AMA Backs All-Inclusive Clinical Trials Registry

Members of the psychiatry delegation to the AMA's House of Delegates were in the forefront of what appears to be turning into a national movement to open pharmaceutical company and Food and Drug Administration (FDA) data on safety and efficacy of medications to scrutiny by physicians and the general public.

In an action that has received national media attention, AMA delegates approved a report calling on the federal government to establish a registry for all clinical trials conducted in the United States. The report by the AMA's Council on Scientific Affairs was issued in response to a resolution introduced at last year's meeting of the House of Delegates by APA and the American Academy of Child and Adolescent Psychiatry (AACAP) (see Original article: page 19).

In a related action, the house passed a resolution—also introduced by APA and AACAP—asking the AMA to study the issue of enhancing access to FDA data on safety and efficacy of medications and to develop recommendations to improve access to those data.

Bias Exists in Published Literature

But it was the call for a clinical trials registry that captured the spotlight at last month's annual meeting of the House of Delegates in Chicago.

The new registry would ensure that trials with negative as well as positive results are publicly available by providing every clinical trial with a unique identifier and ensuring inclusion in an electronic database.

During reference committee hearings, where reports and resolutions are first aired for debate and testimony by any house member, child and adolescent psychiatrist David Fassler, M.D., said there is a bias in the published literature toward studies with positive findings that can ultimately influence practice patterns.

“Physicians need and deserve as much access to data as possible,” he said.

In an interview with Psychiatric News, Fassler said the Section Council on Psychiatry was able to emphasize to fellow physicians in the house that problems around publication bias were not confined to psychiatry (see box on Original article: page 44).

“There is considerable evidence, for instance, of publication delay and bias affecting practice patterns around the use of medications to treat cardiac arrhythmias,” he said.

But Fassler said the issue was brought to the section council's attention by psychiatrists who were concerned about publication bias, and he noted that the AMA action underscored the vital importance of involvement with organized medicine.

The companion resolution seeking AMA recommendations on improving access to FDA data on safety and efficacy arose in part from publicity surrounding reports of suicide risk associated with the use of SSRIs in children and adolescents. Fassler told Psychiatric News that in a February meeting with the FDA, data were made available from 25 studies—some of which were never published—raising questions about the safety and efficacy of SSRIs in children and adolescents (Psychiatric News, March 5).

“The general impression is that SSRI antidepressants can be extremely helpful for some, but not all young people,” he said. “But it is critically important to have access to data from all the studies with respect to safety and efficacy, both for clinical practice and to inform the design of future studies.”

Companies, Journals May Support Registry

Merck was one of the pharmaceutical companies that said it supports the idea of a registry of clinical trials, and the International Committee of Medical Journal Editors—which includes representatives from leading journals such as the Journal of the American Medical Association, New England Journal of Medicine, and Lancet—has said it may consider requiring trials to be listed in a registry before results are considered for publication.

Prior to the AMA house action, that committee had on its Web site extensive“ uniform requirements” for manuscripts submitted to medical journals that included the following statement:

“Editors should consider seriously for publication any carefully done study of an important question, relevant to their readers, whether the results are negative (that is, convincingly allow the null hypothesis to be accepted) or positive (that is, allow the null hypothesis to be rejected). Failure to submit or publish negative studies, in particular, contributes to publication bias. Many studies that purport to be negative are, in fact, inconclusive; publication of inconclusive studies is problematic, since they add little to biomedical knowledge and consume journal resources.”

The statement is posted online at<www.icmje.org>.

AMA Trustee Joseph M. Heyman, M.D., said the organization is encouraged by early signs of support for a clinical trials registry.

“The AMA announced... that it would call on the Department of Health and Human Services to create a comprehensive, centralized clinical trials registry so that scientists, investigators, and clinicians could easily find information on trials,” Heyman said. “Posting the results of such trials would address growing concerns over publication and outcome bias in clinical trials. The AMA further called on all institutional review boards to make registration in this database a condition of approval.

“We hope that all pharmaceutical companies will follow Merck's lead in deciding to support the AMA's call for a national registry,” he added. “The AMA also welcomes the recent news that the International Committee of Medical Journal Editors may be considering a proposal that would require trials to be listed in a registry before the results would be considered for publication.”

House Supports Partner Co-Adoption

In other actions taken by the house, the psychiatry delegation provided strong support to a resolution introduced by the Medical Student Section calling for legislative and other efforts to allow adoption of a child by a same-sex partner, or opposite sex nonmarried partner, who functions as a second parent or co-parent to the child.

The resolution was passed by the house easily.

On the floor of the house, Fassler emphasized scientific data supporting the notion of partner co-adoption.

“This is an issue on which we really do have solid science,” he said. “Research demonstrates that children raised by same-sex parents do just as well as children raised in more traditional families.”

He read from a 1999 AACAP statement on the issue and added, “Outcome studies show that children do better with two caring and consistent parents in their lives. Passing this resolution underscores our commitment to the emotional health and well-being of children. It also sends a clear and important message that our AMA places science ahead of personal beliefs or political agendas.”

Delegates also passed a resolution, introduced by APA and other groups, to return to Honolulu, Hawaii, for the House of Delegates interim meeting in 2007 or 2008 (see next issue).

Other Actions

These other issues were also addressed by the house: