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: ThePopTort

Has the FDA Cleaned House? Meh, Not So Much.

By Amanda

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Red and White Promises, Photo by Migraine Chick I?ll admit it.  I spend a lot of time worrying about dangerous drugs and medical devices.  Just this morning I thought twice before taking an over-the-counter NSAID (same drug class as VIOXX) to quell my migraine.  I suppose I can?t help being paranoid, after all I helped write the CJ&D?s reports THE BITTEREST PILL ? How Drug Companies Fail To Protect Women and How Lawsuits Save Their Lives  and HEART SICK ? Hazardous Heart Devices and the Importance of Litigation 

Both reports contain example after example of the same story of drug and medical device companies getting FDA approval for their products that sometimes do more harm than good and how these companies keep these dangerous product on the market despite injuries and deaths.

And its not just The PopTort questioning the effectiveness of the FDA to police our food and drugs in this country.  A recent online poll said that 47 percent of respondents think that the FDA ?does a poor job? (this apparently is an improvement from last year which indicated 58 percent of respondents disapproved of the agency).  But even if the public is warming up to discussed changes proposed by the Obama administration, this morning in a Forbes article, Jeffrey Lieberman, the chairman of psychiatry at Columbia Medical Center suggested that the FDA ?is still doing business as usual.?

The Forbes article cites the recent approval of Vanda Pharmaceuticals anti-psychotic drug Fanapt ? a drug which gained FDA approval this week after receiving a ?not approvable? by the FDA less than a year ago.  The FDA had wanted more testing of the drug, but Wednesday gave it the green light with only the data from the original clinical trial of only 3,000 people.

This might have done wonders for Vanda stock, but what will it do to the potential patients who may take this drug?  Of all the things that are changing at the FDA right now, we shouldn?t lose sight that the agency should redouble its efforts to ensure the drugs and medical devices it improves are in fact safe and effective.  Emphasis on the safe part.

Full post as published by ThePopTort on May 08, 2009 (boomark / email).

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