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January 12, 2009

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Integrity in Science Watch

Week of 01/12/2009

Legal Scholar Sunstein Tapped for Key Reg Spot

President-elect Barack Obama has chosen former University of Chicago law school colleague Cass R. Sunstein to head the influential Office of Information and Regulatory Affairs, which will have a powerful say over the pace and content of government regulations in the new administration. Housed within the Office of Management Budget, OIRA during the Bush years allowed business interests and others to challenge scientific data used to justify regulations; established duplicative layers of peer review for government scientific documents; asserted greater control over agency guidance documents; and required agencies to identify specific "market failures" before enacting new rules. The net effect was a sharp slowdown in regulatory activity, with those regulations that did emerge from the bureaucracy usually far weaker than the scientific evidence would justify.

Sunstein, who has written extensively on regulatory issues, is a firm proponent of using cost-benefit analysis when considering proposed regulations. In a sharply-worded attack on the precautionary principle contained in his review of Frank Ackerman and Lisa Heinzerling's 2004 book "Priceless," which argued government regulators have an overriding moral duty to protect human life, Sunstein agreed there may be some cases where that is true, but they are rare. "Most of the time environmental questions do not involve evildoers or sins. They involve complex questions about how to control risks that stem both from nature and from mostly beneficial products, such as automobiles, cell phones, household appliances, and electricity," he wrote. "In resolving those questions, we cannot rely entirely on cost-benefit analysis, but we will do a lot better, morally as well as practically, with it than without it."

University of Texas legal scholar Thomas O. McGarity, who is associated with the pro-precautionary principle Center for Progressive Reform, noted in a 2002 review that "Sunstein has always preached a "soft" version of cost-benefit analysis that takes an honest stab at quantitative assessment of the costs and benefits of major health, safety, and environmental regulations, but does not necessarily allow the result to dictate the ultimate outcome of any given rulemaking effort." In a surprising new paper from the business-backed American Enterprise Institute Center for Regulatory and Market Studies, Rutgers University professor Stuart Shapiro called for the incoming Obama administration to repeal the Bush-imposed peer review rules and fight hard against allowing business to run to court to complain about rejected data challenges. "These actions will both please his supporters and would be the first actions ever taken to actually simplify the regulatory process," he wrote.

BLM Uses Corporate Science, Consultants for New Plan

Relying almost entirely on corporate-funded science, the Department of Interior's Bureau of Land Management (BLM) announced plans to open 2.6 million acres in Western Oregon to forest, energy, and mineral development. BLM's decision was based on an environmental impact statement that draws heavily on the timber and energy development industries.

Using erosion data provided by timber giant Weyerhauser, the report argued that the current road system on public lands needs overhaul. Existing roads are susceptible to weathering and erosion, which can lead to sediment in streams, the report said. New paved roads, which will allow easier access to timber, will alleviate the problem, the report claimed.

An economic analysis by forest product industry consultant Paul F. Ehinger & Associates suggested that the outdated Northwest Forest Plan raised timber prices thus resuscitating demand for new development and timber harvest. The plan was developed in the 1990s as an agreement between the environmental community and industry in part to protect the threatened northern spotted owl. The report also offers advice from Methane Energy Corp., which believes it can extract 1.2 trillion cubic feet of natural gas through the development of hundreds of wells over the next 10 years.

The conservation group Oregon Wild and hundreds of other groups and individuals are protesting the last-minute plan issued by the outgoing Bush administration.

Energy Nominee Brokered BP Biofuel Gig

Energy Secretary-designee Steven Chu was part of a deal establishing "the largest university-industry alliance in U.S. history" while he was director of the Lawrence Berkeley National Laboratory, Mother Jones magazine reported. The Nobel Laureate created the lab's Energy Biosciences Institute - an alliance between the lab, the University of California at Berkeley, the University of Illinois, and BP - to conduct research into biofuels. The institute, one of the many university-industry alliances examined in the Center for Science in the Public Interest report "Big Oil U," is funded by $500 million from BP. In exchange the company gets first rights to license any discovery made in the research program. Chu defended the partnership, calling it a way to "get largely CO2-neutral fuels in a responsible way."

