Integrity in Science Watch|
Week of 09/08/2008
NTP, FDA at Odds on Bisphenol-A
On the eve of a Food and Drug Administration hearing on the health effects of the plasticizer bisphenol-A used in food packaging, the National Toxicology Program affirmed that the chemical may harm the brain and prostate of developing infants, fetuses, and children, and disrupt their behavior. Three weeks ago, the FDA issued a report calling the chemical safe. The final NTP report, released last week, downgraded the levels of concern for some developmental effects that had been expressed in an earlier draft after an outside peer review panel made those suggestions. One member of that panel, Nancy Kerkvliet, professor of environmental toxicology at Oregon State University, chairs the science advisory council of the Annapolis Center, a conservative science policy think tank funded by industry.
Meanwhile, new research from the Yale School of Medicine that came out last week found that the chemical causes brain and mood disorders in monkeys. Like most of the studies of BPA that show possible health problems (see this literature review in Environmental Health Perspectives), the latest study’s authors reported no conflicts of interest. The two main studies used by the FDA for its analysis were funded by a unit of the American Chemistry Council, an industry trade group. The FDA’s public meeting will take place September 16 near Washington.
Big Pharma U.? Harvard Offers Glaxo Sweetheart Deal
Harvard and the pharmaceutical company GlaxoSmithKline have entered into a five-year, $25 million deal to support stem-cell research that gives Glaxo special rights to intellectual property generated by the collaboration. Joint projects will take place either on campus or in the company’s labs. Glaxo will get the rights to any patents generated in its labs, including those generated by university scientists, and first rights to a non-exclusive license for any discoveries made on campus. A Harvard spokesman also said the research consortium “will be overseen by a steering committee made up of equal numbers of Harvard and GSK personnel.”
Harvard is just one of several universities that have signed special deals with drug firms this year, according to the Financial Times. Pfizer formed a three-year, $14 million collaboration with four research universities to study diabetes: the University of California Santa Barbara, Caltech, the Massachusetts Institute of Technology, and the University of Massachusetts. Columbia University entered into an agreement with AstraZeneca to develop therapeutics for metabolic diseases. And the University of Washington at St. Louis has entered into an agreement with AstraZeneca. The drug industry is increasingly turning to campus-based researchers to supplement its own lagging research and development efforts, which have fallen on hard times. The number of new drugs coming out of industry labs and approved by the Food and Drug Administration is at record-low levels.
Hearing Journal Slams Researcher for Failing to Disclose
The Ear and Hearing Journal editorialized last week that a controversial study published in 2005 contained an “incomplete and misleading” conflict of interest disclosure statement. The study downplayed the risk of hearing loss to firefighters from blaring sirens. The study’s author, William W. Clark of the Washington University School of Medicine in St. Louis, acknowledged in the study that he "provided consulting services for manufacturers of emergency firefighting equipment." But he added that “no external funding was received for this study.” In fact, Federal Signal Corp., which manufactures emergency equipment, helped conceptualize the study and acquired the original data for Clark, according to documents uncovered in a civil action filed by Chicago firefighters. The court eventually fined Signal Corp. $50,000 for attempting to cover up their involvement in the study, and barred Clark from testifying in the case. The Ear and Hearing Journal noted that its disclosure policy calls for “all funding sources supporting the work to be acknowledged.”
EPA Says DOT Underestimated Gas Mileage Benefits
The Environmental Protection Agency last week accused the Department of Transportation of using unrealistic data on gasoline prices that resulted in an underestimation of the economic benefits of increasing fuel economy standards to 31.6 miles per gallon by 2015. The DOT’s estimate was based on gas prices now and 2015 that ranged between $2.04 a gallon and $3.37 a gallon. Gas prices were already over $3 a gallon when Transportation Secretary Mary Peters released the proposal in April and still hover above $3.50 per gallon in most parts of the country. The EPA also said the DOT undervalued the societal value of better fuel economy by failing to consider the costs of climate change. “EPA has several concerns with the methodology used to determine the relative benefits and costs of the alternatives analyzed,” Susan Bromm, director of EPA's Office of Federal Activities, said in the letter to DOT.
Science Overlooked 11 Cell Phone Studies, Critics Charge
Science, the nation’s leading general science journal, erred when it said only two studies showed DNA damage from cell phone use, Microwave News charged last week. The Science article, which said both studies were under investigation for relying on falsified data, failed to mention eleven other peer-reviewed journal articles showing changes in DNA breaks from cell phone use, and three others showing chromosomal changes in response to cell phone radiation. The articles date from 1998 through 2008, and show a range of effects including damage to mouse sperm cells and human lymphocytes, and possible increased breakage of human DNA. Microwave News is a frequent critic of the cell phone industry.
Odds and Ends
A new study in the British Medical Journal suggests the drug industry may not be generating much additional sales from direct-to-consumer advertising . . . . Washington University in St. Louis, whose chancellor sat on a committee for the Association of American Medical Colleges that called for stronger institutional conflict of interest policies, announced it will set up a 19-member committee to formulate SUCH a conflict of interest policy. One week ago the National Institutes of Health sent reminders to universities to establish policies that protect “federally-funded research from compromise by [financial conflicts of interest].” . . . Rusi P. Taleyarkhan of Purdue University had his “named professor” title removed and lost $25,000 in additional pay after the university upheld findings of misconduct in his nuclear fusion research, according to the New York Times . . . . The New Statesman review of an archive containing nearly one million documents showed the asbestos industry exposed millions of people to asbestos knowing its dangers and used PR firms and politicians to hide a truth that it had secretly known since 1961 that “the only really safe number of asbestos fibers in the work environment is nil” . . . .
Cheers and Jeers
* Cheer to the New York Times and the Associated Press for including in a story on molecular breast imaging that the study was paid for by Bristol-Myers Squibb as well as Susan G. Komen for the Cure Foundation.
* Jeer to network anchors Charles Gibson, Katie Couric, and Brian Williams for appearing on the hour-long "Stand Up for Cancer" telethon that ran on all three national networks last Friday. The group's goal is a sharp increase in funding for cancer research. Among the many unproven statements made during the hour: All men over 50 should get an annual prostate exam, even though the U.S. Preventive Services Task Force recently issued a report questioning its usefulness to men over 75. Tip of the hat for this jeer and his noting of other media and drug industry connections to the telethon to University of Minnesota journalism professor Gary Schwitzer, publisher of HealthNewsReview.org.