Fact check: False claim that the FDA was involved in the controversial Tuskegee study
The claim: Food and Drug Administration approved the Tuskegee Syphilis Study
While some Americans celebrated the government's approval of a coronavirus vaccine, others used the announcement on Pfizer's full authorization as an opportunity to spread misinformation about the country's vaccine regulation agency.
"The FDA approved the Tuskegee experiment also y'all have a good day," an Aug. 23 Facebook post reads.
The post was shared almost 5,000 times within two days.
The Tuskegee Syphilis Study was a federally funded study that left Black men in Alabama untreated for syphilis for 40 years, even after penicillin had become widely available as a treatment for the disease, according to the U.S. Centers for Disease Control and Prevention.
It's not the only recent claim invoking the Tuskegee study to cast aspersions on a government agency in the COVID-19 spotlight. One misleading post claimed the study was conducted by the CDC in an attempt to question its handling of the COVID-19 pandemic. (We rated that claim missing context, as the CDC had a role later in the process but didn't exist until 14 years into the study.)
Isaiah Jamal Beard, the Facebook user who posted the FDA claim, told USA TODAY he wanted to start a conversation about the distrust between his community and the government, caused in part by experiments like the Tuskegee study.
"I stated this based off my own knowledge that the (U.S. Public Health Service) conducted the experiment, which the FDA is a part of," he wrote in a Facebook message.
It's true the FDA is part of the Public Health Service, which started the study in 1932. But it only became part of it in 1968 – almost 36 years after the study had already started.
And the FDA had no role in the study even after that point, a spokesperson said. The FDA focuses on the regulation of health products, and it does not conduct human clinical trials.
Study conducted by Public Health Service
Between 1932 and 1972, the U.S. Public Health Service and the Tuskegee Institute carried out the Tuskegee study, originally called the "Tuskegee Study of Untreated Syphilis in the Negro Male."
Six hundred Black men were part of the study: 399 of them had syphilis and 201 were in the control group without the disease.
The researchers both withheld treatment for the men with syphilis and failed to accurately describe the program to obtain informed consent. Tuskegee community members thought it was "a special government health care program," according to the CDC, as they received free medical exams, free meals and burial insurance.
But trying to connect the FDA's role in regulating COVID-19 vaccines with the Tuskegee study is inaccurate.
FDA doesn't conduct clinical trials or experiments
The FDA was not involved in the study, agency spokesperson Shannon Hatch told USA TODAY in an email.
She referred to the CDC's timeline of the study, which describes the Public Health Service as the government body that started the study.
The FDA is part of the Public Health Service, but it only became part of it in 1968 during a reorganization of federal health programs, according to an FDA history timeline. That's 36 years after the start of the Tuskegee study.
Since then the FDA's mission has remained largely the same: To regulate and ensure the safety, efficacy and security of human and veterinary drugs, and medical devices, according to the agency's website.
The FDA does not conduct clinical trials, its website states. It evaluates their results for any product up for approval or emergency use authorization, as it did with the COVID-19 vaccines.
Since its beginning in 1906, the FDA's main role has been the regulation of various products.
With the passing of the Food and Drugs Act in 1906, the agency – then known as the Bureau of Chemistry – started regulating misbranded and adulterated foods, drinks and drugs, according to the FDA's timeline.
In 1927, the Bureau of Chemistry was divided into two entities, one of them the Food, Drug and Insecticide Administration created for "regulatory functions," the timeline states. The agency's name was later shortened to its current name in 1930. That same year the FDA started regulating canned food, excluding meat and milk products.
While the Tuskegee study was ongoing, the FDA continued to regulate new health products such as insulin in 1941, penicillin in 1945 and food additives in 1958.
Our rating: False
We rate the claim that the FDA approved the Tuskegee Syphilis Study FALSE, based on our research. The study was approved, conducted and overseen by the Public Health Service and later the CDC. The FDA was not involved in the study, an agency spokesperson said. The FDA's main role is to regulate products impacting people's health. It does not conduct clinical trials or experiments.
Our fact-check sources:
- USA TODAY, Aug. 23, Pfizer-BioNTech COVID-19 vaccine becomes first to win FDA's full approval, paving way for boosters, mandates
- USA TODAY, Aug. 21, Fact check: CDC didn't oversee the Tuskegee study. But the agency isn't blameless, experts say
- Isaiah Jamal Beard, Aug. 24, Facebook message exchange with USA TODAY
- CDC, accessed Aug. 24, The Tuskegee Timeline
- CDC, accessed Aug. 24, The U.S. Public Health Service Syphilis Study at Tuskegee: Frequently Asked Questions
- USA TODAY, July 25, 2017, 45 years ago, the nation learned about the Tuskegee Syphilis Study. Its repercussions are still felt today
- USA TODAY, Feb. 26, America has a history of medically abusing Black people. No wonder many are wary of COVID-19 vaccines
- Shannon Hatch, Aug. 24, Email exchange with USA TODAY
- U.S. Department of Human and Health Services, accessed Aug. 24, HHS Organizational Chart
- FDA, accessed Aug. 24, Milestones in U.S. Food and Drug Law
- FDA, accessed Aug. 24, What We Do
- FDA, accessed Aug. 24, Clinical Trials: What Patients Need to Know
- FDA, accessed Aug. 24, FDA History
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Our fact-check work is supported in part by a grant from Facebook.