I received this note that I am passing on:
THE GOVERNMENT ACCOUNTABILITY PROJECT (GAP) invites you to join us for “From Vioxx to Avandia: Whistleblowers and Dangerous Drugs” – a Live Telephone Conference Call with Q & A on Thursday, June 21st, at 6:00pm – 7:00pm eastern.
The call will feature David Ross, Ketek FDA whistleblower and Mark Cohen, GAP Food & Drug Safety Director.
To take part: email richards@whistleblower.org. To receive the call-in info by text message, please include the number in your email.
GAP has been involved in a number of prominent cases related to restricting the presence of dangerous drugs on the market, most notably Vioxx. The Vioxx scandal came to light when Dr David Graham, a top FDA scientist and GAP client, testified before a Congressional committee that Vioxx had likely caused as many American fatalities (heart attacks and strokes) as had the Vietnam war. Moreover, as it was structured, FDA could not be relied upon to protect the American public from future drug disasters.
Join us for a live conference call with David Ross, the former FDA medical officer who blew the whistle on the mishandling of the approval process for the antibiotic Ketek, and Mark Cohen, GAP food and drug safety director.
The revelations that Dr. Ross and others made resulted in significant restrictions in the approved uses for Ketek.
The recent controversy over the diabetes drug Avandia seems to confirm Dr Graham’s critique of the agency’s culture and processes. Reforms being discussed by Congress right now could go some way toward changing the way the agency balances the interests of rapidly bringing new drugs to market and the interests of ensuring that news drugs are truly safe and effective.
Join us on this live conference call to get the latest update on the progress of these reforms and to put questions directly to David Ross and Mark Cohen regarding our work on Drug Safety and the experience of being a whistleblower within the FDA
For call-in details, email richards@whistleblower.org.
