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August 18, 2008

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Integrity in Science Watch

Week of 08/18/2008

States Consider BPA Restrictions; FDA Says 'Safe'

Eleven U.S. states and Canada are considering bills that would ban or sharply reduce exposures to the chemical bisphenol-A (BPA), which is used to make plastics, even though the Food and Drug Administration last week released a draft policy concluding the chemical is safe. Some of the toughest rules are contained in California legislation that would ban the use of BPA in any products used by children aged 3 and under. Approximately 2.3 billion pounds of BPA were produced in the U.S. in 2004. The chemical industry has launched a campaign to generate public opposition to the California proposal, which is under consideration by the state Senate.

The chemical industry is seeking to undermine new regulation with inaccurate claims that government and scientific bodies have not found adverse health effects from low doses of bisphenol-A. Steven Hentges, executive director of the Polycarbonate/BPA Global Group at the American Chemistry Council, an industry trade group, also claimed that Health Canada found that infants are not exposed to harmful levels of BPA. Hentges' claim rests on a study by the Gradient Corporation, a product defense consulting firm that has received substantial sums from companies to write reports defending products such as cigarettes and BPA. A spokesman for Health Canada rejected the ACC's interpretation. "The data show BPA intakes are highest in infants and young children and . . . neurodevelopmental and behavioral effects . . . were observed in laboratory animals at very low levels of exposure, and close to levels to which infants and young children are exposed," said Alastair Sinclair, a spokesman for Health Canada.

The FDA draft assessment on BPA drew a heated response from environmental groups. "It's ironic FDA would choose to ignore dozens of studies funded by (the National Institutes of Health) - this country's best scientists - and instead rely on flawed studies from industry," said Pete Myers, chief scientist for Environmental Health Sciences. Last December a Milwaukee Journal Sentinel investigation of a National Toxicology Program report on BPA that found it to be of some concern for fetuses and small children gave more weight to industry funded studies. FDA will hold a public hearing to evaluate the safety of BPA on Sept. 16 in Washington, DC.

Endangered Species Act Overhaul Endangers Science

A former Fish and Wildlife Service scientist claims Interior Secretary Dirk Kempthorne's proposal to give other agencies the final say in endangered species designations will sharply reduce the role of science in making such determinations. The proposed rule change, which would represent the most significant overhaul of the Endangered Species Act (ESA) since 1986, would allow federal agencies to implement projects such as mining, logging, and road construction without first consulting FWS or National Marine Fisheries Service experts about the effects of these actions on listed plants and wildlife. Officials within agencies such as the Department of Transportation or the Office of Surface Mining - many of whom have no biological background - would be given the job instead. The proposed rule change codifies a provision in the polar bear listing that greenhouse gas emissions cannot be considered or addressed as threats to species survival and recovery. "This is just the same old final assault by the administration as they're going out the door" said Mike Lockhart, a retired FWS biologist.

Environmentalists charge that the proposed change, like earlier efforts by federal agencies to perform ESA consultations on their own, is illegal and will not withstand court challenges. Federal rules proposed in 2004, which would have legalized the Environmental Protection Agency's ongoing practice of approving pesticides without going through the consultation process mandated by the ESA, were thrown out by a federal judge. Federal agencies in charge of construction projects have historically resisted FWS' efforts to protect species. "These agencies have their own constituencies and their own political pressures," Lockhart says. "Those things will weigh more heavily than natural resource protections." Comments on the proposed regulations are due by September 15 and can be filed online at www.regulations.gov.

FDA Releases New COI Guidelines

The Food and Drug Administration has released a final guidance for how the agency will manage conflicts of interest rules on its more than 40 advisory committees. According to an Aug. 4 press release, FDA is instituting a cap of $50,000 as the maximum personal financial interest an advisor may have in all companies that may be affected by a particular meeting. If an advisor's personal financial interest is greater than $50,000, he or she will not be allowed to participate in that meeting unless they get a special waiver from the commissioner. If less than $50,000, lower-ranking FDA officials may, in certain situations, grant a waiver, but will do so only if they determine that there is an essential need for the advisor's particular expertise. Waivers, which include a description of the advisor's personal financial interest and why the need for the expertise was essential, will all be posted on the FDA's website two weeks ahead of the meeting. Under the FDA reform law passed last October, the agency must reduce the total number of waivers granted by 25 percent over the next five years. The final guidance is effective for advisory committee meetings scheduled after December 2, 2008.

ACCME Proposes Restrictions on CME Presenters

Compelled by a recent court decision and policy recommendations by the Association of American Medical Colleges, the Accreditation Council on Continuing Medical Education has proposed restricting physicians who write promotional materials or promote products for private firms from either writing or presenting continuing medical education sessions. The ACCME proposal said the voluntary group had received complaints from physicians who took the CME courses that their instructors had engaged in such activities and should "therefore (be) excluded from controlling the content of CME," which is currently in ACCME regulations. The proposal would effectively physicians who serve on industry speakers bureaus from teaching CME activities on those subjects. The trade group for the for-profit CME industry is protesting the way ACCME is orchestrating the change.

Odds and Ends

Deputy assistant Interior Secretary Paul Hoffman resigned last week following a controversial tenure in which he attempted to rewrite Park Service management policies to favor recreation over conservation and remove all references to evolution. . . . The Fish and Wildlife Service has reduced by 23 percent the acreage of protected critical habitat for the federally threatened spotted owl, even as the species continues to decline by four percent annually. The environmental group Earthjustice says that the move, which resulted from a Fish and Wildlife Service settlement with the timber industry, is based on the agency's Spotted Owl Recovery Plan released last year that was widely criticized by scientists. . . . Alan Schatzberg, the Stanford psychiatrist who is president-elect of the American Psychiatric Assocation, resigned from leading an National Institutes of Health-funded project studying mifepristone's (RU-486) effects on women with depression after it was revealed he owned more than $6 million in stock in Corcept Therapeutics, which manufactures the drug. . . . The Washington Post called on the Bush administration to withdraw a rule that would hamstring the Occupational Health and Safety Administration's ability to regulate workplace toxins. "The plan is an attempt by Labor's policymakers to wrest control of the risk assessment process from scientists at" OSHA, today's editorial stated.

Cheers and Jeers

*Cheer to the Archives of Internal Medicine for correcting a failure to disclose the multiple conflicts of interests of lead author Perry Pickhardt in a recent article on colonography screening.

*Jeer to Rob Lyons of Spiked-online.com for failing to disclose that Todd Seavey works for the American Council on Health & Science, a group funded by the chemical industry. Within the article, which is about the best and worst of contemporary health issues, Seavey claimed that "despite near-constant claims in the media that chemicals in the environment are making people sick, there is no good evidence that trace amounts of environmental chemicals cause human illness."