Do Today’s Medical Ethics Prevent New Breakthroughs?
We probably wouldn't have anaesthesia under today's FDA...
October 6, 2012 - 7:00 am
It is doubtful whether, if current ethical standards, such as those governing informed consent, had existed in the past, medicine would have made much progress. The idea that patients had to consent to experimental treatment did not occur to Edward Jenner, the discoverer of vaccination, for example. He just went ahead anyway. As for the discoverers of anaesthesia, their lack of experimental precaution would nowadays have landed them in gaol.
Circumstances alter cases, however. The thread by which human life hangs has become distinctly thicker in the last century, and therefore the premature loss of life seems anomalous. The more life we have, the more precious it seems to us, or at any rate the worse the loss of it.
Medical ethics, then, have of necessity changed with the times. A recent editorial in the New England Journal of Medicine discusses the ethical problems of studying the safety of new drugs once they have been licensed for use and marketed.
Because of doubts about the cardiovascular safety of a new drug, rosiglitzaone, used to lower the blood sugar in Type II diabetes, the Food and Drug Administration ordered that a trial comparing its side-effects with those of a similar drug, pioglitazone, should be conducted. Critics of the FDA argued that enough was already known about the harms of the drug to withdraw its license or at least limit its use; but the FDA thought otherwise.
Such a trial gave rise to an ethical problem: what to tell the patients taking part in it? The problem was that those patients ascribed to the drug suspected of being more dangerous were not expected to derive any benefit from it; at best, the drug would prove as safe as the control drug, and therefore fail to do them harm. But who would agree to take part in such a trial if informed that to do so could only do him harm, not good? The fact that he was thereby helping to answer an important pharmaceutical question, and thus adding to the public health, would hardly console his widow, or him. Yet the FDA needed a definitive answer, for to ban a drug on a mere suspicion, when a company had invested billions of dollars in its development, would appear arbitrary.