In response to the New York state lawsuit against a pharmaceutical company for allegedly concealing information about the safety and efficacy of an anti-depressant drug, the American Academy of Child and Adolescent Psychiatry (AACAP) affirms its support for policies that require the registration of clinical trials and the release of all clinical research data. Child and adolescent psychiatrists must be able to treat patients with the security of knowing the medications are safe and effective. To generate that security the AACAP has taken steps to support its members and protect all patients.
In response to the two FDA warnings on antidepressant medications, the AACAP leadership immediately provided members with all available information on the warnings. A special panel of FDA officials, pharmaceutical industry representatives and AACAP researchers was convened by the AACAP at its annual scientific meeting to discuss warnings and the steps being taken.
In June 2003, AACAP submitted a resolution to the AMA House of Delegates asking the AMA to study the impact of funding sources on the outcome, validity and reliability of pharmaceutical research; and to develop guidelines to assist physician-researchers in evaluating and preserving the scientific integrity, validity and reliability of pharmaceutical research, regardless of the funding source. The AMA report on this request will be considered at the June 11 – 16, 2004 Annual Meeting in Chicago. The report makes four recommendations, including three new AMA policies that would prevent funding sources from impeding publication of all research findings.
AACAP presented at the February 2004, FDA advisory panel hearing on child and adolescent suicidality and anti-depressant drugs. Laurence Greenhill, M.D., the AACAP representative, asked the FDA to help assure that, if medications are used in treatment, they are safe and effective. AACAP recommendations included the request for the mandatory registration of clinical trials as written by Drummond Rennie in JAMA.
For the June 2004 AMA House of Delegates, the AACAP has submitted a resolution asking the AMA to report on the issue of access to FDA data regarding the safety and efficacy of medication, and to develop recommendations to improve access to clinically relevant research collected by the FDA.
The onslaught of information and charges surrounding the use of antidepressants in treating children with serious depression has been confusing and frightening. Child and adolescent psychiatrists know that these medications improved the lives of many children and that it would be tragic if the current messages deter parents from seeking the treatment their children need.
The FDA’s decision to ask Columbia University to review the research data and to determine whether SSRIs may increase suicidal behavior in some children is an important step towards better understanding of medications for depression.
In the interim, AACAP President Richard Sarles, M.D., states, “It is imperative that families and physicians monitor any child who is taking an antidepressant for changes in the level of depression or other new behaviors. Early detection and early treatment is the best course with depression, and mental health for all children is what our young people deserve. AACAP will work toward this end.”
For additional information contact Kathy Pasley, 202.966.7300 extension 120, or Mary Crosby, extension 127.
