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Sham Surgery Shakes Up Scientists, Ethicists

WebMD Health News

Feb. 9, 2000 (Cleveland) -- Imagine being prepped for surgery, wheeled into an operating room, and having a hole drilled in your head but no real surgery performed. In this scenario it would be a sham, a placebo surgery -- except for the very real hole in your head. This is exactly what happened to several people who participated in a study to test a new surgery for Parkinson's disease involving the implantation of fetal cells in the brain. Medical experts publicly question the ethics of this approach.

Daniel P. Sulmasy, MD, PhD, director of the Bioethics Institute of New York Medical College, tells WebMD that the first canon of medicine is "First, do no harm." He points out that it is difficult to "do no harm if you are drilling holes in a person's head."

Neurosurgeon Robert A. Ratcheson, MD, who served as a reviewer for the National Institutes of Health's Parkinson's study that uses this placebo surgery, says this approach is not only ethical, but necessary to protect the public from "widespread use of invalid surgeries."

When scientists are developing new drugs, they often test the new compounds against a placebo or sugar pill. This, too, is ethical, if there is no effective treatment for the disease, Herbert Rakatansky, MD, says in an interview with WebMD. "For example, you wouldn't use a placebo to test a treatment for pneumonia because there are antibiotics, which effectively treat pneumonia. To use a placebo would be harmful and therefore unethical," he says. In such cases, the ethical approach is to compare the traditional treatment against the treatment being studied, according to Rakatansky, chairman of the American Medical Association's Council on Ethical and Judicial Affairs and clinical professor of medicine at Brown University in Providence, R.I.

That, says Sulmasy, is where placebo surgery falls off the ethical rails. Sulmasy, Sisters of Charity chair in ethics at St. Vincent's Hospital in New York, says that new surgical techniques should be tested against "standard surgeries. When you do that, from a scientist's point of view, you up the ante because you have to prove that it is better than the standard." In the case of the Parkinson's surgery, Sulmasy says the fetal cell implants should have been tested "against pallidectomy, which is an accepted surgery for Parkinson's." Pallidectomy is a surgery in which some very small amounts of brain tissue are cut away.

Ratcheson, who is a member of the board of directors of the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), says comparing the experimental surgery to pallidectomy would just "muddy the waters, it would contaminate the study. Basically this study is attempting to evaluate a procedure with total objectivity in the results analysis. The only way that you can protect the public is by insuring that an invalid or dangerous procedure does not achieve widespread use." He says, too, that pallidectomy is not without risks and so is hardly a benign treatment.

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