Bioidentical Hormones
The promise of being ageless is baseless, but is it dangerous?
Bioidentical hormones are being sought by an increasing number of women to treat the symptoms of menopause. This alternative therapy is the subject of Suzanne Somers’ new book, Ageless: The Naked Truth About Bioidentical Hormones, which has drawn a lot of attention—and the ire of the medical community. What’s the bottom line?
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Bioidentical hormones have the same active ingredients as conventional, FDA-approved hormone drugs.
Most of the FDA-approved hormone drugs contain equine (horse) estrogens and estrodiol, plus one of several progestines. They are designed to replenish female hormone levels that typically drop during menopause. Bioidenticals mostly have estrone, which is a weak type of estrogen. Some are a combination of estrone, estrodiol and estriol, another weak estrogen.
“What the promoters of bioidenticals tend to suggest is that estrone and estriol are much safer than conjugated equine [estrogens] or estrodiol,” says Dr. David Plourd, assistant professor of obstetrics and gynecology at Naval Medical Center in San Diego. “Well, says who? There is zero data on that. What they are is weaker, so you need a lot more of them.”
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The risks of bioidenticals are undetermined.
Patient safety is at the heart of the medical community’s beef with bioidenticals. “I call them bio-unknowns,” says Plourd. “The claim is made that they are safer and efficacious despite a paucity of data.”
Dr. Nanette Santoro of the department of obstetrics/gynecology and women’s health at Albert Einstein College of Medicine says this mode of hormone administration “at best can be considered experimental and at worst is medical malpractice. …The absence of data confirming harm is not the same thing as safety.”
The risks associated with conventional hormone therapies are well known and well managed by physicians, who weigh potential benefits against potential risks for qualifying patients.
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Bioidenticals are usually prepared in compounding pharmacies.
Pharmacists in compounding pharmacies customize orders for patients by combining approved drugs. Those who want custom-mixed drugs will probably not be able to fill their prescriptions at the local Wal-Mart or CVS; most major chains will not get out the mortar and pestle to personalize an order, and insurance companies may reject coverage. Compounding pharmacies are legal and approved by the FDA, but are not regulated by the FDA. A small-scale FDA study found compounded drugs to be 34 percent more prone to error, with most errors related to incorrect dosage.
According to a November 2005 opinion by the American College of Obstetricians and Gynecologists (ACOG), there is no scientific rationale to support tailored or individualized therapeutic regimens.
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Without naming Somers or her Ageless book directly, the AMA adopted a policy on Nov. 13, 2006, to counter “potentially misleading or flawed information about custom-compounded bioidentical hormones.” It has also formally expressed concern about the promotion of bioidenticals as safe and effective by “non-medical professionals.” How’s that for diplomatic?
The AMA has now urged the FDA to:
- conduct surveys for drug purity and dosage accuracy
- require drug manufacturers and compound pharmacies to report adverse effects
- require warnings and precaution labels on bioidentical hormones.
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Medical advice should come from a licensed health practitioner.
Suzanne Somers’ heart may be in the right place: She wants to help menopausal women who have uncomfortable, unresolved symptoms and who fear aging. And yes, at age 60 she still looks good in a leotard. But we need to demand and require more stringent qualifications of our medical advisors.
Somers, a best-selling author and professional promoter, is described as a “respected brand” on the dust jacket of Ageless. And she did interview 15 doctors for the book.
However, some of the doctors have written grievance letters to the publisher, charging that the benefits of bioidenticals were overstated and the risks understated. Somers’ credibility had been strained before by not disclosing her liposuction treatments when she was selling Thighmasters and by taking hormones after a bout with breast cancer, which is known to increase risk of cancer recurrence. A four-way argument on Larry King Live among Somers and her three cohorts did not manage to resolve the issue of bioidenticals’ benefits and risks. Perhaps, like an old Three’s Company plot, this will all be chalked up to a big misunderstanding.
“Bioidentical Hormones” has been reviewed for accuracy by Dr. David Plourd, assistant professor of obstetrics and gynecology at the Naval Medical Center in San Diego, Calif.
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Confused by health myths and misinformation? Each week, Rich Maloof talks to leading health experts to bring you the straight facts on a broad range of health topics.
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Rich Maloof is a regular contributor to MSN Health & Fitness. He specializes in health as well as technology and music. Rich has also written for CNN, Yahoo!, Women's Health, Billboard and the “For Dummies” book series.
I am a physician. This article is fairly innacurate and misleading. The authors points will be redone for accuracy below
Bioidentical hormones have the same active ingredients as conventional, FDA-approved hormone drugs.
-Bio-identical just means the same as your body makes. Most of the junk doctors try and peddle are not found in nature, but they are patented by a drug company because they are specifically not natural. There are some approved Bio-identical formualtions that are commercially available, Climara, Alora, Vivelle, Prometrium, Prochieve, etc.
- The other point that the noble author and "reviewer" failed to mention is that bio-identical usually also means "non-pill", the liver was not designed to be bombarded with a bolus of mutant hormone, hence, the headaches, and bloodclots and other factors, which HAVE been shown with oral - conjugated (read fake) hormones, and HAVE NOT been found with bio-identical non pill formulations.
So yes both the type of hormone and the route of administration are actually important. Conjugated Estrogen Pills probably cause cancer and whole host of other problems. Bio-identical, non-oral hormone replacement may provide the benefits of hormones with a minimization of the risks.. After all, think about it... is it young women/men with high estrogen/testosterone that get breast/prostate cancer, or older women/men with low levels of them that get it?.. hmm.. interesting.. maybe hormones are actually good for you.. Wait a second, that's logic and thats dangerous!
The risks of bioidenticals are undetermined.
Not true. Small studies exist. Big studies will never be done, because, as above bio-identicals are not FDA approvable, hence, no patent, hence no money to be reaped on the back end, hence why take the risk of doing a 100 Million dollar trial with no reward. Blame the greedy FDA and Pharm corps if you really want an answer to this question
Bioidenticals are usually prepared in compounding pharmacies
Also incorrect. As mentioned previously, bio-identical only means exactly the same as in your body. They also usually mean something other than a pill, becuase the oral route is bad for the liver. Approaches that go thru the skin are thought to be safer. Having your pharmacist make it up is also an option but can be prone to some variation. In other words you can have your pure estrogen made by a pharmacist or buy a commercially available patch or cream from him. Your choice. If you are scared about variation, which is a legitamate concern, buy the commercial (but bio-identical) one.
Medical advice should come from a licensed health practitioner
Ideally and in a very medical-legal legalese way, yeah sure. BUT the reality is most docs havent picked up a journal and read about this stuff, they are too busy to deal with something new, and why should they write for something that may not be FDA approved as opposed to something that is, even though it may be better for thier patient, at least thier rear is covered should someone in this sue-happy society decides to go after them. You all in society can blame yourself for this problem.
MSN Health & Fitness does not provide medical or any other health care advice, diagnosis or treatment.
