Jeffrey Dach MD
A 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 as a perfect example of trashy, junk journalism.
Before we analyze this AP News article trashing Bioidentical Hormones, 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.” Would she then go to the nearest blood bank to remove the blood which contains these dangerous non-approved chemicals? (See above left image- arm with blood being removed). Above Left Image: Removing Bioidentical Hormones by donating blood . Courtesy of the Guardian.
Bioidential Hormones Are Present in Our Bloodstream
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 or crazy, like trying 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.
Non-FDA Approved ?
This AP News article attempts to discredit bioidentical hormones as non-FDA approved, and not proven safe nor effective.
Both 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 confusing.
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 (see left image).(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. Left image cover for Lehninger Texbook of Biochemistry.
Examining the Misinformation Line by Line:
But first, let’s take a closer look at the disinformation in the AP article (in bold italic below):
“Millions of women have tried custom-compounded hormones …. since 2002, when a big federal study found risks from traditional hormone replacement therapy, or HRT.”
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 hormones. (15)
“However, 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:
“Bioidentical” 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 consumption.
“…many 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 chart of FDA approved bioidentical hormones available at the corner drug store:
|Hormone Product||Year of FDA Approval||Manufacturer|
|Alora (estradiol):||FDA approved 1996||Watson Labs|
|Climara (estradiol):||FDA approved 1994||Bayer|
|FemPatch : (estradiol)||FDA approved 1997||Parke Davis|
|Vivelle-Dot (estradiol):||FDA approved 1994||Novartis|
|Estraderm: (estradiol)||FDA approved 1986||Novartis|
|Esclim: (estradiol)||FDA approved 1998||Women’s First Healthcare|
|Estrace (estradiol):||FDA approved 1993||Bristol Myers Squibb|
|Estring: (estradiol)||FDA approved 1996||Pharmacia UpJohn|
|Prometrium (progesterone):||FDA approved 1998||Solvay Pharmaceuticals|
|Crinone: (progesterone)||FDA approved 1997||Columbia Labs|
|AndroGel (testosterone):||FDA approved 1999||Unimed / Abbott|
|Testim (testosterone):||FDA approved 2002||Auxilium|
“…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.
“They 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)
“Hormone 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 wrong.
“The 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 hormone levels.
“Compounding 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.
“Many 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.
The bottom line? “Women need to understand there’s no rigorous evidence these preparations are any more effective or any safer than traditional hormone therapy.”
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.
“For 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 evidence.”
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.
NON-FDA Approved Indications
Doctors write 65 million prescriptions yearly for non-FDA approved medications, as part of routine medical practice. (8) This is called Off-Label prescribing. 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.
Jeffrey Dach MD
Articles With Related Interest
Links and References
Bioidenticals: Estrogen without FDA approval for menopause? By Marilynn Marchione,
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, drug interactions
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.
(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 21, 2007
(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.
(15) http://jnci.oxfordjournals.org/content/early/2010/09/23/jnci.djq345.abstract Breast Cancer Incidence and Hormone Replacement Therapy in Canada. Prithwish De, C. Ineke Neutel, Ivo Olivotto and Howard Morrison. J Natl Cancer InstVolume102, Issue19Pp. 1489-1495
(16) Lehninger Principles of Biochemistry by Albert Lehninger, David L. Nelson, Michael M. Cox. W. H. Freeman; Fifth Edition edition (June 15, 2008)
Jeffrey Dach MD
7450 Griffin Road Suite 190
Davie, Fl 33314
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