like to know about estrogen is, why did it take so 
long to do these tests? They've been giving synthetic estrogen 
for how many years?
    Dr. Alving. I think they were probably developed, maybe in 
the last, about 40, 45 years old.
    Mr. Burton. Did the FDA test those?
    Dr. Alving. In terms of tests such as the Women's Health 
Initiative?
    Mr. Burton. Yes.
    Dr. Alving. They did not. And I think really the only----
    Mr. Burton. You don't need to go into detail. They didn't 
do it?
    Dr. Alving. As far as I know, they did not.
    Mr. Burton. And they just conducted a test in 1991?
    Dr. Alving. They started it in 1991.
    Mr. Burton. And the tests showed that the people who had 
the estrogen had higher rates of heart disease and what else 
was it?
    Dr. Alving. Well, if you look at Prempro or estrogen plus 
progestin, it was a higher rate of heart disease and breast 
cancer and stroke, blood count.
    Mr. Burton. This they found after 40 years?
    Dr. Alving. Five years.
    Mr. Burton. But they've been using it for 35 or 40 years?
    Dr. Alving. Yes.
    Mr. Burton. What do we pay those people for over there? I'm 
not being facetious. I mean, because they're getting billions 
and billions and billions of dollars and they are still putting 
mercury in almost every vaccination for adults and we have a 
tremendous increase in Alzheimer's. My grandson got autism 
after getting nine shots in 1 day, seven of which contained 
mercury. We've got an epidemic in that. And now we're finding 
out that the synthetic estrogen caused problems probably more 
than it helped.
    Now, you said they've gone to lower doses of some of these 
estrogen products, right? Those are still the synthetics, 
aren't they?
    Dr. Alving. Yes, lower doses have been approved by the FDA.
    Mr. Burton. OK, they've been approved. Have they tested 
those lower doses?
    Dr. Alving. No.
    Mr. Burton. Oh, my God. Do you mean to tell me they had a 
test, then went 5 years, and it showed that people were getting 
sicker by using the stuff, and so they went to lower doses? 
Why? If it's causing more problems than it's solving, why not 
take it off the market until they do all the testing? Until 
they test lower doses, higher doses, middle doses? It makes no 
sense.
    Do you know why they didn't? I want to tell you why they 
didn't. I know why. Because the pharmaceutical companies would 
lose a lot of money. Just like they would lose a lot of money 
if they took mercury out of all the vaccines.
    Do you know, and I want you to hear all this, because I 
want you to take it back to FDA and HHS. The NIH, I think it 
was, just completed a study saying that the mercury in 
children's vaccines and adult vaccines really didn't cause any 
problems. One of the principal studies that they cited was from 
Denmark. And the company in Denmark that did the study 
manufactures thimerosal, which is 50 percent mercury, and they 
sell it into the United States.
    Would you say they have a conflict of interest? Hell, I 
would think so.
    Anyhow, the NIH and HHS and the other agencies over there 
are too tied to the pharmaceutical industry and it's going to 
come up and bite them in the butt one of these days. It really 
is. Because the American people are finding this out.
    Now, why in the world they're going with lower doses of a 
product that caused women's problems like high blood pressure, 
heart attacks, whatever else you mentioned there, I don't have 
it all in front of me right now, why in the world they would 
even continue to do that instead of taking it off the market 
until it's properly tested boggles my mind. And the only 
conclusion you can come to is the pharmaceutical companies 
would take a hit. And they don't want to do that. They just 
don't want to do that.
    Can you give me another answer?
    Dr. Alving. Yes.
    Mr. Burton. What's the other answer? I'd like to hear it.
    Dr. Alving. I think you make some very good points. I think 
what women want hormone therapy for most, if you ask any woman 
of a certain age in this room, is for hot flashes, for the 
symptoms of menopause.
    Mr. Burton. Well, I date some women about your age, and I 
want to tell you, they take them for other reasons, too. 
[Laughter.]
    Dr. Alving. And so, I think that what the, we are unable to 
really, we'd have to wait another 5, 10 years go get the answer 
on these hormones. So what has been asked in the meantime is to 
take the lowest dose for the shortest period of time, and the 
FDA has put this type of branding and warning on every product, 
whether it's bioidentical or not.
    Mr. Burton. But these are still the synthetic hormones, are 
they not?
    Dr. Alving. No, they put the branding also on the 
bioidenticals.
    Mr. Burton. Oh. Well, you said that the FDA was evaluating 
the safety of herbal medicines now, didn't you?
    Dr. Alving. I said the NIH, because the FDA has not 
approved any herbal medicines. It is not under FDA approval. 
They do not regulate them.
    Mr. Burton. Does the FDA have to approve herbals?
    Dr. Alving. No, they don't.
    Mr. Burton. But they do have to approve the synthetics?
    Dr. Alving. Well, anything that is made by a drug company, 
yes.
    Mr. Burton. So the synthetics that have been causing all 
these health side effects, they have to approve but they never 
tested until just recently. And the herbals, I noticed the way 
you phrased that, you said that HHS is looking at the safety of 
the herbal medicines.
    Why didn't they look at the safety of the biologically 
altered medicines that they've been prescribing for years, 
doctors have? I wonder why they didn't do that earlier?
    Dr. Alving. That would be in the province of the NIH to 
conduct the clinical trials. And I think that this was then 
started in 1991, and as I've told you even then it was 
considered to be a very brave undertaking.
    Mr. Burton. In 1991?
    Dr. Alving. Yes.
    Mr. Burton. But the women who didn't take the hormones, 
synthetic hormones, did better over all the ones that didn't?
    Dr. Alving. That's correct.
    Mr. Burton. Oh, man.
    Dr. Alving. Well, it all depends on what you're talking 
about.
    Mr. Burton. Let's just look at overall health.
    Dr. Alving. Overall, I would say yes, that's why the trial 
was stopped.
    Mr. Burton. Yes, they did a lot better if they didn't take 
the synthetics.
    Dr. Alving. Absolutely. And that's why the trial was 
stopped.
    Mr. Burton. And synthetics have been used for 40 some 
years, approximately.
    Dr. Alving. Yes.
    Mr. Burton. And they started testing them 10 years ago?
    Dr. Alving. Yes.
    Mr. Burton. And HHS and FDA let that happen. What are we 
paying them for over there? I just don't understand it.
    I still can't understand why they went to lower doses of a 
product that was causing all of these health side effects. I 
just can't understand it. Do they know? Does HHS and FDA and 
our health agencies, do they know that the smaller doses won't 
produce the same side effects?
    Dr. Alving. They do not know that.
    Mr. Burton. Then why do they do it?
    Dr. Alving. Because what they've also done, what they have 
seen is that these side effects occur over a period of time. 
And that's why they have said, in the absence of knowing, we 
are going to tell all women about these risks at whatever dose, 
even though we don't know if it's safer or better, but we're 
going to let them know the risks and we're going to say, use it 
the shortest period of time at the lowest possible dose.
    Mr. Burton. You know, in a perfect world, every doctor in 
the country, in the world, would know what the HHS and FDA are 
saying should be done. But they don't. They don't read all the 
circulars and they don't see all this stuff. When my wife was 
dying of cancer, I talked to doctors about the things that were 
talked about in medical journals and they didn't know anything 
about it. We changed doctors, but it was too late, she died 
anyhow.
    But it just boggles my mind that you would go on with lower 
doses of a substance that's caused all these problems when you 
know that they cause severe side effects and you knew that 
women that didn't even take the stuff did better health-wise, 
so you go to lower doses. Then the doctors back at my hometown 
and elsewhere are supposed to understand all this when they've 
been out of medical school for 10, 15 years. I just don't get 
it.
    And I don't understand why they haven't done studies on the 
herbals right now. Why hasn't HHS conducted a study on 
biological hormones, bioidentical hormones? If they did a study 
on the synthetics, why didn't they do it on those?
    Dr. Alving. I think the reason that they chose, as I said, 
that dose and that particular drug at that particular time in 
1991 was that is what the majority of American women who were 
taking hormone therapy were taking.
    Mr. Burton. Well, this is 2004.
    Dr. Alving. Yes, and times have changed.
    Mr. Burton. That was 13 years ago.
    Dr. Alving. I know. Times have changed.
    Mr. Burton. Why haven't they started testing on these 
bioidentical hormones that aren't from pigs and cows and all 
this other stuff?
    Dr. Alving. I think if the funding were available----
    Mr. Burton. If the funding--do you know how much money we 
give you guys over there? Do you have any idea? We give you 
billions and billions and billions and every year you want 
more. And we've got women who are getting sicker than a dog and 
some probably dying from something that was never tested. And 
then what you say after you find out that the stuff that you 
were putting in their bodies was causing more problems than if 
they didn't take it at all, you say, oh, we're going to go back 
and we're going to just cut the doses, instead of saying, why 
not just get off of it or go on these bioidentical hormones, or 
at least study them? And you haven't even started to study on 
them, have you, the bioidentical hormones?
    Dr. Alving. They have not started any long terms studies in 
terms of women's health as an issue.
    Mr. Burton. Have you started any short term studies?
    Dr. Alving. The bioidenticals that have received FDA 
approval have undergone short term studies.
    Mr. Burton. What do they show?
    Dr. Alving. They are looking for efficacy against hot 
flashes and any adverse effects that could be picked up on a 
short term study.
    Mr. Burton. I see. Are they showing any side effects at all 
like the long term study that we showed with the synthetics?
    Dr. Alving. Not that I am aware of. And that would be for 
the labeling of the FDA.
    Mr. Burton. If they did a short term study, why didn't they 
decide to go on with a long term study? If the short term study 
was beneficial, why not go with a long term study to find out 
their side effects?
    Dr. Alving. I think one of the issues is that of cost and 
duration. One would have to continue such a study for about 10 
years----
    Mr. Burton. Well, if you did it with synthetics and you 
knew it didn't work and it cost a lot of money to do that 
study, why wouldn't you say, OK, we're going to spend a like 
amount on the bioidentical hormones? Why?
    Dr. Alving. May I say why?
    Mr. Burton. Yes, I'd like to know. I think I know why. It's 
because the pharmaceutical companies won't make any money off 
of it.
    Dr. Alving. What I would say is that what it appears is 
that the reason one would take hormones long term is to prevent 
chronic diseases. Most women take hormone therapy for about 5 
years or less. And they take it for menopausal symptoms. Since 
this study was started in 1991, newer drugs have come out. For 
example, we have other drugs that will protect against 
osteoporosis.
