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January 21, 2009

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Integrity in Science Watch

Week of 01/21/2009

NSF, Big Coal Big R&D Winners

The National Science Foundation and government-funded carbon mitigation programs would get huge increases in research spending from the $825 billion stimulus program unveiled in Washington on Friday. The NSF-funded research, currently at $6 billion annually, would get an additional $3 billion over the next two years, according to the plan. Carbon capture and sequestration research will get an additional $2.4 billion in funding.

"Clean coal," which has been the target of a heated advertising campaign by environmental groups in recent weeks, would receive a bigger increase than all renewable energy research combined, which would receive just $2 billion over the next two years in the program. However, the full $825 billion American Recovery and Reinvestment Act ($550 billion in spending; $275 billion in tax cuts) would spend $4.5 billion on upgrading the electricity grid and would make large investments in alternative energy installations, which should trigger greater private sector investment in alternative energy sources like wind and solar.

On the biomedical side, the $30 billion National Institutes of Health would get only $1.5 billion over the next two years from the stimulus package. Instead, the program would make a major down payment on creating an authoritative comparative effectiveness research agency, which is designed to inform medical decision makers about what works best in health care. The $1.1 billion recommendation for comparative effectiveness research would send $400 million to the Health and Human Services department for studies at agencies like the Center for Medicare and Medicaid Services; $400 million to NIH; and $300 million to the Agency for Healthcare Research and Quality, which previously housed a minor research program on comparative effectiveness. Sidestepping controversies surrounding industry participation in the program's management, the bill would set up an all-government coordinating council, and would give the Institute of Medicine $1.5 million to develop a list of research priorities by June.

Analysts cautioned the first Obama administration budget, due out in early February, could redraw the priorities. But for now, hard sciences, traditional DOE research programs and competitiveness initiatives (the manufacturing-oriented National Institute for Standards and Technology would receive a 2-year $520 million shot-in-the-arm for its annual $700 million budget) appear to be the big percentage winners. "Although NSF only funds about 20 percent of its proposals, you have to wonder if the agency really has that many good proposals lying around," said Kei Koizumi, who tracks R&D policy for the American Association for the Advancement of Science.

Biz-Backed Free Market Groups Promote DDT

The authors of a new report claiming European Union pesticide regulations will retard efforts to combat malaria are affiliated with an industry-funded group whose previous forays into public policy included denying global warming, combating efforts to curb smoking, and promoting expansion of genetically-modified crops to alleviate world hunger. The two editors of "The EU's Nasty Bite," Phillip Stevens and Caroline Boin, are affiliated with the International Policy Network (IPN), a London-based group that argues for free market solutions to environmental and health problems. The report claims that the EU's proposed Thematic Strategy for Pesticides would ban pesticides like DDT that are also used to control vector-borne diseases such as malaria. The EU plan was designed to strengthen controls over harmful pesticides used in crop production.

Conservative-leaning think tanks like IPN have waged a multi-year campaign to promote renewed use of DDT to kill malarial mosquitoes. Other groups pushing the pesticide include the Institute of Economic Affairs and the Competitive Enterprise Institute. The three groups have personnel in common and share an ideological opposition to environmental and health-motivated restrictions on corporate activity. These groups have undertaken extensive efforts, many of them funded by tobacco giant Phillip Morris, to link Silent Spring author Rachel Carson to malarial deaths. While DDT is still used in parts of the developing world for indoor spraying to control household mosquitoes, its efficacy is limited in many regions due to mosquitoes developing resistance. Recent research also points to significant increased risks of breast cancer from exposure to DDT.

The IPN has received funding from ExxonMobil, Eli Lilly, and other corporate donors. Contributing authors to the group's latest pro-DDT report include Richard Tren, director of Africa Fighting Malaria, who previously authored a 2002 paper entitled "Who's Afraid of Climate Change?" for IPN; Professor Sir Colin Berry, who has received significant research funding from Medtronic;David Zaruk, who is currently with Cefic, the European chemical industry council, and has worked in advocacy and communications for the chemical industry since 1995; Sir Richard Feachem, who leads the ExxonMobil-funded Global Health Group at UC Berkeley; and Professor Paul Reiter, who called the IPCC's Fourth Assessment Report (2007) on climate change a "polemic." Reiter is affiliated with the Competitive Enterprise Institute and the Annapolis Center for Science-Based Public Policy, which has received $763,500 in funding from ExxonMobil.

EPA Issues Weak C8 Water Advisory

On the eve of leaving office, the Bush administration released a watered down health advisory for drinking water tainted by the toxic chemical C8, the Charleston Gazette reported last week. The chemical, which is used to produce nonstick products like Teflon, endangers health, but regulators have not set a binding federal limit for emissions or human exposure, according to the article. Dupont, the company that makes the chemical, submitted research conducted in 1997 to the Environmental Protection Agency revealing the chemical to be "extremely toxic" to animals.

