Alex Olivares, Brian Kalyuzhny, and Nick Melkadze
Biogen, a large biotech company that specializes in the treatment of neurological diseases, has been conducting studies on Aducanumab. They claimed that this drug slows the progression of Alzheimer’s in humans by attacking the amyloid-β protein, and after doing some testing, submitted it for FDA approval. Despite all the FDA experts saying there was no evidence that the drug had any effects on Alzheimer’s disease, the drug was approved through the accelerated approval pathway. More research needs to be done into their connection and on the drug as a whole — research that doesn’t have fundamental problems such as weakly defined differences between low and high dosages, absurdly high drop-out rates, and the questionably valid application of their tests onto actual patient cognition. With a new experimental design and further testing, the drug should have a fair chance in getting FDA approval in the usual way that new products do. However, using this special form of accelerated approval for a drug that has all these problems is unthinkable — especially given the fact that it was almost unanimously voted against by the FDA’s own expert independent advisory committee — leading us to question whether the decision was made purely based on the science and the benefit of Alzheimer’s patients.
