http://www.usatoday.com/news/health/2008-01-09-bioidentical-hormones-fda_N.htm

FDA cracks down on makers of 'bioidentical' hormones

By Liz Szabo and Julie Appleby, USA TODAY

The Food and Drug Administration ordered seven pharmacies Wednesday to stop making "false and misleading" claims about custom-made "bioidentical" hormones for menopausal symptoms.

Though seven pharmacies were targeted for misleading marketing by the agency, they are only a tiny fraction of the estimated thousands of pharmacies that custom-mix so-called bioidentical hormones. Pharmacies are allowed to "compound" their own drugs if they have a doctor's prescription for a product not otherwise commercially available.

Women began turning to such custom-made treatments in larger numbers after a landmark study in 2002 that found traditional brand-name drugs produced by pharmaceutical companies may raise the risk of heart attack, breast cancer or stroke.

The FDA took action against the pharmacies, which often market their compounds online, for three main reasons. It said the businesses claimed their mixtures could prevent or treat illnesses such as Alzheimer's disease, stroke and cancer; claimed the mixtures were superior to approved commercial drugs; and used the hormone estriol, a weak estrogen that isn't FDA-approved.

Makers of bioidentical hormones say their custom-made compounds are tailored to a woman's individual needs, based on the contents of her saliva. Actress Suzanne Somers has promoted them energetically.

But Kathleen Uhl, director of the agency's Office of Women's Health, says saliva tests aren't a reliable way to balance out hormones, which fluctuate by the hour. Tailor-made hormone therapies pose the same risks as commercially prepared hormone therapies, Uhl says.

Wyeth, which makes two of the most commonly used brand-name hormone therapies, Prempro and Premarin, asked the FDA in 2005 to take action against compounders making similar products.
Compounding pharmacies protested, and the FDA says it received nearly 70,000 comments from both sides.

Terry Scarborough, an attorney for one of the pharmacies that received a warning letter, notes that a group of pharmacists has sued the federal government, arguing that the FDA doesn't have authority to regulate compounded drugs.

"Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate," says L.D. King, executive director of the International Academy of Compounding Pharmacists. "This is a decision that should be left to doctors."

Wulf Utian, executive director of the North American Menopause Society, praised the FDA's action. He discourages women from turning to compounded hormones.

"If there is a reason to be on hormone therapy, there are more than enough approved products out there," Utian says

A medical doctor wrote eloquently about this topic in an op-ed piece in the Tucson Citizen:

http://www.tucsoncitizen.com/daily/opinion/87533.php

GUEST OPINION: MEDICINE AND MENOPAUSE
David vs. Wyeth: FDA places Big Pharma profits above well-being of women

FRANK COMSTOCK
Published: 06.09.2008

Women seeking relief from the symptoms of menopause are often flooded by confusing reports on hormone replacement therapy.

A recent column in this newspaper, criticizing local U.S. Rep. Gabrielle Giffords for supporting patients' right to access compounded hormones with estriol, only adds to this confusion (May 20 column by Anne T. Denogean, "Giffords takes bad step by opposing FDA hormone ruling").

As a physician who sees hundreds of women affected by hormone imbalances, I am concerned that patients are not getting the full picture. Thousands of women in Arizona are being prescribed compounded hormones that contain estriol.

I and my colleagues have found these drugs to be valuable treatments for women suffering from the painful symptoms of menopause.

And while the Food and Drug Administration is now trying to restrict my patients' access to these drugs, I, my fellow doctors and our patients across Arizona are grateful to Congresswoman Giffords for sponsoring a resolution that admonishes the FDA's policy.

The FDA announced earlier this year that it would "halt" the compounding of hormone treatments with estriol, one of three estrogens that a woman's body naturally produces.

The agency admitted that it knew of no adverse events associated with estriol. It's clear that safety concerns did not prompt this action. So what did?

The campaign against compounded estriol was initiated by Wyeth Pharmaceuticals after a federal study of its hormone products was stopped early because of increased risks of heart disease, cancer and stroke.
As a result, sales of Wyeth's products fell dramatically.

In return, the company petitioned the FDA to restrict the availability of compounded hormones, which compete with Wyeth's manufactured drugs.
Interestingly, even though Wyeth told FDA that estriol was "a serious threat to public health," the drug-maker marketed a product containing estriol in Europe as "ideal therapy" for menopausal women.

Many physicians, like me, believe that women should be prescribed hormones that are chemically identical to their body's natural hormones rather than the horse urine-derived products made by Wyeth.

What's critical is that doctors continue to have treatment options open to them so they can decide on a patient-by-patient basis which treatment option is most appropriate.

Hormones with estriol are always compounded pursuant to a doctor's prescription. The FDA shouldn't interfere with this important doctor-patient relationship.

Doctors have prescribed estriol for three decades, and its use is accepted by state boards of pharmacy, by the Pharmacy Compounding Accreditation Board and by the U.S. Pharmacopeia, which Congress recognizes as the official standards-setting authority for all pharmaceutical ingredients.

Today, estriol is the active ingredient in a drug being tested as a treatment for women suffering from multiple sclerosis.

Clinical trials funded in part by the National Institutes of Health are showing promise.

When Wyeth petitioned the FDA to restrict patients' access to alternatives to its own products, more than 70,000 patients and doctors filed comments in response - the vast majority of whom opposed Wyeth's request.

The FDA should listen to them - not Wyeth.

As a doctor, it is up to me - not the FDA - to decide if estriol is right for my patients.

The FDA should stop catering to big drug-makers more concerned about corporate wealth than patient health.

If women suffering from menopause can't access alternatives to Wyeth's one-size-fits-all drugs, only the drug-maker benefits, not patients.

Frank Comstock is a medical doctor in Tucson.