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January 16, 2007

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Integrity in Science Watch

Week of 01/16/2007

National Research Council Sinks OMB Risk Assessment

The National Research Council (NRC) last week dealt a blow to the Bush administration's war on science, calling a White House plan to overhaul how the government weighs new health and safety rules "fundamentally flawed." Officials at the White House's Office of Management and Budget, which unveiled the plan in a draft bulletin issued last January, immediately said the agency would modify its proposal. Risk Policy Report reported today that some Democrats and environmentalists fear that could mean parts of the draft bulletin could simply be implemented at individual agencies. At issue are analytical tools called "risk assessments" that the federal government uses to estimate the probability of harm from things such as chemical exposures or the failure of an engineered structure. The NRC, a branch of the National Academy of Sciences, said the White House should direct the federal agencies to develop their own technical guidelines for risk assessments rather than setting a one-size-fits-all guideline that the council found "too simplistic and restrictive."

The committee also took issue with many of the standards in the draft bulletin. The bulletin's definition of an adverse health effect was too narrow because it implies that only clinically apparent effects should be considered adverse, the panel noted. Public health goals would be better served by controlling exposures before they cause impairment, NRC said. "We began our review of the draft bulletin thinking we would only be recommending changes, but the more we dug into it, the more we realized that from a scientific and technical standpoint, it should be withdrawn altogether," said John F. Ahearne of the scientific research society Sigma Xi, who headed the NRC panel.

EPA 'Short List' for Clean Air Panel Includes Scientists With Industry Ties

At least three scientists with ties to industry have made it to the Environmental Protection Agency's "short list" of candidates for a scientific review panel that will advise the agency on air quality standards for nitrogen and sulfur oxides. On the short list for EPA's Clean Air Scientific Advisory Committee NOx and SOx Primary Review Panel is longtime industry consultant Roger McClellan, a former president of the Chemical Industry Institute of Toxicology, a research organization whose member companies include W.R. Grace, Chevron, Dow Chemicals, Dupont, ExxonMobil and Union Carbide. EPA's notice states that McClellan works for clients in the private sector, but does not provide further details. McClellan has actively spoken against tightening standards for soot particles, most recently in a CBS Evening News interview last month.

Also on the short list:

  • Richard Schlesinger of Pace University reviews toxicological studies on various fuels as a scientific adviser to the American Petroleum Institute, according to EPA's announcement. EPA has previously noted that Schlesinger has also received funding from the Electric Power Research Institute and the Health Effects Institute, the Boston-based non-profit jointly funded by the automobile industry and EPA.
  • Christian Seigneur is vice president of the Department of the Department of Air Quality Studies at Atmospheric and Environmental Research Inc., whose clients include the American Petroleum Institute, Electric Power Institute and Health Effects Institute.

The deadline for comments on the EPA panel is today.

UCLA Bans Drug Makers' Gifts to Docs

The University of California at Los Angeles will limit industry influence on patient care by prohibiting doctors from accepting gifts from pharmaceutical companies' sales representatives, according to university spokesman Dale Tate. The new guidelines, which were adopted by the School of Medicine's Faculty Executive Committee in November, would prohibit physicians from accepting small gifts like pens and notepads, as well as meals and payment for attending a meeting. The new policy also places stricter controls on free drug samples and requires pharmaceutical sales representatives to make appointments if they want to talk to doctors.

The move follows similar gift bans adopted at Stanford University, the University of Pennsylvania and Yale University. (Yale still allows free drug samples.) About 90 percent of the pharmaceutical industry's $21 billion marketing budget is directed at physicians, according to an article (subscription required) in the Journal of the American Medical Association.

Industry Funding and Research Outcomes Linked in Psychiatry Studies

A study in the November 2006 issue of the journal Psychological Medicine provides further evidence of a link between industry funding and the outcomes of medical research. The study, which examined articles in four peer-reviewed psychiatric journals from 1992 to 2002, found that favorable outcomes were significantly more common in studies funded by the drug manufacturer (78 percent) than in studies without industry sponsorship (48 percent) or with funding by a competitor (28 percent). The study also found that the percentage of studies funded by industry increased significantly within those 10 years, from one-quarter in 1992 to more than half in 2002.

