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FDA's delay in prostate cancer therapy is attacked

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=1420396&contenttype=sentryarticle...

WASHINGTON --
Oncologists do not usually need bodyguards when they present scientific data at a medical symposium.

But when Howard I. Scher of the Memorial Sloan-Kettering Cancer Center and Maha Hussain of the University of Michigan spoke at a recent meeting of the American Society of Clinical Oncology, they were in fear for their safety.

The two doctors have been at the center of an unusually bitter debate over an experimental therapy for prostate cancer, ever since they helped persuade the Food and Drug Administration to delay approving it, enraging both patients and investors. The first-of- its-kind therapy, called Provenge, is a "vaccine" designed to extend the lives of patients with advanced prostate cancer by stimulating their immune systems.

The debate over Provenge illustrates the highly charged atmosphere that often surrounds new treatments as the desperation of deathly ill patients increasingly converges with the high-stakes intensity of biotech investing in the anything-goes forum of the Internet. The result in this case has been anonymous threats, accusations of conflicts of interest, Capitol Hill protests, congressional lobbying and vitriolic postings on blogs, Web sites and MySpace pages.

"This case may be different and all the more controversial because it's at the intersection of patient advocacy and the nervous world of biotech investors," said Daniel P. Carpenter, who studies the politics of health care at Harvard University. "It makes for a much more volatile politics."

A panel of experts recommended in March that the FDA approve Provenge. But in May, the agency instead asked for more evidence that the vaccine works after specialists, including Scher and Hussain, questioned its effectiveness.

Scher and Hussain told the FDA that Dendreon Corp., the small Seattle biotech company that developed Provenge, submitted a study to win approval for the drug that was so small that the apparent benefit it showed could have been the result of chance.

The FDA's surprise decision unleashed a spasm of criticism by prostate-cancer patients, advocacy groups and investors in Dendreon.

After the price of Dendreon's stock quadrupled and then plummeted, irate investors wrote hundreds of letters to the FDA and Congress, posted blistering critiques in Internet chat rooms, and created Web sites and MySpace pages denouncing the FDA, Hussain and Scher. They alleged various motives for the decision, including internecine rivalries within the FDA and pressure from larger rival drug companies.

"Why else would they object?" said Ray Vestal, a Huntsville, Ala., investor. His "Approve Provenge Now" MySpace page asks, "Hey, Hey, FDA, How Many Dads Did You Kill Today?" as images of Hussain and Scher flash across a backdrop of crooked crosses and Mozart's "Requiem" plays. "Perhaps there's something else behind the scenes," he said.

Patients and advocacy groups, meanwhile, borrowing strategies from AIDS activists and breast-cancer advocates, mounted an orchestrated lobbying effort. They launched a letter-writing campaign and Web sites, staged a Capitol Hill rally June 4, and demanded and got a meeting with FDA Commissioner Andrew C. von Eschenbach the same day. They began lobbying to amend FDA legislation moving through Congress to allow easier access to experimental treatments.

Scher and Hussain, meanwhile, began receiving anonymous e-mails, phone calls and letters attacking and sometimes threatening them.

"We have been harassed and trashed for giving our opinion in an area of our expertise," Hussain said. "It's been a nightmare, to say the least."

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