BETHESDA, Md. (PRWEB) September 23, 2008
While off-label uses are legal and in many instances may be in the best interests of patients, they have not received the same degree of independent scrutiny through randomized clinical trials as have approved indications. A drug approved for marketing may be labeled, promoted and advertised by the manufacturer for only those uses for which the drug's safety and effectiveness have been established by the FDA. The economic implications of off-label medication use are substantial for public sector payers as well as for the revenue of the pharmaceutical industry.
"The data presented in the article underscore the limitations of both first and second generation antipsychotic drugs and the desire of clinicians to improve outcome in schizophrenic patients. The off-label status of the drug treatments are problematic because studies required to establish support are both expensive and expose risk to the company's market by the possibility of new or serious adverse events and/or not being able to establish efficacy. Since a company is not allowed to promote an off-label use, the importance of so-called opinion leaders, who are free to independently discuss treatment approaches, increases substantially. The financial opportunities for both the company and the opinion leader can lead to blurred boundaries," observed senior author David Pickar, MD, President of Gabriel Sciences and Adjunct Professor, Johns Hopkins Medical School.
Gabriel Sciences and David Pickar, MD
Gabriel Sciences is a biotech company with the mission to advance treatment and understanding of mental illness through its translational research, including collaborative opportunities with academic medicine. David Pickar MD, founder, is former Chief of the Experimental Therapeutics Branch at National Institute of Mental Health (NIMH) with current adjunct appointments as Professor of Psychiatry at Johns Hopkins University School of Medicine and Uniformed Services University of Health Sciences.