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March 9, 2009

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Integrity in Science Watch

Week of 03/09/2009

Comparative Effectiveness Panel Missing Consumer Reps

The Institute of Medicine panel slated to make recommendations for the $1.1 billion earmarked for comparative effectiveness research has no representation from broad-based consumer or patient advocacy groups, a Center for Science in the Public Interest analysis reveals. The legislation, which gave IOM $1.5 million to conduct the three-month study of how to spend the comparative effectiveness money contained in the stimulus package, required that the quasi-government agency's final report consider "input from stakeholders." While the proposed 16-member panel included five physician specialists, three medical technology assessment experts, three insurers (two of which are also provider networks) and three officials currently or formerly associated with Medicare, the only patient or consumer representative named to the panel's tentative roster was from the Alzheimer's Association, a single-issue patient advocacy group that receives substantial support from the drug industry.

Comparative effectiveness research compares the clinical- and cost-effectiveness of competing approaches to treating and preventing disease. Information generated by the research could be used by payers and providers to improve health care quality and outcomes while holding down costs. "More research on what works and what doesn't, tied to financial incentives to provide the higher-value care, could help to reduce costs without harming quality," said Peter Orszag while head of the Congressional Budget Office. He's now President Obama's budget chief and a major player in the administration's health care reform efforts.

Some patient advocacy groups that receive financial support from industry and conservative leaders such as talk show host Rush Limbaugh and Hudson Institute senior fellow Betsy McCaughey launched a major campaign to eliminate comparative effectiveness research from the stimulus bill. They alleged it would lead to "bureaucrats" telling doctors what to do and be a first step toward medical rationing. The stimulus bill did not specify how information generated through comparative effectiveness research would be used.

Setting priorities for the $1.1 billion that will be spent on such research over the next two years could be similarly contentious. Comments on the IOM's proposed panel will be accepted until March 23rd and can be filed here.

Obama Ends Stem Cell Limits, Vows Transparency

In a White House ceremony this morning, President Obama will remove limits on federal funding of stem cell research, according to press accounts. He will also issue a "scientific integrity" executive order giving agencies authority to let science drive policy and increasing transparency of scientific decision making. However, the administration cannot give federally-funded stem cell researchers the right to create new embryonic stem cell lines, which is prohibited by the 1996 Dickey-Wicker amendment. Rep. Diane DeGette (D-CO) told the New York Times that she will pursue repeal of the law.

Harvard Reviewing Med School COI Policy

Reeling from a student review that gave Harvard Medical School an F in how well it monitors and controls drug industry money on campus, the school last week launched a thoroughgoing review of its conflict-of-interest policy. The effort is being advised by David Korn, who developed the Association of American Medical Colleges' model conflict-of-interest policy. Korn is now vice-provost for research at Harvard. According to the New York Times, the American Medical Student Association survey found that about 1,600 of 8,900 professors and lecturers at Harvard reported that they or a family member had a financial interest in a business related to their teaching, research or clinical care.

Meanwhile, Sen. Charles Grassley (R-IA)'s ongoing investigation of financial conflicts of interest on the nation's medical school faculties found that three Harvard psychiatrists failed to report at least $4.2 million in payments from Pfizer between 2000 and 2007. At least 149 faculty members were on Pfizer's payroll. In a letter to Pfizer CEO Jeffrey Kindler, Grassley also accused Pfizer of having one of its sales representatives take photos of students protesting drug industry influence on campus. "I find this troubling as I have documented several instances where pharmaceutical companies have attempted to intimidate academic critics of drugs," Grassley wrote.

EPA Seeks Experts for IRIS Update Review Panel

The Environmental Protection Agency is looking for independent experts to sit on an advisory panel that will review updates to its Integrated Risk Information System, a database that was designed to include the latest information about the toxicity of commonly used chemicals. The new panelists will join the EPA's Science Advisory Board Exposure and Human Health Committee, a 17-member board that reviews the scientific soundness of draft chemical assessments. Most entries in the IRIS database are now over a decade old; some are over three decades old; and the few updates that have been done in recent years have largely relied on industry-funded studies. A recent Government Accountability Office report concluded the IRIS database is among the government's most troubled programs. Nominations for the review panel should be submitted to the EPA by March 23.

