Who Wrote The Mysterious Provenge Letter?
6 CommentsBy Ed Silverman // October 25th, 2007 // 3:42 pm
The evidence isn’t entirely clear yet, but the latest court filing by a non-profit group, which filed a lawsuit against the FDA for not approving the Dendreon prostate-cancer vaccine, indicates an NIH doc named Alison Martin (see picture) may have helped write the letter.
Which mysterious letter? And why is it mysterious? For those who haven’t followed the Provenge controversy, we will repeat some background: After an FDA advisory panel last spring recommended full agency approval, a curious thing happened - two FDA panel members wrote the agency urging a go-slow approach, and the FDA shortly thereafter decided to delay approval.
The behind-the-scenes machinations caused a firestorm - the two cancer docs received threats, cancer patients have rallied outside FDA offices, and a debate ensued about the use and approval of experimental meds. The suit, meanwhile, 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.
In particular, the drama has centered on the origins of the letters written by the two panel members, Howard Scher and Maha Hussain, which some believe were orchestrated by Richard Pazdur, who heads the FDA’s Office of Oncologic Drugs and is now rumored to become the agency’s new safety chief. The non-profit, Care To Live, argues the letters underscore the notion that there was a concerted effort among some at the agency to scuttle Provenge, a move that would benefit rival products in which people tied to the panel members allegedly had various interests.
A draft copy of one of the letters, which was obtained by the non-profit under a Freedom of Information Act request, doesn’t indicate that it was written by Howard Scher (see photo), a Memorial Sloan-Kettering Cancer Center oncologist, but the author identifies himself as the primary investigator for the Prostate Cancer Trials Endpoint initiative. Pazdur’s name also doesn’t show up. Nor does Martin’s name. The Care To Live attorney, Kerry Donahue, says he doesn’t have documentation to verify Martin’s involvement, but cites sources who led him to mention her in the latest motion.
Martin didn’t respond to a telephone message or an e-mail. And it’s not clear why she would participate in writing such a letter. However, she is familiar with both Scher and Hussain. In March 2005, for instance, all three participated in an FDA oncology drugs advisory committee meeting. And a June 2004 National Cancer Institute progress report on prostate cancer mentions research funding to various projects, including one called Spores. Martin was a member of the NCI working group and Scher, in his capacity at Sloan-Kettering, was a Spores co-investigator. As noted, it’s a small prostate-cancer world, after all.
MK
This story just gets stranger and stranger. Clearly ’something’ atypical happened in the Provenge FDA process and although it’s not necessarily a crime or evil, the COI thing and letter thing sure do give the impression that something very wrong happened in the process.
Hey FDA, it’s not the action it’s the coverup that’ll bring you down.
Get a clue.
Scott
Those in power at the FDA think they are above the law and unaccountable. It has gone on for so long that they are incapable as an institution to investigate, punish the miscreants and “do the right thing.”
One federal district judge in Ohio can turn that around. What a substantial service to America that would be.
Assuming he takes his responsibility to the Constitution and laws of the U.S. seriously, we might just see a course correction in Rockville, MD.
I prayerfully await the progress of CaretoLive v. FDA, et al, in correcting a shameful national tragedy.
Lucy
Ed,
It’s too bad Dr. Martin did not return your call. I would be interested to know:
1) What is Alison Martin’s relationship to Dr. Scher?
2) Why would she write a letter for him?
3) Is this the first time she has written a letter on his behalf?
4) Is she aware of a November 2006 presentation by Dr. Daniel Petrylak, a lead investigator of the Taxotere SWOG 9916 Phase 3 trial, at the Chemotherapy Foundation in New York that reported a remarkable increase in survival of AIPC /HRPC patients who received Taxotere after Provenge when compared to their survival predicted by the Halabi nomogram?
5) In her view, are there other clinical trials that would be affected by a positive Provenge determination?
Scott
Ed,
Why won’t FDA, NCI et al reveal the following:
Who asked Dr. Martin to become involved in writing the Scher letter?
Who else was involved?
What other drafts of the letter exist? Why were they not produced?
Where are the emails that transmitted this draft letter? Why were they not produced?
Who were all the participants (besides Dr. Martin) to a meeting held to discuss the content of the draft letter?
Who helped Dr. Hussain write her letter?
Who asked Dr. Scher and Dr. Hussain to sign letters?
Who leaked these letters to The Cancer Letter?
When, if ever, before this case has the FDA not followed an overwhelming (17-0 and 13-4) vote of an Advisory Committee to approve a drug/biologic agent for an end-stage disease?
When, if ever, before this case, have dissenting Advisory Committe members been asked to sign letters to the FDA urging the majority AC vote be disregarded?
Coverups of illegal/improper activity don’t work. FDA would be well-advised to control the damage by coming clean and letting the chips fall.
It’s only going to get worse.
pamela
How did the non profit get these documents so fast under the FOIA? Don’t you usually have to go to court to access these type of documents!!
very amusing.
Tony F
Ed,
I’ve written this before here and I’ll repeat it again because it needs to be repeated…
1. Thank You! for continuing to keep the public aware of how this travesty has come about and aware of who the players are in the drama…
2. Just when you think all the stink associated with the Provenge FDA story has been aired, along comes even more in this apparent never-ending tale.
One can only imagine what the dinner table or pillow talk must be in the Hussain, Pazdur and Scher households… Scher has adolescent progeny; one has to wonder what they think about when hearing the allegations against their father that he’s allied himself–professionally and likely financially–against Provenge for selfish reasons and, at the same time, has a huge part in the responsibility of the 83 men who DIES each DAY from prostate cancer here in the U.S.A. What about the claims that he’s been dishonest in his voluntary disclosure to the FDA of but 3 conflicts of interest when internet information has disclosed 17 COI’s including the Proquest and Novacea financial bits.
I’m shaking my head in wonder and disgust at the deeds, as alleged in the lawsuit and on message boards, that Pazdur, Hussain and Scher have prepatrated against TERMINAL cancer patients and against all Americans.
If true, shame, Shame, SHAME!!!!