BioIdentical Hormone Disinformation

From AP Medical Writer, Marilynn Marchione

A USA Today article trashing bioidentical hormones caught my attention because it contained almost pure misinformation.  Written by Associated Press AP medical writer Marilynn Marchione, this syndicated article was broadcast over the news media including the New York Times, Kansas City Star, Fox News, Guardian, Huffington Post and many others.

Marchione's writing is a perfect example of trash, or junk journalism.  I find it  astounding that the news media force feeds this kind of nonsense to the public.  Medical writer Marchione's article discredits bioidentical hormones as non-FDA approved, and not proven safe nor effective.  Before analyzing the nonsense in her article, let's take a humerous look at what if Marchione took her own advice seriously, assuming that naturally occurring human hormones are harmful and dangerous non-approved chemicals. Left Image: Trash can courtesy of wikimedia commons.
 
I 'm Horrified! They Are in My Body!!

Get Them Out of There, Please !

Marilyn 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 a child. Oh My Gosh!!!  Get them Out !!

Also, Marilynn Marchione might be horrified to know that there are thousands of other non-FDA approved natural substances (chemicals) floating in her blood stream.   Oh, the Horror of it!!.  How can I get these non-FDA approved chemicals out of my body!!!

Left Image: Another AP medical writer took Marchione's article seriously, and went to the blood bank to remove all the bioidentical hormones. (note: the photo is actually a soldier in the army donating blood.)  Image courtesy of wikimedia commons.

Also, Marilynn Marchione might be horrified to know that doctors write 65 million prescriptions yearly for non-FDA approved medications, as part of routine medical practice.  Two examples are phenobarbital, an anti-convulsant, and chloral-hydrate, a sedative. 

So Please, AP News writer Marilynn Marchione, 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 primates (this includes AP medical news journalists and monkeys) for 40 million years. That's a long time, even for an AP journalist.

Both FDA Approved and Non-FDA Aproved

But Wait! No need to even worry about it, because, Bioidentical Hormones ARE INDEED FDA approved.  Marilynn Marchione 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 Principles of Biochemistry Chapter 23 Hormonal Regulation.  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 BY DEFINITION, the same chemical structure is FDA approved in the human body or any where 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.

But first, lets take a closer look at Marilynn Marchione's disinformation (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.

Marilynn Marchione is correct about the massive switch.  In 2002, millions of women abandoned synthetic hormones, and embraced bioidentical hormones when 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 lost sales, and secondly,  breast cancer rates dropped precipitously when masses of women stopped synthetic hormones and started bioidenticals instead. This is illustrated on the chart below showing a decline in breast cancer rates when doctors stopped writing prescriptions for the "monster homones" (Prempro) used in the WHI study.

Left Image : Chart shows incidence of breast cancer (top chart blue arrow) which drops suddenly in 2002 when physicians stop writing Prempro prescriptions (bottom chart red arrow).

Source from Figure 2 in The Decrease in Breast-Cancer Incidence in 2003 in the United States NEJM Volume 356:1670-1674  April 19, 2007  Number 16 by Peter M. Ravdin et al.

In Panel A (upper chart), Quarterly Incidence of Breast Cancer in Women between the Ages of 50 and 69 Years, (2000–2004).

Panel B (lower chart) shows the number of prescriptions reported in the United States for the combined estrogen–progestin preparation Prempro and the conjugated equine estrogen Premarin, according to year.

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.

Marilynn Marchione writes deliberate misinformation in the above statement.  Bioidentical hormones (human estrogen and progesterone) are safer and healthier 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.  In addition, Dr Holtorf's article cites 196 research studies comparing bio-identical hormones to synthetic patented hormones (like Provera).  Dr Holtorf's article concludes ,"Bio-identical Hormones are associated with lower risk, and are more efficacious than synthetic counterparts.  Until evidence is found to the contrary, bio-identical hormones remain the preferred method of HRT."  See my article on the safety of bioidentical hormones for more on this topic.

"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 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, 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 list of FDA approved bioidentical hormones available at the corner drug store:

Alora (estradiol):      FDA approved 1996 - Watson Labs
Climara (estradiol):   FDA approved 1994 - Bayer
FemPatch :             FDA approved 1997 - Parke Davis
Vivelle-Dot (estradiol): FDA approved 1994 - Novartis
Estraderm:              FDA approved 1986 - Novartis
Esclim:                   FDA approved 1998 - Women's First Healthcare
Estrace (estradiol):  FDA approved 1993 -Bristol Myers Squibb
Estring:                  FDA approved 1996 - Pharmacia UpJohn
Prometrium (progesterone): FDA approved 1998 - Solvay
Androgel (testosterone): FDA approved 2000 
Unimed Crinone:       FDA approved 1997 - Columbia Labs

FDA approved Estradiol containing products:Estrace, Progynova, estrofem, Alora, Climara, Vivelle, Vivelle-Dot, Menostar, Estraderm TTS Estrasorb Topical, Estrogel, Elestrin, Lunelle Estring, Femring

FDA approved Progesterone products Prometrium, Utrogestan, Minagest, Microgest, CRINONE, PROCHIEVE, Cyclogest

FDA approved testosterone:Testoderm, Androderm, AndroGel

Custom-compounded hormones are not approved by the federal Food and Drug Administration and have not been proved safe or effective.

