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Defying federal warnings, a Tucson pharmacy continues to make customized "bioidentical" hormones for women, as protests against the federal crackdown grow.

Nearly five months after the U.S. Food and Drug Administration warned several small, independently owned U.S. pharmacies — including Reed's Compounding Pharmacy in Tucson — about using an unapproved ingredient and making what it called false claims about safety, none has stopped making the hormones, while fighting in court and in Congress to keep doing so.

However, the FDA's action appears to have discouraged some patients from using these hormones, some doctors from prescribing them and a few insurance companies from covering them.

Even so, "we are not going to stop — no one is," said Dana Reed-Kane, co-owner with her father, Tom Reed, of Reed's Compounding Pharmacy, 2729 E. Speedway.

The pharmacy mixes doctor-prescribed, customized medicines — including female hormones — tailored to individual patients using plant-based ingredients as an alternative to synthetic drugs manufactured by large pharmaceutical companies.

"Bioidentical" hormones have a chemical structure nearly identical to hormones naturally produced by the body.

"We are continuing to compound these hormones as we always have, because we believe we are not doing anything illegal and because patients need to have a choice for a therapy that is designed for them," Reed-Kane said.

"We are hoping with the resolution moving through Congress the FDA will back off."

This month, a "sense of Congress" resolution was introduced in the House of Representatives asking the FDA to stop its effort to effectively ban compounded female hormone-replacement drugs that use an estrogen known as estriol. The FDA says estriol remains unapproved by the agency, making it illegal to use.

Eighty percent of compounded bioidentical female hormones include estriol. The FDA now says it "expects" the pharmacies to stop using estriol, but it has stopped short of a "cease and desist" order.

The FDA acted after Wyeth, a giant pharmaceutical company, complained that estriol-containing drugs "pose a serious public health threat" and should be banned. Wyeth has seen sales of its own hormone-replacement drug, Prempro, plummet since large national studies found high rates of heart attacks, strokes and breast cancer among women who used it.

It was those findings that prompted many women to try more "natural," bioidentical alternatives, including those made and sold at compounding pharmacies.

Among the congressional resolution's nine co-sponsors is Rep. Gabrielle Giffords, D-Ariz. Nearly 150 women in Giffords' District 8 — which is in Southern and Southeastern Arizona and includes much of Tucson — sent letters protesting the FDA's action and asking her to intervene.

"For me to go off these (compounded) hormones would be a disaster," said Joan Brundage, 62, one of those who petitioned Giffords' office for help.

"I started on (the Wyeth drug), but it didn't work for me. I had very bad side effects from it," Brundage said. "The estriol works so well — it gave me my life back. And if I can no longer get it, I really don't know where I would turn."

Responding to these pleas, Giffords listed several reasons for asking the FDA to stop its campaign against estriol, noting that it has been used in the United States and Europe "for decades" without any evidence that it's unsafe.

She pointed out that estriol carries what is known as a "USP monograph" — an approval standard from the United States Pharmacopeia recognized by state boards of pharmacy and endorsed by Congress.

"I know of no other precedent for FDA banning an ingredient with a USP monograph absent documented health and safety issues," Giffords wrote in a letter to her constituents.

"Doctors are in the best position to determine the best medications for their patients, and absent real safety issues, the FDA should not interject itself into the doctor-patient relationship. Eliminating (estriol's) availability would unnecessarily disrupt the lives of countless women," she wrote.

The FDA's action "represents a denial of care to women" because some insurance companies have stopped covering these compounded hormones, Giffords said.

"We have seen about a 10 percent drop-off in our business since the FDA's warning came out," Reed-Kane said. "But that has coincided with the economic downturn, so we can't be sure of the real effect."

The Reeds have spent about $25,000 in legal fees fighting the FDA's action, she added.

That includes supporting a lawsuit filed by 10 pharmacies challenging the FDA's jurisdiction over their products. In 2006, a Texas judge agreed with the pharmacies, ruling that compounded agents are not "new drugs," and so they remain legal. The FDA is appealing that decision.

However, the University of Arizona physician who led the Arizona arm of the national studies that found significant risks with female hormone-replacement therapy (using Prempro) welcomed the FDA's red flag on compounded hormones.

But she stopped short of endorsing the FDA's efforts to restrict or ban them.

"There is no doubt we need more research on the safety and effectiveness of replacement hormones — but I mean a whole range of hormones that we don't know enough about," said Dr. Tamsen Bassford, UA chief of family and community medicine.

"This is a much broader issue than targeting just one form of these hormones," Bassford said. "And I am not a regulatory expert, so I can't say if the FDA's approach is the right way to go about this."

She said she prescribes only those hormones that she knows are regulated for proper formulation and dosage.

"I'm just unsure of the oversight for compounded drugs, so I don't prescribe them. Saying they are 'bioidentical' does not mean they don't have the same range of risks and benefits as any hormonal agent. We just don't know."

For now, the Reeds are waiting for the outcome of the Texas case and monitoring the effect of the congressional resolution.

"We are continuing compounding until somebody makes us stop," Reed-Kane said.