In the post on Tuskegee trial, we read about the unethical scientific studies. There is another scientific study which also has been extremely unethical and was another stepping stone in framing the present rules and regulations of the clinical trials. That study was ‘the Guatemala STD experiments’ (1946 to 1948) which is, in ethical sense, even worse than the Tuskegee Trial. This trial was funded by the National Institutes of Health, with the co-operation of Guatemalan authorities.
One of the chief researchers involved with the Guatemala experiments, was physician John Charles Cutler, who was the official of the US Public Health Service (USPHS). He was also involved in the Tuskegee experiments. He was an Assistant Surgeon-General in the US government, and later on became the Professor at the University of Pittsburgh and Acting Dean of the Graduate School of Public Health during 1968–69. 
The Background
Like the Tuskegee one, the Guatemala Trial was also a science experiment done to study sexually transmitted diseases (STDs) including syphilis (described in post on Tuskegee trials) and gonorrhoea, in Guatemala, Central America.
Gonorrhoea is caused by bacteria called Neisseria gonorrhoeae, and it’s symptoms include a thick green or yellow discharge from the vagina or penis, pain/burning sensation while urinating and, bleeding during inter-menstruation period in women. If left untreated, it may lead to infertility.
These STDs were affecting the general public, especially the military manpower during crucial time of World War II, leading to great loss .
The treatment for these STDs which were already in use, were ineffective or not clear. Syphilis was found to be treated by penicillin in 1943, but the stock was limited. It was also unclear whether penicillin provided long-term protection against syphilis and also if it could provide protection against other STDs as well. Hence, the goal of the study was:
-To understand the effect of syphilis and other sexually transmitted diseases on the body
-To test whether existing treatments were effective.
Different medications, including the antibiotic penicillin and the arsenical agent orvus-mapharsen were to be tested.
The Experiment Methodology:
As the study required patients for the study, the researchers planned to infect the unexposed human subjects with the disease-causing agents (*harm).
According to the ethical standards of the experimenting group, the disease-causing agent could be introduced in the volunteers if they provide their consent. The consent was to be obtained only after making them understand all the risks involved, which is doubted if happened.
In the experiments to understand about the disease gonorrhea, the researchers proposed to expose the prisoners at Terre Haute, a prison at Indiana, with the gonorrhoea-causing bacteria. This study was headed by Dr. John F. Mahoney, Assistant chief of the PHS Venereal Disease Research Laboratory, Washington with Dr. John Charles Cutler and funded by National Institutes of Health.
They planned to first infect the prisoners with the bacteria and then give them the treatment to prevent them from contracting the disease, i.e. prophylactic treatment. In order to persuade the prisoners to volunteer into the study, the prisoners were lured with $100.
To infect the male prisoners with the disease, the researchers deposited different strains and concentrations of gonorrhoea on the sex organs. Just the process of depositing the bacteria on the sex organs did not produce infection and the researchers concluded that the process of sexual intercourse with the infected person may be required for the gonorrhoeal infection to be transmitted. Therefore, they planned to use, prostitutes (women) as a medium to pass the infection to the men (*highly unethical).
Hence, the researchers decided to shift the base of the study to Guatemala, due to the strangest reason!!
The reason was that the prostitution was legal in Guatemala. Also, low rate of the STDs there, made the researchers believe that it was a better place for the study (*extremely unethical).
Surprisingly, this research proposal received approval and funding from the Deputy Surgeon General and the National Institutes of Health.
Cutler, in guise of helping Gautemala government in building labs and training physicians, got access to the military, orphanages, mental health centers and prisons.
In order to have infected prostitutes, cotton swab was moistened with pus carrying gonorrhoea bacteria and inserted into their genitals. It is doubtful if the prostitutes were explained about the risks. This procedure caused all of them get the disease.
As these sex workers, got the disease, as bad as it may sound, they were used to transfer the disease to the men, as planned. However, later in the course of study, the prisoners refused to be a part of this study as they dreaded that the drawing of blood samples made them weaker and they refused adamantly even on being lured with alcohol and free sex!!
That is when they switched to the army men who were also intoxicated and made to sleep with prostitutes. There is doubt about the army men being informed as well, that this was a part of a medical experiment.
The experiment got no significant outcome, as the men did not contract gonorrhea, but only infected females. Hence Cutler and group turned their attention back to the artificial inoculation approach, this time by deep inoculation into the patient’s urethra, which caused infection in the men (*extremely unethical).
It is believed that even mental patients in Gautemala were infected with the STDs in the course of this study. The patients were tried to be infected through eyes, genitals, oral route and even through injecting pus into their spinal cords. Finally in 1948, due to official replacements, Cutler concluded his work and returned home to avoid any criticism. Some of the group member remained in Gautemala to maintain the record of the patients, however, it is not sure if they were treated.
As a result of this study, 1,308 subjects were exposed to STD, out of which only 678 were known to have received the treatment and caused around 83 deaths.
After the death of Dr. Cutler in 2003, his papers were given to the archives of the school. Eventually, the informations about these experiments were uncovered by Professor Susan Mokotoff Reverby of Wellesley College, in the archived papers in 2003. She presented her findings about at an academic conference in 2010 and also informed the Centers for Disease Control and Prevention (CDC)
(Just for info: Read this paper titled Ethical Failures and History Lessons: The U.S. Public Health Service Research Studies in Tuskegee and Guatemala by Prof. Reverby)
On October 1, 2010, the U.S. President Barack Obama, Secretary of State and Secretary of Health and Human Services apologized to Guatemala.
The U.S. government asked the Institute of Medicine to review these experiments in January 2011. Meanwhile the Presidential Commission for the Study of Bioethical Issues formed a panel of international experts which published ‘Ethically Impossible: STD Research in Guatemala from 1946 to 1948‘ in September 2011.
In March 2011, lawsuit was filed against the U.S. government claiming damages for the Guatemala Experiments which failed stating that the U.S. government could not be held responsible for actions committed outside of the U.S.
Hence, In April 2015, lawsuit was filed against the private institutes like Johns Hopkins University, the pharmaceutical company Bristol-Myers Squibb, and the Rockefeller Foundation seeking $1 billion for damages.
On January 4th, 2019, US District Judge Theodore Chuang rejected arguments from the defense based on the Supreme Court decision protecting foreign companies from US lawsuits over human rights abuses abroad also applied to domestic firms. This decision is a clear victory for the victims and loved ones.
(Just for info: read the recent update)
However, the justice is yet to served, even after around 70 years of the unethical experiment.
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Read other posts by The Biotech Notes:
Overview of Immune system: Innate and Acquired Immunity.
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References:
Kara Roger (2018) Guatemala syphilis experiment. Encyclopaedia Britannica, inc. https://www.britannica.com/event/Guatemala-syphilis-experiment
Rodriguez (2013) First, Do No Harm: The US Sexually Transmitted Disease Experiments in Guatemala. Am J Public Health. 103(12): 2122–2126.
Subramanian (Feb 26, 2017) Worse Than Tuskegee. Slate.com.
Speak Project (Jan 3, 2020) Rockefeller Foundation Sued $1 Billion for Infecting Citizens with Syphilis. Landmark Court Filings.
LeeF (Jan 1, 1946) Guatemala Syphilis Experiment (1946-53): U.S. Doctors Secretly Infected Soldiers, Prisoners and Mental Patients with Syphilis and other STD’s. thewaronliberty.com.
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