More Congressmen Call For Provenge Probe
7 CommentsBy Ed Silverman // January 31st, 2008 // 3:40 pm
Three more lawmakers have added their names to the list of congressman who have asked the House Energy and Commerce Committee to hold a hearing into allegations that undislosed financial conflicts of interest among FDA advisory committee members may have swayed an FDA decision to delay approval of Provenge, a prostate cancer vaccine being developed by Dendreon.
Vern Buchanan, a Florida Republican, Chris Van Hollen, a Democrat from Maryland, and Pat Murphy, a Pennsylvania Democrat, each wrote letters to John Dingell, who chairs the committee, to urge him to investigate. “As a member of Congress, I believe we must provide the necessary oversight to ensure that the federal approve process of life-saving therapies such as Provenge is prompt and efficient,” Buchanan wrote.
Last month, Mike Michaud, a Maine Democrat; Dan Burton, a Republican from Indiana, and Tim Ryan, a Democrat from Ohio, were the first members of Congress to take an interest in the controversy. Here is the Buchanan letter and this is the Murphy letter. The Van Hollen letter is to the right (please click for a larger image).
You may recall that an FDA advisory panel last spring recommended full agency approval. But then two FDA panel members wrote the agency urging a go-slow approach, and the FDA shortly thereafter decided to delay approval. One panel member was Howard Scher, an oncologist at Memorial Sloan-Kettering Cancer who serves on the advisory board of a venture capital firm that invested in Novacea, which is developing a rival cancer med. The other was Maha Hussain, a University of Michigan oncologist.
The behind-the-scenes machinations caused a firestorm - the two cancer docs say they received threats; the chain of events fueled debate about the use and approval of experimental meds, and some cancer patients and Dendreon investors filed a lawsuit against the FDA. The suit claims the two panel members held undisclosed financial conflicts of interest and alleged a Byzantine power play involving a key FDA official who sought to sway the outcome, although a federal judge recently dismissed most of the suit.
Lawrence
We need to put a stop to the REAL Terrorist that are effecting this Country, they are known as the FDA.
phil_vardena (Pharm. D.)
Hi Ed,
thank for your continuing coverage!
Also don’t forget the exchange of mail between the conflicted doctors and public servants!
Some mails were directed to the FDA Commissioner, Dr. Andrew von Eschenbach, who says he did not receive them! That’s a red flag!
As an aside, the two cancer docs say they received threats, but to date there’s no proof! Did they say they received threats to attract sympathy?
Regards,
phil
henry lucas
I was one of those who requested the letter that is above. Caretolive and arighttolive should have said they were going to publish the letter. We don’t want to stoop to the Scher/Hussein level.
A Scott
PLease stop mentioning the “death threats” as these were never substatiated and were loosely based on possibly threatening verbage included in an email. Can we focus more on the known facts of the grossly overlooked conflicts of interest and the “leaked letters” that Von E, the FDA chair denies ever receiving???
Recall, Martha Stewart served jail time for less serious actions!
A. Scott
PR@CTL
Henry,
CTL did not release any letters.
Thurly
I would hope that if there is a Congressional investigation that one of the committee requests will be to produce the threatening email. All of us, who believe Dr. Scher to have done something murderously bad, are interested in seeing the specific language of the threat. None of us (that I know of) would ever have considered writing an email that would so certainly undermine our cause to expose wrong-doing in the FDA.
I wouldn’t be surprised to find the email had a tracking number — something similar to “HFM-A.O 7-2571″.
Advanced Prostate Cancer » Public Petition About Conflicts of Interest At The FDA
[...] more Congressmen request hearing re: Provenge approval process: http://www.pharmalot.com/2008/01/more-congressmen-call-for-provenge-probe/ Letter from Physicians for Provenge urging Congressional hearings. None of the Doctors hold any [...]