FDA: Black Wednesday

Brother Johngalt and I explore some unexpected internecine disagreement in the "Pharmaceuticals" topic. I tried to explain in an answering comment that I'd like to see the FDA focus on safety and let the medical community -- a Hayekian collection of doctors, patients and researchers -- explore efficacy and benefits.

In addition to that response, I'd like to hide behind another WSJ editorial (another paid link). Dr. Mark Thornton, "a former medical officer in the FDA Office of Oncology Products, [who] volunteers as president of the Sarcoma Foundation of America" shares my disappointment.

May 9, 2007, should be cited in the annals of cancer immunotherapy as Black Wednesday. Within an eight-hour period that day, the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient's immune system against cancer. The FDA's hubris will affect the lives and possibly the life spans of cancer patients from nearly every demographic, from elderly men with prostate cancer to young children with the rarest of bone cancers.

I invoked Hayek because the problem here is a command and control structure. One drug is disallowed because it displays a 94% efficacy rate instead of 95%. One oncologist who votes in a minority on the first panel "launched an unprecedented PR campaign" against those who voted to approve and ultimately prevailed. It disturbs me that one doctor, who may be right or wrong, is enabled by our government to keep other Doctors from trying the treatment.

Though the author is a doctor, he knows that this ruling might cause the company or its investors to drop the product entirely, further driving up the risk premium for the pharmaceutical sector. Better to invest in something safe, like soap or cigarettes.

Both the Provenge and Junovan clinical trials provided evidence that patients lived longer compared to control groups. But according to the FDA, these "survival advantages" that statisticians talk about had "issues." When the issues were discussed in the Provenge public meeting the majority of the committee (in a 13-4 vote) thought the issues, while relevant and important, were superseded by the solid immunology science behind the product.

Pharmaceuticals Posted by John Kranz at May 14, 2007 11:58 AM