NEJM Day: Boosting RDV, Attacking HCQ

On October 8, the New England Journal of Medicine fired a new salvo against Hydroxychloroquine. It published the results of a tragicomic RECOVERY trial, and the “final report” of NIAID study of Gilead’s Remdesivir (Remdeathivir). 

The fake news media treats this RECOVERY paper as news, and claims it proves that HCQ does not help severe patients. In fact these results were published in the media on June 4. The RECOVERY researchers severely overdosed and poisoned their patients with HCQ. Even with such overdoses of HCQ, no adverse cardiac events occurred, which is consistent with other clinical data.

Remdesivir for the Treatment of Covid-19 — Final Report (“RDV FR”), Beigel et al., October 8  is a new version of Remdesivir for the Treatment of Covid-19 — Preliminary Report (“RDV PR”, no pun intended), Beigel et al, May 22. It took the authors another four months to manipulate the data before publishing it.

As expected, about 35% of the patients in both Remdesivir and placebo groups also received Hydroxychloroquine (RDV FR Appendix, Table S3). About 80% of patients in each group received antibiotics, and the paper does not specify which ones.

Contrary to the principles of scientific archiving, both PR and FR papers share the same DOI number and the URL (doi: 10.1056/NEJMoa2007764, https://www.nejm.org/doi/full/10.1056/NEJMoa2007764)

Contrary to common sense and best methodological practices [1], the trial was conducted in 60 sites, plus sub-sites. This trial is both a “multicenter RCT that ignores site differences” and “centralized multicenter collaborative RCT” [2], known for their ability to produce misleading results. In this case, the NIAID and/or Gilead probably cherry-picked both patients and doctors.

This is reminiscent of an account regarding a COVID-19 patient who was denied Remdesivir in Gilead’s “compassionate care” program (outside of this trial) when he was in severe condition, but was administered the drug later, after he improved.

So far, the prior conclusion that this RDV clinical trial was fraud is reinforced. 

Work in progress

References

[1] Helena Chmura Kraemer, Ph.D., Pitfalls of Multisite Randomized Clinical Trials of Efficacy and Effectiveness, Schizophrenia Bulletin, 2000, https://doi.org/10.1093/oxfordjournals.schbul.a033474

[2] Helena Chmura Kraemer, Thomas N. Robinson, Are certain multicenter randomized clinical trial structures misleading clinical and policy decisions?, Contemporary Clinical Trials, 2005, https://doi.org/10.1016/j.cct.2005.05.002

via Science Defies Politics

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October 9, 2020 at 06:57PM

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