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. 

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