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Comments about: Support Michaud's call for hearings on Provenge FDA's denial of prostate cancer treatment under cloud of conflict-of-interest allegations
Rep. Mike Michaud, D-2nd District, and two House colleagues, Rep. Dan Burton, R-Ind., and Rep. Tim Ryan, D-Ohio,...
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c-survivor of brunswick, ME
Feb 11, 2008 6:43 AM
Thankyou Dr Trowbridge for the excellent column, for your work at the abigail alliance and to your service to our country and all of humanity. I truly hope and pray we may balance the issue of safety for chronic drugs like vioxx with the need for options for people dying and suffering late stage cancer. Too many people are dying needlessly and too much promising research is being stifled for these late stage cancer therapies while the FDA waffles. This, in the presence of those conflicts of interest feels like being spat on after already being kicked in the face.report abuse
Skitahoe of Los Angeles, CA
Feb 11, 2008 2:07 AM
Vioxx presents an example of what's wrong in the country. Companies can pay off victims of drug and other problems, like Doctor's malpractice, with confidentiallity agreements, and problems don't come to the surface.

The FDA wouldn't need to worry about companies hiding the negative side effects, or Doctors who shouldn't be if confidential settlements couldn't be made.

In fact, if all new approved drugs required both positive and negative results to be posted on an FDA publically available site anyone could see the sort of results the drug was getting. This could be done as a condition of Approval in every case for say one year. After a year, if no major detrimental problems were seen, it could be optional, but any time a patient wanted to post, it would be available to them.

If on review the FDA found reason to question the approval, or perhaps eliminate some applications because of problems, they could.

In short, the FDA could approved drugs more easily because companies couldn't hide negative side effects being seen or felt as they'd end up on the FDA website. Ultimately greater trust would result between the FDA and the drugmakers.

Today the FDA is more inclined to obstruct drug development than assist it, they need to be shaken to the core and rebuilt, but so do the laws that have permitted drugs like Vioxx and Fen-Fen to do tremendous damage before it became public knowledge. Likewise Doctor's having their problems exposed might prevent deaths like the recent death of Kanye West's mother.

This is not meant to be a witchhunt, both drugs and Doctors are occasionally going to have unhappy customers, but when numerous problem of the same type occur with a drug or Doctor, there would be reasons for either the FDA to investigate, or for the public to look at other possibilities.report abuse

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