Treatment at Random: The Ultimate Science or the Betrayal of Hippocrates?

Abstract

Medicine’s principle contract with the patient has for centuries rested on traditional values espoused by the society and the physician: the restoration of health and dignity of the individual through compassionate care. The patient’s benefit has been the primary objective of medical intervention. This goal, unambiguously stated in the works of ancient Greek physicians, is explicitly declared in a code of medical practice that over the centuries has come down to us as the Hippocratic Oath. This simple principle of a beneficent medicine has secured the patient’s trust of the physician and has formulated a doctorpatient relationship with which individuals and society at large have been comfortable since antiquity. In return, society compliments the physician with high esteem. In Homer’s world of heroic deeds, “the physician is of the worth of many other men.” This relationship has been workable while the principal responsibility of care rests with the physician in a one-to-one exclusive affiliation with the patient. Corporate health care delivery, as it has evolved in the last century, whether provided by the state or the insurance company, is now challenging this unique relationship and is introducing new concepts of responsibility for the physician that are threatening to undermine medicine’s traditional character of beneficence. In the process of treating individuals, physicians are now required to consider the welfare of the state, of the society, or of the institution in which they practice. They are now asked to consider the value of life, the cost of life, and the worth of extended life! But how can the restoration of an individual’s health leave the society poorer? Why is it now necessary for the physician to declare a commitment to the interests of the society as well as to the individual patient? A practice that has emerged during the second half of the 20th century and continues unabated at the dawn of the 21st century is that of treatment allocated at random. This novel approach, often confused with therapy in the minds of physicians and unsuspecting patients, is in essence a research instrument in the service—many believe— of medical progress. Randomization involves a process by which the treatment to be allocated to an individual is not decided by the physician in charge, but by someone or something else (these days probably by a computer in a remote office that is not necessarily programmed to the individual patient’s welfare). This practice has been elevated to the “gold standard” of clinical science. This gold standard, the randomized trial, is a method of evaluation of the safety and efficacy of a novel treatment or diagnostic procedure in a group of individuals, half of whom will be subjected to the new procedure. The other half may receive a standard or established treatment, no treatment, or a dummy treatment known as a placebo. Who receives what, is a matter of chance. Why is randomization necessary? Because—it is argued—in this manner, bias in selecting patients with favorable prognostic factors for the treatment under investigation From the Parnassus, Park Hill, Loughton, Essex, United Kingdom.