Other articles by Carla Mcclain:

Months-long measles scare is fading Warned pharmacy still sells hormones Cops, firefighters advised to get shots for measles Phoenix pair fund cancer-research chair Patient advocacy growing as a business Pima gets $50K in state funds for measles control Lleva fama a familia a TV en rol de su hijo New cases of measles spur new shot clinic Fame follows family with child's TV role New case of measles is the 11th in county

Health Care
Sierra Tucson
Eating Disorders Program Coordinator Health Care
CENTRAL ARIZONA COLLEGE
DIRECTOR OF HEALTH INFORMATION MANAGEMENT Trades/Construction
RANCHO RESORT
MAINTANANCE POSITION Administrative & Professional
Tucson Urban League
CEO/President Sales and Marketing
Everready Glass
Sales Reps Mechanical
Komatsu Equipment Co
Resident Field Mechanic Administrative & Professional
Jorgensen Brooks Group
Counselor

A Tucson pharmacy that sells custom-mixed hormones for menopausal women has been warned by the federal government to stop claiming the products are safer than or superior to standard hormone replacement drugs.

Reed's Compounding Pharmacy, 2729 E. Speedway, is one of seven U.S. compounding pharmacies that received letters from the Food and Drug Administration this week warning they're breaking the law by making "false and misleading" claims about their alternative "bioidentical" hormones.

But the Tucson owners of Reed's point out that the FDA is reacting to a complaint against compounding pharmacies filed by the giant pharmaceutical company Wyeth — maker of the synthetic hormone drug Prempro that was found too risky for many patients in large national studies.

It was those findings that have prompted many women to try more "natural" hormone replacement alternatives — known as bioidentical hormones, often made and sold at compounding pharmacies.

Compounding pharmacies mix specific ingredients to create a drug that can be tailored to a patient's needs and a doctor's specifications.

Like all hormone replacement drugs, those obtained at compounding pharmacies require a doctor's prescription.

In another move against compounding pharmacies, Wy-eth also is supporting the FDA's claim that compounded drugs now must be approved by the FDA — a claim rejected by a federal judge and now under appeal by the FDA.

Currently, the agency does not review compounded, or custom-mixed, drugs for safety and effectiveness and encourages patients to use FDA-approved drugs whenever possible.

Also included in the FDA's letter to Reed's and the other compounding pharmacies is a warning to stop Internet sales of their hormone products.

"We've never done Internet sales for anything, not even our supplements," said Dana Reed-Kane, a pharmacist who co-owns Reed's with her father, Tom Reed, also a pharmacist.

"All seven of the compounding pharmacies targeted by the FDA are small, independently-owned, local pharmacies," she said.

"I do have a high profile in this industry — I'm active at a national level — so I wonder if that's why they are coming after us. It does seem as if this may be driven by the big drugmakers who want us out of business."

In letters to the pharmacies, the FDA said the claims about the "bioidentical hormone replacement therapy" products are not supported by medical evidence. "We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," the FDA's chief medical officer, Dr. Janet Woodcock, said in a statement.

The agency said it is concerned that the claims of safety and effectiveness mislead patients, doctors and other health-care professionals.

In addition to citing the menopausal use, some pharmacies claimed the products could prevent or treat serious diseases, including Alzheimer's, stroke and some cancers, the agency said. Officials said there is no credible evidence to support those claims.

"We always tell people there have been no head-to-head studies between natural and commercially produced hormone replacement drugs," Reed-Kane said.

"Best option" for some patients

"But a lot of physicians feel that bioidentical, compounded hormones are the best option for their patients.

"We just say this is an individual decision, based on your needs, your quality of life, and that it is a decision between you and your doctor."

But Reed's has stripped down the information on its Web site out of concern about the FDA's crackdown, she said.

"But we have never made any claims our hormones could cure diseases," she said.

It was a landmark 2002 study that found certain replacement hormone compounds made by drug companies — specifically Prempro — raised the risk of heart attacks, breast cancer and strokes.

Since then, many women have turned to the estrogen, progesterone and testosterone products sold by compounding pharmacies.

"I think they're great — I like my natural hormones, and for me it is a safety issue," said Felicia Dutiel, who took Prempro for several years before she switched to bioidentical hormones prescribed by her doctor and compounded at Reed's.

"If you compare the chemical structure of Prempro to these natural hormones, the difference is startling. The ingredients in the compounded hormones are plant-based, natural ingredients," she said. "But they are just as effective as the synthetic hormones."

The FDA's warning won't dissuade her from taking the compounded hormones, Dutiel said.

"I'm not impressed with what they're doing at all," she said. "I don't trust the FDA under this administration — they seem to exert a lot of political control over what should be health issues."

But the executive director of the Program in Integrative Medicine at the University of Arizona does not criticize the FDA's warning.

"I think there is a big movement in this country that likes to say natural is safer, but in terms of hormones we don't know if that's true," said Dr. Victoria Maizes.

"These drugs have not been tested side-by-side with the manufactured drugs. And there is certainly no evidence that any form of hormones prevents Alzheimer's or other diseases."

But Maizes does prescribe bioidentical hormones — in the form of skin patches rather than pills — for women with severe menopausal symptoms.

Bioidentical hormones are made by the big pharmaceutical companies as well as compounding pharmacies.

"If women want to go to a compounding pharmacy, I have no problem with that," she said. "They may want to eliminate or substitute for an ingredient they are sensitive to in a drug."

She said she has worked with Reed's and does not know why the store has been targeted by the FDA.

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

L.D. King, executive director of the International Academy of Compounding Pharmacists, said the FDA's action will deny hundreds of thousands of women access to many commonly compounded bioidentical hormones, "substituting its judgment for that of doctors."

FDA officials stressed that they are not cracking down on all forms of compounding.

In addition to Reed's in Tucson, warning letters went to Panorama Compounding Pharmacy of Lake Balboa, Calif.; Saint John's Medical Plaza Pharmacy of Santa Monica, Calif.; Murray Avenue Apothecary of Pittsburgh; Village Compounding Pharmacy of Houston; Pharmacy Compounding Specialties of Dallas; and Pacifica Pharmacy of Torrance, Calif.