In 2002, DuPont agreed to provide residents with bottled water or install water treatment equipment when the level of C8 in drinking water exceeded .5 parts per billion. The EPA's new plan recommends residents use bottled water only if C8 levels exceed 0.4 parts per billion. That restriction is ten times higher than the standard recently adopted in New Jersey under EPA administrator designate Lisa Jackson, the story said.

Device Maker Sues Whistleblower for Slander

Peter Wilmshurst, a cardiologist with the Royal Shrewsbury Hospital in the United Kingdom, was sued for slander over claims that NMT Medical, a manufacturer of a device meant to close congenital holes in the heart, withheld trial data because the data might "undercut sales," the New York Times reported. Wilmshurst claimed that the company failed to provide him with diagnostic tests that might have proved his contention that the device frequently failed to seal off blood flow within the heart, according to the article. The company disputed the claim, saying Wilmshurst turned on it because the trial's failure undermined his theory of a link between individuals with congenital heart openings and migraine headaches.

In 2003, Wilmshurst was given an award by the UK-based charity HealthWatch for his 20 years work exposing research misconduct. In his acceptance speech, he explained that "institutions and journals trust researchers not to fall prey to the temptation" of dishonesty. "We need to put in place robust checks on research," he said. The organization is now raising funds to cover his legal defense against the NMT Medical slander suit.

Meanwhile, in other medical device news, Sen. Charles Grassley's ongoing conflict of interest investigation revealed that spine surgeon Thomas Zdeblick failed to tell the University of Wisconsin about an estimated $19 million he received from Medtronic over five years for designing and promoting the firm's spinal products. Robert Golden, dean of University of Wisconsin's medical school, told the Wall Street Journal that the school's disclosure requirements were "indefensible" and would be toughened.

FDA Lit Rule Promotes Off-Label Drug Use

In another midnight action by the Bush administration, the Food and Drug Administration last week issued a final guidance allowing medical sales personnel to distribute peer-reviewed scientific literature to physicians that promotes the off-label use of drugs and devices. The only limitation in the guidance was that the studies must be based on "well-controlled" clinical studies, which wasn't carefully defined. The guidance said that allowable studies included "historically controlled studies, pharmacokinetic and pharmacodynamic studies, and meta-analyses if they are testing a specific clinical hypothesis." Marketing studies, sometimes called seeding trials because they are designed to encourage investigators to use the drug or device, could be distributed under the guidance as long as the peer-reviewed journal had a conflict-of-interest disclosure policy. Consumer groups, including the Center for Science in the Public Interest's Integrity in Science project, unsuccessfully opposed the proposed guidance.

Meanwhile, Eli Lilly agreed to settle a Justice Department suit alleging the company illegally promoted the anti-psychotic drug Zyprexa for use among children and the elderly. The charges in the suit included allegations that company sales representatives improperly distributed medical journal articles that promoted the off-label uses. A new study appearing in last week's New England Journal Medicine revealed that Zyprexa and other anti-psychotics that are routinely prescribed off-label double patients' risk of dying from sudden heart failure.

Palin Sues to Block Whale Protections

Alaska Gov. Sarah Palin said her administration will sue to block Endangered Species Act protection for a population of beluga whales in Cook Inlet, a saltwater channel running from Anchorage to the Gulf of Alaska. The National Oceanic and Atmospheric Association announced last October that the population, which numbered as high as 1,300 in the 1970s but has plummeted to just 375 animals in recent years, was in danger of extinction and would be listed as endangered. Palin's administration says that the endangered listing, which would require federal agencies to consult with NOAA scientists before issuing permits for commercial activity that may disturb the whales, would disrupt business activity including offshore oil and gas operations in Cook Inlet.

Odds and Ends

New Jersey environmental chief Lisa Jackson, President-elect Obama's pick to head the EPA, vowed to base agency decisions on science, not politics, in a confirmation hearing before the Senate Committee on Environment and Public Works. ... Jane Lubchenko, President-elect Obama's pick to head the National Oceanic and Atmospheric Association, called for a renewed commitment to science that recognizes "the extent of human domination of the planet." ... RAND Health, a division of the RAND Corp., unveiled a health care reform website called COMPARE to "help public and private decision makers systematically assess and compare the effects of different (proposed) policies." The initiative is funded by insurance, drug, medical supply and health service companies.

Cheers and Jeers

  • Jeer to Steve Sternberg of USA Today for failing to disclose that ,b>Paul Ridker of Brigham and Women's Hospital in Boston has received funding from a number drug companies including AstraZeneca, Merck, Novartis, and Schering-Plough, who manufacture statin drugs, and he holds a patent on testing patients for C-reactive protein. Ridker was the lead author of the AstraZeneca-funded JUPITER study, which found statins benefit people with elevated CRP levels.

  • Cheer to Ken Ward, Jr. of the Charleston Gazette for uncovering the Environmental Protection Agency's proposed rule for the chemical C8 (see story above).