Pharmalot’s Ed Silverman is reporting that a group called Care to Live filed a federal lawsuit against FDA commissioner Andrew von Eschenbach and FDA advisory panel member Dr. Howard Scher of Memorial Sloan Kettering. It its complaint (found here), Care to Live outlines allegations of conflicts of interest beyond the scope of a normal FDA review.
While nothing new (these claims are all over the internet) and I have discussed them in Behind the Scenes of Provenge, this certainly takes the battle over Provenge to a new level. To recap, Dr. Howard Scher, who maintains a financial/consulting interest in rival firm Novacea, voted to reject Provenge (along with Dr. Maha Hussain, who also maintains a financial interest in Novacea) just weeks before Novacea closed a near billion dollar deal with Schering-Plough—a deal that, according to a banker at Morgan Stanley, could have been worth less had Provenge been approved. Was this a conscious torpedoing of Provenge for financial gain or merely the most remarkable coincidence of timing known to modern man?
Rather than recap all of this, what I want to focus on is the very quiet PR firm in the middle—WeissComm Parnters. The company has worked with both Dendreon and Novacea in the past (although refused to disclose its current relationship with either firm). Given Ruder Finn’s rather high-profile embarrassment of its client Novartis last week, it’s interesting to see WeissComm take a decidedly different approach—clam up and go black.
The questions I’ve asked (and have not received an answer on) are: What role, if any, did the PR agency have in the days leading up to the advisory committee hearing? What information, if any, may have been shared between the two companies via the agency? Did WeissComm orchestrate a call or meeting on behalf of Novacea to “brief” either Drs. Scher or Hussain prior to the Provenge advisory committee hearing? Has WeissComm paid any consulting fees to either Drs. Scher or Hussain on behalf of Novacea that may not show up as direct payments on behalf of the company? I don’t know if WeissComm did anything inappropriate or not. But there are many, many unanswered questions and this agency could be in a position to provide some answers.
The review of the decisions behind the scenes of the Provenge review and the rather unique relationship that Drs. Scher and Hussain have with a rival firm will be an interesting area to watch unfold.
While nothing new (these claims are all over the internet) and I have discussed them in Behind the Scenes of Provenge, this certainly takes the battle over Provenge to a new level. To recap, Dr. Howard Scher, who maintains a financial/consulting interest in rival firm Novacea, voted to reject Provenge (along with Dr. Maha Hussain, who also maintains a financial interest in Novacea) just weeks before Novacea closed a near billion dollar deal with Schering-Plough—a deal that, according to a banker at Morgan Stanley, could have been worth less had Provenge been approved. Was this a conscious torpedoing of Provenge for financial gain or merely the most remarkable coincidence of timing known to modern man?
Rather than recap all of this, what I want to focus on is the very quiet PR firm in the middle—WeissComm Parnters. The company has worked with both Dendreon and Novacea in the past (although refused to disclose its current relationship with either firm). Given Ruder Finn’s rather high-profile embarrassment of its client Novartis last week, it’s interesting to see WeissComm take a decidedly different approach—clam up and go black.
The questions I’ve asked (and have not received an answer on) are: What role, if any, did the PR agency have in the days leading up to the advisory committee hearing? What information, if any, may have been shared between the two companies via the agency? Did WeissComm orchestrate a call or meeting on behalf of Novacea to “brief” either Drs. Scher or Hussain prior to the Provenge advisory committee hearing? Has WeissComm paid any consulting fees to either Drs. Scher or Hussain on behalf of Novacea that may not show up as direct payments on behalf of the company? I don’t know if WeissComm did anything inappropriate or not. But there are many, many unanswered questions and this agency could be in a position to provide some answers.
The review of the decisions behind the scenes of the Provenge review and the rather unique relationship that Drs. Scher and Hussain have with a rival firm will be an interesting area to watch unfold.
