Stan N. Finkelstein, MD (Senior Research Scientist, Massachusetts Institute of Technology, Engineering Systems Division;Associate Professor of Medicine, Harvard Medical School)
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Title: Finding New Lives for Old Drugs: Ideas about using a Systematic Approach
Abstract: When drugs are approved by regulatory agencies like the European Medicines Agency and the U.S. Food and Drug Administration to enter the market, they are labeled only for specific therapeutic uses, for which detailed evidence from clinical trials established their safety and efficacy. For many of these drugs, sooner or later, some evidence emerges (or at least a good reason to believe) that they would be efficacious for other uses, often referred to as “off-label uses”. In the U.S., prescribing of medicines for off-label uses, by qualified physicians is perfectly legal, though pharmaceutical companies would be breaking the law if they advertised or promoted them for such unauthorized uses. Such off-label uses are only
occasionally the object of later clinical trials to confirm their therapeutic value.
In this seminar, I will begin by reviewing evidence from a data-based study that examined the proportion of all drug prescribing that is off-label and identified the kinds of medicines that are most often used in this fashion. Then I will share some ideas and plans for new research aimed at systematically identifying medicines whose off-label uses could be evaluated through the conduct of “pseudo-trials,” using matched patient cohorts from electronic medical record databases.
The ultimate objective is to develop convincing evidence of these additional therapeutic uses of older drugs, in order that they can be prescribed more widely, and enable more patients to benefit from them.
Speaker Bio: Stan N. Finkelstein, M.D. is a Senior Research Scientist in the the MIT Engineering Systems Division. He also serves as Associate professor of Medicine at Harvard medical School and is a member of the faculty of the Division of Clinical Informatics at Beth Israel Deaconess Medical Center. He received his Masters of Science and Bachelors of Science degrees in
Chemical Engineering from MIT in 1971, and an M.D. from Harvard Medical School in 1975.
Since 1975, he has worked actively in the field of medical technology assessment and transfer at MIT. He conducts research and teaches classes in the development and evaluation of medical practice and technology and in health economics and policy, both at MIT and Harvard Medical School.
An active consultant to U.S. and international pharmaceutical, biotechnology, and medical device firms, as well as to health services organizations and government agencies; Dr. Finkelstein is an expert in outcomes research. His areas of specialization extend to the business-government interface related to medical technology, especially product development, clinical research design and third-party reimbursement. Dr. Finkelstein is author, editor, or contributor to several books and numerous articles on these subjects.
Dr. Finkelstein’s current research interests include analyses relating to the economics of illness and pharmaceutical treatment and to low probability, high consequence public health events. His publications include studies of cost of illness and cost-effectiveness of treatment. He is co-author of several recent articles that address the link between treatment of illness and productivity at work, and the role of advancing science and technology in changing patterns of medical treatment.