A Conflict to Come:
Medical Science for the Purpose of Making Science,
not for Dealing with Patients
Abstract: The placebo-controlled, randomized trial was banned from routine use 26 years ago in the 1st Amendment to the Helsinki Declaration, provided an active therapy is available for comparison. This demand has been ignored ever since, a fact hardly altered by the new formulation in the Helsinki Declaration. It is necessary to place a stronger ban upon placebo-based studies in order to enable consideration of other methods.
The purpose of medical science should be to improve various aspects of prevention, therapy and diagnosis of patients and you will hardly find anyone who would admit that its actual practice differs from this. However, the personal impact of science upon its practitioners and their departments have gradually changed the pattern in a dangerous way. Science is now so strongly related to the economics of research and its aspects of career, employment, sponsoring and the process of drug registration that, in some cases, it is reasonable to state that
Patients are serving science more than science is serving patients.
Were the scientists before the 2nd World War rather solemn types, contemporary scientific brigades show a different behaviour. Science is considered something which can be learned and practised according to a certain fashion. Words like 'evidence' evoke positive feelings, but a man-made hierarchy controls the actual use of these words. And in their adherence to current techniques, today's scientists have blocked the way to new insights that might be won by changing our attitudes. Moreover, science has turned grossly inhuman, but that could be its weak side, and I believe it may some day be this aspect which makes reorientation necessary.
When will the conflict between patients and medical scientist come to the surface?
The potential has been there for a long time but has so far been 'successfully ignored' by the scientists. Two aspects shall be considered here: 1) placebo-based studies and 2) informed consent.
Already in 1975, the Helsinki Declaration for Biomedical Ethics demanded that "every patient – including those of the control group – should be assured of the best proven diagnostic and therapeutic method." This obviously implies that the use of an inert substance (placebo) or even sham therapy could only be employed when no active therapy was available which was of any value to the patient. The scientists, however, continued placebo-studies, also when e.g. lack of substance B was associated with a more adverse outcome than its active control, and even when the same study group had proven substance A to be superior to nothing. It is easier to prove a therapy against something useless than against something which works – and it is apparently incomprehensible to current scientists that other methods should be used once an effective drug or other therapy has been found. Still this year, placebo-based studies are appearing although in the latest amendment of the Helsinki- Declaration in October 2000 (1,2), the relevant passage had been made clearer, probably in the hope that now (even) the scientists would understand the message (3).
The item of informed consent is even older. In the Nazi-era of Germany, physicians were testing a variety of methods and physiological interventions upon concentration-camp prisoners before applying them on what they then conceived as 'real' (survivable) humans. Their excuses were often that they were behaving as everybody else in their society were doing. Then, in 1947, military judges (in that sense medical laymen) condemned this action, as everybody should now be able to understand. Today, a similar danger is looming: doctors are again doing what most of their colleagues do, ignoring the before-mentioned ethical precautions, and in the new version of the Helsinki Declaration, even the informed consent was finally buried in some cases of emergency medicine and intensive care (meaning that it was banned before, but that did not disturb the scientists - in practice, even this requirement has long been ignored in intensive care and emergency medicine). With the ability of wide-ranging interpretation, as seen for the placebo groups, it can be foreseen that informed consent may disappear much more widely as was really attempted from the authors of the Declaration.
And that is why the conflict has got to come!
Cyberspace has in a few years altered medical publication habits. Simultaneously, various economical considerations have made a quality-control mandatory. Huge materials are now available, which could offer a tremendous basis for various therapeutical attitudes, once a targeted standardization has taken place. However, in the current appreciation of placebo-based studies and so-called 'evidence-based medicine,' there seems not to be any need for alternative methods. Physicians tend to consider anything 'unscientific' which is not based upon randomized, placebo- controlled studies. In this way, the route is currently blocked for deviating research-methods, which again raises concern about, where a publication would at all be possible and whether anybody would notice the study if it did not involve a placebo-group. Perhaps we shall wait until the potential patients themselves voice a demand for more ethical methods? At least, that is why also I have an interest in the conflict to come.
Once again, a comparison must be
All therapeutical aspects of medicine must be related according to existing methods – that may sound too simple but this is why comparisons must be possible to make. However, if patients get their right and a stronger ban is posed upon unethical studies as is yet conceived, the placebo-based controlled study will today only exceptionally offer any possibility for testing a method. When necessary, scientific alternatives are there.
1. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Eur. J. Emerg. Med. 8, 221-224 (2001).
2. http://www.wma.net/e/policy/17-c_e.html
3. Schou, J. The declaration of Helsinki and emergency medicine research (editorial). Eur. J. Emerg. Med. 2001;8, 167-168.
John Schou, M.D.
Revised Dec. 3, 2001 according to suggestions made by Dr. Per Dalen.
I am most grateful to his initiative.
The above text was, as could be expected, rejected by three leading medical journals in October and November 2001. To my fealing, physicians, in being unwilling to decide against highly unethical aspects, have lost the competence of deciding upon this problem - instead, it must be referred to the laymen, the potential victims of medical research, where a more sound understanding can be expected but, unfortunately, also the failure to understand certain aspects of science.
Please help to spread knowledge about this aspect, perhaps in referring directly the URL of this page.
http://www.schou.de/conflict.html
Inserted on Nov. 16, 2001.
Regrettably, Oct. 2000 the WMA has surrendered to mainly American demands (FDA, the pharmaceutical industry and the majority of unethical scientists in unrevealed proportion) and permitted placebo controls. Only in those cases in which "harm" may result, these are not "acceptable" . The issue of the definition of harm is left unresolved. The "revision" to Helsinki does not appear in the Declaration itself. It occurred as a result of a WMA committee meeting, in which the participants "clarified" the "interpretation" of that paragraph. Related to the abuse when placebo was forbidden once an active therapy existed, the worst must be expected.
Revised Nov. 27, 2001
Back to homepage Index:
Quotations on research methodology
New link inserted Nov. 9, 2003:
Read: The Research Victim