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Integrity in Science Watch

Week of 12/08/2008

Industry-Funded Study Drives Feedlot Exemption

The Environmental Protection Agency used an industry-funded study, which has been accused of faulty methodology to exempt large industrial animal livestock operations from hazardous waste reporting requirements under the Clean Air Act. It is one of many midnight rules under review at the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA). The exemption was based on information provided by the 2006 National Air Emission Monitoring Study (NAEMS), conducted at Purdue, Cornell, Iowa State and other universities, and overseen by EPA. The study was financially backed by the Agricultural Air Research Council (AARC), which is funded by the pork, chicken and dairy industries.

The EPA commissioned the study, which was designed to come up with new methods for measuring livestock air emissions, after a 2003 National Academy of Sciences report highlighted erroneous and incomplete information from previous procedures, according to a Purdue website. But a Government Accountability Office report released in September expressed doubts the new methodology generated by the 2006 industry-funded report and now in use by EPA will be effective. The Department of Agriculture's Air Quality Task Force told GAO that "the technologies used to collect emissions data were not functioning reliably."

In October at a House Energy and Commerce subcommittee meeting Rep. Diana DeGette (D-CO)called the EPA's proposed exemption a good example of "Alice in Wonderland thinking." The United Nations estimates that farm animals around the world generate 18 percent of the emissions that contribute to global warming. The final rule was sent to OMB on October 24.

Medical Centers Rush to Post Conflicts of Interest

Some of the nation's leading medical schools and centers will begin revealing the financial relationships of faculty members with industry in response to ongoing investigations by Sen. Charles Grassley (R-IA). The New York Times reported last week the Cleveland Clinic will post on its website a current directory of all its physicians, listing their educational and professional backgrounds, their medical specializations and their relationships with industry. Each physician and scientist will be required to list the names of companies with which they have collaborations, and will identify whether they have equity, the right to royalties, a fiduciary position or a consulting relationship that pays $5,000 or more annually, according to the clinic's website. Cleveland Clinic's Innovation Management and Conflict of Interest Committee will manage the process.

The University of Pennsylvania School of Medicine also announced last week it will begin launch of a website next spring where patients at its Penn Medicine complex and the public can search for the outside financial activities of its doctors and scientists. "When all of us are up there transparently, it may make us a little more responsible," Arthur H. Rubenstein, dean of the medical school and head of Penn Medicine, told the Philadelphia Inquirer. However, Mayo Clinic officials last week said they will not post researchers' industry ties online. An official for the clinic stated physicians are required to share conflict information with patients, and they are confident the policy works.

Pharma Cooks Their Books

A fifth of studies submitted to the Food and Drug Administration during 2001 and 2002 that led to 33 new drug approvals never appeared in the medical literature, a new study in Public Library of Science (PLoS) Medicine found. The results that did appear in the literature were usually the more positive ones, and in some of those cases, the published version of the trials left out important data that had been submitted to the FDA.

The "main thing that jumped out at me was the addition and deletion of primary outcomes," said Lisa Bero, a University of California, San Francisco health policy expert and co-author of the study. "Those are the most important outcomes of a trial. To find that one disappeared from a paper, or just appeared in a paper, is pretty amazing to me." The National Institutes of Health-funded study suggested that failure to publish all studies may be leading to incomplete data being used to promote drug sales.

Midnight Regs Rush Oil Shale Development

The Bush administration has finalized new regulations that would pave the way for extraction of oil shale on two million acres of public land in Utah, Colorado, and Wyoming, despite admissions by industry and other scientists that the technology is years away from viability. The regulation lifts a congressional moratorium imposed on the process on public lands, which was intended to allow industry to develop the technology on its private holdings. Environmentalists say that the process, which involves converting a waxy substance found in rock into synthetic crude oil, has extensive environmental impacts and is energy- and water-intensive. The Bureau of Land Management rule becomes effective on January 17, three days before the Obama administration takes office.

The move is part of a recent push on the part of industry and federal agencies to increase oil and gas development on federal lands in the Intermountain West, a move that biologists say is already impacting native wildlife. Also in Wyoming, the Bureau of Land Management (BLM) is moving forward with natural gas development that scientists say threatens rare sage grouse and native mule deer. Conservationists say that the BLM discounted research showing that the development has caused declines in wildlife populations, and relied instead on industry-funded research showing that development and wildlife are compatible. "The BLM gives equal weight to industry PR jocks and peer-reviewed scientists," said Rollin Sparrowe of the Theodore Roosevelt Conservation Society, who resigned from an advisory committee formed to advise the BLM on natural gas development in Wyoming.

....and Toss CWA Stream Protections

Also last week, the Bush Administration approved a new rule that will make it easier for mining companies to dump debris into streams and rivers. The rule comes in the wake of an EPA finding that dumping from mountaintop removal coal operations did not violate the Clean Water Act, a reversal from the agency's previous position. Studies by the agency's own scientists have shown that water tested downstream from mining debris dumping sites had high levels of hazardous chemicals and could kill wildlife.

In an effort to limit the ability of Congress to stop administrative public land decisions, the Bureau of Land Management issued a final rule late last week eliminating the authority of Congress to withdraw land from uses like mining, the New York Times reported. The rule was proposed in October, and the public was given 15 days to comment on the action.

Blood Doctor Sued (Again) for Speaking Out

University of Toronto hematologist Nancy Olivieri has been sued by Apotex, Inc. for allegedly breaching a settlement agreement that stated neither she nor the company would "disparage" one another. Olivieri has consistently spoken out about the need for scientific integrity in the wake of Apotex's decision to cancel Olivieri's role in a study of deferiprone, a drug manufactured by the company. Olivieri's research led to a 1995 study published in the New England Journal of Medicine that said deferiprone could lead to iron overload. Apotex is seeking an unspecified amount of damages for breach of contract, $500,000 in aggravated and punitive damages, and other relief.

Odds and Ends

An industry consortium says that "partial capture" of carbon dioxide emissions could allow for construction of new coal-fired power plants. The new research out of MIT's Carbon Sequestration Initiative, a consortium sponsored by Peabody Energy, Ford, ExxonMobil and others, says that technologies that allow for partial capture of carbon emissions could "get construction moving again" in the face of the EPA's freeze on construction of new plants that lack controls on the greenhouse gas. ... Science has conceded (subscription required) that several studies show that cell phone use may cause DNA breakage. The admission contrasts with a previous Science report that only two studies- both under investigation for possible fraud- showed a connection between cell phone use and DNA breakage. ... A panel of experts convened by the National Academy of Sciences concluded that the EPA needs to revise its risk assessment process, citing "decision-making gridlock" that has made some assessments, like the one for cancer-causing trichloroethylene, drag on for nearly three decades. The report recommends the first major reforms to the EPA's process for analyzing environmental and health risks of toxic substances in 25 years.