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The Bioidentical Hormone Debate

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In my column for Salon.com this month, I examine Oprah Winfrey's coverage of health and medicine, and I argue they are suspect.

 

My column this month in Salon criticizes Oprah Winfrey's approach to science and medicine.   A lot of the piece focuses on Bioidentical Hormones (BH), which Winfrey's guests endorsed in two episodes that aired earlier this year, one featuring Robin McGraw and a second featuring Suzanne Somers

BH is a term used to describe pharmaceuticals that closely mimic the natural hormones produced by women.  It's also a term meant to help draw a contrast with so-called conventional hormones (CH), progesterone and estrogen treatments (the usual drugs were Premarin and Prempro) that doctors wrote countless prescriptions for until the Women's Health Initiative showed they did more harm than good. 

 So are bioidenticals different or better than other hormones? Let's take a closer look that these claims.

 The Evidence:

 Despite their name, BH are synthesized in a lab from a both plant (soy or yam) and animal (pigs and horses) hormones.  CH products come from the same sources.  Thus, many experts have concluded that the term BH is just a marketing term that helps to sell the perception that one drug is more natural, safer and better than another. 

 Regarding safety and effectiveness:  In a detailed review of the scientific literature in 2007, a physician from the University of Pennsylvania school of medicine dissected the research and concluded that "there is a dearth of scientific evidence to support these claims."  He also concluded that the use of compound pharmacies and prescriptions for blood and saliva tests to customize therapy lack validity and are "in direct contradiction to evidence-based guidelines."  Furthermore, "scientific uncertainties associated with compounded BH make their use less preferable to that of CH, as CH have been and ocntinue to be assessed by clinical trials regarding both benefits and risks...."

(the manuscript of the paper, which I have, indicates that the physician who wrote the piece, Dr. Michael Cirgliano, has no conflict of interest with drug makers)

 That being said, there are a lot of passionate supporters of bioidenticals.  Recently, those supporters got some traction in an opinon piece in the Wall Street Jounal

"There are 25 years of scientific research with hundreds of studies in the U.S. and Europe that have demonstrated that bioidentical hormones, estradiol and micronized progesterone, are equally or more effective than synthetics -- and safer. Yet mainstream medicine has buried its head in the sand and refused to take these studies seriously," wrote the authors of the essay, three health care providers who founded the Bioidentical Hormone Initiative

On their website (linked above), you can find their review of the literature on bioidentical versus conventional hormone therapy.   The BHI review cites 81 different studies to back their claim that bioidenticals are best.  But let's take a closer look.

Several of the studies were authored by a BH enthusiast named H.M. Lemon who, according to another reviewer,  conducted only 1 clinical trial, looking at estrogen.  That trial failed when 25% of his subjects developed breast cancer, while a smaller number developed precancerous changes to the uterus. 

Many of the studies are in animals, and many others seem to tell us things we already know.   For example, one study looks at women's exercise tolerance (a marker of heart health) after they took estrogen and "natural progesterone" compared to estrogen and medroxyprogesterone (CH).  Those who took the CH had lower exercise tolerance, an implication that this particular prescription of CH is adversely affecting blood flow.   But we already know about hormones and cardiac risks, and that women with higher risk require careful thought behind a choice of hormone replacement. 

Another study dates back to 1981, where researchers at Johns Hopkins looked at breast cancer rates in women.  According the BHI review, the study "demosntrated the profound anti-breast cancer action and protective role of natural progesterone against breast cancer."  But if you take a look at the study, what the researchers did was to look at two groups of premenopausal, infertile women--those who were progesterone deficient and those who who had other causes of infertility.  They found women in the progesterone-deficient group had a higher risk of breast cancer. 

The claim seems out of place.  After all, the Hopkins study looked at premenopausal women, which is not the population who would normally take hormone-replacement therapy.  Also, the study didn't replace hormones in any of the women, and so its puzzling why the authors use it as support for their argument that BH are better and safer. 

How An Oprah "Expert" Made This Even More Confusing:

 In a video segment of Winfrey's January 15th episode , "The Great Hormone Debate:  Should You Replace Your Hormones?", Winfrey featured Dr. Prudence Hall discussing BHT.  In that episode, Dr. Hall made the following claim:

"There are now major studies out showing that bioidentical natural hormones decrease death in women. There’s a Swedish study that looked at 28,000 women. It’san ongoing study and they’ve looked at women for 15 years and what they found is they found that every single category of death in women, 12 categories deep, was dramatically decreased when women were on the bioidentical hormones"

I contacted Dr. Hall's office to ask her for the reference to that study--she faxed me several abstracts, but none of them dealt with a study featuring 28,000 Swedish subjects.  One of the studies, noted as "very important," featured 6500 Swedish women.  But the conclusions of the study, that women who used continuous estrogen and progesterone therapy had a higher risk of breast cancer, doesn't teach us anything we don't already now.  In fact, that conclusion seems to further discredit Suzanne Somers, who has been using continuous, aggressive hormone therapy. 

