Fact check: Thalidomide, COVID-19 vaccine comparisons are misleading
Brian GordonThe claim: Thalidomide, a rapidly approved drug, was banned in the early 1960s after it was discovered to cause birth defects in newborns.
Thalidomide and its side effects continue to be cited by vaccination skeptics as a cautionary tale of a harmful drug that governments allowed to hit the market. Since March, multiple social media posts have drawn parallels between thalidomide and the development of COVID-19 vaccines, warning people to be cautious of quickly produced medicines.
One tweet on thalidomide, reposted on Facebook and shared more than 1,000 times, asks "RAPID 8 months tested vaccine?" That is followed by, "THALIDOMIDE was a RAPID APPROVED drug introduced in 1957 to counteract nausea and insomnia in pregnant women. It was marketed in 50 countries before being withdrawn in 1962 due to malformations in newborns." It advises, “Be very careful with what’s coming,” above a black-and-white photo of children with missing and deformed arms.
Tyler Green, an Australian resident who sent the thalidomide tweet, told USA TODAY the goal of his post was to encourage people to be “appropriately cautious of hastily approved medications.”
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Discovering defects
Thalidomide was introduced in the late 1950s and widely marketed as a safe, over-the-counter sleep sedative. It was eventually sold in 46 countries, though never in the United States. According to an article from Northwestern University, thalidomide sales at the time rivaled those of aspirin.
Around 1960, doctors started prescribing the drug to pregnant women experiencing morning sickness. Doctors and newspapers, however, soon reported that babies whose mothers took thalidomide were being born with phocomelia, a rare condition that causes missing, shortened and flipper-like limbs.
By 1962, most countries where thalidomide was sold banned the drug, but not before it caused an estimated 10,000 children to be born with phocomelia.
Executives of a West German pharmaceutical company eventually stood trial for continuing to produce and sell the drug even after reports of phocomelia arose. The charges were dropped in 1970, after the company agreed to pay victims $27.3 million ($183 million in today’s money).
'A complete overhaul'
The rise and fall of thalidomide prompted regulators across the globe to strengthen testing protocols for new drugs.
Though thalidomide was never approved in the United States, it was given to around 20,000 residents in clinical trials and distributed to more than 1,000 physicians. Credit for keeping the drug out of American’s medicine cabinets belongs to an FDA inspector named Dr. Frances Kelsey, who blocked thalidomide’s approval, withstanding pressure from pharmaceutical officials and her own agency.
“The case of that drug led to a complete overhaul in the approval and marketing of drugs in the US and beyond,” said Julie Swann, a systems engineer at N.C. State University who advised the federal government’s response to the 2009 swine flu pandemic.
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In 1962, Congress passed the Kefauver-Harris Amendments, which set new safeguards for drug testing and approval. Manufacturers now had to prove drugs’ efficacy before they entered the market. The FDA gained more supervision over clinical trials, which over the years became more complex and thorough.
The new regulations positioned doctors and the FDA as “important market gatekeepers between consumers and pharmaceutical companies,” writes Xaq Frohlich, a history professor at Auburn University who researches the history of the FDA.
Today, drug development in the United States involves a preclinical stage with no human subjects, followed by three phases with progressively more volunteer subjects. Only then may the FDA approve a drug.
Modern vaccine development
As global death totals rise, governments have accelerated their development and testing of COVID-19 vaccines. Some counties have already approved the Pfizer and BioNTech vaccine, and other vaccines appear on the horizon.
Though health experts acknowledge the process has been quickened, they assure the process producing COVID-19 vaccines has been unlike what happened six decades ago with thalidomide.
“Like in all things, there can be mistakes or new knowledge that arises, but it is a misrepresentation to use thalidomide as a case study of what is happening in the federal approval process now,” Swann said. She noted government regulators today have “many more checks and balances” to monitor drug safety.
In the United States, where the coronavirus has already killed more than 300,000 people, Operation Warp Speed has let companies manufacture vaccine doses even as trials were being conducted. Still, no vaccines will be administered until they receive FDA approval and a CDC recommendation.
Thalidomide is no longer widely prescribed, but it is still used to treat two conditions: inflammation tied to Hansen’s disease (also known as leprosy) and multiple myeloma.
Our ruling: Missing context
We rate this claim as MISSING CONTEXT, in that it may mislead without more information. Thalidomide did cause birth defects in an estimated 10,000 babies before being pulled from the market in the early 1960s. Yet connecting thalidomide to COVID-19 vaccines is misleading. Thalidomide did not undergo the same extensive clinical trials as the COVID-19 vaccine; it actually instigated reforms in drug testing and approval. There is no evidence that the accelerated process behind COVID-19 vaccines circumvented the modern standards of health regulators like the FDA.
Our fact-check sources:
- Bara Fintel, Athena Samaras, and Edson Carias, 2009, Northwestern University, “The Thalidomide Tragedy: Lessons for drug safety and regulation”
- James Kim and Anthony Scialli, Toxicological Sciences, 2012, “Thalidomide: the tragedy of birth defects and the effective treatment of disease”
- New York Times, Dec. 19, 1970, “West German Thalidomide Trial Ends; $27‐Million to Go to Deformed Children”
- Robert McFadden, New York Times, Aug. 17, 2015, “Frances Oldham Kelsey, Who Saved U.S. Babies From Thalidomide, Dies at 101”
- U.S. Food and Drug Administration, Sept. 10, 2012, “Kefauver-Harris Amendments Revolutionized Drug Development”
- Xaq Frohlich, “The Rise (and Fall) of the Food-Drug Line”
- Kim Hjelmgaard, USA TODAY, Dec. 8, “'V-Day': A year after COVID-19 pandemic began in China, UK is first in West to start vaccinations”
- Karina Zaiets, Mitchell Thorson, Shawn J. Sullivan, and Janie Haseman, USA TODAY, Dec. 8, “US coronavirus map: Tracking the outbreak”
- Elizabeth Weise, USA Today, Dec. 8, “Trading COVID-19 vaccines. Regular deliveries. Tracking doses. What we know about Operation Warp Speed distribution process.”
- Mayo Clinic, “Thalidomide: Research advances in cancer and other conditions”
Brian Gordon is a statewide reporter with the USA Today Network in North Carolina. Reach him at bgordon@gannett.com or on Twitter @briansamuel92.
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