Former reviewer of psych drugs for FDA, back when they had backbone vs Pharma. User of FDA reviews to sort out truth vs lies in publ'd articles on clin trials.
Feb 7, 2023 • 6 tweets • 2 min read
At first glance, it seems like the bottom line is "there's no publication bias in this field. But how can you study publication bias if you look only at studies that are published. What about the UNpublished studies? #PLOSONE dx.plos.org/10.1371/journa…
To be fair, they report having looked at study registrations. But it says they searched "clinicaltrials.com" (vs ".gov"), which is the URL for PPD, a contract research organization (CRO) that does Pharma trials. I hope this was a typo.
Jun 16, 2022 • 6 tweets • 4 min read
This seems a bit fishy. The graph of change in the primary outcome shows that real separation between pimavanserin and placebo occurs ONLY at Day 43 (6 weeks). Seems convenient that this is the primary outcome date. Were they geniuses, or was that time point cherry-picked?
we showed an abysmal lack of transparency in the reporting of antidepressant trials.
Half of the trials were positive (P<0.05 on 1º outcome) & half were negative. But you never wd hv known it from the publ'd lit
Oct 26, 2021 • 10 tweets • 2 min read
FDA Drug Approval and the Ethics of Desperation ja.ma/3vJ9T9P via @JAMAInternalMed part of @JAMANetwork
“approving drugs for which benefits have not been established can derail scientific progress, expose patients to medications with risks that outweigh benefits, and allow hope to be exploited for commercial benefit, with high costs to the health care system.”
Jun 15, 2021 • 13 tweets • 4 min read
“In recent years, under steady pressure from the pharmaceutical industry and the patient groups it funds, the F.D.A. has progressively lowered its standards of effectiveness and safety required for drug approvals.” via @nytopinion @akesselheim nytimes.com/2021/06/15/opi…
“…reached a low point last week when the F.D.A. approved aducanumab, a treatment for Alzheimer’s disease that has not been convincingly shown to work and can cause brain swelling and hemorrhage.”
Apr 4, 2020 • 13 tweets • 7 min read
Digging further in2 this confusing FDA-issued "Emergency Use Authorization" for chloroquine & hydroxychloroquine.