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December 3, 2007

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Integrity in Science Watch

Week of 12/03/2007

Report Shows Conflict-free Advisers Easily Found

When the original 2001 Vioxx study appeared in the New England Journal of Medicine, its industry-funded authors dismissed data showing the drug raised the risk of heart attack by suggesting the comparison drug in the trial had been cardio-protective. Last month, the Food and Drug Administration did something similar with a study of conflicts of interest on its advisory committees. The agency's press release said it would be difficult to create advisory committees free from conflicts of interest. The study, which cost taxpayers $60,000, according to FedSpending.org, also claimed the advisors granted conflict-of-interest waivers had greater expertise than those without conflicts serving on the committees.

In fact, a Center for Science in the Public Interest reanalysis of the data contained in the report revealed that the FDA and the report should have drawn the opposite conclusions. The report examined four committees created during 2006 that granted 17 waivers. It took just 88 person-hours to identify 30 independent experts with all the expertise needed to fill those slots. Each of the 30 affirmatively declared in the medical literature that they had no conflicts of interest. Moreover, the expertise of those potential candidates, according to the report's own methodology, was greater than either the conflicted or unconflicted experts chosen to serve on the committees.

In a letter sent today to Commissioner Andrew von Eschenbach, a coalition of consumer groups called on the FDA to reopen consideration of an agency proposal made last March that would forbid anyone who has financial ties with industry worth more than $50,000 from serving on advisory committees. It would also deny voting rights to advisers with lesser conflicts. "While the FDA's proposed guidance doesn't go far enough, this study shows that those barred or restricted under its limited provisions could be easily replaced," said Merrill Goozner, director of CSPI's Integrity in Science Project. Recently passed legislation only requires the agency to reduce total waivers by 20 percent over the next five years, which is well short of the total ban on conflicts of interest sought by consumer groups.

Group Challenges ESA Decisions

Fifty-five endangered species have been denied protection for political reasons, according to an environmental group that filed lawsuits on November 15 to reverse six of those decisions. The lawsuits, filed by the Center for Biological Diversity (CBD), alleged that political appointees at the Fish and Wildlife Service (FWS) interfered with decisions by agency scientists to list two species and to provide critical habitat for four others. In all six cases, Julie MacDonald and other high-ranking Interior Department officials reversed findings of agency biologists that were based on the best available science, the suits alleged. "The depth of corruption within the Department of the Interior goes way beyond Julie MacDonald," said CBD's senior counsel Michael Senatore. Most of the decisions the group is contesting involve the designation of critical habitat, which protects the land that the species need to recover.

Last week, FWS Deputy Director Ken Stansell announced that the agency would reconsider or withdraw an additional seven endangered species decisions influenced by MacDonald. An Interior Department Inspector General report released in March criticized MacDonald and triggered the new review.

EPA Removes Everglades Expert

The U.S. Environmental Protection Agency's top expert on Everglades restoration was removed from his position after expressing concerns about pollution management, the St. Petersburg Times reports. Richard Harvey, who directs the EPA's South Florida office, had been the agency's representative in Everglades restoration efforts for seven years. He was taken off the project after objecting to plans by the Army Corps of Engineers to pipe polluted water from Central Florida's Lake Okeechobee into Biscayne National Park. The plans were the Corps' first effort to address the long-term problem of lake pollution caused by agricultural runoff. Harvey was the fifth expert to be taken off the Everglades restoration project or fired for criticizing the project's inadequate attention to environmental safeguards. "With politics what they are, scientists have to be extremely careful about what they say," said Harvey. The pipeline plan was abandoned after Harvey was removed from his position. A $5 billion bill to restore the Everglades, which, according to a Time reporter who has written a book on the Everglades, will only "preserve America's dysfunctional approach to water resources," passed both houses of Congress over President Bush's veto last month.

Lawsuits: BP Violated State Revolving Door Regs

Ongoing claims in the lawsuits filed in 2005 by people injured in an explosion at BPs Texas City refinery allege that the company avoided upgrading its safety equipment by hiring a former state regulator to manage relations with state authorities, the Houston Chronicle reported. The plaintiffs argued that BP violated the state's revolving door law when it hired Ruben Herrera, an air quality engineer formerly with the Texas Commission on Environmental Quality (TCEQ), placing him in the position of promoting the air quality permit that he had worked on as a state regulator. According to emails released in the proceedings, Herrera began talking to BP about a job while he was processing its application for a permit at the TCEQ and offered advice to BP engineers and consultants about how to file the application. Eleven days after starting work for BP, Herrera began negotiations for the company on the permit with his former co-worker. Texas health and safety laws call for the automatic denial of an air or water quality permit if the company involved hires the state regulator who had been handling the permit application. BP has agreed to pay $50 million in federal fines for violations of the Clean Air Act on grounds that it did not properly maintain its equipment and has settled almost 4,000 lawsuits related to the blast.

Odds and Ends

Rep. Peter DeFazio (D-OR) told American Medical News that he will push legislation next year requiring drug and device companies to disclose any gifts to physicians greater than $25. H.R. 3023, introduced last July by DeFazio and four co-sponsors, had set the floor at $50. . . . New Scientist revealed that Italian field trials showing possible health benefits of genetically-modified maize may have been suppressed; Piero Morandini of the University of Milan asserted that the GM varieties contained one one-hundredth the amount of fumonisin, a fungal toxin linked to spina bifida, than conventional varieties. . . . Twelve states have announced they will sue the EPA for weakening industry reporting requirements under the Toxics Release Inventory, which require businesses to inform communities of the toxic chemicals they use and release. . . .Twenty-five members of Congress last week sent a letter to the EPA calling for further study of the environmental and health impacts of a plan to expand the amount of hazardous waste that can be incinerated and exempted from regulation. . . .Board member John Reed of the California Institute for Regenerative Medicine violated state law when he wrote to CIRM staff pushing for a $638,000 grant to a stem cell researcher at the Burnham Institute in La Jolla. California's Proposition 71 prohibits board members from trying to influence grant applications from their home institutions; Reed is Burnham's president.