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.
The AANS/CNS, the only medical organization to have a policy statement on the use of sham surgery, says they issued their statement "in response to the Parkinson's surgery controversy," says Ratcheson. "And clearly NIH is in favor of placebo surgery and in fact insisted on a placebo surgery trial of the Parkinson's surgery." The AANS/CNS statement says that in "certain specific neurological conditions, the use of 'placebo surgery' may reduce investigator and patient bias in analyzing treatment outcome and, therefore, increase the likelihood that results of a trial will be interpreted correctly."
Any trial using placebo surgery should also follow the very strict consent process used in medical placebo controlled trials according to the AANS/CNS, a sentiment that Rakatansky echoes. Rakatansky says that it is essential that the patient understands that he or she may be getting a sham procedure but still will be subject to the standard surgical risks, such as infection.
Although the AANS/CNS statement is specific in requiring that the sham operation be safe, Sulmasy says that it is impossible to guarantee safety in the operating room. "An invasive procedure, such as a burr hole in the skull, always carries a risk. There is a chance one might slip ... but even if such harm is unlikely, changing the contour of the skull by putting in a hole seems harmful in itself."
Nevertheless, Sulmasy, a member of the Ethics and Human Rights Committee of the American College of Physicians/American Society of Internal Medicine, says it is time for a national airing of this issue. "It is good that a question like this is rising to the national level," he says. In his opinion, the issue needs to be addressed from the standpoint of "judging what can and cannot be done regardless of scientific merit."
- Scientists and ethicists are divided over whether sham surgeries should be performed as part of studies testing new treatments.
- In a sham, or placebo surgery, the patient is cut but no real surgery is performed.
- Some say that a sham surgery is necessary to have a true comparison to the traditional surgery, but others argue that it is unethical to subject a patient to risks of surgery unnecessarily.