Integrity in Science Watch|
Week of 05/14/2007
While Senate Snubs Conflicts Limit in FDA User Fee Bill . . .
The Senate last week by a tie vote narrowly defeated an amendment to the prescription drug user fee act that would have slapped strict limits on the Food and Drug Administration’s ability to appoint scientists with conflicts of interest to its advisory panels. The amendment, sponsored by Senators Richard Durbin (D-IL), Jeff Bingaman (D-NM), and Barack Obama (D-IL), would have allowed a maximum of one scientist with a conflict of interest on any committee. While the vote was largely along party lines, six Democrats, including Health committee chairman Ted Kennedy (D-MA) and presidential candidate Chris Dodd (D-CT), voted against the measure. Republicans Charles Grassley (IA), Olympia Snowe (ME) and Susan Collins (ME) voted in favor.
Besides reauthorizing the FDA’s financial reliance on industry user fees, the bill, which now moves to the House, contains several provisions strengthening the ability of the FDA to protect the public from unsafe drugs. It gives the agency the power to demand that companies monitor drugs once they’re on the market; earmarks funds for more safety officials; appoints a chief scientist; protects agency scientists’ right to voice individual opinions; and gives the public access to the results of clinical trials that have been submitted to the agency for new drug approvals. Broader reforms backed by consumer groups, such as limits on direct-to-consumer advertising, public posting of all clinical trial results, and an independent safety department, failed to make it into the bill.
. . . A Conflict-Free Panel Seeks Tighter Limits on Anemia Drug
The Oncologic Drugs Advisory Committee last week voted overwhelmingly in favor of the Food and Drug Administration issuing sterner warnings to oncologists who overuse anti-anemia drugs in patients undergoing chemotherapy. Recent studies have shown that over-prescribing the infusion drug that stimulates red blood cell production – it is commonly known as EPO – actually increases mortality among patients suffering from breast, head-and-neck, and other solid tumor cancers. The drugs, Amgen’s Aranesp and Johnson & Johnson’s Procrit, have been heavily promoted in print and television advertisements as a way to avoid chemo-related fatigue.
None of the 17 members of the advisory panel needed a waiver of conflicts of interest to serve on the committee. The vote came one day after a New York Times investigation revealed that oncologists and renal physicians receive sizable fees from Amgen and J&J in direct proportion to how much drug they prescribe, a marketing scheme that promotes overuse of the drugs.
Few Waivers Eliminated by FDA’s Proposed Guidance
The Food and Drug Administration’s recent proposal to limit conflicts of interest on its advisory committees would eliminate just one of every ten panelists who currently gets a waiver, a Center for Science in the Public Interest investigation shows. The FDA’s draft guidance, which is open for public comment for another week, would eliminate scientists from advisory committees if they have earned more than $50,000 in the past year from a company that has a stake in the outcome of a committee’s meeting. The guidance, which is not binding on the agency, would also prohibit scientists with lesser conflicts from voting at the session. Since last September, 168 waivers have been granted to the 572 scientists who served on 47 FDA advisory panels. Just 17 of those waivers were for conflicts greater than $50,000.
EPA Spring Cleaning: Dismantling Libraries, Clearing Out Labs
The EPA has begun dismantling its libraries and dispersing their contents, according to Public Employees for Environmental Responsibility. The EPA had promised to consult with Congress before taking its library system apart, but it is moving forward without consultations or setting up an adequate substitute system. The Office of Enforcement and Compliance issued a memo last month stating that it was concerned about losing access to original reference documents because of the cuts.
Meanwhile, EPA researchers lack money for supplies, lab animals, and skilled lab technicians to conduct research, Environmental Science and Technology reports. There has been a 25 percent decline in inflation-adjusted research and development budgets between 2004 and 2008. Scientists say the agency is increasingly turning to the companies it regulates and industrial trade groups for its toxicological and engineering data.
Cheers and Jeers
- Cheer: To the New York Times for mentioning in its heart health story that a defibrillator study was funded by Medtronic Inc., the leading manufacturer of implantable defibrillators.
- Cheer: To Newsweek's Sharon Begley for her column "Just Say No -- To Bad Science," where she points out how sample selection bias can skew scientific results. One example: most industry funded studies of estrogen-like bisphenol-A that show no toxic effects were done on rats that are insensitive to estrogen. "That's like trying to measure how stress affects lactation ... using males," she wrote.
- Jeer: To the Massachusetts Medical Society for making it very difficult to find conflict-of-interest disclosures for the editorial board members of its popular Journal Watch newsletters. Readers of today's review on using antidepressants in pregnancy, authored by Harvard professor Claudio Soares, could not find the fact that he receives grant support from Eli Lilly and consults for Wyeth and GlaxoSmithKline in the article. It could be found however, by drilling two pages down from journal's "site map" page.
On March 12, 2007, Integrity in Science Watch reported that an article in the American Journal of Clinical Nutrition written by Adam Drewnowski of the University of Washington failed to disclose that his previous research had been funded in part by industry associations and that he owned stock in beverage companies. The allegation that he owned stock in beverage companies was based on an Associated Press report that was incorrect. We regret the error.