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 placebo pills.

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 limbs.

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 procedure works.

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 should never take precedence over the individual.