Safer Medicines - putting patient safety first

Putting patient safety first

Barriers to the Uptake of Human-based Test Methods, and How to Overcome Them

Our article, written with Center for Responsible Science and published in ATLA, identifies some of the reasons for the glacial uptake of new, improved methods of safety assessment, and suggests ways forward, such as:

"...validation needs to become relative, rather than absolute. If a new test, or tests, can be shown to outperform what is currently required, that alone should suffice to ensure the continual and incremental replacement of underperforming tests with better ones, even if they are not yet perfect themselves. Unless this system of gradual improvement (which operates in almost every other sphere of endeavour) is adopted, the perfect will remain forever the enemy of the good."

"Perhaps the greatest barrier to the replacement of animal tests is the legal protection that they afford to pharmaceutical companies in litigation regarding adverse drug reactions. It is therefore imperative to increase awareness of the fallacy of such protection: unpredictive tests do not protect patients, and should no longer protect companies who continue to use them, when more-predictive methods not reliant on interspecies extrapolation are available."

Everyone understands that failing to update computer software leads to serious damage to computers. Yet we allow outdated protections for human health to go unfixed for decades. Is it any wonder that adverse drug reactions are now our fourth leading cause of death?

 

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