Regulatory discoherence: The case of remdesivir

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.

Image credit: Photo by Thirdman from Pexels

Continues…

To read the whole story, subscribe to the Geneva Health Files newsletter.

If you like this story, do consider supporting Geneva Health Files. I seek to make this a reader-funded initiative. You can make a contribution using a paypal account: paypal.me/genevahealthfiles Your donations are crucial to keep this effort going!

If you wish to share information or have suggestions, write to me: patnaik.reporting@gmail.com

One thought on “Regulatory discoherence: The case of remdesivir

  1. 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/

Leave a Reply to Ronald M. Chavin Cancel reply