ACOEM Mold Review Relied on Authors Paid to Testify in Mold Suits

The American College of Occupational and Environmental Medicine failed to disclose that its position paper on mold, which downplays the risks to human health from the minute fungi, was written by scientists who regularly testify as expert witnesses for defendants in mold lawsuits. According to an article in the Wall Street Journal (subscription required), two of the paper's three authors – Bryan Hardin and Bruce Kelman – are paid $375 to $500 an hour in their role as principals of the environmental risk management company Veritox Inc., a firm that regularly works for the defense in mold cases. The third author, Andrew Saxon of the University of California at Los Angeles School of Medicine, is paid $510 to $720 an hour for consulting and testifying in mold litigation.

Two other medical societies have issued position papers on mold written, in part, by legal defense experts. Last year, Integrity in Science Watch uncovered that the American Academy of Allergy, Asthma and Immunology's scientific review "The Medical Effects of Mold Exposure" failed to disclose that two physician-authors, including Saxon, were insurance company defense experts. The exposé led the association's journal to strengthen its disclosure requirements.

Trial Lawyers Backed Researcher Who Linked Autism to MMR Vaccine

The Times of London reported late last month that Andrew Wakefield, who in 1998 claimed to have found a link between the MMR vaccine and autism, received more than ₤400,000 from lawyers trying to prove the vaccines weren't safe. The legal aid fund distributed a total of ₤3.4 million to doctors and scientists who supported a lawsuit against vaccine manufacturers. According to the Times, Wakefield began working with the lawyers two years before he published an article in the British medical journal Lancet suggesting a link between autism and the measles, mumps and rubella shot.

NIH Finds Former Pitt Scientist Falsified Data on Embryonic Stem Cells

A postdoctoral fellow at the University of Pittsburgh is the latest scientist implicated in the South Korean stem-cell scandal. The National Institutes of Health found that Jong Hyuk Park, who worked in Gerald P. Schatten's laboratory from August 2004 through February 2006, fabricated two figures in a paper submitted to the journal Nature, then lied to his colleagues about the fabrication and attempted to cover it up, according to a Jan. 9 notice in the Federal Register. Park had previously worked in the laboratory of disgraced cloning scientist Hwang Woo-Suk; his boss Schatten was listed as a co-author of one of Hwang's fraudulent papers, although he later said he had done no work on the study.

Study Finds Ghost Authorship Common in Industry-Funded Studies

A study of 44 industry-sponsored drug trials in Denmark in the 1990s has found evidence of ghost authorship in three-quarters of the trials, suggesting such practices are widespread in industry-backed studies. The prevalence of ghost authorship increased to 91 percent when the authors included cases where a person qualifying for authorship was just listed in the acknowledgments. The researchers also noted that the study, which appeared yesterday in PLoS Medicine, may underestimate the frequency of ghost authorship. "It is likely that we have overlooked some ghost authors, as we had very limited information to identify the possible omission of other individuals who would have qualified as authors," they wrote.

Cheers and Jeers

  • Jeers: In the Jan. 2 Washington Post story "FDA proposal stresses caution on painkillers," reporter January Payne quotes Jack DiPalma, immediate past president of the American College of Gastroenterology, saying the occasional use of the painkillers is safe. Not disclosed was DiPalma's grants from Braintree Labs, which makes gastroenterological products that could be used to counteract the side effects of painkillers.
  • Jeers: Dr. Stanley Gall, identified only as a member of the American College of Obstetricians and Gynecologists by reporters Nikita Stewart and Rob Stein in the Jan. 10 Washington Post ("D.C. Bill Would Mandate Vaccine"), favored legislation making Merck's cervical cancer vaccine mandatory in the District of Columbia. The reporters did not disclose that Gall's research is funded by Merck and that he is a consultant and serves on the speakers bureau for Merck.
  • Jeers: In a Jan. 4 New York Times article, "Mother Wonders if Psychosis Drug Helped Kill Son," by Alex Berenson, S. Nassir Ghaemi criticizes Eli Lilly for having "downplayed the side effects" of Zyprexa. Ghaemi receives funding from competing bipolar drug manufacturers, GlaxoSmithKline and Abbott Laboratories. When queried about the failure to follow the Times'policy on disclosure, Business Day editor Mark Getzfred said that since Ghaemi also has financial ties to Eli Lilly, disclosing conflicts of interest was unnecessary.

Odds and Ends

The Centers for Disease Control's National Center for Environmental Health/Agency for Toxic Substances and Disease Registry is accepting nominations for a new Board of Scientific Counselors through Jan. 16, 2007. To submit nominations or for further information, contact Sandra Malcolm, Committee Management Specialist, at smalcolm@cdc.gov ... A Congressional Research Service (CRS) report on the closure of several libraries administered by the Environmental Protection agency reiterates serious concerns about the continued availability of the agency's collections during the restructuring process.