The behind-the-scenes battle continues to rage between the FDA and a determined group of patients and investors who have agitated for nearly three years for the agency to approve the Provenge prostate cancer vaccine. Known as Care To Live, they are appealing a federal court decision 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, destroyed (see here) or simply not produced in accordance with the law.
In a bid to avoid oral arguments, the FDA has filed a brief arguing that Care To Live and its attorney have made allegations about FDA conduct without factual support; charged Pazdur with lying about his document production; continue to promote a 'conspiracy theory' and engages in 'baseless speculation;' and the group has made 'baseless attacks.' Here is the FDA filing.
Of course, their effort may be overtaken by events, because Dendreon, which makes Provenge, has a May 1 PDUFA date. The real issue, though, is how the FDA handles alleged conflicts. As noted previously, the Provenge episode was a pox on former FDA commish Andy von Eschenbach, whose staff turned the proverbial tin ear to this drama. So far, it remains to be seen whether Margaret Hamburg, the new commish, will is either failing to be more responsive such concerns remains to be seen.
18 Comments
Ed - I don't think you completed the thought here - what do you think the alternate/"or" is?
"So far, Margaret Hamburg, the new commish, is either failing to be more responsive such concerns remains to be seen."
This seems to me (a non-attorney trained in the school of legal hard-knocks, in about half a dozen legal hell-holds) like an example of "strange bedfellows": DOJ representing FDA. Makes it pretty tough for private citizen(s) to ever allege regulatory malfeasance by FDA. FDA has what amounts to sovereign immunity...they are right even when they are wrong.
Private citizen(s) face the same uphill battle when trying to raise issue as to constitutionality of federal statutes, e.g. the PDUFA under the federal declaratory judgment act. There have been a number of VERY pro-pharma federal statutes passed recently which should be challenged in federal court.
There is a pathologically intimate relationship between our government and the corporation- and this includes the FDA and the DOJ.
The FDA receives much of its funding from the very industries it is suppose to regulate. The FDA considers members of these industries their clients.
Provenge was ready to go three years ago. People died because it was not approved. If the FDA had nothing to hide from the largely deliberately ignorant public, then those documents that should be released should not be an issue.
How convenient for the FDA to file a brief stating, "Care To Live and its attorney have made allegations about FDA conduct without factual support", when (a) Pazdur has admitted to destroying documents and (b)the FDA FOIA office stonewalled CareToLive's FOIA request for several months and when they finally responded, responded with a BIG FAT 0 and refused to perform a computer search and document recovery of Pazdur's computer. Unbelievable!!
The FDA assembled an expert advisory panel and they voted 17-0 that PV was safe and 13-4 that there was substantial evidence of efficacy. It was unprecedented that they did not follow their advisory panel's recommendation. This was a sad day for the men dying from AIPC. It's a shame.
We are “…the largely deliberately ignorant public….” Big Corporations with all their moolah do their best to make sure we "see no evil, hear no evil, and speak no evil."
FDA advisory meetings are much like Kabuki theatre. Highly stylized in form, but rarely any real substance. The decisions have already been made.
Even if Provenge is approved, that does NOT mean crimes were not committed. A quick read of DeepCapture (www.deepcapture.com) will convince you that the SEC Office of the Inspector General (OIG) currently must be investigating what happened to the approval of Provenge in May 2008 as well as the bear raid on April 28, 2009...a bear raid that was "announced" on the Yahoo! DNDN Message Board by someone named "monthaphyumchareon" 30 minutes before DNDN's stock dropped from $24 to $7...in 75 seconds!
"Allegations of Failure to Investigate The OIG has opened an investigation into complaints from an investor alleging that the SEC failed to investigate instances of market manipulation and other misconduct in connection with the review, and eventual nonapproval, of a developmental drug. The investor also has alleged that the SEC failed to investigate a recent bear raid on the stock of the company that developed the drug, causing a severe plunge in the stock price. The OIG has reviewed several hundred pages of documents, including numerous e-mails and attachments provided by the complainant. The OIG expects to complete its investigation and issue a report of investigation in the next reporting period."
http://www.sec-oig.gov/Reports/Semiannual/2009/semifall09.pdf
If indeed there was a conspiracy to keep Provenge from market, and if indeed the US Attorney General, Congress, HHS, and others ignored warnings of corruption within our government and Wall Street for the past 3 years in the matter of Provenge approval, then this may be one of the biggest cover-ups in US history.
No one died because of Watergate. But since May 8, 2008, when the FDA turned down the approval of Provenge, more than 83,000 men have died of prostate cancer. Many could have been helped if the agency had given the treatment Conditional approval. Who will speak for the dead? Where is their justice?
Can you imagine the time and effort, paid for by TAXPAYER DOLLARS, that went into this FDA "brief??"
Jeez...it isn't even brief.
So we get screwed two ways. DNDN is denied in 2007 after "Byzantine" shenanigans. Then we pay up the WAZOO to have the FDA and DOJ deny anything ever happened.
Want to take a guess as to what the taxpayer's paid to the FDA/DOJ for this denial of wrongdoing??
Makes me sick.
But not as sick as when I think about all the men with advanced Pca that were denied access to ProVenge for more than 2 1/2 years.
THAT burden will "bless" the likes of Scher, Pazdur and others who helped derail PV approval.
JustMe, "the FDA FOIA office stonewalled CareToLive’s FOIA request for several months".
Within the last decade, FDA stonewalled several of my FOIA requests. In fact, they sat on at least one of my requests for several years. My requests for 483's and EIR's related to clinical research in support of NDAs and sNDAs for products whose market approvals were "expedited" under the PDUFA.
