Erick Turner
@eturnermd1.bsky.social
Advocate for and researcher on transparency in medical research. Former FDA reviewer of psychotropic drugs back when the FDA was a tougher gatekeeper.
Maybe I should start numbering these soap opera "episodes".
Pazdur JUST turned down the offer to be CDER Director. Now he accepts. Negotiating tactic?
Pazdur JUST turned down the offer to be CDER Director. Now he accepts. Negotiating tactic?
November 12, 2025 at 6:30 PM
Maybe I should start numbering these soap opera "episodes".
Pazdur JUST turned down the offer to be CDER Director. Now he accepts. Negotiating tactic?
Pazdur JUST turned down the offer to be CDER Director. Now he accepts. Negotiating tactic?
Today's episode of the FDA soap opera. First, Tidmarsh leaves, then Pazdur and Thanh Hai say no thanks to the "opportunity" to be CDER Director, and now they're asking for "anyone interested" to apply. 🙄 @akesselheim.bsky.social
November 10, 2025 at 7:44 PM
Today's episode of the FDA soap opera. First, Tidmarsh leaves, then Pazdur and Thanh Hai say no thanks to the "opportunity" to be CDER Director, and now they're asking for "anyone interested" to apply. 🙄 @akesselheim.bsky.social
I like what the authors have done here...apply EBM principles to a specific drug class. This brings it to the attention of specialty physicians whose radar screens don't normally cover 'meta' topics like EBM.
pubmed.ncbi.nlm.nih.gov/41198383/
pubmed.ncbi.nlm.nih.gov/41198383/
November 9, 2025 at 8:20 PM
I like what the authors have done here...apply EBM principles to a specific drug class. This brings it to the attention of specialty physicians whose radar screens don't normally cover 'meta' topics like EBM.
pubmed.ncbi.nlm.nih.gov/41198383/
pubmed.ncbi.nlm.nih.gov/41198383/
New JAMA Psychiatry report on clinical trial of ketamine vs midazolam (aka. Versed, a short-acting benzo mainly used as an anesthetic). No difference in efficacy found. High rates of AEs in both gps.
@floriannaudet.bsky.social @chrisaikenmd.bsky.social
watermark02.silverchair.com/jamapsychiat...
@floriannaudet.bsky.social @chrisaikenmd.bsky.social
watermark02.silverchair.com/jamapsychiat...
November 2, 2025 at 7:01 PM
New JAMA Psychiatry report on clinical trial of ketamine vs midazolam (aka. Versed, a short-acting benzo mainly used as an anesthetic). No difference in efficacy found. High rates of AEs in both gps.
@floriannaudet.bsky.social @chrisaikenmd.bsky.social
watermark02.silverchair.com/jamapsychiat...
@floriannaudet.bsky.social @chrisaikenmd.bsky.social
watermark02.silverchair.com/jamapsychiat...
I remember reading that FDA Advisory Committee meetings were in jeopardy but didn't realize they were on their deathbed.
(Screenshot from the Pink Sheet. I can't share the article b/c I don't subscribe ($$$!!!).)
(Screenshot from the Pink Sheet. I can't share the article b/c I don't subscribe ($$$!!!).)
October 17, 2025 at 7:27 PM
I remember reading that FDA Advisory Committee meetings were in jeopardy but didn't realize they were on their deathbed.
(Screenshot from the Pink Sheet. I can't share the article b/c I don't subscribe ($$$!!!).)
(Screenshot from the Pink Sheet. I can't share the article b/c I don't subscribe ($$$!!!).)
This is weird. Looking up Wellcovorin in Drugs@FDA shows one NDA (prob from long ago) and 4 ANDAs (subsequent generic applications), all by GSK and of them DISCONTINUED. So it seems Wellcovorin is being brought back from the dead.
September 24, 2025 at 8:00 PM
This is weird. Looking up Wellcovorin in Drugs@FDA shows one NDA (prob from long ago) and 4 ANDAs (subsequent generic applications), all by GSK and of them DISCONTINUED. So it seems Wellcovorin is being brought back from the dead.
This should come as good news for advocates of psychedelics being approved by the FDA.
The incoming CDER Deputy Director is a former FDA-er who went to Usona, a non-profit developing psychedelics.
The incoming CDER Deputy Director is a former FDA-er who went to Usona, a non-profit developing psychedelics.
June 25, 2025 at 5:04 PM
This should come as good news for advocates of psychedelics being approved by the FDA.
The incoming CDER Deputy Director is a former FDA-er who went to Usona, a non-profit developing psychedelics.
The incoming CDER Deputy Director is a former FDA-er who went to Usona, a non-profit developing psychedelics.
