JAMA Editors May Ban Authors Who Hide Financial Ties
Amid revelations that Merck employed ghost-writers on dozens of published Vioxx studies and that a company-funded review allegedly manipulated data to hide the drug’s dangers, the editors of the Journal of the American Medical Association last week called for steeper penalties on authors who fail to disclose conflicts of interest, hide or manipulate data, or claim to have done work actually done by others. The proposed penalties ranged from requiring public letters of apology to a ban on publishing in the journal. “When integrity in medical science or practice is impugned or threatened—such as by the influence of industry—patients, clinicians, and researchers are all at risk for harm, and public trust in research is jeopardized,” editor-in-chief Catherine DeAngelis and deputy editor Phil Fontanarosa wrote. The editorial marks a hardening attitude by some journal editors toward repeated failures by scientists to reveal their financial ties to industry (see this week’s Cheers and Jeers below). In August 2006, DeAngelis rejected a ban on authors who failed to disclose conflicts of interest, claiming authors would simply seek out other journals. “It cleans our house by messing others,” she wrote then.
The shift was triggered by two studies in the latest JAMA, and came just a few weeks after the journal published corrections involving radiologists who failed to disclose their lung cancer screening study had been funded by the tobacco industry. One new study contended that Merck minimized deaths among patients who had been given Vioxx by manipulating pooled data contained in clinical trials involving Alzheimer’s and dementia patients. The second article found that Merck employees or a Merck contractor, Scientific Therapeutics, prepared manuscripts and then recruited academic researchers as authors. Despite playing a minimal role, the recruited academics were frequently listed as first or second authors when the articles appeared in print. Both studies relied on documents obtained in court suits. Merck rejected the studies’ findings, noting that five of the authors consulted for plaintiff attorneys and a sixth testified against Vioxx before a Senate panel. Sen. Chuck Grassley (R-IA) seized on the latest revelations to demand that Merck and Scientific Therapeutics turn over all documents related to the studies by May 2.
Medical Firms Disclosure Offers Fall Short of Proposed Bill
A dozen of the nation’s leading pharmaceutical and medical device companies announced plans last week to disclose financial gifts and grants to physicians. But nearly all stopped short of meeting requirements in legislation that was introduced in Congress earlier this month. At least one company – Schering-Plough Corp. – refused to go along with industry’s voluntary efforts. In a letter to the Senate Aging Committee, the company said it has no plans to publish charitable contributions or education grants. Sen. Charles Grassley (R-IA) and Sen. Herb Kohl (D-WI), sponsors of the Center for the Science in the Public Interest- supported Physician Payments Sunshine Act, would require drug and medical device manufacturers to publicly post all gifts and payments to doctors over $25. Although the legislation does not prohibit financial ties between doctors and drug companies, those who do not disclose those payments could be penalized at least $10,000.
Most companies’ voluntary programs fell well short of the bill’s requirements. Medtronic Inc. and AstraZeneca PLC told Grassley they will post payments for professional meetings and patient groups this summer, but not payments to individual doctors. Merck said that its plan was still being developed, while Amgen and Abbott Laboratories have formed working groups to examine the issue. Only Boston Scientific said it was developing a system to disclose payments to physicians. Zimmer Inc. and Stryker Orthopedics Inc. have reached an out-of-court settlement with the U.S. Justice Department that requires disclosure of physician payments. Watchdog groups described the industry response as inadequate and an attempt to sidetrack the legislation.
BPA Safety Concerns Continue to Grow
The National Toxicology Program (NTP) last week issued a preliminary finding that bisphenol-A (BPA) can lead cancer, hormonal and neurological problems, as well as behavioral changes in animals. The chemical, used in many plastic bottles, food containers, and linings of food cans, has been found in the urine of 93 percent of Americans. “There is some concern for neural and behavioral effects in fetuses, infants and children, at current human exposures,” the report noted. However, the draft brief emphasized that more research is needed to truly understand BPA’s impact on human health at current concentration levels. In light of the NTP report’s conclusions, the House Committee on Energy and Commerce chaired by John Dingell (D-MI), called on the FDA to reconsider the safety of BPA. "These findings of BPA's dangers are based on the totality of research around this chemical," Dingell said. "I hope the FDA is willing to reconsider their position on BPA for the safety of our infants and children." The Canadian government plans to declare BPA as toxic. Wal-mart said that its entire assortment of baby bottles will be free of the material by the early next year; and two major manufacturers, Playtex Infant Care, and Thermo Fisher Scientific said their products will be free of BPA by the end of the year.
