THE NEED FOR REGULATORY COHERENCE: LESSONS FROM REMDESIVIR
The story of Gilead’s drug remdesivir, one of the earliest candidates of repurposed medicines that showed promise for the treatment of COVID-19, should hopefully have lessons for regulatory authorities the world over.
In reporting this story with my colleagues in the cross-border investigations team working on this project, we spoke to a number of experts from different parts of the world, in trying to understand how regulatory processes work. And what approvals from regulatory authorities mean for governments, for clinicians, for people and for companies.
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Here are clinical trials in which remdesivir failed to shorten hospital stays or reduce deaths:
https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1
https://pubmed.ncbi.nlm.nih.gov/33264556/
https://www.nejm.org/na101/home/literatum/publisher/mms/journals/content/nejm/0/nejm.ahead-of-print/nejmoa2023184/20201202/images/img_medium/nejmoa2023184_f2.jpeg
https://www.nejm.org/na101/home/literatum/publisher/mms/journals/content/nejm/0/nejm.ahead-of-print/nejmoa2023184/20201202/images/img_medium/nejmoa2023184_f3.jpeg
https://rebelem.com/remdesivir-in-moderate-covid-19/
https://www.medrxiv.org/content/10.1101/2020.08.10.20171637v1
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7190303/
https://finance.yahoo.com/chart/GILD
Remdesivir is totally useless against all viral diseases, including the flu, common cold, and Ebola:
https://www.nejm.org/doi/full/10.1056/NEJMoa1910993
https://www.nejm.org/na101/home/literatum/publisher/mms/journals/content/nejm/2019/nejm_2019.381.issue-24/nejmoa1910993/20191206/images/img_xlarge/nejmoa1910993_f1.jpeg
Remdesivir is fraudulently indicated for end-stage COVID-19 when in truth, it has absolutely no benefit in reducing the cytokine storm, in fact, might make it slightly worse:
https://www.nature.com/articles/s41591-020-1051-9
https://www.nature.com/articles/s41591-020-1051-9/figures/5
https://www.mdpi.com/tropicalmed/tropicalmed-05-00112/article_deploy/html/images/tropicalmed-05-00112-g004.png
Remdesivir, hydroxychloroquine, and chloroquine cause cardiovascular QT interval prolongation and sinus bradycardia:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7571425/
https://www.sciencedirect.com/science/article/abs/pii/S0022073620305835
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7598346/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7682945/
Remdesivir causes liver damage:
https://theprint.in/health/govt-reviewing-remdesivir-use-for-covid-after-hospitals-report-liver-damage-in-patients/454169/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7381904/
https://pubmed.ncbi.nlm.nih.gov/33006138/
Remdesivir causes kidney damage:
https://www.rxlist.com/consumer_remdesivir_rdv/drugs-condition.htm
https://pubmed.ncbi.nlm.nih.gov/33252992/