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Integrity in Science Watch – March 3, 2008

EPA Boots Gov Scientist after Industry Complaint

Responding to pressure from the chemical industry, the Environmental Protection Agency last summer dismissed a public sector scientist from an outside advisory panel charged with evaluating the safety of a common flame retardant, the Los Angeles Times reported. Studies have shown that Deca-BDE, a polybrominated diphenyl ether (PBDE) widely used as a flame retardant in electronics equipment, has been shown to skew brain development, alter thyroid hormones, and slow learning and motor skills development in animals. The EPA is expected to issue new standards for the chemical late next month.

A year ago, the EPA appointed toxicologist Deborah Rice of the Maine Department of Health and Human Services to chair a Deca-BDE review panel, but removed her last August after the American Chemistry Council accused her of bias. Rice had been instrumental in getting Maine to ban the chemical. The EPA also removed Rice’s comments from its preliminary Deca-BDE review, claiming the civil servant’s views created the perception of conflict of interest. The Environmental Working Group (EWG) says that the redacted document could result in a significantly weaker standard for the chemical. EWG also accused the EPA of having a double standard, since 17 panelists on seven EPA advisory committees impaneled last year had ties to industry.

Surgeon Payments Disclosure Bill Advances
Congressmen took aim at the often cozy relationship between medical device companies and surgeons at a packed Senate Committee on Aging hearing last week. The Physician Payments Sunshine Act, co-sponsored by Sen. Chuck Grassley (R-IA) and Sen. Herbert Kohl (D-WI), would require drug and medical device manufactures to disclose all financial dealings with doctors, including gifts, honoraria, travel expenses, educational grants, and funding for clinical trials. “These types of unethical payments are not anecdotal, but rather have been pervasive and industry-wide for far too long,” Kohl said in his opening remarks.

After executives from Stryker Corp. and Zimmer Holdings Inc. admitted widespread use of gifts and consulting fees to surgeons who use their hip and knee replacement products, Health and Human Services assistant inspector general Greg Damske testified that many consulting arrangements involve little or no work and are primarily used to buy loyalty from surgeons. In a New Jersey U.S. District Court settlement last September, five orthopedic implant manufacturers admitted paying more than $221 million to surgeons in 2007, and all but Stryker agreed to pay a $310 million settlement. “There were abuses and excess in the past, not just at Zimmer but across the industry,” admitted Zimmer vice president Chad Phipps.

The companies and the Advanced Medical Technology Association, the medical devices industry trade group, supported the sunshine bill, but pushed for weakening amendments. Charles Rosen, a professor at the University of California Irvine and President for the Association for Ethics in Spine Surgery, said the industry and surgeons were incapable of policing themselves and advocated even tougher laws. “It is so embedded now among most of the people running these societies, including the educational foundations, that I don’t think it’s possible to change that without something from the outside happening,” he said.

Philip Morris Ends 8-year Academic Research Program
Philip Morris, the largest tobacco-industry sponsor of American academic studies, has ended an eight-year program that funded university research across the country, Science reported. However, anti-tobacco researchers warn the industry will likely continue to fund academic research through other channels. The Philip Morris External Research Program (PMERP) supported 470 research proposals from 60 medical schools over the eight years.

Launched in 2000, PMERP had been criticized as an extension of Philip Morris research programs launched to cast doubt on the dangers of smoking. Although researchers on the Philip Morris dole learned in September of 2007 that PMERP was ending, the company’s decision only came to light through a letter from University of California (UC) President Robert Dynes to UC chancellors. Dynes reminded the chancellors at each of the university’s 10 campuses to closely monitor research funding from tobacco companies to comply with new guidelines prohibiting tobacco industry research support. In 2006-2007, the University of California campuses received 23 grants from Philip Morris that totaled to $16 million. Meanwhile, Stanton Glantz, a UC San Francisco professor and long-time anti-tobacco advocate, warned that the tobacco industry will continue to impact academic research. Glantz cited Edythe London, a UC Los Angeles researcher who received a $6 million grant from Philip Morris to study addiction as evidence that tobacco-industry funded research at American universities will continue long after PMERP ends.

Yazoo Pumps Face EPA Veto
Environmental Protection Agency administrator Stephen Johnson has begun the process of vetoing the Yazoo Pumps, a $200 million Army Corps of Engineers project that would drain more than 300 square miles of wetlands in Northwestern Mississippi. The Corps, backed by the big farmer-oriented Delta Counci in pushing for authorization for the project, said that the pumps are necessary to reduce flooding in the lower Mississippi Delta. Opponents, including environmentalists and 541 scientists who wrote the EPA last December, contend that the project would drain or damage more than 200,000 acres of wetlands important to migratory birds, threaten endangered species, and lower water quality. The scientists also point out that wetlands reduces flood damage by storing and slowly releasing storm waters.

