|Is Sham Surgery Ethical?
Rabbi Chaim Steinmetz
Is Sham Surgery Ethical?
by Rabbi Chaim Steinmetz
One of the mainstays of medical research is the double blind control group. Patients involved in drug studies are routinely divided into two groups, one which takes the experimental drug, and another which takes a placebo. The results of the two groups are compared, allowing researchers to exclude external factors that may be affecting the patient, such as the psychosomatic effects of taking medicine. In recent years, the Food and Drug Administration and National Institutes of Health have been encouraging researchers testing new surgical techniques to use control groups. One group receives the experimental surgery, while the control group receives "sham surgeries", where they undergo a similar but useless surgical procedure. In a recent study using fetal tissue to treat Parkinson's disease, all forty patients were operated on, and had four tiny holes drilled into their foreheads; however, only twenty of the patients received the transplant of fetal tissue, while the control group got the surgery without the transplant (NYTimes, April 22, 1999). These studies raise a difficult ethical question: Is it acceptable to perform a surgery that will have no benefit for the patient?
It must be noted that as a general rule, Halacha prohibits injuring any person, including self injury (Shulchan Aruch CM420:31). The reason for this is that the human body is a gift from God, and man has no right to injure or destroy it (Rabbi S.Z. Zevin, L'Or HaHalacha 318-338). This prohibition does not necessarily rule out all forms of self injury. Under certain circumstances, Rabbi Moshe Feinstein (Iggrot Moshe CM2:66) allows purposeful wounding such as plastic surgery, while others are more restrictive (Tzitz Eliezer 11:41). Clearly, participation in a surgical study, even for the control group, could be considered a "purposeful" form of injury, and acceptable according to halacha. However, two halachic concerns remain.
The first concern relates to the possible exaggeration of medical benefit. Dr. Arthur Caplan, director of the University of Pennsylvania Center for Bioethics, has opposed sham surgery on the grounds that "this is going to extremes to worship at the altar of placebo controls" (Wall Street Journal, December 11, 1998). Similar concerns exist in halacha. In many cases, Jewish law prohibits autopsies. However, one may violate the Torah in order to possibly save a life. But how do you define this possibility? Is the possibility that the doctors performing the autopsy may gain medical knowledge that could save a life in the future sufficient reason for an autopsy? According to Rabbi Ezekiel Landau (NB YDII:201), a possible future benefit is insufficient reason to violate halacha. He gives the following example to illustrate his view. A doctor is allowed to boil water, even on Shabbat, in order to sterilize his instruments for a life saving surgery. However, this would not allow any person to boil water on Shabbat on the off chance that it may be necessary for a life threatening surgery. Similarly, he says that one only suspends Halacha in the face of a clear danger, not for a possible future medical benefit. While others adopt a more liberal view of medical benefit (Mishpetei Uziel YD28), the point made by Rabbi Landau is extremely significant. Not every type of medical benefit is sufficient reason for us to override ethical concerns. If "sham surgeries" become a routine method of research, researchers will no longer review each surgical study to see if it is absolutely necessary to use a control group.
A second concern has to do with proper consent. While all patients in the study sign that they consent to the sham surgery if they are picked for the control group, is a patient, desperate to try an experimental cure, giving wholehearted consent? There is a similar concern in halacha regarding to gambling. The Talmud (Sanhedrin 24b) mentions an opinion that gambling can be considered a form of theft. According to Rashi, that opinion holds that because gamblers play with the expectation that they will be winners; therefore, their consent is never a true, wholehearted consent.
While the halacha generally permits "non-professional" gambling (Rama CM 370:3), the concerns raised by the opinion in Sanhedrin 24b are very real. It is quite possible that patients will consent to sham surgery only because they are desperate for a cure. This type of consent is ethically suspect.
There is no question that there is sufficient warrant in Halacha to allow sham surgery when required. However, there are major halachic concerns about using sham surgery, and it should not be used unless absolutely necessary.
Rabbi Chaim Steinmetz is the Rabbi of Tifereth Beth David Jerusalem, Quebec Canada, H4V 1A1. His e-mail address is firstname.lastname@example.org.