5 comments:
Wow. Also significant in the matter of Dr. Scher's conflicts of interest is the fact that Dr. Scher was granted a waiver by Dr. Randall Lutter to participate in Dendreon's FDA advisory panel for Provenge because an individual with lesser conflicts of interest was unavailable. How legitimate is that assertion? The above statement appears to be a complete fabrication. Placing Dr. Scher on the Provenge advisory panel, with disregard for his financial interest in the outcome, appears to have been intentional, planned and calculated.
Why were Dr. Scher and Dr. Hussain allowed to vote on the Provenge advisory committee, much less participate, given their substantial conflicts of interest? According to Pat Harley, Consumer Safety Officer at the Center for Biologics Evaluation and Research (CBER), the advisory panel for Provenge was initially planned to be composed of only of the CBER employees.
Who at the FDA leaked these confidential internal letters written by Dr. Scher, Dr. Hussain and Dr. Fleming to The Cancer Letter?
Did anyone ask Dr. Scher, Dr. Hussain or Dr. Fleming to write their letters to the FDA? Did Dr. Scher, Dr. Hussain and Dr. Fleming receive any assistance in the development of their letters?
Are the policies, processes, and procedures within the FDA adequate to address what appears to be an egregious example of conflicted interests on the part of Dr. Scher?
As Dr. Chuck Bennett so elequently stated, Dr. Scher’s participation in the Provenge advisory panel is akin to a defendant's own sibling participating on a jury resulting in a hung jury decision. Knowing of Dr. Scher’s close professional relationship to ProQuest Investments, how is the public to believe that the FDA made the correct decision? Surely you can see the travesty of his participation in this matter. Such conflicts of public and personal interest jeopardize the legitimacy of one proclaiming to act on behalf of the public’s best interests.
As you may be aware, September 16th - 22nd is Prostate Cancer Awareness Week. Please join us September 18th to rally against the FDA's decision regarding Provenge for the treat of prostate cancer. Every voice counts. You can find out more at http://www.arighttolive.com
Are you being paid by Dendreon?
Thank you for your comments. To answer your question, no, I am not being paid by Dendreon. See post:
http://pharm-aid.blogspot.com/2007/08/clearing-air-on-provenge.html
Scher reported only 3 COI's to the FDA per his filing in late February available at the FDA website which appears to be composed of ownership of 1 stock and 2 competing industry interest.
Internet research shows the following for Scher thus far:
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. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
14. PROQUEST INVESTMENTS: consultant, scientific advisory board; Limited Partner FINANCIAL interest
15. MEDIVATION, INC: principal investigator MDV3100
There appears to be a significant and disturbing difference between his 3 disclosures to the FDA and the alleged 15 COI's found so far on the internet. It seems incomprehensible for someone with the training and education Scher has to "forget" so many apparent COIs… that is simply beyond all reasonableness and suggests intentional dishonesty or deceit.
Even more disturbing is the FDA's Office of Inspector General and others at the FDA to whom this information has been supplied and their apparent failure to investigate these charges that Scher has more COI's than he disclosed to them. When such information is provided and such allegations of potential federal law violation is involved, any ordinary citizen has the right to expect our government to investigate such allegations timely and thoroughly.
As a "temporary government employee" at the FDA, he is obligated, under Federal law, to provide full and complete disclosure. If he didn't, he may have the potential for liability for law violation(s) as well as for providing false data to the FDA under which he secured a waiver in order to participate on the Provenge AC meeting March 29th.
Tony F--
Before assuming there were omissions, in Scher's COI, it is important to know the time frames. He might have jointly held stock with his wife in Pfizer back in early 1990s, is that still relevant today? I don't know.
As I've said before, there is nothing inherantly wrong with having relationships with other firms. Most top-tier researchers have relationships with many, many firms. However, this is the first incident I can ever remember where a researcher with a clear COI bucked against the majority of reviewers for reasons that are not clear. It's not like Provenge had major adverse event issues. I could understand that.
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