FDA urged to control custom-made hormones

Natural hormones from soy and yam
Thousands of American women use the compounded hormones to alleviate the hot flashes, flushes, sweats, sleeplessness and other hallmarks of menopause. The hormones are derived from soy and yam but have an identical chemical structure to the substances found in the body. The products sold by Wyeth are based on the urine of pregnant mares.

Women who use the bio-identical hormones, along with their doctors and pharmacists, all say the system is a throwback to when just about every medicine was made to fit both a doctor's order and a patient's need.

"Every woman is different. There is blood work done to ensure where their hormone level is at, so based on those results and their symptoms, we will come up with a formula. It's sort of old-fashioned," said Manhattan's Dr. Jeffrey Morrison of the process he uses with patients like Lynn Leibowitz.

The doctor-pharmacist-patient "triad" involves constant adjustments that just can't be made to the mass-produced drugs that Leibowitz, a Manhattan psychologist and psychoanalyst, used to take, said David Miller, the New Jersey compounding pharmacist she uses.

"We'll keep going month after month until we find the right combination for the patients," Miller said of his work at Millers of Wyckoff, the New Jersey pharmacy his grandfather started in 1929.

As for Leibowitz, she says the custom-compounded hormones have left her feeling better — and more in control — since switching a year ago.

"I love knowing what my hormone levels are," said Leibowitz, who began taking hormones eight years ago after she underwent a hysterectomy at 48. "I feel much safer and it's more compatible with my body chemistry."

That sort of anecdotal evidence doesn't sway other doctors.

In November, the American College of Obstetricians and Gynecologists said there is no scientific evidence supporting claims of increased efficacy or safety for estrogen or progesterone regimens made by compounding pharmacies for women.

Same or worse safety issues
The group said women should consider compounded hormones to have the same or even additional safety issues as FDA-approved hormone products.

That same month, the FDA sent warning letters to 16 companies marketing unapproved alternative hormone therapies. The FDA said the companies were selling drugs without the agency's approval. The action mirrored in part what Wyeth requested in its petition, but was not linked to the filing of the document just weeks earlier, said Steele, the company spokeswoman.

And a 2004 review that appeared in Menopause, the journal of the North American Menopause Society, found little to recommend about compounded hormones: "In the absence of a sound scientific basis, practitioners should not advocate the practice of compounding (hormones) because it is not in the patient's best interest, it is potentially harmful and it lacks a scientific underpinning," the review concluded.

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