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January 2, 2008

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Integrity in Science Watch

Week of 01/02/2008

Waxman Investigates EPA Denial of Clean Air Waiver

House Oversight and Government Reform Committee Chairman Henry Waxman (D-CA) will investigate the EPA's rejection of a tough California rule restricting greenhouse gas emissions from automobiles. In a letter to EPA administrator Stephen Johnson, Waxman said the agency's action ignored the law, science, and common sense. The agency announced last month that California's request for a waiver under the Clean Air Act was unnecessary because the new energy bill represented a "clear national solution."

California filed the request for a waiver in December of 2005, citing the failure of the federal government to regulate automobile greenhouse gas emissions and the "serious and well-recognized" harms associated with climate change. California, long recognized as a leader among the states in adopting regulations tougher than national standards, has filed 53 Clean Air Act Waiver requests since 1967. This was the first denied by the EPA. EPA legal and technical staff unanimously advised Johnson to grant the waiver, and warned that its denial would result in loss of any ensuing lawsuits. Agency staff also told the Los Angeles Times that Johnson made his decision after auto executives met with vice president Dick Cheney last month and a Chrysler executive wrote to the White House outlining why California's request should be denied. The EPA said it would comply with Waxman's request and turn over all communications related to the denial.

Shrinks with Rx Ties Again Dominate DSM Writing Panel

More than two-thirds of the American Psychiatric Association task force charged with revising the influential Diagnostic and Statistical Manual of Mental Disorders (DSM) have financial ties to the pharmaceutical industry, and several members of the 27-member body failed to disclose significant elements of their dealings with industry when the panel was announced last July, according to a story in U.S. News and World Report. For instance, task force chair David Kupfer of the University of Pittsburgh School of Medicine reported payments from two small companies that provide continuing medical education, but not the fact that those firms got their funding from Forrest Pharmaceuticals and Pfizer.

APA medical director James Scully pledged full disclosure for the 150-plus psychiatrists who will be named later this year to the panels that will construct the next DSM, which is due in 2012. But he rejected a call by some members of the group to exclude anyone with ties to the drug industry. An analysis of the last DSM found that 56 percent of the 126 panelists had ties to drug companies.

EPA Allows Use of Ozone-Destroying Chemical

The EPA will allow continued U.S. use of methyl bromide, an agricultural fumigant that is being phased out worldwide because it depletes the stratospheric ozone layer. The chemical is used to sterilize soil and eliminate pests prior to planting crops such as strawberries and tomatoes. Its use has been restricted since the 1987 passage of the Montreal Protocol on Substances that Deplete the Ozone Layer. The United Nations in 1994 determined that ending use of methyl bromide was the most significant action nations could take to protect the ozone layer, and signatories to the Protocol agreed to end all use of the chemical by 2005. The Bush Administration has increasingly pushed for critical use exemptions citing economic concerns, which have been allowed since 1997. The treaty initially limited such exemptions to national security or medical needs when there was no alternative.

Despite the successes of the Montreal Protocol, which has resulted in an 88 percent reduction in methyl bromide use below 1991 levels, scientists with NASA and NOAA say the Antarctic ozone hole broke records for area and depth in 2006. The Pesticide Action Network of North America is pushing for a total ban on all fumigant pesticides, which include methyl bromide, metam sodium, dazomet, 1,3-dichloropropene (Telone), chloropicrin, and methyl iodide, calling them "the most toxic chemicals used in agriculture."

UMass Med School Tightens Conflict of Interest Rules

The teaching hospital affiliated with the University of Massachusetts in Worcester has adopted strict conflict of interest rules limiting physician interaction with drug and device manufacturers, the Boston Globe reported. The new rules prohibit doctors from joining speakers bureaus that promote individual products or accepting meals or gifts from company salespersons. Corporate contributions to continuing medical education can continue under the new rules, but the money must go into a central fund rather than to individual departments or physician-trainers. And while physicians on faculty can still sign lucrative consulting deals with companies, such consultants will no longer be able to sit on the hospital's formulary and supply purchasing committees. "You don't want to chase drug company money out of the system completely," said David Rothman, whose Center on Medicine as a Profession at Columbia University is pushing for tighter conflict-of-interest rules at academic medical centers. "Drug companies are not tobacco companies. We all need them."

Former CPSC Staffer Blows Whistle on Agency Failings

The Consumer Product Safety Commission cannot be trusted to ensure the safety of the products it regulates, a former agency employee claimed in the Washington Post. According to Robin Ingle, who worked for the CPSC from 1998 to 2006, the agency has repeatedly bowed to pressures from industry and failed to place tighter restrictions on dangerous products or to release scientific reports detailing those dangers. The release of a report showing a rise in All-Terrain Vehicle (ATV) deaths in 2003 was delayed for several months during which the agency's general counsel, a former attorney for the ATV industry, tried to force staff to insert language saying that the risk of riding ATVs was decreasing. The agency has also refused to require manufacturers of portable generators and drain cleaners to incorporate safety features, because doing so would have raised the cost and was objected to by manufacturers. "This pattern of suppressing scientific research [was] the agency's standard operating procedure," Ingle said. "The agency should listen to its own scientists and stop silencing the life-saving research happening in its buildings."

Zetia Risks Concealed by Manufacturer

Merck and Schering-Plough have failed to publish the results of studies showing their popular cholesterol-lowering drug Zetia may cause liver damage, the New York Times reported. Documents posted on the Food and Drug Administration's website suggested that unpublished company studies reveal a risk of serious liver damage among patients who take the drug along with a statin such as Lipitor or Zocor, which is how doctors usually prescribe Zetia. The manufacturers are already under scrutiny for failing to report the results of another Zetia study, known as Enhance, from which some patients were dropped because they showed elevated liver enzymes. Merck and Schering are on track to earn more than $5 billion this year from sales of Zetia, despite a lack of evidence that the drug actually lowers risk of heart attacks and strokes through its cholesterol-lowering action.

Odds and Ends

Hwang Woo-Suk, the Korean stem cell researcher who falsified research, requested government permission to resume his research on cloning studies using human eggs. Last year Hwang was stripped of his license and fired from Seoul National University for alleged embezzlement, accepting funds under false pretenses, and illegally purchasing human eggs for research. . . . President Bush nominated Stanley Suboleski, a former executive and current consultant with Massey Energy, as assistant secretary for fossil energy. Massey, one of the nation's largest coal producers, faces $2.4 billion in federal fines for more than 4,000 alleged environmental violations in West Virginia and Kentucky.