Institution: Brigham and Women's Hospital, Boston, MA
Grant Title: Off-Label Prescribing: Comparative Evidence, Regulation, and Utilization
Grant Number: K08 HS018465
Duration: 5 years (2008-2014)
Total Award: $799,800
Project Description: The proposed research has three aims:
- Develop a comprehensive typology of off-label drug use that categorizes the different ways prescription drugs are used beyond the specific indications approved by the Food and Drug Administration (FDA).
- Identify selected drugs in three categories (oncologic, neuropsychiatric, and 'orphan') and define the range of off-label uses, assess the association between the quality of the evidence base and the prevalence of off-label prescribing for drug-diagnosis pairs and determine predictors of non-evidence-based off-label drug uses.
- Evaluate the effect of specific external scientific, market, and regulatory/legal events on the frequency, characteristics, and costs of off-label drug use.
Career Goals: Dr. Kesselheim is an Instructor in Medicine at the Harvard Medical School; a Staff Physician at the Faulkner Hospital in Jamaica Plain, MA; and an Affiliated Physician at the Dana-Farber Cancer Institute in Boston. The grantee received his MD from the University of Pennsylvania School of Medicine and his JD from the University of Pennsylvania Law School. He served his residency in Internal Medicine at Brigham and Women's Hospital and went on to earn his MPH in Clinical Effectiveness at the Harvard School of Public Health. Dr. Kesselheim is committed to a career as an academic health services researcher focusing on how legal and regulatory issues affect health care delivery, particularly in the pharmaceutical market. He would like to make contributions to policy discussions regarding issues such as the proper use of drugs, the cost-effectiveness of drug use, and how to best incentivize pharmaceutical research and development.
Progress to Date: For Aim #1, typology development was initiated through a series of qualitative data-collecting interviews with whistle-blowers in pharmaceutical fraud cases regarding illegal promotion of off-label drug use settled by the Department of Justice in the past decade. The first study under Aim #2 has been completed which looked at trends in off-label drug use related to four drugs for rare disease. Work on Aim #3 is underway.
Future Plans: Dr. Kesselheim will initiate the qualitative analyses of physicians and experts to define the nature and causes of off-label prescribing as described in Aim #1. Work will continue on Aim #2 as will the time-series analyses for Aim #3.
Highlights and Specific Accomplishments:
- University of Pennsylvania School of Medicine Young Alumnus of the Year, 2008.
- Brigham and Women's Hospital Karen Kaufman Memorial Book Award, 2005.
- American College of Legal Medicine Schwartz Award, 2002.
- Burton Award for national excellence in legal writing, 2002.
- Recipient, Alice Hersh New Investigator Award, 2010.
K-Generated Publications: None thus far.