19. Ten Bioidentical Hormone Fallacies
A recent article on Huffington Post on the topic of
hormones for menopause caught my attention. (1)
I was puzzled by the fact that the author had no medical credentials, medical
training or even a rudimentary knowledge of biological science. Rather, she is an actress with a theater arts
degree from UCLA. She chronicled her menopause experience with a book and blog
entitled, “Menopause Makeover”. To make up for her lack of medical knowledge,
the author joined up with an academic physician who advocates synthetic,
chemically altered hormones (progestins), and SSRI antidepressants for
menopausal symptoms. The latest article
by the two women, "10 Hormone Therapy Facts ", is a compilation of
nonsense, falsehoods, and half truths, with a hidden agenda promoting the synthetic hormone industry by
maligning natural bioidentical hormones.
Ten Hormone Facts Should Be Renamed 10 Ten Hormone Fallacies
Firstly, the article attempts to malign bioidentical
hormones, claiming they are unregulated, non-FDA approved and not supported by
science. These claims against bioidentical hormones are false, and a
smokescreen to hide the really frightening fact that synthetic hormones are
monsters that cause cancer and heart disease, as shown in the Women's Health
Initiative study. Secondly, the article
tries to confuse the difference between bioidentical hormones and synthetic,
chemically altered hormones made by the pharmaceutical industry. Do not be
confused, they are very different. Synthetic hormones are chemically altered
monsters that cause cancer and heart disease. Bioidentical hormones are
identical to hormones found naturally in the human body, the safe and effective
choice. Thirdly, the article contradicts
itself, stating that blood testing is not needed, while the author earlier
reported that blood testing revealed a high estrogen level. Obviously, blood
testing of hormone levels was needed. Fourth,
the article quotes the Menopause and Endocrine Societies as authorities without
revealing their financial ties to the synthetic hormone makers such as Wyeth. Fifth, the author says that bioidentical
hormones did not work for her. Quite to the contrary, millions of women use
bioidentical hormones every day for relief of menopausal symptoms and quality
of life. Bioidentical hormones work quite well. Sixth, after ranting that bioidentical
hormones don't work, the author reports they DO work, and admits she uses
estradiol, a bioidentical hormone.
Estrogen alone without progesterone causes increased risk of endometrial
cancer. This important information is omitted from the article, possibly
harming women readers who accept the author as a medical authority, incorrectly
concluding that estrogen without progesterone is acceptable. It is not acceptable, and is a disservice to
go through the article in detail. Note: the article text is in italics:
hormone treatment made my menopausal symptoms worse.
splurged for Somers' expensive Beverly Hills doctor recommendation, assuming he
must have the answers. He confirmed I was menopausal and gave me tubes of
compounded triple estrogen gel and compounded 10 percent micronized
progesterone gel, with orders to apply them regularly. After a few months of
visiting this overpriced Beverly Hills doctor, my menopause symptoms were
exaggerated and my moodiness turned into depression. "
comment: The above described bioidentical hormone program of
topical estrogen and progesterone is the correct one, used by millions of women
daily. It is safe and effective. However, close patient monitoring is required,
and the patient should be alerted to watch out for signs of hormonal excess.
Test revealed my estrogen levels were 7 times higher than normal
blood test revealed that my estrogen levels were seven times higher than
normal, my increased weight now placed me into the overweight BMI category, and
my severe crankiness made it impossible to work. There is no need for testing
of hormone levels, either in saliva or blood. The science has shown that there
is no predictable correlation between hormone levels in saliva or in blood and
severity of symptoms. “
comment: The author
of this article should have studied Uzzi Reiss’s books on bioidentical hormones
which explain the symptoms of estrogen excess.(12) These symptoms are fluid retention, bloating,
breast enlargement and tenderness. Once
these estrogen excess symptoms are identified, the patient should hold off
using the estrogen until symptoms dissipate and are relieved. Educating the patient about estrogen excess
symptoms, and when to hold hormone dosage is the key to successful treatment
Control Pills Can Make Ovarian Function Erratic
Birth control pills complicate the story
considerably. Birth control pills are a
form of chemical castration, causing artificial cycles without ovulation. Once the pills are stopped, there is usually a
delay of months before normal ovarian function and normal cycling resumes, and
patients typically experience menopausal symptoms. Upon starting a bioidentical hormone program,
the patient will feel better. However, a
few months later with resumption of ovarian function, there may be hormonal
excess with symptoms of bloating, breast enlargement and mood disorder. This is
not a failure of the medication, rather it is a failure of patient monitoring
and failure to alert the patient to estrogen excess symptoms. Blood testing is
useful here to show elevated estrogen levels.
