Popular Menopause Treatment Comes Under Fire From Drug Company

April 5, 2006 — -- Menopause started for Jane Danielewicz 10 years ago, but it didn't come with hot flashes. Instead, she suffered debilitating cognitive symptoms.

The University of North Carolina English professor was 43 at the time, but she felt she was losing touch with reality. At times, she said, it was so bad she couldn't even drive or read.

"You imagine somebody made a jigsaw puzzle on the table, and that jigsaw puzzle is you, and somebody comes along and jiggles the table and the pieces break apart," she said.

Her doctor had first prescribed an estrogen patch, but it didn't help for long. In 2000, after hearing about "bio-identical" hormone replacement therapy from a friend, she requested a measurement of her hormone levels from the Wisconsin-based pharmacy Women's Health America. Women's Health then sent the results of a saliva test to her doctor, who wrote a prescription for progesterone cream, which Women's Health custom-made for her.

"Within two weeks, I knew that there was hope," Danielewicz said. She now feels like she did before menopause and credits her customized medication with saving her when manufactured drugs didn't work as well.

Some pharmacists specialize in compounding drugs, a process in which drugs are custom-mixed for a patient. Compounding is commonly done for patients who are allergic to a dye in a drug, for example, or when a drug manufacturer discontinues production of a drug.

Wyeth Petitions FDA

Wyeth Pharmaceuticals, a global drug company that manufactures hormone replacements, wants the Food and Drug Administration to regulate competition from pharmacies that compound bio-identical hormone replacement therapy -- also known as BHRT.

Wyeth's drug Premarin, which is used to treat menopausal symptoms, is an estrogen derived from the urine of pregnant horses. BHRT, meanwhile, uses plant-derived estrogens and is typically formulated based on the hormonal reading taken from a woman's saliva sample. Because of that matching process, advocates hail BHRT as a more appropriate way to replace hormones diminished in menopause.

The FDA has been taking comments on the issue since Oct. 6, 2005, when Wyeth filed a petition demanding that the government take action to stop compounding pharmacies from selling BHRT drugs, alleging illegal marketing and manufacturing.

The comment period ended on Tuesday, but no date has been set for the FDA to rule on the petition.

Wyeth's petition also raised safety concerns, claiming there had been too little research and alleging that BHRT drugs were not accompanied by appropriate warning labels.

"These pharmacies' failure to provide this legally required information demonstrates that they are simply trying to dupe an unsuspecting patient population," Wyeth's petition reads.

BHRT advocates said they were flabbergasted by the allegation that they were out to "dupe" the population. They point out that a person can only get BHRT with a doctor's prescription.

And, they say, when a doctor writes such a prescription -- for a customized dosage, form, or combination of medicines not commercially available -- it is a pharmacy's responsibility to make or "compound" the drug.

The FDA regulates manufacturing, but not compounding.

Wyeth, however, alleged in its petition that with the growing market for BHRT drugs, compounding pharmacies had begun to veer toward wholesale manufacturing and therefore should be regulated as such.

L.D. King, executive director of the International Academy of Compounding Pharmacists, sees things differently.

"Wyeth's aims are clear: to restrict the ability of physicians to prescribe and patients to use customized BHRT following studies that have raised serious health concerns with the company's [Wyeth's] own products," King said in a statement released by the association after Wyeth filed its petition with the FDA.

'They Have to Do Something'

A government study of Wyeth's hormone replacement drugs, Prempro and Premarin, was discontinued in 2002 when it became apparent that taking Prempro heightened the risk of breast cancer, coronary heart disease, stroke, and pulmonary embolism, and that Premarin increased risk of stroke. A class-action lawsuit on behalf of women who had taken Prempro was filed shortly thereafter.

Against this backdrop the popularity of BHRT drugs like progesterone has surged, taking a significant bite out of Wyeth's dominance in the market for hormone replacement therapy.

"They really have cut into their sales, so they have to do something," said Marla Ahlgrimm, founder and CEO of Women's Health America, one of several BHRT-providing organizations specifically mentioned in Wyeth's petition.

Women's Health America, along with the compounding association, say Wyeth is out to prevent competition, and they have encouraged popular opposition to Wyeth's petition.

At least 27,000 comments from doctors, patients and the general public have been filed with the FDA in opposition to Wyeth's petition. It is not known when the FDA may rule on the issue.

Ahlgrimm says that in asking the FDA to step in and regulate compounding, Wyeth is threatening a necessary practice.

"The moral of the story is that we're all unique and you can't just offer one choice to each individual patient," she said.

Wyeth spokeswoman Candace Steele insists that women's health, not profits, is the motivation for Wyeth's petition.

The Stakes Are High

"The heart of this is that women are not receiving the appropriate information," she said. "We're not at all interfering or asking that the agency interfere with medical practice or legitimate compounding."

"There is a lot at stake," King said. Wyeth's petition, if successful, would represent "a devastating blow to the access [to BHRT] women need" because of the FDA's lengthy approval process for new drugs, he said. King estimated that 38 million prescriptions would be in jeopardy.

Jane Danielewicz said she hoped she wouldn't lose her progesterone.

"The idea of not taking it anymore is really scary," she said.

Arthur Delaney is a freelance desk assistant for ABC News.