I believe, to this day, that the "stonewalling" by FDA of my FOIA requests was willful, because multiple NDAs were involved, ALL of which were granted "expedited" market approvals under the PDUFA.
For lack of a better analogy, the "hare" (pharma's NDAs) made it to the finish line (market approval) long before (years actually) before my FOIA requests for information (the "tortoise") from FDA even made it out of the starting blocks. This was intentional.
I strongly believe that the Prescription Drug User Fee Act (PDUFA) is substantially to blame for encouraging both FDA misconduct and clinical research misconduct (research fraud). The PDUFA deprives citizens of 5th amendment equal protection and 9th Amendment equal treatment under law. It is very much a rigged contest between expedited market approvals for pharma and regulatory sanctions and/or formal legal proceedings for research fraud. This explains why there are waves of dangerous drugs and biologicals in the marketplace, ever since the initial enactment of the PDUFA in 1992.
An excerpt from Davidson v. Vivra Inc., U.S. Supreme Court No. 04-537, filed on September 17, 2004, states at page 23, "FDA officials acting in their personal capacities and the Prescription Drug User Fee Act, enactments I, II, and III (PDUFA I, II, and III) are essential elements in this drug approval enterprise. Serial corporate bribery by Big Pharma of the FDA (acting in their personal capacities) under color of official right provided by the PDUFA I, II, and III, can be likened to the gasoline which fuels the engine of this thoroughly corrupt [drug approval] enterprise. See Opening Brief [9th Circuit docket #03-17342], Page 24, lines 7-12."
this is a sysmbol of injustice in the great american system ,this country does not care about people ,it is the corrupt american system ,PASS IT NOW <DO NOT WAIT TILL MAY 1,save the lives of people waiting for it (dndn)
FDA stop coffee breakes and donuts ,do your job .pass it NOW ..DO NOT WAIT
So the FDA, with perhaps a smirk on its face, tells CTL that Dr Pazdur could not find any notes/files and those that he did find were deleted on his computer. Thank God there is a FOIA that has teeth in it....
Anytime the majority, in this case 13 to 4 and 17 to 0, are disregarded by a select few. Questions will and should arise from those affected. And they should be welcomed. I want to thank Care to Live for bringing those questions to the court system. I'm just sad that Care to Live is fighting this fight ALONE. Where is our American media??? Last I checked, they are NO where to be found. Dig deep CTL!! Dig deep.
The "...GOVERNMENT of the people, by the people, for the people, shall not perish from the Earth."
--Abraham Lincoln
I have been involved in this debacle since the beginning. Coined the term "Approve Provenge Now" at the first DC rally regarding Provenge. Also, petitioned the University of Michigan President, Mary Sue Coleman, regarding Dr. Maha Hussain's unusual activities after the FDA Advisory Panel's vote on approving Provenge and continue support shining light on the dark holes and crevices of the FDA.
Our government has forsaken all citizens in their quest of their corrupt relationships with big business. You can gut a fish but not cut off the head and the fish will rot very fast. If you cut off the head and not gut the fish, it will stay fresh for some time. Folks we have a lot of bad stuff at the top in our government. Its time for big change.
Bruce E. Holmes,PE 2nd VP, Care to Live
For those interested, Mike Kearney of CTL has a bit to say about this decision and posts some factually thoughtful rebuttal along with email exchanges between Howard Scher and Alison Martin that clearly depict the bias and conspiratorial nature of a conflicted federal bureau in panic mode. Takes a moment and put this decision into perspective by visiting CTL at their www.caretolive.com webpage.
50 pages to write essentially nothing. This is amazing and a total waste of our taxpayers hard earned money. On page 33, it says that no IT was used to try to find not only this document but possibly other incriminating documents that shows Pazdur orchestrated this whole fiasco. Why not unless they have something to hide?
I hope the court is going to see through this and force FDA to submit pazdur's computer to complete review by an IT expert in order to get to the bottom of this. I would have thought DOJ would have wanted to find out since their agency by its name(department of Justice) is to seek justice not to defend criminal activities.
In an OPED News article of November 27, 2009, titled “Are Big Pharma and the PDUFA to Blame for Healthcare Mess?”, I tried to explain my perspective on Big Pharma, the PDUFA, and the Healthcare Mess. Here are a few excerpts which I believe are relevant to this thread:
“...not all U.S. citizens want or need unfettered access to potentially dangerous drugs whose market approvals were expedited under the PDUFA.”
“The only expedited new drug approvals should be reserved for compassionate use by cancer and pre-terminal patients, not expedited approvals for the vast majority of citizens who would like nothing more than to feel secure in knowing that marketed drugs bear a reasonable measure of safety.”
So, do I support expedited new drug approvals for drugs such as provenge for use by cancer patients? Yes, with qualifications. I’d sure hate to see cancer patients injured for causes related more to provenge treatment than to their cancer. Do I care that there are investors who are agitated? Not at all. Corporate profits should not be given preference to drug safety. It’s all about the patients. Oh, by the way, is anyone worried that provenge, once approved, will be illegally off-label marketed as a cancer “preventive” to all men worldwide? There would be an entirely different set of safety concerns as to provenge if used for more than just hormone refractory prostate cancer. I think we have to stop short of proclaiming provenge to be a “cure” [much less a preventive] for prostate cancer.
As for Scher, given his many COI’s, I don’t see how anyone could belief that he acted on behalf of the public’s best interest. How was he vetted? Which is the greater evil? The PDUFA or so-called FDA “advisory” meetings? I’d be interested in knowing whether FDA senior management had COI’s relative to provenge.
Two questions would help me better understand this debate: what was the stated basis for Scher’s “go slow” recommendation for FDA? How were the pivotal studies designed? What controls were used? Can someone provide a link to the biological review by CBER?