FDA Shifts; Amgen, J&J in the Dock

Maybe I should leave the country more often.

I'm in Bordeaux to give a speech, but the morning papers bring news of major developments on two major issues I've been working on and writing about for the past several years. First, the Food and Drug Administration announced yesterday that it will no longer allow scientists with conflicts of interest valued at more than $50,000 a year to serve on advisory panels; and no one with lesser conflicts who gets a waiver allowing them to serve will have a vote.

It's a start in cleaning up the advisory committee process, and, as this Washington Post story points out, tacit admission that there are scientists and physicians without conflicts available to fill these slots. However, that $50,000 cut-off point seems awfully high, especially since the medical literature is filled with scientific surveys suggesting even small gifts like meals and meeting chotzkes can influence prescribing patterns. Moreover, even non-voting scientists with ties to industry can influence the direction of committee deliberations.

Congress will stlll have a say in this matter, and if it doesn't want to go to an outright ban, the Hill might consider limiting the number non-voting members with conflicts to one or two per committee, or even designating two or three key committees (Cardiovascular Drugs, Oncology Drugs and Drug safety come to mind) where the agency can "experiment" for a year or two with having no one getting waivers. Let's put the ban to a test to see if it really affects the quality of advice the FDA receives.

The other issue in the news involves the House Energy and Commerce committee launching an investigation into Amgen's and Johnson & Johnson's (its Ortho Biotech division) marketing practices for the anti-anemia drugs, Epogen, Procrit and Aranesp. Topping the list of questions was when the companies knew there was scientific proof that overuse of these drugs has needlessly harmed dialysis and cancer patients.

It was 1999 when I first wrote about the harm caused by raising red blood cell counts to near normal levels in dialysis patients. I heard about the issue from a patient advocacy group. The following year, Amgen stopped providing financial support for that group. If Energy and Commerce actually gets around to holding hearings on this issue, I suggest it adopt a standard that any patient or physician group that testifies disclose any and all financial support -- including dollar amounts -- that they receive from companies whose products are under investigation.