Center for Science in the Public Interest

For Immediate Release: February 19, 2008

Integrity in Science Watch

Week of 02/19/2008

Med Schools Lag in Adopting Institutional Conflict-of-Interest Policies

Nearly a decade after the infamous Jesse Gelsinger case, less than half the nation’s medical schools have adopted policies governing institutional conflicts of interest, a new survey showed. Institutional conflicts arise when universities license patents to or invest money in start-up companies conducting research at the university. The survey, published last week in the Journal of the American Medical Association, found just 30 of 86 medical schools had adopted such policies despite the 2004 guidance from the federal government urging them to do so. The issue came to the fore in 1999 after the Gelsinger family, whose 18-year-old son died in gene therapy experiment at the University of Pennsylvania, sued because they had not been adequately warned about the risks. The clinical trial had been organized and funded by a physician-researcher at the school whose start-up company was funded in part by the university.

The survey did find higher compliance with requests to adopt policies regarding conflicts of interest of top officials (about 70 percent of schools surveyed), institutional review board members (81 percent), and governing board members (69 percent). But the report, whose lead author was Susan Ehringhaus, a lawyer at the American Association of Medical Colleges, noted several flaws in the policies. For instance, while they generally required IRB members to notify each other about individual conflicts, “substantial gaps exist in informing institutional IRBs of potential institutional conflicts of interest in research projects under review.” An accompanying editorial by David Rothman, who directs the Center on Medicine as a Profession at Columbia University, asked “whether it is naïve to trust institutions to monitor and discipline their own financial activities, particularly when the financial returns can." He suggested federal regualtion may be forthcoming.

CDC Will Release Rewritten Great Lakes Study – in a Month

The Centers for Disease Control plans to release a completely revamped version of the controversial study of Great Lakes environmental hazards within “four or five weeks,” the agency’s chief spokesman said. The agency had come under fire for delaying release of a report linking environmental pollution to health effects in the region and reassigning the report’s chief author, Christopher DeRosa, the chief of toxicology at the CDC’s Agency for Toxic Substances and Disease Registry.

According to Glen Novak, chief of media relations for CDC, Howard Frumkin, director of the National Center for Environmental Health, strongly objected to the methodology of the Great Lakes report, which had been originally slated for release last July. The study correlated toxic releases in 26 areas around the Midwest between 2001 and 2004 with health outcomes in those areas from 1988 to 1997. “There was an implication of a cause and effect relationship, but that was the wrong order,” Novak said. He said the revamped study will be “significantly changed” from the original, and Frumkin may bring in an outside panel to review the final draft.

Prior to his reassignment last December, DeRosa had insisted that residents living in Federal Emergency Management Agency trailers along the Gulf Coast be warned about the long-term cancer risks from formaldehyde leaking from building materials used in the trailers. The federal government pledged last Friday to ramp up its efforts to move hurricane victims out of the trailers and into apartments or hotels following a joint FEMA and CDC study confirming that many of the trailers were contaminated with dangerous levels of formaldehyde. Approximately 100,000 hurricane victims are still living in trailers, including 7,000 families.

Meanwhile, the agency continued to decline to comment on DeRosa’s reassignment, calling it a “personnel issue.” Rep Bart Gordon (D-TN), chairman of the House Committee on Science and Technology, has demanded that CDC director Julie Gerberding take steps to protect DeRosa from retaliation. “I cannot understand how an agency charged with protecting the public’s health is attempting to muzzle one of its own scientists,” he said. “We need to ensure that retaliation against Dr. DeRosa for blowing the whistle on important public health issues stops today and that he is protected from further retribution.”

OSHA Injury Records Wrong, Top Record-Keeper Says

Robert Whitmore, the chief of the Occupational Safety and Health Administration’s record-keeping division now on administrative leave, has accused the nation’s employers of vastly underreporting injuries and illnesses in the workplace, the Charlotte Observer reports. Both OSHA and the National Association of Manufacturers denied the charges. The public criticism was included in the newspaper’s six-part series documenting systematic violations of the nation’s worker-protection laws at a North Carolina chicken processing plant, and a failure by the firm to report many of those injuries to the federal government. Whitmore filed a “hostile workplace” complaint last July for being put on paid administrative leave after a verbal confrontation with a supervisor.

FDA Delay on Trasylol was Deadly, Researcher Alleges

The Food and Drug Administration’s delay in taking action against Trayslol, a heart surgery drug produced by Bayer, left 22,000 additional patients vulnerable to kidney failure, congestive heart failure, stroke, and death according to researcher Dennis Mangano. In an interview with 60 Minutes aired last Sunday, he said that if the FDA had taken action following his 2006 study, which tracked the long-term health of 3,900 heart patients and was published in the New Journal of Medicine, thousands of lives could have been saved. The drug was routinely given to a third of all U.S. heart-bypass patients to limit blood loss.

Bayer suspended worldwide sales of Trasylol in November of 2007 after the FDA finally requested removal of the drug from the U.S. market. After Mangano presented his data to an FDA advisory committee in September 2006, the FDA only issued a public health advisory. A day later, the agency learned that the German-based pharmaceutical company had failed to tell the FDA’s reviewers about a company-funded study suggesting that Trasylol increases the risk of death and stroke. Between the publication in January 2006 of Mangano study and November 2007, when Trasylol was removed from the market, "there were approximately 431,000 patients who received the drug," Mangano told 60 Minutes. “As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month.” The company is investigating whether Trasylol can be re-released following additional research.

Odds and Ends

In their February newsletter, the Obesity Society expressed support for NYC’s public health initiative to have chain restaurants post nutrition information on menus. The article, however, made no mention of the fact that the society's incoming president, David Allison provided a declaration last month for the New York State Restaurant Association’s lawsuit against the city’s initiative. . . .A group of renowned scientists released a statement Friday at the annual American Association for the Advancement of Science urging an end to political inference in science. Organized by the Union of Concerned Scientists (UCS), the group called for the next president and Congress to establish an environment that would allow federal science to flourish. The statement coincided with a UCS report detailing how the current administration has misused research findings and hampered scientific progress . . . .The Food and Drug Administration issued conflict of interest waivers to John Modlin and Robert Couch, members of the Vaccines and Related Biological Products Advisory Committee, for meetings on Wednesday and Thursday of this week. The committee will primarily discuss GlaxoSmithKline’s vaccine for the rotavirus and select an influenza strain for the 2008-09 vaccine. Modlin, a Professor of Pediatrics at the Dartmouth-Hitchcock Medical Center, receives consulting fees of less than $10,000 from both a GlaxoSmithKline and a competing pharmaceutical firm. Couch, Director of the Center for Immunity and Infection Research at the Baylor College of Medicine, was granted a conflict of interest waiver despite receiving more than $300,000 through a contract and between $100,000 to $300,000 through a subcontract from a pharmaceutical firm affected by the panel’s decision on the influenza virus strain. . . .The U.S. Office of Special Counsel ruled earlier this month that Environmental Protection Agency administrator Stephen Johnson didn’t break federal laws in March 2006 while speaking at a Republican fundraising event held at the law firm of disgraced lobbyist Jack Abramoff, the Wall Street Journal reports.

Cheers and Jeers

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