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March 23, 2009

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Integrity in Science Watch

Week of 03/23/2009

Groups Urge Reg Review Reform

Public interest groups including the Center for Science in the Public Interest are urging the Obama administration to voluntarily limit White House involvement with rulemaking at federal agencies. The administration asked for public comment after overturning a Bush era executive order that had given the Office of Information and Regulatory Affairs (OIRA) greater power to delay rules and ignore recommendations by agency scientists. "Previous executive orders have given OIRA undue discretion to override policy decisions that were based on sound science and the exhaustive work of federal agency experts,"said Kirsten Stade, Manager of CSPI's Integrity in Science Project. "[W]e welcome the new Administration's commitment to ensuring the integrity of the administrative process."

How the Obama administration and OIRA will use cost-benefit analysis going forward remains a major concern for some of the groups, which say the process often works against public health and environmental protections. Cost-benefit analysis often relies on inflated industry estimates of costs and discounts non-monetary benefits, they say. Cost-benefit analysis is a "truly distorted approach to regulatory decision-making that . . . [slants] regulatory analysis in opposition to protective regulations, so as to benefit industry," the Center for Progressive Reform noted in its comments.

Other groups asked the White House to bolster public participation in the rulemaking process. OMBWatch took aim at the lack of transparency in rulemaking, while the Center for American Progress recommended that agencies use the Internet to foster "robust interactivity" between members of the public and agency staff during rulemaking. Comments on the new executive order can be filed through March 31 and should be addressed to oira_submission@omb.eop.gov.

JAMA Demands Silence on Disclosure Complaints

Calling public airing of alleged failures to disclose conflicts of interest "a serious ethical breach of confidentially," the editors of the Journal of the American Medical Association in an online editorial Friday said it will require anyone who complains to the editors to remain silent while an investigation is underway. The editors also will require individuals making allegations that authors of a journal article failed to disclose relevant conflicts to "provide a written detailed explanation of the unreported conflicts of interest and provide documentation to support the allegation."

The new policy is the result of a public spat with Jonathan Leo, a professor of neuro-anatomy at Lincoln Memorial University in Harrogate, Tenn., who last fall informed the JAMA editors that Iowa University psychiatrist Robert Robinson, the lead author of a study evaluating the use of Lexapro (escitalopram) for poststroke depression, had failed to disclose his serving on the speakers bureau of Forest Laboratories, which makes the drug. A subsequent investigation confirmed the charge, and a correction appeared earlier this month.

However, Leo also sent his original complaint to the New York Times and publicly aired the issue in the British Medical Journal, leading to several heated telephone exchanges between the editors and Leo. The Wall Street Journal Health Blog reported earlier this month that JAMA editor-in-chief Catherine D. DeAngelis told the newspaper that Leo was "a nobody and a nothing." The editor also notified Leo's dean that the professor was engaged in actions that "were potentially damaging to JAMA's reputation," according to last week's editorial by DeAngelis and deputy editor Phil B. Fontanarosa. The editors denied that they had impugned Leo's reputation, even as they stuck by their decision to pressure the dean to curb Leo's public statements and established new rules requiring silence while alleged failures to report conflicts of interest are under investigation. "As a faculty member (assistant dean of students) of a school preparing physicians who will care for patients, Leo certainly is 'somebody doing something' very important," they wrote. "To characterize Leo any other way would be erroneous and disrespectful, and this was never done by the editor-in-chief of JAMA."

Silenced Seroquel Study Seeps to the Surface

AstraZeneca hid the results of a 1997 clinical trial suggesting that the antipsychotic drug Seroquel caused weight gain and diabetes, the Washington Post reported last week. The Food and Drug Administration approved the drug despite having access to the data in the study, which the agency said it didn't have the authority to place in the public domain. Details of the study emerged in lawsuits filed by people claiming they were injured by the drug. According to plaintiffs attorneys, AstraZeneca officials buried a number of studies or "cherry-picked" data that put the drug in a favorable light. An AstraZeneca spokesman told the paper the trial "did not identify any safety concerns."

