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Date: 8 Oct 1999 03:50:51 GMT
From: CIRCARE <veracare at erols.com>
Subject: US Doctors Conduct Sham Head Drilling Surgery in Placebo trial
Resent-From: rich at roadster.math.missouri.edu
From: Vera Hassner Sharav
CITIZENS FOR RESPONSIBLE CARE & RESEARCH
142 West End Ave, Suite 28P
New York, NY 10023
Tel. 212-595-8974 FAX: 212-595-9086
E-mail: veracare at erols.com
US doctors repeated an experiment in which they drilled holes in the
heads of Parkinson's patients -- some of whom serving as placebo
controls! These patients were persuaded to undergo the surgical
procedure with no medical justification, but rather for experimental
purposes. "Richard Nicholson, editor of the Bulletin of Medical
Ethics, said the trial appeared to breach the Helsinki declaration on
research, which says that the interests of science and society ahould
never take precedence over the individual."
But Ethical considerations and risks to human subjects seem to be swept
aside in highest risk American Government sponsored experiments that
are being conducted on vulnerable American patients.
This time, the sham surgical experiment was conducted by doctors at
Mount Sinai Med Center, NYC and U of So. Florida in an effort to learn
"If foetal tissue transplants are found to be safe and effective" as a
treatment for Parkinson's disease.
The experiment has raised serious concerns of the Royal College of
Surgeons in England, but was approved by the academic Institutional
Review Boards and the National Institute of Health.
DOCTORS DRILL INTO PATIENTS' HEADS IN PLACEBO SURGERY
AMERICAN SURGEONS have carried out sham operations, which involved
drilling holes in patients' skulls, as placebo surgery designed to test
the effectiveness of a new treatment for Parkinson's disease. The
patients, who all suffer from the debilitating neurological disorder,
were put under general anaesthetic for the placebo operation. The
results are to be compared with those of a second group of patients who
received the genuine treatment, involving the transplant of foetal
brain cells, in the same way as new drugs are tested alongside inert
The operations have drawn criticism for breaching a fundamental
principle of medical ethics - that doctors should avoid doing harm to
patients. The President of the Royal College of Surgeons of England
said yesterday that the development was "very worrying".
Surgeons from the University of South Florida and the Mount Sinai
School of Medicine in New York selected 36 patients with Parkinson's
disease who had failed to respond to medical treatment for the
disorder, which leaves sufferers with an uncontrollable tremor in their
The patients agreed to be allocated randomly either a transplant of
foetal brain cells or a similar placebo operation. They were promised
free medical treatment for their condition and a free transplant if the
operation was proved to work.
Transplants of foetal brain cells for patients with Parkinson's disease
are being tested in 18 centres around the world. The researchers, who
describe their study in the New England Journal of Medicine (NEJM), say
a placebo- controlled trial is the only way to establish whether the
The study was sponsored and approved by the National Institutes of
Health, the US federal funding body for research. Placebo-controlled
trials are the gold standard for assessing new drug treatments but they
carry no risk to the patients who receive the placebo, which is usually
a sugar pill.
In the Parkinson's study, however, the patients in the placebo group
were not risk-free: they had a general anaesthetic, which carries risks
in itself; the hole drilled in their skulls runs the risk of causing
bleeding and infection that could lead to meningitis; and six months'
treatment with the anti-rejection drug cyclosporin exposes them to the
risk of renal failure. Furthermore, Parkinson's disease patients tend
to be elderly - and all of these dangers are greater in older people.
Thomas Freeman and colleagues say in the journal that controlled trials
are essential in surgery and cite a list of operations, including
tonsillectomy and circumcision, which were never tested and whose
routine use has now been abandoned. They say the risks of the surgery
for Parkinson's were clearly explained and accepted by the patients.
"If foetal tissue transplants are found to be safe and effective,
thousands of patients with Parkinson's disease stand to benefit and
further research will be encouraged. If the transplants are found to be
ineffective, or if they offer nothing more than a placebo effect,
hundreds or even thousands of patients will be spared the risks and
financial burdens of an unproven operation," they say.
Barrie Jackson, president of the Royal College of Surgeons of England,
said he had not come across sham surgery before. "I would need a lot of
persuasion to undertake it," he added.
Richard Nicholson, editor of the Bulletin of Medical Ethics, said the
trial appeared to breach the Helsinki declaration on research, which
says that the interests of science and society ahould never take
precedence over the individual.