The above 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 for compounding.  However, all the raw materials used in to make the compounded products are FDA approved.   

Therefore Your Drivers License is Invalid

Marilynn Marchione's statement is the equivalent of saying your state drivers license is invalid because it was not issued by the federal government.  This is nonsense.  Driver licenses are regulated by the states, not the federal government.

Another example might help to understand Marilynn Marchione's deceptive statement.  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?

Marilynn Marchione 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, indicating Marilynn Marchione's statement is false.

They may carry the same cancer and heart risks as traditional treatments and have had even less testing to find out.

Marilynn Marchione is wrong again. The French Cohort study, showed no increased cancer in the bioidentical group.   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. 

Less Heart Disease Risk on Calcium Score Studies

Two calcium scoring studies showed no increased risk of heart disease associated with bioidentical hormones. A study of CAT calcium scores by 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). These same results had already been published 2 years previously in a calcium score study by Budoff in J Womens Health 2005. 

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 Marilyn's medical experts are, 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.  For hormones, the amount of sex hormone binding globulin is another variable that determines hormone dosage.  This idea of standard dosing is regurgitated drug company propaganda.

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. Saliva testing for cortisol is done with 4 samples to catch the diurnal variation.  Saliva testing  normally 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, with estrogen and progesterone peaking around day 19-21 of the cycle. 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.

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 pharmacies should be making the exact same formulation when given the same prescription.  I have found that when dealing with the larger national compounding pharmacies, quality control is better, and formulations are more consistent between pharmacies.

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.

In 2001, the government tested 29 products from compounding pharmacies and found that one-third did not meet standard quality benchmarks, including potency problems, Manson writes in her book, Hot Flashes, Hormones and Your Health.

Using this same logic, FDA approved drugs should be abandoned because ten per cent of FDA approved drugs are later banned.  These drugs were found ineffective or harmful after FDA approval.  

My patients rely on me to select only the most reliable compounding pharmacies with the highest quality and reputation.  Compounding is highly competitive, and if we find quality control issues, we switch pharmacies. It's that simple.

What are Others Saying?

Here is what Lawrence D. Rosen, MD had to say on his blog about Marilynn Marchione AP Medical News writer:

"I think the American public has had enough of politics-as-usual and will see through this nonsense. But it still doesn't make this kind of journalistic trash acceptable."  

Here is another comment on the same blog:

"Had a comparable reaction when I saw the flurry of articles. Journalistic trash is probably the kindest way to put it.  Clearly, the health editors at the AP have either totally sold out to ... Big Pharma, missed several lithium doses, or both! I don't think this is the last we're going to hear about Marilyn and her strange story series."

In Conclusion

AP journalists like Marilynn Marchione provide regurgitated drug company propaganda, and medical misinformation masquerading as medical advice.  Rather than rely on these medical light weights, it's best to seek out a knowledgeable MD in your area who can assist you.   Thousands of practicing MD's prescribe bioidentical hormones across the nation. They be found at the ACAM Directory  and the A4M Directory.

Left Image: Dr Kent Holtorf, one of thousands of physicians in the US prescribing bioidentical hormones routinely. Courtesy of Kent Holtorf MD

Links to Related Content:

The Evidence for Bio-Identical Hormones

ACOG Wrong on BioIdentical Hormones by Jeffrey Dach MD

The Importance of BioIdentical Hormones by Jeffrey Dach MD

The Safety Of Bio-Identical Hormones by Jeffrey Dach MD

The Battle for BioIdentical Hormones by Jeffrey Dach MD

BioIdentical Hormones, Cook Book or Tailor Made? by Jeffrey Dach MD

Breast Cancer Prevention and Iodine Supplementation by Jeffrey Dach MD

Links and References

http://www.usatoday.com/news/health/2009-10-29-menopause-herbal_N.htm
Bioidenticals: Estrogen without FDA approval for menopause?
By Marilynn Marchione, The Associated Press

Miserable in menopause, Elizabeth Alsgaard pondered an awful choice: Drenching hot flashes or hormone therapies that might raise the risk of cancer. What former actress Suzanne Somers raved about held much more appeal — custom-mixed "bioidentical" hormones, just like ones the body makes.

