1/4 I salute the authors for planning and conducting this complex and important study. Two observations: 1) This was [as far as I can tell - I will stand corrected if not] an open-label study with patient reported outcomes thelancet.com/journals/lance…2/4 2) Intervention arm:
476/2198 non-actionable variants; AE= 21,7%
152/725 actionable variants; AE=21.0%
Mar 22, 2020 • 16 tweets • 5 min read
1/ So, I have additional comments to this study, which is wreaking havoc out there. Please also see the excellent commentaries by @jpogue1
Most importantly: THIS STUDY DOES NOT PRESENT A SINGLE DATAPOINT ON CLINICAL EFFICACY OR SAFETY. sciencedirect.com/science/articl… #medtwitter2/ Please appreciate that the authors are taking appropriate reservations with respect to the preliminary nature of the data presented. Also appreciate that time is of some essence here and that results that may be of significance to public health should be available ASAP.
2) What was the suggested added value to mankind from the study proposal?
3) What kind of scientist pitches such a study proposal?
4) Importantly: What kind of scientists says "Great idea, let's go"?
2/4
Mar 21, 2019 • 8 tweets • 8 min read
1/7 @medsinpregnancy#pregnancy#postpartumdepression
So, the FDA approves Brexanolone for postpartum depression - a 60-hour continuous infusion at about $25K - with this accompanying picture 😡👇
I refuse to let this pass in silence... bit.ly/2uhwGKR2/7 @medsinpregnancy#pregnancy#postpartumdepression
Approval is based on two Pivotal phase III trials reported in Lancet comparing infusions of this drug to placebo in two populations of postpartum women with moderate and high HAM-D scores, respectively: bit.ly/2TPprJA
