Cancer Patients Take On Justice Department
5 CommentsBy Ed Silverman // October 2nd, 2007 // 8:31 am
Here a conflict. There a conflict. Everywhere a conflict of interest. That’s one of the central themes in the controversy over the Provenge prostate-cancer vaccine. And the latest allegation is aimed at the Justice Department by CareToLive, a non-profit group that was formed recently to force the agency to approve the vaccine. What’s the conflict? In its lawsuit, the group complains the Justice Department simultaneously represents the FDA, the FDA commish, an FDA division head and an FDA panel member in what the group charges is a conspiracy forged by individuals who may wind up testifying against one another.
The Dendreon product was recommended for approval last spring by an FDA panel, but was then delayed after two panel members wrote FDA commish Andy von Eschenbach urging a go-slow approach. CareToLive, which reps cancer patients and Dendreon investors, alleges the panel members - one of which is Howard Scher of Memorial Sloan-Kettering Cancer Center - held numerous undisclosed financial conflicts of interest. The lawsuit also alleges their letters were orchestrated by Richard Pazdur, who heads the FDA Office of Oncologic Drugs, as part of political infighting to further his career.
“It is conceivable and even likely that defendant Pazdur and Scher will be testifying against each other, and that defendant von Eschenbach will be testifying against them both,” the motion states. “Under this scenario it is impossible for the same counsel to represent the competing interest of the parties…
“…As in the cases wherein the DOJ files these kinds of motions in criminal cases, there is the possibility that (CareToLive) could cooperatively obtain testimony from some of the defendants to the detriment of others, or to resolve the case in ways that might be favorable to some of the defendants but not others. By having single representation, the lips of all defendants are sealed through the one counsel that must try to protect all interests collectively, even if those persons’ best interests are different.”
Whether this gambit will work remains unclear. The CareToLive motions in this case, generally, have been characterized by rather blunt and, sometimes, overwrought language. But by throwing down this particular gauntlet, the non-profit is not only prodding the government once again to do more, but also poking it in the eye.
Tony F
Unbelievable!
Ed, you’ve just added another chapter in the on-going saga of Provenge, for TERMINAL prostate cancer patients, and how our government–through the FDA–is failing these men and their families. Shameful, imo…..
If I were any of the 3 mentioned Defendants in this lawsuit, I’d have already gotten my own attorney to insure that MY interests were being protected.
It seems clear as more and more information about the who, what, when, where, how and why comes out that Scher, imo, has the most to lose. Someone’s going to be made a scapegoat and, thus far, Scher appears to be on the bottom of the totem pole. I’d be worried–very worried–if I were in his shoes with how he’s handled (or should that be mis-handled?) his Conflict of Interests and his CONFIDENTIAL letter to the FDA after the Advisory Committee meeting.
I wondered how he explains all this to his wife and children about being served, possibly at home, with papers indicating he’s being sued? And, how do his co-workers and fellow doctors view all this; they have access to the internet and can get the same info others are posting about him with which to compare that which Scher is telling them himself. It surely must be most embarrassing and humiliation to have such information becoming public.
We know from the Waiver he submitted to the FDA that he claims to have only 3 COI… 1 stock and 2 competing companies… or so he claims.
Internet research shows possibly 17 COI for Scher which do NOT include that he’s reported to be an “Executive” of Sloan Kettering Hospital in NYC as well as being on their Board of Directors. Those 17 are:
1. NOVACEA: grants & research support; STUDY CHAIR of DN-101; Direct competitor to Provenge
2. GPB BIOTECH: financial conflict of interest per Scher in MedPage
3. PHARMION: financial conflict of interest per Scher in MedPage
4. SANOFI-AVENTIS: grants & research support
5. BRISTOL MYERS SQUIBB: consultant, grants & research
6. MILLENNIUM PHARMCEUTICALS: grant of research support
7. COUGAR BIOTECHNOLOGY: principal investigator; advisory board;
8. INNOVIVE PHARMACEUTICALS: principal investigator
9. INFINITY PHARMACEUTICALS: principal investigator
10. BIOGEN-IDEC: jointly held stock with spouse
11. PFIZER: jointly held stock with spouse
12. GENTA: scientific advisory board (as of March 6, 2007; since removed from web, but cached)
13. CONFOMA THERAPEUTICS: scientific advisory board
14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
15. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
16. MEDIVATION, INC: principal investigator MDV3100
17. PROQUEST INVESTMENTS: consultant, scientific advisory board; Limited Partner FINANCIAL interest
Additionally, Scher was reported in the media from the June ASCO conference in Chicago to publicly complain that none of his fellow Oncologist and Urologist doctors were stepping up to his defense in the Provenge matter.
Wouldn’t you think the lack of support from his peers just might indicate that they do NOT agree with Scher and what he’s done?… at least, that’s how I interpret all of this.
Thanks, one more time, for continuing to expose this travesty and for giving some much need publicity to both the Provenge story and the CareToLive not-for-profit organization which is trying desparately to get Provenge available for these TERMINAL prostate cancer patients… NOW!
