Provenge Activists Take To YouTube
3 CommentsBy Ed Silverman // September 21st, 2007 // 3:51 pm
The controversy prompted nearly 200 people to rally at FDA headquarters in Maryland early this week in hopes of convincing Congress to force the agency to revisit its unexpected decision last spring to delay approval of the Dendreon prostate-cancer vaccine. That followed an FDA advisory panel meeting in which a majority recommended approval, but in the interim, two panel members quietly wrote the agency to urge a go-slow approach.
Since then, threats were made against those two doctors, a lawsuit was filed against the FDA, and there are allegations of conflicts of interest, which are now being probed internally by the FDA, sources tell us.
At issue, though, is whether the FDA followed its own procedures properly and the larger debate over the use of experimental meds. Here’s the recently made video urging Provenge approval, which has a decidedly professional tone….
Hat tip to YourCancerYourChoice
phil_vardena (Pharm. D.)
I just wished to thank you….Your effort in shedding light over the FDA shortcomings is amazing.
Please keep it up and runnning!
Regards,
phil
Ray
As always Ed, thanks for keeping the Provenge Saga out there!
MyPharmalotID
Just incredible…CDER (Dr. Pazdur), which fought to control the Advisory Committee on Provenge (and lost that battle), and CBER, which won the responsibility for overseeing the meeting, fought an internal political battle over which division would control approvals of drugs such as this. Yet, by a series of actions that included the use of two panel members (Drs. Scher and Hussain) with significant, unreported conflicts of interest; invited letters to the FDA that were intended to disparage Provenge (we still do not know who within the FDA asked Drs. Scher, Hussain, and Fleming to write their letters to the agency; nor do we know who assisted Dr. Scher, for one, with the preparation of his letter (and what these letter writers’ COIs were)); the leaks of all three of these letters to the non-peer-reviewed The Cancer Letter (the FDA has yet to identify the mole within its organization…by the way, has that person also leaked information to hedge funds and others on Wall Street?); and the possible threat of some type of demonstration around May 8 that would have embarrassed the FDA while Congress was debating this year’s PDUFA legislation, CDER succeeded in derailing Provenge approval.
So, while the agency is forcing Dendreon to provide additional data on a drug that its own AC voted 17-0 as being safe and 13-4 as having demonstrated substantial evidence of efficacy, as many as 60,000 or more men will die of prostate cancer…many of whom could have benefitted from Provenge.
And the FDA is supposed to be the agency that protects the nation’s health? Give me a break!