Big Business Drives Research Agenda at Land Grant Schools
The dean of the University of California at Davis’ College of Agricultural and Environmental Sciences recently acknowledged that roughly 20 percent of the college’s $165 million annual research budget comes from industry. Officials at land grant universities are increasingly fearful that state and federal budget cuts are forcing universities to forge closer ties with agri-business giants such as Dupont, Monsanto, and Calgene, which will inevitably influence the research agenda and curriculum at these institutions. Professors are already lamenting this influence, calling Syngenta’s involvement in UC Berkeley’s Department of Plant and Microbiology, for instance, “a mistake.” President Bush’s proposed 2009 budget cuts funding for land grant universities by a third.

Boxer: EPA “in Crisis” over Greenhouse Gas Rules
Senate Committee on Environment and Public Works chair Barbara Boxer (D-CA) called the agency “in crisis” last week after releasing a memo from senior staffer Christopher Grundler to EPA chief Stephen Johnson asking him to grant California’s request to enact greenhouse gas emission standards. Johnson’s denial marked the first time in agency history that it has denied a California request to implement clean air policies more stringent than the national standard. California has traditionally led the nation in enacting clean air rules.

Odds and Ends
The Association of American Medical Colleges and the Association of American Universities has called for all medical schools and major research universities to develop and implement institutional financial conflicts of interest policies within the next two years. A recent survey showed just two-thirds of medical schools have or are working on such policies . . . . Former timber industry lobbyist and Undersecretary of Agriculture Mark Rey apologized to a federal judge for his agency’s failure to analyze the environmental impact of using toxic flame retardants. U.S. District Judge Donald Molloy said the agency’s failure to follow his orders was “shameful,” “unreasonable,” and showed a “systematic disregard of the rule of law.” The judge issued the orders following a lawsuit filed by Forest Service Employees for Environmental Ethics, which charged that the retardant killed 20,000 fish in Oregon . . . . Eleven conservation organizations last week notified the U.S. Fish and Wildlife Service of their intention to sue over the agency’s decision to remove the northern Rocky Mountain gray wolf from the list of endangered species. The groups expressed concern that the removal could result in killing of up to 80 percent of wolves throughout the northern Rockies . . . . Two farm groups suspended $1.5 million in grants to the University of Minnesota. The executive director of the Minnesota Soybean Growers Association and the Minnesota Soybean Research and Promotion Council said that “the university hurt the farmers’ feelings” after researchers at the university issued a study that found biofuels may worsen global warming . . . . Pfizer cancelled its Lipitor ads featuring Robert Jarvik, the inventor of the artificial heart who is not a practicing physician, on the eve of a Congressional hearing investigating whether the ads misled consumers . . . . Sen. Charles Grassley sent a letter to 15 drug companies last week questioning what they are doing to meet public demand for greater transparency in educational grants. Grassley asked the drug companies to follow Eli Lilly’s lead, which posts its grants on its website.

Cheers and Jeers
* Jeer to Jennifer Corbett Dooren of the Wall Street Journal for failing to disclose that FDA panel member and Baylor College of Medicine professor Robert Couch received more than $300,000 through a contract and between $100,000 to $300,000 through a subcontract from a pharmaceutical firm affected by the Vaccine and Related Biological Products Advisory Committee decision last week on which virus strain to use for this year’s influenza vaccine.

* Cheer to Jacob Goldstein of the Wall Street Journal Health Blog for reporting that Peter Hotez, a professor at George Washington University Medical Center, is the inventor of and holds the patent on a hookworm vaccine. The vaccine is being developed by the non-profit Sabin Vaccine Institute, which has pledged to make it available if successful to all countries affected by hookworm on a cost-plus basis. The blog item covered Hotez’ article that envisioned turning Guantanamo Bay into a tropical disease research center.

* Jeer to Mike Stobbe of the Associated Press for failing to note that Carol Baker, a Baylor College of Medicine professor, had financial ties to Merck, Novartis Group, Sanofi Pasteur, and Inhibitex. Baker is a member of the Center for Disease Control’s Advisory Committee on Immunization Practices, which has made headlines last week for recommending flu vaccinations for everyone under the age of 18.

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