BY MIKE MAGEE

July 25, 1972 was fifty years ago this week and it is a day that all AP Science journalists know by heart. As Monday’s AP banner headline read: “On July 25, 1972, Jean Heller, a reporter on The Associated Press investigative team, then called the Special Assignment Team, broke news that rocked the nation. Based on documents leaked by Peter Buxtun, a whistleblower at the U.S. Public Health Service, the then 29-year-old journalist and the only woman on the team, reported that the federal government let hundreds of Black men in rural Alabama go untreated for syphilis for 40 years in order to study the impact of the disease on the human body. Most of the men were denied access to penicillin, even when it became widely available as a cure. A public outcry ensued, and nearly four months later, the “Tuskegee Study of Untreated Syphilis in the Negro Male” came to an end.”

Eight years earlier, a young physician from Detroit, Irwin Schatz, came across a study in a medical journal titled “The Tuskegee Study of Untreated Syphilis: 30 Years of Observation.”Incredulous, he shot off a letter to the editor: “I am utterly astounded by the fact that physicians allow patients with a potentially fatal disease to remain untreated when effective therapy is available.” It was later revealed that Dr. Schatz’s message was read by Anne R. Yobs, one of the US Public Health Service employees who designed the Tuskegee Study, and who wrote to her superior, “This is the first letter of this type we have received. I do not plan to answer this letter.” 

On June 16, 1966, the New England Journal of Medicine published an article titled “Ethics and Clinical Research.” Written by a highly respected Harvard physician, Henry K. Beecher, the head of anesthesiology at Massachusetts General Hospital, the article referred to “troubling charges” that had grown out of “troubling practices” at “leading medical schools, university hospitals, private hospitals, governmental military departments (the Army, the Navy and the Air Force), governmental institutes (the National Institutes of Health), Veterans Administration hospitals and industry.”

“Since World War II,” Beecher continued, “the annual expenditure for research . . . in the Massachusetts General Hospital has increased a remarkable 17-fold. At the National Institutes of Health, the increase has been a gigantic 624-fold. This ‘national’ rate of increase is over 36 times that of the Massachusetts General Hospital. . . . Taking into account the sound and increasing emphasis of recent years that experimentation in man must precede general application of new procedures in therapy, plus the great sums of money available, there is reason to fear that these requirements and these resources may be greater than the supply of responsible investigators. All this heightens the problems under discussion. . . . Medical schools and university hospitals are increasingly dominated by investigators. Every young man knows that he will never be promoted to a tenure post, to a professorship in a major medical school, unless he has proved himself as an investigator. If the ready availability of money for conducting research is added to this fact, one can see how great the pressures are on ambitious young physicians.”

After Irwin Schatz first raised the issue, the AMA still endorsed continuation of the Tuskegee  study. Not until 1972, when the glare of publicity reached what was known as the “Tuskegee Experiment,” was the study finally shut down. It led to a $10 million out-of-court settlement to cover the lifetime health needs and burial expenses of participants. 

Tuskegee also led to the 1974 National Research Act, which finally incorporated some of the protections recommended at the Nuremberg Trials. Voluntary consent was now required for all participants in US medical research funded by federal dollars. A study’s design had to be reviewed and pre-approved on ethical grounds by an institutional review board, a body of local professionals who would critique each proposed study and attest that it met ethical standards. Finally, the act established the National Commission for the Protection of Human Subjects of Biomedical Research, which was charged with identifying “the basic ethical principles which should underlie the conduct of biomedical and behavioral research involving human subjects.”

Even so, the official apology for the violations of the Nuremberg Code (also known as crimes against humanity) at Tuskegee would have to wait another quarter century, when President Bill Clinton at last acknowledged, “The United States government did something that was wrong—deeply, profoundly, morally wrong.” 

And in the spirit of  “Gone, but not forgotten”, I recommend for tonight’s summer viewing “The Dropout” streaming on Hulu. It documents the felonious activities of Elizabeth Holmes and her disgraced biotechnology company Theranos. 

Why? Because Dr. Beecher had it right. While the various different patient protections provide some improvement at the margins, the core of the problem (as I lay out in CODE BLUE: Inside The Medical-Industrial Complex), is a profit seeking Medical-Industrial Complex built on an integrated career ladder (Academic Medicine to Industry to Government), and absent appropriate checks and balances. 

What can be done about it? See page 315-324 in CODE BLUE for my suggestions.

Mike Magee MD is a Medical Historian and author of  “CODE BLUE: Inside the Medical-Industrial Complex.”