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The Dark Past of Clinical Trials and What That Means for Science Today

by Blair Hoeting (University of Cincinnati, ’22)

Research is an integral part of science. It is how we learn more about the world around us and what will get us through the COVID-19 pandemic. However, over the course of history, and as recent as less than 50 years ago, some research studies have committed horrible atrocities against its victims. This includes atrocities committed against minorities and low-income populations. These experiments went on for decades, with the victims kept in the dark about what was actually happening to them. From this, many laws were created in regard to clinical trials that allow research to be what it is today. It’s important to know about these atrocities so we can understand the power of science and why we have protocols in place.

Between 1932 and 1972, 600 African-American males were enrolled in the Tuskegee Syphilis study in Alabama, funded by the U.S. Public Health Service and later the CDC, which aimed to investigate what untreated syphilis would look like in late stages. At the time, the only other study on syphilis occurred in 1928, which looked retrospectively at white men who were already infected, and pieced notes together to draw conclusions. This study differed, as it was a prospective study, aiming to look at the progression of the disease as it happens. Under the guise that this population of people would never receive treatment, the researchers claimed that the study didn’t break any ethical guidelines. There was also a belief that race impacted how someone was affected by the disease, and that African-Americans would experience more severe cardiovascular symptoms. 400 of these 600 men enrolled in the study had syphilis. However, they were never informed about their diagnosis or the risk of transmission to others, or what complications may arise from their disease. Participants were also told that by enrolling in the study, they would receive free health care and treatment for “bad blood,” a general term for various conditions and fatigue at the time. The men were repeatedly lied to about the study’s purpose and by the study’s conclusion, 128 of the men died, 40 of the wives had contracted the disease, and 19 children were born with syphilis. 

Though the study didn’t end until 1972, the study’s first publishing was in 1934 with preliminary data, and a full paper was published in 1936. This means that the scientific community was aware that this study was occurring and did not make any public criticisms. Furthermore, many of the men only discovered they had syphilis when they were registered for the draft in World War II, and would have to get treated in order to enroll. However, the researchers were successful in blocking treatment to the research participants. By 1947, it was known that penicillin could be used to treat and cure syphilis and several treatment centers across the country were set up in an effort to eradicate the disease. When a treatment center was established near Tuskegee, the researchers were able to block all participants from receiving enough penicillin in order to be cured. The beginnings of public criticism did not occur until 1955, followed by several scientists expressing concern through the 1960s. The CDC made it clear they intended to continue the study until all participants had died. However, the study was terminated in 1972 after public outcry and the press was made aware of the unethical practices, citing a lack of informed consent. As a result, there is now a requirement for clinical trials to provide informed consent, where patients are told about the nature of the trial and possible risks or side effects and communication of diagnosis or related health information. Institutional Review Boards were also established that would be in charge of overseeing clinical trials in order to ensure proper protocol, consent, and patient safety. In 1974, after a class-action lawsuit, 51.8 million dollars in today’s currency was paid out to the families of the victims as well as free medical treatment for life. However, it wasn’t until 1997 when the White House formally apologized for wrongdoings of the government and their part in the study. Five of the eight surviving victims attended.

The Cincinnati Radiation experiments occurred from 1960-1971.  These experiments were initially started in order to study how soldiers exposed to nuclear warfare would react over long-term doses of large amounts of radiation. Dr. Eugene Saenger, a radiologist associated with the University of Cincinnati, applied for and received funding from the U.S. Department of Defense for these experiments and found his victims at Cincinnati General, now called University of Cincinnati Medical Center. Over 90 people were blasted with radiation equivalent to 20,000 x-rays at once. Many patients experienced symptoms of nausea, vomiting, weakness, fatigue, etc. One-fourth of the victims died within 2 months of their radiation exposure, and three-fourths of the victims died within a year of exposure. Cancer patients receiving treatment at Cincinnati General were recruited for this study under the promise that it would help their cancer. The majority of those selected were African-American and socio-economically disadvantaged. Patients received no consent forms for the first five years of the experiment. From 1965-1969, the consent forms did not properly explain side effects or the risk of death. It was later updated to explain possible side effects but still neglected to mention the risk of death. Some family members alleged that the researchers faked some of the signatures on the consent forms. Even though institutional review boards were not required until 1974, the radiation experiments were reviewed by a faculty committee of research (FCR) created by the University of Cincinnati, who would provide feedback on protocols and approve them. The FCR approved further study in 1967 after several revisions to the protocol despite concerns about the high death rate, and the experiments continued on for 5 more years- until the study became public knowledge. This was due to the work of Martha Stephens, a now-retired University of Cincinnati English professor, who set out a massive investigative journalism project that made these experiments known. She published a Junior Faculty Association report in 1972, which eventually led to high volumes of press coverage and the termination of the experiment when the president of the University of Cincinnati severed ties with the Department of Defense and the National Institute of Health refused to fund the experiment. In fact to this day, the only robust source about these experiments is the book she wrote, entitled The Treatment: The Story of those who died in the Cincinnati Radiation Tests.

Stephens went on to do more press and research about the experiments in the 1990s, which led to uncovering the identities of the victims and a class-action lawsuit in 1994. This, however, did not mean that the past was completely negated. Six months after he became a defendant in the lawsuit, Dr. James G. Kereiakes, the medical physicist who calculated the appropriate radiation air doses for the entirety of the study, was awarded the Daniel Drake Medal, the highest honor of the UC College of Medicine to this day. He was awarded this despite the medical atrocities he committed. The settlement of the trial was not reached until 1999. In the end, 4 million dollars was paid out to the families, but after being split among all the families, each received approximately 50,000 dollars. As a part of the lawsuit, a memorial plaque was constructed that read “In Memoriam: Radiation Effects Study 1960-1972”. This plaque was placed outside near what is now the University of Cincinnati hospital. However, this plaque made no mention of Dr. Saenger or the fact it took place in Cincinnati. In 2001, it was moved due to construction and its permanent location became the back of a parking garage. To make matters worse, in recent years, the plaque was obstructed by bushes, which were only removed after an online outcry called to make the plaque visible again. Dr. Eugene Saenger and his lab still have plaques commemorating them and their careers inside the hospital, complete with a shelf that has some of Dr. Saenger’s old treatment equipment and personal items for display. 

No amount of justice can ever rectify what happened to the victims of these experiments. However, it’s important to understand the laws and regulations that came from them and what that means for research and clinical trials. Informed consent is mandatory, meaning that participants will be made aware of the purpose of the study, what treatment they are receiving, the potential risks and side effects of the treatment, and ensuring they fully understand the information they received. Institutional review boards are also mandatory, consisting of a board of people in charge of ensuring that the methods of research that involve human subjects are ethical and that the welfare and rights of participants are protected. This also includes ensuring the informed consent process was thorough. These practices will ensure that humans who are participating in studies are safe. In the wake of COVID-19 vaccine trials and distribution, it’s important to remember this fact, as these clinical trials are more known to the public than any other clinical trial and recent history, and it could be what ends this pandemic.

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