Lest We forget, 2022 marks the 50th anniversary of the *discovery* of the insidious Tuskegee Syphilis Experiment...
July 25, 1972, marks the day that the Tuskegee syphilis experiment (also known as the Tuskegee syphilis study or Public Health Service syphilis study) was exposed to the public. It was an infamous clinical study conducted between 1932 and 1972 in Tuskegee, Alabama by the U.S. Public Health Service to study the natural progression of untreated syphilis in poor, rural black men who thought they were receiving free health care from the U.S. government.
The Public Health Service, working with the Tuskegee Institute, began the study in 1932. Investigators enrolled in the study a total of 600 impoverished, African-American sharecroppers from Macon County, Alabama; 399 who had previously contracted syphilis before the study began, and 201 without the disease. For participating in the study, the men were given free medical care, meals, and free burial insurance. They were never told they had syphilis, nor were they ever treated for it. According to the Centers for Disease Control, the men were told they were being treated for "bad blood," a local term used to describe several illnesses, including syphilis, anemia and fatigue.
The 40-year study was controversial for reasons related to ethical standards; primarily because researchers knowingly failed to treat patients appropriately after the 1940s validation of penicillin as an effective cure for the disease they were studying. Revelation of study failures by a whistleblower led to major changes in U.S. law and regulation on the protection of participants in clinical studies.
Now studies require informed consent (with exceptions possible for U.S. Federal agencies which can be kept secret by Executive Order), communication of diagnosis, and accurate reporting of test results.
By 1947, penicillin had become the standard treatment for syphilis. Choices available to the doctors involved in the study might have included treating all syphilitic subjects and closing the study, or splitting off a control group for testing with penicillin. Instead, the Tuskegee scientists continued the study without treating any participants and withholding penicillin and information about it from the patients. In addition, scientists prevented participants from accessing syphilis treatment programs available to others in the area.
The study continued, under numerous US Public Health Service supervisors, until 1972, when a leak to the press eventually resulted in its termination. The victims of the study included numerous men who died of syphilis, wives who contracted the disease, and children born with congenital syphilis.
The Tuskegee Syphilis Study, cited as "arguably the most infamous biomedical research study in U.S. history," led to the 1979 Belmont Report and the establishment of the Office for Human Research Protections (OHRP). It also led to federal laws and regulations requiring Institutional Review Boards for the protection of human subjects in studies involving human subjects. The Office for Human Research Protections (OHRP) manages this responsibility within the US Department of Health and Human Services (HHS).
The U.S. Public Health Service Syphilis Study at Tuskegee highlighted issues in race and science. The aftershocks of this study, and other human experiments in the United States, led to the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the National Research Act. The latter requires the establishment of institutional review boards (IRBs) at institutions receiving federal support (such as grants, cooperative agreements, or contracts). Foreign consent procedures can be substituted which offer similar protections and must be submitted to the Federal Register unless a statute or Executive Order requires otherwise.
In the period following World War II, the revelation of the Holocaust and related Nazi medical abuses brought about changes in international law. Western allies formulated the Nuremberg Code to protect the rights of research subjects. In 1964, the World Health Organization's Declaration of Helsinki specified that experiments involving human beings needed the "informed consent" of participants.[60] In spite of these events, the protocols of the study were not re-evaluated according to the new standards, even though whether or not the study should continue was re-evaluated several times (including in 1969 by the CDC). U.S. government officials and medical professionals kept silent and the study did not end until 1972, nearly three decades after the Nuremberg trials.
Writer James Jones said that the physicians were fixated on African-American sexuality. They believed that African-Americans willingly had sexual relations with infected persons (although no one had been told his diagnosis). Due to the lack of information, the participants were manipulated into continuing the study without full knowledge of their role or their choices.
Since the late 20th century, IRBs established in association with clinical studies requirements that all involved in the study be willing and voluntary participants.
The Tuskegee University Legacy Museum has on display a check issued by the United States government on behalf of Dan Carlis to Lloyd Clements, Jr., a descendant of one of the U.S. Public Health Service Syphilis Study at Tuskegee participants. Lloyd Clements, Jr.'s great-grandfather Dan Carlis and two of his uncles, Ludie Clements and Sylvester Carlis, were in the study. Original legal paperwork for Sylvester Carlis related to the study is on display at the museum as well. Lloyd Clements, Jr. has worked with noted historian Susan Reverby concerning his family's involvement with the U.S. Public Health Service Syphilis Study at Tuskegee.
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