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March 20, 2007

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Integrity in Science Watch

Week of 03/20/2007

ExxonMobil Lobbyist: "I Had the Authority"

ExxonMobil lobbyist Philip Cooney yesterday admitted making 181 editing changes to climate change reports while serving as chief of staff for the White House Council on Environmental Quality. In sworn testimony before the House Government Reform and Oversight Committee, Cooney said he relied on a 2001 report prepared by the National Academy of Sciences. "I had the authority and responsibility to make recommendations to the documents in question, under an established interagency review process," Cooney said. Cooney spent 15 years working as a lobbyist for the American Petroleum Institute before assuming his role at the White House.

Several Democrats questioned Cooney's objectivity. "When I look at the role you played at API and at the White House, they seem virtually identical," Chairman Henry Waxman (D-Calif.) said. The issue of censorship is also being pursued by the House Science and Technology Committee, which sent letters to the heads of 11 agencies last week asking how they handle media requests for scientific information. The letters were prompted in part by revelations earlier this month that the Fish and Wildlife Service had instructed employees in Alaska not to discuss climate change, polar bears, or sea ice while traveling in countries around the Arctic region. The House last week passed a whistleblower protection act that would prohibit political appointees and high-ranking agency officials from interfering with government scientists' right to publish and speak out on public issues.

Conflicted Kidney Doctors Dismiss FDA Anemia Drug Warning

An industry-backed doctors' group last week cautioned renal physicians to carefully scrutinize a Food and Drug Administration warning that anti-anemia drugs made by Amgen and Johnson & Johnson's Ortho Biotech division could increase the risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when given in high doses. The Renal Physicians Association, which receives funding from Amgen and J&J, released a statement last week calling the advisory potentially "misleading" and asserting that some of the recommendations do not apply to chronic kidney disease patients. The association encouraged doctors to make treatment decisions on a case-by-case basis.

UCLA to Investigate Misconduct Allegations Surrounding Smoking Study

The University of California at Los Angeles is conducting an independent review of a controversial 2003 report that downplayed the risks of second-hand smoke, Nature (subscription required) reported. The study, led by UCLA epidemiologist James Enstrom, found that spouses of smokers had essentially the same rates of death from lung cancer and heart disease as spouses of non-smokers. Scientists at the American Cancer Society, which provided data for the study, criticized its results, noting among other things that there was a 25-year gap in the data during which exposure to second-hand smoke could not be verified. Enstrom had received industry funding for the study - unbeknownst to the cancer society - through the Center for Indoor Air Research. Enstrom had previously acted as a consultant and researcher for lawyers working for R.J. Reynolds and Philip Morris. Not mentioned in the Nature article was that the study's co-author, Geoffrey Kabat, formerly of the State University of New York at Stony Brook, has also conducted an epidemiological review for a law firm that has several tobacco firms as clients

Questions about the study resurfaced because the University of California system is considering whether researchers should be prohibited from accepting money from the tobacco industry.  In response to the concerns, UC President Robert Dyne told the regents last month that UCLA "will conduct a thorough review of the documents" and "will take further steps to determine whether any research misconduct took place."

Experts Protest FDA’s Drug Review Procedure

Drug safety and regulations experts are protesting the reauthorization of the Prescription Drug User-Fee Act, which requires pharmaceutical companies to pay user fees to the Food and Drug Administration to cover the costs of the review process for brand-name drugs.  More than 20 experts issued an open letter last week asking lawmakers to review the country’s drug approval system. Many critics view the user fee system as putting the FDA on the drug manufacturers' payroll, possibly skewing the review process and results.

The letter calls the drug review program incomplete and dangerous. “The FDA lacks the resources and authority it needs to carry out its duty of safeguarding public health,” said Susan F. Wood, Ph.D., a former director of the Office of Women’s Health who resigned her post following the delay of approval for Plan B, the over-the-counter emergency contraceptive. The letter recommends that the FDA eliminate deadlines for drug reviews to allow for adequate evaluation and analysis and increase funding for scientific research, training of medical staff, drug safety epidemiology and risk management.

(Cheers and) Jeers

Odds and Ends

The American Journal of Clinical Nutrition is investigating allegations that authors of a review that raises questions about the link between obesity and consumption of sweetened beverages did not disclose previous financial ties to firms or industry groups that sell sweetened beverages. . . OMB Watch released a report last week detailing the effects of recent regulatory changes put in place by President Bush that would make it more difficult for federal agencies to issue regulations. . . The New Mexico Health Center is expected to finalize new guidelines that will limit pharmaceutical companies' reach on campus within the next few months, the Albuquerque Journal (subscription required) reported...