By its very nature, medicine depends on scientific inquiry and experimentation. The vast amounts of money invested in pharmaceutical research, however, tend to obscure three basic truths:
- Not all research has scientific value.
- Many drugs tested have limited effectiveness, or prove to be more dangerous than first believed.
- Most new drugs prove to be no better than medicines that are already available.
Approximately 95% of all clinical trials fail for one of these three reasons. For patients, the situation is further complicated when the experiment uses either a non-therapeutic substance (i.e., a placebo), or a fake surgical procedure.
In 1963, Dr. Henry K. Beecher explored the validity of surgical placebo therapy in “Ethics and experimental therapy.”
The Power of Suggestion
When conducting an experiment, researchers have to consider all variables that may affect an experimental outcome. Under ideal conditions, a patient benefits exclusively from being treated with a new drug or an improved surgical procedure.
But researchers also are aware of the mind-body connection and how the 'power of suggestion' may cause improvement even when no real treatment is provided. For this reason, clinical trials are designed with a placebo to ensure the results are caused by the tested drug and not some other factor.
In the last century, however, medical researchers did not only use placebos as medical therapy, but also performed fake surgeries on patients without their knowledge or consent.
Are There Benefits to Fake Surgical Procedures?
Beecher claimed that there were many instances when modern medicine relied on fake surgeries. He cited one case where a respected surgeon opted to treat an inflammatory digestive condition (i.e., tuberculosis peritonitis) simply by opening up the stomach and “letting in a little light and air.”
In another example, a patient suffering from chest pains (i.e., angina pectoris) was told that an operation would fix the problem. Instead, the surgeon merely created a “skin incision over both internal mammary arteries.” After the fake surgical procedure, the patient was able to exercise and perform other physical activities without any chest pain.
Although unsettling to a modern reader, in Beecher’s day the practice of performing fake surgeries as ‘placebos,’ in place of accepted medical treatment, was not uncommon. At no time did the patients know that a real procedure had not been performed. Sometimes, the fake procedure produced some improvement in a patient’s condition — in other instances, the patient died.
Statistical Morality to the Rescue
Although the ethical implications here are obvious, Beecher erred on the side of caution in his criticism and defended the practice of surgical placebo therapy in terms of statistical morality. In its simplest sense. statistical morality places a specific incident in human terms, rather than in the context of abstract numbers.
Using myasthenia gravis (an autoimmune neuromuscular condition) as an example, Beecher discussed a real research study in which 1,000 suffering patients would be recruited either to undergo a real thymectomy (i.e., removal of the thymus) or a fake operation. Beecher then applied the practical morality of statistics to the proposed research study.
According to Beecher, the estimated death rate from a thymectomy was about 7.5%. Assuming that the death rate for a fake operation would be no worse than for a thymectomy, Beecher suggested decreasing the number of recruited patients. If the study sample size were reduced to 50 patients, with 25 patients receiving a real thymectomy and the other 25 patients undergoing a fake operation (i.e., a skin incision as before), then patient deaths would be limited to 4 out of 50, instead of 75 out of 1,000.
Of course, the proposed research benefits would depend entirely on whether a patient was one of the 4 fatalities, or survived with the other 46 subjects. In that sense, the ethics of surgical placebo therapy is a matter of personal perception.
References
Beecher HK. 1963. Ethics and experimental therapy. JAMA. 186:858-859.
Corrigan O. 2003. Empty ethics: the problem with informed consent. Sociology of Health and Illness. 25(3):768-792.
Spink JD. 1980. Pharmaceutical product liability: the standpoint of the pharmaceutical house. In: Harcus AW, Editor. Risk and Regulation in Medicine. Association of Medical Advisers to the Pharmaceutical Industry.
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