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July 16, 2007

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Integrity in Science Watch

Week of 07/16/2007

Conflicted Docs to Vote at High Profile Avandia Hearing

The Food and Drug Administration late last week granted six conflict of interest waivers for the advisory committee meeting later this month that will consider the safety of the diabetes drug Avandia. One of the waivers went to Steve Nissen of the Cleveland Clinic, whose analysis in the New England Journal of Medicine in June triggered public concern that Avandia may increase the risk of heart disease. Under the terms of the waiver, Nissen, whose institution conducts numerous clinical trials for Glaxo and its competitors, will only be able to present data and answer questions from the committee, but won’t be allowed to vote or participate in the committee’s deliberations. The FDA reform bill that cleared the House last week limits conflict-of-interest waivers to one per meeting, but allows for unlimited use of waivers such as the one Nissen received.

The five other waivers included one for Curt Furberg of Wake Forest University, a noted safety expert and frequent industry critic. He’s served on the data safety monitoring board of an Avandia trial funded jointly by the National Institutes of Health and GlaxoSmithKline, the drug’s sponsor. Noting his expertise in epidemiology, the FDA waiver gave Furberg, who has already editorialized in favor of the FDA taking action, the right to participate in the discussion but no vote. This waiver conforms with an FDA draft guidance that would amend its advisory committee process to allow unlimited waivers for anyone who earned $50,000 a year or less from industry, but would prohibit them from voting at committee sessions. The agency granted full participation rights to Columbia University’s Thomas Pickering, a cardiovascular disease expert. The agency claimed it couldn’t find anyone with comparable expertise for the slot.

Meanwhile, the Oncology Drugs Advisory Committee, which meets later this week to discuss a prostate cancer drug made by GPC Biotech Inc. and Eli Lilly’s breast cancer drug Evista, includes six scientists and clinicians requiring conflict-of-interest waivers. Most of the financial conflicts involved stock ownership in competitors of the companies whose drugs will be discussed by the committee.

Hospital Exec Touts Asthma Device, Silent on Hospital’s Role

Paul Levy, the chief executive officer of Harvard University-affiliated Beth Israel Deaconess Medical Center in Boston, last week used his popular blog to tout a new device for treating severe asthma that he found "fascinating." It should stir up interest in the device since Levy's blog, Runningahospital.blogspot.com, is ranked 13th among the world's top blogs in health and medicine, according to EDrugSearch.com. Levy called the invasive procedure, which involves using a catheter-controlled device to deliver heat to reduce internal muscle swelling in blocked air passageways, a "huge development in the treatment of this very pervasive disease. . . If it works as presented," he said, "this would be one of those medical developments that actually offers a reduction in the cost of health care."

The device is still in clinical trials so data to support Levy’s statements isn’t available. The blog item also hid Beth Israel Deaconess’ role in the procedure's development. A link took Levy’s readers to the website of the device's manufacturer, Asthmatx of Mountain View, CA, which is sponsoring the clinical trial. The Asthmatx website contained a page listing the 32 clinical trial sites on five continents, including arch-rival Brigham and Women's Hospital in Boston. Neither Levy's blog nor the Asthmatx website revealed that Beth Israel Deaconess was also one of those sites, having announced its role a year ago in a press release. The hospital is also listed as a trial site in the government's clinical trials registry. Levy also failed to mention that his hospital has had a consulting contract with Asthmatx or its predecessor company at least since 2001, according to documents filed last year with the Securities and Exchange Commission.

Most medical journals have long required that physicians conducting clinical trials for the private sector reveal those conflicts of interest when publishing studies. Newspapers and electronic journalists in recent years have followed suit when reporting on medical advances. But the blogosphere operates without rules, even when the blogger runs one of the nation's leading teaching hospitals.

Green Chemistry Bill Soars through House Committee

The House Science and Technology Committee last Wednesday approved a bill that would allocate nearly $200 million over three years for green chemistry research and development. Although the field, which seeks to develop environmentally benign chemicals for eventual replacement of toxic compounds currently in use, has been in development since passage of the Pollution Prevention Act of 1990, it has received little government attention or support. The Green Chemistry Research and Development Act next goes to the House floor, where it has passed by large majorities twice in previous years before being hung up in the Senate on procedural matters.

The EPA’s existing program, which encourages partnerships with industry, lists the American Chemistry Council as a partner. This chemical industry trade association blasted a 2006 University of California-Berkeley report prepared for the state legislature that criticized chemical policies in California and the nation for their inadequate environmental safeguards and failure to promote investment in green chemistry. According to Terry Collins, a leading green chemist at Carnegie Mellon University, “We’re asking the system to make substantial changes to protect human health and the environment, and we’re going to have to get rid of a whole lot of products. Green chemistry is proposing changes that are sometimes very hard for companies to deal with.”

Former Surgeon General Decries Administration Censors

Former U.S. Surgeon General Richard Carmona last week told a House committee that Bush administration political appointees repeatedly prevented him from speaking out on public health issues like stem cell research, contraception and abstinence-only sex education. Carmona decried the Administration’s marginalization of “science for reasons driven by changing political winds.” The day after the hearing, Sen. Edward Kennedy (D-MA) and Rep. Henry Waxman (D-CA) demanded documents from the U.S. Department of Health and Human Services that Carmona said revealed administration interference in his work. Waxman also announced plans to introduce the Surgeon General Independence Act, which will protect the office from political interference. Meanwhile, the Senate Health, Education, Labor and Pensions Committee held a confirmation hearing for Bush’s new pick for the post, James W. Holsinger of Kentucky, a former Veterans Administration physician. At the hearing Holsinger disavowed his 1991 paper on male homosexuality, and pledged to resist efforts to politicize the office.

Odds and Ends

China executed Zheng Xiaoyu, the head of its Food and Drug Administration, for taking bribes from drug companies to approve unsafe products. . . Sen. Barbara Boxer (D-CA) told EPA administrator Steven Johnson at a hearing last week that “instead of listening to science, the Administrator seems to be listening to the wish lists of polluting industries” when it comes to ozone pollution. . . Sen. Charles Grassley (R-IA) sent a letter last week to National Institutes of Health director Elias Zerhouni demanding that whistleblowers get legal protection. The letter was prompted by a Washington Post article reporting low morale and fear of retribution by director David Schwartz at the National Institute of Environmental Health Sciences.

Cheers and Jeers

  • Cheer: to the New York Times for disclosing that Gregory Simon of the Center for Health Studies in Seattle, whose research reportedly showed that antidepressant drugs do not increase the risk of suicide among new recipients of the drugs, had received research funding from the pharmaceutical industry.
  • Jeer: to the New York Times for failing to disclose in the same article that David Shaffer of Columbia University, described as uninvolved in Simon’s study but supportive of its findings, has served as a consultant for antidepressant makers Pfizer and GlaxoSmithKline and an expert witness for several drug companies.