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June 18, 2007

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Integrity in Science Watch

Week of 06/18/2007

Cell Phone Assn. Involved in NAS Deal

According to National Academy of Sciences regulations, no more than 49 percent of the money for any study conducted by the quasi-governmental agency can come from private industry. Yet a new NAS panel that will set the research agenda for measuring cell phone health risks (see last week’s Integrity in Science Watch) derives all of its funding from the Cellular Telephone Industry Association (CTIA), the industry trade group. The industry cash was funneled through a 1999 Cooperative Research and Development Agreement between the Food and Drug Administration and CTIA.

The agreement states that the FDA's Center for Devices and Radiological Health will recommend what research will be conducted under the agreement and review the results, but “the CTIA will administer research conducted by third parties.” “Both groups – CTIA and FDA – are engaged in research guidance. Both groups have an input into research goals and responsibilities," said Michelle Chenault, an associate director the FDA’s CDRH. Responded NAS Executive Director E. William Colglazier: “Our contract is with FDA, and we consider the government to be the sole sponsor and funder of the study.”

Another recent example of industry attaching strings when it underwrites government research involves the Environmental Protection Agency, which has launched the first nationwide study of air quality effects from large-scale animal feeding operations. The study is being financed by livestock producers. The study will measure levels of particulate matter, hydrogen sulfide, volatile organic compounds and ammonia emitted from livestock facilities, which will allow the EPA to determine if they comply with the Clean Air Act. One provision of the agreement exempts feedlots from prosecution for Clean Air Act violations during the study period.

Owl Scientists Cry Foul over Species Recovery Plan Revamp

Endangered-species experts in the academic community have accused former industry lobbyists now in key positions at the Agriculture and Interior departments of misrepresenting their work in order to override agency scientists and weaken a proposed spotted owl recovery plan, which is now open for public comment. The so-called “Washington Oversight Committee,” which includes undersecretary of Agriculture Mark Rey, a former timber industry lobbyist, and deputy secretary of the Interior Lynn Scarlett, the former chief executive of the Reason Foundation which receives substantial funding from the American Forest and Paper Association, cited several recent studies in quashing the original plan offered by the Fish and Wildlife Service (FWS), which proposed stronger protections for old growth forests.

“The authors of the studies specifically cautioned against using the results to guide forest management actions for spotted owls," said Dominick Dellasala, a scientist involved in drafting the original FWS plan. The studies showed that spotted owls appeared to be thriving in parts of their range outside old growth forests. The former lobbyists seized on that finding to craft a proposal that gives local Forest Service and Bureau of Land Management (BLM) officials greater leeway to determine which owl-dwelling forest lands need protection.

Meanwhile, the tide appears to be turning against government appointees who manipulate science. A federal judge in Idaho has struck down new cattle industry grazing regulations because the BLM ignored agency scientists. The BLM’s rules, proposed by the livestock industry and issued in 2005, loosened restrictions on grazing on 160 million acres of public lands throughout the western U.S. Judge B. Lynn Winmill said the rules violated federal environmental laws and failed to heed warnings from government scientists that the changes could have “significant and long-term adverse effects on wildlife resources and biological diversity in general.” In a similar vein, federal district Judge John C. Coughenour in Washington has thrown out a policy that weakened Endangered Species Act protections for wild salmon by equating hatchery fish with wild fish.

Conflict of Interest Charges Roil Cochrane Collaboration

Cochrane Collaboration officials have launched an investigation into charges that peer reviewers substantially changed the author's conclusions in a controversial guideline challenging the routine use of anticoagulants to treat blood clots. David Cundiff, a Los Angeles-based physician and lead author of the guideline, in an article that appeared on Medscape last week also claimed that four of the seven peer reviewers had conflicts of interest. The review is posted on the Cochrane website and backs continued use of the drugs. In his Medscape commentary, Cundiff claimed there is no evidence supporting the use of warfarin, heparin, and other anticoagulants, which has been standard medical practice for lung and leg blood clots since the 1940s. He also said that epidemiological evidence suggests they cause internal bleeding that leads to unnecessary deaths.

The Cochrane Collaboration, founded in 1993 to promote evidence-based medicine, now has a strict policy forbidding conflicts of interest for its authors, editors, and peer reviewers. But at the time the review was commissioned in 2001, the voluntary organization had no policy, according to Gerald Fowkes, a professor of epidemiology at the University of Edinborough and head of the group that approved the guideline. An independent check by the Center for Science in the Public Interest confirmed that at least three of the peer reviewers – Martin H. Prins of the Netherlands, David Bergqvist of the University of Uppsala in Sweden, and William Hiatt of the University of Colorado – have recent ties to drug makers. Though Cundiff has no ties to industry, he told Cochrane’s editors that his research interest in anticoagulants resulted from a malpractice case involving a patient’s death after he failed to prescribe anticoagulants. The case resulted in his losing his medical license.

Polluters Cite Oil Industry-Funded Scientist to Cloud Ozone Picture

Permissible levels of smog-producing ozone should be lowered, an Environmental Protection Agency science panel unanimously agreed in March. But in a series of closed door meetings this month at the White House’s Office of Management and Budget, the first of which excluded the EPA, industry lobbyists claimed the science is still in doubt. According to Greenwire (subscription required), the lobbyists cited the work of William Adams, a retired professor of exercise science at the University of California-Davis, who claims the EPA proposal to lower the permissible ozone level misinterpreted his findings that lung capacity improves at the lower levels. Adams’ research was supported in part by an unrestricted grant from the American Petroleum Institute. A final standard will be issued next year.

Odds and Ends

The federal claims court hearing lawsuits filed by parents of autistic children exposed to thimerosal, a mercury-containing vaccine preservative, has cut off access to the vaccination results database maintained by the Centers for Disease Control, Legal Times reports. . . Profits from the resale of infusion drugs once constituted 65 percent of oncologists’ income, according to Bristol Meyers Squibb documents. But once Medicare reformed its cancer drug payment schedules, doctors turned to performing expensive procedures to maintain income, whether or not it benefited patients, the New York Times reported . . . The National Institute of Environmental Health Sciences asked John Bucher, a 24-year veteran of the agency, to run its National Toxicology Program, which tests chemicals for their safety and carcinogenicity.

Cheers and Jeers

  • Cheer: To psychiatrist Daniel Carlat, who, in an op-ed in the New York Times, called for revoking the accreditation of continuing medical education courses sponsored by commercial interests. Over half of all CME courses are now paid for by the drug industry.
  • Jeer: To psychiatrist Daniel Carlat, who failed to disclose in his op-ed that he could personally benefit from the change. His newsletter, the $109-per-year Carlat Psychiatry Report, offers "up to 12 hours per year of Category One CME credit" for passing the CME post-test contained in each monthly issue. The newsletter takes no money from the pharmaceutical industry.
  • Cheer: To the Washington Post for disclosing the conflict of interests of professor Ethel Siris in a story on osteoporosis.