Scientists Decry Wolf Delisting

The Obama Administration's recent decision to remove the Rocky Mountain wolf from the endangered species list was premature and not based on science, according to prominent wolf biologists. Interior Secretary Ken Salazar announced he would uphold the Bush Administration's last-minute delisting decision and turn management of the species over to the states of Idaho and Montana. Gray wolves were one of the first species listed under the Endangered Species Act in 1973 after being nearly exterminated through hunting and predator control programs, and were reintroduced into Yellowstone National Park and central Idaho in the 1990s. Although the Rocky Mountain population has recovered to about 1,650 wolves, state management plans in Idaho and Montana would allow hunting until only 300 remained-a level that scientists say is inadequate to ensure genetic diversity and interbreeding among subpopulations in the area. "During the Bush Administration, there was no effort to make credible science-based decisions on species recovery," said Carlos Carroll, an ecologist with the Klamath Center for Conservation Research in Orleans, California, who wrote comments on the original Bush Administration proposal to delist the wolves. "I am mystified as to why Salazar rushed forward" with the decision. Conservation groups have vowed a legal challenge.

Pork Producers Battle to Beat Back Antibiotics Ban

Responding to legislation introduced last week by Rep. Louise Slaughter (D-NY) that would ban the use of antibiotics in livestock, the National Pork Producers Council (NPPC) cited industry-backed research that challenged the validity of the science behind the legislation. The bill would ban the use of antibiotics in healthy cattle, hogs, sheep and poultry, and would require drug manufacturers to prove there is no danger to public health from microbes developing resistance to antibiotics. A statement issued by NPPC claimed a report from the Institute of Food Technologists, which receives financial support from numerous corporate sponsors including the livestock chemical industry, showed that "correlating the risk of antibiotic use in animals and antibiotic resistance in humans is not possible." NPPC also cited research from the Animal Health Institute, which is the trade association of animal-drug companies.

Odds and Ends

The House Science and Technology committee will monitor spending under the American Recovery and Reinvestment Act, also known as the stimulus bill, "to insure that waste, fraud and abuse are at a minimum," Rep. Brad Miller (D-NC) said at a hearing last week. ... A study by Leslie Wolf, an associate professor of law at Georgia State University, found fewer than half of the Institutional Review Board (IRB) conflict-of-interest policies at 117 medical schools that receive National Institutes of Health funding consider fees and bonus payments by research sponsors for enrolling patients in clinical trials as conflicts of interest, according to a university press release. ... Brown University's Alpert Medical School has begun revising its conflict of interest policy for faculty, according to the Brown Daily Herald. Associate Dean of Medicine Philip Gruppuso said the new policy will ban pharmaceutical marketing on campus. ... Environmental Protection Agency Administrator Lisa Jackson has announced that she will discontinue EPA's Performance Track program, which rewarded companies that voluntarily reduced pollution. Environmentalists say the program benefited business more than the environment.

Cheers and Jeers

  • Cheer to Shankar Vedantam of the Washington Post for reporting how the Food and Drug Administration and AstraZeneca failed to reveal the details of a study showing unwanted side effects from the antipsychotic drug Seroquel (See story above).

  • Jeer to Judith Graham of the Chicago Tribune, Stephen Smith of the Boston Globe and Rob Stein of the Washington Post for failing to disclose the financial ties of authors of a study published (subscription required) in the New England Journal of Medicine suggesting that prostate cancer screening does not save lives. Graham and Smith quoted Gerald Andriole, lead author of the study, without noting that the Washington University School of Medicine surgeon had received consulting fees from Aeterna Zentaris, Ferring Pharmaceuticals, Negma Steba, Onconome, Veridex, AstraZeneca and Amgen and research support from GlaxoSmithKline. Stein quoted co-author E. David Crawford, a urology professor at the University of Colorado, Denver, without noting he received lecture fees from GlaxoSmithKline and AstraZeneca.