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February 11, 2008

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Integrity in Science Watch

Week of 02/11/2008

Whistleblowers Under Fire

CDC, FDA Scientists Silenced and Demoted

Top officials at the Centers for Disease Control are blocking publication of a 400-page, peer-reviewed report documenting toxic hot spots in the eight-state Great Lakes region after demoting the scientist who led the study, the Center for Public Integrity reported. The House Science and Technology committee last week complained to CDC director Julie Gerberding about the seven-month delay in issuing the report and vowed an investigation into “disturbing allegations about interference with the work of government scientists” at the CDC’s Agency for Toxic Substances and Disease Registry (ATSDR). The report, which warns that more than nine million people may face elevated health risks from exposure to dioxin, PCBs, pesticides, lead, mercury, or six other hazardous pollutants, was slated for release last July.

The study’s chief author was Christopher De Rosa, the director of ATSDR’s division of toxicology and environmental medicine and, according to the story, “a highly respected scientist with a strong international reputation from his 15 years in charge of the division.” Howard Frumkin, the chief of ATSDR, told him the Great Lakes study was “well below expectations” and removed him from his position. De Rosa is seeking reinstatement to his former position, claiming that Frumkin illegally retaliated against him. CDC officials refused to talk to the Center for Public Integrity.

In a separate incidident, the Food and Drug Administration should document all meetings between its staff and companies regulated by the agency, Sen. Charles Grassley (R-IA) said last week in the wake of an investigation that found the agency blindly accepted conflict of interest charges leveled by a private company against one of its scientists. The Center for Veterinary Medicine removed adverse events coordinator Victoria Hampshire from her position in January 2005 after top officials at a Wyeth Pharmaceutical subsidiary lodged the complaint. At the time, Hampshire was preparing to go before an advisory committee where she planned to oppose reintroduction of the company’s ProHeart 6 canine heartworm drug, which triggered severe allergic reactions in some dogs.

At a private meeting two months prior to her reassignment, company officials gave then-acting FDA Commissioner Lester Crawford and chief counsel Dan Troy numerous slides from a private investigator’s report that accused Hampshire of running a website that sold a competitor’s product. Grassley’s investigation found those allegations to be false. Moreover, the FDA’s Office of Internal Affairs used those documents, which Grassley called “rife with error” and easily refuted, to seek a criminal investigation of Hampshire. “Industry representatives ought to have a good working relationship with FDA,” he said, “but under no conditions should the scientific process be compromised by industry pressure.”

Meanwhile, whistleblower protection advocates are hoping the House and Senate will quickly reconcile and approve legislation that would protect scientists like De Rosa and Hampshire. Besides beefing up legal rights that have been largely eviscerated by the U.S. Court of Appeals for the Federal Circuit (it has rejected 179 of 180 whistleblower complaints), the House version would prevent federal agencies from retaliating against scientists who reveal when their superiors distort or suppress government science. The Bush administration has lobbied against both versions of the bill and threatened a veto.

Obesity Society Leader Backs Chains on Menu Labeling

The incoming president of obesity researchers’ professional society last month provided expert testimony in support of a New York State Restaurant Association’s lawsuit that seeks to overturn a city ordinance requiring calorie labeling on restaurant menus. David B. Allison, a professor of biostatistics at the University of Alabama at Birmingham and president-elect of the North American Association for the Study of Obesity (also known as The Obesity Society), claimed there is no credible evidence that “providing restaurant patrons with calorie information on menu items will reduce individual or population levels of obesity.”

That position was immediately blasted by a prominent researcher, who accused Allison of selective use of evidence. “Menu board labeling will increase the public's awareness of the quality of the foods they are consuming and will help them better manage their food choices,” said Simone French, a professor of community health at the University of Minnesota. She claimed Allison’s paid testimony ignored studies showing an association between excessive weight gain and fast food consumption. Allison, who becomes NAASO president in October, has a long history of financial ties to the food and drug industries. He has served as a consultant to Frito-Lay, Coca-Cola, Bayer, Pfizer and Amgen, and served on advisory boards for the Wheat Council, Kraft Food and Nabisco.

