FDA Panels Would End Conflicts Of Interest, According To House Proposal
3 CommentsBy Ed Silverman // August 7th, 2007 // 9:51 am
That’s the language attached to an agriculture appropriations bill passed by the House last week after a move by US Representative Maurice Hinchey, Democrat of New York. The funding measure heads to the Senate, where the language faces a tough fight - opponents include Ted Kennedy, the Senator from Massachusetts, The Boston Globe reports.
Hinchey’s proposal goes further than a rule the FDA itself proposed earlier this year. The agency suggested barring panel members with financial ties to drug and medical device makers that exceed $50,000. Members whose grants or consulting fees totaled less than $50,000 during the previous 12 months would be allowed to serve on panels, but not vote. The FDA is still sifting public comments and has not issued a final proposal.
The issue has come up repeatedly this year. Last spring, a panel approved the Provenge prostate-cancer vaccine, but two members later wrote the FDA suggesting a delay. They’ve since been widely criticized by patients and investors who have cited ties to rival companies.
Last week, two panels met in which the FDA issued waivers - six for the Avandia panel and three for the Tysrabi panel. One Tysabri panel member held stock in rivals worth $75,000. The waiver was granted because the holdings represent a small percentage of the member’s net worth and the products made by rivals generate only small amounts of revenue. But the move suggests the FDA may find excuses even after its own rule becomes final.
The FDA complains that it’s increasingly difficult to find potential panel members free of conflicts…
…because of rising industry funding to academics and leading docs. The agency says it can’t find enough scientists free of conflicts within the FDA or other federal health agencies, such as the National Institutes of Health and the Centers for Disease Control and Prevention, the Globe notes. So the FDA argues waivers are necessary to find qualified experts for its panels.
That viewpoint is endorsed by Kennedy, who has argued that Craig Mello and Phillip Sharp, Nobel-Prize-winning Massachusetts sci entists, would face limits on participating on FDA panels if stricter rules were successful, the paper writes. “Many of the nation’s best scientists wear both hats - working in an academic lab one day and consulting for a start-up biotech firm the next,” Kennedy said in May, rejecting a move to impose an “inflexible” cap on the number of waivers the FDA can grant.
Curt Furberg, a drug safety expert at Wake Forest University who served on the Avandia panel, expects congressional interest will lead the FDA to further refine what it considers to be a conflict of interest. Furberg is paid $200 annually to consult for the NIH on a diabetes study that includes Avandia. The FDA permitted him to serve as a temporary adviser for the Avandia panel but barred him from voting, the Globe notes.
He argues the FDA packs panels with clinicians more apt to keep questionable products on the market to help their patients but includes fewer drug safety proponents who argue for restrictions and market withdrawals. “My assumption is it is going to be tougher to stack the committee with people who have conflicts,” Furberg tells the Globe. “The first step is to limit the number of people with potential conflicts. The other is to define conflict more explicitly.”
A Hinchey spokesman reminds Pharmalot that the congressman has proposed such language each year for the past few years, but that “the Senate is always a stumbling block.”
Here is the actual language…
SEC. 729. None of the funds made available in this Act may be used to–
(1) grant a waiver of a financial conflict of interest requirement pursuant to section 505(n)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)(4)) for any voting member of an advisory committee or panel of the Food and Drug Administration; or
(2) make a certification under section 208(b)(3) of title 18, United States Code, for any such voting member.
MyPharmalotID
Defining the conflicts of interest (COI) will be the real challenge. It should be a rather simple matter to identify relationships with pharmaceutical companies, investment houses, hedge funds, and the like. But devining COIs related to the potential for monumental changes in an industry and in one’s career…such as those that the approval of Dendreon’s Provenge, an immunotherapy, might have had on the chemotherapy industry (more specifically, on the trials being run by Novacea, Schering Plough, and Sanofi-Aventis, for example) and on those individuals who are involved in trials using chemotherapeutic drugs (e.g., Asentar and Taxotere) is quite another. A review of the COIs related to the participants in the March 29, 2007, Advisory Committee (AC) on Provenge, and specifically, to those of Drs. Scher and Hussain, are noteworthy in this regard.
Doctor Deep
Let’s ponder why the distinguished Senator Kennedy would oppose any limitations on conflicts of interest on FDA panels…could it be that during his 2006 campaign, he received a QUARTER MILLION DOLLARS from pharma/healthcare interests and 300 THOUSAND DOLLARS from securities & investment firms? (The above information from this site: http://www.opensecrets.org/politicians/indus.asp?CID=N00000308&cycle=2006). God bless and strengthen those in Congress who are trying to right this ship!
Tony F
Expanding on the Dendreon’s Provenge March 29th FDA AC meeting at which the 17 panel members voted 17-0 that Provenge appears safe and 13-4 that it has “substantial efficacy”, two members who voted “NO” on the latter pursued a post-AC meeting, very public and very unusual campaign to derail the positive vote by the committee in favor of Provenge.
Dr. Howard I. Scher, of New York’s Sloan Kettering, was granted a Waiver to sit on this committee in judgment of Provenge by the FDA. In his Waiver application, he told the FDA he had 3 Conflict of Interests: 1 stock and 2 competing firms.
Internet research appears to show 16 for Scher thus far:
—especially note Items #1 and #16
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. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
15. MEDIVATION, INC: principal investigator MDV3100
16. PROQUEST INVESTMENTS: consultant, scientific advisory board; Limited Partner FINANCIAL interest
Perhaps the good Senator from Massachusettes (the Chappaquiddick Kid), might see his way to reviewing the above information to see, if just maybe, he might revise his thinking on Conflict of Interest legislation? It’s about time for the responsible legislators start looking out for the interests of the American people first.