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Sunday, June 1, 2008

FDA Wants to Leave Hormone Replacement in the Hands of Major Pharmaceutical Firms

Wouldn't you know it!

Now it really looks as though major pharma might win this battle. Please make yourself aware of what is going on and why. If we - the consumer - don't do something about it, we could lose our possibility of purchasing bio-identical hormones.

Would this happen if a bio-identical viagra were available??

Critics say move would leave drug firms in charge of hormone replacement

By CLARE HOWARD
OF THE JOURNAL STAR

Posted May 31, 2008 @ 09:10 PM

PEORIA —
Peoria Heights pharmacist John Preckshot and compounding pharmacists across the country received a "warning" from the Food and Drug Administration to stop working with physicians on individualized formulations of bioidentical hormones using estriol.

The warning was in the form of an official letter to seven compounding pharmacists. Preckshot did not receive a letter, but the message clearly reached him and his entire industry.

Preckshot will be in Washington, D.C., this week visiting U.S. Rep. Ray LaHood and others, calling these letters a political move to squeeze compounders out of the market and leave hormone replacement entirely in the hands of major drug companies.

Dr. Jill Carnahan, one of a number of Peoria-area physicians prescribing bioidentical hormones, said she "absolutely" will continue to prescribe them.

"Certainly, politics is involved here. Since the Women's Health Initiative, more women and their doctors have been concerned about hormone replacement therapy," she said.

"Bioidentical hormones give women more options, and they are no more dangerous than what is already out there. I believe they are much safer. Pharmaceuticals are already using these compounds, and they just don't want the competition."

The FDA letters came after the pharmaceutical company Wyeth filed a petition with the agency asking that compounders be prevented from using estriol.

Preckshot said the issue is not a question of drug safety or effectiveness, but a move by major drug companies to maintain market share in the face of increasing numbers of women who are switching to bioidentical hormones.

Compounded bioidentical hormones cannot be patented, so there is little incentive for major pharmaceutical companies to market them, Preckshot said, noting that Wyeth, a leading manufacturer of synthetic female hormones, instigated this latest move against compounders.
Wyeth spokesman Doug Petkus said his company filed a petition requesting the FDA restrict estriol because it is not an approved product.

"It's the craziest thing," said Jeff Robins, a registered pharmacist and compounder with Preckshot. "Wyeth has sold estriol in Europe for years and years and knows it is safe. This is all about market share."

Petkus said the company sold estriol in Germany for a short period of time.

Robins said hundreds of local women who use bioidentical hormone replacement could lose that option if the FDA is not pressured to reverse its position.

LaHood spoke from Dubai, where he was on a Middle Eastern trip focusing on oil prices. He expects to be back in the capital Monday.

As a member of the House agriculture committee that has oversight over the FDA, LaHood is in a strong position to weigh in on this debate.

"John (Preckshot) has made a difference over the years, and I'm looking forward to talking with him about this. I'll be taking a careful look at what he tells me," LaHood said, noting that members of Congress are generally not experts on compounding pharmaceuticals and rely on credible experts like Preckshot.

Elmwood compounding pharmacist Cathy Windish estimates the number of central Illinois women potentially affected by this FDA position is in the thousands.

"This is ridiculous. It's the stupidest thing, and it is not based on science. Our position supporting estriol and bioidentical hormones is science based," she said, noting that Wyeth uses horse urine in its synthetic formulations.

"Look at the studies of the major drug manufacturers. They have the money to pay for many studies and then select only those that support their medications. As a scientist, I've seen how they shape their message," she said.

Windish believes the current move is in reaction to the growing demand by women and their physicians for bioidentical hormones.

"It's growing exponentially, everyday," she said.

One Peoria woman who switched to bioidentical hormones is Camy McLaren, who said her mother developed breast cancer after using a synthetic hormone replacement.

"She took Premarin for over 25 years. I knew I wanted to avoid that, but when I went to my gynecologist, she gave me Premarin when I hit menopause," McLaren said.

She switched doctors, and her new physician prescribed bioidentical hormone replacement therapy.

Ursula Schulz, a Peoria woman who has used bioidentical hormones for years, said, "I think this situation is awful. This is about a woman's right to choose."

In agreement is Peorian Susie Hall.

"This is about access to a customized bioidentical hormone made specifically for your needs vs. synthetic, one-size-fits-all hormones. It's really terrible, the government is trying to eliminate choice," Hall said. "It's all about money."

Robins said the FDA gets a large percent of its funding from leading drug manufacturers.
"The reality is, the majority of FDA funding comes from the manufacturers ... the people the FDA is supposed to be policing. That leaves the door open for a conflict of interest," Robins said. "What the FDA has done is not an official stance, but they've sent out letters of warning. It's basically a threat."

Preckshot left for Washington on Saturday on a lobbying trip planned by an organization called Patients and Professionals for Customized Care. He said he is looking forward to speaking with LaHood, who has a record of supporting small compounders.

LaHood was in the Middle East recently and could not be reached for comment.

Preckshot also will visit the offices of U.S. Sens. Barack Obama and Dick Durbin.

"Once again it's government intervention into what should be the right of patients and physicians to practice individualized health care," said Preckshot, who has worked in the pharmaceutical field for more than 30 years and has compounded for more than 20 years.

"Compounding is more responsive to individualized care. We have run into loggerheads with Big Pharma before. The big companies are watching the growth of compounding."

About five years ago, compounding represented just 1 percent of drug sales, but that has grown to 3 percent now as more doctors and patients demand alternatives to standardized commercially produced drugs, Preckshot said.

Clare Howard can be reached at 686-3250 or choward@pjstar.com.

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