FDA Medical Device Panel Issues Conflict of Interest Waivers
The Food and Drug Administration has issued conflict of interest waivers for three members of the Ophthalmic Devices Panel for its meetings later this week. On April 24, the panel will review an implantable miniature telescope (IMT) manufactured by VisionCare Technologies that can be used to correct vision impairment. David Musch, an associate research scientist at the University of Michigan School of the Public Health, received a conflict of interest waiver because the University of Michigan served as a site for a clinical trial of the IMT. Although Musch did not help conduct the study, his supervisor, Paul Lichtor, served as the principal investigator and the university received between $101,001 and $300,000 from VisionCare Technologies. Similarly, Neil Bressler, a professor of ophthalmology at John Hopkins University School of Medicine, received a waiver because his hospital served as a clinical site for the IMT trial and received a grant under $100,000 from the company. On April 25, the panel will discuss post-market feedback of phakic intraocular lenses and laser-assisted in situ keratomilesis (LASIK) surgery. Dale K. Hever, chairman of the Department of Ophthalmology at the Medical College of Wisconsin, received a waiver after taking a speaker’s fee of up to $10,000 and consulting for an undisclosed firm involved in the sight-correcting processes.
Odds and Ends
A half dozen consumer groups, including the Center for Science in the Public Interest, Consumers Union, and the Government Accountability Project, sent a strongly-worded protest to the Food and Drug Administration opposing a draft guidance that will govern how industry can promote the off-label use of drugs and devices. The proposal would lower the criteria and drop agency review of journal reprints on off-label uses that could be given doctors by drug and medical device industry salespeople . . . . Sen. Herb Kohl (D-WI) and Sen. Robert Bennett (R-UT) agreed last Tuesday at a Senate Appropriations subcommittee hearing that the Food and Drug Administration needs more funding. The Bush Administration has proposed increasing the agency budget for next year by only 3 percent, which FDA commissioner Andrew C. von Eschenbach, said would not even cover increased costs . . . . Organon failed to inform the FDA and the public about potentially fatal side effect of it neuromuscular blocking agent, Raplon, which was taken off the market in March 2001. Jeffrey Feldstein, the company’s associate director of medical services for antithrombotics, leveled the charges in a lawsuit filed in the New Jersey federal court against Organon and Schering-Plough, which acquired the company . . . . House Energy and Commerce Committee chairman John Dingell (D-MI) is wondering if Merck and Schering-Plough made up minutes of a November 2007 meeting of medical advisers called to discuss the cholesterol medication, Vytorin. The minutes in question were actually written in December 2007 and have been contradicted by one of the meeting’s attendees, James Stein, a University of Wisconsin professor . . . . The British Medical Journal reported last week that Andrew Wakefield, the doctor behind the late 1990s collapse of public confidence in measles, mumps, and rubella vaccine, will soon go before a General Medical Council fitness-to-practice panel. The doctor, along with the two other authors of a 1998 Lancet study on inflammatory bowel disease and autism, is accused of professional misconduct for falsifying data . . . . The EPA’s Inspector General (IG) is now investigating the agency’s much criticized decision to remove Deborah Rice from a Maine scientific peer review panel at the behest of the chemical industry trade group, the American Chemistry Council. The investigation was triggered by a letter from the EPA’s Deputy Administrator asking the IG to determine if Rice removal was consistent with existing federal laws and guidelines. The panel was reviewing the safety decabrominated diphenyl ether, a common flame retardant . . . . Leaders of the American College of Occupational and Environmental Medicine are speaking out against industry pressure to underreport workplace injuries, and have scheduled a meeting with top officials at the Occupational Safety and Health Administration next month to press their concerns, the Charlotte Observer reported.
Cheers and Jeers