Categorising “dissociation” as an AE for esketamine seems absurd – isn’t that exactly what the drug is meant to do? It would be interesting to study whether patients experiencing “dissociation” short-term have better or worse longer-term treatment outcomes.
I’d be far more worried about long-term downsides, especially if patients after treatment manage to get their hands onto street ketamine. We had a ketamine ‘epidemic’ in the 2000s here in the UK, some use was purely recreational but a minority of people were using it to self-medicate against depression, often taking very large amounts on a daily basis.
I’m dismayed at how discussions about medical esketamine routinely ignore the vast body of experience – including clinical experience – amassed by ketamine users and professionals treating them in the UK in the 2000s.
I’m getting tired of the line that “there is very little scientific knowledge about the long-term effects of the drug”.
There’s plenty of knowledge gathered here in Bristol / UK where we had a recreational ketamine epidemic in the late 1990s and 2000s. Presumably, a sizeable share those taking ketamine were self-medicating.
Bristol’s BRI hospital reportedly performed lots of bladder surgery during that time. I’m amazed nobody in the scientific community seems to have reached out to BRI, or to Bristol’s drug councelling services.
I think we all need to keep in mind that 18 years is an arbitrary legal (not biological) cutoff point. Puberty is a process not an event.
So treating >18 and <18 on a yes/no basis will miss a lot of nuance. It might be the best we can do with existing data, but we need to make this caveat more explicit.
Dear Peter Gotzsche,
leaving aside the specific case of antidepressants, I’d be interested in your wider perspective on what should count as reliable evidence from clinical trials.
I’m aware that bias and distortions are widespread, having authored this study for TranspariMED: https://www.transparimed.org/single-post/2017/12/14/New-study-documents-the-harm-caused-by-evidence-distortion-in-medical-research
Is your perspective that none of the currently available sources of information on drug safety and efficacy are reliable? If so, what does that imply for clinicians and patients in areas of medicine beyond psychiatry? Should we dismiss all published clinical evidence and go by doctors’ and patients’ personal experiences alone?
Genuinely interested in your view, RSVP.
Thank you!
Interested readers can find a quick overview of clinical trial reporting rules in the US and weak FDA enforcement here:
https://www.transparimed.org/single-post/fda-cutera-university-of-virginia
Here more on EU rules:
https://www.transparimed.org/single-post/ctis-euctr-penalties
A more in-depth analysis is here, with focus on the UK:
https://committees.parliament.uk/writtenevidence/39638/pdf/
Useful background on why this issue is so important for patients here:
https://docs.wixstatic.com/ugd/01f35d_def0082121a648529220e1d56df4b50a.pdf
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Categorising “dissociation” as an AE for esketamine seems absurd – isn’t that exactly what the drug is meant to do? It would be interesting to study whether patients experiencing “dissociation” short-term have better or worse longer-term treatment outcomes.
I’d be far more worried about long-term downsides, especially if patients after treatment manage to get their hands onto street ketamine. We had a ketamine ‘epidemic’ in the 2000s here in the UK, some use was purely recreational but a minority of people were using it to self-medicate against depression, often taking very large amounts on a daily basis.
Some really bad outcomes, example here:
https://www.vice.com/en/article/av4njj/ketamine-slowly-ruins-your-bladder-and-kills-you-863
I’m dismayed at how discussions about medical esketamine routinely ignore the vast body of experience – including clinical experience – amassed by ketamine users and professionals treating them in the UK in the 2000s.
Report comment
I’m getting tired of the line that “there is very little scientific knowledge about the long-term effects of the drug”.
There’s plenty of knowledge gathered here in Bristol / UK where we had a recreational ketamine epidemic in the late 1990s and 2000s. Presumably, a sizeable share those taking ketamine were self-medicating.
Example:
“At the age of 23, Nancy had died slowly over seven years, her body trashed by a steady diet of ketamine.”
https://www.vice.com/en_uk/article/av4njj/ketamine-slowly-ruins-your-bladder-and-kills-you-863
Bristol’s BRI hospital reportedly performed lots of bladder surgery during that time. I’m amazed nobody in the scientific community seems to have reached out to BRI, or to Bristol’s drug councelling services.
Report comment
I think we all need to keep in mind that 18 years is an arbitrary legal (not biological) cutoff point. Puberty is a process not an event.
So treating >18 and <18 on a yes/no basis will miss a lot of nuance. It might be the best we can do with existing data, but we need to make this caveat more explicit.
Report comment
Dear Peter Gotzsche,
leaving aside the specific case of antidepressants, I’d be interested in your wider perspective on what should count as reliable evidence from clinical trials.
I’m aware that bias and distortions are widespread, having authored this study for TranspariMED:
https://www.transparimed.org/single-post/2017/12/14/New-study-documents-the-harm-caused-by-evidence-distortion-in-medical-research
Is your perspective that none of the currently available sources of information on drug safety and efficacy are reliable? If so, what does that imply for clinicians and patients in areas of medicine beyond psychiatry? Should we dismiss all published clinical evidence and go by doctors’ and patients’ personal experiences alone?
Genuinely interested in your view, RSVP.
Thank you!
Report comment