Given that hamfull effects are possible, even a very small hamfull effect would be tragic given how many patients have been enrolled with very little knowledge gained compared to what could be achieved by enrolling a much lower number in an RCT.
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Replying to @load_dependent @kausikdatta22 and
This is not really different from the discussions about HCQ a while back, good safety profile in other conditions, observational data etc does not preclude negative effects.
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Replying to @load_dependent @kausikdatta22 and
Do you agree that if there is significant uncertainty as to benefit, one is necessarily also uncertain whether there is harm?
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Replying to @load_dependent @GermHunterMD and
Thanks for the clarification, Lars. A few things I submit for your consideration: the safety of CP administration was addressed in a study with a cohort of 5,000 patients—which then expanded to 20,000 patients. Preprint uploaded in June, it showed excellent safety profile. 1/
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Replying to @kausikdatta22 @load_dependent and
While authors did note numbers which spoke to clinical benefits of transfused CP, they didn’t make a deal of it—strictly staying within the bounds of a safety study. I hope this addresses your concerns re possible harm from CP—especially when weighed against harm from COVID19. 2/
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Replying to @kausikdatta22 @load_dependent and
As far as the EAP trial goes, the primary goal of the trial was to provide CP access to an expanded number of COVID19 patients—NOT to make a claim on efficacy/clinical benefit. Benefits reported in the Aug preprint are incidental, based on mortality/hospital stay as endpoint. 3/
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Replying to @kausikdatta22 @load_dependent and
It is understood that this was not an RCT; it didn’t have the ability to compare CP against standard of care, nor establish any causality. But does that negate the significant mortality benefits observed in a huge number of patients, incl. critically ill ones? 4/
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Replying to @kausikdatta22 @GermHunterMD and
I don't understand, what do you mean by "mortality benefit" when you agree no causality can be established? The "huge number" is irrelevant when the design and analysis is does not allow causal inference.
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Replying to @load_dependent @kausikdatta22 and
Yes I agree with Lars here. If you do not have a comparison group then you cannot assess safety. It's entirely possible that this treatment caused a significant increase in mortality - we would not know from this study as conducted
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Replying to @GidMK @load_dependent and
"It's entirely possible that this treatment caused a significant increase in mortality." Can you pls explain further? The observation is 6-7 out of every 10 patient—in ICU & receiving CP—had clinical improvement & did not die. What would an "increase in mortality" look like here?
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We have no idea because there's no comparison group. What if only 1-2 out of 10 died without treatment? How would we know?
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Replying to @GidMK @load_dependent and
"What if only 1-2 out of 10 died without treatment?" So, you seem to be saying we should deliberately ignore the number of patients who died from COVID19—& mortality rates—before idea of CP as a plausible therapeutic modality was introduced/tested. Am I getting this correctly?
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Replying to @kausikdatta22 @load_dependent and
No. I'm saying without an appropriate comparison group we do not know if more/less patients would have died without the treatment. This is the entire basis of clinical research
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