Sham Surgery Shakes Up Scientists, Ethicists
WebMD News Archive
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,
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.