FDA Issues Three Waivers for Back Device Panel
The Food and Drug Administration has granted financial conflict of interest waivers to three physicians who will be serving on the Orthopedic and Rehabilitation Devices Advisory Panel that meets July 17. The panel will consider Medtronic’s application to approve a prosthetic spinal disc for the reduction of back pain in older adults.
The physicians voting on the device will include the University of Alabama’s John Kirkpatrick, who owns stock in Zimmer Corporation and Johnson and Johnson, two leading Medtronic competitors. According to FDA documents, Kirkpatrick’s holdings are each valued between $15,000 and $25,000. Panelist Stuart Goodman of Stanford University authored a study funded by Stryker, which manufactures a bone growth supplement. He also has recently received between $10,000 and $50,000 in consulting fees from Medtronic competitors, according to the FDA. Finally, Edward Hanley owns Medtronic stock valued between $25,000 and $50,000. Moreover, his employer, the Carolinas Medical Center, was involved in testing the Medtronic prosthetic disc that will be before the advisory committee, according to the FDA. House-passed FDA reform legislation, which soon goes to conference, would limit conflict-of-interest waivers to one per meeting.
Klamath Panelists Challenge Interior's Use of NAS Study
Several members of the National Academies of Science Klamath River panel who were contacted by CSPI last week defended the 2002 report that was later seized on by Bush Administration officials to justify a water release that may have led to the largest die-off of salmon in the nation’s history. According to the panelists, former Secretary of the Interior Gale Norton asked the NAS to limit its report to the narrow question of the biological needs of coho salmon and suckerfish. Bureau of Reclamation officials then used those findings to overrule Fish and Wildlife Service (FWS) scientists who were opposed to releasing water to farmers. An estimated 70,000 chinook salmon eventually died in the incident. The final report largely agreed with the FWS scientists, the panelists said, contrary to recent reports in the Washington Post. Panelist Jeffrey Mount of the University of California at Davis said Norton’s charge to the committee was “very cleverly worded,” which forced a conclusion that would justify the change in policy.
Politics Endanger Species Safety Net
Endangered species protection dropped sharply under the current administration, the Los Angeles Times reported last week. The paper documented a species recovery program plagued by corruption, a lack of funding, and a hostile administration willing to overrule agency scientists. The Bush Administration, according to the article, granted federal protections to only 58 species in the past six years compared to 231 species protected under the four-year administration of the senior George H.W. Bush. Fifty-four of the 58 listings were triggered by lawsuits filed by conservation groups. Meanwhile, an estimated 279 species received no federal protection and many became extinct while waiting for listing, according to the Center for Biological Diversity.
Carbon Footprint of Livestock Glossed over in Live Earth Fanfare
This weekend, Live Earth concerts to raise awareness of global climate change were broadcast from all seven continents to millions of viewers. Absent from the discussion surrounding the event were the findings, reported in the United Nation Food and Agriculture Organization’s 2006 report, Livestock’s Long Shadow, that the livestock sector is responsible for fully 18 percent of global greenhouse gas emissions – more than the automotive industry, air travel, and all other forms of transport combined. The UN report also named the livestock sector as the single largest land user on the planet, with livestock production occupying 70 percent of the earth’s agricultural land and 30 percent of its total terrestrial surface.
NIH Director Testified in Asbestos Cases While on Gov't. Payroll
National Institute of Environmental Health Sciences director David Schwartz provided expert witness services for two law firms involved in asbestos litigation shortly after becoming head of the agency in 2005, an investigation by Sen. Charles Grassley (R-IA) has revealed. When Schwartz filed his outside activity reports with the National Institutes of Health, which is the NIEHS’ parent agency, an ethics officer warned director Elias Zerhouni that Schwartz “may not be sensitive to the implications of his and his staff members' involvement in private litigation involving subject matters and substances that are within the NIEHS portfolios. . . I can't imagine that testifying under oath on the subject is not a conflict of interest for him," the email warned. NIH Deputy Director Raynard Kington then told Schwartz that “we are bending the process a bit” and “may not be able to do this again.” Grassley gave Zerhouni until July 10 to reveal how much, if anything, Schwartz got paid for his expert testimony. Science Magazine is reporting he received $150,000 between 2005 and 2007. Grassley is also seeking a list of all NIH employees who have provided expert testimony for law firms since 2003.
Odds and Ends
The Senate Committee on Energy and Natural Resources will hold hearings this week on the nominations of Clarence H. Albright and Lisa E. Epifani to high-ranking positions in the Department of Energy. Albright has been a lobbyist for the Texas power company Reliant Energy since 2004, while Epifani is an attorney who has represented the gas and electric industry since 1999. . . . California Governor Arnold Schwarzenegger uses money from the non-profits California State Protocol Foundation and the Simon Wiesenthal Center, among others, to fund his travel according to the Los Angeles Times. The Times reports these non-profits may serve as a cover for interest groups aiming to win favors from the governor. . . China sentenced another high ranking food and drug safety official to death for corruption, according to the New York Times. . . Conservations groups are charging that the National Cattlemen's Beef Association, property developers and other business interests got the Bush administration to water down wetlands protection for small bodies of water, the New York Times reported.
Cheers and Jeers