Fair—but wasn’t it revealed that they had suppressed research and/or actively campaigned to get the drugs into widespread circulation?
Seems like in this case, the Dutch did a little trial off-label 15 years ago and then other doctors independently and without nudging from pharmaceutical companies followed suit.
Fair—but wasn’t it revealed that they had suppressed research and/or actively campaigned to get the drugs into widespread circulation?
Seems like in this case, the Dutch did a little trial off-label 15 years ago and then other doctors independently and without nudging from pharmaceutical companies followed suit.
I don't know about suppressing research, but Purdue actively marketed Oxy as "addiction-proof" to doctors. If Lupron makers are actively marketing the drug as "safe and reversible", then that's a similar situation.
Both are ultimately cases of 'too good to be true' medicine. Chronic pain is a legitimate moral conundrum for doctors, because the most effective drugs to treat it come with serious addiction risks. When a newly-hyped miracle drug comes along promising doctors the best of both worlds (make their patients pain go away without turning them into junkies in the process), of course lots of doctors jumped on the bandwagon (the kickback compensation also helped grease the wheels).
With trans/potentially trans minors, the longer the doctors wait to facilitate transition, the tougher time the patients will have 'passing', because they'll have gone through their natal puberty which is pretty much a one-way trip. But the sooner the transition is facilitated, the greater the risk of patients regretting what they thought they wanted but turned out to be 'irreversible damage'.
So between newly hyped "safe and effective" puberty blockers promising a "pause button" on natal puberty, and "studies" showing that early transitions neeeeeeever backfire, doctors are being told things about youth gender medicine that are quite literally too good be true.
In the case of Oxy, the manufacturers were ultimately held accountable for their "too good to be true" marketing campaign. In the case of Lupron, the only difference might be that if the drug companies can show that Tumblr/TikTok activists are doing all the marketing on a pro-bono basis, then the manufacturers hands might be cleaner than those of Purdue.
Yeah, to me the only "smoking gun" that the pharmacos are complicit is that they're clearly profiting from gender-affirming prescriptions while refusing to seek FDA approval. No law saying they *have* to seek approval, but I could see some potential for willful negligence/unjust enrichment claims.
If they are promoting (even subtly) the use, then you should be able to go after them; otherwise, you can't really hold the companies liable. Maybe you could make them put extra, prominent warnings on the label: This medication has been approved for X and Y ONLY; the FDA has not approved this product as either safe or effective for any other indication.
But doctors and clinics and insurers should definitely be on the hook for off-label use if they can't show that they relied on high-quality evidence.
To their credit, Reuters has reported that the drug makers are indeed slapping those warning labels on their products. It looks like the buck-passing phase is slowly beginning.
Fair—but wasn’t it revealed that they had suppressed research and/or actively campaigned to get the drugs into widespread circulation?
Seems like in this case, the Dutch did a little trial off-label 15 years ago and then other doctors independently and without nudging from pharmaceutical companies followed suit.
I don't know about suppressing research, but Purdue actively marketed Oxy as "addiction-proof" to doctors. If Lupron makers are actively marketing the drug as "safe and reversible", then that's a similar situation.
Both are ultimately cases of 'too good to be true' medicine. Chronic pain is a legitimate moral conundrum for doctors, because the most effective drugs to treat it come with serious addiction risks. When a newly-hyped miracle drug comes along promising doctors the best of both worlds (make their patients pain go away without turning them into junkies in the process), of course lots of doctors jumped on the bandwagon (the kickback compensation also helped grease the wheels).
With trans/potentially trans minors, the longer the doctors wait to facilitate transition, the tougher time the patients will have 'passing', because they'll have gone through their natal puberty which is pretty much a one-way trip. But the sooner the transition is facilitated, the greater the risk of patients regretting what they thought they wanted but turned out to be 'irreversible damage'.
So between newly hyped "safe and effective" puberty blockers promising a "pause button" on natal puberty, and "studies" showing that early transitions neeeeeeever backfire, doctors are being told things about youth gender medicine that are quite literally too good be true.
In the case of Oxy, the manufacturers were ultimately held accountable for their "too good to be true" marketing campaign. In the case of Lupron, the only difference might be that if the drug companies can show that Tumblr/TikTok activists are doing all the marketing on a pro-bono basis, then the manufacturers hands might be cleaner than those of Purdue.
I guess it’s unclear to me if the pharma companies are actually making those claims about the off-label usage. I think that’s key.
And that Reuters article mentions new warnings getting slapped on some of the meds as they stand now, even for suggested usage.
Yeah, to me the only "smoking gun" that the pharmacos are complicit is that they're clearly profiting from gender-affirming prescriptions while refusing to seek FDA approval. No law saying they *have* to seek approval, but I could see some potential for willful negligence/unjust enrichment claims.
If they are promoting (even subtly) the use, then you should be able to go after them; otherwise, you can't really hold the companies liable. Maybe you could make them put extra, prominent warnings on the label: This medication has been approved for X and Y ONLY; the FDA has not approved this product as either safe or effective for any other indication.
But doctors and clinics and insurers should definitely be on the hook for off-label use if they can't show that they relied on high-quality evidence.
To their credit, Reuters has reported that the drug makers are indeed slapping those warning labels on their products. It looks like the buck-passing phase is slowly beginning.