However, in most cases testing is not required since the clinical
picture is obvious.
Hormones Not Supported by Science
went wrong? I trusted a resource not supported by science. I was taking
unregulated hormones. It was eye-opening to learn that natural compounded
bioidentical hormones were unregulated by the FDA. There was no standardization
for producing the product, and no tests on the formulations. There are NO real
natural hormone products available."
comment: The author clearly had a bad experience with this
first doctor, and then incorrectly concludes there is something wrong with the
bioidentical hormones, saying that bioidentical hormones are not supported by
science, unregulated, non-standard, and untested. Of course, this is all
nonsense. Bioidentical hormones are heavily regulated, tested and supported by
science. The statement, “There are NO real natural hormone products available”
is more nonsense. Quite to the contrary, millions of women are using them every
Science DOES support the use of bioidentical
hormones for menopausal symptoms. Go to Medline and do a search for estrogen or
progesterone and 90,000 articles will come up. Dr. Holtorf’s review article , “The
Bioidentical Hormone Debate”, published
in PostGraduate Medicine, cites 196 medical studies showing that bioidentical
hormones are safer and more effective than synthetic chemically altered
Bioidentical hormones are heavily regulated as both
FDA approved products at the corner drug store and as compounded preparations.
Compounding does not fall under the jurisdiction of the FDA, so FDA regulation
is not needed or even desired. Instead, Compounding pharmacies have a separate
system of regulation at the state and local level which is rigorous and
recognized by the AMA. Look for a compounding pharmacy with PCAB
) “Natural: The word "natural" is a marketing term. There is no
scientific evidence that custom-compounded bioidenticals are safer or more
effective or more "natural" than standard pharmaceutical bioidentical
prescriptions. The only "natural" hormones are the hormones being
made by your body. “
Comment: The word “natural” is not only a marketing term.
Natural means anything found in the natural world that cannot be patented. This next comment is a tautology as
bioidentical is still bioidentical whether found in FDA approved prescriptions
or in compounded preparations. We know
from the Women’s Health Initiative study JAMA 2002 , that synthetic hormones
are monsters that cause cancer and heart disease. Bioidentical hormones are
safe and do not increase risk of cancer or heart disease as shown in the French
“Bioidenticals: Laboratories create formulations that are either identical
(bioidentical) or not (non-bioidentical) to those in your body. There are FDA
approved prescription estradiol products that are bioidentical that are not
My Comment: This is correct.
“Compounded hormones: Made in a pharmacy by combining, mixing or altering
ingredients to create a customized hormone for an individual patient.
Compounding pharmacies must be licensed and regulated by the State Pharmacy
boards. However, they do not have to demonstrate the safety, effectiveness and
quality control, based on large, scientific studies that the FDA requires of
pharmaceutical manufacturers. Compounding pharmacies use chemically synthesized
hormones made from plants --the same government-approved ingredients that are
used in a manufacturer's laboratory. "Compounded" formulations are
neither safer nor more "natural."
Comment: Compounded Pharmacies are not under FDA
jurisdiction, and that is why they are not regulated by the FDA. Instead, they
are regulated by the state and local government. To expect and insist on FDA
regulation for compounding pharmacies is like saying your state driver's
license is invalid because it was not issued by the federal government. If one rejects compounded medications, then
one would also reject intravenous antibiotic treatment at the hospital which is
also a compounded medication. Obviously,
there is a problem with the logic used here.
What Does FDA Approval Mean? The author creates
confusion about the meaning and significance of FDA Approval. Food and Drug Administration approval does not
confirm that the drug is the most effective or the safest drug for you. FDA approval means the drug is more effective
than placebo for its indicated use and benefits outweigh risks. Drug Manufacturers spend 500 to 800 million
doing clinical studies submitted for FDA approval, because of the future
prospects for greater profit. The
chemical structure of a bioidentical hormone, like other natural substances,
cannot be patented, so there is very little financial incentive for a drug
company to spend all that money on clinical studies when profits cannot be
Drugs are FDA approved for certain medical
indications. About 20% of the time,
doctors prescribe drugs for non-FDA approved indications. For example, the use
of SSRI antidepressants as a non-hormonal treatment for hot flashes is a
non-FDA approved use of the drug. Mainstream doctors engage in hypocritical
reasoning when they criticize others who prescribe compounded bioidentical
hormones as non-FDA approved. The
problem with this argument is that intravenous medications given at the
hospital are also non-FDA approved compounded medications. Get
rid of compounding and you must throw out most medications dispensed at the
hospital which are, in fact, compounded medications.
