Firm Seeks Crackdown on Custom Made Drugs

The Associated Press
Friday, April 21, 2006; 5:00 AM

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 cannot allow this practice to continue," the Wyeth petition, signed by Washington attorney Andrew S. Krulwich, reads in part.

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 like 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.

"They haven't been studied for safety or effectiveness and are not produced in facilities that meet good manufacturing practices," said Larry Sasich, a pharmacist with the Health Research Group of the consumer watchdog Public Citizen. "We suspect a majority of patients aren't aware of this."

Medical researchers concluded in 2003 that hormone replacement pills should be taken only as a brief treatment to help women weather the worst symptoms of menopause.

Those findings hit Wyeth hard. Sales of the company's Prempro and Premphase, which combine estrogen and progestin, and its Premarin, an estrogen-only pill, fell to $880 million in 2004 from $2.07 billion in 2001, the year before the Women's Health Initiative released its hormone-replacement results. Compounding pharmacists and their backers allege that Wyeth seeks to stifle competition by calling in the FDA.

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