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.
The editorial mentions a practice of the pharmaceutical companies that appears to me natural (that is to say in accordance with human nature) but dishonest. The companies commission several, or many, controlled trials of their new drugs, but when it comes to publishing the results have hitherto been allowed to publish only those that are favorable to their products.
By means of omission, they are thus able to exaggerate the benefits, or minimize the risks, of the new drugs. This seems to have happened on a large scale with the SSRI anti-depressants: by failing to publish trials which demonstrated little or no benefit of these drugs, the companies were able to convey an entirely false impression to doctors of their efficacy. Thus the publication of properly-conducted and scientifically sound trials can, by the old rhetorical means of suppressio veri and suggestio falsi, mislead and has actually misled. By the way, only seven of the forty-two trials of rosiglitazone were published before the FDA gave it its imprimatur.
A solution is obvious: the registration of all trials and the compulsory publication of their results, favorable or unfavorable. But a still small voice at the back of my mind asks, “If this had been the policy in the 1840s, should we now have anaesthetics?” After all, people soon began to die of ether and chloroform.
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