Chemically Synthesized Hormones
By using the phrase, “Compounding pharmacies use chemically synthesized hormones”, the
author is again confusing the reader with the difference between synthetic
hormones and bioidentical hormones. They are quite different. Synthetic hormones are chemically altered
monsters. On the other hand, bioidentical
hormones have the same chemical structure as those found in the human
body. How the hormone was made or
manufactured is not important as long as the chemical structures are identical. A good example is water made by combining an
oxygen molecule with two hydrogen molecules.
The manufacturing process is irrelevant, since the final chemical
structure is H2O, water, a natural substance that cannot be patented.
The North American Menopause Society (NAMS), a non-profit organization of
expert scientists and clinicians, "does not recommend custom-compounded
products over well-tested, government-approved products for the majority of
women." The Endocrine Society has stated that, "Post-market surveys
of such (compounded) hormone preparations have uncovered inconsistencies in
dose and quality."
comment: The author omits that both NAMS and Endocrine
Society have publicly acknowledged financial ties to the drug industry. In addition, both organizations advocate the
use of synthetic “monster” hormones, and as such, represent the financial
interests of the synthetic hormone industry (such as Wyeth and Abbott), rather
than the health of the public. Half of
the board of trustees of NAMS receives money from Wyeth in the form of
consulting fees or research support.
Wyeth makes Prempro and Pristiq.
These Financial Disclosures are listed page 10 of the NAMS 2007 position
statement on Hormones for Menopause.
Medical education and research requires authors to publicly disclose
financial ties to the drug industry which alerts the reader to a biased
To determine whether hormone therapy is appropriate and safe, one's risk
factors must be assessed based on personal and family medical history, as well
as personal preference. There is no "one size fits all."
Comment: Personal and family medical history is always part
of any medical evaluation. The above statement refers to risk factors for
breast cancer. All women are at risk
for breast cancer from environmental carcinogens, and more so if there is an
underlying genetic abnormality such as the BRCA gene for breast cancer. The important fact to remember is that
Bioidentical Hormone therapy is safe and effective, while synthetic “monster”
hormones are the ones that cause cancer and heart disease, and should be
“ Low dose hormone therapy, used judiciously, still remains the most effective
way to treat the troubling symptoms of menopause for those who need it and who
can use it safely.”
Comment: Since mainstream physicians know that synthetic
“monster” hormones are dangerous, causing cancer and heart disease, they shrug
their shoulders and accept “low dose” synthetic hormone therapy as more
desirable than the higher dosage used routinely. Less of the harmful monster
hormone is given to the patient.
Synthetic chemically altered hormones are “Monsters” at any dosage. Stay
“There is no need for testing of hormone levels, either in saliva or blood. The
science has shown that there is no predictable correlation between hormone
levels in saliva or in blood and severity of symptoms. Unless there are unusual
complications, it is the standard of care to treat symptoms if needed and
adjust medications according to response, not saliva levels.”
Comment: There are no blood tests for synthetic hormones, so
proponents of synthetic hormones pretend that lab testing is not needed. The reality
is that very useful blood, urine and saliva testing is available for the entire
range of bioidentical hormones. If your doctor doesn’t do some sort of testing,
you need a new doctor.
) “Standard prescription hormone therapy is the safest form available. It has
been tested by the FDA and manufactured in a highly regulated manner. Doses are
Prescription hormone therapy” is coded language for
chemically altered synthetic “monster” hormones shown to cause cancer and heart
disease in the Women’s Health initiative study. That’s not so safe. “Tested by the FDA” is a misnomer and
error. The FDA doesn’t do any testing. The drug company pays for testing and
then submits the results on paper to the FDA for approval. The testing has to
show drug efficacy over placebo. That’s all. Sometimes the testing is fudged.
Ten percent of FDA approved drugs are later banned, and another ten per cent
are given a “black box” warning. (17)
There are also FDA approved non-hormonal therapies available to treat menopause
symptoms for those who cannot take hormones.
Comment: The above statement a reference to the use of SSRI
antidepressants for menopausal symptoms. These drugs were recently shown to be
no better than placebo for depression.(16) Regarding efficacy for hot flashes, drug
company funded studies showed efficacy over placebo was marginal at best. (14-15)
Synthetic altered hormones are bad
enough, they cause cancer and heart disease. SSRI antidepressant drugs like Effexor™ and
Pristiq™ are even worse; they are chemically addictive with horrendous
withdrawal effects.(18-19) The use of SSRI antidepressants for menopausal
symptoms should be condemned as a misguided adventure. The practice should be halted.