The remaining studies Dr. Hall faxed included:  one of 6440 Swedish women that concluded androgen (male hormones) reduce the risk of heart disease and that estrogen protects helps prevent memory loss.  

What are Really Debating Here? 

  • Semantics:  Instead of BH versus CH, is it just Premarin/Prempro (the drugs doctors have backed off from prescribing) versus other hormone replacement products? 
  • Sources:  Do you get your hormones from a physician and standard pharmacy (which are regulated by the FDA), or do you buy them at a health food store or get them made at a compunded pharmacy (unregulated for safety, quality and effectiveness)? 
  • Duration of Therapy:  Here's the big question, and one tha, frankly, makes  Oprah and Somers look irresponsible. Somers, as I mentioned in my Vital Signs piece, has been on hormones continuously for quite sometime.  But she's developed breast cancer and had to have a hysterectomy.  The best medical evidence clearly points against the kind of regimen she endorses.  So then how long is right?  Right now, nobody seems to know, which is why doctors generally only suggest very short courses of replacement therapy.

I still think the biggest lessons here are that science and medicine are complex and ever-changing fields.  What's true one day may not be true the next, but we have to follow the best medical evidence. 

People like Suzanne Somers and other advocates for BH often accuse drug makers or doctors of being in bed with pharma and trying suppress "the truth" about bioidenticals.  But every study, wherever you stand on this issue, receives funding from somebody that stands to bias their results.  Rather than solely focus on the money trail, look instead at the quality of the science--which studies give us valid results, the kind that can be repeated to ensure they're accurate, and can be applied most to a very specific group or people (in this case, postmenopausal women).  It's also worth being very clear about the risks of anything you put into your body in terms of what it is, the amount and how long you take it. 

________-

www.rahulkparikh.com

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Comments (5)

Submitted by Virginia Hopkins (not verified) on Fri, 05/15/2009 - 5:00pm.

Dr. Parikh --

Your arguments against bioidentical hormones are almost word for word those of other BH-bashers such as Dr. Wulf Utian, so I assume you’re getting your information from the same source. Most in the BH community would welcome rational, well-informed discourse about what forms of hormones work the best for the women taking them. In that spirit, let me address some of the oft-made talking points in this article.

“Bioidentical hormones” is not a term “used to describe pharmaceuticals that closely mimic the natural hormones produced by women.” It is a term to describe pharmaceuticals that exactly match the natural hormones made by women. The issue here is not whether these hormones are made in a lab, or extracted from yams or soybeans—they all are—the issue is what the hormone molecule looks like when it comes out of the lab or the processing plant. The molecules in bioidentical hormones exactly match the estradiol, progesterone and testosterone (for example) molecules made by a woman’s ovaries.

And in fact, it is these exact same bioidentical hormone products that are sold by the barrel to the companies that make synthetic hormones, who then take them through a manufacturing process that adds a ethyl group here and an acetate group there so that the molecule is patentable – e.g. no longer natural/bioidentical. The barrels that arrive at the manufacturer are USP progesterone, USP testosterone and USP estradiol, for example. These natural, bioidentical hormones are then tweaked to produce a synthetic hormone. Those synthetic hormones are usually more potent than the natural hormones, do not have all the effects of the bioidentical hormones, and also have their own unique effects, most of them undesirable.

Furthermore, many of the pharmaceutical hormone products prescribed by conventional doctors and sold by prescription are bioidentical hormones. For example, all USP estradiol sold in pill and patch form is bioidentical. All USP testosterone sold in pill, patch, gel and injectable forms is bioidentical.

Bioidentical hormones is not a marketing term, it is a term that is used to distinguish real hormones from not-found-in-nature hormones. That distinction  is necessary and important in educating women about safer alternatives to the synthetic hormones that have proven to be so dangerous.

Here is the conclusion of an article recently published in the New England Journal of Medicine: “In summary, the increased risk of breast cancer associated with estrogen-plus-progestin therapy declined markedly soon after discontinuation of the therapy and was unrelated to a change in the use of mammography. This finding supports the hypothesis that the recent reduction in the incidence of breast cancer among women in certain age groups in the United States is predominantly related to a decrease in the use of combined estrogen plus progestin.”

