Editorial

A Paradigm Shift: Are We Ready?

Niranjan Kissoon, M.D., Editor

Unfortunately, in many instances we have not heeded the many valuable lessons of history. As early as 1934 it was recognized that variations in care might not be due to differences in conditions of the recipient as it is to differences in the viewpoint and standards of the medical practitioner. This was the conclusion of a study in which 1,000 children in the New York public schools were examined to determine whether they required a tonsillectomy. In this sample, 61 children already had their tonsils removed; therefore, the researchers sent the remaining group of children to doctors. The physicians duly reported that 45% of those students needed a tonsillectomy. The other students who were told they did not require tonsil removal were sent for a second opinion. On second opinion the doctors examined and concluded that 46% of this group needed a tonsillectomy. The remaining were told their tonsils were fine, but were sent to yet another group of physicians. These new physicians concluded that 44% of this group needed a tonsillectomy. At the end of the study, only 65 of the original 1,000 children had not either had their tonsils removed or had been told they needed to be removed.

There is no evidence in this study that these physicians were not acting in the best interests of their patients, and using the best medical judgement. However, history is rife with examples in which our best medical judgement was flawed. For example, as early as during the French Revolution, blood letting occupied a place of honor. Leeches and blood letting were said to be in harmony with political liberalism, because they acted by "relieving the patient from oppression" as opposed to the mere treatment of symptoms. In fact, France alone was importing more than 41 million of these medicinal slugs every year. The prestigious British Medical Journal begun in 1828 chose the name Lancet to signal its scholarly intent and cutting edge therapy.

History repeatedly has shown us the tragedy of relying solely on supposed benefits without rigorous randomized trials. For example, the sedative Thalidomide was widely sold without prescription in Europe, South America, Australia and Japan during the late 1950s. It did what it promised; it put people to sleep. However, in 1961 scientists discovered to their horror that 7,000 _ 11,000 women who took Thalidomide while pregnant gave birth to children with malformed arms and legs. An even more famous example of the risk of relying solely on doctors' judgement involves the lobotomy. In 1936 Portuguese neurologist Egas Moniz, MD and Swiss physiologist Walter Hess developed a method of severing the connection between the frontal lobes of the brain and its emotional center. By the time Moniz and Hess shared the Nobel Prize for Medicine in 1949, thousands of lobotomies were being performed every year. At the end of the 1950s however, careful studies revealed that the procedure severely damaged the mental and emotional lives of those who underwent it.

The randomized clinical trial, which has become the gold standard of evidence, will provide the scientific underpinnings to clinical judgement. However, it was borne as much out of financial desperation as a scientific curiosity. In 1946 when Britain was still devastated by the just-ended World War, streptomycin was hailed as the effective treatment for TB. Austin Bradford Hill, an economist by training, and himself a tuberculosis victim, designed the first randomized clinical trial. He divided patients into the control group (receiving only bed rest) and the experimental group (receiving both bed rest and streptomycin). After six months, 14 of 52 in the control group died whereas 4 of 50 patients in the experimental group died. The publication of his results in 1948 in the British Medical Journal was recognized as a significant breakthrough in medicine and the argument the physician deserved the total freedom of an artist was irreparably weakened. The randomized trial did not eliminate the need for expert clinical judgement, nor should it. Instead it placed clinical judgement within a new scientific framework. As D.D. Reed, a former colleague of Hill stated, "statistical methods may be no substitute for common sense, but they are often a powerful aid to it."

Experience has so far taught us that health is a societal issue and is too important to be left solely in the hands of individual providers. Therefore, personal opinions without any physiologic basis or scientific underpinnings are no longer acceptable. Treatment protocols or clinical pathways based on evidence or collective wisdom is becoming increasingly popular and will be the wave of the future whether we are willing participants or not. It would seem therefore that we should be the leaders in this enterprise in order to extend the parameter of beneficence and contract the boundaries of non-malfeasance. There is always a price to be paid, even for treatment that offers great benefit. With the wide array of healthcare options and the aggressive marketing of pharmaceutical and healthcare companies, the words of Arthur M. Blumfield, MD from 1933 is even more relevant today. Dr. Blumfield declared that every hospital should have a plaque in the physician and student entrance which states: "There are some patients whom we cannot help; however, there are none we cannot harm".

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