The fight to bring the following events to light have been led by many heroes. Three that stand out are Ted (
On May 9, 2007 the FDA sent Dendreon a Complete Response Letter (aka denied approval) indicating that despite a 17-0 vote on safety and 13-4 vote in favor of drug efficacy, Dendreon needed to submit additional data to be granted drug approval. The FDA had never before overruled an advisory committee for a life saving drug.
The official reason given by the FDA for this delay is that “questions about the drug were raised at the Advisory Committee meeting.” Of course, the committee meeting is based on raising and addressing questions. There is a mounting body of evidence that there were other motives for the delay. There is reason to believe that there was a power struggle within the FDA about which committee controls cancer drug approvals, there seem to be a group that was interested in continuing the hegemonic role of chemotherapy in cancer treatment, there were specific financial interests of two key dissenting members on the committee, and the National Cancer Institute appears to have had an interest in keeping Provenge off the market in order to protect their prostate cancer drug programs.
There were signs that the delay would occur…especially three letters that were leaked to the public by a widely read newsletter entitled The Cancer Letter during the period between the Advisory Committee meeting on March 29, 2007, and the May 9, 2007, letter delaying the drug. These letters were written by two dissenting members on efficacy from the committee, Dr’s Howard Scher and Maha Hussain, and statistician Thomas Fleming.
The letters, especially Dr. Scher’s, were deeply flawed. David Miller from Biotech Stock Research and a group of very knowledgeable message board posters wrote convincing rebuttals, pointing out the statistical and logical flaws in the letters.
Both Dr’s Scher and Hussain had conflicts of interest in the matter as either they or their relatives had financial interests in competitors of Provenge. Dr. Scher in particular had a very large financial interest in a competitor names Novacea, which signed a lucrative partnership with big pharma after the Provenge delay—a partnership that may not have been possible without the delay. Under current revised FDA Conflict of Interest policy these two doctors would not have been allowed on the Advisory Committee.
Both doctors have claimed that they have had death threats due to their role in the delay, although these threats have not been substantiated.
There is much evidence, partially substantiated by National Cancer Institute documents that were turned over on August 3, 2008, in response to the Freedom of Information Act (FOIA) requests from the CTL lawsuit, that Dr. Scher had help with his letter. It was first reported in April 08 that a draft of the letter was found on Alison Martin’s computer at NCI, and her involvement was substantiated by the FOIA documents. These documents also provide further evidence of Dr. Richard Pazdur’s involvement. Dr. Pazdur is the head of ODAC, the committee that had always, prior to the Provenge committee review, been the exclusive committee for cancer drug reviews. He has a long history of power plays, including the well-publicized role in the delay of Imclone’s drug Erbitux, which was made famous by Martha Stewart’s insider trading.
On December 13, 2007, Representatives Michael Michaud, Dan Burton, and Tim Ryan wrote John Dingell, Chairman of the House Committee on Energy and Commerce, expressing serious concerns about the failure of the FDA to approve Provenge. On February 13, 2008, Chairman Dingell’s committee responded to the call for hearings in the matter of conflicts of interest (COIs) regarding how the FDA handled Dendreon’s application for Provenge by rejecting the request on very shaky grounds, including the claim the rejection of the drug was not final. As Ted has pointed out in court, it was final for the men who have died prematurely due to the delay.
In the past year CareToLive and other advocates, meanwhile, have staged rallies and protests around the country. They have taken out ads in major newspapers, purchased billboards and ads on buses, and helped journalists with stories about this issue.
In addition, they have filed a lawsuit to investigate this decision and force the FDA and NCI to turn over documents and correspondence regarding the Provenge decision. The FDA has stonewalled the orders from the suit and have stayed the order to turn these documents until December of 08 because of their busy schedule.
There was a separate claim against the NCI to turn over their correspondences, and in early August they did so, although one key letter from Dr. Scher was withheld on very shaky grounds. The legal proceedings and FOIA documents in late July and early August make a few things clear.
1. FDA Commissioner Andrew Von Eschenbach, despite claiming that “the FDA would provide a bridge, not a barrier” to immunotherapy treatments at a conference two months prior to the Provenge delay, did not have an active role in the decision; in fact, he appears to have had no role, and probably no understanding, of this drug. This would provide evidence that supports that theory the Dr. Pazdur in fact had the power to play a large, if not complete, role in derailing a drug approval from a rival committee within the FDA that he considered a threat his committees control of cancer drug applications.
2. Dr. Pazdur, who attended the meeting despite the fact that his committee was not involved and was seen consulting with committee member Hussain during the proceedings, was in fact involved. The fact that he continues to stonewall FOIA requests adds more fuel to this theory.
3. There is no question that NCI played a key role in supporting the Provenge delay.
This is clearly a story of organizations that should be looking out for dying patients looking out for personal interests, and a story of a lack of adult supervision.
It is all of our responsibilities to do something about this. To find out how you can help, click this link:
http://caretolive.com/ways-to-help/
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