BREAKING—wow—WHO just recommended **against** the use of @GileadSciences’s drug remdesivir in hospitalized #COVID19 patients, citing “there is currently no evidence that remdesivir improves survival or reduces need for ventilation in these patients”. 🧵
👉 who.int/news-room/feat…
2) “data from over 7000 patients across the 4 trials were considered.
The evidence suggested no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes.
The guideline development group...”
3) “recognized that more research is needed, especially to provide higher certainty of evidence for specific groups of patients. They supported continued enrollment in trials evaluating remdesivir.”
4) WHO gave a “conditional recommendation”: issued when the evidence around the benefits and risks of an intervention are less certain. In this case, there is a conditional rec against the use of remdesivir. This means that there isn’t enough evidence to support its use.”
5) That said, it is actually NOT surprising. The EUA application of Remdesivir was actually submitted before the WHO’s large SOLIDARITY trial was published. But WHO sent it along to Gilead. Did Gilead withhold from FDA?
6) Indeed, it’s possible FDA approval of Remdesivir for in-hospital COVID ignored world's biggest clinical trial data which showed no improvement in survival, progression to ventilation, or hospital discharge. Gilead likely didn't forward the data to FDA.
7) You can hear the clear concern in WHO’s chief scientist @doctorsoumya’s voice defending the strength of trial & making the timeline quite clear when Gilead first got SOLIDARITY data showing no benefit. Either Gilead withheld it from FDA—or the FDA knew.
8) Trial was first publicly reported on Oct 16th but, that’s already **3** full weeks after Gilead first got the main results privately from @WHO. So @GileadSciences knew & either failed to disclose to FDA, or FDA looked the other way. Which is it?
10) and the WHO’s Solidarity trial also checked Remdesivir in diff groups: young and old, Low and high risk. No group benefited significantly from it. Nothing.
📍Reinfection worry re-emerging—another documented reinfection case - this time of a 21 year old women in South Korea. There are now officially 26 confirmed reinfections and 1 death, and 572 suspected reinfections of #COVID19. Infection is rare but not blue moon rate it seems.
3) notably, it was two different virus strains. “The spike protein D614G substitution that defines the clade “G” emerged in reinfection, while mutations that characterize the clade “V” (ie, nsp6 L37F and ORF3a G251V) were present at initial infection.” academic.oup.com/cid/advance-ar…
BREAKING—FDA has granted emergency use authorization for @Regeneron’s monoclonal antibody cocktail REGEN-COV2 (Casirivimab and imdevimab), the same drug given to Trump when he was infected with #COVID19. Only for mild/moderate cases—not hospitalized. 🧵 fda.gov/news-events/pr…
2) There are a lot of rules and FDA stipulations for REGEN-COV2 cocktail use though— cannot be used if patient on oxygen (Trump was) or hospitalized. Children must be 12 or old and weigh 40 kg or more.
3) And it’s only for those mild/moderate with “high risk of progressing to severe #COVID19”—and thus need to be defined carefully what constitutes high risk of progressing:
📍NEW—Texas Army National Guard has just arrived in El Paso—they have been assigned the grim work of dealing with the overflow of deceased bodies now piled up in 10 refrigerated mobile morgues. It is hard work—previously county jail inmates. #COVID19
⚠️Crap crap—El Paso morgue crisis escalated fast. First it was jail inmates moving deceased bodies for $2/hour, then $27/hour job posting, and now Texas National Guard summoned up to help at El Paso’s overflowing morgue.
3) All the while, TX Senator Ted Cruz called Senator Brown a "complete ass" for asking a maskless Dan Sullivan (R) to wear his mask in the Senate. Since then, 87-year-old Chuck Grassley (R) & Rick Scott (R) have both tested positive for #COVID19 & El Paso having morgue crisis.
📍DEVASTATING ANIMATION—Containment measures 🆚 #COVID19 case surges and hospitalizations 🏥 by state.
Hospitals are now almost full nationwide and ICU beds will soon run out. Please don’t do anything to risk spreading the virus over the holidays. Please stay safe everyone. 🙏