FDA has bigger problems than conflicts of interest
re "F.D.A. Rule Limits Role of Advisers Tied to Industry", NY Times, 3/22/07
http://www.nytimes.com/2007/03/22/washington/22fda.html?ref=us
To the Editor:
Removing FDA advisers who are paid substantial amounts by companies or their competitors from ruling on those companies’ drugs or devices may strike a blow against conflicts of interest. But it may also strike a blow against the interests of all Americans.
The FDA is remarkably, outrageously, and dangerously conservative in their approval of new drugs, often leaving patients in pain or dead rather than let them try something which might work, even if not yet proven. The FDA should lean more toward allowing experimental drugs as long as the risks do not seem greater and more likely than the potential benefits, and as long as those risks are fully explained.
Given how difficult it has been in recent years for drugs to get approved even with the participation of people who might have had a extra financial motivation in their decisions, it will be even worse with those people removed. I’m all for removing conflicts of interest, but the FDA’s obvious fear of lawyers and low regard for the intelligence of American patients and doctors is a much bigger problem.
| Print article | This entry was posted by Rossputin on 03/31/07 at 03:36:10 am . Follow any responses to this post through RSS 2.0. |
Yours truly
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03/31/07 @ 12:46:12 pm
"The FDA should lean more toward allowing experimental drugs as long as the risks do not seem greater and more likely than the potential benefits, and as long as those risks are fully explained."
The FDA frowns on approving experimental drugs because once a drug is accepted as legimate, a competing drug only needs to prove it works better to receive the nod to go on the market. Clearly, the FDA could easily modifty this situation by creating an experimental drug class for treatments with few side effects and encouraging results. Drugs with only preliminary findings may help those who would otherwise die waiting for the results of more studies. The classification should have a probationary period attached to the temporary acceptance to give companies more time to get more conclusive results.