People may wonder why sectors of the population are reluctant to accept vaccinations. Jeff came across the infamous Tuskegee experiment while studying for a masters degree in medical ethics and law. Tuskegee is a town in Alabama, USA where the study began in 1932 and ran until 1972.  Jeff is a senior student in London.

Tuskegee: A cautionary tale of medical research

Jeff Sapiro, London

I had taken up an academic teaching role and was developing ethics and law teaching on undergraduate and postgraduate health care programmes.

My work in the NHS (National Health Service in the UK) often brought me into close contact with staff who were conducting research as well as patients who were participating as research subjects. Later, as a member of a research ethics committee, I was aware of the thorough care taken to ensure the safety, transparency and proper conduct of health care research, and the safeguards that were integrated into the research process at every stage of a study.

During my MA programme I came across the ‘Tuskegee Syphilis Study’ as it was informally called.

In order to obtain knowledge about the progression of syphilis infection, the Tuskegee Study recruited African-American men who were given misleading information about the study. Treatment that was known to be effective at curing the debilitating disease syphilis was deliberately withheld from them.    

The contrast between that study and my experience of medical research was stark. The facts of the Tuskegee study, which had commenced in 1932 and was still running, right into the early 1970s, struck me as extraordinary in terms of either its blindness or its deliberate disregard of basic ethical standards in medical research. 

The Tuskegee Study

A ‘demonstration project’ – the first major blood testing and treatment programme for syphilis – was set up in 1930. Assumptions were made that racial differences were an important factor in the disease process. Even though local physicians reported that there was considerable syphilis in both the white and black population, the focus of the survey was confined to black men, women, and children. Injections of heavy metals and mercury rubs were the only treatments in use for syphilis at this time. Some of these treatments were given, but the treatment component of the study soon unravelled due to lack of funding.

Penicillin had been discovered in 1928, but its mass production and distribution were still some years off. In the U.S. the drug was made available to the general public in 1945.

Following the completion of the ‘demonstration project’ the U.S. Public Health Service (PHS) developed a further plan to test African-American men for syphilis using ‘spinal taps’ – the dangerous and painful procedure of inserting a needle into the spinal column to remove fluid. The researchers never mentioned that the procedure was purely diagnostic, and invited the men to come for ‘a last chance for special free treatment’. Spinal taps were performed on 296 men. 

Spurious treatment

The Study had been scheduled to finish once the data obtained had been worked up. However, the doctor who had supervised the study developed a new plan to run for 5 to 10 years. About 400 men would be given small amounts of what would be called ‘treatment’ for syphilis. The ‘treatment’ would comprise only aspirins and tonics. Autopsies would be carried out when death occurred in order to examine the tissue damage caused by the syphilis. 

One of PHS’s researchers commented: “As I see it, we have no further interest in these patients until they die”. No thought was given to the ethics of informing the men that they were receiving treatment when in fact they would remain without any effective treatment. 

No effective treatment given

By 1943, PHS’s staff working at the Venereal Disease Research Laboratory on Staten Island, New York, reported that penicillin appeared to be highly effective in killing the spirochetes of syphilis. In 1946 the PHS report found that those who had received no treatment for their illness had had their life expectancies “reduced by about 20%.” Despite this, the study continued, the men continuing to be deprived of effective treatment. The PHS regional medical director stated that he hoped that the availability of antibiotics had not interfered too much with the project.  

The Study continued into the 1950s. Articles and reports by the PHS implied that the men were willing volunteers, and failed to mention that aspirins and tonics were being wrongly described to the men as ‘treatments’ for syphilis.

Criticism starts

Major criticisms of the study began to emerge from 1955. A physician who recognised that effective treatment was being withheld wrote: “It seems to me that the continued observation of an … individual suffering with a chronic disease for which therapeutic measures are available, cannot be justified on the basis of any accepted moral standard: pagan (Hippocratic Oath), religious (Maimonides, Golden Rule), or professional (A.M.A. Code of Ethics).”

Susan Reverby (2009)¹ comments that ” Powerful men in a government bureaucracy, medical uncertainties, and racial beliefs kept the Study going … No one was asking the men in the Study what they thought. No one inside the PHS or at Tuskegee Institute seems to have considered that they should.”

In 1968 a PHS employee questioned the study’s ethics. He emphasised his concern about political ramifications, given that the selected research subjects were 100% African-American: “This in itself is political dynamite and subject to wild journalistic misinterpretation”. He pointed out that it fed into existing beliefs amongst the African-American community that they had long been used for ‘medical experiments’ and ‘teaching cases’ in the emergency wards of county hospitals. He argued that the Study’s purpose and procedures would be read as racist and deceptive, and possibly illegal and immoral and even murderous. 

Stopping the study

Despite arguments from within the PHS in 1970 that the study should be stopped, the study continued for another two years, until in 1972 a journalist put out a piece over the Associated Press wire headed “Syphilis Victims in U.S. Study Went Untreated for 40 Years.” The lead sentence said “For 40 years the United States Public Health Service has conducted a study in which human beings with syphilis, who were induced to serve as guinea pigs, have gone without medical treatment for the disease and a few have died of its late effect, even though an effective therapy was eventually discovered.”

Even then, the Study’s former director would not acknowledge the deceptions, declaring that “There was nothing in the experiment that was unethical or unscientific.”

Later in 1973, a class-action lawsuit was filed on behalf of the study participants and their families, resulting in a $10 million, out-of-court settlement in 1974.

The Tuskegee legacy

A recent study² investigated whether the study’s disclosure to the public contributed to racial disparities in health and healthcare utilization in the years following 1972. The researchers found that there was a correlation between the disclosure and increases in medical mistrust and mortality among African-American men. They suggested that this appears to have spread far beyond the area where the Tuskegee study took place.

The effectiveness of a health care system rests on a relationship of mutual trust and respect between health professionals and those for whom health care and treatment will be beneficial. A damaging consequence of a lack of such trust is that those who need help may be deterred from accessing that help.

Finally, apology

In 1997, President Bill Clinton issued a formal Presidential Apology for the study: “Medical people are supposed to help when we need care, but even once a cure was discovered, they were denied help, and they were lied to by their government … The people who ran the study at Tuskegee diminished the stature of man by abandoning the most basic ethical precepts. They forgot their pledge to heal and repair. They had the power to heal the survivors and all the others and they did not. Today, all we can do is apologise.”

In learning about medical law and ethics, students on health and social care programmes need to understand the ethical and legal dimensions of their decision-making, and to appreciate what constitutes the best ethically-informed practice. As a lecturer, the use of case studies such as Tuskegee have had a central role in my teaching, helping students to explore the key ethical and legal issues that they will face in the course of their professional work.

The description in this article of the infamous study in Alabama is not intended to suggest that life-saving medical interventions such as vaccination be avoided, especially in the face of a global pandemic. But rather that the events that took place in Tuskegee may help in understanding the reasons for suspicion of medical authorities and, for example, the occurrence of ‘vaccine hesitancy’ amongst some sections of the community.

References

¹  Reverby, Susan M (2009) Examining Tuskegee (The John Hope Franklin Series in African American History and Culture). The University of North Carolina Press. Kindle Edition.

²  Marcella Alsan and Marianne Wanamaker (2017) Tuskegee and the Health of Black Men. National Bureau of Economic Research Working Paper 22323. Accessed at  http://www.nber.org/papers/w22323