Sunday, May 29, 2016

Human experimentation

I recently saw an article on repair of vesicovaginal fistulae ( As a surgeon, I found this bit of history interesting. Surgery during the 19th century was difficult. Ether was first demonstrated in 1846. The surgeries on the slave women were between 1845 and 1849. It is also worth reading an article by LL Wall on the ethics of Dr. Sims work (
Since I'm not a gynecologist, I thought I needed to read up on the condition. Vesicovaginal fistulae, and rectovaginal fistulae, are a complication of childbirth and still a scourge in the third world ( Most of the most dangerous countries for pregnant women are in sub-Saharan Africa, where poor women have limited access to obstetrical services, and so may suffer the consequences in terms of maternal death or fistula formation.
Anesthesia wasn't the norm for anyone in the first part of the 1800s, but became more common in the second half of the century. Only later did Dr. Sims use anesthesia, when it became standard. By that time, he had moved to New York and had a nearly all white clientele.
Throughout the south, slaves received varying levels of medical care, some reasonable for the time, some not. The owners gave consent. A friend visited one of these slave hospitals and she said that it reminded her of a veterinary hospital. But, at the time, alternatives were limited.
The standards for risk in clinical research have evolved over time, mostly since WWII, with the human experimentation on Jews, Poles, Gypsies and others by German physicians, and the Tuskegee experiment, and others, such as radiation experiments (see The Plutonium Files by Eileen Welsome). In all of these cases, the "research" had no intention of helping those subjects. I grew up knowing one of the survivors of the German experiments. She suffered from the sequelae for her entire life.
When I started my fellowship, in 1989, I remember the statement being made that an average of 1 person per year died as a result of experimental chemotherapy protocols that were being studied at my institution. Given the type of tumors we studied, without treatment, nearly all would have been dead within a year. Refining treatment has added months, or in some cases years to their average life expectancy.
I remember my patient. She was in her 20s and had a very aggressive type of tumor. She was white and middle class. But, her life was made shorter by the treatment she received. Do I feel responsible? Yes. Can I live with myself? Yes. I know she was on a protocol that was thought to possibly help her, as well as possibly helping more patients in the future. 
So, within limits, I think it reasonable to take some risk.
Certainly slavery is unacceptable. As is experimentation which has no chance to help the patient, yet has significant risk. But, there must always be a first patient or medicine can't advance. So, we try to help those for whom there is no other treatment. I would consent to a trial when I had no other option for treatment of myself or my children. It might offer us some benefit, and hopefully will help to create better treatment for future patients.

Did Dr. Sims put these slave women at risk? Yes. Might they have benefited from treatment? Maybe. There was no other option at the time, but to live with urine, and possibly feces, always dribbling out. Were these surgeries unacceptable? I don't know. Certainly, it is appropriate to acknowledge the patients.