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
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.
References:
1. World Medical
Association Declaration of
2. http://www.wma.net/e/policy/17-c_e.html
3. Schou, J. The
declaration of
John Schou, M.D.
Revised
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.
Addendum:
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
Quotations
on research methodology
New link inserted
Nov. 9, 2003: