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April 23, 2007

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Integrity in Science Watch

Week of 04/23/2007

Medicare Proposes Paying for Comparative Clinical Trials

Medicare may soon begin paying for drugs and devices used in clinical trials that compare the effectiveness of competing FDA-approved therapies. A draft memo circulated earlier this month by the Center for Medicare and Medicaid Services would reverse a policy that has been in effect since June 2000. Under that policy, the agency pays for the routine physician costs of seniors who participate in clinical trials, but not for the “investigational” drug, device or test, even if it is already FDA-approved and routinely covered by the Medicare outside the clinical trial. This policy prohibited Medicare from participating in trials comparing competing treatments, which could save taxpayers money by steering seniors to less costly but equally effective medicines and procedures. “We’re proposing a change so that we will be able to participate in these studies,” said Leslye Fitterman, an epidemiologist with CMS’ Coverage and Analysis Group. “We would pay for the drug if (CMS) already pays for it outside the study.”

At stake is the ability of Medicare to generate objective, scientific data for making payment decisions that can save taxpayers money without harming beneficiaries. The issue came up earlier this year when CMS refused to pay for the routine cost of care for seniors who took part in a National Institutes of Health-sponsored clinical trial comparing two Genentech drugs for macular degeneration (MD). According to the Wall Street Journal, Genentech refused to provide NIH with free drugs, which made the cost of the trial prohibitively expensive for the agency to manage alone. Lucentis, which costs about $2,000 a shot, is already approved for the condition and costs Medicare over $200 million a quarter. Avastin, which is essentially the same drug but is only approved for use against cancer, costs $40 a shot when used for MD. Physicians using Avastin off-label have reported results comparable to Lucentis. A successful government-sponsored test, if published a major peer-reviewed journal, would allow Medicare to pay for the cheaper alternative.

The CMS draft policy should give a boost to legislation co-sponsored by Sen. Hillary Clinton (D-NY) that would create a new federal agency free from conflicts of interest to conduct comparative effectiveness trials. In a recent review in Health Affairs(subscription required), Gail Wilensky, the head CMS in the George H.W. Bush administration, noted that “there is widespread agreement on the attributes that need to be associated with a comparative-effectiveness center: objectivity in the selection of what is studied, credibility in the findings, and independence—from political pressures generated either by government or by private-sector stakeholders.”

Senate Committee Moves Flawed FDA Reform Bill

The Senate’s Health Education Labor and Pensions committee last week approved reauthorization of prescription drug user fees without including a ban on conflicts of interest on Food and Drug Administration advisory committees. The bill allows the FDA to use some industry-paid fees for identifying unsafe drugs and reviewing direct-to-consumer advertising. But its conflict of interest provisions only require giving the public two weeks advanced notice before placing scientists with ties to industry on advisory committees. A recently proposed FDA guidance would prohibit anyone with over $50,000 a year in financial ties to drug firms from serving, and would prevent anyone with lesser ties from voting. “I understand the argument” of those who want a total ban, Sen. Ted Kennedy (D-MA), chairman of the committee, said at the outset of the hearing. But “we’re doing this so we can get the best advice.” The House, meanwhile, began hearings on its FDA reform bill last week. Rep. Lois Capps (D-CA) questioned the agency’s continued reliance on scientists with conflicts of interest.

NIEHS Still Outsourcing Environmental Health Perpsectives?

Congressmen Henry Waxman (D-CA) and Dennis Kucinich (D-OH) are demanding that the National Institutes of Health abandon plans to privatize Environmental Health Perspectives, the premier journal in its field. According to their early April letter (http://oversight.house.gov/story.asp?ID=1240) to NIH director Elias Zerhouni, the National Institute of Environmental Health Sciences (NIEHS) through the National Library of Medicine will soon release a new request for proposals from universities or academic publishers interested in taking over EHP. The House Committee on Oversight and Reform is investigating NIEHS’s efforts to sell publishing rights to the journal and opposes any action before its investigation is complete, the letter said. An earlier attempt to privatize EHP was halted by NIH because geographical restrictions favored Duke University Press, the former employer of NIEHS director David Schwartz. Recent budget cutbacks at EHP will be apparent to readers in next month’s issue.

One On, Two Conflicted Scientist Off EPA Air Pollution Panel

Ignoring protests from consumer watchdog groups, the EPA has appointed two conflicted scientists to the Clean Air Scientific Advisory Committee primary advisory panel that will evaluate NOx and SOx pollution. In January, CSPI wrote to the EPA opposing the nomination of Richard B. Schlesinger, who has received financial support from the American Petroleum Institute, and Christian Seigneur, who works for Air Quality Division at Atmospheric & Environmental Research (AER) Inc., which is funded by three organizations (API, the Electric Power Research Institute and the Health Effects Institute) that receive money from industries that have a direct financial interest in the committee's decisions. The final roster did exclude Roger McClellan, the New Mexico-based industry consultant whom clean air advocates also protested.

NEJM Bars Industry-backed Prof for Leaking Trial Results

The New England Journal of Medicine has barred Columbia University cardiologist Martin Leon from peer-reviewing papers or writing reviews or editorials for five years after he broke the news embargo on the recently published COURAGE trial, which showed that drug therapy was as effective as invasive procedures in curbing heart attacks, the Heartwire on WebMD (registration required) reports. Leon, one of the paper’s original reviewers, told reporters at a late March conference that the trial was “rigged to fail, and it did.” Leon’s comments, reported in the Wall Street Journal, sent device manufacturer stocks plunging. Leon runs an annual conference on Transcatheter Cardiovascular Therapeutics that relies on fees from drug device manufacturers. An NEJM spokeswoman said the sanctions were imposed because reviewers are required to remain anonymous.

Odds and Ends

The FDA’s antiviral advisory committee that meets Tuesday to consider Pfizer’s application for Celsentri (maravicoc), the first drug in a new class of anti-AIDS medicines, includes Duke Medical Center’s Barbara Alexander, who "a href="http://www.fda.gov/ohrms/dockets/ac/07/waivers/2007-4283w01-Alexander-ack.pdf">receives less than $10,000 a year in speaking fees from Pfizer. The FDA claimed it couldn’t find her expertise in AIDS-related co-infections elsewhere . . . More than 20 health and environmental advocacy groups have urged(subscription required) the Bush administration to toughen air quality standards for ground-level ozone. The current standard hasn’t been updated since 1997.

Cheers and Jeers

  • Cheer: To senior editor Bette Hileman of Chemical and Engineering News for an editorial calling for an unbiased panel to analyze the conflicting evidence on the safety of bisphenol A, which has been the subject of numerous industry-funded studies downplaying its risks. “In light of the potential health effects of BPA exposure and the inconsistent study outcomes, it is especially important that an unbiased panel with no conflicts of interest and with a detailed knowledge of the field evaluate the literature on BPA, consider the weight of evidence in regard to adverse effects, and choose valid studies to include in its report.”
  • Cheer: To Jeff Donn of the Associated Press for his moving feature story about the FDA’s hounding of Victoria Hampshire, who uncovered the dangerous side effects of Wyeth’s heartworm drug for dogs.
  • Jeer: To the Orange County Register for quoting the University of Virginia’s Patrick J. Michaels without disclosing his ties to energy industries.