FDA head asks for investigation into Aduhelm drug approval

Re:FDA head asks for investigation into Aduhelm drug approval by raphlinus on Saturday July 10, 2021 @02:31PM (#27795422)

It's not holding up so well in RCT's, like this one[1] that was just discussed on TWiV 778[2].

BTW, I've joined the legions who are addicted to TWiV. It's a time commitment for sure, but it's fascinating how different the perspective is on important topics (like delta variant) than the mainstream press.

[1]: https://bmcinfectdis.biomedcentral.com/articles/10.1186/s128...

[2]: https://www.microbe.tv/twiv/twiv-778/

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Re:FDA head asks for investigation into Aduhelm drug approval by mcguire on Saturday July 10, 2021 @07:41PM (#27797279)

[1]: "The mean age was 42 years (SD ± 15.5) and the median time since symptom onset to the inclusion was 4 days [interquartile range 3–6]. The primary outcome of hospitalization was met in 14/250 (5.6%) individuals in ivermectin group and 21/251 (8.4%) in placebo group (odds ratio 0.65; 95% confidence interval, 0.32–1.31; p = 0.227). Time to hospitalization was not statistically different between groups. The mean time from study enrollment to invasive mechanical ventilatory support (MVS) was 5.25 days (SD ± 1.71) in ivermectin group and 10 days (SD ± 2) in placebo group, (p = 0.019). There were no statistically significant differences in the other secondary outcomes including polymerase chain reaction test negativity and safety outcomes."

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Re:FDA head asks for investigation into Aduhelm drug approval by forcry on Sunday July 11, 2021 @11:35AM (#27801630)

Only a very low dose of Ivermectin was used. From the study limitations..

> Low percentage of hospitalization events, dose of ivermectin and not including only high-risk population.

I think one would at least use any of the protocols that were being used by the doctors who are seeing an efficacy.

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