Sham Surgery: To Cut or Not to Cut--That Is the Ethical Dilemma

Placebo-controlled trials are known as the gold standard of research design because "the placebo effect must always be taken into account if any assessment is to be objective" (Johnson 1994). It can be argued that placebo surgery reduces the bias and increases objectivity in result analysis, which protects the public at large from potentially dangerous procedures being available as a result of incorrect interpretation of test results. Placebo surgery also has the potential of saving society from the financial burdens of unproven operations (Freeman et al. 1999). However, just because it is important as a research tool and deeply rooted in the scientific tradition does not allow researchers to use individuals as a means to an end. Franklin G. Miller (2003), in his ethical analysis of "sham surgery," claims that "critics made sweeping categorical claims that placebo surgery is necessarily or presumptively unethical based on ethical analysis of one study of sham-controlled fetal tissue transplantation."

I have been extremely critical of the government-financed, placebo-controlled clinical study using fetal tissue for those suffering from Parkinson's disease because it violates the ethical principles of respect for persons, beneficence, and justice. First, serious questions were raised about the ability of potential subjects to give valid, voluntary informed consent. Second, the use of anesthesia, the drilling of burr holes into the subject's head, and the use of cyclosporine did not present "minimal risks" for the subjects in the placebo group. These risks were serious because of the potential for harm and even death. Third, there were serious justice concerns about the exploitation of vulnerable people and the fair and equitable allocation of resources. In addition, there were serious questions raised about whether this was a scientifically valid clinical trial design. From an ethical standpoint, I concluded that placebo surgery in controlled trials using fetal tissue for Parkinson's disease should be stopped immediately (Clark 2002). I never made a "sweeping categorical" condemnation of all placebo surgery. My condemnation was specifically of this particular research study.

In his seminal work, "Surgery as Placebo," Beecher (1961) argues that it is a well-established fact that placebos can produce objective change. As a result, placebo-controlled trials for surgical interventions became a reality. The fact that placebo surgery became a reality does not mean it is ethical in every situation, nor should it be categorically rejected as unethical. Each clinical trial must be examined on its own merits. Emanuel and Miller (2001) argue that one of four criteria must be met before placebo-controlled trials are required from a scientific standpoint:

1. there is a high placebo response rate.
2. the condition is typically characterized by a waxing and waning course, frequent spontaneous remission, or both.
3. existing therapies are only partly effective or have very serious side-effects.
4. the low frequency of the condition means that an equivalence trial would have to be so large that it would reasonably prevent adequate enrollment and completion of the study.

Applying their criteria to the randomized, placebo-controlled clinical trial of arthroscopic surgery for osteoarthritis of the knee would seem to justify the placebo surgery in this case. However, a thorough analysis of this procedure is needed to determine whether it passes ethical scrutiny.

In clinical research it is important to demarcate an analysis of therapeutic and nontherapeutic interventions. A therapeutic intervention is an intervention administered with therapeutic intent with the hope of providing a direct benefit to the subject. A nontherapeutic intervention is not administered with therapeutic warrant but serves merely to assist researchers in answering the scientific question at hand. The intervention must be reasonable in relation to the importance of the knowledge that can reasonably be expected to result (Weijer 1999). Because arthroscopic surgery is a nontherapeutic intervention, which offers no prospect of benefit to the individual subject, Weijer proposes two separate ethical...