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[AlaskaAngel]

Fight brews over natural vs. synthetic hormone treatments


http://www.azcentral.com/php-bin/clicktrack/email.php/5400342

Fight brews over natural vs. synthetic hormone treatments

Kate Nolan
The ArizonaRepublic
Jun. 26, 200612:00 AM

Since Kay Bell started taking bioidentical hormones, she has lost 20 pounds, gone down two dress sizes and her head no longer aches at 2 p.m. daily.

But the Mesa real estate agent's delight has turned to outrage since a major drug company complained to the Food and Drug Administration about the "natural" estrogen she has taken for a year.

The complaint filed by Wyeth, a global pharmaceutical company, demands that the FDA regulate bioidentical hormones.


Fearing her treatment would be outlawed, Bell wrote a letter to the FDA, pleading for restraint.

So did more than 40,000 others, including the pharmacists who prepare the hormones, doctors who prescribe them and the menopausal women who use them.

"The petition has had quite a response. It's a large consumer issue," FDA spokeswoman Susan Cruzan said in Maryland.

The FDA, citing the complexity of the issue, postponed a decision that was due in April.

Meanwhile, the agency quietly conducted unannounced inspections of compounding pharmacies, the mostly small drugstores that make bioidenticals, and collected samples from them. The action has irked compounding pharmacists because their drugstores are regulated by the states.

Mainstream doctors as well as alternative practitioners prescribe bioidentical hormone replacement therapy (BHRT), which is in wide use in Europe. Unlike manufactured estrogens, bioidentical doses can be individualized. While they are made from plants, they are molecularly identical to human estrogen. Prescriptions for bioidentical hormones aren't tracked, but compounders and doctors agree that demand is growing.

Wyeth's complaint

In an October letter written by its law firm, Wyeth argued that bioidentical hormones should carry health warnings and be federally regulated. Wyeth manufactures Prempro, a synthetic hormone compound that is FDA regulated and has suffered recent sales losses.

Resisting the rising tide of bioidenticals, the pharmaceutical firm's letter also criticized Suzanne Somers, TV sexpot and author of The Sexy Years, a chronicle of her bout with menopause, for popularizing bioidentical hormone therapy.

But the heart of Wyeth's argument is a demand that the FDA "initiate enforcement and regulatory action" against compounding pharmacies, charging that compounders are introducing drugs to the market without testing or proper labeling, and manufacturing drugs that require FDA approval. Wyeth has asked the FDA to order compounding pharmacists to use warning labels and conduct drug testing of their formulas.

Candace Steele, a Wyeth spokeswoman, said the company doesn't oppose compounded hormones but contends that some providers make false claims about their safety and fail to individualize prescriptions.

"The FDA says all estrogens carry the same risks. We want women to understand that," Steele said.

A spokeswoman said the FDA position on estrogen applies only to manufactured drugs.

Pharmacies react

Compounders charge that implementing Wyeth's demands would remove bioidenticals from the market and narrow women's choices.

The drop in sales came after a Women's Health Initiative study of Prempro was stopped in 2002 because the product, which once enjoyed a near monopoly, seemed to increase risk for heart disease and stroke. Wyeth estimated that worldwide, Prempro revenues dropped from $1 billion in 2002 to $850 million by 2004 but said it recently has rebounded.

After the unfavorable study, Prempro remained on the market, but in 2003 the FDA required a warning label that says the drug doesn't protect against heart disease but may increase risk of it, in addition to stroke, breast cancer, pulmonary embolism and blood clots.

The International Association of Compounding Pharmacists countered Wyeth's complaint with a letter that questioned Wyeth's reasoning.

"This is quite unique, a frontal blast by Wyeth. It's the first time we've seen it," said L.D. King, director of the Texas compounding group. "The FDA does a good job. We think the regulatory scheme works quite well," he said.



"It would appear that Wyeth is trying to take out any compounded medication that competes with their Prempro product," King said. "It would appear to be profit motivated."

Wyeth's spokeswoman responded that the company is concerned about its product, but its interest in women's health motivated the action.

In Arizona, a stronghold for alternative-drug therapies, Wyeth's complaint is not sitting well with drug compounders.

"Wyeth appears to be trying to shut off their competition," said Evelyn Timmons, founder of Mountain View Pharmacy in Phoenix and a national leader in the compounding field.

According to Timmons, Wyeth has asked the FDA to stretch beyond its reach.

"They seem to be saying compounders require the same rules of manufacturing," said Timmons, past president of the AmericanCollege of Apothecaries, the national specialty board for compounders.

John Musil, the Scottsdale-based owner of the Apothecary Shops, a group of compounding pharmacies, argued that Wyeth's positions seem to cancel each other out: Wyeth says bioidenticals are the same as synthetic hormones and require the same warnings but also says they should undergo independent testing.

"We agree bioidentical hormones have not undergone the same testing as a manufactured product. We welcome research," Musil said, claiming that bioidenticals have been used successfully for years. He wants the choice of hormone therapy to remain with the patient and the physician.

A worrisome development for compounders has been the arrival of FDA inspectors on their premises.

"All of our pharmacies have been visited recently by the FDA," Musil said. FDA officials have requested samples of compounded items to test whether they fall within prescribed dosages.

The director of the Arizona State Pharmacy Board turned down a request by FDA inspectors to smooth the way for them with area compounders.

"I asked them, is that legal?" Hal Wand said. Inspections typically respond to a complaint where a pharmacy is suspected of doing something wrong, for example, in cases where a patient is injured, he said.

Assessing health risks

Dr. Gino Tutera, a Scottsdale doctor who specializes in hormone treatments, said Wyeth's demands would take away a patient's right to choose. Tutera, who uses only bioidenticals, said his patient load has quadrupled in a year and a half.

He said he believes bioidenticals don't carry the same risks as synthetic hormones.

They can be given in smaller doses than the uniform synthetics, and the synthetic hormones have extra carbon atoms that, Tutera said, account for the increased risk of blood clots. Tutera has completed a 10-year study of 976 women who used natural hormones. To be published in a medical review this year, the study showed no cases of cancer. He said his patients rarely have developed heart problems.

Dr. Jennifer Nevels, head of the women's medicine department at the Southwest College of Naturopathic Medicine in Tempe, also welcomes further research into bioidenticals. She said animal studies suggest that a mild bioidentical estrogen called estriol may resist breast cancer and cancer of the inner lining of the uterus. The school specializes in natural approaches to medicine and researchers there are doing studies with bioidentical hormones administered in ways that resemble women's physiology.

Some medical authorities suggest that the natural vs. synthetic argument dodges the problem, which may be estrogen itself.

Dr. Alison Stopeck, director of the breast cancer program at the ArizonaCancerCenter in Tucson, said Wyeth raises a legitimate complaint.

"We don't know that the biosynthetic hormone is safer. We know less about compounded drugs than about the Wyeth product," said Stopeck, who rarely prescribes Prempro because it contains progesterone, a hormone associated with breast cancer; she sometimes prescribes Estrace, the manufactured version of the estrogen estradiol.

"The body turns off hormones for a reason. After menopause, the body is turning them off. Maybe long-term exposure to estrogen is bad," Stopeck said. "You can't say, 'just because it's natural it's safe.' There's no data to support that taking the hormones of youth makes you live longer," Stopeck said.