Appalling but not surprising.
Excellent article.
The following is a summary of numerical points. Each is detailed on the webpage at the following link, which also includes comments regarding the page:
https://emcrit.org/pulmcrit/pulmcrit-eleven-reasons-the-nejm-paper-on-remdesivir-reveals-nothing/"
PulmCrit – Eleven reasons the NEJM paper on remdesivir reveals nothingApril 11, 2020 by Josh Farkas
#1. Lack of a control group
#2. Cherry-picking Patients
#3. Loss of patients due to “no post Day 1 clinical data”
"Of 61 patients initially included in the trial, 7 were excluded due to an absence of clinical data after the first trial day. This is disconcerting. What happened to these patients? Did they die from anaphylaxis? Did they get well, sign out against medical advice, and go party? This is unknown – but I’m worried that these patients actually didn’t fare so well."
#4. Lack of defined sample size or stopping rule
#5. Lack of a primary endpoint
#6. Lack of information about the subjects
#7. Inclusion of many patients who weren’t very ill
#8. Delayed administration of Remdesivir
#9. Outcomes weren’t that awesome
#10. Possible signs of harm are obscured without a control group
#11. Heavy involvement of pharma
This publication is grossly flawed, with many sources of bias. Overall, it reveals no meaningful information about Remdesivir. Like any new medication with unclear side-effects, Remdesivir should be subjected to RCTs.
Gilead is a multi-billion-dollar pharmaceutical company, with ample resources. We are in the midst of a pandemic, with an abundance of COVID patients. There is no excuse for Gilead not to perform a well-powered, double-blind RCT. Hopefully such studies will be forthcoming shortly.
Until an RCT is performed, further compassionate use of remdesivir probably isn't justified. This may simply represent a distraction when managing these extremely complex patients.