    Mr. Burton. Are they synthetics?
    Dr. Alving. I'm talking about other drugs against 
osteoporosis, the bisphosphonates, for example. We have other 
drugs for heart disease, statins.
    Mr. Burton. Have those been tested, the ones that you're 
talking about that just came out?
    Dr. Alving. Well, yes. In terms of risks and benefits, and 
all of them have----
    Mr. Burton. No, no, no. Have they had any long term tests 
with placebos and all that?
    Dr. Alving. As long term as the FDA requires.
    Mr. Burton. And how long is that?
    Dr. Alving. I think, I am going to say at least 3 to 4 to 
up to 10 years. I would have to go back and look at that 
literature to get the specific literature.
    So what I'm trying to say is that there has been a changing 
of the landscape in terms of the drug therapies. Some women 
don't even want to take hormone therapy at all----
    Mr. Burton. I wouldn't either.
    Dr. Alving [continuing]. And don't have hot flashes.
    Mr. Burton. You say they've got these for men. There ain't 
no way, Jose, I'm going to take that stuff. You guys over there 
are using human beings as guinea pigs without testing them. 
You're a lovely lady, but this, it really isn't right. It isn't 
right to run a study after 40 years or 30 years and then find 
out that the people who are taking the medicine that the 
pharmaceutical companies are producing are doing worse than the 
ones that aren't taking it. Then what you say instead of 
stopping it is, OK, we're going to go to lower doses.
    That's like saying, OK, one bullet won't kill you, so we'll 
cut it in two and just use half a bullet.
    Dr. Alving. It will half kill you.
    Mr. Burton. Yes, it will half kill you. Let me ask you 
this. Is the National Center for Complementary and Alternative 
Medicine looking at bioidentical hormones as a possible 
recommendation for FDA to suggest to women? Are they looking at 
that right now?
    Dr. Alving. They are not looking at that to my knowledge.
    Mr. Burton. Why? Why?
    Dr. Alving. Because they are centered on the other 
alternatives that are undergoing study that I mentioned.
    Mr. Burton. And the other alternatives are?
    Dr. Alving. As I mentioned, black cohosh and the 
flavonoids, phytoestrogens, other things such as that.
    Mr. Burton. Are those natural hormones?
    Dr. Alving. They're natural agents, in that you can buy 
black cohosh, it's extracted. Now, you don't know what else is 
in there, because it's not regulated by the FDA.
    Mr. Burton. Well, you know what, I really would want the 
one that's approved by the FDA because it would only kill me. 
[Laughter.]
    And I don't mean to be facetious, but since my grandson 
became autistic, I started checking into the things that FDA is 
putting on the market and the conflicts of interest that have 
taken place by some of the advisory committees over there who 
have an interest in pharmaceutical stocks that are making the 
decisions on this stuff. There's too much money and too much 
complicity between the pharmaceutical companies and our health 
agencies.
    And if you've got a study that shows that women are getting 
more heart disease, for instance, from taking these synthetic 
hormones than a woman who doesn't take any, that would lead you 
to believe they're better off not taking it. Wouldn't that lead 
you to believe you're better off not taking it?
    Dr. Alving. But I would make another----
    Mr. Burton. You can answer in just a second. And if that 
conclusion is accurate, why would you say, OK, we're going to 
cut the dose in half and you just take half the poison? Why?
    Dr. Alving. In the Women's Health Initiative, the women who 
were enrolled in the studies were between 50 and 79 years. The 
mean age was 63 years. In fact, it's been very highly 
criticized for that. When you do a study, as you can see, you 
get criticism from all sides.
    So one of the critics, a big criticism of this, you started 
this in women whose mean age is 63 years old. That's not who 
has hot flashes. Well, this was not a hot flash study. 
Currently, the FDA guidelines, and I don't work for the FDA, I 
work for NIH, are that these drugs are to be used for treatment 
of menopausal symptoms. And about the average age of women 
having menopausal symptoms is around 45 to 50. So you're 
getting a different age range.
    Mr. Burton. I hear you. I'm going to yield to Ms. Watson, 
but let me just say one more thing in conclusion. That is when 
my wife got breast cancer, and she took those damned hormones 
for years, those synthetics, we found, when we went to buy 
furniture, went to buy groceries, an absolute plethora of women 
who were having breast cancer problems. It is an epidemic. 
Women don't talk about it to people like me, but they'll talk 
about it to another woman who's experiencing breast cancer.
    And I want you to know, it's an epidemic. It's absolutely a 
sin. It's a sin. It's an absolute sin for our Government to 
approve things that we're putting into human bodies, especially 
women, of age 30, 50, 100 that hasn't been properly tested. And 
you say they don't have enough money over there. They have 
enough money. It's just where they set their priorities. And if 
they find out that the synthetic estrogen is causing women to 
have severe heart trouble and other problems, and the women who 
don't take it are doing much, much better, then why in the 
world would they not take it off the market?
    And the reason is the same reason that they haven't taken 
mercury out of vaccines. Mercury is one of the most toxic 
substances on the face of the Earth. When we had a spill in my 
district, they brought in people who looked like they were from 
outer space, in uniforms, to clean up a spill of this much. And 
they evacuated the neighborhood. And yet we're putting it into 
our kids' bodies, into your body, if you got a flu shot or a 
tetanus shot or anything else right now. And it's one of the 
contributing factors, according to scientists around the world, 
of autism and other neurological diseases, like Alzheimer's.
    Yet the FDA continues to let it be on the market. And at 
the same time, they're doing the same thing with estrogen, only 
in lower doses. And it is absolutely criminal. And that's being 
subsidized by me and you and the taxpayers, and nobody's doing 
a doggone thing about it. And it really bothers me.
    And you're a lovely lady, but we've got a problem.
    Go ahead, Ms. Watson.
    Ms. Watson. I want to thank Mr. Chairman for his passion, 
his interest, his concern. And we work together as a team. We 
both have an aversion to using these toxic substances in 
medication that's ingested by humans, and so I've always looked 
for a biological, natural kind of alternative.
    If you don't get anything else out of these hearings, Madam 
Colonel, just know that there is a directive to ask NIH and WHI 
to start research that will include the biological identical 
hormones. We are finding from casual information coming in that 
they are far more healthful and they have a far more beneficial 
way of treating. Because they're done on an individual basis.
    Dr. Alving. Yes.
    Ms. Watson. And not everything works for everyone.
    Dr. Alving. I understand that.
    Ms. Watson. So I wish that you would go back as an emissary 
of this approach. The women of the world will thank you, 
particularly the women here. And I as a woman definitely am 
going to push this with my partner here, who, and I don't have 
to explain to you how deeply he feels about this, I think 
you've been hearing it for quite a few minutes. And we're going 
to work as a team to be sure that we take the toxic substances 
out of the environment.
    My big thing right now is mercury. We're trying to get 
mercury out of dental amalgams and we're being fought by the 
dental community. And they say, well, it's sealed and so on. 
But you crack a tooth, vapors come up.
    So we have to change the thinking. We have to change the 
culture. And I hope that now that we're in a new millennium, 
the FDA can follow behind us a little bit in changing the 
culture. We certainly are going to be working toward that. And 
thank you, Mr. Chair. I'm going to zip to the floor.
    Mr. Burton. Well, Doctor, thank you very much. We didn't 
mean to abuse you. But the one thing I try to do when we have 
witnesses from HHS and our health agencies, FDA, is to try to 
impress upon them the strong feelings that we have in the 
Congress. And it's not just me. We've had a number of votes on 
the floor on reimportation and other things where the 
pharmaceutical companies are concerned. And they've been 
surprising in that the representatives of the people realize 
what's going on.
    I want to continue to give you guys billions of dollars. I 
really do. I think we have the highest quality and standard of 
life and health of any country on the face of the Earth, 
because we have good health agencies. But they drop the ball 
too many times. And they're allowing the pharmaceutical 
industry to have too much influence.
    I want the pharmaceutical industry to make a lot of money. 
But I don't want them to do it at the expense of people because 
we haven't tested these things properly. And I hope that you'll 
look at these complementary medical procedures, the hormones, 
the natural hormones we're talking about, we're going to have 
witnesses testify at the next panel. And incidentally, if 
you've got a minute, if you can stick around and listen to what 
they say, or have you already heard what they have to say?
    Dr. Alving. I'd be happy to stick around.
    Mr. Burton. OK, well, thank you very much for being here.
    Well, we have 10 minutes before we conclude our first vote. 
I think I probably ought to run over and vote and come back. I 
really apologize for the mess we've got today. What you're 
saying and doing is going to be recorded and passed onto my 
colleagues, and it's very important. So I hope you'll bear with 
me and stick around for a little bit. We'll be right back as 
soon as the votes are taken.
    [Recess.]
    Mr. Burton. First of all, I want to apologize once again. 
It's been a long day. But we want to get as much information 
from this hearing as possible. So we're going to be here as 
long as it takes.
    We now have Adriane Fugh-Berman. Would you come to the 
table, Dr. Fugh-Berman. And David Brownstein, Dr. Brownstein, 
he's the director of Holistic Medicine. Ms. Carol Petersen, 
pharmacist with the Women's International Pharmacy.
    Ms. Fugh-Berman is the assistant professor of physiology 
and biophysics at Georgetown Medical Center.
    Ms. Vicki Reynolds, hormone replacement therapy patient, 
Houston, TX. And Steven F. Hotze, Dr. Hotze, founder of the 
Hotze Health and Wellness Center.
    OK, we're going to start with Dr. Fugh-Berman. Since we 
have a pretty large panel, we'd like to get to questions as 
quickly as possible. So if you can keep your comments to 5 or 6 
minutes, we'd really appreciate it, if it's possible. Thank 
you.

 STATEMENTS OF ADRIANE FUGH-BERMAN, M.D., ASSOCIATE PROFESSOR, 
DEPARTMENT OF PHYSIOLOGY AND BIOPHYSICS, GEORGETOWN UNIVERSITY 
SCHOOL OF MEDICINE; DAVID BROWNSTEIN, M.D., CENTER FOR HOLISTIC 
    MEDICINE; CAROL PETERSEN, MANAGING PHARMACIST, WOMEN'S 
 INTERNATIONAL PHARMACY; VICKI REYNOLDS, OWNER, TEXAS RELIANT 
AIR-CONDITIONING AND HEATING, INC.; AND STEVEN F. HOTZE, M.D., 
                HOTZE HEALTH AND WELLNESS CENTER

    Dr. Fugh-Berman. Thank you, Mr. Chairman.
