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.
