Report: FDA Fails to Find Advisers Without Industry Ties
The Food and Drug Administration's latest report on the make-up of its advisory panels reveals that little has changed in the 15 months since Congress required the agency to document its efforts to find scientists without ties to industry. In a report sent to Capitol Hill on Jan. 31, FDA Commissioner Andrew von Eschenbach reported that 24 percent of advisers to the agency’s seven centers and offices received conflict-of-interest waivers between November 2005 and January 2007. The Center for Drug Evaluation and Research (CDER) had the worst performance, with 146 of 417 advisers, or 35 percent, requiring waivers because they owned stock in, consulted for, or served on the speakers' bureaus of firms with products up for approval or their competitors.
The agency's ability to identify advisers without conflicts of interest has not budged since Congress acted. Although the agency says it reviewed the resumés of 724 candidates to fill the 175 open slots on its committees, its ratio of waivers per meeting was nearly identical over the period. For instance, CDER granted 42 waivers for the 8 meetings in the first quarter of last year compared to 30 waivers for 6 meetings in the fourth quarter. The advisory committee that met last November to discuss Pfizer's application to use the painkiller Celebrex for juvenile arthritis was typical. While just 2 of the 8 permanent members required waivers, 4 of the 8 temporary specialists appointed to the committee for their expertise had conflicts.
When questioned about the agency's failure to reduce its reliance on outside advisers with ties to industry, acting deputy commissioner Randall Lutter said that "it is very difficult to get the quality of the expertise we want without going to people who have some sort of relationship with industry related to product development." But as a Lancet (subscription required) editorial noted in 2005 shortly before Congress passed its law, "it is hard to believe that in a country with 125 medical schools – not to mention the pool of international experts – the FDA cannot find experts who do not have financial ties with companies whose products are under review." A New York Times editorial has pointed out that "unless the FDA makes a more aggressive effort to find unbiased experts or medical researchers start severing their ties with industry, a whiff of bias may taint the verdicts of many advisory panels." Lutter said that FDA plans to issue a guidance document aimed at reducing its reliance on conflicted advisers "very soon." Former deputy commissioner Scott Gottlieb promised the new guidance last July at a meeting sponsored by the Center for Science in the Public Interest.
'State Climatologists' Stripped of False Titles
Delaware Gov. Ruth Ann Minner (D) has become the latest state official to ask a climate-change skeptic to stop identifying himself as a "state climatologist." In a letter to David R. Legates sent earlier this month, Minner asked him to stop using the title when making public statements about global warming, noting that his views are contrary to her adminstration's, the Wilmington, Del., Oregonian reported earlier this moth that Oregon Gov. Ted Kulongoski (D) had asked Oregon State University President Edward John Ray to stop George Taylor, head of the Oregon Climate Service, from calling himself the "state climatologist." And Virginia Gov. Tim Kaine's (D) administration told global-warming skeptic Patrick J. Michaels last year not to use the title anymore, noting that there has never been "evidence that any governor since 1980s had made such an appointment." However, just last week, an article in Nature (subscription required) reported that Michaels had been Virginia's state climatologist since 1980 and failed to note Michaels' numerous ties to the fossil fuels industry.
CDC Vaccine Committee Accused of Whitewashing Thimerosal Dangers
The Centers for Disease Control and Prevention's Advisory Committee for Immunization Practices (ACIP) last week determined it is safe for pregnant women, infants, and children to receive the flu vaccine, despite concerns from some health advocates about the use of the mercury-containing preservative thimerosal in the vaccine. The Institute of Medicine has recommended since 2001 that mercury not be injected into these sensitive populations, but the CDC now recommends flu shots for pregnant women and children ages six months through 5 years. While most routine childhood vaccines are currently available in mercury-free or reduced mercury versions, the majority of flu shots still contain 25 micrograms of mercury. The Environmental Protection Agency has established guidelines for safe exposure to mercury at 1 microgram per kilogram of body weight per day.
Central to the health advocates' concerns about CDC's recommendations are conflict-of-interest accusations surrounding the doctor who presented the committee with a review of the evidence on the dangers of thimerosal. Dr. Jay Lieberman has been a consultant to Merck, GlaxoSmithKline, and Sanofi-Pasteur and is on the speakers' bureaus for all three vaccine-makers, which use thimerosal in their products. "It's obvious this committee's ties to the drug companies are dictating what will come to light regarding the use of mercury in vaccines," said Claire Bothwell, board chairwoman of the National Autism Association, in a statement.
Positive Results More Likely in Breast Cancer Trials Involving Drugmakers
Studies of breast cancer medicines that involve drug manufacturers are more likely to show positive results than those without their involvement, according to a study to be published in the April 1 edition of the journal Cancer. The study, led by Dr. Jeffrey Peppercorn of the University of North Carolina School of Medicine in Chapel Hill, analyzed 140 trials reporting breast cancer therapy results over the past decade in select journals at five-year intervals. Of the 140 trials, 67, or 48 percent, reported some form of drug company involvement, meaning the studies had received funding or drugs from a manufacturer or at least one of the study's authors worked for a drug company. Drug company participation increased from 44 percent in 1993 to 58 percent in 2003. Besides the increased likelihood of reporting results that favoring the experimental therapy, industry-funded studies also were significantly more likely to use "single arm" designs – that is, a study whose patients get the same treatment with no control group to compare efficacy. Drug company-sponsored trials also tended to target patients with advanced disease. Three of the four authors of Cancer study, including Peppercorn, had financial ties to manufacturers of anti-cancer drugs.
Cheers and Jeers
Odds and Ends
Richmond, Va.-based tobacco giant Philip Morris USA is donating $25 million to the University of Virginia, primarily for research "to help prevent youth smoking, improve the effectiveness of smoking-cessation efforts and reduce the harm caused by smoking," the university said in a press release. ... The House Oversight and Government Reform Committee is holding a follow-up hearing Thursday to examine political interference in federal climate science. ... Merck & Co. announced last week that it is suspending its campaign to get state legislatures to require pre-teen girls to receive a vaccine for human papillomavirus, the Wall Street Journal (subscription required) reported. Merck is the manufacturer of the only vaccine currently on the market. ... Michigan's Henry Ford Health System last month became the first health care system in the country to require drug companies to acquire certification before conducting business there, as part of an overall strategy to reduce drug reps' influence that also included bans on free lunches, gifts, and other perks, the Detroit News reported.