High Court Nixes FDA Preemption of State Rx Suits

The Supreme Court last week upheld a patient's right to sue in state courts when companies fail to adequately warn about the dangers posed by prescription drugs. Wyeth Pharmaceuticals and the Food and Drug Administration (under President George W. Bush) had argued that the FDA's labeling decisions preempted state tort laws, which require manufacturers to notify consumers about the potential dangers from using their products. The case, Wyeth v. Levine, involved a suit by a musician who lost her arm to gangrene after being given an intravenous injection of the anti-nausea drug Phenergan. Last year a similar case involving medical devices had been decided in favor of the manufacturer. But the statute regulating medical devices specifically states that federal regulation preempted state laws. No such language exists in the nation's drug laws. Last week, in the wake of the Supreme Court decision in the drug case, legislation was introduced in Congress to repeal the preemption clause in the medical device law.

In the 6-3 decision, Justice John Paul Stevens, writing for the majority, concluded that Congress saw state liability laws as bolstering, not undercutting, the FDA's mission of ensuring drug safety. With 11,000 drugs on the market in the U.S., he wrote, the FDA's own advisory panels have said the FDA lacks adequate resources to protect the public. The decision cited recent FDA Science Board and Institute of Medicine reports criticizing the FDA's drug safety performance. The decision also overturned a 2006 Bush administration policy that declared that state law interfered with the FDA's mission. The agency's position, authored by former chief counsel Dan Troy, who prior to joining the agency represented numerous drug companies, was "inherently suspect" because it supplied no supporting evidence, Justice Stevens wrote.

Scientists Restored to Endangered Species Oversight

Last week President Obama issued a memo that directs the heads of all agencies to resume consulting the National Marine Fisheries Service and Fish and Wildlife Service when evaluating projects that may harm endangered species. The directive overturns the Bush Administration's December 16 "midnight" rule that removed scientists at the two agencies from the process of deciding whether federal actions could harm listed species. The Bush rule left these decisions up to officials at the agencies. Obama's memo directs the agencies to ignore the Bush rule while the Secretaries of Commerce and Interior decide its fate. Repeal would require a lengthy rulemaking process.

Odds and Ends

The Obama administration's stimulus package included another $1 billion for the "clean coal" pilot project known as FutureGen, the Washington Post reported. The pilot project, located in Illinois, is backed by most local politicians but is opposed by some environmentalists. ... The Obama administration promised to overhaul the system for awarding government contracts to private entities, and put the Office of Management and Budget in charge of improving agency oversight of contracts. ... In 2007, pharmaceutical firms donated at least $172,000 to the Utah Family Foundation, which Sen. Orrin G. Hatch helped found, the same time that the Pharmaceutical Research and Manufacturers of America hired the Republican lawmaker's son as a lobbyist, the Washington Times reported. ... President Obama has tapped Nancy-Ann DeParle to be the director of the White House Office of Health Reform despite ties to companies that have a direct stake in the health care debate, the New York Times reported. ... In an effort to influence the Obama administration's Cuba policy, Sen. Robert Menendez (D-NJ) put a hold on Harvard University physicist John Holdren's appointment as head of the White House Office of Science and Technology Policy and Oregon State University marine biologist Jane Lubchenco's nomination to lead the National Oceanic and Atmospheric Administration, the Washington Post reported. ... The Union of Concerned Scientists turned 40 last week. Happy birthday! ...

Cheers and Jeers

  • Jeer to Nicholas Bakalar of the New York Times for failing to disclose that Harvard Medical School's William G. Christen, lead author of a study suggesting vitamin B supplements may be effective in combating age-related macular degeneration, took funding from a company, Roche's DSM Nutrition Products, that manufactures the supplements. Christen was quoted as saying more research was needed to corroborate the findings.