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June 30, 2008

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Integrity in Science Watch

Week of 06/30/2008

White House Editing EPA Report Touting Greenhouse Gas Limits

The Bush administration is pressuring the Environmental Protection Agency to rewrite a report that offers a roadmap and cost justification for using the Clean Air Act to limit carbon emissions, the Wall Street Journal reported today. The White House’s Office of Management and Budget wants the report to say that controlling green house gases will require a whole new law, even though the Supreme Court ruled in 2007 that carbon dioxide is a pollutant subject to EPA regulation. The original draft of the report, which must pass OMB scrutiny before it can be published, also claimed that reducing carbon emissions will give the economy a $2 trillion boost. The report was due out June 23. The edited version could be released later this week, the Journal article said.

Meanwhile, the House Select Committee on Energy Independence and Global Warming released documents showing that the White House refused to open an e-mail from the Environmental Protection Agency last December that concluded that greenhouse gases are pollutants. The e-mail was the EPA’s response to a 2007 Supreme Court ruling requiring the agency to evaluate greenhouse gases’ effects on health and the environment. The White House Office of Management and Budget left the message unopened, and ten days later the White House denied California’s request to regulate auto tailpipe emissions. “This administration has shown its contempt for Congress, its contempt for the rule of law, and . . . its contempt for science,” said Rep. Edward Markey (D-MA), the committee chairman.

Leading Climate Scientist Renews Call to Action

James Hansen of the National Aeronautic and Space Administration told a House panel investigating global warming last week that the changes needed to avert catastrophic impacts of climate change have been blocked by special interests “who hold sway in Washington and other capitals.” The climatologist, who directs the NASA Goddard Institute for Space Studies in New York, first called attention to man’s contribution to global warming in 1988. Hansen, who will give a keynote address at the July 11 Integrity in Science conference in Washington, said that the lack of action to curtail greenhouse gas emissions constituted “high crimes against humanity and nature” and that the CEOs of coal and oil companies should face prosecution. “We have used up all slack in the schedule for actions needed to defuse the global warming time-bomb,” Hansen said.

Undisclosed Industry Pay to Docs under Fire – I

Stanford University is the latest target of a Senate investigation of conflicts of interest within the scientific research community. Lead by Sen. Charles Grassley (R-IA), the investigation last week accused Stanford of failing to sufficiently monitor the corporate ties of Alan Schatzberg, the university’s chair of the department of psychiatry. Schatzberg owned $6 million in stock of Corcept Therapeutics, maker of the abortion drug, miferpristone. He failed to disclose to the university the scale of his investment while overseeing a National Institute of Health-funded study of the drug. Because Schatzberg disclosed his relationship with Corcept Therapeutics at speeches and in research articles, he is not the target of the investigation. Rather, Grassley is focusing on Stanford’s failure to adequately monitor Schatzberg and other faculty’s conflicts of interest. Although Stanford’s disclosure policy requires faculty to report stock valued at more than $100,000, it does not require the disclosure of the exact value of the stock. "Obviously, $6 million is a dramatically higher number than $100,000 and I am concerned that Stanford may not have been able to adequately monitor the degree of Dr. Schatzberg's conflicts of interest with its current disclosure policies," Sen. Grassley wrote in a letter to the university’s president, John Hennessy.

Stanford is the latest in a string of universities to come under Grassley’s scrutiny. According to Science magazine, the senator is investigating 30 individuals at 20 universities for breaking federal conflict-of-interest reporting rules. Current regulations require researchers using NIH funding to notify their institutions of income over $10,000 or more a year, or five percent ownership in a company that could be impacted by government-funded research. If researchers at institutions have failed to meet regulations, their institutions could face fines or suspensions of NIH funding, according to NIH officials.

Undisclosed Industry Pay to Docs under Fire – II

The pharmaceutical industry routinely taps well-paid and highly respected doctors to act as sales people for their medications, according to an investigation published in the British Medical Journal last week. The drug industry consciously seeks out "key opinion leaders" (KOLs) among academic physicians to promote sales of individual products with company-dictated presentations to other physicians, according to Ray Moynihan, an Australian journalist and visiting editor of BMJ. “Key opinion leaders were salespeople for us, and we would routinely measure the return on our investment, by tracking prescriptions before and after their presentations,” said Kimberly Elliott, a drug sales representative for nearly 20 years in the United States who has since left the industry. “If that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back." A typical KOL could earn as much as $25,000 a year, the article said.

Survey Shows Americans Support Doctor Disclosure

Most Americans support disclosure of physicians' conflicts of interests, a new survey from the Prescription Project revealed. Sixty-four percent of those surveyed said that is important to know their physician’s financial ties to pharmaceutical companies and 68 percent added they would support laws requiring drug companies to disclose gifts to doctors. Additionally, 52 percent believe that accepting gifts from industry influences doctors’ prescribing decisions. The Prescription Project is a Boston-based organization working to limit pharmaceutical marketing to physicians. “Our survey clearly shows that national legislation like the Physician Payments Sunshine Act (sponsored by Sens. Charles Grassley, R-IA, and Herbert Kohl, D-WI) would be embraced as a way to help consumers understand and assess the impact of those interactions,” said Robert Restuccia, executive director of The Prescription Project. The proposed law requires drug and medical device manufactures to disclose all financial dealings with doctors, including gifts, honoraria, travel expenses, educational grants, and funding for clinical trials greater than $500.