Lucy
Dear Ed,
I read with great interest your article entitled “Cancer Patients Take On Justice Department,†dated October 2, 2007 describing conflicted scientists serving on FDA advisory committee for Provenge. What many journalists before you have failed to properly explore is the merit of the conflicts of interest accusations. Provenge advocates are not attacking science-based dissent. Rather, Provenge advocates are attacking opinions tainted by undisclosed conflict of interest. Even one waiver for conflicts of personal and public interest is too many and can have dire consequences for those who depend on impartial FDA review.
Unlike the COX-2 inhibitor situation, where public and personal conflicts of interest jeopardized the safety of patients, the Provenge example is reversed. Competing public and personal interests are keeping a recognized safe drug for a terminal indication from the market needlessly. Furthermore, it’s important to note that the conflicts of personal and public interest can arise not only from drug manufacturers, but also from Wall Street and venture capital.
And this would not be the first time where the FDA has let internal politics sway a decision on a new drug application (NDA) for a safe and effective treatment. You may be aware of a Government Accountability Office report which concluded that the FDA did not follow its normal procedures when deciding whether to allow the “morning after†contraceptive Plan B to be sold over the counter. The report showed that the FDA allowed politics to dictate the decision on Plan B. The GAO’s final report described an appalling level of manipulation and suppression of the science. Congressman Henry Waxman described the Plan B decision … “as preordained from the outset.†Many fear that Provenge was prejudged too.
Not only are Dr. Scher’s conflicts of interest inappropriate and not fully disclosed, but Drs. Scher, Hussain and Fleming letters against Provenge’s approval urging a go slow approach are inappropriate as well and and an apparent attempt to sway the final Provenge determination by the FDA. According to David Miller of the Biotech Research Newsletter, Dr. Scher has admitted publicly he knew the letter was intended to be leaked and that he did not personally write sections of the letter. Combined with undisclosed conflicts of interest, including an ongoing relationship with a venture capital fund that held a Board of Directors seat of a competitor company that directly benefitted from Provenge’s delay, rightfully has people who depend on impartial FDA review very concerned.
Did Drs. Scher, Hussain, and Fleming receive any assistance in the development of their letters? If so, who assisted them? Were any of the people who assisted them associated with companies that are competitors of Dendreon in the prostate cancer space? Were any of the people who assisted them associated with financial institutions that held positions from which they would benefit if Provenge were not approved? Who leaked the letters written by Drs. Scher, Hussain, and Fleming to The Cancer Letter? If FDA and HHS investigators have been unable to identify the source of the leaks, have they brought in the FBI? If not, why not?
Thank you for your revealing article. If good people are complacent, important change will not occur.
Dr. Von Eschenbach, FDA Commissioner and Michael Milken
phil_vardena (Pharm. D.)
What puzzles me the most is that the FDA’s own appointed AC Panel said 17-0 that Provenge is safe and 13-4 it is effective (two “NO” votes being those of Dr. Scher and Dr. Hussain).
Never before the FDA reversed an AC Panel recommendation.
FDA now says the “approvable” letter is science-driven?
But, science says Provenge works! Whose science is the FDA talking about?
I think that Dr. Andrew von Eschenbach, the FDA Commissioner, should really, once and for all, step in and approve Provenge and fire someone at the FDA and put and end to this tranvesty.
The more it goes, the more damage it does to the FDA and to US institutions credibility.
Thanks, Ed, for your outstanding job.
Tom Smith
My question is where and the hell is the SEC, DOJ regarding Scher/Paroquest/Novacea??????? Why has the FDA not both internally and DOJ investigated Scher for not claiming these VERY important coi’s on his signed waiver! Something sures smells at the FDA! The FDA knows that PROVENGE works they are just in bed with BIG CHEMO PHARMA blocking its approval because Provenge and all immunotherapies will put drive down sales of chemo agents to -0- within a few years! Andy VON Eschenbach makes me sick!! How does that guy sleep at night! ~11,500 dead from AIPC since May 9th aka BLACK WEDNESDAY!
Kyoto27
“But by throwing down this particular gauntlet, the non-profit is not only prodding the government once again to do more, but also poking it in the eye.â€
Ed,
Very true, but maybe the Justice Department may just need to have its ‘blind eye’ poked — in much the same way as the
SEC could use a few Seeing Eye Dogs to help them patrol Wall Street.
In a way it’s ironic that had Pazdur & Co not thrown down the first gauntlet –poking CBER in the eye at the AC hearing, followed by the over-the-top Cancer Letter crusade…it is doubtful IMO whether many of today’s advocates would be around to poke anyone in the eye. I also think Scher would have escaped scrutiny if Pazdur & Co hadn’t gone ballistic. In that regard, it is still puzzling that Scher went along with the Pazdur charade (carrying all the baggage that he was carrying) which showed IMO either (1) a lot of chutzpah or
(2) that these guys have been around the block together a few times with a lot of IOUs collected on both sides.
Now wouldn’t it be nice if CTL’s poke in the eye got our Justice Department to actually start looking at criminal behavior –and not
Provenge advocates looking for due process?
And thank you Ed for keeping everyone honest!