Citizen or Subject?

One of my favorite parts of Amity Shlaes's The Forgotten Man is when the publisher of Good Housekeeping is at the White House (for dinner as I recall) and is told about the new FDA that will replace her cherished "Good Housekeeping Seal of Approval."

I have tiresomely suggested a privatized FDA based on the Underwriter's Laboratory/CSA model, but I think I'd take about anything over what we have now. While 30,000 die each year of prostrate cancer, the FDA is empowered (again) to keep its most promising new drug off the market for a couple of years so that the developer can complete some more t-dotting and i-crossing. And only the WSJ Ed Page and I seem to care.

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.

And the even larger question is are we citizens or subjects? Must we go quietly die in the corner while we wait for our goverment to "approve" a treatment that was voted 17-0 for safety?

Pharmaceuticals Posted by John Kranz at April 20, 2009 12:38 PM