FDA flip-flop mobilizes prostate cancer patients to activism - Los Angeles Times

December 30, 2007

or

The

debate over Provenge highlights how difficult it is for scientists and the FDA

to reach a decision about some drugs, says Dr. Penson, an associate

professor of urology and preventive medicine at the Keck School of Medicine at

USC/Norris Cancer Center. He conducted some studies on Provenge and attended

the FDA advisory committee meeting on the therapy last March.

Penson says he was struck by the committee's essential dilemma: Approve too

quickly and an ineffective drug might enter the marketplace. Approve too slowly

and patients might be denied a potentially useful therapy.

" Provenge prolongs life, but not tremendously, " Penson says.

" There is a three- to four-month survival advantage. That may not seem

like a lot to you or me, but these men are really desperate. "

Because therapeutic cancer vaccines work differently than traditional cancer

drugs, some experts say the FDA needs to evaluate them differently. Other

measures of benefit may need to be used for immunotherapies prescribed for

advanced disease instead of the traditional measures, such as tumor growth,

used for chemotherapy, they say.

snip

The

prostate cancer community should rally around the issue of more research and

new treatments -- not simply the issue of Provenge, says Bearse of the National

Prostate Cancer Coalition.

" For most men, any excuse is a good excuse not to take care of your

health, let alone be an advocate for it. That mentality has to change in a big

way, " he says. " Only when we have a grass-roots swell even greater

than what has transpired with Provenge will we achieve parity with breast

cancer on the path to a cure. "

Girgus, who bought stock in Dendreon, says he hopes he can one day benefit from

the drug. But he says his fight now is for others, including his adult sons.

" This has made an activist out of me, " he says, noting that in

October he asked his local grocer why the store commemorated breast cancer

awareness month each October by using pink grocery bags but did not recognize

prostate cancer awareness month in September.

" I said, 'Where are the blue bags?' " Girgus recalls. " The store

manager is a lovely lady. She said, 'I didn't know about that. But I promise

you we will have blue bags and blue ribbons in September.' "

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