An announcement that comes amid "growing clamor" for increased transparency in clinical trial reporting, the Boston Globe reports (Rowland, Boston Globe, 9/8).

PhRMA's database would publish results within a year of their conclusion; would feature only summaries of unpublished studies; would exclude some data, such as early stage studies and unfinished trials; would include trials not published in medical journals; and would contain only trials completed after Oct. 1, 2002 (Kaiser Daily Health Policy Report, 9/7).

The site also would not publish trials that are still enrolling patients or details from trials on drugs that fail to receive FDA approval (Henderson, AP/Atlanta Journal-Constitution, 9/8).

PhRMA said that along with recent actions from GlaxoSmithKline, Merck and Eli Lilly, which recently announced they are creating separate trial registry Web sites, all major drug companies have now committed to making public trial information.

According to the Globe, PhRMA's announcement "follows months of criticism" from patient advocates and others that drug companies have "downplay[ed]" negative clinical trial results (Boston Globe, 9/8). GSK last month agreed to settle a lawsuit filed by New York Attorney General Eliot Spitzer (D) that will require the company to post all of its clinical trial results online by the end of 2005.

The lawsuit alleged that GSK withheld data from clinical trials that indicated the antidepressant Paxil is no more effective in adolescents and children than a placebo and in some cases is more likely than a placebo to cause suicidal thoughts (Kaiser Daily Health Policy Report, 9/7).

PhRMA's Reasons

American Medical Association Trustee Dr. Ronald Davis said, "People have been concerned for quite some time that nondisclosure of unfavorable studies has skewed the scientific literature and possibly medical practice. But recently, tangible evidence of that concern has arisen" (Meier, New York Times, 9/8).

PhRMA said that its announcement, coming two days before a congressional hearing on clinical trial reporting, was not a reaction to "public pressure," the Globe reports. Caroline Loew, PhRMA vice president for scientific and regulatory affairs, said, "The Web site today is really part of a much longer, ongoing initiative that we have taken over the past three years," adding that the site "is not a direct response to the ongoing congressional environment" (Boston Globe, 9/8).

Alan Goldhammer, PhRMA associate vice president for regulatory affairs, said, "We made a conscious decision to address one specific issue with this database -- the transparency of clinical trial results" (Silverman, Newark Star-Ledger, 9/8). Goldhammer added, "It is going to fulfill the needs of practicing physicians."

Reaction

Some medical journal editors and health providers called PhRMA's proposal an "inadequate solution because it would not specify, among other things, when and how tests would be reported," the Times reports. New England Journal of Medicine Editor Jeffrey Drazen said the proposed site would be "self-serving" (New York Times, 9/8).

Drazen added that the industry offering was "too little, too late" and would not be effective because companies would feel no need to report negative studies on a voluntary registry (AP/Atlanta Journal-Constitution, 9/8).

Marcia Angell, former editor in chief of NEJM, said the proposal does not go far enough because the Web site will not include interim changes in studies. "The reason for registering trials at inception is so that sponsors cannot decide to make changes as the trial progresses -- for example, shorten the duration of the trial if a drug looks effective early but not later," Angell said, adding, "Such a registry will not address the problem of biased publication."

David Fassler, a University of Vermont psychiatrist who wrote an AMA resolution calling for a mandatory national registry, said the PhRMA proposal is a step in the right direction, but a registry ultimately "needs to be overseen by an independent entity, with or without government oversight" (Newark Star-Ledger, 9/8).

Congressional Action

The House Subcommittee on Oversight and Investigations on Thursday will hold a hearing "where several drug makers are expected to be lambasted" for refusing to disclose negative clinical trial results related to antidepressant use in adolescents, the Star-Ledger reports (Newark Star-Ledger, 9/8).

Sen. Edward Kennedy (D-Mass.) and Rep. Henry Waxman (D-Calif.) are expected to introduce separate bills within the next few weeks that would regulate mandatory clinical trial reporting (Kaiser Daily Health Policy Report, 9/7).

Waxman, along with Rep. Edward Markey (D-Mass.) could introduce a bill as early as Thursday, the Times reports. According to the Times, AMA has been working with HHS to develop legislation that would create a mandatory, regulated registry of trials. Under the AMA proposal, trials would need to be registered before receiving approval from institutional review boards, which is required for all studies involving human subjects. PhRMA has said it believes legislation on the matter is unnecessary (New York Times, 9/8).

Medical Journal Editors' Proposal

Meanwhile, a group of medical journal editors at Thursday's congressional hearing is expected to announce that they will require clinical trials to be registered with a national registry before they will consider publishing articles based on those trials, the Times reports. Although the International Committee of Medical Journal Editors has not yet released details of its proposal, the group since June has signaled that it "planned a major shift in publication policy," the Times reports (New York Times, 9/8).

The editors' proposal would follow last week's announcement from NIH that the agency planned to make available at no cost to the public the results of all NIH-funded research six months after the work is published in a scientific journal. The proposal, which NIH has been considering for more than a year, would require federally funded researchers to submit their papers to the agency after they have been accepted for publication and edited by a journal (Kaiser Daily Health Policy Report, 9/7).

Davis said the editors' move would be an important step to ensure consistency in trial reporting but is not a final solution. "If you have 10 journals following such a policy but 500 others that are not, then trials that are not registered" may not be disclosed, Davis said (New York Times, 9/8).

Forest Laboratories Agrees To Post Trial Data

In other trial reporting news, Spitzer on Tuesday said Forest Laboratories had responded to an investigation into its trials by agreeing to create an online registry and post summaries of all of its studies conducted after Jan. 1, 2000, as well as some earlier studies, the Wall Street Journal reports (Windham, Wall Street Journal, 9/8).

Spitzer in June sent a request to Forest asking for additional information about its drug promotion practices and off-label clinical trials. In a study published in the American Journal of Psychiatry, data showed that Forest's antidepressant Celexa could help some young people with depression. However, Forest had come under fire for failing to publish results of a second study on the safety and efficacy of Celexa in children that contained less-positive results than those in the published study (Kaiser Daily Health Policy Report, 9/1).

Under the agreement, Forest is required to post its summaries by Dec. 31, 2005. Spitzer said Forest's move "continues the trend toward disclosure of clinical testing data so that doctors will be in position to make informed determinations." He added, "We're going to keep going until we can persuade all companies to participate" (Wall Street Journal, 9/8).