17. BioIdentical Hormones Trashed by AP News
Left Image: Red Blood Cells Seen with Scanning Electron
Microscope, Courtesy of Bruce Wetzel and Harry Schaefer of the National Cancer
USA Today article trashing bioidentical hormones caught my attention because it
contained almost pure misinformation.(1)
Written by an Associated Press AP medical writer, this syndicated
article was broadcast over the news media.
The writing is a perfect example of trash, or junk journalism. I find it astonishing that the news media
feeds this kind of nonsense to the public.
The AP article attempts to discredit bioidentical hormones as non-FDA
approved, and not proven safe nor effective.
Before analyzing the nonsense in the newspaper article, let's take a
humorous look at what if the author took her own advice seriously, assuming
that naturally occurring human hormones are harmful and dangerous non-approved
chemicals. The author, an AP medical
writer, might be horrified to know that these non-FDA approved bioidentical
hormones, (estradiol, progesterone, estriol and testosterone), are floating
around in her blood stream right now, and have been since she was born.
So please don't do anything impulsive and crazy to
remove these non-FDA approved chemicals from your body. They are supposed to be there. In fact, these same little non-FDA approved
bioidentical hormones have been present in the blood stream of all primates
(this includes AP medical news journalists and monkeys) for 40 million years.
That's a long time, even for an AP journalist.
Doctors write 65 million prescriptions yearly for
non-FDA approved medications, as part of routine medical practice. (8) Two examples are phenobarbital, an
anti-convulsant, and chloral-hydrate, a sedative.(8) Another example is intravenous antibiotic
treatment at the hospital, a non-FDA approved compounded drug prepared by the
hospital compounding pharmacy.
FDA Approved and Non-FDA Approved
But Wait! No need to even worry about it, because,
Bioidentical Hormones ARE INDEED FDA
approved. The author even says so in her
article. This list of FDA approved bioidentical hormones is presented
below. But wait! How can bioidentical
hormones be both FDA approved and non-FDA approved? If they are in a bottle at
the corner drug store, they are FDA approved, and if they are in my body, they
are non-FDA approved. This is really
The answer can be found in the textbook of
biochemistry used by all medical schools, Lehninger’s Principles of Biochemistry Chapter 23 on Hormonal
Regulation.(16) This authoritative source
says the chemical structure of a hormone is independent of where it is. The
hormone can be in the human body, in a glass of water, in a bottle at the
corner drug store. This doesn't matter;
the hormone has the exact same chemical structure. This means that if a bio-identical hormone is
FDA approved in a bottle of pills at the drugstore, then the same chemical
structure is FDA approved in the human body or anywhere else, it's the same
stuff. But for some strange reason, the
FDA doesn't work that way and separate paperwork has to be submitted for each
one. Welcome to the US government.
the Misinformation Line by Line:
But first, let’s take a closer look at the
disinformation in the AP article (in bold italic below):
of women have tried custom-compounded hormones .... since 2002, when a big
federal study found risks from traditional hormone replacement therapy, or
The author is correct about the massive switch in
2002, when millions of women abandoned synthetic hormones, and embraced
bioidentical hormones after a federal study, the Women's Health Initiative,
found that a combination of premarin and provera caused cancer and heart
disease. This NIH study used Prempro, a
combination of Premarin and Provera, and was terminated early. The culprit was Provera, a synthetic,
chemically altered form of progesterone, which has been known for decades to
increase risk of cancer and heart disease.
The form of estrogen used in the study was Premarin, a horse estrogen
from pregnant horse urine. This massive
switch to bioidenticals shows that women are smart. Two important things happened after
this. Synthetic hormone drug maker Wyeth
lost 4 billion dollars in sales, and secondly, breast cancer rates dropped
precipitously when masses of women stopped synthetic hormones and started
bioidenticals instead. This data was published in 2007 in: “ The Decrease in
Breast-Cancer Incidence in 2003 in the United States” by Peter M. Ravdin et al.
(14) Another study showed a similar
decrease in breast cancer rates in Canada after discontinuing synthetic
instead of a safer option, (women) are getting products of unknown risk that
still contain the estrogen many of them fear, women's health experts say.”
This is deliberate misinformation. Bioidentical hormones are safer and more
effective than the synthetic chemically altered "monster" hormones
used in the Women's Health Initiative study.
The safety of bioidentical hormones was demonstrated by the French
Cohort study, which showed no increased cancer in the bioidentical group. (9) In addition, Dr Holtorf's article cites 196
research studies comparing bio-identical hormones to synthetic patented
hormones (like Provera). (10) Dr
Holtorf's review of the medical literature concludes:
Based on both physiological results
and clinical outcomes, current evidence demonstrates that bioidentical
hormones are associated with lower risks than their nonbioidentical
counterparts. Until there is evidence to the contrary, current evidence dictates
that bioidentical hormones are the preferred method of HRT. (10)
See my article on the safety of bioidentical hormones for more on this topic. The USA Today article continues:
is a marketing term that has no accepted medical meaning.
