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by ajhurliman 595 days ago
GLP1s have been on the market for at least a decade, they’re pretty well studied at this point. Their sudden popularity is due to the FDA allowing it to be prescribed for obesity (instead of diabetes), not the discovery of a new drug.
2 comments

> Their sudden popularity is due to the FDA allowing it to be prescribed for obesity (instead of diabetes), not the discovery of a new drug.

That's not true. I started on liraglutide, which is a previous-gen GLP-1 agonist. It was approved for that purpose in early 2010-s. It worked, but it required daily injections due to its short half-life. It also was unpleasant, as you could feel its effects wax and wane throughout the day.

Ozempic was approved for diabetes in 2018, but became available in sufficient quantities for that purpose in 2019. Doctors started prescribing it off-label for weight loss in 2020 (that's when I also got switched to it), and it was approved by the FDA for weight-loss in mid-2021.

So while we could have moved faster, it's not like there were decades of time lost.

Wait a sec. Something which provides such an unambiguous quality of life upgrade by addressing one of the biggest health problems in the country, is only now available because of regulations?

Surely it's not that simple.

Seems wild right? Would you believe that there’s a male contraceptive that’s been actively used in other countries successfully for over a decade, is easily and painlessly reversible, and non-hormonal?
It took the FDA four years to pull Thalidomide from the market. Hell, it was OTC in the early days and often prescribed for morning sickness.

They're more cautious now when it comes to pregnancy related drugs. As someone who was not born with flippers instead of hands, I'm pretty happy about that.

> It took the FDA four years to pull Thalidomide from the market.

BZZT! Wrong.

Thalidomide had _never_ been approved in the USA for the morning sickness, thanks to the FDA. The only pregnant people receiving it were getting experimental pre-approval samples (now illegal) and during the clinical trials. See, for example: https://www.reuters.com/article/fact-check/fda-did-not-appro...

You're correct, I was mistaken. Although my mistake may actually help to support my stance.

It was used, and marketed, for morning sickness primarily in other countries (Germany in particular). It's an important distinction, because the US FDA actually stopped it's approval in the US. It seems that "only" about 20,000 American study participants were given the drug at that time. So more than half of the dead/deformed babies came from Germany.

Had the German equivalent of the FDA prevented the drug from going to market many babies might not have been born with deformities.

There are VERY good reasons to be slow in approving drugs that might impact a fetus.