Saturday in Whitewater will be partly sunny with a high of 94. Sunrise is 6:16 AM and sunset 7:34 PM, for 13h 18m 24s of daytime. The moon is a waning gibbous with 66.4% of its visible disk illuminated.
On this day in 1845, the first issue of Scientific American magazine is published.
Beatrice Dupuy reports Vaccine testing falsely equated with thalidomide development decades ago:
CLAIM: “Rapid 8 month tested vaccine? Thalidomide was a RAPID APPROVED drug introduced in 1957, to address nausea and insomnia in pregnant women. It was marketed in 50 countries before being withdrawn in 1962 due to malformations in newborns. Be careful with what is coming.”
AP’S ASSESSMENT: Missing context. There are different approval processes for the coronavirus vaccines and the drug thalidomide. Thalidomide was not approved for sale in the U.S. when first introduced in the 1950s. The drug did not undergo extensive trials as is being done with COVID-19 vaccines currently being developed.
Dr. S. Vincent Rajkumar, a professor of medicine at the Mayo Clinic in Rochester, Minnesota, who has studied thalidomide and use of the drug to treat myeloma, said you cannot compare the coronavirus vaccine and thalidomide.
“One was trying to solve the problem of sleeplessness and was marketed with zero data, no efficacy or safety or randomized trials,” he said of thalidomide. “The other is trying to solve the problem of a life-threatening pandemic that has killed hundreds of thousands of people and there are two randomized trials showing the vaccines are highly effective.”
“The fact that people were efficient and fast does not mean that any of the safety steps were skipped,” Rajkumar said.
Unlike the early trials of thalidomide in the 1960s, the coronavirus vaccines from Pfizer and Moderna have undergone several trial phases including animal and human tests. The vaccines have been tested in more than 60,000 humans and both companies showed more than 90 percent effectiveness. Trial patients reported mild side effects like muscle aches and sore arms.
Dr. Frances Oldham Kelsey, an FDA officer in the early 1960s, found that there was not enough safety data on thalidomide as U.S. clinical trials were still being conducted and helped prevent it from being approved for use in the U.S. During the 1950s, clinical trials could be conducted without FDA approval.
These fundamental differences in testing have not stopped a GOP candidate from linking the histories of COVID-19 vaccines and thalidomide. Brad Reed reports GOP candidate caught in a ‘blatant lie’ while attacking FDA’s approval of COVID-19 vaccine:
A Republican congressional candidate on Tuesday was called out for being completely wrong about the Food and Drug Administration’s past approval of the drug thalidomide.
Posting on Twitter, New Jersey Republican Billy Prempeh attacked the FDA’s full approval of the novel coronavirus vaccine by falsely claiming that the agency had caused several women to suffer from severe birth defects after approving thalidomide for pregnant women in the 1950s.
“Thalidomide was given to pregnant mothers in the 50s and 60s to treat nausea,” he wrote. “The result? Severe birth defects. The FDA approves lots of unsafe things. This is about profit not health. Do your due diligence. But hey, what do I know? I’m just some guy named Billy.”
While some American women did suffer birth defects after taking the drug, they took the drug despite the fact that it had not been approved by the FDA, as outlined by an article by the University of Chicago Medical Center.
“The FDA subsequently identified 17 cases — 10 linked to Kevadon that Merrell had distributed to 1,267 doctors under the auspices of its ‘investigational’ trial,” writes the University of Chicago Medical Center. “But the country was spared the broad-based catastrophe visited upon Europe.”
But hey, what do they know? They’re just some institution called the University of Chicago Medical Center.