From Mark Davies, Royal Women's Hospital
Philip Cohen raises many pertinent issues with regard to the ethical conduct
of clinical research in humans
(7 August, p 18).
Placebo surgery is an extreme
example at one end of the spectrum of exposure to risk for subjects in
randomised controlled trials. The focus of Cohen’s article was on the risk of
placebo surgery to the control group. However, it must be noted that the
subjects in the treatment group who are getting the experimental surgery are at
equal (if not greater) risk from surgery that may in time prove to be
ineffective.
It should also be noted that placebo surgery is not only necessary to allow
for the placebo effect, but also ensures that control subjects are treated in
exactly the same manner as treatment subjects (apart from the intervention).
This ensures that any bias on the part of doctors, nurses and relatives after
surgery is virtually eliminated.
In all areas of clinical research, the risks involved need to be considered
with regard to the overall burden of the disease to individuals and society.
Where the burden is great and the potential benefit large, it is then up to the
individual to decide whether or not to take part in the trial.
Herston, Brisbane
