Welcome to this edition of the APCR member spotlight. In this feature, we highlight APCR members who are doing exciting things in the field of clinical research. This week we are featuring Peter H. Rheinstein, MD, JD, MS, FAAFP, FCLM, FAPCR.
Peter H. Rheinstein, MD, JD, MS, FAAFP, FCLM, FAPCR
At-Large Board of Trustees Member, AMA Delegate and Past President, APCR
Chairman, American Board of Legal Medicine
Chairman, MedDATA Foundation
Chairman, United States Adopted Names Council
President, Academy of Medicine of Washington, D.C.
Publisher, Discovery Medicine
Severna Park, MD
What is your current role?
As President of Severn Health Solutions, I consult for pharmaceutical companies as well as the legal and investment communities on issues related to drug regulation and development, including the design and performance of clinical trials. My medical sub-specialty is geriatrics, and I currently serve on the Board of Directors of the Collington Life Care Community. My legal specialties are federal regulation and life sciences law.
What is the best part of your occupation?
The best part of my occupation has been the ability to meet and learn from and, hopefully, provide some measure of help to people in the different roles that I have been privileged to undertake.
How did you become interested in clinical research?
Louis Lasagna, MD was my Professor of Clinical Pharmacology at Johns Hopkins in the mid-1960s. In 1962, Dr. Lasagna had delivered testimony to Congress during the Kefauver hearings on the 1962 amendments to the Food, Drug and Cosmetic Act. His guidance resulted in, among other things, the requirement for controlled clinical trials as necessary for proving drug effectiveness as a condition for regulatory approval of a new drug.
Al Kolbye, MD, JD, MPH was Deputy Director of the FDA’s Bureau of Foods in the early 1970s. We became friends through the American College of Legal Medicine (ACLM). I had joined ACLM shortly after enrolling in evening law school at University of Maryland during my final year as a medical resident. In 1974, shortly after my graduation from law school, Al recruited me to the FDA. I had intended to stay only a few years, but I found the work so fascinating that I stayed until 1999 when I retired from the FDA to take a job in the private sector.
How did you become involved with the APCR?
During my years at the FDA, I was a frequent speaker at meetings of APCR’s predecessor organizations. I joined the then American Academy of Pharmaceutical Physicians in 1997 when the Board of Trustees modified their bylaws to allow federal employees to become members.
Explain how you benefit from being a member and/or fellow of the APCR.
Being a member (and now fellow) of APCR has helped me to maintain and build contacts with the clinical research community. These contacts have helped me to keep my fingers on the pulse of clinical research, to obtain consulting assignments and to recruit the experts I need to work with me on those assignments.
What would you like to see occur in the field of clinical research (i.e., scientific advances, greater awareness of the field, etc.) during your career?
My mother died from Alzheimer’s disease and, as a geriatrician, I am reminded constantly of the ravages of this disease, the uncertainties regarding its etiologies and the continuing failure to find adequate treatments. Sometimes I even fantasize about alternative etiologies and treatments.
What are your hobbies outside of the office?
Family and friends come first. However, I am also a longtime health club member, a 30-year member of the Annapolis Yacht Club, a 35-year member of the Chartwell Golf & Country Club and a 50-year member of the Johns Hopkins Club.
What is something surprising that most people do not know about you?
I supported myself as a teaching assistant in mathematics both as a graduate student and as a medical student. During free time in medical school, I worked as a research assistant at the NIH Division of Computer Research and Technology. Mathematics was my first love, but I found the work far too solitary.
Recently, The Cancer Genome Atlas (TCGA) has resurrected the closet mathematician in me, and I have partnered with Steven Lehrer, a friend from medical school, to examine potential genetic markers that may help predict a patient’s response to therapy.
Feel free to review my LinkedIn profile. I’ll try to cover additional material in my Delegate’s report from the AMA House of Delegates meeting that ended on June 13.