Bioidentical hormone replacement: Safety requires oversight

The AMA at its November Interim Meeting adopted policy calling for FDA surveys of compounded hormones' purity and for adverse event reporting.

Posted Dec. 11, 2006.

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Three is company, says the title of the 1970s sitcom. Many doctors might find one of its stars, Suzanne Somers, surprise company in the exam room.

Somers recently released her second book touting bioidentical hormones as a cure for many of the complaints of aging, including the sometimes severe symptoms of menopause. Ageless: The Naked Truth About Bioidentical Hormones quickly made a number of bestsellers' lists. It even reached No. 1 in the New York Times advice category.

Many of her readers are likely patients worried about the health risks of traditional hormone therapy discovered by Women's Health Initiative. They're eager to bring their symptoms under control and looking for safer alternatives. Chances are they're going to bring Somer's ideas up with their doctors.

Those patient-doctor conversations are a good thing because the medical profession has concerns with the safety and efficacy of these products when created through pharmaceutical compounding.

Last month, the American Medical Association took a stand on the issue at its Interim Meeting.

The Association adopted policy asking the Food and Drug Administration to conduct surveys of compounded bioidenticals for purity and accuracy. It also calls for mandatory adverse event reporting by the hormones' makers, including pharmacies, and a registry of these occurrences.

Bioidentical hormones have the same chemical and molecular structure as hormones produced in the human body. Traditional hormone therapy relies on estrogen or estrogen-progestin products made by pharmaceutical companies and approved by the FDA. Compounded bioidenticals are typically derived from plants and formulated by a pharmacy to meet individual patient needs. They are not FDA regulated.

In the past few years these custom-compounded hormones have come under increasing criticism from the medical community, including the American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine, the American Assn. of Clinical Endocrinologists and the Endocrine Society.

Some of their makers, and even some physician proponents, have promoted the products as a safer, natural alternative to traditional hormone therapy. The problem, the medical groups say, is that no scientific evidence exists to support claims that they're less risky than their FDA-approved counterparts. The National Institutes of Health also warns that there are "scant data on the benefits and adverse effects of these compounds."

Given that the compounded products have the same chemical composition as traditional therapy, the risks for heart disease, stroke and breast cancer must be considered the same until it is proven otherwise.

Companies manufacturing traditional hormone therapy must include black-box warnings of the risks. The makers of compounded products don't have the same requirement. This leaves women unaware of potential risks. That is why the AMA and others are calling for standardized patient information in compounded bioidenticals' packaging.

Because the FDA doesn't test these products, the medical groups also worry about their purity, potency and quality. Agency surveys of bioidenticals can help ensure their safety.

Wyeth, a leading maker of FDA-approved hormone therapy, shares these concerns. It filed a petition with the agency last fall asking for enforcement actions against compounding pharmacies that violate the rules by stepping into manufacturing, as opposed to making individualized products. It calls for labeling that describes the products' risks. The FDA has not made a decision on the issue.

The International Academy of Compounding Pharmacists responded to the AMA vote by accusing organized medicine of being in cahoots with Wyeth. The pharmacists group denies Wyeth's claims that compounding pharmacies are in the manufacturing business. It notes that there is no evidence that compounded drugs are unsafe, given that the Women's Health Initiative studied only traditional therapy.

The group has enlisted thousands of women taking bioidenticals in its fight against the company's petition. As of April, nearly 30,000 had written the FDA, the academy reported.

But until more study has been conducted and federal quality control has begun, there is no way to know if their faith in the safety and efficacy of these products has been misplaced. Women deserve better.

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External links

AMA on new policy regarding bioidentical hormones (link)

National Institutes of Health State-of-the-Science conference statement on management of menopause-related symptoms (link)

Endocrine Society (link)

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