Tuskegee syphilis experiment by USA Government FDA

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A doctor draws blood from one of the Tuskegee test subjects

The Tuskegee Study of Untreated Syphilis in the Negro Male[a] was an infamous and unethical clinical study conducted between 1932 and 1972 by the U.S. Public Health Service.[1][2] The purpose of this study was to observe the natural history of untreated syphilis; the African-American men in the study were told they were receiving free health care from the United States government.[3]

The Public Health Service started working on this study in 1932 in collaboration with Tuskegee University, a historically black college in Alabama. Investigators enrolled in the study a total of 600 impoverished, African-American sharecroppers from Macon County, Alabama. Of these men, 399 had previously contracted syphilis before the study began, and 201 did not have the disease.[2] The men were given free medical care, meals, and free burial insurance for participating in the study. The men were told that the study was only going to last six months, but it actually lasted 40 years.[2] After funding for treatment was lost, the study was continued without informing the men that they would never be treated. None of the men were told that they had the disease, and none were treated with penicillin even after the antibiotic was proven to successfully treat syphilis. According to the Centers for Disease Control, the men were told that they were being treated for "bad blood", a colloquialism that described various conditions such as syphilis, anemia, and fatigue. "Bad blood"—specifically the collection of illnesses the term included—was a leading cause of death within the southern African-American community.[2]

The 40-year study was controversial for reasons related to ethical standards. Researchers knowingly failed to treat patients appropriately after the 1940s validation of penicillin was found as an effective cure for the disease that they were studying. The revelation in 1972 of study failures by a whistleblower, Peter Buxtun, led to major changes in U.S. law and regulation on the protection of participants in clinical studies. Now studies require informed consent,[4]communication of diagnosis, and accurate reporting of test results.[5]

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; they withheld penicillin and information about it from the patients. In addition, scientists prevented participants from accessing syphilis treatment programs available to other residents in the area.[6] The study continued, under numerous US Public Health Service supervisors, until 1972, when a leak to the press resulted in its termination on November 16 of that year.[7] The victims of the study, all African American, included numerous men who died of syphilis, 40 wives who contracted the disease, and 19 children born with congenital syphilis.

The Tuskegee Syphilis Study, cited as "arguably the most infamous biomedical research study in U.S. history",[8] led to the 1979 Belmont Report and to the establishment of the Office for Human Research Protections (OHRP).[9] It also led to federal laws and regulations requiring Institutional Review Boards for the protection of human subjects in studies involving them. The OHRP manages this responsibility within the US Department of Health and Human Services (HHS).[10]

On May 16, 1997, President Bill Clinton formally apologized on behalf of the United States to victims of the experiment.

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