Meanwhile, a new study from Stanford University suggests that biofuels are anything but carbon-neutral. The study, by Stanford Atmosphere/Energy Program director Mark Jacobson, ranks 12 non-traditional energy technologies for their potential to improve energy security, mitigate global warming, and improve air quality. According to the study, both corn-based and cellulosic ethanol are more polluting than nuclear and coal with carbon capture and storage, while wind and solar technologies top the list. "Biofuels are the most damaging choice we could make in our efforts to move away from using fossil fuels," Jacobson said.

NEJM Amends Disclosure Policy to Cover Patents

The Massachusetts Medical Society, publisher of the New England Journal of Medicine, has amended its policy for reporting patent holdings of authors after being sanctioned for dispensing continuing medical education credits for a controversial 2006 paper that failed to disclose relevant conflicts of interest. The original paper advocating CT scanning to detect lung cancer, which could be read for CME credit, did not reveal the authors'patents or the fact that it was funded in part by the tobacco industry, according to the Cancer Letter. The corrections, now available online, states that two of the study authors, Claudia Henschke and David F. Yankelevitz of Columbia University, received royalties from General Electric and the Cornell Research Foundation for a patent on the image screening process used in the study. NEJM never notified physicians who read the article for CME credit about the corrections.

Odds and Ends

The Department of Health and Human Services' inspector general will release a report today condemning the Food and Drug Administration's oversight of conflicts of interest for doctors conducting trials for new drugs and medical devices, the New York Times reported. The FDA told the IG that policing conflicts of interest wasn't worth the effort, the paper reported. ... Senate Democrats plan to undo some of the Bush Administration's last-minute regulations, according to E&E News, including changes to the Endangered Species Act that allow federal officials with no biological background to make decisions formerly made by Fish and Wildlife Service scientists. ... A coalition of environmental, ranching, and animal protection organizations petitioned Agriculture Secretary nominee Thomas Vilsack to end the controversial Wildlife Services program that killed 2.4 million wild animals at a cost of more than $100 million last year. ... The Fish and Wildlife Service denied a 2007 petition by the conservation group WildEarth Guardians to list 475 species under the Endangered Species Act on the grounds that the petition lacked substantial scientific data on which to base a listing. All the species are listed as "imperiled" in the FWS database, the group argued. ... Marcia Angell, former editor-in-chief of the New England Journal of Medicine, wrote in the New York Review of Books that the relationship between "Drug Companies & Doctors (is) A Story of Corruption." The condemned the pharmaceutical and medical community for rampant conflicts of interest.

Cheers and Jeers

  • Jeer to the government of the United Kingdom for taking £200 million from PepsiCo, Kellogg, and other manufacturers of sugar-sweetened beverages, snacks and cereals to help finance its Change4Life program, which is aimed at "reversing the rising tide of obesity."

  • Cheer to the Lancet (subscription required) for an editorial about Change4Life that said "ill-judged partnerships with companies that fuel obesity should have been avoided."

  • Jeer to the New York Times' Economix online column for failing to reveal that one of its frequent contributors, Princeton health economist Uwe E. Reinhardt, sits on the board of directors of Amerigroup, a major health insurer, and Boston Scientific, one of the nation's leading medical device manufacturers. According to Healthcare Renewal, in 2007 Reinhardt earned a combined $340,307 and held $4.3 million in stock in the two firms, whose fiduciary interests he is legally required to protect.

  • Cheer to Paul Goldberg of the Cancer Letter for his investigation of the New England Journal of Medicine's failure to publish a complete financial disclosure for Claudia Henschke's connection to the tobacco industry and General Electric, which led to sanctions against NEJM's publisher, the Massachusetts Medical Society, by the Accreditation Council for Continuing Medical Education and forced NEJM to change its policy on disclosing relevant patents (see the above story).

  • Jeer to the Boston Globe for running an op-ed by Peter J. Pitts of the Center for Medicine in the Public Interest without disclosing that the organization is funded by the pharmaceutical industry and Pitts is affiliated with Manning Selvage & Lee, a public relations and lobbying firm with numerous pharmaceutical and health care industry clients.

  • Cheer to The Onion for reporting that the powerful Rest and Fluids industry is behind the patient care administered by thousands of doctors. According to this widely-read newspaper, four out of five doctors recommend the controversial treatment for ailments including the common cold and influenza.


    In the Jan. 5 issue of Integrity in Science Watch, the jeer should have read "the prenatal use of vitamin D supplements." We apologize for any confusion that may have caused.