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nebris"I'm old enough to remember when just saying "Thalidomide" could make people shudder." ~Nebris
Trump has boasted frequently about his success in speeding up the approval process for drugs, a move long urged by pharmaceutical companies, which regard it as a costly obstacle to getting their products to market. And in the coronavirus emergency, epidemiologists and bioethics experts generally are going along with steps that could make a vaccine available sooner.
After all, what could go wrong?
The FDA’s website itself holds a possible answer, in the form of a tribute to a now-forgotten hero of bureaucracy, a physician and pharmacologist named Frances Kelsey. In 1960, she joined the FDA, where her job was to review applications for drug approval.
The first application she handled was for a sedative called thalidomide, which was used in the treatment of leprosy and was being marketed to prevent “morning sickness,” the nausea and vomiting that affects some women during pregnancy. The drug company presented data that it said proved its safety. It was already being sold over the counter in other countries.
Kelsey was unconvinced and asked for more data. The company sent in more studies, but she was adamant. Among other red flags, the manufacturer hadn’t proven that thalidomide was safe when taken by pregnant women. This was, of course, a period in American history when government regulations were more commonly referred to as “life-saving” than “job-killing,” and the Eisenhower and Kennedy administrations appear not to have interjected themselves into the debate.
https://news.yahoo.com/trump-pushes-warp-speed-effort-on-coronavirus-vaccine-ignoring-lessons-from-a-longago-drug-calamity-140324220.html
Trump has boasted frequently about his success in speeding up the approval process for drugs, a move long urged by pharmaceutical companies, which regard it as a costly obstacle to getting their products to market. And in the coronavirus emergency, epidemiologists and bioethics experts generally are going along with steps that could make a vaccine available sooner.
After all, what could go wrong?
The FDA’s website itself holds a possible answer, in the form of a tribute to a now-forgotten hero of bureaucracy, a physician and pharmacologist named Frances Kelsey. In 1960, she joined the FDA, where her job was to review applications for drug approval.
The first application she handled was for a sedative called thalidomide, which was used in the treatment of leprosy and was being marketed to prevent “morning sickness,” the nausea and vomiting that affects some women during pregnancy. The drug company presented data that it said proved its safety. It was already being sold over the counter in other countries.
Kelsey was unconvinced and asked for more data. The company sent in more studies, but she was adamant. Among other red flags, the manufacturer hadn’t proven that thalidomide was safe when taken by pregnant women. This was, of course, a period in American history when government regulations were more commonly referred to as “life-saving” than “job-killing,” and the Eisenhower and Kennedy administrations appear not to have interjected themselves into the debate.
https://news.yahoo.com/trump-pushes-warp-speed-effort-on-coronavirus-vaccine-ignoring-lessons-from-a-longago-drug-calamity-140324220.html