) “Whether hormone therapy is needed
depends on severity of symptoms, including hot flashes, night sweats, vaginal
dryness and irritability. Hormone therapy should be individualized, which may
mean trying different doses and schedules, as well as different routes of administration.”
Comment: Mainstream medicine will ask patients to “live with
it” if the menopausal symptoms are not severe enough to warrant treatment. Millions of smart women have rejected
synthetic hormones, and SSRI antidepressants, and are finding success with
bioidentical hormone programs.
formulas and inconsistent compounded dosing can be dangerous and has
jeopardized the health of many women, including myself. I wished I had known
the dangers involved with compounded-hormones. After my menopause symptoms were
stabilized with a standard prescription of bioidentical estradiol, I found a
new way of eating, lost 30 pounds and updated my beauty regime without cosmetic
surgery or alterations. I have never been healthier.”
Comment: The author clearly blames inconsistency in her
compounded formula for an episode of hormonal excess. I would disagree, and
suggest the hormonal excess may have been due to resumption of hormonal
production following cessation of synthetic birth control pills. To avoid hormonal excess, our office staff
monitors patients by phone very closely, reminding them of the warning signs of
hormonal excess. At the earliest sign of hormonal excess, the patient stops
using the estrogen cream. This type of program is very safe. In my experience prescribing compounded
hormone preparations and monitoring patients, the formulas have been consistent
and standardized, and patients have been happy with the results. For the highest consistency, we use only the
large national pharmacies that specialize in bioidentical hormones.
At the end of the article, the author returned to Estradiol,
a bioidentical hormone. Yet the author omits the historical information that
Estrogen alone (Premarin) causes endometrial hyperplasia and cancer. That is
why progesterone must be given with the estrogen to prevent endometrial
hyperplasia. Omitting this information
is a disservice to women and potentially harmful for readers.
This "10 Facts" article is a mixture of
nonsense, falsehood and half truth. The quality of information reflects the
author’s credentials, which are none, other than briefly visiting a few doctors
for symptoms of hormonal imbalance. The medical information appearing in the
article comes from regurgitated drug company propaganda advocating synthetic
chemically altered “monster” hormones and SSRI antidepressants for menopause, performing a disservice to women. A safer, more effective alternative is
bioidentical hormone therapy. Rather
than rely on this type of biased advice, a more balanced viewpoint is available
from well known medical experts such as David Brownstein, Kent Holtorf, Bruice Kenton, Sangeeta Pati, C. W. Randolf, Erika Schwartz,
and Jonathan Wright. Read their books
The history of modern medicine is replete with the
medical victimization of women. A few
discarded examples are: radical mastectomy, excessive hysterectomies, and bone
marrow transplant for breast cancer.
Synthetic hormones belong on that list. The latest medical hoax is SSRI
antidepressants for hot flashes. Take
back control of your bodies. Do not allow yourselves to be victims of synthetic
hormones and antidepressants for menopausal symptoms. The proper treatment is bioidentical hormone
therapy. Bioidentical hormone doctors are available in your area. You can find them with doctor’s directories
from organizations like ACAM and A4M.
Update 2016: Since this chapter was written, the Huffington Post Article has been modified significantly, and the comments have been removed.
For references and links, see my web site: www.bioidenticalhormones101.com
Articles with related Interest:
BioIdentical Hormones Trashed by AP News
Bioidentical Hormones According to the LA Times
Ten Bioidentical Hormone Fallacies
References for Chapter 19. Ten
Bioidentical Hormone Fallacies
(1) http://www.huffingtonpost.com/staness-jonekos/10-hormone-therapy-facts_b_615199.html 10 Hormone Therapy Facts Every Woman Should
Know by Staness Jonekos
(2) Postgrad Med. 2009 Jan;121(1):73-85. The Bioidentical Hormone
Debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer
or more efficacious than commonly used synthetic versions in hormone
replacement therapy? Holtorf K. Holtorf Medical Group, Inc., Torrance, CA
(3) http://www.ncbi.nlm.nih.gov/pubmed/18928825 Prim Care. 2008
Hormones in wellness and disease
common practices, current state of the evidence, and questions for the future.
Schwartz ET, Holtorf K.
Could transdermal estradiol +
progesterone be a safer postmenopausal HRT? A review.
L'hermite M, Simoncini T, Fuller S, Genazzani AR. Maturitas. 2008
Jul-Aug;60(3-4):185-201. Epub 2008 Sep 5. Department of Gynecology and
Obstetrics, Université Libre de Bruxelles, Bruxelles, Belgium.
