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Drug's delay mobilizes prostate patients to activism

December 31, 2007|Shari Roan | Times Staff Writer

He'd been fighting prostate cancer for 12 years, and his doctor told him the disease was spreading, but Ted Girgus still had hope.

In 2006, the retired college administrator had moved from Ventura County to Bellingham, Wash., to be closer to his three sons, his daughter and his wife's family as his health worsened. While there, however, he learned of a Seattle-based company conducting studies on a new kind of cancer therapy, one that might extend the lives -- at least by a couple of months -- of men who had exhausted all other options.

"As an advanced-prostate cancer patient, I was elated," Girgus says. "The company was sending all their data to the Food and Drug Administration, and the FDA had fast-tracked the drug." Fast-tracking means the agency sees promise in a drug and agrees to evaluate it as soon as possible.

In March, an FDA advisory committee voted to recommend approval of the therapy, a cancer vaccine genetically engineered to prod the patient's immune system to attack the disease with renewed vigor. But, in May, the FDA announced that it would require more data on the therapy -- called Provenge and made by Dendreon Corp. -- before reconsidering approval. The agency said there appeared to be no evidence that the vaccine was effective.

That turnaround has outraged many men with prostate cancer. They had been hoping for a promise of extra time, no matter how limited. It also has fueled a level of patient activism common among women with breast cancer but rarely seen among prostate cancer patients.

A coalition of prostate cancer patient advocacy groups, Raise a Voice, led a rally last June at the FDA and met with agency officials to push for more prostate cancer therapies. The coalition includes the Los Angeles-based Prostate Cancer Research Institute, Us Too International, Malecare, the Prostate Health Education Network and several state prostate cancer organizations.

The investor-led group Care to Live has held rallies in Washington, D.C., and Chicago and purchased bus and newspaper advertisements in Washington calling for a review of the FDA's decision. That group, which is funded by private donations, also filed a lawsuit alleging that the FDA's decision was influenced by conflicts of interest. The Abigail Alliance for Better Access to Developmental Drugs has backed the protests; that group has sued the FDA to allow dying patients greater access to unapproved products that have cleared preliminary safety tests.

Also, cancer doctors, patients and even one former FDA official have written editorials and letters to the FDA questioning the agency's approval process and calling for more research and better treatments for prostate cancer. Earlier this month, three members of Congress called for a congressional hearing to investigate the FDA's decision on the vaccine.

The reaction has been notable both for its tenor -- the two FDA advisory committee members who asked for more information on efficacy have received death threats -- and its focus on a specific drug. Other disease-specific activists generally support general research and development, not one medication.

Regardless of the emphasis, prostate cancer activists say, the response could herald a new era of patient advocacy. Often embarrassed by the disease and reticent to call attention to themselves, prostate cancer patients have been a relatively undemanding group considering the number of people afflicted.

About 230,000 American men are diagnosed with prostate cancer each year, and 27,000 die of the disease -- statistics that are roughly comparable to breast cancer. Yet federal funding for breast cancer research is more than double that of prostate cancer, according to the National Institutes of Health.

"This has really kick-started the prostate cancer community and given us some motivation and focus," says Jan Manarite, a Raise a Voice volunteer and Florida educational facilitator with the Prostate Cancer Research Institute, or PCRI, a nonprofit education and research organization on prostate cancer. "I think we're finally learning about advocacy. I hope this experience helps us learn how to work effectively with the FDA."

Raise a Voice does not accept funding from Dendreon or other drug companies. PCRI accepts unrestricted educational grants from businesses, including pharmaceutical companies. It received two unrestricted grants from Dendreon in 2000 and 2003.

Some activists are dismayed by the occasional ugliness of the debate and say the movement needs to grow beyond this incident.

"While it was nice to see some people in the prostate cancer community mobilize, the way a few people handled it by making death threats was appalling," says Jamie Bearse, executive vice president of the National Prostate Cancer Coalition, a nonprofit, education and advocacy group based in Washington, D.C. "All the protests in the world won't get this drug approved if the science is not where it should be."

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