4 ms·

>We do not admit competitive medications from other first world countries without full FDA approval. Thalidomide. You lose.

CptFribble 8y ago
https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide > In the United States, Food & Drug Agency pharmacologist Frances Oldham Kelsey M.D. withstood pressure from the Richardson-Merrell Pharmaceuticals Co. and refused [FDA] approval to market thalidomide, saying further studies were needed. and > Although thalidomide was never approved for sale in the United States at the time, over 2.5 million tablets had been distributed to over 1,000 physicians during a clinical testing program. The Fine Article is talking about drug prices. The Thalidomide scandal in the USA was about a large clinical trial. The two are related, but different.
smnrchrds 8y ago
"Worldwide, an estimated 24,000 babies were born with thalidomide-induced malformations. An additional 123,000 stillbirths and miscarriages were due to thalidomide, according to conservative estimates." [0] "New study finds 45,000 deaths annually linked to lack of health coverage" [1] It's a balancing act. Bad drugs kill people. Unaffordable drugs kill people too. Is there any evidence that the balance FDA has chosen leads to less deaths than the balance EU regulators have chosen, or a third point entirely? [0] https://www.cbc.ca/news/health/thalidomide-explainer-1.4434746 https://www.cbc.ca/news/health/thalidomide-explainer-1.44347... [1] https://news.harvard.edu/gazette/story/2009/09/new-study-finds-45000-deaths-annually-linked-to-lack-of-health-coverage/ https://news.harvard.edu/gazette/story/2009/09/new-study-fin...
opo 8y ago
I am pretty sure regulators in Europe do not use the same drug approval process that was used in the 1960s. For example: >...The Mutual Recognition Agreement (MRA) between FDA and European Union allows drug inspectors to rely upon information from drug inspections conducted within each other’s borders. https://www.fda.gov/internationalprograms/agreements/ucm598735.htm https://www.fda.gov/internationalprograms/agreements/ucm5987... Approving new drugs without adequate testing will cost lives, being over cautious can also cost lives though. An example of that was the FDA refusing to allow beta-blockers: >...For example, consider FDA’s incredibly long delay in approving beta-blockers to reduce the risk of second heart attacks. By the mid-1970s this had been documented in clinical trials, and a number of beta-blockers were approved for this use in Europe. But in the U.S., FDA imposed a moratorium on beta-blocker approvals due to the drugs’ carcinogenicity in animals. ... Finally, in 1981 FDA approved the first such drug, boasting that it might save up to 17,000 lives per year. That meant, of course, that as many as 100,000 people may have died waiting for FDA to act —an explosive point, but one that very few journalists pursued http://www.jpands.org/vol15no4/kazman.pdf http://www.jpands.org/vol15no4/kazman.pdf

CptFribble 8y ago

https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide > In the United States, Food & Drug Agency pharmacologist Frances Oldham Kelsey M.D. withstood pressure from the Richardson-Merrell Pharmaceuticals Co. and refused [FDA] approval to market thalidomide, saying further studies were needed. and > Although thalidomide was never approved for sale in the United States at the time, over 2.5 million tablets had been distributed to over 1,000 physicians during a clinical testing program. The Fine Article is talking about drug prices. The Thalidomide scandal in the USA was about a large clinical trial. The two are related, but different.

smnrchrds 8y ago

"Worldwide, an estimated 24,000 babies were born with thalidomide-induced malformations. An additional 123,000 stillbirths and miscarriages were due to thalidomide, according to conservative estimates." [0] "New study finds 45,000 deaths annually linked to lack of health coverage" [1] It's a balancing act. Bad drugs kill people. Unaffordable drugs kill people too. Is there any evidence that the balance FDA has chosen leads to less deaths than the balance EU regulators have chosen, or a third point entirely? [0] https://www.cbc.ca/news/health/thalidomide-explainer-1.4434746 https://www.cbc.ca/news/health/thalidomide-explainer-1.44347... [1] https://news.harvard.edu/gazette/story/2009/09/new-study-finds-45000-deaths-annually-linked-to-lack-of-health-coverage/ https://news.harvard.edu/gazette/story/2009/09/new-study-fin...

opo 8y ago

I am pretty sure regulators in Europe do not use the same drug approval process that was used in the 1960s. For example: >...The Mutual Recognition Agreement (MRA) between FDA and European Union allows drug inspectors to rely upon information from drug inspections conducted within each other’s borders. https://www.fda.gov/internationalprograms/agreements/ucm598735.htm https://www.fda.gov/internationalprograms/agreements/ucm5987... Approving new drugs without adequate testing will cost lives, being over cautious can also cost lives though. An example of that was the FDA refusing to allow beta-blockers: >...For example, consider FDA’s incredibly long delay in approving beta-blockers to reduce the risk of second heart attacks. By the mid-1970s this had been documented in clinical trials, and a number of beta-blockers were approved for this use in Europe. But in the U.S., FDA imposed a moratorium on beta-blocker approvals due to the drugs’ carcinogenicity in animals. ... Finally, in 1981 FDA approved the first such drug, boasting that it might save up to 17,000 lives per year. That meant, of course, that as many as 100,000 people may have died waiting for FDA to act —an explosive point, but one that very few journalists pursued http://www.jpands.org/vol15no4/kazman.pdf http://www.jpands.org/vol15no4/kazman.pdf