    I'm here today representing the National Women's Health 
Network, which is a consumer advocacy group that takes no money 
from drug companies, medical device companies or dietary 
supplement companies.
    Sex hormones, including estrogen and testosterone, do 
decline with age. But restoring hormone levels to youthful 
levels has not restored youth in anyone. But it's quite an old 
concept. It's actually more than 100 years old. Animal testicle 
extracts used to be injected into men, and in the 1920's there 
was a briefly popular operation in which slices of animal 
testicles were actually inserted into men's scrota.
    So the first promotion of hormones for rejuvenation was 
first directed toward men. But in the last few decades, most of 
the emphasis of hormones for sort of achieving youthfulness has 
really been aimed at women. And hormones are very useful 
therapies for many medical conditions, insulin, for example, 
for diabetes. Estrogens are actually very, and different kinds 
of estrogens are very useful for treating hot flashes. Hot 
flashes and vaginal dryness are actually the only proven 
benefits of hormone therapy, estrogen therapy at this point.
    But unfortunately, hormones don't prevent aging, and 
unfortunately, there is no such thing as a harmless hormone. 
All hormones, including the hormones that we make within our 
own bodies, have side effects. And claims that bioidentical, 
natural or naturally occurring hormones are safer than 
conventional hormones are not backed by science. I'm just going 
to talk about estrogen today, just for time reasons. The three 
estrogens that humans make are estriol, estradiol and estrone. 
And these are the hormones that are touted by compounding 
pharmacies and some alternative physicians as harmless 
alternatives to conventional therapy.
    So people may recommend estriol alone, estriol and 
estradiol, which is called Bi-Est sometimes, or all three, 
which are called Tri-Est. Sometimes they're combined with other 
hormones. Synthesized versions of these hormones, and they are 
synthesized, are identical to human versions. But just because 
humans make a hormone doesn't mean that it's good for us. High 
doses of insulin can kill you. High doses of adrenaline can 
kill you. High doses of thyroid can kill you, even if they're 
natural. And cortisol, which is an adrenal hormone that is 
promoted on Dr. Hotze's site, for example, increases the risk 
of osteoporosis, increases glucose levels and causes immune 
suppression. It is, however, a mood elevator, so probably 
people feel good as they're developing osteoporosis and 
diabetes. [Laughter.]
    I've said that even the hormones that we make within our 
bodies are not harmless. There are many studies that show that 
women who have naturally higher levels of estrone, estradiol, 
and estriol, actually of estradiol and estrone in their bodies, 
are at higher risk of breast cancer than women who have 
naturally lower levels of these hormones. A meta-analysis, for 
example, that was published in the Journal of the National 
Cancer Institute in 2002 analyzed nine studies on the subject 
and found that levels of estradiol, estrone, testosterone, DHEA 
and other sex hormones were strongly associated with breast 
cancer risk in postmenopausal women. So postmenopausal women 
who had higher naturally occurring levels of these natural 
hormones had higher breast cancer risk.
    And more recent studies that have been done in 2003, 2004, 
have also backed this up. Higher levels of testosterone are 
also associated with higher breast cancer risk in women.
    Natural hormone proponents believe that estriol decreases 
breast cancer risk. And in contrast to other estrogens, does 
not increase uterine cancer risk. This belief is based on 
publications, every single one of them more than 30 years old 
and all of them written by one guy, Henry Lemon. Lemon 
theorized that estriol could be a useful treatment in 
preventing and treating breast cancer. There's only one 
commentary by a guy named Fallingstad that isn't written by 
Lemon, and it quotes an unpublished study by Lemon that says 
that Lemon successfully treated some cases of breast cancer 
with estriol.
    Even Henry Lemon never claimed that. Henry Lemon never 
published a clinical study of estriol. There is some evidence, 
he did have some evidence from cell cultures, high doses of 
estriol in breast cancer cells in culture will decrease the 
growth of cells. But this is true of every estrogen. Low doses 
stimulate growth, high doses decrease growth. In fact, estrogen 
used to be used as a treatment, high doses of estrogen. So 
that's true of any estrogen, it does not evidence.
    Henry Lemon never published a clinical study. He did, 
however, publish a review on estriol in 1980 in which he 
describes giving estriol to 24 women. Six of them had their 
metastases grow. That's one quarter of the treated population. 
So this experiment can hardly be considered a success in breast 
cancer treatment. Two women also developed endometrial 
hyperplasia, a precancerous condition to endometrial cancer. We 
know that estrogen causes endometrial or uterine cancer. And 2 
out of 24 subjects in this study did develop the precursor to 
uterine cancer.
    In the review that the author wrote, he still seems to be 
enthusiastic about estriol. I have no idea why. But I think 
it's really frightening that there are still people today who 
think that his theory holds any water.
    We actually have information on estriol. Estriol is a 
perfectly decent treatment for hot flashes. And it's used in 
Europe, it's a very commonly used hormone therapy in Europe. 
It's been used for decades in England and Sweden and other 
countries. It's a conventional treatment, sold by conventional 
drug companies. And in conventional medicine in Europe, it was 
thought that you didn't have to use it with a progestin to 
protect the uterus because it's such as weak estrogen.
    So there were many women who received estriol alone because 
it was thought it was too weak to cause estrogen induced 
uterine cancer. That turned out that to be wrong. We now know 
that estriol is associated with endometrial hyperplasia and 
endometrial cancer. Women who have ever used estriol, this is a 
Swedish study, had twice the risk of endometrial cancer as 
women who never used estriol, and 5 years worth of use of oral 
estriol tripled the risk. The use of vaginal estriol did not 
seem to be associated with an increased risk.
    So this is less of a risk than with stronger estrogens, but 
it still caused cancer in women. So nowadays, estriol is used 
with a progestin in the same way that other estrogens are.
    In terms of cardiovascular risk----
    Mr. Burton. Excuse me, Doctor, if you could summarize. I 
want to make sure we get to the questions. We have six people, 
five people on the panel.
    Dr. Fugh-Berman. OK. Then I won't cover the data on 
cardiovascular risk.
    There is no reason to think that the estrogens promoted by 
compounding pharmacies protect against heart disease or stroke 
because estradiol has actually been tested in trials. There has 
been a randomized placebo controlled trial of estradiol and 
natural bioidentical hormone in 664 women after a stroke, and 
it did not protect against stroke. There is also another trial, 
the Esprit trial, in more than 1,000 women with a previous 
heart attack, estradiol did not protect against heart attack or 
death.
    So it's not true that only conjugated estrogens have been 
tested in randomized controlled trials. So has estradiol.
    So compounding pharmacies are uniquely unregulated, at 
least with commercially available pharmaceuticals of the 
quality of the preparations is regulated, that's not true of 
those in compounding pharmacies.
    And I'll just conclude by saying that human studies, and 
they have all the references, show that naturally high levels 
of estrone and estradiol are associated with breast cancer 
risks. Estriol pills increase uterine cancer risk and estradiol 
does not protect against heart disease or stroke.
    And I just wanted to add one thing, Mr. Chairman. I'm very 
sorry about your wife, and I agree with you that pharmaceutical 
estrogens were really over-promoted inappropriately for really 
dozens of years for things that they shouldn't have been used 
for. And that they do contribute to increased breast cancer. 
But the estrogens that are promoted by compounding pharmacies 
are also very likely to increase the risk of breast cancer in 
other women. Thank you.
    [The prepared statement of Dr. Fugh-Berman follows:]

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    Mr. Burton. Before we go to the next witness, who did you 
say sponsors your foundation?
    Dr. Fugh-Berman. I don't have a foundation. I'm an 
associate professor of physiology at Georgetown University 
School of Medicine.
    Mr. Burton. Does Georgetown get any grants from NIH?
    Dr. Fugh-Berman. Does Georgetown get any grants from NIH? 
I'm sure there are researchers there who do. I do not.
    Mr. Burton. Do you get any benefit from any of the 
pharmaceutical companies or any of that?
    Dr. Fugh-Berman. No. And if you're talking about my 
consumer advocacy, the consumer advocacy group that I 
represent, the National Women's Health Network, we also do not 
get any NIH funding.
    Mr. Burton. Where do you get your funding?
    Dr. Fugh-Berman. Twenty-five dollar a year membership and 
some foundation support.
    Mr. Burton. What foundations?
    Dr. Fugh-Berman. Private foundations not associated with 
any drug companies.
    Mr. Burton. Where do the foundations get their money?
    Dr. Fugh-Berman. From their investment portfolios, I 
assume.
    Mr. Burton. Could you for the record give me a list of the 
people that contribute to the foundation? I'd like to see where 
the money comes from.
    Dr. Fugh-Berman. I can give you a list of the foundation 
funders of the organization.
    Mr. Burton. That would be helpful. Thank you.
    Dr. Brownstein.
    Dr. Brownstein. Chairman Burton, I'm honored to be speaking 
to you, and I bring you greetings from the Wolverine State.
    Mr. Burton. Just north.
    Dr. Brownstein. Many of us involved in holistic medicine 
have gotten into it because of an ill family member or an 
illness themselves. And I got involved in it just as your 
interest seems to have been peaked in it from ill family 
members because my father was very ill with heart disease.
    I had wanted to be a doctor since I was a little child. And 
I was conventionally trained in medical school, began a 
conventional practice, was not interested in anything 
alternative or holistic. I used to tell my patients, don't do 
the alternative therapies, because I thought they were 
worthless, even though I didn't know much about that. And I 
would make derisive comments to them. I remember telling my 
mother-in-law, don't take your vitamins, because I thought she 
was wasting her money, which she never fails to remind me of 
today.
    However, all through medical school and post-medical school 
and residence, my father was very ill with heart disease. He 
had his first heart attack at 40, his second heart attack a few 
years later. He had bypass surgeries in the midst of a number 
of years. He had a couple of angioplasties. He had continual 
angina for 25 years, cholesterol that was uncontrolled in the 
300's or 400's on cholesterol lowering medications. He was 
seeing the best doctors from the University of Michigan and 
wasn't getting any better.
    And I finished my residency, I'm in a busy conventional 
practice. And a patient sees me and gives me a book, Healing 
with Nutrition by Dr. Jonathan Wright. I took that book home, 
wasn't much interested in it, but I flipped to the section on 
cardiovascular disease, since my father was dying before my 
eyes. He did not have long to live at that point. And Dr. 