"Anything I can put into my body that's natural has to be better," said Alsgaard, a California audiologist who admitted having "no knowledge base to go on other than fear" when she took Somers' advice. Audiologist Elizabeth Alsgaard spent about $1,000 for saliva tests, hormone creams and custom-compounded hormone pills the doctor prescribed. Six months later, she was still miserable in menopause.

http://www.thewholechild.us/integrative_/2009/06/alternative-medicine-in-the-news-a-bit-too-much.html

Alternative Medicine" in the news... a bit too much? "Alternative Medicine," a term I don't like very much, has been featured in numerous AP news reports this week, all by the same writer. Something's fishy.  At face value, it's a bit strange to see all of these articles in print in a three-day period (Sunday-Tuesday). But look a little further, and it gets really weird. All of these articles are by the AP. In fact, they are all by the same writer, Marilynn Marchione. Is it just me, or is this just a little too coincidental? There have been no major research studies released to spur such a prolific outburst of medical articles on one subject, all with the same slant. I wish I could look for the silver lining, as did the widely-read blog, The Daily Kos, commenting on article #1: "Suffice it to say that it is refreshing that 'alternative medicine' is being treated with the respect that thousands of years of human experience should be. I hope we can progress further to reframe medicine as the treatment of living systems rather than the repair shop for machines."

Unfortunately, though, these articles are all incredibly biased against alternative medicine. Why would one writer for the AP spend so much ink bashing alternative medicine? The 5th article above provides what is likely the biggest clue - who has the most to lose with integrative medicine (which, by the way, is a blend of conventional and CAM therapies - the best of both, based on efficacy and safety evidence) being considered as a possible solution for health care system woes? Well, it's not "Big Herba." You do the math.

I think the American public has had enough of politics-as-usual and will see through this nonsense. But it still doesn't make this kind of journalistic trash acceptable.  

http://blogs.acponline.org/acpinternist/2009/06/throwing-baby-out-with-snake-oil.html
Throwing the baby out with the snake oil. Tuesday, June 9, 2009
A few weeks ago, I vented my frustration about reports that budget-conscious patients where prioritizing supplements and vitamins over standard medical care. Apparently the news got the Associated Press even more fired up. A new AP IMPACT report goes after alternative medicine like it's a potential terrorist network. And mainstream medicine is on the conspiracy! "Some medical schools are teaching future doctors about alternative medicine, sometimes with federal grants," the article warns. The author notes that most CAM (complementary and alternative medicine) education is designed to teach doctors about the products their patients may be using. "But some schools have ties to alternative medicine practitioners and advocates." Well, yes, in order to learn about alternative medicine you might actually have to have contact with those who provide it.

Absolutely, alternative medication is controversial and some treatments are total scams. But is demonizing the whole field--and anyone who tries to study it--going to help sort out what's helpful and what's harmful? When one of the top problems with CAM is that patients don't tell their doctors what alternative therapies they're using, maybe we should be calling for more research and more cooperation, not less.

http://www.usatoday.com/news/health/2008-12-13-breast-cancer-hormone_N.htm
New study firmly ties hormone use to breast cancer
Study results were given Saturday at the San Antonio Breast Cancer Symposium.

They are from the Women's Health Initiative, which tested estrogen and progestin pills that doctors long believed would prevent heart disease, bone loss and many other problems in women after menopause. The main part of the study was stopped in 2002 when researchers saw surprisingly higher risks of heart problems and breast cancer in hormone users.

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. Breast cancer rates decline after ccessation of synthetic HRT.

http://jnci.oxfordjournals.org/cgi/content/full/djm111v1
Journal of the National Cancer Institute Advance Access published online on August 14, 2007  JNCI Journal of the National Cancer Institute, doi:10.1093/jnci/djm111
Declines in Invasive Breast Cancer and Use of Postmenopausal Hormone Therapy in a Screening Mammography Population. Karla Kerlikowske, Diana L. Miglioretti, Diana S. M. Buist, Rod Walker, Patricia A. Carney For the National Cancer Institute–Sponsored Breast Cancer Surveillance Consortium

http://www.sciencedaily.com/releases/2007/08/070814162852.htm
Drop In Breast Cancer Incidence Linked To Hormone Use, Not Mammograms
ScienceDaily (Aug. 15, 2007) — A recent decline in breast cancer incidence is unlikely to be caused by a decrease in mammography screening, according to a study published online August 14 in the Journal of the National Cancer Institute. It is more likely due to the drop in postmenopausal hormone use.

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

http://www.cnn.com/2007/HEALTH/conditions/09/26/unapproved.drugs/index.html
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.

Jeffrey Dach MD
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