The unintended ethics of Henry K Beecher.

2374 www.thelancet.com Vol 387 June 11, 2016 In the summer of 1966, the medical profession was hit with a bombshell. Henry K Beecher published “Ethics and Clinical Research”, a landmark article, often called “Beecher’s bombshell”, which described 22 examples of clinical research he deemed ethically questionable. Beecher hit his mark. Describing the aftershock in the pages of this journal, one writer explained, “His article aroused controversy among American research-workers and highlighted a problem which had grown insidiously and almost unnoticed by the generality of American doctors”. For onlookers beyond US borders, Beecher seemed to have attacked a distinctly American problem. But the outcome— regulations for nearly all American-funded research with human subjects—rippled across the globe. In 1974, the US Government passed the National Research Act, which set rules that required “institutional review” of studies at home and abroad—rules that have remained embattled ever since and were contrary to Beecher’s plan. Published 50 years ago this month, Beecher’s article fundamentally changed the practice of clinical research ethics after World War 2, but did so in ways that Beecher neither expected nor supported. By dropping his bomb on his own profession, Beecher inadvertently created the very circumstances he had hoped to avoid. The article was hugely controversial, and so was Beecher. When his piece appeared in 1966 in The New England Journal of Medicine, Beecher was the esteemed chief of anaesthesiology at Massachusetts General Hospital in Boston, a post he had held for more than two decades after a bootstrap climb to medical prominence. Raised in rural Kansas during World War 1, he changed his German surname to the Anglophone Beecher in the 1920s, and travelled east to take his medical degree at Harvard. During World War 2, he did infl uential pain research that thrust the problem of placebos to the centre of debates over how properly to design clinical trials. Never shy of a good fi ght, in 1968 he would lead the Harvard Committee to Examine the Defi nition of Brain Death, which set infl uential, controversial standards that allowed doctors to remove patients from life support. Beecher was ambitious, he was contentious, and he adored the limelight. One reason Beecher is widely remembered today is that he refused to let people forget him. By publishing “Ethics and Clinical Research”, he aimed to rock the profession out of moral complacency. But Beecher pointed out the ethical failings of the medical profession in a characteristically public way. 1 year earlier, Beecher had given a lecture at an elite conference well attended by science journalists, where he discussed cases of unethical research. Perhaps unsurprisingly, Beecher’s report of doctors who used humans as guineapigs for their research appeared in news stories around the country, including in The New York Times and The Wall Street Journal. When Beecher returned from the lecture, his colleagues rebutted his claims with a press conference of their own. Galvanised, Beecher used the text of his conference talk as the kernel of “Ethics and Clinical Research”. He sent the paper to The Journal of the American Medical Association, but the journal rejected it with no option to revise— some speculate because of a desire to avoid the scrum around Beecher. (To be fair, this early draft of the piece was also an organisational nightmare.) Beecher then sent the article to The New England Journal of Medicine, which agreed to publish it with careful editorial input. A week before the piece appeared in June, 1966, Beecher braced the Director of Massachusetts General Hospital: “unhappily, it may produce a considerable amount of controversy”, Beecher wrote in a letter now archived at Harvard’s Countway Center for the History of Medicine, “and you may be approached by members of the press for comment”. Signalling a reputation for melodrama, he assured his boss that ”I have not exaggerated the material”, explaining how editors had worked to keep “the public protected from exaggeration on my part” so that the piece is “as unexaggerated as possible”. Beecher’s article added to friction within the medical profession about the ethics of research, to be sure. But it also, importantly, added to strife about the propriety of exposing weaknesses of the medical fraternity to those outside the profession. The art of medicine The unintended ethics of Henry K Beecher