WASHINGTON – Thousands of women who rely on custom-made hormone drugs for relief from menopause symptoms have flooded the government with letters opposing a drug company’s effort to get health officials to crack down on pharmacies that sell them.
The drug company Wyeth wants the Food and Drug Administration to rein in the market for bio-identical hormone replacement therapy drugs. The hormones are custom mixed or compounded by specialized pharmacies according to a doctor’s prescription.
Compounding pharmacists can alter the dosages of a medicine, prepare it in creams or liquids that are easier to take than pills or eliminate preservatives or other secondary ingredients that might cause allergies in a patient.
Wyeth claims that some compounding pharmacies that prepare customized hormone preparations are duping women with products that pose a serious health risk. It wants federal regulators to weigh in with seizures, injunctions and warning letters.
FDA spokeswoman Susan Cruzan declined to comment, other than to say compounded hormones are not FDA-approved. The agency recently told Wyeth it needs more than six months to review and respond to both the petition, filed in October, and the more than 27,000 comments it has elicited. Most are either form letters or messages submitted through the agency’s Web site.
“They can’t take these away from us. Is there anything that can be done?” said Donna Mabin, 68, a retired cashier from New Carlisle, Ohio, who was among those to write. “Those drug companies want to get the money out of natural hormones and they don’t care if we get sick or not.”
Many women turned to the estrogen, progesterone and testosterone products sold by compounding pharmacies after a 2002 study, part of the massive Women’s Health Initiative that tracked 161,000 women for 15 years, found replacement hormones made by drug companies such as Wyeth raised the risk of heart attacks, breast cancer and strokes.
Critics of the compounding pharmacies want to dispel the notion that the hormone replacement therapies such pharmacies make necessarily work better or are safer.
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