Wright talked about how he used natural hormones to treat heart 
disease.
    When I started pulling the literature on natural hormones 
and heart disease, there was a plethora of literature on 
testosterone and heart diseases dating back to the early 
1900's, most of it out of Europe. And I became very interested 
in that, and I checked my father and his testosterone level and 
DHEA level and estrogen levels, and ended up putting my father 
on three or four natural hormones, natural testosterone, DHEA, 
natural progesterone and pregnenolone.
    Within a matter of a week of putting him on these four 
hormones, a 25 year history of angina resolved, never to 
return. His cholesterol, which was stuck in the mid 300's, went 
below 200, off cholesterol lowering medication. He lost weight, 
he had a pale, sick looking face that now turned pink. His 
friends and my mothers friends were asking what's going on with 
him, he's looking so much better. He was able to walk around 
without popping nitro pills all day. Once this conventional 
physician saw the changes in my father with using natural 
hormones, I decided that's what I wanted to do in medicine.
    Since that point about 12 years ago, I have been 
researching and utilizing natural hormones. And though I agree 
with Dr. Fugh-Berman that there are a lot of problems with 
estrogens in the environment, I think most of us men and women 
are over-estrogenized. The problem isn't so much estrogen 
deficiency, it's a hormonal imbalance, in part exacerbated by 
estrogen excess. And the use of conventional hormones 
exacerbates that and causes problems, like stroke, heart 
disease, heart attacks, just as was found in the Women's Health 
Initiative.
    What I've found is that an imbalanced hormonal system leads 
to chronic illness, such as auto-immune disorders, lupus, MS, 
Hashimoto's, Grave's Diseases, the list can go on and on. It 
leads to cancer, breast cancer, uterine cancer, ovarian cancer, 
thyroid cancer, headaches, heart disease, the list goes on and 
on.
    And when somebody can get their hormonal system rebalanced 
natural hormones, these conditions get markedly better. I see 
it every day in my practice. Those of us that have used natural 
hormones see the results in our patients and these items need 
to be studied and they need to be kept available for patients. 
As a physician, I want to be able to prescribe natural hormones 
when they are indicated. We need the help of compounding 
pharmacists to utilize these items.
    My experience has been that most people with chronic 
disorders have severely deficient levels of hormones when I 
check them, including DHEA and pregnenolone and thyroid and 
testosterone, with elevated estrogen levels present.
    I'd like to just close by just explaining to you what a 
normal hormone is. And I've got it in my handout, I wanted to 
do a Power Point presentation, but I was told I wasn't able to 
do it, although I would have my own projector.
    Mr. Burton. If we had the other committee room. But we had 
a big hearing there on scandal in Iraq. So we had to pass on 
that.
    Dr. Brownstein. Well, you don't even have to look at that 
handout. Let me just explain to you in my mind what a natural 
hormone is. The hormones work in our body in a lock and key 
model. Just as you go out to your car door to start your car, 
your key fits in your car door fine. If I put my key in your 
car door, it's not going to fit quite right.
    A natural hormone has the same structure as our own 
hormones. So it's like the key that goes to find its lock. And 
there are hormone receptors in our bones, our hearts, our 
brain, our lungs. So when this key or this hormone goes to find 
its receptor, it's like a perfect fit. It's like a perfect 
puzzle fit.
    When you use a synthetic hormone that's been altered, this 
puzzle piece doesn't fit quite right. It's been altered. And 
that's what I had for the slides to show you, just the 
difference between the two. But this difference in this puzzle 
piece not fitting quite right is what leads to the adverse 
effects of synthetic hormones. And you just, as a practicing 
physician, you just don't see the adverse effects with the 
natural hormones that you do with the synthetic hormones. It 
doesn't make sense to me to use something that doesn't fit 
quite right in the body, when there is something available that 
has a perfect fit.
    [The prepared statement of Dr. Brownstein follows:]

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    Mr. Burton. I want to talk to you after the hearing.
    Dr. Brownstein. And I have some books for you that I'd like 
to give you.
    Mr. Burton. Well, don't give me too much to read. I have in 
my office 9 million books. And although I read fairly fast, I 
ain't going to get through them all. But I would like to talk 
to you about that.
    Ms. Petersen.
    Ms. Petersen. Thank you, Chairman Burton. It's a pleasure 
to be here.
    I am one of the compounding pharmacists. I can speak for 
thousands and thousands of patients and thousands of 
practitioners throughout the United States. We have a quiet 
revolution going on here in health care. People are no longer 
accepting substandard care, and they're finding alternatives 
and alternative practitioners such as Dr. Brownstein and Dr. 
Hotze. It makes a huge difference in their lives.
    I've been involved in this business since 1993, and 
professionally and personally it's been the most rewarding 
business of my whole life. People often ask us, where do these 
hormones come from, when we talk about natural or bioidentical 
hormones. Because they are identical to human, conceivably you 
could think, well, maybe we squeeze these out of humans, and 
certainly it could be done. In France for the longest time 
their source of progesterone was human placenta, and they 
extracted it from there.
    But it's made semi-synthetically. Many plants have a 
compound in their body made from cholesterol that is very, it's 
in their body and it's similar to cholesterol in the human 
body. This is the basis for all the steroidal hormones, like 
estrogen, progesterone, testosterone, DHEA, cholesterol is. 
From this plant nucleus that is similar to cholesterol, they 
can make in the laboratory any of the hormones that you would 
wish to have. You can make them chemically identical to human, 
you can alter them and get a patent. For example, birth 
controls are 100 percent synthetic, but also made from this 
beginning plant material.
    So the big difference is what it does in your body, just as 
Dr. Brownstein had said. I'd like to say that the FDA has the 
ability to authorize drugs in this country. And I believe that 
they should have full power to do so when anybody wishes to 
introduce into the general population something that is a brand 
new chemical. Lord knows we have plenty of those. And I think 
they don't regulate them as well as they should in many cases.
    We don't reward manufacturers very well, there are some 
ways around it, for instance the estrogen patches. The 
companies have to obtain a patent on the patch, not the 
hormone. I think if our medical industry took a positive stance 
and looked for ways to be using these hormones in a positive 
way, and some of them are, we'd end up much better.
    The other really interesting thing about using bioidentical 
hormones is I think reflected in some papers that were written 
by a professor at the University of Washington. He wrote 
several papers on N-1 studies. He believes that our current 
gold standard of double blind placebo crossover studies are a 
farce. You and I are not biochemically identical, you and I 
aren't biochemically identical. If you participate in a study, 
no matter how large, whatever you glean from there does not 
apply to me as an individual. It never can. I am biochemically 
unique.
    So with N-1 studies, a certain protocol is embarked on with 
a patient for a particular issue and it's done for a while, a 
washout period maybe, another trial tried, until you find what 
works best. And I submit that compounded bioidentical hormones 
made for the individual and done in a clinical practice 
satisfies this N-1 study. That's probably the only real 
scientific, true scientific method for each individual.
    Bioidentical hormones are very easy to track. You can test, 
as Dr. Brownstein has mentioned, you can test in saliva, urine, 
blood. It doesn't take a rocket scientist to figure out if 
something is lower than normal. I'm not talking about higher 
than normal, lower than normal. And you have symptoms of those 
hormones being lower than normal. And you take those hormones 
and you put it back in that patient, you can recheck 
clinically, you can recheck blood saliva and urine, it's all 
available now. And you can make a big difference for that 
particular person's life. And I have heard it over and over and 
over again, thank you for giving me back my life, thank you for 
giving me back my brain, thank you for giving me back my wife. 
And money can't buy what that kind of practice is.
    [The prepared statement of Ms. Petersen follows:]

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    Mr. Burton. I have some questions for you when we get to 
how you determine what the level should be in each individual.
    Ms. Reynolds.
    Ms. Reynolds. I'm also very honored to be here, and I want 
to thank you for your time, because I know your time is 
important now.
    Mr. Burton. That's fine. No more votes for another hour or 
so.
    Ms. Reynolds. After 40 years, 40 plus years of frustration, 
exasperation and desperation, I finally had what I considered 
at least now a quality of life, because of prescribed all 
natural hormone replacement therapy. And my saga began at age 
13, and I know that I speak for many women in America and many 
of my friends who have suffered the same symptoms and the same 
things that I have suffered. As a teenager, it began with 
excessive pain, excessive bleeding that would last sometimes a 
solid week, extreme pain and nausea and missing school.
    This continued throughout my teen years. This continued on 
up into my 20's. And after I married, I don't know if some of 
the symptoms disappeared, or maybe you just get so busy that 
maybe you put some of those symptoms behind you. But these 
continued, these same symptoms continued. I went for my year 
examinations as I thought I was supposed to. I would explain 
each time, and I would go through these symptoms. And either I 
got a shake of the head or I got, well, some women are just 
that way. I thought, well, OK, so some women are just that way.
    OK, so you go to another doctor and you explain your 
symptoms and finally in your 30's, you tell them, you know, I 
think I'm losing some of my hair. I only have half my eyebrows. 
Do you think possibly maybe I have a problem? And they 
prescribe things for you that then cause you to have other 
things that they then have to prescribe something else on top 
of that to counteract what they have already prescribed for 
you, which causes you to have other problems, such as 
dizziness, nausea and breaking out in rashes.
    So then you decide, well, you know, I believe I could live 
with what I was presently having rather than go into a whole 
new realm of concerns for which I'm sure there would not be an 
answer. So I thought, OK, I think I look forward to menopause, 
because I bet all this will be behind me.
    Well, of course, that's not the case. Once you hit 
menopause, you have those symptoms you've carried over from 
teenage years and your married life, and you've just about 
killed everyone in your family. So then you get to move into 
menopause with a whole new set of symptoms, of fatigue, of 
dizziness, of nausea, of high fevers and you still are not 
given answers to your problems, except that, well, you know you 
are getting older. Well, yes, I know that I'm getting older. 
But when I was here when I was 30, it was because some women 
are just that way. Now suddenly it's because I'm just getting 
older is why I'm having these symptoms.
    So after being prescribed about six synthetic medications, 
which each one gave me a new symptom with which I had to deal, 
and of course, you don't know what to do except go back to your 
doctor, who then gives you another prescription drug in order 
to treat the new problem you've just acquired.
