Senate FDA Bill Lacks Strict Conflict of Interest Guidelines
A key Senate committee will hold its final hearing Wednesday on legislation that renews the Food and Drug Administration’s financial reliance on industry user fees but doesn't restrict the agency’s use of experts with financial ties to industry. The Food and Drug Administration Revitalization Act (S. 1082), co-sponsored by Sen. Ted Kennedy (D-MA) and Sen. Michael Enzi (R-WY), contains several provisions that would enhance the agency’s ability to protect the public from unsafe drugs. But its conflict of interest provisions do not even incorporate an FDA proposal released last month that would prohibit any scientist with either $50,000 in corporate stock or remuneration in the past year from serving on any drug, device or food advisory panel. The FDA’s proposed guidance would also forbid any scientist with lesser conflicts from voting at a meeting.
Seven consumer groups, including the Center for Science in the Public Interest, Consumers Union, and the Union of Concerned Scientists, sent a letter last week to all members of the Senate’s Health Education Labor and Pensions Committee (HELP) saying S. 1082 and the FDA’s proposed guidance do not go far enough. The groups called on Congress to eliminate entirely from FDA advisory panels any scientist with a conflict of interest within the past three years. The House under Republican leadership passed such a bill in 2005 in the wake of the Vioxx fiasco. “The experience of the National Institutes of Health and several states indicates that there is no merit to the claim that the FDA must allow conflicted experts to serve on its advisory committees because they have unique expertise,” the letter said. The Senate bill merely encourages the FDA to reach out to professional societies and universities to find non-conflicted experts, and asks the FDA to release the names and waivers of scientists with conflicts of interest two weeks before a meeting.
The consumer groups are also pushing the HELP Committee to strengthen the drug safety provisions of the bill. They want public posting of the results of all clinical trials, more power for the drug safety office, improved surveillance of drugs once they hit the market, and greater restrictions on direct-to-consumer advertising. Individuals can comment on the legislation by sending emails to Help_comments@help.senate.gov or to Chairman Kennedy via his website.
Iowa State Gives Conoco Special Alt-Energy Deal
Iowa State last week joined the growing list of universities signing exclusive pacts with major oil firms to pursue alternative energy research projects. Under the eight-year, $22.5 million pact with ConocoPhillips, Iowa State will develop new technologies for producing biofuels. The Ames-based university gave the nation’s fifth-largest oil firm non-exclusive royalty-free licenses to any patents produced under the agreement; first rights to exclusive licenses; and the right to review faculty research proposals prior to disbursing grants. “Our faculty makes proposals, and (ConocoPhillips) decide if they have an interest in pursuing that topic,” said Robert C. Brown, a professor of mechanical engineering at Iowa State and head of the Office of Biorenewables Programs. But “they can’t dictate to our faculty what they will or won’t do.” ConocoPhillips will also review any papers developed under the program prior to publication to ensure professors don’t release proprietary data. Similar programs, such as the ones linking Stanford with ExxonMobil and the University of California-Berkeley with British Petroleum, have drawn heated protests from faculty and campus groups for subverting academic independence.
Conflicted Kidney Docs Snub FDA on EPO
The National Kidney Foundation last week proposed new anemia treatment guidelines for patients with chronic kidney disease that ignore the latest red flag from the Food and Drug Administration. Last month, the FDA warned physicians that raising red blood cell counts above 12 g/dL using Amgen’s Epogen and Aranesp “increased the risk for death and for serious cardiovascular events.” The agency’s new warning label on the drugs called for using the lowest possible dose needed to eliminate blood transfusions. Doctors were also warned to cease drug therapy if a patient reaches a 12 g/dL hemoglobin count. The NKF’s anemia working group, on the other hand, recommended only that physicians not go above 13 g/dL while aiming for hemoglobin target “generally in the range of 11 to 12 g/dL.”
The NKF guidelines drew immediate fire from Daniel Coyne, professor of medicine at Washington University in St. Louis. “They’re clearly diverging from the FDA statement that you shouldn’t exceed 12,” he said. “By saying use 12 as a target, it leaves half the population at any given time above 12 because there’s a lot of variation.” Nine of 16 physicians on the NKF anemia working group have financial ties to Amgen. One of its two co-chairs is a part-time employee of DaVita, the nation’s second largest dialysis chain. Dialysis clinic revenues and profits rise when Epogen use increases. Coyne also consults for Amgen and other producers of anti-anemia drugs.
Bush Backs Away from Controversial Nominees
The Bush administration last week withdrew its controversial nomination of William Wehrum and Alex Beehler to key Environmental Protection Agency posts. Wehrum, who has been acting chief of the air and radiation office for nearly a year, helped liberalize rules for electric utility plants that he represented when he was a private attorney. Beehler, who championed anti-regulatory causes while at Koch Industries, had been tapped to be the EPA’s new inspector general. In his previous government post, Beehler sought to exempt the Defense Department from costly environmental clean-ups. Sen. Barbara Boxer, who chairs the Senate’s Environment and Public Works Committee, called the nomination withdrawals “good news.”
Bush Ups Ante at Regulatory Agencies
Environmental Science and Technology reported last week that the Bush administration ordered the Office of Management and Budget to review all regulatory agency guidance documents for documentation of market failures to justify their issuance. The agency will also have to “assess the significance of that problem, to enable assessment of whether any new regulation is warranted,” the order said. Consumer groups said this latest administration maneuver is designed to slow down environmental and public health risk assessment procedures.
Odds and Ends
Scientific recommendations and predictions in the latest United Nations Intergovernmental Panel on Climate Change were toned down at the request of the Chinese and American governments, the Washington Post reports . . . Sources told Inside EPA that Senator Joe Lieberman is vowing to keep a close watch on White House regulatory czar Susan Dudley, who received a controversial recess appointment . . . An EPA children’s health advisory panel issued a call for tougher air pollution standards despite having four scientists, out of 25, with significant ties to industry.
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