Bill Broadens Advisory Committee Disclosure beyond FDA

The House last week passed a bill requiring all federal agencies to publicly post any conflict of interest waivers for scientists sitting on federal advisory committees at least two weeks before the advisory committee meets. The legislation also requires anyone asked to serve as a constituency representative on a committee, such as a business or consumer representative, to disclose personal conflicts of interest to the committee. H.R. 5687, entitled the Federal Advisory Committee Act Amendments of 2008 and sponsored by Rep. Henry Waxman (D-CA), also would prevent political litmus tests for anyone sitting on a committee. A spokeswoman for Rep. Waxman said that the White House objects to the measure and the Senate is unlikely to consider the bill this year.

NCI Science Advisers Put Amgen-J&J Cash on Hold

The National Cancer Institute’s scientific advisory board last week shelved accepting $5 million from manufacturers of anti-anemia drugs that would have been used to study the drugs’ tumor promotion mechanisms through National Institutes of Health R01 grants, the Cancer Letter (subscription required) reported Friday. The Food and Drug Administration earlier this year slapped black box warnings on Amgen’s Epogen and Aranesp and Johnson & Johnson’s Procrit, which are used to increase energy in cancer patients, because they also speed up mortality at higher doses. Taking money earmarked for specific projects would undermine the peer-review process that usually determines priorities for NIH funding. “It is a huge ethical no-no to try and cheapen the current of the R01s,” said Arthur Caplan, director of the University of Pennsylvania Center for Bioethics. NCI Director John Niederhuber told the committee that NCI was “under pressure from Congress to address this issue.” Amgen spent $22.7 million on lobbying last year, according to the Center for Public Integrity, more than any other pharmaceutical company.

Odds and Ends

The Department of Veterans Affairs will send letters to the more 30,000 veterans taking Chantix, Pfizer’s smoking cessation medication, warning them about the drug’s side effects, which include heart irregularities, seizures, dizziness, depression, and suicide. The letter was announced a week after an ABC News report revealed that the VA failed to warn vets with post traumatic stress disorder about of the drug’s side effects before they took part in a Chantix study. . . . An Egyptian-born nuclear physicist who criticized the Iraq war filed suit last week after losing his security clearance and job at a government-financed laboratory. . . . The Supreme Court announced last week that it will hear a Navy appeal of a judge’s order requiring Navy ships to turn down their sonar whenever marine mammals are within 1.25 miles. The appeals court ruled earlier that the Navy’s high-powered sonar injures and kills up to 17,000 marine mammals annually, including whales.

Cheers and Jeers

  • Jeer to Hilary Hylton of TIME magazine for failing to disclose that Jessica Kahn, a pediatrician at Cincinnati Children's Hospital Medical Center, has spoken at Merck sponsored events supporting their human papilloma virus (HPV) vaccine, Gardasil. In the article, Kahn downplayed reports of side effects associated with the vaccine.

  • Cheer to Jon Kamp of the Wall Street Journal for noting that David Malenka, a cardiologist at Dartmouth-Hitchcock Medical Center, received research funding from Guidant Corp. and Abbott Laboratories, manufacturer of heart stents. Malenka was the lead author of a recent study to be published in the Journal of American Medical Association, emphasizing the safety and efficacy of heart stents.

  • Jeer to Terri Somers of the San Diego Union Tribune for her article about the Manhattan Institute for Research Policy study praising pharmaceutical companies’ efforts to develop new drugs. Somers failed to disclose that the think tank received funding from drug companies in the past as does Joseph A. DiMasi of the Tufts Center for the Study of Drug Development, who served as an analyst for the report.
  • Cheer to David Steitfeld of the New York Timesfor disclosing that Keith Collins, a former Agriculture Department economist and author of new study highlighting the relationship between high food prices and ethanol production, received funding from food maker Kraft. Steitfeld quoted Collins in a story about using land reserved for conservation for agriculture.

  • Jeer to the National Post, an Ontario, Canada-based newspaper, for failing to report the funding sources of the American Council on Science and Health, a corporate-backed think tank and advocacy group, when it published an op-ed by ACSH president Elizabeth Whelan attacking the Center for Science in the Public Interest’s Integrity in Science project, which publishes this newsletter. 
  • Cheer to Arlene Weintraub and John Cady of BusinessWeek for exposing the failure of researchers and guidelines writers to fully disclose financial ties to Pfizer, maker of the anti-smoking drug, Chantix. The drug has come under attack for its serious side effects.

The next edition of Integrity in Science Watch will be dated July 21, 2008. Hope to see you at the Rejuvenating Public Sector Science conference on July 11th!