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.
Pinned
Erick Turner
@eturnermd1.bsky.social
· Dec 10
Leveraging Registered Reports to increase transparency in trial publication – Open Pharma - Innovations in medical publishing
Publication bias undermines the credibility of clinical trial reporting and negatively affects the reputation of pharma sponsors. Registered Reports (RR) is a peer review process designed to eradicate...
www.openpharma.blog
Wouldn't it be nice if u could read a published pharma-sponsored clinical trial about some new drug & be confident that the results are what they appear to be?
@chrisdc77 & I think it's very achievable using the @RegReports peer review model.
Our proposal ⬇️ www.openpharma.blog/blog/transpa...
@chrisdc77 & I think it's very achievable using the @RegReports peer review model.
Our proposal ⬇️ www.openpharma.blog/blog/transpa...
More from the FDA soap opera. I don't subscribe to the (very expensive) Pink Sheet, so apologies for the teaser.
"As diff's emerged betw FDA staff & senior political leaders over its COVID-19 safety review, CBER Dir Vinay Prasad added an old colleague & critic of COVID-19 policy 2 the center."
"As diff's emerged betw FDA staff & senior political leaders over its COVID-19 safety review, CBER Dir Vinay Prasad added an old colleague & critic of COVID-19 policy 2 the center."
December 15, 2025 at 8:25 PM
More from the FDA soap opera. I don't subscribe to the (very expensive) Pink Sheet, so apologies for the teaser.
"As diff's emerged betw FDA staff & senior political leaders over its COVID-19 safety review, CBER Dir Vinay Prasad added an old colleague & critic of COVID-19 policy 2 the center."
"As diff's emerged betw FDA staff & senior political leaders over its COVID-19 safety review, CBER Dir Vinay Prasad added an old colleague & critic of COVID-19 policy 2 the center."
Right, there's the weird split screen going on. They seem to want to make it harder to get vaccines approved but easier to get drugs approved.
December 5, 2025 at 12:36 AM
Right, there's the weird split screen going on. They seem to want to make it harder to get vaccines approved but easier to get drugs approved.
Most people have been surprised upon learning that you only need 2 positive clinical trials to get approved. Wait till they hear that now you need only one!
The FDA plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval. www.statnews.com/2025/12/04/f...
FDA to lower number of trials required for approval of drugs, other medical products
The FDA plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval.
www.statnews.com
December 5, 2025 at 12:23 AM
Most people have been surprised upon learning that you only need 2 positive clinical trials to get approved. Wait till they hear that now you need only one!
Reposted by Erick Turner
Story now updated w/ the answer:
"Three sources close to Pazdur told STAT that concerns about the legality of a new drug review program, Makary and Prasad inserting themselves into drug review decisions, and Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave."
"Three sources close to Pazdur told STAT that concerns about the legality of a new drug review program, Makary and Prasad inserting themselves into drug review decisions, and Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave."
Was it Prasad's Friday vaccine email? Was it the politicized review process established for the national priority voucher products? Or some other bridge too far that hasn't yet come to light? A huge loss for the American public, which was set to benefit from a quarter century of Pazdur's experience.
BREAKING scoop: Top drug regulator Rick Pazdur filed papers to retire from the FDA at the end of this month, according to agency sources. He alerted leaders at the drug center this morning. He could still withdraw the papers. www.statnews.com/2025/12/02/r...
December 2, 2025 at 10:53 PM
Story now updated w/ the answer:
"Three sources close to Pazdur told STAT that concerns about the legality of a new drug review program, Makary and Prasad inserting themselves into drug review decisions, and Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave."
"Three sources close to Pazdur told STAT that concerns about the legality of a new drug review program, Makary and Prasad inserting themselves into drug review decisions, and Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave."
The latest episode of the FDA soap opera ⬇️
Convenient summary of the preceding episodes along the right side. 🙄
Convenient summary of the preceding episodes along the right side. 🙄
December 2, 2025 at 11:22 PM
The latest episode of the FDA soap opera ⬇️
Convenient summary of the preceding episodes along the right side. 🙄
Convenient summary of the preceding episodes along the right side. 🙄
Proud to have been a member of @floriannaudet.bsky.social's team. Great to see this out!
A Registered Report is a publishing format in which the study question, hypotheses, and full methodology are peer-reviewed and accepted before the results are known.
November 29, 2025 at 7:26 PM
Proud to have been a member of @floriannaudet.bsky.social's team. Great to see this out!
Reposted by Erick Turner
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/
Latest episode of the FDA soap opera
www.nytimes.com/2025/11/02/h...
www.nytimes.com/2025/11/02/h...
F.D.A. Drug Unit Chief Resigns, and Is Sued by Drug Company
www.nytimes.com
November 3, 2025 at 5:58 PM
Latest episode of the FDA soap opera
www.nytimes.com/2025/11/02/h...
www.nytimes.com/2025/11/02/h...
