Two Medical Groups To Meet With Staffs of Three Democratic Senators To Discuss Clinical Trial Database
Representatives of the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry plan to meet on Thursday with staff members of three Democratic senators who might introduce legislation that would require pharmaceutical companies to make public the results of all clinical trials in a database administered by the federal government, the New York Times reports. Both groups are members of the American Medical Association, which last week approved a resolution that calls on the federal government to establish such a database (Meier, New York Times, 6/23). The resolution seeks to provide physicians and patients with more information about the medications tested in clinical trials, such as potential side effects not mentioned in public literature, and to make public both positive and negative results. Pharmaceutical companies currently must submit all clinical trial results to FDA, but the agency cannot disclose all of the information, which is considered proprietary. FDA officials in most cases must obtain consent from pharmaceutical companies before they can make clinical trial results public (California Healthline, 6/21). APA trustee Dr. David Fassler said, "We certainly view this as a partisan issue." He added, "Physicians and patients need as much information as possible to make medical decisions."
Representatives for both of the groups called the Thursday meeting with Sens. Tim Johnson (D-S.D.), Edward Kennedy (D-Mass.) and Christopher Dodd (D-Conn.) preliminary. However, according to the Times, the meeting "suggests that a congressional debate over how the drug industry discloses and presents information about drug trials could soon unfold." Kennedy has said he plans to reintroduce a bill that would expand protections for participants in clinical trials and may also address the database issue in the legislation. In addition, an AMA spokesperson on Tuesday said that the offices of several lawmakers have contacted the group, expressing interest in the issue. A spokesperson for Sen. Chuck Grassley (R-Iowa), who has launched a congressional investigation into allegations that an FDA official did not disclose negative information about the effects of antidepressants in children, said that the senator has not decided whether to introduce legislation to address the clinical trial database issue. According to the Times, although a few pharmaceutical companies have supported calls for a clinical trial database, "a unified industry position has yet to emerge" (New York Times, 6/23).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.