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October 22, 2007

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Integrity in Science Watch

Week of 10/22/2007

IOM to Offer Guide for Managing Medical Conflicts of Interest

A new committee of the prestigious Institute of Medicine will begin meeting next month to develop guidelines for managing conflicts of interest in medical research, education and practice. The IOM's tentative appointments to the 15-member panel include three members granted conflict-of-interest waivers because of their ongoing ties to drug and medical device companies, and at least one other with recent ties to industry that were neither waived nor revealed on the IOM website. "Our policies on what constitutes a conflict of interest for which a waiver might be requested focus on current financial relationships rather than on past relationships," said Marilyn Field, the IOM staffer coordinating the panel.

The proposed members of the committee who have current conflicts of interest include James Childress, a professor of ethics at the University of Virginia, who consults for Roche and Johnson & Johnson; Peter B. Corr, who recently retired from a top science position at Pfizer, Inc., where he still owns stock; and Todd Dorman, director of continuing medical education at Johns Hopkins Medical Institutions, who owns stock in and consults for medical device firms. His medical education program also receives funding from medical product companies. Another proposed panel member, Deborah Grady, a professor of medicine at the University of California at San Francisco, revealed in articles she wrote last year that she had recently received fees for serving on the safety monitoring boards of Organon and Intarcia Therapeutics, received grants from Berlex, Bionovo, Eli Lilly, and Pfizer, and received salary support from Merck and Wyeth-Ayerst Research. Those relationships were not considered conflicts by the IOM.

A 2006 report by the Center for Science in the Public Interest exposed loopholes in the conflict-of-interest disclosure policy at the National Academies, which includes the IOM. The report recommended that instead of using a standard that says a conflict must be current to warrant disclosure and waivers, the IOM should move to a policy more in line with the Journal of the American Medical Association, which requires that any conflicts within the past five years be disclosed, or the New England Journal of Medicine, which uses a two-year look back period. "Hopefully, this new panel will include a thorough review of the IOM's own policies," said Merrill Goozner, director of the Integrity in Science project at CSPI, in a letter sent today to the agency's leadership. The letter also noted the proposed committee’s failure to include prominent researchers in the field, some of whom have been critical of excessive industry ties to the medical profession. The absence of experts like Jerome Kassirer, former editor of NEJM, Sheldon Krimsky of Tufts University, Lisa Bero of UCSF, or Eric Campbell of Massachusetts General Hospital "detracts from the purported balance of a committee that has been asked to come up with a consensus," the letter stated.

Comments on the IOM's proposed committee are due October 31 and can be filed on its website.

Med School-Industry Ties Exposed; Influence Denied

A majority of department leaders at the nation's 125 medical schools and 15 large teaching hospitals have significant ties to health care companies, according to a new survey published last week in the Journal of the American Medical Association (subscription required). Among the 459 department chairs responding to the 2006 survey, 27 percent worked as consultants for individual companies or served on advisory boards; 14 percent received cash from speakers' bureaus; and 11 percent served on corporate boards of directors. In all, about sixty perecent of department heads had some ties to industry. The academic leaders were also asked to evaluate the impact that corporate grants and research funding had on their departments' ability to deliver unbiased education. Only 20 percent thought that small restricted grants (less than $10,000) negatively influenced training for faculty and medical students. That number rose to 42 percent if the grants were up to $100,000, and over 50 percent if greater than $100,000. But if the grants were unrestricted, just 21 percent thought it biased the education experience, even if the grant was up to $100,000. "These findings illustrate the common misconceptions that small gifts are less influential than larger gifts and that unrestricted gifts are less influential than restricted gifts," wrote Eric Campbell of the Institute of Health Policy at Massachusetts General Hospital and colleagues. The research was financed by the Greenwall Foundation.

Scientists Accuse DuPont of Distorting Study Results

Emails made public in federal court in West Virginia reveal that Dupont misrepresented the findings of its Epidemiology Review Board, a team of independent experts who had looked at the health effects of the chemical C8 or perfluorooctanoic acid (PFOA). The company has used PFOA for more than 50 years at its Washington Works plant south of Parkersburg, primarily in the manufacture of Teflon. Following the conclusion of a study of workers at the plant, the company announced "that there are no human health effects known to be caused by PFOA," and said that the study had been reviewed by the independent panel. E-mails released as part of a lawsuit over PFOA pollution in drinking water near the plant show that members of the expert team called Dupont's statements "somewhere between misleading and disingenuous," and said that members of the team "were unanimous in believing that the results do show a health effect."

Effort in Congress to Void Medical Decision Decried

A coalition of consumer groups led by Consumers Union last week opposed a House resolution that would override a medical decision by the Center for Medicare and Medicaid Service to cut off payment for overuse of drugs that raise red blood cell counts in cancer patients. The Food and Drug Administration last spring issued a black box warning against overusing the drugs after clinical trials showed too high red blood cell counts spurred tumor growth and increased mortality in some patients. The new CMS payment restrictions soon followed. Last week, the FDA wrote a letter to Rep. Pete Stark (D-CA) and Rep. Henry Waxman (D-CA) indicating that CMS’s new payment policy was in line with the new label. The move prompted a lobbying campaign in Congress to overturn the CMS decision by the companies that sell the drugs, Amgen and Johnson & Johnson. They were joined by the American Society of Clinical Oncologists, which represents cancer physicians whose earnings come in part from sale of the drugs. ASCO also released a new clinical practice guideline today to support its claim that the CMS payment policy goes beyond the FDA black box warning. Five of 13 members of the guideline-writing committee, including ASCO co-chair Alan E. Lichtin, have financial ties to either Amgen or J&J. Lobbying Congress "is not the proper venue for their objections," noted the consumer groups' letter. "In late September, CMS invited ASCO to submit evidence to support the agency reopening its coverage decision. It is altogether fitting and proper that physicians in community practice and physicians at CMS who determine payment policy adjudicate their differences in this manner, rather than through Congressional intervention."