    Well, when I went through a series of all of these where I 
had other symptoms with which they were now going to give me 
other prescription medications to treat those new symptoms, on 
the last prescription drug I was given, which was the patch, 
which caused a whole realm of new things that we could be all 
day into the next vote on this one, so I'll just tell you that 
I had several symptoms to deal with at that point. And the last 
climactic symptom I had was severe migraine headaches that 
lasted 3 days. And so when I called the doctor, and I noticed 
that one of the side effects listed other than the fact that I 
could die of a heart attack was also one of the side effects, 
and that I could have dizzy spells. But in case I had severe 
migraine headaches, do notify your physician.
    I notified my physician. And my physician called me in a 
prescription for the severe migraine headache, without saying, 
oh, by the way, why don't you come in to see me. When I hung up 
the phone and I realized he was just going to call me in a 
prescription for something to cover that new symptom, I called 
him back and I said, you don't want to see me, you don't want 
to know why I'm having this headache? I believe there must be a 
reason. He said, no, I don't need to see you, I have called you 
in a prescription.
    I said, and what is this prescription? And when he told me 
the name of it, he said, it's the newest thing on the market 
for treating severe migraine headaches. I said, oh, wonderful, 
could you give me the name of some patients for whom you've 
given this to that I might talk to them about what now this 
might do to me? And he said, no, because it's so new I haven't 
prescribed anyone this medication yet. I said, thank you so 
much. Since you don't need to see me, I don't need to see you 
again either.
    At that point, I found a magazine article that talked about 
Dr. Hotze's wellness center that treated with all natural 
medications. I ended up there, and I ended up getting on all 
natural hormone therapies, which I have yet to have a symptom 
that I have to take something else for.
    And I am well. I have energy, which we have more than just 
night sweats when we go into menopause, ladies and gentlemen. 
We have all kinds of things happen to us. And all of those 
things are gone. I have energy. I feel good. I lost the 20 
pounds that I gained during all this 40 plus years of battling 
with this. And I am at least alive. My family can tolerate me. 
I don't feel the need to strangle people at any moment, in some 
cases. And I have a quality of life.
    And I hope that this option is never taken from me.
    [The prepared statement of Ms. Reynolds follows:]

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    Mr. Burton. Thank you for that story. It's very, very 
interesting. Do men get night sweats, too? [Laughter.]
    Ms. Reynolds. They're contagious. [Laughter.]
    Mr. Burton. Dr. Hotze.
    Dr. Hotze. There is a solution for women in mid-life who 
experience a host of health problems related to hormonal 
decline and hormonal imbalances. The solution is natural, 
biologically identical hormones. They are safe, they are 
natural and they are effective.
    As Vicki so articulately presented her history of problems 
that she had, in our Health and Wellness Center in Houston, I 
have seen thousands of women, we see 1,500 new guests every 
year, we call our patients guests, they're not patients, 
they're guests. We elevate treatment, we think doctors ought to 
treat their customers as nicely as other businesses do. So we 
take care of our guests when they come in.
    And 35 percent fly in from across the country. They have 
sought help in their local areas, New York, Los Angeles, and 
they can't find physicians that will help them overcome their 
problems. And their problems can be as simple as breast 
tenderness, mood swings, fluid retention, weight gain and 
headaches that may happen premenstrually, irregular menstrual 
periods, breakthrough bleeding, depressed moods, premenstrual 
and irritable moods.
    Eventually, as Vicki mentions, as they move through their 
menstrual life, their hormones begin to decline, particularly 
progesterone. And what do they get? They get loss of energy, 
they get weight gain, they begin to lose their hair. Their 
eyebrows start to fall out, their hands are cold, they shiver, 
they can't think clearly, they're irritable, they're depressed, 
they're anxious, they get panic attacks, they go to bed, they 
can't sleep. They channel surf all night long. We channel surf 
during the day, they gripe at us. But at night, they channel 
surf all night long because they can't get to sleep. They wake 
up tired, they go to bed tired and they wake up tired. And they 
often have to slug it out all week at work so they can get home 
on Saturday so they can go to bed for 2 days so they can make 
it through the next week.
    They visit their physician and their physician runs a blood 
test and says, everything is normal. And they go, I'm not 
normal. Well, you're not normal, but I think there might be a 
problem. You need a little antidepressant. And they'll put them 
on Prozac and Effexor and Zoloft and a whole host of them and 
completely ruin their lives. If they didn't have libido before 
they start, though, they won't have any libido after that. If 
they used to say, well, I don't think about sex, now they say, 
I don't even care that I don't think about it any more when 
they get on these drugs.
    Then they get headaches, so they put them on the headache 
medication and they put them on sleep medication and anti-
inflammatory medication and before you know it, these women, 
their personalities have been completely changed, and then they 
may try the birth control pills or the counterfeit hormones, 
which cause a host of problems, as Dr. Alving so clearly told 
us. The Women's Health Initiative clearly told us what has been 
in the literature for over 14 years. Since 1989 there have been 
five major studies that showed that the counterfeit hormones 
are dangerous, they cause tremendous side effects.
    And any physician that listens to a woman, the woman will 
tell you, Doctor, these make me feel bad. And I say, if they 
make you feel bad, don't take them. That's the best sign in the 
world is how you're feeling. If your energy level is gone, you 
gain weight, you don't think clearly, get off the stuff. My dad 
used to tell me, and he wasn't a doctor, beware of doctors, 
they will poison you to death with their drugs. And do you know 
that the leading cause of death in America is not cancer, it's 
not heart diseases, if you look at the facts, it's iatoragenic 
illness, drug-induced illness from the drugs that doctors give 
patients. It's the leading cause of death. You'll find it's the 
third leading cause, but if you do the statistics, it's the 
leading cause of death.
    The drugs that the FDA approves kill Americans every day, 
100,000 in the hospital every year. And these are drugs that 
are given and prescribed by doctors and given in appropriate 
doses in the hospital and it kills them. My suggestion is, 
well, why do people get sick to begin with? Well, they get sick 
because their hormones decline. Just like a diabetic young 
person may get diabetes when their insulin declines. We would 
never withhold insulin, we replenish insulin.
    When your hormones, Congressman and Congresswoman and staff 
members, begin to decline, you're going to begin to feel the 
symptoms of the aging process. Yes, it's natural. Yes, it's 
common. But it's not healthy. That's when you're going to get 
heart disease, that's when you're going to get diabetes, that's 
when you're going to get cancer, you're going to get arthritis.
    What can you do to prevent that? You're not going to 
prevent death, but you can sure improve the quality of life by 
simply replenishing, in your body, replenishing in your body 
the same hormones that your body used to make in adequate 
amounts when you were younger. Keep them at a normal level.
    And for gosh sakes, do not take the drugs that the drug 
companies are putting out. Because they will kill you, and the 
women's health study has said that, I've been saying that for 
10 years. And I was out on the extreme when I said that 10 or 
15 years ago on my radio programs and all over town. Well, Dr. 
Hotze's a little out on a limb, he's saying these drugs are bad 
for you.
    Well, guess what? Now that it turns out I was right, did 
they say Dr. Hotze was right? No, they went, well, we don't 
want to bioidentical, let's just put them on some other drugs. 
So we're going to go on Premarin light. You've heard of Miller 
and Miller Lite. Dr. Alving told us that now they have offered 
Prempro light. We'll kill you slower, not as fast as we would 
have. You'll get cancer, it will take you twice as long to get 
cancer. Then if that doesn't work, we'll just put you on drugs 
and drug you up.
    So ladies, if you start acting a little bit weird, and you 
don't feel good and your doctor, most likely it's going to be a 
man, and the way men look at women, he's going to look at you 
and say, I just think you're a hypochondriac. But he's not 
going to say that. He'll go, I think you might have a little 
problem with depression. Ninety percent of the women between 35 
and 55, 90 percent of the antidepressants that are prescribed 
are prescribed to women. Why do doctors give women all the 
antidepressants? Why don't the men get the antidepressants?
    As to studies, there is a plethora of studies, and I would 
be glad to forward these to the doctor at the end of the table, 
who is an academician at a medical school and frankly, with all 
due respect, should be ashamed that she hasn't read this 
plethora of literature. I'll be glad, I'm the president of the 
American Academy for Biologically Identical Hormone Therapy. 
Dr. Fugh-Berman, I will be glad to forward you catalogs of all 
this information that you can read and make up your own 
decision. I'll be glad to send you that. And I will send you 
that as soon as we get back to Houston. Then you can comment on 
it after that.
    In 1981, the Johns Hopkins Public School of Health did a 
study published in the American Journal of Epidemiology, a 20 
year study. It showed that there was one chemical in a woman, 
when she lost the chemical, she had a 555 percent increase of 
breast cancer and a 1,000 percent increase of death of all 
kinds from cancer. And wouldn't it be nice if you knew what 
that particular molecule was? The Johns Hopkins School of 
Public Health determined when it was missing, that women had a 
555 percent increase of breast cancer. Dr. Berman, do you know 
what that was, have you read the article?
    Dr. Fugh-Berman. Perhaps if you had included a reference in 
your testimony, that would have been helpful.
    Dr. Hotze. I did.
    Dr. Fugh-Berman. It's also a epidemiological study, not a 
randomized control trial, and I am extremely familiar with 
hormones.
    Mr. Burton. I don't want to lose control of the hearing. 
[Laughter.]
    Dr. Hotze. Anyway, the hormone was progesterone. So the 
dramatic increase in risk factor for women getting cancer is 
the decline in their progesterone levels and progesterone is a 
naturally occurring hormone that women have and every cell in 
their body requires it.
    Finally, there is a solution for women's health problems in 
mid-life and thereafter. When should a woman start taking 
bioidentical hormone replacement therapy? As soon as she starts 
having symptoms, which can happen, in the case of somebody like 
Vicki, at 13. She may need just a little bit of progesterone.
    But this is the solution, and this is safe and it's 
effective. We have treated thousands of women. I have done 
numerous clinical studies and presented them at medical 
conferences. We are now training doctors, OB-GYNs in Houston, 
TX. We are leading a wellness revolution that will change the 
way mainstream medicine, and the way men and women in America 
area treated in mid-life through the use of biologically 
identical hormones.
    And we thank you, Congressman Burton and you, Congresswoman 
Watson, for your interest in alternative, safe, effective 
alternatives for health problems. And this would save the 
country billions of dollars. The last thing that people need 
when they're older is all these drugs they drug them up with. 