This statement is entirely wrong. The term
bioidentical has a definite meaning and is widely used. The term, bioidentical,
means a hormone chemical structure which is identical to that found in the
human body. Both the Endocrine Society
and ACOG (American College of Obstetrics and Gynecology) define the term,
"bioidentical", exactly the same, even though the two definitions are
worded differently. It is an
embarrassment to medical science that the word “bioidentical” has to be used at
all. All hormones should have been
manufactured as bio-identical hormones.
However, because of U.S. patent law which prevents patenting a
bioidentical hormone chemical structure, the drug industry created chemically
altered hormones which could be patented and sold at higher profit
margins. These altered-synthetic
hormones are monsters that should never have been approved by the FDA for human
prescription drugs contain hormones that chemically match estrogens and
progesterones made naturally by the body.”
This is correct. These bioidentical hormones have
gone through the FDA approval process showing they are safe and effective. Here a partial list of FDA approved
bioidentical hormones available at the corner drug store:
Year of FDA Approval
“…Custom-compounded hormones are not
approved by the federal Food and Drug Administration and have not been proved
safe or effective. “
This is a misleading and deceptive statement. Custom compounding is regulated at the state
level, not by the federal government or the FDA. So, of course compounding is not
FDA approved. No FDA approval is
required or even desired. Are we going
to reject intravenous antibiotic treatment at the hospital because, as a
compounded medication, this is also non-FDA approved and not proven safe or
effective? Aspirin is FDA approved for
over the counter sales. If the
compounding pharmacy crushes the aspirin tablet and places the powder into
capsules, the aspirin becomes non-FDA approved aspirin, even though it is the
same stuff. Starting to make sense now?
The author falsely claims that bioidentical hormones
have not been proven safe and effective as required for FDA approval
process. Take a look at the list of
bioidentical prescription hormones above. These are all FDA approved and proven
safe and effective.
may carry the same cancer and heart risks as traditional treatments and have
had even less testing to find out.”
The author is wrong again. The French Cohort study,
showed no increased cancer in the bioidentical group. (9) Again, look at, Dr Holtorf's article in Postgraduate
Medicine listing 196 research articles showing Bio-identical Hormones are
associated with lower risk, and are more efficacious than synthetic
counterparts.(10) Two calcium scoring
studies showed no increased risk of heart disease associated with bioidentical
hormones. A study of CAT calcium scores by Dr. JoAnn E. Manson in the June 2007
JAMA actually showed less heart disease in the women taking unopposed estrogen
(they had hysterectomies and were not given the synthetic progestins). (11) These same results had been published 2 years
previously in a coronary calcium score study by Dr. Budoff in the 2005 Journal
of Women’s Health. (12)
preparations do not need to be customized for each woman; a few standard doses
work for almost everyone, medical experts say. “
I don't know who the medical experts were, but I
have found dosage varies for bioidentical hormones just as dosage varies for
any other drug. Pick up any medical
pharmacology text book. What you find is
drug dosage varies according to age, body weight, genetics, and hepatic
metabolism of the drug.(7) The advice
to use standard dosing comes from drug company marketing literature, and is simply
saliva tests that some women are given to tailor formulas are of dubious value
because hormone levels fluctuate widely throughout the day.”
Again the above statement is an oversimplification
that is misleading. For some hormone levels salivary testing is
advantageous. For example, saliva
testing with four samples throughout the day shows salivary cortisol levels are
highest in the morning and lowest in the evening before sleep. Regarding sex hormones, in young cycling
females, hormones vary according to a monthly pattern of ovulation called the
menstrual cycle. Estrogen and progesterone
peaking around day 19-21 of the cycle.
Here, salivary hormone testing every two or three days can show this
variation and the peaks. In older, post
menopausal women who are no longer ovulating, menstrual cycles have stopped and
hormone levels typically decline to low levels.
As a general rule, wild daily hormone fluctuations simply do not happen
for post-menopausal woman. Rather,
hormone levels decline to low levels, and since ovulation has stopped, hormone
levels don't change much from day to day as revealed by blood testing of
pharmacists use such different methods that a customized prescription can
contain widely varying amounts of hormones depending on who fills it.”
This is a completely wrong and misleading statement. If a prescription for hormone cream is sent
to two different compounding pharmacies, and the two creams analyzed, they
should have the same amounts of hormones.
If they don't, then something is wrong and needs to be fixed. Each compounding pharmacy should make up the
exact same formulation when given the same prescription. In
other words, there should be reproducibility and consistency from one pharmacy
to another. The reality is that there
are so many small compounding pharmacies that quality control can be an issue. I
have found that this becomes a non-issue when dealing with the larger national
compounding pharmacies that specialize in hormones. The quality control is better, and
formulations are more consistent.
compounders use estriol, a form of estrogen not approved for sale in the United
States. The FDA is in a battle with compounding pharmacies over its use.”
