Doctors seek volunteers who don't mind being given a hole in the head

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Anyone fancy a hole in the head? American surgeons will be happy to oblige. Volunteers are being sought to have holes drilled in their skulls in sham operations designed to test a new surgical treatment.

Anyone fancy a hole in the head? American surgeons will be happy to oblige. Volunteers are being sought to have holes drilled in their skulls in sham operations designed to test a new surgical treatment.

Sham surgery, a novelty here although it causes British surgeons to throw up their scalpels in horror, is well established in the US. At least three studies are being done, more are planned and the idea has been embraced by the US Food and Drug Administration and the National Institutes of Health, the American federal funding body for medical research.

The view is that new operations need to be tested in the same way as new drugs - against a placebo. Otherwise, how can we know that the act of wheeling a patient into hospital, giving them an anaesthetic and ministering to their needs when they wake is not itself beneficial?

The treatment under test is neurosurgery for Parkinson's disease. Foetal brain cells are injected into the brains of patients with Parkinson's in the hope that the cells will grow and establish new neural networks to replace those damaged by the disease.

The transplants are being offered in 18 centres around the world but the benefits remain unclear. Researchers have launched placebo-controlled trials to establish whether the treatment works, and the issue has provoked a vigorous debate in the latest issue of the New England Journal of Medicine.

Volunteers for the sham surgery have a general anaesthetic, a hole drilled in the side of their skull (almost but not quite all the way through) and six months of treatment with anti-rejection drugs (the same as the treatment given to the real patients who need it to prevent rejection of the foetal tissue injected into their brains).

Despite the risks, American researchers defend the approach, saying there is a "reasonable balance" with the potential benefits to society. British ethics experts say the studies breach a fundamental ethical principle, laid down in the Helsinki declaration on medical research.

That says the interests of science and society should never take precedence over the interests of the individual.

The history of surgery is littered with operations, such as tonsillectomy and circumcision, which were never tested and whose routine use has been abandoned.

The journal says: "Patients may undergo operations performed by surgeons who stand to benefit financially, academically and by reputation but who fail to disclose that the operations have unproved benefits and undefined risks."

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