FDA urged to control custom-made hormones
Drug maker calls for crackdown on compounding pharmacies 

The Associated Press

Updated: 11:26 a.m. ET April 21, 2006

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 pharmacies 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 regulations to weigh in with seizures, injunctions and warning letters. 

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

FDA weighing complaints, comments

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, flied in October, and the more than 27,000 comments it has elicited.  Most are either from 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. 

No scientific evidence  

"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. 

"It seems to be an attempt to use the FDA to inappropriately eliminate competition," said L.D. King, executive director of the International Academy of Compounding Pharmacists, a Sugar Land, Texas group.   

Wyeth counters it wants women to realize the risks of what a spokeswoman for the Madison, N.J.- based company characterized as a "growing, unlawful practice." 

"We filed our petitions so that we can ensure that women who received these bio-identical hormones also receive truthful information about the risks of therapy," Wyeth spokeswoman Candace Steel said. 

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 Milers 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. 

Copyright 2006 The Associated Press.  All rights reserved.