Why do you think sitting in a nursing home they drool and they 
can't talk to you and
you go, Mama's losing her mind? They've got her drugged up on 
anti-anxiety, anti-depressants and sleep medications. Get her 
off the drugs, get her out of there, she's liable to be normal 
again. I've seen this happen.
    [The prepared statement of Dr. Hotze follows:]

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    Mr. Burton. Thank you, Doctor.
    Dr. Hotze. Thank you, sir.
    Mr. Burton. The one thing I wish you could help me with is, 
I'm a little bit older now and I've never understood women. And 
if you could find some way to give me some kind of a hormone 
replacement that would make me understand women. [Laughter.]
    Dr. Brownstein, Dr. Fugh-Berman, I will have some questions 
for you in a minute. But I have to tell you, after listening to 
your testimony, it sounds remarkably similar to testimony we've 
had from people who represent the pharmaceutical companies who 
have been before me over 4 years. And that's why, and I don't 
mean to impute your integrity at all, but that's why I asked 
you where your funding was coming from and what the foundation 
funding sources were.
    Dr. Fugh-Berman. Could I respond?
    Mr. Burton. Sure.
    Dr. Fugh-Berman. I'm really flattered to be accused of 
that, or even----
    Mr. Burton. You're not accused.
    Dr. Fugh-Berman. No, no, but I am really flattered, because 
actually I do a lot of work against pharmaceutical companies. 
And the National Women's Health Network does as well. 
Pharmaceutical companies shudder when we come into FDA advisory 
committee rooms. So yes, it's a novel position to be in.
    But I just also wanted to say that actually, I have 
practiced alternative medicine for many years. I was medical 
director of two clinics in Washington, and I currently teach in 
the only masters degree granting program in alternative 
medicine in the United States at Georgetown, which we just 
started last year. So I'm normally seen as a sort of nuts and 
granola, herbs and dietary supplement person. So this is a very 
interesting position for me to be in.
    Mr. Burton. OK. Dr. Brownstein and Dr. Hotze, what I'd like 
to know is, where is your practice, Dr. Brownstein?
    Dr. Brownstein. Outside of Detroit.
    Mr. Burton. You're outside of Detroit. Do you have people 
come in, like Dr. Hotze, that stay for a while and you do a 
battery of tests on them and then you decide what hormone 
replacement therapy, natural hormone replacement therapy they 
should take?
    Dr. Brownstein. We have people come in from all over the 
country and out of the country. We check levels before we 
institute any hormonal therapy, pre and post. And we follow our 
patients closely.
    Mr. Burton. I was looking at your chart here. In the chart 
there was a picture who looked like she was severely 
overweight. And then it shows another picture right after that. 
Is that the same lady?
    Dr. Brownstein. That's the same lady with 6 months of 
treatment with natural hormones.
    Mr. Burton. Six months? How much weight did she lose?
    Dr. Brownstein. About 75 pounds.
    Mr. Burton. Was this without weight control?
    Dr. Brownstein. She was a lady around 40 years old, had a 
baby and fell apart during the pregnancy. And she had normal 
blood tests for thyroid levels. When I put her on a small 
amount of thyroid hormone plus a few natural hormones that were 
imbalanced, her health recovered.
    Mr. Burton. And she lost weight?
    Dr. Brownstein. She lost that weight.
    Mr. Burton. Without any dietary weight loss substances?
    Dr. Brownstein. Took no dietary substances.
    Dr. Fugh-Berman. Thyroid will make anyone lose weight.
    Mr. Burton. Yes. Thank you, Dr. Berman.
    [Simultaneous conversations.]
    Dr. Hotze. That's not correct.
    [Simultaneous conversations.]
    Dr. Brownstein. That's not correct.
    Mr. Burton. In any event----
    Dr. Hotze. That's the difference between a clinician and an 
academician.
    Mr. Burton. Well, I don't want to get into a fight here. 
I'm glad you're sitting at opposite ends of the table. 
[Laughter.]
    But what I'd like to----
    Dr. Hotze. Well, we'll juice it up a little bit, because we 
heard your hearings get pretty good.
    Mr. Burton. Well, I've never been known to back way from a 
fight. [Laughter.]
    But in any event, what I'd like to know is, you've spoken 
in generalities. She mentioned studies, clinical studies, that 
sort of thing. Do you have any clinical studies or anything 
that we could--and I don't want you to give me this much----
    Dr. Hotze. Yes, sir, I do, and we will send you those. I 
have clinical studies from my office, and I will send you the 
clinical studies also that I promised you.
    Mr. Burton. Has the FDA or HHS ever taken issue with you, 
come into your office and----
    Dr. Hotze. No. And they can't, because FDA has no authority 
over the practice of medicine. That's all governed by the State 
Board of Medical Examiners.
    Mr. Burton. How about HHS or any of the health agencies?
    Dr. Hotze. They have no authority over----
    Mr. Burton. Have any of the State health agencies given you 
a hard time?
    Dr. Hotze. No.
    Mr. Burton. The reason I ask is because, some people who 
practice alternative modalities of medicine have had problems 
with various Government agencies. And they literally put some 
of them out of business.
    Dr. Hotze. True, they do. Unfortunately, they pick on the 
little ones that aren't strong. They will pick on people that 
will back down. But they don't pick on us.
    Mr. Burton. Got that. Ms. Petersen, how do you determine 
through your pharmacy, how do you determine what substances 
people need to take, hormone replacement, that will help make 
them better?
    Ms. Petersen. Actually, we don't. The practitioners do.
    Mr. Burton. So you work with people like Dr. Brownstein and 
Dr. Hotze?
    Ms. Petersen. That's quite right. And as both doctors 
referred to, there's really a plethora of information out 
there. There's very much a lot of basic research in the fields 
of endocrinology, physiology and even medicine that identify 
what symptoms are related to what hormone. We know that from 
those basic studies. And then we also have quite a bit of 
literature on when you use a particular hormone, how much it 
takes to get to normal blood levels. So there are ranges of 
these hormones that are used.
    And within that paradigm, knowing what clinical response 
you expect to get, and what the usual dose ranges are and what 
blood levels or saliva levels or urine levels you can 
anticipate improving, with all those tools, the clinician is 
very straightforward, very scientific to determine what people 
need.
    Mr. Burton. So what you do, Dr. Brownstein, Dr. Hotze, is 
that you take blood tests, saliva tests, urine tests, and you 
analyze those and you decide from those tests whether or not 
there's a deficiency of certain hormones?
    Dr. Hotze. First, everyone in this room, as you age, your 
hormones are going to decline. There are scientific studies on 
that. And women know that.
    So the first thing we do, I do, I'm a clinician, the first 
thing we do is take a copious 26 page history. The history 
tells you everything. If you understand how the hormones work, 
when a woman walks into your office, she's 38, she had a baby, 
and now she's experiencing breakthrough bleeding and she's 
experiencing mood swings, breast tenderness, you know she needs 
progesterone.
    Mr. Burton. Yes.
    Dr. Hotze. So we don't draw a blood level on progesterone, 
we will draw a blood level on thyroid and some of the other 
hormones. But if a woman is menopausal, she's not making any 
hormones, you don't have to check her blood for that, she's 
already told you. So you replenish it in the average normal 
range that is accepted and that relives the symptoms.
    Mr. Burton. How do you determine that?
    Dr. Hotze. Well, you do a physical exam.
    Mr. Burton. Do you do diagnostic tests?
    Dr. Hotze. Yes, we do tests. But if any woman in menopause 
walks in, I can look at her and know what her size and weight 
is, and she tells me her symptoms, I'm going to know the dosage 
that she needs to take. And that's the starting dose. And then 
we work, we see her back in followup and make adjustments.
    Mr. Burton. How about you, Dr. Brownstein? Do you do it the 
same way?
    Dr. Brownstein. I check, as I said before, pre and post 
levels in everyone.
    Mr. Burton. How do you do that, through blood tests, saliva 
tests, urine tests?
    Dr. Brownstein. Blood and urine tests. And the idea of 
being a physician is to put the whole picture together for the 
patient, to look at their physical exam, look at their history, 
look at their blood work and look at whatever other signs you 
can come up with and then put the whole picture together, not 
rely on one aspect only to treat people.
    And when you look at the whole picture, I think you can get 
a better treatment regimen together for somebody.
    Mr. Burton. I see, and then you prescribe pretty much all 
holistic hormonal replacements?
    Dr. Brownstein. If someone has strep throat, I'll prescribe 
penicillin. There is a place for drug therapies.
    Mr. Burton. I know, but I'm talking about as far as the 
deficiencies in people.
    Dr. Brownstein. I will only prescribe natural hormones.
    Mr. Burton. What about men? You've been talking a lot about 
women.
    Dr. Hotze. I'll speak specifically. Men also, as they age, 
lose, their testosterone level declines. So a man at 40 will 
have one-half the testosterone level he had in his 20's, at 50 
a third, at 60 a quarter. Testosterone is essential. It affects 
your initiative, your assertiveness, sense of well-being, self-
confidence, moods, goal orientation, your drive, direction, 
decisiveness, analytical ability----
    Mr. Burton. I feel sick already. [Laughter.]
    Dr. Hotze. Your analytical ability, and we know this 
because if a man loses his testicles from cancer or injury, he 
has difficulty, he can't read a map, he can't think in three 
dimensional terms.
    Mr. Burton. But you treat----
    Dr. Hotze. So when you give them testosterone, oh, my gosh, 
it's huge, and I take it myself, and I have for 7 years. It's 
remarkable.
    Dr. Brownstein. Mr. Chairman, you mentioned that heart 
disease, or somebody mentioned heart disease was the No. 1 
killer in the United States. I have yet to see a patient with 
severe heart disease have a normal testosterone level, man or 
woman. They all have low levels. And when you look at the 
literature on testosterone and heart disease, there is tons of 
it. I have file cabinets at work of testosterone and heart 
disease relationships.
    Mr. Burton. So for men, you will check their testosterone 
levels and you'll compensate?
    Dr. Hotze. Prescribe, yes.
    Dr. Brownstein. Check all their hormone levels, but yes, 
testosterone is one of the things.
    Mr. Burton. Ms. Watson.
    Ms. Watson. I want to thank all the witnesses, and sorry to 
be late coming in. We're always conflicted.
    Dr. Hotze, I believe in holistic medicine. What do you see 
are the problems today, when I say today, I mean today, in the 
use of naturally occurring biological methods for addressing 
the hormone loss? What is the problem? Is the problem with the 
FDA?
