Unten der Link, den Schweizer_Hasenfuss in # 479 nicht posten konnte.
Ich hab die wichtigsten Kritikpunkte in Deutsch zusammengefasst:
KRITIKPUNKTE:
1. Es gab bei der Chicagoer Remdesivir-Studie keine klinische Kontrollgruppe. Das ist bei Pharma-Tests unüblich.
2. Die Patienten, die Remdesivir erhielten, wurden aus tausenden Interessenten "handverlesen" ausgewählt. Die Droge bekamen nur solche Patienten, die ohnehin höhere Erholungschancen hatten (jünger, besserer Allgemeinzustand, kein Bluthochdruck, keine Nierenschäden usw.)
3. Ingesamt 61 Patienten wurde zur Remdesivir-Studie zugelassen, doch am nächsten Tag wurden sieben von ihnen aus unerfindlichen Gründen nachträglich ausgeschlossen. Über sie ist nichts bekannt. Könnte sogar sein, dass sie gestorben sind.
emcrit.org/pulmcrit/...m-paper-on-remdesivir-reveals-nothing/
#1. Lack of a control group
As a multi-billion-dollar pharma giant, Gilead has the ability to perform RCTs. Administration of a relatively new drug with unclear side-effects should occur within the context of a controlled trial. Administration of unproven medications under the auspice of compassionate use opens the door to all sorts of unknown toxicities and dangerous practices.
Lack of any control group makes it extremely important that the patients were selected in an unbiased fashion, representing an average group of patients with COVID-19. Unfortunately, this wasn’t the case…
.
#2. Cherry-picking Patients
Remdesivir was aggressively sought-after by thousands of patients with COVID-19. Of these patients, 61 ended up receiving the drug. Why did these 61 patients receive medication, out of scores of patients applying to receive it?
The manuscript is extremely coy regarding how many patients applied to use remdesivir and how this application process worked. For example, there is no documentation of how many patients applied. There is no data comparing characteristics of patients included in the study versus patients denied medication. Given lack of any control group (#1 above), lack of transparency about this selection process is stunning.
The fact is that Gilead excluded many patients at a higher likelihood of dying (e.g., patients on vasopressors or patients with renal failure). The manuscript doesn’t mention vasopressors, but this was an exclusion factor in the United States.
Through reliable sources, I am aware of one case where a patient was initially denied remdesivir because the patient was too ill (renal failure, vasopressor requirement). Subsequently this patient improved clinically, so Gilead changed their mind and decided that the patient was a candidate for remdesivir! Thus, it seems that the selection process may have been designed to capture patients maximally likely to recover, rather than patients maximally likely to benefit from remdesivir.
#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.