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September 18, 2006

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Integrity in Science Watch

Week of 09/18/2006

New Study Confirms Butadiene Cancer Link, But Creates Loophole

A new study that will be released Tuesday by the Health Effects Institute (HEI), the Boston-based non-profit jointly funded by the automobile industry and the Environmental Protection Agency, confirms that 1,3 butadiene, a major air pollutant from automobiles and chemical plants, causes leukemia and other cancers, but only at high exposures. Leukemia mortality among rubber workers in the study was 170 to 270 percent higher than unexposed groups. However, the HEI researcher, Elizabeth Delzell of the University of Alabama, who has also received funding from the International Institute of Synthetic Rubber Producers and the American Chemistry Council, is about to publish a related study that will claim that the workers who got cancer were the ones who were occasionally exposed to especially high doses of butadiene. A number of industry consultants are co-authors of the paper. If accepted by regulators, this "peak exposure" theory could be interpreted to mean that butadiene is not as dangerous as previously thought. The peak exposure theory is based on sophisticated modeling that assigned exposure values to various jobs held by workers as long as 30 years ago. No measurements were ever taken.

The HEI synopsis of the report, which reflects the views of its peer reviewers, left the door open for accepting the "peak exposure" theory. While the synopsis does say that butadiene exposure estimates in the study "may be too high," and the cancer risks identified in the study "could actually be associated with lower measured concentrations of exposure," it goes on to say that if the forthcoming study from Delzell and the industry consultants "confirms that (exposure) estimates from the current investigation are accurate, this study will provide a firm basis" for assessing risk. That would eliminate the need for chemical plants to engage in further clean ups under the EPA's so-called residual risk rules; it also could affect future automobile emission rules. A residual risk rule now under consideration at the EPA has "do nothing" as one option for chemical plants that produce butadiene and routinely emit small amounts into the atmosphere.

Groups Protest Nomination of Industry Sympathizer to Top OMB Position

The Bush-appointed nominee to head the Office of Information and Regulatory Affairs, an arm of the Office of Management and Budget, has drawn sharp criticism from environmental and health advocacy groups. A report released last week by Public Citizen and OMB Watch said Susan Dudley's "ideological opposition to regulation, support for radical policies that would impair public safeguards and ties to industry" made her unfit to manage the highly influential regulations department, which has the power to weaken, delay, or eliminate public health measures. As past director of regulatory studies at the industry-funded Mercatus Center at George Mason University, Dudley opposed the EPA's attempts to strengthen policies regulating arsenic in drinking water and levels of smog. "Dudley is little more than an industry factotum," said Gary D. Bass, OMB Watch executive director. "Not since OIRA was created in 1980 has there been a less appropriate nominee."

FDA Finally Ousts Advisor Over Conflict of Interest, But Only After A Company Protests

The Food and Drug Administration booted a physician from its Anti-Infective Advisory Committee last week after receiving a complaint about his conflicts of interest from the company whose drug was about to come before the panel. Dr. Thomas Fleming, a long-time member of numerous FDA advisory panels, in 2002-3 reviewed studies on the antibiotic Factive for Oscient Pharmaceuticals' predecessor firm. He subsequently questioned the company's use of non-inferiority trials, which had been used in the initial approval of Factive. The company then protested his presence on a new committee looking into the company's request to expand the use of the drug, which also relied on a non-inferiority trial. The FDA denied him a conflict-of-interest waiver and he was not permitted to serve. (In a non-inferiority trial, the drug is compared to an already approved drug rather than a placebo. Since many antibiotics are only marginally better than placebo, critics - including several FDA examiners - believe that the statistical margins of error in antibiotic non-inferiority trials can lead to approving drugs that may not be effective.)

According to a report in the Wall Street Journal, FDA officials said their refusal to grant Fleming a waiver was unrelated to Oscient's complaint or his concerns about non-inferiority trials. The FDA let stand waivers granted to Peter Gross, a professor of medicine at the University of Medicine and Dentistry of New Jersey, and John Bradley of Children's Hospital in San Diego. Both waivers were for consulting with competitor firms. Fleming told the Journal that he is concerned that the integrity of the advisory committee process "would be significantly compromised if there is a possibility that a company could intervene in the committee-making process." The flap had no bearing on the ultimate vote, since the full panel voted 11-2 against Oscient's application to use Factive for sinusitis. The FDA usually follows the advice of its advisory committees.

NIH Passes Buck on Conflict-of-Interest Cases

The second-ranking official at the National Institutes of Health last week told a House subcommittee that only "minimal" disciplinary actions had been taken against employees who broke conflict of interest rules to consult with industry. The excuse? Technically, the high-ranking employees were members of the Public Health Service, a quasi-military corps within the Department of Health and Human Services. The "NIH concluded that the facts [warranted] referral to the corps, which has independent authority to determine the most appropriate level of discipline for its commissioned officers," said Raynard Kington, deputy director of NIH. He also revealed that Trey Sunderland, chief of the geriatric psychiatry branch at the National Institute of Mental Health, and Thomas J. Walsh, a top officer at the pediatric oncology unit of the National Cancer Institute, had not yet been punished for receiving hundreds of thousands of dollars as consultants for drug companies while on the government payroll. John Agwunobi, Assistant Secretary for Health for the Department of Health and Human Services for the Public Health Service, refused to discuss displinary cases that were still underway. The HHS Office of the Inspector General also came in for criticism during the hearing for failing to investigate conflicts of interest at NIH.

Harvard Prof Cleared of Ethics Violations Gave Major Gift to Dental School

It turns out that Dr. Chester Douglass, who last month was cleared of violating Harvard Medical School ethics rules after misrepresenting a graduate student's research linking water fluoridation to cancer in young boys, gave $1 million to the university in 2001 for its new $22 million dental research facility, which was completed in 2004, the Harvard Crimson reports. According to the Environmental Working Group, a number of Harvard alums involved in public health have asked interim president Derek Bok, who recently authored University in the Marketplace: the Commercialization of Higher Education,to release the details of its investigation into Douglass, who consults for Colgate-Palmolive Co. and edits its publication, "The Oral Care Report." A Harvard spokesman said the university has turned the results over to the federal Office of Research Integrity, which found no further cause to investigate.

Odds and Ends

A new Government Accountability Office report released by Rep. Henry Waxman shows that corporations and industry trade groups filed more than half the Data Quality Act challenges in 2003-04. Nearly half resulted in groups appealing agency decisions, and some complaints took up to two years to resolve . . . The Consumer Federation of America's annual National Food Policy Conference held in Washington last week included several Center for Science in the Public Interest staffers and top government officials as unpaid speakers. The conference's costs were partially underwritten by major food corporations and trade groups such as Food Products Association, Mars, Inc., the National Yogurt Association, and Safeway.


In last week's item, "EPA Committee Will Debate Best Ways To Monetize Human Life," the University of Maryland professor who chaired the committee is Maureen Cropper, not Maurice Cropper. We apologize for the error.