Adequate safety testing of experimental treatments paramount even in a pandemic setting


Although there could be an extreme impulse to fast forward treatments in a pandemic setting, it is very important to conduct adequate safety checks on investigational drugs and vaccines. The treatment cannot be worse than the disease itself.

This is where repurposed drugs (existing drugs that are investigated for new therapeutic purposes) have an advantage as they often have extensive safety date backing them and are amenable to being fast-tracked. This is also, where biologics (vaccines and antibodies) have their limitations. Just because a biologic is safe in a primate model, by no means proves that it is going to be safe in humans.

Let us not forget the PAREXEL trial that went catastrophically wrong more than 14 years ago, when eight healthy young men took part in a clinical trial of an experimental leukaemia drug, TGN1412. The drug that had been shown to be safe in monkeys however led to the men fighting for their lives soon after treatment and has left some with permanent immune issues.

Having a safe treatment is especially vital in COVID-19 management when approximately 80% of people testing positive for SARS-CoV-2 may only get a mild disease.

Reference
https://pubmed.ncbi.nlm.nih.gov/17256444/


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