    Dr. Hotze. There is a potential coming problem with the 
FDA. Pharmacies, just like medical doctors, are all governed 
and regulated by their various State boards of pharmacy. The 
FDA has recently tried to extend, and we believe illegally 
attempted to extend its jurisdiction to govern pharmacies, 
particularly compounding pharmacies. They have already issued a 
compliance policy guideline that would prohibit compounding 
pharmacies that make products for veterinarians where they 
prohibit them from buying it in bulk. That's what their 
compliance policy is, which has no force of law, but people 
think it does, and they intimidate people.
    Now, what they want to do, and all compounding pharmacies 
buy their products in bulk from a pharmaceutical manufacturer, 
whether their products are synthetic or whatever. Compounding 
pharmacies don't just make bioidentical hormones, they make a 
plethora of drugs based upon a doctor or pharmacist patient 
relationship.
    So the FDA wants now to restrict bulk use of ingredients in 
that pharmacy. That shuts them down. They can't do it any more. 
That's how you make a compounded product, you buy in bulk. They 
will next move to humans and say, we're going to restrict you 
doing this in humans, you can't buy the bulk product.
    And then Vicki won't be able to get hormones any more, 
because the way they want to control the doctors that are 
practicing alternative medicines is shut down the compounding 
pharmacies. That's their goal.
    So what we would like to ask you, we need your help, 
Congresswoman Watson and Chairman Burton. We need to ask you if 
you would consider writing a letter to the FDA, asking them to 
focus their efforts on tracking all these dangerous drugs from 
the pharmaceutical companies, which they say they don't have 
enough money to do, and leave the pharmacies under the 
jurisdiction of the State boards of pharmacies, in other words, 
stop the intervention. They are intimidating the little guys.
    Now, I'm big enough, I can go out and hire a lawyer and 
spend hundreds of thousands of dollars. I haven't had to do 
this, but I've joined in coalitions that have fought the FDA. 
I'm willing to do that. But a little guy on the corner can't do 
it. And they're going to shut all the little people down.
    Ms. Watson. Let me ask you, what is the FDA's position on 
intervening? Do they feel that maybe the studies have not 
been----
    Dr. Hotze. They don't intervene on biologically identical--
they haven't intervened on biologically identical hormones. 
They haven't done that. But they want to shut down compounding 
pharmacies.
    Ms. Watson. Why is this?
    Dr. Hotze. Because, with all due respect to the FDA, 
they're regulatory bureaucrats. Every regulatory agent wants to 
control things. And when Kesler got into power, he wanted to 
control dietary supplements. He wanted--you couldn't get a 
vitamin unless you went to your doctor and your doctor wrote a 
prescription.
    What are the odds of your doctor writing you a prescription 
for vitamins? In most people, they'll never do it, because when 
my dad asked me, when he had heart disease in 1988, he said, 
son, I read about vitamins, the doctor says I need to take 
vitamins. He said, what do I take? I said, Dad, what the hell 
do I know? I'm a doctor. I don't know anything about vitamins. 
And he said, will you find out? And I did. That's how I got 
into alternative medicine. Very similar story to Dr. 
Brownstein's, my dad's heart disease and health problems got me 
into alternative medicine.
    Ms. Watson. Well, do they lean more toward the synthetics?
    Dr. Hotze. Yes, of course. Yes, they do.
    Ms. Watson. Is it to the benefit of the pharmaceutical 
companies?
    Dr. Hotze. Voila! If something doesn't seem logical, like, 
you mean, I can get something, I can replenish my body with 
water if I'm thirsty, but you want me to drink Coke when I'm 
thirsty, but all I need, I'm dying in the desert and all I want 
is water, and you're going to do a double blind study, well, 
you're trying to sell me that Coke.
    The same thing with the hormones. We have available, as we 
age, the ability to replenish our hormones with the same 
identical hormones your body used to make in adequate amounts. 
Oh. But you can't patent those.
    Dr. Fugh-Berman. Could I clarify something about 
bioidentical hormones? This is important.
    Bioidentical hormones are available in commercial 
pharmaceutical preparations. Compounding pharmacies buy them 
from drug companies. You can get 17 beta estradiol, the exact 
bioidentical estrogen that is in our bodies, in patches, in 
pills, in vaginal tablets, inc reams. Is that not correct?
    Ms. Petersen. That's absolutely correct, it's only partial.
    Dr. Hotze. It's partial.
    Dr. Fugh-Berman. What is different? What is different in 
the preparations that you use than in the commercially 
available pharmaceutical versions of estrone, estradiol and 
testosterone?
    Ms. Petersen. I can tell you that in a minute. Say 
prometreium progesterone comes in 100, 200 milligrams. I have 
many, many people who use 10 milligrams, 15 milligrams, 50 
milligrams, 250 milligrams. You cannot do it with a commercial 
product and it's not appropriate for them.
    Also the fillers and the binders in some things, our 
pharmacy does a lot of work with environmentally sensitive 
people. We pay attention to that. Commercial products are not 
appropriate. There's dyes and fillers that will cause severe 
reactions with them.
    Dr. Brownstein. The other thing that Carol is pointing out 
is that, all these therapies need to be individualized.
    Ms. Petersen. Yes.
    Dr. Brownstein. You require a different dose than the lady 
next to you. And when you're relying on pharmaceutical 
companies, they only have a couple of doses fits all size.
    Ms. Watson. Let me just say this. I'm an example----
    Mr. Burton. Hold on a second.
    Dr. Fugh-Berman. We tailor medications in conventional 
medicine. What my problem with this is not that these people 
are too alternative, but that they're too conventional. These 
are the same sorts of claims that were made without data by the 
company that made Premarin.
    Mr. Burton. Would you yield?
    Ms. Watson. I'll yield to the Chair.
    Mr. Burton. Let me just say this. As we age, and I know 
you're very young, we take a lot of pills. Can you imagine me 
breaking these pills apart and trying to see? You can't do 
that. You'd go crazy first of all, and you'd probably kill 
yourself.
    I think what Drs. Brownstein and Hotze are trying to say is 
that this is going to be, they're going to try to find out what 
your deficiencies are and tailor it to the individual. And a 
one size fits all commodity coming out of a pharmaceutical 
company won't cut it.
    Dr. Fugh-Berman. Right. And it's fine to tailor therapy. We 
do that in conventional medicine, we do it in alternative 
medicine, and I consider myself a practitioner of both.
    Mr. Burton. Well, my doctors don't.
    Dr. Fugh-Berman. But the idea that there are known normal 
levels of all hormones is actually not true. That we don't know 
what the normal age levels are of, for example, estrogen. You 
cannot tell from blood levels of estrogen who's having hot 
flashes and who isn't. So blood levels of 20 year olds are 
higher in estrogen than blood levels of 70 year olds, but you 
can't tell who's having hot flashes, you don't know what a 
normal level of estrogen in a 70 year old is.
    So this is an aura of science over something that is not 
scientific. Also saliva is not an appropriate, salivary hormone 
tests are not appropriate for several hormones, including 
progesterone, and that's been shown in scientific studies.
    Ms. Watson. Can I get my time back? [Laughter.]
    Mr. Burton. Ms. Petersen, do you want to respond real 
quick, and then it's back to my good buddy.
    Ms. Petersen. I did. It's like looking at one thing, and 
none of the practitioners look at an estradiol level without 
looking at the clinical picture. Some women normally have very 
high estrogen levels throughout their whole lifetime. And when 
they drop, they may not drop very much, but they notice a huge 
difference. You have to tie the two.
    You can't rely on a test, and I agree, saliva tests are not 
the best tests. And there is some possibility of its use for 
some diagnostics, but not across the board. I agree entirely. 
It's just a tool. You can't just use one tool. You can't take a 
saliva test, no matter how good the test, or the blood test, 
and you can't figure out how many milligrams of this or that 
will do it for you. It's trial and error. You have to work with 
the patient and the clinical response.
    Dr. Hotze. And that's scientific. That's the history of 
medicine. Evaluate, make a diagnosis. Start on preparation of 
medications, see how the guest or the patient does. Make 
adjustments. That's scientific. That's the science of medicine.
    Ms. Watson. Dr. Fugh-Berman, I wasn't here for all the 
testimony, so let me direct this to you. In describing the 
condition of my own health, I have difficulty with patent 
medicines. I have side effects, and I have to continue to 
change. I use holistic medicine most often, because it has been 
customized to my own system. I can't take anything harsh and I 
usually have to break down prescriptions because they're just 
too strong for my system.
    Can you explain what problems you might have with seeking 
the natural hormones that are customized and will help an 
individual? I find that in patent medicine, there are so many 
additives, and I remember my doctor said, read labels. So I 
read labels on everything. When I see the additives, I know I'm 
going to be in trouble. And I'm trying to find the right kinds 
of foods that will go with my system. I don't know if that's a 
hormonal thing or not. But as I age I become more and more 
allergic to almost everything.
    So can you describe for me why you think the natural kinds 
of hormonal treatments are not as good as the others?
    Dr. Fugh-Berman. I wouldn't actually say that. I would say 
that the use of estriol, Bi-Est, Tri-Est or commercially 
available pharmaceutical preparations are effective for hot 
flashes and vaginal dryness. Those are the only things that 
they have been proven to be effective for.
    It's important to individualize any of these medications to 
a woman, especially now that we know that estrogens don't 
provide other health benefits, and that they do provide risks. 
However, there is no evidence that natural bioidentical 
hormones, whether they are in pharmaceutical drugs or in 
compounded prescriptions, are safer than synthetic estrogens.
    Ms. Watson. You said there is no evidence?
    Dr. Fugh-Berman. There is evidence that they are----
    Ms. Watson. Hold on. How do we gather evidence?
    Dr. Fugh-Berman. From observational studies or randomized 
controlled trials. We have randomized controlled trials showing 
that estradiol increases stroke risk. We have information from 
epidemiological studies that estriol increases endometrial 
cancer risk.
    This is not an unknown. This is known, and it's consistent 
with what we know about other estrogens. In my testimony, while 
you were away, I pointed out that even higher levels of 
naturally occurring estrogens in our own body are actually 
associated with higher levels of breast cancer risk. So there's 
no such thing as a harmless hormone. Hormones have risks.
