Remember the ending of the movie King Kong? A policeman said "Well, the planes got him!" but Carl Denham said "Oh no, it wasn't the airplanes. It was beauty killed the beast."Of course, the press picked up on that right away because it made for a much more interesting story. It had, as they say, more human interest.
Now, instead of a beast we have Avandia, a blockbuster reeling to and fro atop the diabetes marketing tower ready to take a nose dive to the ground -- in fact it may already be on the way down.
"The total number of Avandia prescriptions written by physicians has fallen by 20% since safety concerns about the drug surfaced last month," said Chris Viehbacher, president of London-based Glaxo's pharmaceuticals business in the U.S. "The number of Avandia prescriptions doctors are writing for new patients has fallen by 40% over that same period." (See "Glaxo Says Avandia Is Victim of Politics").
Glaxo -- Avandia's marketer and guardian angel -- is shifting the blame for Avandia's woes away from impersonal science (the planes) and towards the human element; ie, those bad Democrats in Congress."It's pretty much Democrats beating up on us," says Viehbacher.
Even though Glaxo is invoking the Waxman et al bogey man, Viehbacher still claims that "In the end science will win."
Meanwhile, neither Glaxo nor the FDA is rushing to show any more "science" to support claims that "Avandia is as safe for the heart as other diabetes drugs."
Please pass this on to friends and colleagues interested in issues of drug safety and reform of FDA drug approval processes.
ReplyDeleteTHE 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.