FIMA Year Book 2009 - Federation of Islamic Medical Associations

Clinicians As Effective Researchersprofessional medical conduct in NewYork, it became apparent to me thatphysicians are not immune to ethicallapses. This becomes even moreimportant in research where patientsare entrusting the physicians to beingtested with an unproven, often notapproved, medication or device. Twopersonal examples will highlight this.a) I did sizable clinical research in theapplication of fluoroquinolones inrespiratory tract infections. Asour team published and presentedour findings in professionalmeetings, I began to receiverequests from several differentpharmaceutical companies to testtheir brand of fluoroquinolones.One such product had obviousneurologic complications, everythird or fourth of my enrolledpatients had some evidence ofneurologic stimulation: irritability,sleeplessness, and even seizures. Ifelt exposing my patients to suchside effects was not appropriateand quickly informed my IRB thatI was canceling the study.b) While studying Ciprofloxacin,which had been showing excellentclinical results (8) one of ourenrolled patients had a grandmal seizure, which she neverhad before. After careful clinicalinvestigation, we determined it wasmost likely the result of a very highblood theophylline level resultingfrom the interaction between theCiprofloxacin and theophylline.Up to that time, Ciprofloxacinhad not been known to increasethe blood theophylline level. Thesponsoring company was quicklyadvised of this complication, and,to its credit, it encouraged us tostudy this interaction in greaterdetail, which we did and thusestablished the Cipro-theophyllineinteraction. (9)The point of these two examples is thatbecause complications can occur whiledoing research, it is the investigators’responsibility and moral/ethical dutyto weigh the risk/benefit ratio carefully,keeping the patients’ interest and wellbeinguppermost in mind.Dr. Stephen E. Straus is a highlyrespected researcher at the NIH.He was the principal researcher in aresearch study on a new investigationaldrug for the treatment of hepatitis.Five patients he treated at the NIHhospital in Bethesda, Maryland,died, which led to news reports andcongressional hearings. The studywas discontinued, and eventually heand his colleagues were cleared ofany wrongdoing. Later on they foundout that the investigational drugwas a mitochondrial poison leadingto severe metabolic acidosis. Strausregularly presents this incident atthe annual NIH course on research.Understanding the importance ofunanticipated risks in clinical researchis highly recommended for all who doclinical research. (10)FIMA YearBook 2009133