WSJ Editorial Page: Prostate Cancer and FDA Politics - Dendreon's Provenge

Prostate Cancer and FDA Politics. WSJ Editorial
Their first priority should be to save patients.
WSJ, Apr 20, 2009

Last week brought hopeful news for prostate cancer patients, with the biotech company Dendreon announcing that its cancer treatment Provenge improved survival and prolonged life in an important study. That may finally be enough for Provenge to win Food and Drug Administration approval, but the tragedy is that it wasn't approved years ago.

Provenge is an advanced cancer "vaccine," which stimulates the body's immune system to attack tumor cells and thereby fight off cancer on its own, instead of using chemotherapy or surgery. In an earlier placebo-controlled Phase III trial (the most rigorous kind), men with late-stage cancer who received Provenge lived a median of 25.9 months, compared with 21.4 months otherwise. After three years, 34% were alive, compared to only 11% for the control group. In March 2007, an FDA advisory panel voted 13 to 4 that there was "substantial evidence" the drug worked, and 17-0 that it was safe.

But later that year, the FDA delayed approval, ruling that the trial did not meet its criteria for statistical significance and that the patient sample was too small. So Dendreon agreed to complete another double-blind trial to FDA specifications, and Dendreon officials say the results have now met those benchmarks. The detailed results will be presented later this month.

The larger question is why Provenge wasn't made available sooner to the 30,000 American men who die each year from prostate cancer. The FDA regularly -- and pointlessly -- slow-walks potentially revolutionary therapies, relying on overly simplistic and unscientific statistical models that don't take into account the fact that some drugs may work better in certain subgroups than in others. Its regulatory blockade is especially cruel to terminally ill patients for whom drugs like Provenge may mean extra months or years of life.

These corroborating data should lead to a shift in the way the FDA evaluates innovative oncology medicines. But they almost surely won't, since the demands of bureaucratic politics to play it safe nearly always trump the needs of patients.