    Sometimes it's worth it taking those risks for somebody who 
has very severe hot flashes, taking a risk of a slightly 
increased chance of having breast cancer might be worth it. But 
there is no evidence that these have other health benefits and 
it's really bothersome to me as a public health physician, as a 
physician concerned about public health, that there are claims 
being made that these compounded prescriptions will increase 
quality of life or prevent any disease. There is no evidence to 
support that, and there is evidence to support that they are 
harmful.
    Ms. Watson. I heard you say twice there is no evidence. And 
it would seem to me that if we did short term and long term 
studies across the board, maybe it would yield some empirical 
evidence that then we can base claims on both sides on.
    I would think, and in my own case, as I said, I chose to go 
to a holistic provider because the patent medicines were not 
helping me. I was becoming allergic to them.
    So would you not agree that we need to go into the studies 
and try using these hormones beyond just the hot flashes and 
the dryness in the uterus? Would you not agree that we really 
need to do some studies to see in what levels, in what dosages 
and so on they could or could not work?
    Dr. Fugh-Berman. You know, for many years, the medical 
profession thought that hormones were going to be helpful.
    Ms. Watson. No, no, no, no. Let me direct--my time is 
getting short. Let me get you on point.
    Dr. Fugh-Berman. There have been studies already done about 
these natural hormones.
    Ms. Watson. But I thought you said there was no evidence, 
no empirical evidence.
    Dr. Fugh-Berman. No. I said that there are randomized 
controlled trials showing that estradiol increases stroke risk.
    Ms. Watson. OK, time.
    Dr. Fugh-Berman. They're referenced in my written 
testimony.
    Ms. Watson. Dr. Fugh-Berman, what would you have against, 
starting today, I think it's July 22nd, going forward to do 
some in-depth kinds of studies to see about the effects of 
using these natural hormones and customizing them to the 
individual? Would you be, as an educator, as a clinician, as a 
doctor, would you be against that kind of research?
    Dr. Fugh-Berman. It depends on what the indications were 
for, Congresswoman Watson.
    Ms. Watson. Will you write a hypothesis----
    Dr. Fugh-Berman. There already have been studies of estriol 
for hot flashes and bone. It helps them.
    Ms. Watson. Hold on. I was very clear in giving you a date. 
And I----
    Dr. Fugh-Berman. What's the position you're studying?
    Ms. Watson. Well, that's your hypothesis, you know. And I 
have a Ph.D in education, I don't have one in medicine. But I 
do know how you formulate a study. What I'm saying to you is, 
would you have, would you object to studies going forward? Not 
what they've already done, but going forward to then be able to 
present empirical evidence?
    Now, let me tell you, I've been in this business of making 
policy for many, many years. For 17 years, I headed up the 
health and human services committee in the State Senate in 
California. We decided many years ago that smoking was bad for 
your health. So I came in with proposals, and I would have to 
convince my own colleagues that we ought to look and do 
research. They laughed, and they said, oh, no, and they were 
looking at the tobacco industry and protecting them and so on.
    So I found that education was the thing. And it took us 14 
years, but we were the first State that prohibited smoking in 
California air space, and now it's pretty universal. So I know 
what it takes to educate, when you make policy, that does no 
harm and does the best good.
    And so I would think that you've got tremendously 
compelling arguments on the other side, and I hear you kind of 
stuck in what was. I'm wondering if you could be flexible to 
see what could be.
    Dr. Fugh-Berman. I wouldn't be against doing long term 
studies with a reasonable hypothesis. However, it's generally 
considered unethical to study a drug with no proven benefit 
when we have evidence of harm.
    Ms. Watson. That is why you do a hypothesis. You make a 
proposal. And I also established bioethics committees in every 
hospital in the State of California, because we were having 
problems with the HMO movement and so on.
    So I was, what I wanted to hear from, and anyone can 
response to this, maybe Dr. Brownstein, would you feel that it 
was ethical to start doing some short and long term studies to 
be able to determine with empirical evidence if this was an 
effective kind of treatment?
    Dr. Brownstein. Well, certainly we need to do studies and 
answer as many questions as we can. I would agree with Dr. 
Berman, I think estrogens are a major problem in the 
environment. They're in pesticides, they're fattening up the 
animals with estrogens, they're in plastics. The natural 
estrogens are the least of any natural hormone that I use. I 
don't use them in most women, I don't use them in men. And I 
use a lot of the other natural hormones to reverse or improve 
people's health and help them get over their chronic illness.
    Dr. Hotze. And Congresswoman Watson, I have already 
initiated studies, and there are a lot of clinical studies. In 
fact, the PEPI study, which was completed in 1995, which is the 
Postmenopausal Estrogen Progestin Intervention study, and I 
think that was Government funded as well, first line of 
treatment for women on estrogen therapy, postmenopausal, the 
first line of treatment they said they needed natural 
progesterone first. But very few doctors prescribe natural 
progesterone, they all prescribe the counterfeit--provera, 
medroxyprogesterone and the other counterfeits, because that's 
what the drug companies sell.
    The drug companies can't patent anything biologically 
identical. They can't do it. You can patent the strength or the 
formula, but you can't patent the hormone. There's no money in 
it for the drug companies. That's the way it is.
    If there's no money in it, they're not going to promote it. 
And that's why we in private practice, like Dr. Brownstein and 
myself and hundreds and thousands of other doctors across the 
country and compounding pharmacists have embraced, we've seen 
what it's done to our patients, and I would say for Dr. Berman, 
I would be glad to offer her a one person test, I invite you to 
come to our office in Houston, be worked up, be evaluated, do a 
2-month trial and see how you feel.
    Dr. Fugh-Berman. Thank you. That would save me $3,000.
    Dr. Hotze. Yes, it would, it would save you that. I'd be 
glad to. Then you could do it from personal experience, see how 
you feel and then talk about it. Because I've been on both 
sides of the aisle. I was over on your side of the aisle at one 
time, too. But I decided to challenge it, think out of the box, 
think unconventionally. And believe it or not, the world would 
always be the same if people never thought out of the box and 
thought conventionally. Thank God you all didn't.
    Congresswoman Watson, if you hadn't been willing to 
challenge the tobacco industry and everybody said, you're crazy 
as you can be----
    Ms. Watson. Do you know what my last proposal to my 
colleagues was? I was commissioning the University of 
California to research the connection between wrinkling and 
smoking. Well, the guys almost laughed me off the floor.
    Dr. Hotze. And they're doing it now probably.
    Ms. Watson. The bill passed. Three years later, they came 
back and made the connection and the rest is history.
    Dr. Hotze. There you go. And of course, Congressman Burton 
too, with the mercury problem.
    Mr. Burton. I thought you were going to talk about my 
wrinkles. [Laughter.]
    Go ahead, I'm just kidding.
    Dr. Hotze. But you thought out of the box and challenged 
the conventional thinking on mercury, both of you have. And to 
your credit. That's wonderful. Thank God for you all being 
willing to do that. And that's what we need, people in the 
medical community to challenge it. All you have to do is listen 
to women and the way they're treated and how they feel and 
they're not being taken care of.
    There's a revolution coming. The doctors in this room and 
across the country, they don't even know it's coming. But there 
are going to be women like Vicki Reynolds that go, Doctor, 
guess what, I'm firing you, good-bye, click.
    Mr. Burton. In any event, what I'd like to do, because it's 
getting late and some of you have to catch planes and so forth, 
I'd like to have your recommendations on what we can do to make 
holistic medicine and these complementary and alternative 
therapies more available and also, any information you have on 
the safety of them and the efficacy of them.
    Dr. Hotze. I will send you that.
    Mr. Burton. We would like to have that.
    And you said something about a letter earlier.
    Dr. Hotze. A letter to the FDA. And if I could have your 
permission to visit with one of your staff members----
    Mr. Burton. Yes. I think Mindi and Brian, Brian is my right 
arm in the office. Brian and Mindi will be happy to sit down 
with you and talk with you about that.
    Dr. Hotze. Thank you very much.
    Ms. Petersen. Chairman Burton, if I might say something.
    Mr. Burton. Sure.
    Ms. Petersen. I would like to propose that we have a money 
back guarantee.
    Mr. Burton. What?
    Ms. Petersen. A money back guarantee.
    Mr. Burton. On what?
    Ms. Petersen. On health care. If you go to your doctor and 
he doesn't get you healthy and that prescription you got 
doesn't make you better, money back.
    Mr. Burton. You know, I want to tell you, that's a very 
interesting statement. We have 600 lobbyists in Washington that 
represent the pharmaceutical industry, 600. There's 535 Members 
of Congress and the Senate. They outnumber us. And any time we 
talk about, Congresswoman Watson and myself, or anybody else 
talks about anything, you would not believe the attacks and 
everything else that takes place.
    Just to give you a little aside, so you'll know why I'm 
saying that what you're talking about is crazy, because it's 
never going to happen, is that in Canada, a woman who buys 
tamoxifen can buy it for $50, $60, and it's a very big help for 
women that have had cancer. In the United States, it costs as 
much as $350 for a 30 day supply. And yet the Food and Drug 
Administration and the pharmaceutical companies and everybody 
else have said, oh, my gosh, we don't want reimportation. And 
they come up with a million reasons why we can't have it.
    That's just one example. There are hundreds and hundreds 
and hundreds of pharmaceutical products that cost four, five, 
six, seven times as much here as they do elsewhere. And yet the 
pharmaceutical companies have been fighting like crazy to stop 
reimportation. They are a very, very powerful lobby. And 
doctors, I think a lot of doctors probably would not be aware 
of a lot of things, so I'm not sure they're going to give you a 
money back guarantee on things they're not aware of, so I don't 
think that's going to happen.
    In any event, I would like to have from you, including you, 
Dr. Fugh-Berman, I'd like to have any recommendations that you 
have that you think we could utilize to help the health of 
women. And don't forget the men. You haven't talked much about 
the men today, and you know, I'm getting up there, I'd kind of 
like to know how I can be more virile and keep my hair and keep 
the color down. So if you have any testosterone with you, throw 
a couple packages up here for me before you leave. [Laughter.]
    In any event, thank you all for being here. Did you have 
any other questions, Ms. Watson?
    Ms. Watson. No, thank you, Mr. Chairman.
    Mr. Burton. But I would like to have anything you think we 
should be doing in writing, so we can followup on it, because 
we will do that.
    Thank you very much. We stand adjourned.
    [Whereupon, at 5:35 p.m., the subcommittee was adjourned, 
to reconvene at the call of the Chair.]
    [Additional information submitted for the hearing record 
follows:]

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