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...
Positions available to work with @akesselheim.bsky.social and his colleagues at PORTAL. Fellowship positions in Pharmaceutical Law and Policy Research.
Physician Fellowship: form.jotform.com/252916841579...
Postdoctoral Fellowship: form.jotform.com/252916475545...
Physician Fellowship: form.jotform.com/252916841579...
Postdoctoral Fellowship: form.jotform.com/252916475545...
PORTAL Postdoctoral Fellowship Application (2026)
Please click the link to complete this form.
form.jotform.com
October 28, 2025 at 5:30 PM
Positions available to work with @akesselheim.bsky.social and his colleagues at PORTAL. Fellowship positions in Pharmaceutical Law and Policy Research.
Physician Fellowship: form.jotform.com/252916841579...
Postdoctoral Fellowship: form.jotform.com/252916475545...
Physician Fellowship: form.jotform.com/252916841579...
Postdoctoral Fellowship: form.jotform.com/252916475545...
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 ($$$!!!).)
(Screenshot from the Pink Sheet. I can't share the article b/c I don't subscribe ($$$!!!).)
Reposted by Erick Turner
Leucovorin devotee PI seems to have continuous difficulty w/trials. See pp.4-5 from FDA
www.thetransmitter.org/wp-content/u...
The technical term for enrolling subjects in a trial that FDA says you may not initiate is BAD.
www.thetransmitter.org/wp-content/u...
The technical term for enrolling subjects in a trial that FDA says you may not initiate is BAD.
Exclusive: Meet Richard Frye, who studies leucovorin for autism
Frye has led two placebo-controlled trials of the folate supplement in autistic people; the first was suspended by regulators, and the other has yet to be published.
www.thetransmitter.org
October 6, 2025 at 2:07 AM
Leucovorin devotee PI seems to have continuous difficulty w/trials. See pp.4-5 from FDA
www.thetransmitter.org/wp-content/u...
The technical term for enrolling subjects in a trial that FDA says you may not initiate is BAD.
www.thetransmitter.org/wp-content/u...
The technical term for enrolling subjects in a trial that FDA says you may not initiate is BAD.
This still feels strange. Drugs have always been approved on the initiative of drug companies. Here, the FDA is saying *it* initiated the approval. It's as if Makary did this to placate RFK Jr and his odd beliefs about autism. @akesselheim.bsky.social
FDA news release www.fda.gov/news-events/... says:
"The FDA is working with GSK, the innovator of Wellcovorin (leucovorin calcium), on a process to include the essential scientific information needed for the safe and effective use of these drug products for adults and pediatric patients with CFD."
"The FDA is working with GSK, the innovator of Wellcovorin (leucovorin calcium), on a process to include the essential scientific information needed for the safe and effective use of these drug products for adults and pediatric patients with CFD."
October 6, 2025 at 12:01 AM
This still feels strange. Drugs have always been approved on the initiative of drug companies. Here, the FDA is saying *it* initiated the approval. It's as if Makary did this to placate RFK Jr and his odd beliefs about autism. @akesselheim.bsky.social
Reposted by Erick Turner
Every single one of these clips was taken today in downtown Portland. Portland doesn’t want or need a federal takeover. If Trump insists on sending federal “resources” he can start with funding health care, bridges, affordable housing, and wildfire protection to name a few.
September 27, 2025 at 9:35 PM
Every single one of these clips was taken today in downtown Portland. Portland doesn’t want or need a federal takeover. If Trump insists on sending federal “resources” he can start with funding health care, bridges, affordable housing, and wildfire protection to name a few.
Reposted by Erick Turner
Portland declares ICE facility out of compliance, demands its clearance. www.portland.gov/mayor/keith-...
City of Portland will issue land use violation notice for ICE facility, triggering process to determine next steps at the site
The City of Portland believes the federal government violated detention conditions of its land use approval 25 times in a 10-month period, according to federal records. Next steps could include fines ...
www.portland.gov
September 27, 2025 at 10:18 PM
Portland declares ICE facility out of compliance, demands its clearance. www.portland.gov/mayor/keith-...
Reposted by Erick Turner
Secret photo shows that Portland has already established an autonomous free zone! They're going to call it the Portland Saturday Market!
#WarRavagedPortland
#Portland
#WarRavagedPortland
#Portland
September 27, 2025 at 5:42 PM
Secret photo shows that Portland has already established an autonomous free zone! They're going to call it the Portland Saturday Market!
#WarRavagedPortland
#Portland
#WarRavagedPortland
#Portland
Reposted by Erick Turner
War-ravaged Portland, 5 minutes ago
September 27, 2025 at 4:29 PM
War-ravaged Portland, 5 minutes ago