Posted on 05/19/2005 5:39:10 AM PDT by OESY
...Former FDA Commissioner Mark McClellan made some progress moving the agency to speed up the drug approval process. But he was pulled away to run Medicare, and agency bureaucrats have since been working feverishly to turn back the clock.
The latest evidence of backsliding was a recent vote of the Oncologic Drugs Advisory Committee (ODAC) to recommend against approving Johnson & Johnson's leukemia drug Zarnestra....
This is a special shame because ODAC used to be a bastion of common sense, wherein clinicians who treat cancer patients would often buck FDA statisticians to approve new drugs. But ODAC is now chaired by osteopath Silvana Martino, who is notably hostile to the drug industry, and so it is unlikely to continue to be an independent check on the FDA.
A related blow for cancer patients was the selection last month of Richard Pazdur to head the FDA's newly consolidated oncology drugs division....
One way Congress could fight back would be with a law ending the moral travesty of placebo-controlled drug trials for terminal diseases. This has been Dr. Pazdur's main delaying tactic, justified as a way to prove efficacy beyond any doubt, regardless of how many people may die in the interim. (The oncologist conference also saw data presented questioning the value of lengthy drug trials.)
As for the White House, its failure to offer adult supervision of the FDA -- an executive branch agency that regulates one-quarter of the economy -- is increasingly notable and unfortunate. The agency has lacked a Commissioner confirmed by the Senate for about year; acting head Lester Crawford has been nominated for the job but is mired in the Senate's confirmation maw and in any case shows little inclination to buck the FDA culture that produced Dr. Pazdur....
(Excerpt) Read more at online.wsj.com ...
The FDA is so corrupt. I'd love to see an investigation into the personal finances and payoffs of all the people in the FDA making decisions.
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