Paper of ours just out in JAMA Network Open @jama.com
"Characteristics of Trials Preceding FDA Approval of Novel Psychiatric Drugs"
@akesselheim.bsky.social
jamanetwork.com/journals/jam...
"Characteristics of Trials Preceding FDA Approval of Novel Psychiatric Drugs"
@akesselheim.bsky.social
jamanetwork.com/journals/jam...
February 1, 2025 at 7:44 PM
Paper of ours just out in JAMA Network Open @jama.com
"Characteristics of Trials Preceding FDA Approval of Novel Psychiatric Drugs"
@akesselheim.bsky.social
jamanetwork.com/journals/jam...
"Characteristics of Trials Preceding FDA Approval of Novel Psychiatric Drugs"
@akesselheim.bsky.social
jamanetwork.com/journals/jam...
Found this ⬇️
Maybe it hasn't yet been a year since they finished the last study in the NDA so they're going to milk it for all it's worth.
clinicaltrials.gov/policy/faq#f...
Maybe it hasn't yet been a year since they finished the last study in the NDA so they're going to milk it for all it's worth.
clinicaltrials.gov/policy/faq#f...
January 26, 2025 at 8:32 PM
Found this ⬇️
Maybe it hasn't yet been a year since they finished the last study in the NDA so they're going to milk it for all it's worth.
clinicaltrials.gov/policy/faq#f...
Maybe it hasn't yet been a year since they finished the last study in the NDA so they're going to milk it for all it's worth.
clinicaltrials.gov/policy/faq#f...
As for withdrawal, there is a section in the patient package insert. But it soft-pedals the issue by suggesting that (1) it's restricted to when people completely stop it, as opposed to missing as little as 1 dose, and that (2) it only happens when the doses are "high".
January 25, 2025 at 1:57 AM
As for withdrawal, there is a section in the patient package insert. But it soft-pedals the issue by suggesting that (1) it's restricted to when people completely stop it, as opposed to missing as little as 1 dose, and that (2) it only happens when the doses are "high".
Well, to be fair, the product labeling (package insert) says the mechanism is unknown for pretty much all these drugs. Example in screenshot below.
But the caution required in the labeling doesn't prevent others from getting all excited about how the "novel" mechanism makes it a "game changer"
But the caution required in the labeling doesn't prevent others from getting all excited about how the "novel" mechanism makes it a "game changer"
January 23, 2025 at 10:10 PM
Well, to be fair, the product labeling (package insert) says the mechanism is unknown for pretty much all these drugs. Example in screenshot below.
But the caution required in the labeling doesn't prevent others from getting all excited about how the "novel" mechanism makes it a "game changer"
But the caution required in the labeling doesn't prevent others from getting all excited about how the "novel" mechanism makes it a "game changer"
"A scoping review of activities intended to reduce publication bias in randomised trials"
Surprised to find no mention of Registered Reports, arguably the most effective activity for reducing publication bias @pci-regreports.bsky.social
systematicreviewsjournal.biomedcentral.com/articles/10....
Surprised to find no mention of Registered Reports, arguably the most effective activity for reducing publication bias @pci-regreports.bsky.social
systematicreviewsjournal.biomedcentral.com/articles/10....
December 26, 2024 at 10:48 PM
"A scoping review of activities intended to reduce publication bias in randomised trials"
Surprised to find no mention of Registered Reports, arguably the most effective activity for reducing publication bias @pci-regreports.bsky.social
systematicreviewsjournal.biomedcentral.com/articles/10....
Surprised to find no mention of Registered Reports, arguably the most effective activity for reducing publication bias @pci-regreports.bsky.social
systematicreviewsjournal.biomedcentral.com/articles/10....
Article: Publication bias in studies on biologic therapy for children with inflammatory bowel disease
pubmed.ncbi.nlm.nih.gov/39686553/
pubmed.ncbi.nlm.nih.gov/39686553/
December 18, 2024 at 5:34 PM
Article: Publication bias in studies on biologic therapy for children with inflammatory bowel disease
pubmed.ncbi.nlm.nih.gov/39686553/
pubmed.ncbi.nlm.nih.gov/39686553/
JAMA Psychiatry, Treatment Expectancies and Psilocybin vs Escitalopram for Depression
"For individuals w low expectations of escitalopram, psilocybin was signif better than escit...but 4 individuals w higher escit expectancies, the treatments were not signif diff"
HT @floriannaudet.bsky.social
December 16, 2024 at 8:53 PM
JAMA Psychiatry, Treatment Expectancies and Psilocybin vs Escitalopram for Depression
"For individuals w low expectations of escitalopram, psilocybin was signif better than escit...but 4 individuals w higher escit expectancies, the treatments were not signif diff"
HT @floriannaudet.bsky.social
"Conclusion: A small proportion [23%] of trials in the chronic low back pain field were registered prospectively and many presented registration inconsistencies..."