Tobacco Giants Sullied Secondhand Smoke Studies

A new study in Circulation shows that the tobacco industry has systematically suppressed and distorted the results of research showing links between heart disease and second-hand smoke. The study, by Eliza Tong of the University of California at Davis and longtime U.C. San Francisco tobacco researcher Stanton Glantz, shows that the tobacco industry discontinued funding researchers who found secondhand smoke contributed to clogged arteries, failed to publish results of other studies showing health effects from exposure, and presented studies showing no harmful effects as "peer-reviewed" when in fact they were reviewed by industry employees. The study documents how the tobacco industry's current research priorities focus on promoting so-called "reduced harm" smokeless tobacco products, without implicating secondhand smoke as having serious health consequences. The study is the result of the researchers' examination of over 5,000 internal tobacco industry memos, letters, and scientific reports that were made public as a result of legal settlements in recent years and are archived in UC San Francisco's Legacy Tobacco Document Library

EPA Ignored Scientists, Suit Charges

Fourteen U.S. states and three environmental groups last week filed a lawsuit against the Environmental Protection Agency (EPA) for failing to heed the advice of its own experts on particulate matter air pollution. The plaintiffs argue that the agency, in failing to tighten the national standard from 15 to 13-14 micrograms per cubic meter as recommended by its Clean Air Scientific Advisory Committee (CASAC), behaved in a manner that was "arbitrary and capricious" under Clean Air Act requirements that the agency set a standard that protects human health and the environment. The agency's decision last year was widely criticized, including by one member of CASAC who commented that EPA may have "illegally made an important regulatory decision without obtaining advice as to its scientific soundness from its congressionally-mandated scientific advisers." The states announced their intention to sue last year, after the agency refused to tighten the PM standard despite the agency's own impact analysis revealing that doing so could save thousands of lives annually.

Odds and Ends

California Gov. Arnold Schwarzenegger, ignoring pressure from the National Rifle Association, signed legislation that will outlaw lead ammunition within the range of the California Condor, which scientists believe is a major cause of the species' decline. . . Psychiatrist John E. Simon of Minnesota will resign from a panel that makes drug recommendations for the state Medicaid program after the Minnesota Psychiatric Society expressed discomfort with his having received over $350,000 in speaking and consulting fees from pharmaceutical firms, the New York Times reports. . . ABC News reports that Tachi Yamada, the current head of the Gates Foundation's global health initiative who previously worked with SmithKline Beecham, was involved in efforts to suppress findings of a link between heart disease and the drug Avandia. E-mails recently released by Sen. Charles Grassley (R-IA) show that Yamada participated in discussions at SmithKline Beecham about lawsuits, publicity campaigns, and other means of silencing researcher John Buse, whose findings of Avandia’s dangerous side effects were later replicated in the New England Journal of Medicine. . . The Office of Research Integrity in the US Department of Health and Human Services has discovered that Norwegian dental researcher Jon Sudbo, who practices dentistry in Seljord, Norway, falsified data on the preventive effects of ibuprofen on oral cancer in his grant application to the National Cancer Institute, in his PhD thesis and in papers published in the New England Journal of Medicine and The Lancet . . . Responding to shipping industry pressure, the White House through the Office of Science and Technology Policy continues to raise scientific objections to a new National Oceanographic and Atmospheric Administration rule protecting right whales by slowing shipping traffic, the Washington Post reported. Responded NOAA's Greg Silber: "We did our homework. Our mandate is to recover an endangered species, and that's what we're trying to do."

Cheers and Jeers

  • Jeer to Ron Winslow of the Wall Street Journal for failing to note that medical device manufacturers underwrite the Cardiovascular Research Foundation, which is run by Columbia University's Martin Leon and held its annual Cardiovascular Therapeutics meeting in Washington this past weekend.
  • Cheer to the New York Times for reporting that James McGregor of the University of Southern California, chair of the Maternal Nutrition Group of the fishing industry-financed Healthy Mothers, Healthy Babies Coalition, convinced the National Fisheries Institute to give $1,000 honoraria to each of the group’s 14 members, with an extra $500 each to the group’s four executive committee members. The story also reported that the seafood industry gave $45,000 last year to the University of Maryland's Center for Food, Nutrition and Agriculture Policy to create the Web site realmercuryfacts.org, which disputes government warnings about mercury in seafood.
  • Jeer to the New York Times for running an op-ed article by Peter Pitts that only identified him as president of the non-profit Center for Medicine in the Public Interest, which "receives financing from the pharmaceutical industry." What was not disclosed was his full-time job as vice president for global affairs at Manning Selvage & Lee, a public relations firm that represents numerous pharmaceutical, health care and food firms.