Groups Protest EPA Omission of Coal Toxicity Info

A coalition of environmental groups led by Earthjustice and joined by the Center for Science in the Public Interest last week lodged a formal complaint with the Environmental Protection Agency for publishing a notice seeking public comment on the toxicity of coal combustion wastes that failed to include the EPA’s own data showing the wastes are toxic and a risk to human health. The independent EPA report showed high rates of leaching of arsenic, selenium, and other heavy metals from landfills where the wastes produced by coal-fired power plants are stored. The groups say the wastes are often dumped illegally in open pits that risk contaminating local drinking water supplies. The notice “focus(ed) on an industry-driven, poorly prepared, misleading, inaccurate DOE/EPA report that paints a rosy picture of coal combustion waste management,” said Lisa Evans, a staff attorney for Earthjustice. “The omission (of the independent EPA report) is outrageous.”

Interior’s Chukchi Sea Review Excluded Major Facilities

While the Interior Department was auctioning off oil leases in the Arctic’s Chukchi Sea, Public Employees for Environmental Responsibility (PEER) last week released documents showing that the agency had excluded parts of company plans for the area from its legally required environmental review. Internal emails, leaked by scientists within the agency and published on PEER’s website, revealed that Shell Oil’s plans for its leases included building a major liquefied natural gas facility and establishing year-round tanker traffic, which agency scientists said would have “important environmental impacts.” The Environmental Impact Statement for the sale did not mention the facility or the tanker traffic. Conservation groups sued to obtain the formal release of the emails and other documents related to the sales, and to stop the execution of the leases until the department fully assesses their environmental impact. The first day of the sales last week brought in record bids from Shell and other oil companies.

Congressional Probe Targets Consulting Group

Representatives John Dingell (D-MI) and Bart Stupak (D-MI) announced that their ongoing investigation into the Environmental Protection Agency’s handling of toxic chemicals will include the role of the Weinberg Group, a consulting firm hired by numerous chemical producers. Last week the Energy and Commerce investigations subcommittee asked the firm for documents related to its involvement in the scientific debate over bisphenol A (BPA) and perfluorooctanoic acid (PFOA), a chemical component of Teflon. The letter cited a 2006 publication by a Weinberg consultant in Environmental Health Perspectives that discounted the link between BPA and disease, and a 2003 letter in which the Weinberg Group promises PFOA manufacturer DuPont de Nemours and Co.that it will “harness, focus, and involve the scientific and intellectual capital of our company with one goal in mind—creating the outcome our client desires.” The company also promised to reshape the debate “by identifying health benefits of PFOA,” and “constructing a study to establish...that PFOA is safe.” This “raise(s) serious questions about whether science is for sale at these consulting groups, and the effect this faulty science might have on the public health,” wrote Rep. Dingell.

Odds and Ends

David Schwartz officially resigned last week as head of the National Institute of Environmental Health Sciences ending a controversial three-year tenure that included a Congressional investigation into his providing expert testimony for law firms involved in asbestos litigation and a failed effort to privatize the agency's flagship journal, Environmental Health Perspectives. . . .The University of Texas business school is the latest academic institution to turn down tobacco industry donations; Altria the parent company of Philip Morris had offered to sponsor events on campus. . . . Merck agreed to pay $671 million to settle claims that it overcharged Medicaid programs for Vioxx and Zocor, and to resolve allegations that it paid improper inducements to doctors to prescribe the drugs. . . . GlaxoSmithKline had clinical trial data indicating its best-selling antidepressant Paxil elevated suicide risk as early as 1989, but covered it up by manipulating how the results were reported, according to the New Scientist (subscription required). The allegations were contained in an expert report prepared by Harvard psychiatrist Joseph Glenmullen, who reanalyzed the data for attorneys who have filed about 30 lawsuits linking the drug to suicides and suicide attempts.

Cheers and Jeers

  • Cheer to Stephanie Nano of USA Today for disclosing that a study showing that more patients survive heart attacks when a doctor uses a mini-vacuum to clear out artery blockages was paid for by Medtronic, the maker of the mini-vacuum used in the study.
  • Jeer: to Jacob Goldstein and Thomas M. Burton of the Wall Street Journal for failing to note that Eric D. Peterson, co-author of a Journal of the American Medical Association study warning patients against discontinuing use of Plavix, received honoraria and research support from the partnership between Bristol-Myers Squibb and Sanofi, makers of Plavix.
  • Cheer to Stephanie Saul of the New York Times for raising questions about the role of unlicensed physician and artificial heart inventor Robert Jarvik in promoting Lipitor, an anti-cholesterol medication. Congress launched an investigation into Pfizer's use of Jarvik in mid-January.