Can we get into a deep dive into the bombshell Reuters dropped, that the drug companies making puberty blockers are actively refusing to pursue FDA approval for use in trans youth?
https://www.dailywire.com/news/puberty-blocking-drug-companies-refuse-to-conduct-safety-trials
Makes sense to me in a twisted, late capitalism way. Usually, FD…
Can we get into a deep dive into the bombshell Reuters dropped, that the drug companies making puberty blockers are actively refusing to pursue FDA approval for use in trans youth?
Makes sense to me in a twisted, late capitalism way. Usually, FDA approval is sought because without it, doctors are reluctant to prescribe the drug, which limits sales. But since so many "affirming" doctors are willing to prescribe Lupron et al off-label, the manufacturers really have no financial incentive to roll the dice on an FDA-controlled risk/benefit study; their revenue numbers are doing just fine as-is.
My main question is: where does the malpractice buck stop? Is it the individual doctors who wrote the prescriptions, the clinics where they operated out of, or like Purdue pharmacy with Oxy, could detransitioners potentially sue the drug manufacturers themselves?
Same principle would seem to apply in both scenarios; plenty of kids willing to volunteer for puberty blockers, so just give some of them placebos.
If giving untested drugs to kids was a FDA dealbreaker, it would be impossible to bootstrap ANY pediatric drugs through the approval process. "Can't give it to kids because it's untested; can't test it because that would require giving it to kids" would be an insurmountable obstacle if it was that cut and dry.
I'd be a little concerned about letting people sue the manufacturers, maybe if they were pushing the off-label use on doctors.
I had some persistent nerve pain in my foot and was prescribed a short-term course of an... antidepressant?(that or something similar) that was apparently known to have reasonably valid off-label uses for my neuropathy.
Had something gone wrong, I'd be inclined to blame the doctor, but not the manufacturer, under the thinking that the doctor was the one who was responsible for suggesting the treatment. (Had something gone wrong I may/may not have been _correct_ in blaming the doctor, just how I might have felt)
Edit, oops forgot this point
Also... if off-label uses are in fact good, but manufacturers can be sued, then that really cracks down on them _across the board_ - all uses.
I'm thinking that refusing to pursue approval when they already know the drug is being pervasively used off-label might qualify as implicitly encouraging the off-label nature of the prescriptions.
I don't think that route could (or should) work. Unless the company is in fact actively (if subtly) endorsing the off-label use (for instance, by distributing articles that promote such use).
I’m thinking that if someone attempted to sue the manufacturer, the manufacturer’s defense could be zillions of articles and “studies” purportedly showing that the drugs were life saving interventions with almost no negative side effects.
Basically, Look, the doctors on the ground and all the major American medical associations swore this was great. How could we know they were all wrong to the point of criminality?
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.
Can we get into a deep dive into the bombshell Reuters dropped, that the drug companies making puberty blockers are actively refusing to pursue FDA approval for use in trans youth?
https://www.dailywire.com/news/puberty-blocking-drug-companies-refuse-to-conduct-safety-trials
Makes sense to me in a twisted, late capitalism way. Usually, FDA approval is sought because without it, doctors are reluctant to prescribe the drug, which limits sales. But since so many "affirming" doctors are willing to prescribe Lupron et al off-label, the manufacturers really have no financial incentive to roll the dice on an FDA-controlled risk/benefit study; their revenue numbers are doing just fine as-is.
My main question is: where does the malpractice buck stop? Is it the individual doctors who wrote the prescriptions, the clinics where they operated out of, or like Purdue pharmacy with Oxy, could detransitioners potentially sue the drug manufacturers themselves?
How do you create a clinical trial for puberty blockers (experimenting on children by definition) that makes it past an ethics review board?
Seeing as kids are already being given the drugs anyway, set up a control group and monitor for years.
That's fine as a scientific study, but it's not how FDA approvals work.
Same principle would seem to apply in both scenarios; plenty of kids willing to volunteer for puberty blockers, so just give some of them placebos.
If giving untested drugs to kids was a FDA dealbreaker, it would be impossible to bootstrap ANY pediatric drugs through the approval process. "Can't give it to kids because it's untested; can't test it because that would require giving it to kids" would be an insurmountable obstacle if it was that cut and dry.
I'd be a little concerned about letting people sue the manufacturers, maybe if they were pushing the off-label use on doctors.
I had some persistent nerve pain in my foot and was prescribed a short-term course of an... antidepressant?(that or something similar) that was apparently known to have reasonably valid off-label uses for my neuropathy.
Had something gone wrong, I'd be inclined to blame the doctor, but not the manufacturer, under the thinking that the doctor was the one who was responsible for suggesting the treatment. (Had something gone wrong I may/may not have been _correct_ in blaming the doctor, just how I might have felt)
Edit, oops forgot this point
Also... if off-label uses are in fact good, but manufacturers can be sued, then that really cracks down on them _across the board_ - all uses.
I'm thinking that refusing to pursue approval when they already know the drug is being pervasively used off-label might qualify as implicitly encouraging the off-label nature of the prescriptions.
I don't think that route could (or should) work. Unless the company is in fact actively (if subtly) endorsing the off-label use (for instance, by distributing articles that promote such use).
Informative discussion of some of the issues here: https://www.nejm.org/doi/full/10.1056/NEJMp0802107
It would be interesting to know if the drug companies are doing any marketing, especially indirectly through sponsored social media content.
I’m thinking that if someone attempted to sue the manufacturer, the manufacturer’s defense could be zillions of articles and “studies” purportedly showing that the drugs were life saving interventions with almost no negative side effects.
Basically, Look, the doctors on the ground and all the major American medical associations swore this was great. How could we know they were all wrong to the point of criminality?
And yet Purdue got sued into the ground over the opioid crisis, so the precedent exists.
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.