http://bmj.com/cgi/content/full/324/7331/240
BMJ 2002;324:240 ( 26 January )
Letters
WMA should not retreat on use of placebos
I
do not think that patients should remain untreated when a proved effective
treatment is available, and I was pleased by the new clause
29 in the revised Declaration of Helsinki. I am dismayed that
the World Medical Association is retreating from this position.1
The association's first condition for the use of placebo in research trials
to be ethically acceptable"Where
for compelling and scientifically sound methodological reasons its
use was necessary to determine the efficacy or safety of a
prophylactic, diagnostic, or therapeutic method"is
so vague that it could be used to justify any trial using a placebo.
For example, to show efficacy we could say that we must have
untreated patients. But under the new Declaration of Helsinki, which
bans placebo controls when there is an effective treatment, mere
efficacy is not enough. It is relative efficacy that is important.
The second condition"Where
a prophylactic, diagnostic, or therapeutic method was being investigated for a
minor condition and the patients who received placebo would not be
subject to any additional risk of serious or irreversible harm"suggests
that unless the patient might die it is quite acceptable to let him
or her suffer. Thus we could use placebos for eczema, for example,
and let the patients scratch. I think that patients have a right to
be treated. They go to doctors to have their problems alleviated,
not to be guinea pigs.
If the reason for back pedalling is the criticism that in developing
countries the best established treatment may be too expensive, this
is not addressed at all. "Too expensive" is not a scientifically
sound methodological reason. We justify trials too small to provide an
answer to the question if an adequate trial were too expensive. The
relevant clause of the declaration states that "The benefits, risks,
burdens and effectiveness of a new method should be tested against
those of the best current prophylactic, diagnostic, and therapeutic
methods." Inserting the word "available" after
"current" would be sufficient to meet the objection of
developing countries. If a treatment is too expensive it is not
available.
Martin Bland
St George's Hospital Medical School, London SW17 0RE mbland@sghms.ac.uk
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1. |
Ferriman A. World Medical Association clarifies rules on
placebo controlled trials. BMJ 2001; 323: 825 |
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Other related articles in
BMJ:
NEWS
World Medical Association clarifies rules on placebo controlled trials.
Annabel Ferriman
BMJ 2001 323: 825.
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