http://www.pharmalot.com/2007/07/dendreon-provenge-and-conflicts-of-interest/
Dendreon, Provenge And Conflicts Of Interest
July 20th, 2007 4:36 pm By Ed Silverman
Pharmalot
At the center of the red-hot controversy over Provenge, the prostate-cancer
vaccine that has provoked passionate debate among patients and investors, is
Howard Scher, a prominent oncologist at Memorial Sloan-Kettering Cancer
Center in New York.
Scher sat on an FDA advisory panel that, earlier this year, unexpectedly
endorsed Dendreon's product. But Scher and one other doc weren't fully
convinced, and wrote the agency about concerns they had with Provenge
trials, triggering an FDA delay. The stock, meanwhile, was gyrating. And
cancer patients and their families were outraged, prompting protests,
bodyguards for the docs at a recent cancer meeting and, of course, Internet
missives.
Some missives have focused on Scher's alleged conflicts of interest. He was
granted a waiver by the FDA before the hearing, but the Internet is filled
with other alleged conflicts not referenced on the form. (That's Scher to
the right).
One allegation involves Scher's association with ProQuest, a venture capital
firm, where he is a scientific advisory board member. As it turns out,
ProQuest's chairman, Jay Moorin, is listed as a board member of Novacea,
another company developing a different prostate cancer treatment. And
ProQuest holds a chunk of Novacea stock.
So we asked the FDA if the agency was aware of this connection and, if not,
whether it would have liked the info prior to the meeting. This is what the
FDA wrote us...
.."The FDA screens advisory committee members in relation to an upcoming
drug or biologic product advisory committee meeting for conflicts of
interest by requiring disclosure of the member's current and past
involvement in matters involving the product at issue, competing products,
or matters involving other 'affected firms' as determined by FDA. For
example, if an advisor's duties as a member of a scientific advisory board
included providing advice to that firm on the product or competing product,
he or she should report it. If the duties did not involve such advice, the
advisor would not be required to report the financial relationship with the
firm."
That's not exactly a straight answer. Meanwhile, we chatted with a
Sloan-Kettering spokeswoman, but Scher never got back to us. Moorin left
voice mail saying he generally doesn't comment to the media, and never
responded to our follow-up message. So is this a conflict of interest? For
safety's sake, should it have been reported to the FDA? If the FDA was
aware, why didn't the agency just say so?
So we asked Art Caplan, who heads the Center for BioEthics at the University
of Pennsylvania, for his thoughts: "This is something that's potentially
relevant. I can't imagine the FDA wouldn't find this of keen interest.In the
thick of this controversy, I would say, prima facie, disclosure is going to
be very important here, because someone wants a cure and there's money on
the line.It's clear we should disclose our conflicts and, when controversy
erupts, we should also disclose marginal conflicts.
One thing I would add is that part of what we're seeing here is conflict of
interest used as a weapon to discredit or attack someone else. It's possible
this doctor felt he didn't have a relevant conflict and the connection had
nothing else to do with the subject. But it becomes very important to start
disclosing, because it'll be used as a club in the fight. Unfortunately, we
haven't figured out how to evaluate disclosure and so it makes all this
sticky."
One of Phamalot's appreciative readers has supplemented Dr. Scher's
substantial potential COIs vs. what he reported to the FDA in his Waiver
Application. Scher disclosed 2 "Grants (Related) and 1 stock COI.
Net research suggests these COIs for Scher:
1. Novcea: STUDY CHAIR of DN-101; Grants & Research support
2. Medivation, Inc: PRINCIPAL INVESTIGATOR MDV3100;
3. Innovive Pharmaceuticals: PRINCIPAL INVESTIGATOR
4. Infinity Pharmaceuticals: PRINCIPAL INVESTIGATOR
5. Cougar Biotechnology: PRINCIPAL INVESTIGATOR; Advisory Board
6. Department of Defense: PRINCIPAL INVESTIGATOR PC Clinical Trials-P1 and
P2
7. Bristol Myers Squibb: Consultant, Grants & Research support
8. Millennium Pharmaceuticals: Grant of Research support
9. sanofi-aventis: Grants & Research support
10. Genta: Scientific Advisory Board (as of March 6, 2007; since removed
from web, but cached)
11. Biogen-Idec: Joint stock with spouse
12. Pfizer: Joint stock with spouse
13. Pharmion: Financial Conflict of Interest per Scher quote in MedPage
14. GPB Biotech: Financial Conflict of Interest per Scher quote in MedPage
15. PROQUEST INVESTMENTS: Consultant, Scientific Advisory Board; Limited
Partner FINANCIAL interest
Particularly noteworthy are items 1, 2 and 15 with, imo, 15 being a lotto
winner..
.
