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FDA's Accelerated Drug Approvals Raise Big Concerns

You may remember a blog I posted two weeks ago about Dr. Charles Bennett, a Northwestern University researcher, and often a harsh critic of the FDA's practices. He was recently banned from the agency's adverse drug reaction database last fall, after a scathing report that gave them a failing grade for drug safety.

Dr. Bennett was interviewed in this morning's USA Today (one of my favorite newspapers in the world) about his concerns over the FDA's decade-long practice of accelerated drug approvals, particularly to some 20 cancer drugs. The advantage advocates cite to justify speedier drug approvals, particularly to terminal patients: Those patients may have been helped even if studies show they don't live longer.

However, the disadvantages may be just as fatal:

  • Most of these new cancer drugs have been approved after being tested on fewer than 300 patients. And, in the case of Velcade (myeloma) and Mylotarg, Czampath and Clolar (leukemia), the total number of patients involved in trials amounted to less than a combined 500 patients.
  • Prescribed to a broader audience, these "accelerated" drugs could generate a high rate of unforeseen side effects.
  • The FDA hasn't required companies who make these "fast track" drugs to do follow-up studies, and only a third of done so.

And, according to an analysis of 26 clinical trials by Dr. Bennett, only a few dozen patients in most cases were actually helped by these drugs. And, rushing unproven, and maybe toxic drugs to market, shouldn't absolve the mega-pharmaceuticals of any accountability either.

There seems to be growing number of medical professionals who are seeing these same major problems with the FDA as I do and are being much more vocal about it. Perhaps, people are starting to understand treating the real cause of illness is much more effective, safer and healthier than trying to "cure" it by taking a pill.

USA Today March 10, 2005

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