By my estimate, more than 1,000 people have died prematurely because of foot-dragging by the FDA. Here’s why:
After an “expedited” analysis that lasted a year and a half, the FDA has finally approved Bristol-Myers Squibbs’ Yervoy (ipilimunab) for metastatic melanoma. The deadliest type of skin cancer, melanoma killed 8,700 Americans last year, according to the National Cancer Institute. BMS submitted its application to the FDA on August 18, 2010, with a target date for approval of December 25. On November 2, the FDA pushed out the target date. On March 25, the FDA approved the lifesaving medicine.
So, the question is: How many patients did the FDA kill by delaying the medicine?
Well, 46 percent of the subjects taking the drug were alive one year later, and 20 percent were alive two years later. In the control group, only 25 percent survived one year, and 14 percent two years. The difference between 46 percent and 25 percent is 21 percent. 21 percent of 8,700 is 1,827 lives. Similarly, the difference between 20 percent and 14 percent is 6 percent, or 522 of 1,827 lives.
Assuming that BMS was willing to supply the medicine as of August 18, 2010, the FDA’s initial period of review (to December 25) took 129 days. This implies that 645 melanoma patients died a year earlier than they would have without the legal requirement for FDA approval. However, because the FDA delayed a further 90 days (to March 25), 450 more patients died a year early. The point estimate for the total number of melanoma patients who died a year early is 1,095.
Of course, many of those would have died after another year. The delay only cost 313 patients two years of life. But I hardly think that’s a comfort to melanoma victims and their families.
(Crossposted at John Goodman's Health Policy Blog.)