[OT] FDA Delay In Cancer Therapy Is Attacked

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FDA Delay In Cancer Therapy Is Attacked

By Rob Stein

Washington Post Staff Writer

Friday, July 6, 2007; A01

Oncologists do not usually need bodyguards when they present scientific data at

a medical symposium.

But when 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 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 C. von

Eschenbach the same day. They began lobbying to amend FDA legislation moving

through Congress to allow easier access to experimental treatments.

Full story

http://www.washingtonpost.com/wp-dyn/content/article/2007/07/05/AR2007070502149_\

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