AMA Votes Unanimously To Press HHS To Establish Full Disclosure On Drug Trials

About 540 American Medical Association members at the group's annual meeting on Tuesday unanimously approved by voice vote a resolution urging HHS to create a national database for all clinical trials and their outcomes, the Philadelphia Inquirer reports. The resolution aims to "give doctors and consumers more complete information about the drugs, including possible side effects not mentioned in the public literature" and to disclose all trial results, including negative ones, according to the Inquirer. Currently, drug companies must submit all clinical trial results to FDA, but the agency is prohibited from disclosing all the information because it is considered proprietary (Smith/Loyd, Philadelphia Inquirer, 6/16). FDA officials also must receive the drug maker's consent before making results public (Wall Street Journal, 6/16). In some rare instances, FDA officials can publicize information if they deem it necessary for the public to know (Heldt Powell, Boston Herald, 6/16). In addition to changing FDA policy and creating a public federal database for all clinical studies, the resolution recommends that research review boards at hospitals, universities and medical centers mandate registration as a condition of approval (Meier, New York Times, 6/16). The resolution also suggests that institutional review boards, which monitor participants in clinical trials, require registration in the federal database before allowing studies to proceed (Wall Street Journal, 6/16).

AMA members said the resolution comes as a result of concerns that drug industry trial sponsorship might be affecting the quality of research and the breadth of results that are published (New York Times, 6/16). Pharmaceutical companies and other for-profit groups fund more than 80% of medical studies nationwide, which critics say contributes to the "hid[ing of] bad news," USA Today reports (Davis, USA Today, 6/16). An AMA scientific committee has studied patterns in research publications, finding that positive studies were more likely to be published -- especially those testing drugs against placebos, which are more likely to show a positive effect. The panel also found that researchers are more likely to seek publication when their research produces positive results because "scientific journals tend to favor such studies," the Boston Globe reports (Mishra, Boston Globe, 6/16). "We are concerned that this pattern of publication distorts the medical literature, affecting the validity and findings of systematic reviews, the decisions of funding agencies and, ultimately, the practice of medicine," Dr. Joseph Heyman, an AMA board of trustees member, said (New York Times, 6/16).

The resolution "adds a strong voice to a growing swell of critics of the drug industry's resistance to disclosing negative test results," according to the Inquirer. The vote comes after New York Attorney General Eliot Spitzer (D) this month filed a lawsuit against GlaxoSmithKline, alleging that the pharmaceutical company since 1998 withheld negative trial information about its antidepressant Paxil's side effects on children and adolescents and misinformed sales staff about its effectiveness. The International Committee of Medical Journal Editors, which includes 12 major medical publications including the New England Journal of Medicine and the Journal of the American Medical Association, is also working on a proposal that is anticipated this summer or fall and would require registration of all clinical trials in a public database or registry as a condition for publication consideration. Drug companies would still be able to publish unregistered research in journals that are not members of the committee, but those journals are "not ... as prestigious," and publication elsewhere would not be "as effective as a marketing tool," the Inquirer reports (Philadelphia Inquirer, 6/16). JAMA editor Catherine DeAngelis said the editors' proposal could help journals deliver more balanced research coverage (USA Today, 6/16).

If FDA had the authority to publish all clinical trial results, such a listing would be difficult to manage, Rachel Berhman, deputy director for medical policy at FDA's Center for Drug Evaluation and Research, said (Wall Street Journal, 6/16). The drug industry previously has resisted developing a public database, and on Tuesday it "hinted ... it might continue to do so," the Inquirer reports. "This has the potential to cause a great deal of confusion," Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America said (Philadelphia Inquirer, 6/16). However, he added that it is too early to tell whether the group will oppose the plan because of several questions about the proposal (Wall Street Journal, 6/16). Wyeth spokesperson Lowell Weiner said the company has not yet seen the proposal and could not comment, but company officials stressed that they already disclose results of all trials, regardless of outcome. GSK spokesperson Mary Anne Rhyne said the company plans to create its own registry of summary data that it will post online (Philadelphia Inquirer, 6/16). Mark Trusheim of the Massachusetts Biotechnology Council said that while the registry "sounds wonderful on the surface ... as you peel it back a bit, it's not going to be helpful." He added, "It will increase caution and cost for biotech companies and extend the time frame to get drugs tested and approved. You don't do real experimentation because you're afraid of making a mistake" (Boston Herald, 6/16).

In related news, Kentucky Gov. Ernie Fletcher (R) was scheduled to speak on Tuesday at the AMA convention in lieu of President Bush, the AP/Louisville Courier-Journal reports. His speech was to address Medicare, Medicaid, malpractice insurance rates and prescription drug costs. Presumptive Democratic presidential nominee Sen. John Kerry (Mass.) also selected a representative to address the conference (AP/Louisville Courier-Journal, 6/15).

NPR's "All Things Considered" on Tuesday reported on efforts by medical journal editors to establish a public registry of clinical trial results. The segment includes comments from DeAngelis; Arnold Relman, former editor-in-chief of the New England Journal of Medicine; and Kevin Schulman, a professor at Duke University (Prakash, "All Things Considered," NPR, 6/15). The complete segment is available online in RealPlayer.