had to share this story I read on truthout.
http://www.truthout.org/issues_05/110305HB.shtml Cardiologist Goes Toe-to-Toe with Drug Companies
By Peggy Peck
MedPage Today
Wednesday 02 November 2005
" One look told him that an FDA advisory panel charged with reviewing the same documents would not approve the drug. But he was surprised when the panel, which met September 9, recommended by an 8-1 vote that FDA give it a thumbs-up. He dropped everything and began an in-depth analysis of the Pargluva data.
Working nonstop with a Cleveland Clinic statistician and with co-author Dr. Eric Topol, chairman of the department of cardiovascular medicine, Nissen finished his analysis in record time.
The paper was published online on October 20 by the Journal of the American Medical Association, just two days after the FDA had sent the drug's makers an "approvable letter" that said Pargluva could be approved if the company supplied more cardiovascular safety data.
On October 27, Bristol-Myers Squibb announced that it would terminate its Pargluva development agreement with Merck. Bristol-Myers Squibb said it will continue discussions with the FDA, but said it might stop development of the drug.
Asked about the stunning reversal of fortune for Pargluva, Nissen said, "I'm not a crusader, I just want the balance between safety and efficacy to be favorable." "I added the bolded text
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