According to the study’s lead author, Dr. Rowan T. Chlebowski, long-term (synthetic) HRT probably caused breast cancer in 200,000 women between 1992 and 2002.  If we assume that about 50% of those women died from the breast cancer, some 100,000 women have died in the past decade because they took synthetic hormones such as the progestins.

(Chlebowski RT, Kuller LH, Prentice RL, “Breast Cancer after Use of Estrogen plus Progestin in Postmenopausal Women,” NEJM Vol 360:573-587 February 5, 2009.)

There’s a misconception that there is some unified group behind the use of bioidentical hormones. In truth, there is no unified group, and there are dozens of different approaches to using them, some of which work fine, and some of which have potential to do harm.

It’s unfortunate that Dr. Hall did not do her homework before appearing on Oprah, a show that reaches millions of women, but there is good evidence that bioidentical hormones are safe and effective. You can read more about this at my website, and specifically the following articles:

Open Letter to Oprah about Bioidentical Hormones www.virginiahopkinstestkits.com/bioidenticalhormonebreastcancer.html

Bioidentical Hormones and Heart Disease www.virginiahopkinstestkits.com/bioidenticalhormonebreastcancer.html

Bioidentical Hormones and Breast Cancer www.virginiahopkinstestkits.com/bioidenticalbreastcancer.html

In addition, I encourage you to read What Your Doctor May Not Tell You about Menopause, a book I co-authored with the brilliant Dr. John Lee, who died in 2003. I have yet to meet any doctor who carefully read that book who didn’t turn on a dime and embrace the concept of bioidentical hormones (although in the book we call them natural hormones).

You have a platform and an opportunity to contribute to real health and healing in women. I urge you to at least consider this other viewpoint, if nothing else than for the 100,000 or so women who died of breast cancer because they used synthetic hormones.

Submitted by saroncarson on Wed, 09/02/2009 - 12:50am.

I would prefer to synthesize BH from plants for international marketing purpose. All it depends on the drug market, environment and demand of the market. The debate ends at personal preference, that’s what I think. 

Submitted by jeffrey561 on Thu, 09/03/2009 - 6:03pm.

Great exposure for a very important debate! I have been researching bioidentical hormone therapy with my wife in great detail and have see a lot of benefits with this treatment.  An informative website that has helped me learn a lot more is,

 

http://bodylogicmd.com/research/hormone-therapy

Submitted by Anonymous (not verified) on Wed, 09/15/2010 - 7:50am.

It's pretty common knowledge that to make money off meds/drugs, corps have to patent their own flavor of the drug. I think that in this case, since bioidentical hormones can't be patented, the solution for the major drug corps is NOT to take the “we have to patent it” route but to work on the DELIVERY process to the consumer….er patient. If McDonald’s can make billions by delivering burgers and fries to millions (I’m not going to get into the health issues of fast food right now), why can’t the drug corps reinvent their strategies and give us what works in an effective, lower cost delivery method? The long-term costs to society of the entire patenting process (which is unnecessary in this case) should be factored into their long-term plans. The fact is, as people get older, they lose their ability to create their own necessary hormones which helps to contribute to health issues. Since we’re heading towards National Health, it makes sense to keep our increasingly aging population of Post-War babies, Boomers and other generations as healthy and productive as possible. Now, I want studies to be done on how hormone drop affects MEN. The poor guys don’t even have the equivalent of a gyn to go to in order to discuss their problems.

BTW I started on hormones, on testosterone, in order to combat osteopenia. My mother has osteoporosis and was getting a new hip when I was diagnosed as being in the “yellow light” area bone wise. After about a year of testosterone and twice a week fairly non-strenuous weight-bearing yoga, my Endo was quite surprised that my hip/back bone scan came up in the “green-zone.” “I was prepared to put you on Boniva,” he said as he sat back, slightly stunned. When I asked him if he could agree that it could be that testosterone DID help rebuilt muscle mass and bone, he could only say that there were no studies out there proving it. There SHOULD be studies and I’m assuming that a smart drug corp will start to shift gears and take the route of giving folks what they need.

What do I think we need? 1. Rapid, effective tests to establish baseline optimal hormone levels for folks in their 30’s with counseling and programs for folks to maintain their optimal weight/BMI. 2) Hormone checks for all men/women in mid-40’s with supplementation of bio-identical hormones beginning and weight/BMI maintenance. 3) All folks on bio-identical hormones/vitamin therapy by their 50’s along with weight/BMI maintenance. Why the weight/BMI inclusion? If you weigh the right amount for your physique, you will experience significantly less health issues. If we expect national health to exist and not go bankrupt within a decade, we will have to set standards like these, standards which could keep many of us active and healthy into out 90’s.

Corporations who don’t see the massive opportunities out there to reinvent the health/nutrition industry will go the route of the dinosaurs.

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