Estriol is commonly use in compounding hormone
preparations, and like many other natural compounds used for many years,
approval was grandfathered in. Formal
FDA approval was not required nor was it requested. Medical research shows that of the three
estrogens, estriol, is the safest and most protective.
bottom line? "Women need to understand there's no rigorous evidence these
preparations are any more effective or any safer than traditional hormone
Again, the above statement is false. Dr Holtorf's
article published in the medical literature cites 196 references showing safety
and efficacy of bioidentical hormones.
years, medical groups have warned against custom-compounded hormones. The
American College of Obstetricians and Gynecologists has denounced claims about
their safety. The American Medical Association has urged more FDA oversight.
The Federal Trade Commission has filed complaints against online sellers who
made health claims for natural progesterone creams without supporting
These organizations are all heavily controlled by
the drug industry, so of course, they are going to oppose natural substances
that cut into profits of the drug industry.
Bioidentical hormones compete directly with the synthetic hormone
profits of the drug industry. That is
what this is all about. This is an
information war to protect drug company profits pure and simple.
For references and links, see my web site: www.bioidenticalhormones101.com
References for Chapter 17.
BioIdentical Hormones Trashed by AP News
Bioidenticals: Estrogen without FDA approval for menopause? By Marilynn
(2) http://www.thewholechild.us/integrative_/2009/06/alternative-medicine-in-the-news-a-bit-too-much.html Alternative Medicine" in
Throwing the baby out with the snake oil. Tuesday, June 9, 2009
(3) http://www.usatoday.com/news/health/2008-12-13-breast-cancer-hormone_N.htm New study firmly ties hormone
use to breast cancer.
(4) http://content.nejm.org/cgi/content/abstract/360/6/573 NEJM Volume 360:573-587
February 5, 2009 Number 6. Breast Cancer after Use of Estrogen plus
Progestin in Postmenopausal Women. Rowan T. Chlebowski, M.D., Ph.D., Lewis H.
Kuller, M.D.,et al. for the WHI Investigators.
(5) http://jnci.oxfordjournals.org/cgi/content/full/djm111v1 J Natl Cancer Inst. 2007 Sep
5;99(17):1335-9. Declines in Invasive Breast Cancer and Use of Postmenopausal
Hormone Therapy in a Screening Mammography Population. Karla Kerlikowske et al.
(6) http://www.sciencedaily.com/releases/2007/08/070814162852.htm Drop In Breast Cancer Incidence
Linked To Hormone Use, Not Mammograms ScienceDaily (Aug. 15, 2007)
(7) http://www.pharmj.com/pdf/cpd/pj_20040626_pharmacokinetics02.pdf Variability in Drug Dosage
Requirements, Alison Thompson. Age, Weight, Genetics . Pharmacokinetic
variability, hepatic metabolism of drugs, clearance with renal elimination,
NEW YORK (CNN) -- Every year, doctors write approximately 65 million
prescriptions for drugs not yet approved by the U.S. Food and Drug
Administration, the federal agency that regulates prescription drugs.
(9) 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.
(10) http://www.holtorfmed.com/pdf/01-Bioidentical-hormone-debate.pdf also see http://jeffreydach.com/files/80618-70584/The_Bioidentical_Hormone_Debate_Ken_Holtorf_MD.pdf
The Bioidentical Hormone Debate: Are Bioidentical Hormones (Estradiol, Estriol,
and Progesterone) Safer or More Efficacious than Commonly Used Synthetic
Versions in Hormone Replacement Therapy? Kent Holtorf, MD1
(11) http://www.nejm.org/doi/full/10.1056/NEJMoa071513 Estrogen Therapy and Coronary-Artery
Calcification JoAnn E. Manson, M.D. et al. N Engl J Med 2007; 356:2591-2602June
(12) http://www.ncbi.nlm.nih.gov/pubmed/15989413 J Womens Health (Larchmt). 2005 Jun;14(5):410-7.
Effects of hormone replacement on progression of coronary calcium as measured
by electron beam tomography. Budoff MJ et al.
(13) http://jama.ama-assn.org/content/287/17/2215.abstract JAMA. 2002;287(17):2215-2220.
Timing of New Black Box Warnings and Withdrawals for Prescription Medications Karen
E. Lasser, MD, MPH; et al.
(14) http://www.nejm.org/doi/full/10.1056/NEJMsr070105 The Decrease in Breast-Cancer Incidence in
2003 in the United States. Peter M. Ravdin, Ph.D., M.D., Kathleen A. Cronin,
Ph.D et al. N Engl J Med 2007; 356:1670-1674April 19, 2007.
Breast Cancer Incidence and Hormone Replacement Therapy in Canada.
Prithwish De, C. Ineke Neutel, Ivo Olivotto and Howard Morrison. J Natl Cancer InstVolume102, Issue19Pp.
Principles of Biochemistry by Albert Lehninger, David L. Nelson, Michael M.
Cox. W. H. Freeman; Fifth Edition
edition (June 15, 2008)