Integrity in Science Watch|
Week of 07/24/2006
CSPI Study Reveals One in Five NAS Advisory Panelists Has Conflicts of Interest
The forum also addressed conflicts of interest at the Food and Drug Administration and the Environmental Protection Agency. FDA deputy commissioner Scott Gottlieb claimed that banning scientists with conflicts from serving on FDA advisory panels (such a bill, sponsored by Rep. Maurice Hinchey, D-NY, has passed the House) would rob the agency of needed expertise. He announced plans to improve the FDA's process for forming advisory panels by making the process more transparent and making the conflict-of-interest definition more specific. Steven Nissen, a cardiologist at the Cleveland Clinic who previously chaired an FDA advisory committee, took the "intermediate position" that "full disclosure of all financial relationships and careful screening of participants" is key to strong, scientific advice. Goozner responded by saying that unconflicted scientists with the requisite expertise were available and "the FDA should work harder to find scientists without conflicts of interest to serve on its advisory committees. While greater transparency is laudable, the real way to rebuild trust in the agency's deliberations is to end these conflicts entirely," he said.
James Conrad, assistant general counsel at the American Chemistry Council defended the integrity of those scientists with ties to industry who have been selected for Environmental Protection Agency science panels. David Michaels, director of the Project on Scientific Knowledge and Public Policy at George Washington University, remarked that "it is undeniable that having a financial interest in the outcome can have a profound effect on the way a scientist interprets scientific data."
A transcript of the forum will be available online within three to five days at: www.integrityinscience.org
Nearly one out of every five scientists appointed to a National Academy of Sciences (NAS) panel has direct financial ties to companies or industry groups with a direct stake in the outcome of the study, a report released at a Center for Science in the Public Interest forum today said. Moreover, the CSPI study found that 66 of 320 scientists on 21 NAS panels had a pro-industry bias due to their extensive financial ties to industry, while only nine were aligned with environmental or health-oriented non-profit groups. About half of the panels evaluated had some scientists with readily identifiable biases who were not offset by scientists with alternative points of view. "The NAS needs to be more transparent, work harder to find scientists without conflicts of interest and do more to balance its committees," said Merrill Goozner, director of CSPI's Integrity in Science Project and co-author of the report. Frederick Anderson, a frequent NAS panelist and a law partner at McKenna Long & Aldridge, said CSPI was engaged in a "witch hunt" against scientists with ties to industry and dismissed the report's findings as a "definitional problem." NAS does not consider a scientist as having conflicts of interest if his or her financial relationship ended before the start-up of the panel. CSPI used a five-year time frame for considering financial ties, which is comparable to the financial conflict-of-interest disclosure policy at the Journal of the American Medical Association.
One in Five FDA Scientists Asked to Manipulate, Exclude Data, Survey Finds
One-fifth of Food and Drug Administration scientists have been pressured to alter or exclude their findings for nonscientific reasons and forty percent said they are afraid to publicly raise concerns over the agency's public health policies, according to a survey released last week by the Union of Concerned Scientists. Nearly 1,000 out of 6,000 FDA scientists responded to the mail survey. Specific FDA departments, like the Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH), found approximately 75 percent of scientists were not at all or only somewhat confident that "FDA adequately monitors the safety of products once they are on the market." Sixty-one percent of the survey's respondents knew of cases where political appointees at FDA departments, such as Health and Human Services, had "inappropriately injected themselves into FDA determinations or actions." "These disturbing survey results make it clear that inappropriate interference is putting people in harm's way," said Francesca Grifo, director of UCS's Scientific Integrity Program. UCS recommended that the FDA increase the transparency of its scientific research and protect government employees who speak out about scientific issues.
Did FDA Rat Out Internal Whistleblower?
The Food and Drug Administration told Merck that one of its safety officials was about to go public with Vioxx' dangers a month before the drug was pulled from the market, according to internal FDA emails obtained by the Associated Press. The agency responded that such notifications are routine. Then, after the drug was withdrawn, the FDA's Brian Harvey recommended to Merck's Ned Braunstein that the company "issue an official rebuttal" to FDA safety officer David Graham's analysis that Vioxx raised users' heart attack risk. Last week, Sen. Charles Grassley (R-IA) asked the inspector general of the Health and Human Services Department to investigate. "That Dr. Graham was and is a critic of the FDA. . . does not mean the FDA should scheme with drug sponsors to discredit its own employees," Grassley wrote. The FDA must maintain a "clear, bright line between the regulated and the regulator."
Pro-Drug Slant Found in Industry-Funded Psychiatry Studies
Reports on industry-funded clinical trials that appear in the nation's four leading psychiatry journals are much more likely to show favorable results than reported trials not funded by industry, a report from Beth Israel Medical Center in New York showed. Dr. Robert Kelly Jr. and colleagues looked at 301 journal articles that reported clinical trial results for 542 drugs over a ten-year period. They found that industry-funded trials favored the sponsor's drug 79 percent of the time while independently-funded trials reported favorable results just 48 percent of the time. The survey was reported in the July issue of Clinical Psychiatry News.
Top Medical Journals Continue to Let Conflicts of Interest Slide
Two leading medical journals stated last week that they had failed to disclose authors' financial ties to drug and device makers when publishing studies about the products. The journal Neuropsychopharmacology said it plans to issue a statement correcting its disclosure lapse for the authors of a review favoring a new implant device to treat depression by administering electric pulses. Eight of the nine authors were consultants for Cyberonics, Inc., the company that makes the device. One of those authors was Charles Nemeroff, editor of Neuropsychopharmacology. He recused himself from the editing and peer review process. The ninth author of the review was an employee of Cyberonics. Meanwhile, the editor in chief of the Journal of the American Medical Association, Catherine DeAngelis, posted an online correction explaining the omission of six authors' financial ties to makers of heart and migraine-related treatments after publishing their study connecting migraines to heart attack rates in women. This was the third such occurrence at JAMA this year.
"If all leading journals agreed to punish authors who fail to reveal their conflicts by refusing to accept further manuscripts from them, a lot more authors would be inclined to fess up," the New York Times editorialized in response to the revelations. "Better yet, journals should try much harder to find authors free of conflicts. That is the best hope for retaining credibility with doctors and the public."