Erick Turner

The speed of the the reviews is already plenty fast due to mandated deadlines for completing the reviews. This is just going to incentivize reviewers to reduce scrutiny, potentially missing serious problems

Hey, here's a thought...
How about offering bonus payments for staffers who complete CORRECT reviews and recommend approval ONLY if the drugs are truly safe and effect?

FDA to offer bonus payments to staffers who complete speedy drug reviews The head of the Food and Drug Administration plans to start offering bonus payments to agency drug reviewers who complete their work ahead of the schedule.

apnews.com/article/drug... to offer bonus payments to staffers who complete speedy drug reviews

FDA will drop two-study requirement for new drug approvals, aiming to speed access The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals.

This could be extremely harmful. False positives, power issues, & rare adverse events come to mind if there is only one trial required 🤦‍♀️

or donate to the ballroom or T-Kennedy Center projects or etc, etc

Note there's a tiny study w N= 11 x 2 = 22 that was published with positive results. If a similarly-size study yielded negative results, something tells me that the investigators and/or journals would have been dismissed it as underpowered and not worth publishing.

Yep, an SMD of 1.8 for any antidepressant is hard to believe. Seems more like what you'd get for open-label (placebo-free) studies. I'd suspect outcome switching and/or burying other studies with less over-the-moon results.

STAT piece first-authored be @lizzylawrence.bsky.social. Perhaps she has insight into the politics.

I can’t imagine RFK Jr NOT supporting a psychedelic, so was this a defeat for him?

(Apologies if this is addressed in the full text of the article, but I lack access.)

Last summer, RFK Jr criticized the FDA for not approving MDMA-assisted psychotherapy for PTSD. Now that he's been given power over the FDA, I figured that any psychedelic would be on a glide path to approval this year. But apparently not!

Trump administration officials blocked FDA effort to fast-track review of psychedelic treatment Trump administration officials vetoed the FDA's plan to fast-track the review of a psychedelic treatment for severe depression, STAT has learned.

It seems that decisions at the FDA can go either way based on a combination of science and politics.
www.statnews.com/2026/02/04/p...

Missing tissue, missing data: Resolving brain volume loss caused by anti-amyloid therapies Anti-amyloid drugs modestly slow Alzheimer’s disease progression, albeit with uncertainty of sustained benefit, particularly as they cause paradoxical acceleration of brain volume changes. Here, we ex...

Article: Missing data about missing tissue ⬇️
dx.plos.org/10.1371/jour...

Misleading Readers without Lies: Understanding Spin and its Relevance to Acupuncture Research This article provides an overview of spin in general and the current state of spin research in acupuncture studies. We introduce the definition and hi…

Nice article, providing an overview of the various types of spin:

Although the article relates spin to research on acupuncture, it applies to research in general.

www.sciencedirect.com/science/arti...

This “stellar groups” has a North Star…@floriannaudet.bsky.social An honor to be helping shine some additional light!

Finally, good to see that they not only used a sham control but also tested whether blinding was successful. Apparently, it wasn't great (screenshot), raising the Q of whether that could have biased the participants and investigators, so the positive results should be taken with a grain of salt

Kudos also to the authors or reviewers for showing not only P values but also effect sizes (Cohen's d). On the primary outcome--the most important result-- they found d = 0.37. That's in the upper end of the range for second-generation antidepressants, but not worthy of hyping it as a "breakthrough"

Just saw a news item abt this article in Nature www.nature.com/articles/s41.... Glad 2 see that the authors provided (or the reviewers insisted) that the figure w the primary outcome results show the full range of scores, showing not only the treatment effect but also how much was NOT treated (lots)

Agree, there's no amount of research one could stop these rumors from spreading.

I'm reminded of a cartoon years ago: "My mind is made up. Don't confuse me with the facts!"

Who could this old colleague be? I have an idea but would rather not speculate. We should find out soon via another news piece.

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."

Comparing stories on the new "souped-up" GLP-1 drug You can report on the positive findings but don't bury the side effects

garyschwitzer.substack.com/p/comparing-...

Do dogs cause autism? The anatomy of an unfalsifiable hypothesis

open.substack.com/pub/youcankn...

The fact that the NEJM seems eager to publish their every utterance makes one wonder whether they're more interested in publishing good science or something that's newsworthy and good for their JIF

bsky.app/profile/etur...

The plot thickens when weighing the one (or two) positive trial(s) vs the evidence from multiple negative trials. If, in some of them, the drug is statistically inferior to a comparator, should that be ignored?

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!

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."

The latest episode of the FDA soap opera ⬇️

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!