Ethics in Mid-Century Cardiovascular Research; Apologia

ETHICS IN MID-CENTURY CARDIOVASCULAR RESEARCH; APOLOGIA HOWARD B. BURCHELL* In the past half-century, concomitant with the tremendous advances in medical care, there have been instances of research involving humans, the ethics ofwhich have been properly challenged. As the situation has evolved, one focus has been on the investigators' alleged disregard of the subjects' autonomy and of an "informed consent" procedure. I believe there has been unethical behavior, but I shall argue that some recent analysts have introduced to the public mind a distorted image of the magnitude of the wrongs. I shall allege that at times there have been errors in the interpretation ofsources ofinformation, and I shall challenge certain generalizations which have been offered as established truths. In addition, it will be implied that some critics have adopted an adversarial stance from our legal brethren , a stance which may be more destructive to the common good than intended. I shall deal mainly with cardiovascular research, as in this area I feel some confidence in judging; and I shall address the importance of the study to patients and to science; the !lawlessness of design; and the skill of the specific investigators, and sensitivity of these investigators to the needs of the subject as a patient. It will be remembered that it was at midcentury that the flood tide of invasive procedures began with catheters and electrode probes, with doors opened to, and funding provided for, investigations not only of the heart but of many other internal organs. There has always been conflict between the physician care-giver (or traditional healer) and the investigator. Can the physician be both? Assuredly, not without conflict of interest. Two of my revered mentors, Sir Thomas Lewis and SirJohn Parkinson, agreed in principle, but presented a contrast in practices. Lewis states: "Efficient medical practitioners are not scientists" [1], an assertion not popular with his clinical colleagues. Parkinson quotes Sir Thomas Browne, "Everyman is not a proper champion for Truth, nor * Department of Medicine, University of Minnesota, 260 Woodlawn Avenue, St. Paul, MN 55105.© 1995 by The University of Chicago. All rights reserved. 0031-5982/95/3804-0937$01 .00 Perspectives in Biology and Medicine, 39, 3 ¦ Spring 1996 327 fit to take up the Gauntlet in the cause of Verity." He puckishly asserts: "Happily there are plenty of men you cannot keep from original research, almost or actually blood thirsty in their pursuit of it; others only need putting on the scent and they're off on the track of truth" [2]. At mid-century there was increasing academic grumbling about any blanket worship of the clinical investigator; at times, clinical investigators regarded themselves as an endangered species. In Britain, Olgivie scathingly derided the amateur in research: "Research is too important to be entrusted to a doubly unqualified amateur with a foot in both camps [practice and investigation]" [3]. In America, William Bean, in his presidential address to the Central Society for Clinical Investigation, stated: "Clinical investigators rarely meditate upon the wide cleavage which separates clinician from investigator in their split personality. As physicians, their prime concern is intimate personal responsibility in caring for sick people; as investigators they are guided by divine discontent and impelled by curiosity as well as ambition for renown. Such a stimulus sometimes suppresses the physician altogether" [4]. Gavin Thurston, physician-barrister, casts further derision on this variety of investigator: "the physician experimenter is liable to be an eager, obsessional fellow who may overbear the physician friend. When they are united in the same body the patient may suffer" [5] . Many other eminent physicians have defined the conflict, including Sir Robert Piatt and Herman Blumgart, an exemplary editor of the journal Circulation [6, 7]. These remonstrations smack of Bernard Shaw's lengthy diatribe in the preface of The Doctor's Dilemma. In this critique, there are some belated accolades for the caring physician and some sympathy for the profession when pilloried: ' 'The melodramatic instinct of the public always demanding that every wrong shall have not its remedy but its villain to be hissed, will blame, not its own apathy, superstition, or ignorance but the depravity of doctors." His allusion to the investigator as a heartless beast is still...