pubmed.ncbi.nlm.nih.gov/39424205/
pubmed.ncbi.nlm.nih.gov/39424205/
December 15, 2024 at 7:52 PM
"Conclusion: A small proportion [23%] of trials in the chronic low back pain field were registered prospectively and many presented registration inconsistencies..."
pubmed.ncbi.nlm.nih.gov/39424205/
pubmed.ncbi.nlm.nih.gov/39424205/
Today I received a request from a fairly big-name journal that should know better, to review a manuscript of a clinical trial involving a "pipeline" drug for MDD. I was tempted, but I declined. Reason ⬇️ I hope the editor reads it. (Why wasn't it desk rejected?)
December 14, 2024 at 12:55 AM
Today I received a request from a fairly big-name journal that should know better, to review a manuscript of a clinical trial involving a "pipeline" drug for MDD. I was tempted, but I declined. Reason ⬇️ I hope the editor reads it. (Why wasn't it desk rejected?)
Well, that message is dated August 10, 2021, the day after our Registered Drug Approval paper came out. You are/were definitely one of the suspects in the lineup!
December 14, 2024 at 12:37 AM
Well, that message is dated August 10, 2021, the day after our Registered Drug Approval paper came out. You are/were definitely one of the suspects in the lineup!
No idea! Maybe it's like "investigating the investigators"?
December 14, 2024 at 12:27 AM
No idea! Maybe it's like "investigating the investigators"?
Excellent piece that seems compellingly prophetic.
Another piece on AI in SciAm (screenshot) also appropriately uses "bullshit" instead of "hallucination"...no doubt you approve.
Another piece on AI in SciAm (screenshot) also appropriately uses "bullshit" instead of "hallucination"...no doubt you approve.
December 13, 2024 at 5:09 AM
Excellent piece that seems compellingly prophetic.
Another piece on AI in SciAm (screenshot) also appropriately uses "bullshit" instead of "hallucination"...no doubt you approve.
Another piece on AI in SciAm (screenshot) also appropriately uses "bullshit" instead of "hallucination"...no doubt you approve.
Here's the DM I referred to above. I guess he was being charitable, saying I was *being*, rather than was, a disgusting hypocrite, leaving a tiny opening for redeeming myself. Rather than respond, since I had been expecting something like this eventually, I just blocked him.
December 13, 2024 at 1:44 AM
Here's the DM I referred to above. I guess he was being charitable, saying I was *being*, rather than was, a disgusting hypocrite, leaving a tiny opening for redeeming myself. Rather than respond, since I had been expecting something like this eventually, I just blocked him.
Also, at the FAQ tab at the page at the link www.cos.io/initiatives/..., the first question is about registration vs RR
December 11, 2024 at 1:54 AM
Also, at the FAQ tab at the page at the link www.cos.io/initiatives/..., the first question is about registration vs RR
Now, if it's the *author* who's interested in not publishing, see the FAQ in the screenshot ⬇️:
"many journals will simply publish a Withdrawn Registration that includes the abstract from the Stage 1 submission plus a brief explanation for the withdrawal."
"many journals will simply publish a Withdrawn Registration that includes the abstract from the Stage 1 submission plus a brief explanation for the withdrawal."
December 10, 2024 at 11:01 PM
Now, if it's the *author* who's interested in not publishing, see the FAQ in the screenshot ⬇️:
"many journals will simply publish a Withdrawn Registration that includes the abstract from the Stage 1 submission plus a brief explanation for the withdrawal."
"many journals will simply publish a Withdrawn Registration that includes the abstract from the Stage 1 submission plus a brief explanation for the withdrawal."
"they will be served as menu..."
Reminds me of this old episode of the Twilight Zone, "To Serve Man" ⬇️
Reminds me of this old episode of the Twilight Zone, "To Serve Man" ⬇️
December 8, 2024 at 5:02 AM
"they will be served as menu..."
Reminds me of this old episode of the Twilight Zone, "To Serve Man" ⬇️
Reminds me of this old episode of the Twilight Zone, "To Serve Man" ⬇️
...but in the last sentence of that last page, cont'd on the page ⬇️, he suggests r=0.1 might not be so tiny, after all. (Then he goes on to talk abt d=0.5, which has been adopted by many in medicine as a threshold for clinical significance, even though Cohen made no mention of clinical trials.
December 4, 2024 at 2:30 AM
...but in the last sentence of that last page, cont'd on the page ⬇️, he suggests r=0.1 might not be so tiny, after all. (Then he goes on to talk abt d=0.5, which has been adopted by many in medicine as a threshold for clinical significance, even though Cohen made no mention of clinical trials.