[Health&Healing] FDA's Accelerated Drug Approvals Raise Big Concerns

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Misty L. Trepke

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FDA's Accelerated Drug Approvals Raise Big Concerns

 

http://www.mercola.com/blog

 

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