Provenge Activists Try Again For FDA Documents
6 CommentsBy Ed Silverman // November 20th, 2009 // 9:16 am
A determined group of patients and investors who have agitated for more than two years for the FDA to approve the Provenge prostate cancer vaccine are pressing their case to obtain undisclosed agency documents. Known as Care To Live, they are appealing a federal court decision last year denying them access to FDA documents pertaining to a series of events two years ago in which the agency unexpectedly delayed approval despite the recommendation of its own advisory panel.
The group alleges undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving Richard Pazdur, the head of the oncology drugs office. The FDA has been fighting the group’s request for documents that was filed under the Freedom of Information Act, some of which the group maintains were deleted or destroyed (see here).
Of course, their effort may be overtaken by events - Dendreon, which makes Provenge and earlier this year released positive study results - today disclosed that the FDA assigned a PDUFA date of May 1, 2010, to respond to its request to market the vaccine (see here). The other issue, though, is how the FDA handles alleged conflicts. The Provenge episode was a pox on former FDA commish Andy von Eschenbach, whose staff turned a tin ear to the problem. Whether Margaret Hamburg, the new commish, chooses to be more responsive to such concerns remains to be seen.
kyoto27
The FDA is not dealing with Alice’s Rabbit Hole when it comes to exploring Richard Pazdur’s Provenge/DNDN files:
There is software available to find the file (e-mail) on his computer, even though his PC’s e-mail software doesn’t know where it is stored…because he said to the FDA that he “deleted” the files.
Why did Richard Pazdur attend the CBER advisory committee hearing; why did he put Maha and Howard on the AC and pass notes to them and why did he go through all the alleged trial by The Cancer Letter when Richard Pazdur said to the FDA that he actually had nothing to do with the CBER panel, or Provenge?
The Provenge files were deleted he said because they were irrelevant to his existence at the FDA? C’mon, let’s stop all the nonsense and recover the Pazdur files on Provenge and let the FDA and CTL take a look at them. If the FDA is a science based agency good; if the files show that the FDA was playing a very sordid political game should America want to know why? So once again, let’s recover the files and end the game….
Evelyn Pringle
I want to know why it takes any court action to access agency records generated by regulatory employees paid for with my tax dollars.
myPharmalotID
The e-mails that Dr. Richard Pazdur assets he destroyed may well still reside on his harddrive.
“Deleting” an e-mail does NOT remove the actual e-mail file; rather, it only makes that portion of the computer’s memory where that e-mail resides available for other uses. His e-mails, however, MUST still reside on the FDA’s e-mail server(s) (by federal law), and they can - and must - be retrieved by a forensic information technology (IT) specialist if justice is to be served.
That the FDA’s FOIA office finds it sufficient simply to ask the good doctor whether or not he destroyed the documents, and to take his word that he did without searching further, is folly! An idiot could do the FOIA Office’s job if that’s all it took to satisfy an FOIA request!!
And for the DOJ to defend against CTL’s actions and prevent the release of the material requested by CTL under the FOIA is, well, almost criminal!
President Obama promised a new day when he was elected when it came to Sunshine in Government! Apparently, HHS in general and the FDA in particular hold themselves apart and above the spirit and letter of the law!
A pox on them both.
More than 76,000 men have died of PCa since the FDA turned down Provenge on May 8, 2007; many could have been helped by having had access to Provenge.
The FDA and the DOJ have blood on their hands.
When will justice be served?
When, indeed?!
Johannes de Suspicioras
In his first day in office, our new president signed an executive memo indicating that efforts to obtain information through FOIA will not be met with the usual “protect the guilty under a cloak of ‘confidentiality’ ” bullshit that’s been the norm over the last several years. The memo should still be on the White House official site.
Perhaps he and our current Attorney General should be made aware of this in such a manner that it would be in their best of interests to put into action what they have promised. i.e. prove to the people their genuine intent, and not blowing smoke up the collective bottoms of the citizens of the US.
Johannes de Suspicioras
Federer
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rogerhopes
Richard Pazdur’s has done nothing wrong he his just doing his job.
Provenge is a scam set up by dndn gold.
Actually gold should be investigated and put together with bernie or share a cell together with him.
firstly lets talk about cancer patients not only they are suffering from this terrible disease now they have to pay lot of money just to live couple of months longer what a scam.
Who on earth do not want cure or medicine for cancer come on guys.
This provenge should be stopped by fda and put as warning to other scamsters.