Below the Fold - goodbye to $2 million coin tosses

FDA Modernization Act 2.0 Removes Requirement for Animal Testing
Wed Jan 11

• Unreliable. Despite passing animal trials, 96% of drugs fail in human trials from safety or efficacy issues. In fact, lab animals only predict toxic responses in humans around 50% of the time (no greater than random chance).
• Hard to reproduce. Mice moved to a larger cage has resulted in inflicted defects disappearing, meaning that lab conditions can be a big influence on a result. Stricter standards have not resolved the issue. In over 800,000 studies, toxicity was only repeatable 70% of the time in the same species.
• Expensive. Not only does animal testing add years to drug development, it costs hundreds of thousands to millions of dollars per drug study.
• Ethically questionable. The essential procedures are physically and psychologically distressing to animals (food and water deprivation, physical restraint, infliction of disease or wounds, and more).

• Microfluidic organs-on-chips simulate human organs on chips the size of USB flash drives. Because the organ-on-chip is highly controllable, researchers can better understand the drug’s effects and fine-tune the dosing.  
• Organoids (blobs of tissue that are miniature, simplified organs) offer a detailed view of how organs form and function. They’ve also been shown to predict patient responses to some cystic fibrosis medications and chemotherapy. 
• Computer models and AI are the fast and cheap alternatives but they’ve already outperformed animal tests in predicting adverse effects of cardiac drugs.