Integrity in Science Watch|
Week of 01/22/2008
Strings Tied to Industry-Academic Collaborations at "Big Oil U"
American universities may be jeopardizing their academic integrity by giving oil, gas, and other polluting industries unprecedented influence over the research those companies fund on campus, according to a report released yesterday by the Center for Science in the Public Interest. A CSPI survey of nine universities with industry-funded research programs aimed at studying and abating global warming found 6 out of the 9 let corporate executives sit on boards overseeing grants; 5 out of the 9 gave companies first rights to intellectual property; and 5 of the 9 let companies review and possibly delay publication of studies. The report revealed that industry investment in energy research plunged over the past several decades, and that the university-based programs fall well short of making up the difference. "It's a cheap subterfuge for carbon-emitting companies," said Merrill Goozner, director of the Integrity in Science project at CSPI and co-author of the report. "They get the prestige of associating themselves with major respected universities, yet can control the direction of research, get first rights to intellectual property, and can delay any finding that doesn't help the bottom line."
According to CSPI, the industry-academic partnerships highlighted in Big Oil U. represent a strategic shift for carbon-emitting industries. Instead of discrediting the science behind global warming, companies increasingly want to be seen as part of the solution. Between 1998 and 2005, Exxon gave more than $19 million to groups that promoted the idea that global warming was a hoax. Yet beginning in 2006, ExxonMobil ads proudly touted its contribution to a program at Stanford, a 10-year $225 million program: "Today an energy company and a leading university share a common goal. The common good." Another ExxonMobil ad bore the Stanford University seal. Stanford gave its industry collaborators special rights in eight of the nine areas measured by the survey. The other energy industry-sponsored programs surveyed were at UC-Berkeley, UC-Davis, Princeton, MIT, Rice, Caltech, Georgia Tech, and Carnegie Mellon.
The report recommends that universities accepting corporate funding adopt policies to protect their autonomy and preserve researchers' academic freedoms. They include prohibiting representatives of corporate donors from sitting on research programs' governing boards; prohibiting industry donors from controlling the content and direction of research programs; eliminating "first rights" intellectual property clauses from donor agreements; and ensuring that company representatives cannot make substantive editorial changes in manuscripts or delay their publication.
NIH Nixes Knowing Outside Grantees’ Conflicts-of-Interest
After admitting it routinely fails to collect and monitor university conflict-of-interest policies, the National Institutes of Health has rejected an inspector general recommendation that it collect detailed financial information from its extramural grantees and reveal what steps institutions are taking to manage, reduce, or eliminate any conflicts of interest. Federal regulations require the 3,000 universities, medical schools, and other research institutions that receive 80 percent of the agency’s $29.2 billion budget manage any financial conflict of interest that "could directly and significantly affect the design, conduct, or reporting" of government-funded research. The grantee institutions must then report those programs to NIH, although they do not have to report individual conflicts of interest. About 325,000 researchers participate in the agency’s 50,000 grants each year.
When asked, NIH could only produce 438 reports filed between 2004 and 2007, according to an investigation released last week by Health and Human Services Department Inspector General Daniel Levinson. Moreover, 89 percent of those reports did not state the nature of the conflicts or how they were managed. The 30 reports that contain that information described cases where "investigators have intellectual property associated with the grant research or financial interests in companies that are subcontractors on the research grants." The method of managing those conflicts was disclosure in presentations and publications. Knowing such information for all institutions "could assist NIH officials in making a determination as to whether follow-up with the grantee institutions is necessary," the report noted.
In the agency response, director Elias Zerhouni said requiring reporting of individual conflicts would put NIH in the business of directly managing researchers at outside institutions. However, it did agree to set up a consolidated reporting system in the Office of Extramural Research, and make the filing of annual reports mandatory as of March 1.
Meanwhile, The Cancer Letter (subscription required) reports that two leaders of the International Early Lung Cancer Action Project from Weill Medical College of Cornell University in New York failed to disclose patents and patent applications in their published reports claiming success for using CT scans for early detection of lung cancer. The controversial clinical trial reports and related articles have appeared in the New England Journal of Medicine, Journal of the American Medical Association, Archives of Internal Medicine, The Lancet, Chest, Clinical Cancer Research, Natural Clinical Practice Oncology, and Cancer Cytopathology without disclosure. Claudia Henschke and David Yankelevitz have both received NIH grants in recent years to conduct research involving lung cancer screening, according to the agency’s grants database. The one awarded patent has been licensed by Weill to General Electric, which manufactures CT scanning machinery. The journals are investigating the failures to disclose the patents. Last October, Congress launched an investigation into a rival NIH-funded group exploring the use of CT scans for early detection of lung cancer after a group called the Lung Cancer Alliance alleged two of its lead investigators took money from the tobacco industry. The Lung Cancer Alliance is funded in part by GE.
