Big Bad Pharma, the FDA, and the reasons why a new Alzheimer’s drug should never have been approved.
The recent approval by the US Food and Drug Administration of the first treatment for Alzheimer’s disease in over 20 years has generated significant controversy. The approval went ahead despite ten of the eleven members of an independent advisory committee voting not to approve the drug. Subsequently, three of the committee members have resigned, with one member calling the FDA move “probably the worst drug approval decision in recent US history”. So why did the FDA approve an expensive drug that probably doesn’t prevent or slow cognitive decline? And why did they work so closely with the pharmaceutical company to re-examine the data after the trials were deemed failures? Rachael look at the evidence and provides an explanation as to why so many therapies for neurodegenerative diseases have failed.
“Dr Rachie” is a senior research fellow at Brain Chemistry Labs in Jackson, Wyoming. Her current work focuses on L-serine as a therapy in neurodegenerative diseases, with particular focus on understanding the mechanisms of L-serine neuroprotection. Her team’s discovery of L-serine as a neuroprotective agent fast-tracked the treatment from the bench to the bedside where two FDA-approved clinical trials for Alzheimer’s and ALS are currently being conducted. She is also pursuing a blood-biomarker for the diagnosis of ALS. As an ex-graphic designer and copywriter, Rachael enjoys combining her love of science, art and social media as a means of communicating science to the public. She is also a keen photographer and spends her spare time in adjacent Grand Teton and Yellowstone National Parks.