Point/Counterpoint:The Case for
Bioidentical Hormones by Steven F. Hotze, by Steven F. Hotze, M.D. Donald P. Ellsworth,
M.D. Journal of American Physicians and Surgeons Volume 13 Number 2
Summer 2008 p43.
A Comprehensive Review of the
Safety and Efficacy of Bioidentical Hormones for the Management of Menopause
and Related Health Risks by Deborah Moskowitz, ND Altern Med Rev
(7) http://www.ncbi.nlm.nih.gov/pubmed/17107222 Treat Endocrinol.
Is Bio-Identical Hormone Replacement Therapy Safer than Traditional Hormone
Replacement Therapy?: A Critical Appraisal of Cardiovascular Risks in
Menopausal Women. Curcio JJ, Wollner DA, Schmidt JW, Kim LS. Women’s
Integrative Medicine Department, Southwest College of Naturopathic Medicine,
Tempe, Arizona, USA.
(8) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2211383/ Breast Cancer Res Treat. 2008
January; 107(1): 103–111. Unequal risks for breast cancer
associated with different hormone replacement therapies: results from the E3N
cohort study by Agnès Fournier,
1 Franco Berrino,2 and Françoise Clavel-Chapelon1*
(9) http://bostonreview.net/BR35.3/angell.php Boston Review MAY/JUNE
2010 Big Pharma, Bad Medicine-How corporate dollars corrupt research and
education by Marcia Angell
(10) http://jama.ama-assn.org/content/288/3/321.abstract Risks and Benefits of Estrogen Plus Progestin
in Healthy Postmenopausal WomenPrincipal Results From the Women's Health Initiative
Randomized Controlled TrialWriting Group for the Women's Health Initiative
Investigators JAMA. 2002;288(3):321-333.
(11) http://www.ncbi.nlm.nih.gov/pubmed/171569 N Engl J Med. 1975 Dec 4;293(23):1167-70.
Increased risk of endometrial carcinoma among users of conjugated
estrogens.Ziel HK, Finkle WD.
(12) http://www.uzzireissmd.com/refs/04.html The Natural SuperWoman, by Uzzi
Reiss MD and Yfat Reiss Gendell, Avery Trade , 2008. web site page containing references
for Estrogen chapter.
(13) http://www.ncbi.nlm.nih.gov/pubmed/12626212 Climacteric. 2002 Dec;5(4):332-40. Combined
hormone replacement therapy and risk of breast cancer in a French cohort study
of 3175 women. de Lignières B, de Vathaire F, Fournier S, Urbinelli R, Allaert
F, Le MG, Kuttenn F.
(14) http://www.cnsspectrums.com/aspx/article_pf.aspx?articleid=922 Beyond Remission, Rationale, and Design of the
Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years
(PREVENT) Study, Susan G. Kornstein, MD CNS Spectr. 2006;11:12(Suppl 15):28-34
This supplement is sponsored by Wyeth.
(15) http://www.news.vcu.edu/news/Low_Doses_of_AntiDepressant_May_Spell_Relief_for_Some_Women_Suffering Low Doses of Anti-Depressant May
Spell Relief for Some Women Suffering from Moderate-to-Severe PMS. Sathya Achia Abraham VCU Communications and
(16) http://jama.ama-assn.org/content/303/1/47.short?home Antidepressant Drug Effects and Depression
Severity, A Patient-Level Meta-analysis. Jay C. Fournier, MA; Robert J.
DeRubeis, PhD; Steven D. Hollon, PhD; Sona Dimidjian, PhD; Jay D. Amsterdam,
MD; Richard C. Shelton, MD; Jan Fawcett, MD JAMA. 2010;303(1):47-53
(17) http://www.ncbi.nlm.nih.gov/pubmed/11980521 JAMA. 2002 May
1;287(17):2215-20. Timing of new black box warnings and withdrawals for
prescription medications. Lasser KE et al.
(18) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC181155/ Prim Care Companion J Clin
Psychiatry. 2001 February; 3(1): 22–27. SSRI Antidepressant Medications: Adverse
Effects and Tolerability by James M. Ferguson, M.D.
J Psychopharmacol. 2009 Nov;23(8):967-74.
Epub 2008 Jul 17. Problems associated with long-term treatment with selective
serotonin reuptake inhibitors. Moret C, Isaac M, Briley M.
Jeffrey Dach MD
7450 Griffin Road Suite 190
Davie, Florida 33314
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