Scientists Seek Interior Oversight
Two dozen scientists organized by the Union of Concerned Scientists and the Endangered Species Coalition lobbied Capitol Hill last week to protest the Bush Administration’s political interference in environmental science. Bemoaning what one organizer called "the systematic dismantling of the Endangered Species Act through the manipulation and suppression of science," the scientists met with Congressional leaders to call for increased oversight of the Interior Department’s Fish and Wildlife Service, which has come under fire in recent years for making politically motivated decisions on the fate of endangered animals and plants. The decisions, which were the work of such political appointees with no science background as Julie McDonald affected at least 50 species. Many of these decisions have triggered lawsuits.
Meanwhile, a Fish and Wildlife Service scientist quit the agency in disgust last week because of political interference at the agency. Mike Lockhart who headed the National Black-footed Ferret Conservation Center in Wyoming, retired after complaining that political pressure had "compromise[d] the integrity" of the recovery program for the species. Black-footed ferrets are dependent for food and shelter on prairie dogs, which have been targeted by the livestock industry and government agencies for control efforts that Lockhart says have been excessive.
Congress: Politics, not Science, Prompted Polar Bear Listing Delay
The Fish and Wildlife Service’s delay in listing the polar bear as an endangered species was not based on science but tied to the Interior Department’s plan to sell oil and gas leases within the bear’s habitat, members of the House Select Committee on Energy Independence and Global Warming said at a hearing last week. The Minerals Management Service (MMS) plans to sell drilling rights in the Arctic’s Chukchi Sea on February 6. If the bear is not listed by then—and the delay announced on January 7 pushes the expected listing beyond that date—the lease sales could proceed without Endangered Species Act-mandated restrictions to protect the polar bear and its habitat.
All the Good News That's Fit to Print
Industry-funded clinical trials that reveal that antidepressant drugs are ineffective almost never get published or are incorrectly reported in the literature, a new study in the New England Journal of Medicine showed. Nearly half (36) of the 74 industry-funded antidepressant trials involving 12,564 patients that were registered with the Food and Drug Administration showed negative or questionable results. Yet 22 of those trials never appeared in the medical literature. Another 11 were publicly reported as having favorable findings, even though a reexamination of their data showed the results to be either negative or questionable. "Selective publication can lead doctors to make inappropriate prescribing decisions," the authors warned. No reason was offered for the bias against publishing negative results. The results mirror a Center for Science in the Public Interest study released in February 2004 that found overwhelming support for using antidepressants in children in the industry-funded studies in the academic literature. Yet an FDA analysis of unpublished studies released a few months earlier showed the drugs were ineffective.
Odds and Ends
The National Toxicology Program will review its final report on Bisphenol-A after receiving voluminous complaints that the report was influenced by industry. Public comments can be sent to email@example.com until Jan. 25. . . . House Oversight Committee Chairman Henry A. Waxman (D-CA) plans to depose Environmental Protection Agency staff after the agency failed to comply with requests requests for documents related to its denial of California’s request to adopt its own greenhouse gas auto emission regulations. EPA administrator Steven Johnson overrode agency scientists in making the decision. . . . Public Employees for Environmental Responsibility has sued the Interior Office of Inspector General to force release of documents behind its report on declining law enforcement within the U.S. Fish & Wildlife Service (FWS). FWS staff say they submitted records detailing obstruction of enforcement that were not included in the final report, including involvement by Safari Club International, a hunting group.
Cheers and Jeers
- Jeer: to Alex Berenson of the New York Times and John Carey of Businessweek for not disclosing in articles questioning drugs used for cholesterol treatment that Scott M. Grundy, who chaired a government panel that wrote guidelines on cholesterol management, received consulting fees from Merck, Schering-Plough and Pfizer among others. Berenson also failed to reveal that Allen J. Taylor received honoraria from Merck.
- Jeer: to Ron Winslow of the Wall Street Journal for failing to note in an article on the controversial cholesterol drug Vytorin that Paul M. Ridker received research support and consulting fees from more than a half dozen pharmaceutical companies.
- Cheer: to Ron Winslow and Sarah Rubenstein of the Wall Street Journal for disclosing that Michael Davidson, Director of Preventive Cardiology at the University of Chicago, worked on the industry-funded trial that won FDA approval of Vytorin and Zetia.
- Jeer: to Neal Simpson of the Brookline Tab for quoting Richard J. Pollack on a proposed new lice program for the Brookline School District without disclosing that the Harvard School of Public Health researcher is a member of the technology advisory board of ParaPRO, which is developing a compound for treating head lice.