I’m Dying of a Disease That’s Not COVID. It Needs Urgency, Too.May 6, 2020
In the fight against COVID-19, the National Institutes of Health, the Food and Drug Administration and the biopharmaceutical industry have joined together to speed experimental drugs through the regulatory pathway. This collaboration and approval process on steroids is not normal. It is instead the result of the huge political and social pressure that this pandemic unleashed.
While it may not have been normal before, it is exactly what we should be doing to prevent the next pandemic—and to save the lives of millions of Americans living with terminal illnesses.
The normal regulatory process today is what I have lived as a patient with a 100 percent terminal disease, Amyotrophic Lateral Sclerosis (ALS), who has been waiting more than two years to get access to a single experimental drug. Normal is bureaucratic rules, regulations and red tape that tie us in knots while grinding progress to a frustrating halt.
Today, there are over 430 clinical trials for COVID-19—all launched within four months—and more than 75 are already in Phase III, which is considered by FDA to be the final trial needed before a treatment can be approved. A number of these trials plan to be completed this year, meaning they will have gone from start to finish in less than eight months.