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December 17, 2007

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Integrity in Science Watch

Week of 12/17/2007

Officials Deny Cancer-Environment Link in Pa.

State and federal officials are backpedaling from the conclusions of an abstract released last Monday that points to environmental causes for the cancer cluster near a former Superfund site in eastern Pennsylvania's anthracite coal region. The abstract, the result of a study conducted by the federal Agency for Toxic Substances and Disease Registry (ATSDR) and other authors, stated that there was "significant evidence for an association" between pollutants and the 131 cases of polycythemia vera – a rare blood cancer that causes heart attack and stroke – within 13 miles of the McAdoo Associates Superfund site in Schuylkill County. Officials with ATSDR and the Pennsylvania Department of Health said the results were premature and should not have been released to the public.

The study's lead researcher, Ronald Hoffman of the Mount Sinai School of Medicine in New York, stands by the abstract's conclusions, saying that the data indicate a likely environmental cause for the disease. The conclusion is an abrupt departure from the ATSDR's claims at a public meeting in October that environmental factors had no role in the unusually large number of cases of the disease in the county. Residents claim the former toxic waste dumping site was never properly cleaned up, though it was deleted from Superfund status in 2001.

House Investigates Slow-Release Drug Study

The investigations subcommittee of the House Energy and Commerce Committee last week gave Schering-Plough and Merck until Christmas to turn over documents from a clinical trial involving the cholesterol-lowering drug Zetia. The New York Times reported last month that the companies had failed to meet last spring's release date for a trial that compared the efficacy of a combination of Zetia and Zocor to Zocor alone. The companies then missed a fall deadline and said they wouldn't release the data from the 720-person Enhance trial until next spring. They also wanted to change the trial's clinical endpoint, which drew heavy criticism from cardiologists who prescribe the drug. The companies backed off that decision last week and reinstated the original protocols of the trial, according to The Wall Street Journal.

The letter, signed by chairman John Dingell (D-MI) and investigations subcommittee chairman Bart Stupak (D-MI), wanted to know why the clinical trial wasn’t registered in the government's database until 18 months after its completion. Until the recently enacted Food and Drug Administration reform law required registration of most clinical trials prior to their start-up, registration was voluntary. Zetia, whose generic name is ezetimibe, was approved by the Food and Drug Administration in 2002 because it lowered bad (LDL) cholesterol. But, unlike statin drugs, it has never been tested in a clinical trial to show that it actually decreases mortality from heart attacks and strokes. Even the Enhance trial will only measure the drug's impact on arterial plaque, not if it reduces deaths from heart disease. The drug is sold primarily as part of Vytorin, a pill combining Zetia and Zocor (simvastatin) that has captured 20 percent of the cholesterol-lowering drug market.

Meanwhile, on the eve of last week's FDA advisory committee meeting considering allowing the over-the-counter sale of a low-dose version of Merck's original statin, Mevacor (lovastatin), the non-profit National Consumers League released a Merck-funded study showing 82 percent of 710 adults surveyed preferred OTC statins to requiring prescriptions. The FDA staff analysis of the Merck application, meanwhile, showed that of the third of "customers" in a simulated marketing trial who thought an OTC statin was right for them, 84 percent made the wrong decision based on government guidelines for appropriate statin use, which many physicians consider overly permissive. Among the two-thirds who decided OTC statins weren't for them, 98 percent made the right decision. The advisory committee for the third time in seven years voted 10-2 against allowing the sale of OTC statins. One of the votes in favor was cast by Columbia University's Thomas Pickering, a consultant for a Merck competitor.

Company Data Shows High Atrazine Levels in Streams

The weedkiller atrazine has been found in Midwestern rivers and streams at levels that could harm fish and wildlife, according to monitoring performed by the chemical's manufacturer Syngenta and scientific experts who commented on the findings. The data, which have not been released to the public but were obtained by the Natural Resources News Service from the EPA, indicate that the levels of the endocrine disruptor were well beyond the levels that cause behavioral and reproductive abnormalities in frogs and fish, according to Nancy Golden, a Fish and Wildlife Service biologist. The company said it would release the data to any researcher who promises to hide its confidential business information from potential competitors. The EPA decided to renew its approval for atrazine in 2006 after concluding in a report that "there is a reasonable certainty that no harm will result to the general U.S. population" from exposure, although the agency concluded that the chemical may have some impacts on amphibians.

