Erick Turner
@eturnermd1.bsky.social
780 followers 200 following 2.4K posts
Advocate for and researcher on transparency in medical research. Former FDA reviewer of psychotropic drugs back when the FDA was a tougher gatekeeper.
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eturnermd1.bsky.social
Of possible future (or present) interest to @retractionwatch.com
eturnermd1.bsky.social
"To clarify, while Dr. Oz doesn't necessarily have a stake in the forthcoming FDA-approved Leucovorin manufacturer, he does have a financial stake in a non-prescription alternative."
eturnermd1.bsky.social
Such a conflict of interest would be very much on brand for this administration.
eturnermd1.bsky.social
...but what's likely to happen is that hype will circulate among parents of kids w autism about a new treatment for autism–the nuance about CFD will be overshadowed. Then they'll be asking their doctors if their kids shdn't B treated w this exciting new treatment. I've already had 1 such inquiry.
eturnermd1.bsky.social
And the news release title is misleading with its "treatment for autism symptoms". The text of the release clarifies that the treatment is not for autism per se but rather for cerebral folate deficiency (CFD), which, as @akesselheim.bsky.social pointed out, requires a lumbar puncture to diagnose...
eturnermd1.bsky.social
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
eturnermd1.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."
Reposted by Erick Turner
wyden.senate.gov
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
sigfreidskaldrup.bsky.social
Secret photo shows that Portland has already established an autonomous free zone! They're going to call it the Portland Saturday Market!
#WarRavagedPortland
#Portland
Reposted by Erick Turner
mrdarcydog.bsky.social
War-ravaged Portland, 5 minutes ago
Reposted by Erick Turner
Reposted by Erick Turner
eturnermd1.bsky.social
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.
eturnermd1.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."
eturnermd1.bsky.social
Good question. If/when they make the review available, then we'll see. But so far it sounds like it was all based on that one very small study. Can't be easy to find a reviewer who's willing to recommend approval based on so little.
eturnermd1.bsky.social
Indeed, less than 40 patients per group
eturnermd1.bsky.social
Dr. Kesselheim @akesselheim.bsky.social
also noted that the study cited by the F.D.A. showed only small improvements in autism symptoms among people with certain folate levels in their spinal fluid.
lizszabo.bsky.social
Before prescribing leucovorin, doctors would first need to determine whether a patient suffered from the deficiency, Dr. Kesselheim said. How they would arrive at that diagnosis short of a risky, expensive spinal tap was not clear, he said.

www.nytimes.com/2025/09/23/h...
F.D.A.’s Approval of a Drug for Autism Upends Review Process
www.nytimes.com
Reposted by Erick Turner
lizszabo.bsky.social
Before prescribing leucovorin, doctors would first need to determine whether a patient suffered from the deficiency, Dr. Kesselheim said. How they would arrive at that diagnosis short of a risky, expensive spinal tap was not clear, he said.

www.nytimes.com/2025/09/23/h...
F.D.A.’s Approval of a Drug for Autism Upends Review Process
www.nytimes.com
eturnermd1.bsky.social
Don't know. It seems the pharma companies have a decision to make...either capitulate or fight it in court, arguing their First Amendment rights are being infringed.
eturnermd1.bsky.social
A couple of new articles on the current FDA leadership's crackdown on Direct-to-Consumer (DTC) advertising.

Excerpt: "...all three of Boehringer’s letters concern a different one of the company’s musical theater-themed Jardiance ads."

I must admit those commercials are very irritating.
eturnermd1.bsky.social
Now Tidmarsh is saying he "never said" he'd abandon Advisory Committee meetings.
www.biospace.com/fda/fda-flip...