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February 4, 2008

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Integrity in Science Watch

Week of 02/04/2008

NEJM Reviewer with Conflicts Leaked Damaging Study to Drug Firm

A peer-reviewer for the New England Journal of Medicine leaked a confidential and unpublished research article to the pharmaceutical company whose drug was the subject of the article, Nature magazine (subscription required) reported. Steven M. Haffner, a professor of internal medicine at the University of Texas Health Science Center, faxed Alexander Cobitz, a scientist at GlaxoSmithKline, a draft of a paper criticizing GlaxoSmithKline's diabetes drug Avandia weeks before it was scheduled for publication. Haffner had worked on the Glaxo-funded study that found the drug efficacious in controlling blood sugar, and served as a paid speaker for the company, receiving at least $75,000 in fees since 1999, according to the New York Times. “The most troubling aspect of this situation is that the integrity of another aspect of the scientific process is called into question—the scientific peer review,” said Sen. Charles Grassley (R-IA), whose investigation into GlaxoSmithKline's handling of Avandia is ongoing.

The May 2007 study, conducted by cardiologist Steven Nissen of the Cleveland Clinic, reported that Avandia increased heart-attack risks of patients by 43 percent compared to other oral diabetes medications or placebos. Cobitz received the leaked report 17 days prior to publication, giving GlaxoSmithKline time to prepare a public response. “Why I sent it is a mystery. I don’t really understand it,” Haffner told Nature. “I wasn’t feeling well. It was bad judgment.” The Food and Drug Administration subsequently slapped a black-box warning on the drug, and sales—once over $3 billion a year—have dropped by more than half.

Polluters Monitor Selves in Delaware

The task of monitoring and reporting air quality violations in Delaware is left largely up to the companies that do the violating, thanks to an air quality management program kept underfunded by the companies themselves. The Wilmington News Journal reports that Delaware’s federally-mandated air quality program is funded by fees paid by polluting industries, but representatives from the regulated companies sit on the panel that helps set the fees. The panel has resisted the state’s efforts to raise the fees, leading to annual shortfalls exceeding a million dollars. The program, within the state’s Department of Natural Resources and Environmental Control, has 24 percent of its staff positions vacant, a fact that "has severely impacted the effectiveness of Delaware's program" according to a 2004 report by the U.S. Environmental Protection Agency. Environmental representatives on the panel have criticized the dominance of industry members, noting that business interests set the fees before DNREC had a chance to recommend a rate.

Prodisc Researchers’ Financial Ties Prompt FDA Investigation

About half of the 17 research centers involved in a study of the safety and effectiveness of Prodisc, an artificial spinal disc, had financial ties to the disk’s manufacturer Synthes, the New York Times reports. The Food and Drug Administration is investigating whether Synthes met its legal obligation to disclose its researchers’ financial interests prior to the agency’s 2006 approval of the medical device. The studies submitted to the FDA also omitted numerous patients who had negative reactions to the artificial spinal disk, which may have biased the results of the trials. Several Prodisc investigators are now conducting clinical trials of other spinal products, including Jack E. Zigler, a spine surgeon the Texas Back Institute, who is researching a new device made by Applied Spine Technologies, where he serves on the scientific advisory board.

Scientists Rebut Exxon-funded Polar Bear Study

The journal Ecological Complexity will publish a rebuttal of an ExxonMobil-funded study that says polar bear declines in Alaska’s Hudson Bay are due to human activity and not to loss of sea ice, the Anchorage Daily News reports. The study, a “viewpoint” written by seven authors with ties to the oil and utility industries and hunting groups, disputed earlier findings by Canada’s leading experts on polar bears that linked the bear’s decline to warmer temperatures and shorter sea ice seasons. Alaska state officials used the study to oppose listing polar bears as a threatened species. The editor of Ecological Complexity said that the article had been peer-reviewed. Andrew Derocher of the University of Alberta, one of the scientists who wrote the rebuttal, said the original article was poor scholarship, was intended to make a political point, and that "credible" experts on polar bears never had a chance to review it.

FDA Panel on Controversial Psych Drug Issues Waivers

The Food and Drug Administration has issued conflict of interest waivers for three members of the Psychopharmacologic Drugs Advisory Committee that will review the safety of Eli Lilly’s Zyprexa Adhera, a long-acting intramuscular injection used to treat schizophrenia. The drug reportedly triggers severe somnolence—a state of extreme drowsiness or sleepiness—in some patients. Public interest in the meeting has forced the FDA to change the meeting’s location and warn it may have to conduct a lottery to see who gets to speak during the portion of the meeting side aside for public comments.

Andrew Leon, a professor of biostatistics in psychiatry at the Weill Medical School at Cornell University, was granted a conflict of interest waiver despite serving on two data safety monitoring boards of Zyprexa competitors, one of which earns him between $10,001 and $50,001. Andrew Winokur, director of psychopharmacology at the University of Connecticut Health Center, served as a co-investigator on clinical trials of a product that competes with Zyprexa. And David Shaffer, the chief of child and adolescent psychiatry at Columbia University Medical Research Center, received a waiver because members of his staff have worked on trials for products competing with Zyprexa. He himself has not.

Odds and Ends

Science magazine editor-in-chief Donald Kennedy last week joined the call for a presidential debate on science policy, but excluded dealing with conflicts of interest in science from his suggested list of questions for the candidates. Candidates should only be asked “what consideration should be given to political affiliation in the appointment of members of advisory committees whose role is to evaluate research quality,” he editorialized. . . . Public Employees for Environmental Responsibility has filed a lawsuit against the Florida Department of Environmental Protection on behalf of Thomas White, a scientist who claims he was fired last year from his job as senior chemist with the agency after trying to expose problems with South Florida water quality planning. White says that DEP officials concealed and destroyed evidence to avoid giving him a chance to defend himself against allegations of data fraud. . . . The Fish and Wildlife Service announced a new code of scientific conduct that drew praise from the Wildlife Society and the American Fisheries Society. “We applaud the Service for taking this step, which is closely commensurate with the code of conduct that the American Fisheries Society has long espoused,” said executive director Gus Rassam.

Cheers and Jeers

  • Jeer to Kim Painter of the USA Today for failing to disclose that the Grain Foods Foundation, an industry-supported group, gave $1.4 million to the non-profit March of Dimes. The story reported that the two groups agreed to put a March of Dimes’ seal touting the benefits of folic acid for pregnant women on white bread sold by Grain Food Foundation members.
  • Cheer to Andrew Pollack of the New York Times for disclosing that Stephen J. Noga, director of medical oncology and hematology at Sinai Hospital in Baltimore, chairs the scientific advisory board of Cryo-Cell International, the company marketing a menstrual blood collection and storage service. Noga was quoted in a story discussing the possibility of using menstrual blood as a source of stem cells.
  • Correction: John Carey of BusinessWeek was improperly jeered in Integrity in Science Watch on January 21, 2008 for failing to disclosure that Scott Grundy, chair of the National Cholesterol Education Program, had consulted for Pfizer. The disclosure was contained in a sidebar that ran alongside the main story.