Meanwhile, the EPA is calling for comments on its Draft Policies and Procedures for the Endocrine Disruptor Screening Program, which will set guidelines for testing chemicals like atrazine. The European Union labeled atrazine an endocrine disruptor and banned its use in 2005. The EPA has allowed its continued use, citing the absence of a standard test for measuring the hormone-disrupting effects of chemicals.

Report: White House Manipulated Climate Science

A new report from Rep. Henry Waxman (D-CA) documents extensive political interference in government climate change science by the Bush Administration. The report concluded a 16-month investigation by Waxman's House Oversight and Government Reform Committee, in which the committee obtained documents from the White House Council on Environmental Quality (CEQ) and the Commerce Department that revealed systematic efforts to control media access to government climate change scientists, alter Congressional testimony on climate change, and edit climate change reports drafted by government scientists. "The Bush Administration has acted as if the oil industry's communications plan were its mission statement," says the committee's website of the report's findings.

Meanwhile, the Interior Department's Office of the Inspector General (OIG) announced that it will investigate fourteen endangered species decisions that were inappropriately influenced by former Deputy Assistant Secretary Julie MacDonald. The investigation, prompted by a request from Senator Ron Wyden (D-OR), will address the agency's failure to protect the greater sage grouse and other species not included in the Fish and Wildlife Service's recent reversal of seven decisions influenced by MacDonald. An earlier OIG report prompted MacDonald's resignation from the agency.

Profit-Driven Researchers Spurn Working with Government Scientists

Nearly 700 companies, most of them new start-ups, are renting space in university laboratories to develop nanotechnology-driven businesses, the Associated Press reported. Thirteen universities in the National Nanotechnology Infrastructure Network provide the space by divvying up $14 million a year in grants from the government's National Science Foundation, which launched the program in 2004. The businesses, which are usually run by professors seeking to commercialize their government-funded inventions, prefer to rent space in university-run labs rather than collaborate with the five national labs, which carry out the $1.4 billion federal nanotechnology research program, the report noted. An NSF official said they avoid the federal labs because they "require collaboration with Department of Energy researchers." Universities involved in the program include Harvard, Stanford, Georgia Institute of Technology, Howard, Penn State, and the universities of California, Michigan, Minnesota, New Mexico, Texas and Washington.

Odds and Ends

The investigations subcommittee of the House Energy and Commerce Committee launched an investigation into the Food and Drug Administration's oversight of Institutional Review Boards' ability to protect human subjects in clinical trials. The immediate focus of a letter to commissioner Andrew von Eschenbach were two biofeedback devices, at least one of which is under FDA scrutiny as harmful. . . . A new study in Science last week shows that the practice of salmon farming may be threatening wild salmon with extinction by exposing them to parasitic sea lice. The aquaculture industry and the National Oceanic and Atmospheric Association's Marine Fisheries Service have discounted the study's conclusions as inaccurate, although they did not cite any other studies on which they based that contention. . . . Seeking to jump on the open-access bandwagon, the for-profit Bentham Science Publishers Ltd. has launched over 200 freely available, peer-reviewed, online journals over the past year. The company hopes to support the website with online advertising. . . . The National Institutes of Health is considering an overhaul of its peer review process, including shortening grant applications to seven pages from the current 25 pages and recommending an "editorial board" model that would refer some grant proposals to outside experts, Science magazine reports. . . . The California Institute of Regenerative Medicine rejected applications from 10 stem cell research groups because they came from institutions with officials on CIRM's board; several board members wrote letters of support for applicants from their own institutions.

Note: The next issue of Integrity in Science Watch will appear on January 2, 2008. We wish all of our readers a happy and safe holiday season.