By Darryl Weiman, M.D., J.D.

Newsletter from the Standards and Ethics Committee for the Eastern Cardiothoracic Surgical

In 1929, a first-year surgical resident, Werner Forssmann, operating on a dog, was able to insert a urologic catheter through a leg vein into the right atrium. The dog survived. Forssmann hypothesized that the same procedure could be done on humans. With a catheter placed in the right side of the heart, he could then study right sided pressures safely and could evaluate the effects of medicines, such as digoxin, injected directly into the heart.

Forssmann brought his idea to his boss and, not surprisingly, his proposal to place a central catheter in humans was rejected. Forssmann, convinced with the importance of cannulating the central circulation in humans, decided to place a catheter in himself. With the help of an operating room nurse, he obtained sterile instruments and with the nurse—who thought that she was to be the experimental subject—locked themselves into the hospital’s small operating room. Forssmann, then did a cutdown into a left arm vein and threaded a lubricated ureteral catheter 65 centimeters from the arm into his body.

Forssmann probably wanted the nurse to be with him in case something went wrong and probably never intended for her to be the subject of the procedure. Forssmann and the nurse then went to the radiology department where a chest radiograph confirmed the position of the catheter in the heart. The catheter was removed and there were no complications.

The next morning, Forssmann showed the radiograph to his boss who immediately fired him. Forssmann was able to get an unpaid appointment with Ferdinand Sauerbruch at the surgical department at the Charite in Germany. Forssmann’s ideas were ridiculed by his colleagues at Charite so he ended up going to the University Hospital in Mainz where he trained in urology.

From Mainz, he went to the Rudolf Virchow Hospital in Berlin for further training in urology and general surgery. After more training, World War II intervened and Forssmann was never able to fulfill his dream of being an academic surgeon.

Forssmann continued his career as a general practitioner and urologist until 1956 when he was informed that he had been awarded the Nobel Prize. From 1958 to his retirement in 1969, he was the Chair of the surgical division of the Evangelist Hospital in Dusseldorf.

History shows the importance of what Forssmann did to himself on that day in 1929. His Nobel co-recipients Andre Cournand and Dickinson Richards, intrigued by Forssmann’s article of 1929, pioneered the work leading to cardiac catheterization as we know today. Catheterization of the right heart led to study of the left heart and, subsequently, to coronary arteriography.

Percutaneous interventions to the coronary arteries and percutaneous interventions for valves are now being routinely done. Millions of lives have been saved due to the development of cardiac catheterization, but do the results justify the means? In this case, I think they do.

Self-experimentation is not new, and Forssmann is not the only Nobel Prize winner in medicine to do this. Barry Marshall was convinced that H. pylori was a cause of gastritis and ulcers. He drank a broth that contained the bacteria and got gastritis which he then cured with appropriate antibiotics. Marshall’s work changed the treatment of these diseases, and he was awarded the Nobel in 2005.

So what are we to make of those who self-experiment? After all, it is difficult to reconcile between reckless endangerment and heroic self-sacrifice. The ethical principles outlined and defined in the Belmont Report of 1979 are a reasonable starting point.

The three main principles of the Belmont Report are (1) respect for persons (autonomy), (2) beneficence/nonmaleficence, and (3) justice. Can we use these principles as guidelines to determine when self-experimentation is justified?

Under autonomy, it seems obvious that the self-experimenter is exercising his personal liberty, and he has probably given himself informed consent. No vulnerable population seems to be involved, and no person is being coerced. However, bias may lead to an underestimation of the risks. Without external oversight, safeguards may be underestimated or totally absent. Even Forssmann made sure his nurse was present in case something bad happened.

With beneficence/nonmaleficence, the goal is to maximize benefits and minimize risks. The self-experimenter is probably minimizing risk for others but, if the risk to himself is high and the hoped for benefit is low, then the experiment should not be condoned. In fact, if dealing with pathogens e.g., Covid, then risks could spread to the community at large especially if proper safeguards (containment?) are not in place.

Justice requires a fair distribution of research risks and benefits. If the self-experimenter bypasses the IRB review process then ethical standards are not considered which can hurt the justice of the whole research endeavor.

So what are we supposed to do? Pursuit of discovery should be encouraged but recklessness should not. Self-experimentation is a gray zone of modern ethics, and the debate is on-going so do not expect an answer from me. However, safeguards should be placed by the IRB and by journals who may be asked to support and publish the results of the experiment.

Remember, Forssmann was able to publish his experiment, and we can still view the chest radiograph he took in 1929, but that happened long before safeguards for human experimentation were in place. Each IRB and journal should balance the value of the knowledge sought, the risks involved, the safeguards in place, and the effect the experiment is setting for future researchers; these should all be part of the decision-making process.

Journals should only publish reports that can be morally justified. Reports should be judged on a case-by-case basis by ethical review boards and by the journal’s editors. Having a decision-making process already in place will go a long way in justifying publication of a self-experimenter’s report.