The infamous syphilis experiments

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R EADERS may be aware of the infamous Tuskegee Syphilis research study that was conducted by the US Public Health Service in Alabama, USA from 1932 to 1972. In it, 399 disadvantaged and misinformed rural black men with syphilis were enrolled in the research to study what happened to people who had syphilis.

The African-American men were only told that they were receiving free health care from the United States Government. However, the aim was to learn about the natural course of the disease, and so when penicillin was discovered during the 1940s and became the drug of choice for the treatment of syphilis in 1947, the treatment was never offered to the black men enrolled in the study.

Instead, they were simply observed and the data recorded until they died.

As was to be expected, several died from the numerous complications of syphilis, including damage to the eyes, heart, liver, bones, joints, and blood vessels.

In the third stage of syphilis, the nerves and brain are severely affected (neuro-syphilis), with difficulty coordinating muscle movements, numbness, paralysis, progressive blindness, mental illness, and sometimes death.

Ethical issues

In retrospect, a number of ethical issues were found to have been associated with this research. Firstly, syphilis was a disease that was present among all the races within the US population, and so why were only black men chosen as the research subjects?

Further, since research is supposed to gain knowledge to help people, why were the black men not offered penicillin to help them when it became known that the drug was effective against syphilis?

Also, the study had originally been projected to last for six months, yet it eventually went on for 40 years.

And while the men had freely agreed to be examined and treated, there was no evidence that the researchers ever informed them about the research or its real purpose. The men had been misled and had not been given all the facts required to provide informed consent.

This research has been used as a classic example of unethical research within the history of scientific research over the past 100 years. However, in 2010, a PhD student in the USA who was researching that study, as well as others, discovered another case of unethical research which echoed the US Government’s Tuskegee study, and which had not been brought to public awareness.

 

The Guatemala study

It was revealed that from 1946 to 1948, US researchers working in Guatemala infected hundreds of mentally ill patients (both male and female) with sexually transmitted diseases while they were housed at Guatemala’s National Mental Health Hospital. The researchers injected the patients with gonorrhoea and syphilis and encouraged many of them to pass it on to others.

The US Public Health Service carried out the experiments under the guise of syphilis inoculations, and they were done with the cooperation of the Guatemalan Government. When the matter came to light in 2010, then US Secretary of State Hilary Clinton issued an official apology to Guatemala, and President Barack Obama telephoned and offered a personal apology to then President Alvaro Colom of Guatemala, who had called the experiments “a crime against humanity”.

We are now discovering that some of the stakeholders in the latter research may be further penalised for their involvement. In January 2019, a federal judge in Maryland, USA, ordered that Johns Hopkins University, Bristol-Myers Squibb pharmaceutical company, and the Rockefeller Foundation must face a US$1-billion lawsuit due to their roles in the 1940s US Government experiment that infected hundreds of Guatemalans with syphilis.

 

Testing penicillin

In the decision, the US district judge rejected the defendants’ argument that a recent Supreme Court decision that shielded foreign corporations from being sued in US courts over human rights abuses also applied to domestic corporations.

The judge’s decision is seen as a victory for the 444 victims and relatives of victims that are suing over the experiment, which was aimed at testing the then-new drug penicillin and its ability to stop the spread of sexually transmitted diseases.

In allowing the case to proceed in court, the judge said permitting the Guatemala lawsuit would promote harmony by giving foreign plaintiffs a remedy in US courts for international law violations by US corporations.

According to the complaint, several Johns Hopkins and Rockefeller Foundation doctors were involved in the experiment, as were four executives from the predecessors of the Bristol-Myers company, namely Bristol Laboratories and the Squibb Institute. Although the experiment began 72 years ago, an earlier ruling had found that no statute of limitations issues existed if the plaintiffs could not have learnt about the experiment prior to 2010.

The takeaway point is that while public health research is critical in order to develop new ways of eliminating diseases, research ethics is a fundamental part that must be considered before any research is proposed. Research ethics, involving prior assessment by a recognised research ethics committee, should therefore be codified in regulations that govern research with human participants.

 

Dr Derrick Aarons MD, PhD, is a consultant bioethicist and family physician; a specialist in ethical issues in health care, research, and the life sciences; the health registrar and head of the health secretariat for the Turks and Caicos Islands, and a member of UNESCO’s International Bioethics Committee (IBC).

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