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Just a little history lesson. Today& #39;s @US_FDA was born out of decades of tragedy. Let& #39;s start with the 1937 Sulfanilamide elixir tragedy, in which 71 adults and 34 children died, from this unproven remedy. 1/ https://www.the-scientist.com/foundations/the-elixir-tragedy-1937-39231">https://www.the-scientist.com/foundatio...
If it was not for Frances Kelsey, we would have seen a disaster in the US for a "safe" drug that was given to pregnant women in Europe called thalidomide, causing deaths and congenital malformations in thousands of children. 2/ https://www.smithsonianmag.com/science-nature/woman-who-stood-between-america-and-epidemic-birth-defects-180963165/">https://www.smithsonianmag.com/science-n...
The series of tragedies, and almost averted ones, in the 20th century led to the Kefauver-Harris amendments in 1962, which required that companies showed their drugs were safe AND effective before unleashed on the public. 3/ https://www.fda.gov/consumers/consumer-updates/kefauver-harris-amendments-revolutionized-drug-development">https://www.fda.gov/consumers...
Since Kefauver-Harris industry has been gunning for @US_FDA saying it stifles innovation, slows drug approval, when none of that is actually true. Even, so concessions have been made at FDA to speed access to drugs. I know because I was part of it. 4/ https://www.lgbtqnation.com/2018/10/30-years-ago-stormed-fda-seized-control-now/">https://www.lgbtqnation.com/2018/10/3...
But industry was never satisfied and we are starting to have drugs we know less and less about and pay more and more for. 5/ https://www.nytimes.com/2015/06/11/opinion/dont-weaken-the-fdas-drug-approval-process.html">https://www.nytimes.com/2015/06/1...
As we listen to @realDonaldTrump remember, even drugs properly studies, often do not pan out. Here& #39;s a short list. 6/ https://www.fda.gov/media/102332/download">https://www.fda.gov/media/102...
The @POTUS is going to run roughshod over @US_FDA despite the lack of evidence. This is 100% political about the President needing a boost before his convention. 7/ https://www.nytimes.com/2020/08/19/us/politics/blood-plasma-covid-19.html">https://www.nytimes.com/2020/08/1...
This is part and parcel of @realDonaldTrump war on science. 8/ https://www.ucsusa.org/resources/attacks-on-science">https://www.ucsusa.org/resources...
The President has no qualms about lying about many things, but when it comes to our health, making up facts, can have deadly consequences. This is what he has done since the beginning of the pandemic. https://www.nytimes.com/2019/12/28/climate/trump-administration-war-on-science.html">https://www.nytimes.com/2019/12/2...
These men tonight, @SecAzar and @SteveFDA will put Americans in harm& #39;s way to satisfy the whims and needs of @realDonaldTrump. Allowing unproven treatments to be widely used is not bold, or compassionate, it is reckless. 10/
And if you& #39;re interested in the history of the @US_FDA read @Harvard& #39;s #DanielCarpenter& #39;s masterful Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. end/ https://press.princeton.edu/books/paperback/9780691141800/reputation-and-power">https://press.princeton.edu/books/pap...
