The last word
Where treatment begins John A Lee Department of Pathology, University of Sheffield Medical School, Beech Hill Road, Sheffield S10 2RX, UK
Bertholt Brecht has a reputation for being rather heavy going but, like anyone else who writes a lot, he did occasionally pen a pithy line. In his play Galileo, he nicely encapsulated an important point about scientific method: “The chief cause of poverty in science is imaginary wealth. The chief aim of science is not to open a door to infinite wisdom, but to set a limit on infinite error.” A couple of millennia earlier, Hippocrates spelt out essentially the same message for medicine with “First do no harm”. And today, of course, we think that we are in the happy position of having developed clinical trial methodology to a degree which ensures not only that we do no harm, but also that treatments are as good as they can be. I was therefore interested to receive a flier recently, for a seminar entitled “Are placebos ethical in clinical trials?” I assume that the title was rhetorical in tone, set up like a paper tiger, straw man, or government target, to be swept away by the force of rational argument. But, with its conflation of placebos and ethics, it does throw a disturbing light on how far we’ve come in a relatively short time. After all, not that long ago, the placebo effect was just about all that medicine had to offer in terms of treatment. In Hippocrates’ day, the emphasis was much more on diagnosis and prognosis than on treatment. Good physicians could often divine the cause of a problem and indicate likely outcomes, but treatment was, by and large, about making the patient comfortable and letting nature take its course. It is only during the past couple of centuries, since the advent of anaesthetics, antiseptics, and antibiotics, that public and professional perceptions of the role of medicine have become so treatment-orientated. And this process, it seems, has accelerated over the last half century, to the extent that we are now being invited to consider whether the oldest inclusion in the pharmacopoeia – the placebo effect, the very presence of the doctor indeed! – is ethical. Ever since it was recognised, the placebo effect has had a bad press. Although it is an inescapable aspect of the doctor–patient relationship, and one that good physicians from antiquity to the present day have used to please both their patients and their bank managers, there has always been 392
a feeling that somehow it’s a bit of a cheat. After all, the doctors aren’t supposed to just turn up – they’re supposed to do something. It can be no coincidence that this anti-placebo feeling has intensified as more and more treatment options have become available. In the early days of interventional medicine, treatments tended to have protagonists, rather than solid data, to promote them. Subsequently, as methodologies developed and people began to realise how important placebo effects could be, trials were carried out with groups randomised to placebo versus treatment, to try and determine whether treatment really added value to the patient, or just to the doctor (since doing something is more expensive than just turning up). But once the beneficial aspects of a treatment are established, trials tend to concentrate on comparing treatment A versus treatment B. Eventually, we reach a situation where placebos begin to be viewed as not just unnecessary, but unethical. This is disturbing. The welldocumented processes of diagnostic and therapeutic drift mean that medical goalposts tend to move over time. What seemed firmly established a few years ago, on the best of evidence, can seem nonsensical a few years later. The danger of abandoning placebos in trials is that it leaves us with diminishing confidence in how far we are from ground zero with our treatments. For example, take routine comparison of two or more complicated chemotherapy protocols for a particular tumour. Does this always let us judge where we are, in the absence of controls for all the other factors in diagnosis and management that have changed since the benefit of this form of treatment was apparently established beyond all doubt? Use of the term ‘unethical’ in this context is more like telling ghost stories to frighten children than mature medical science. History clearly shows that playing the ethics card is often more about resistance to change, fear of the unknown, and simple intellectual inertia, than about attempts to rationally define a set of moral principles for use in a particular situation. Hippocrates is still right, and to ensure that we do no harm, we must keep firmly fixed in our minds the point where the added value of treatment begins. THE LANCET Oncology Vol 2 June 2001
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