Don't Let Bureaucracy Impede Research for ALS, Says Ethicist

This transcript has been edited for clarity.

Hi. I'm Art Caplan. I'm at the Division of Medical Ethics at the Grossman School of Medicine at NYU in New York City.

Amyotrophic lateral sclerosis (ALS) is a horrible disease. Some of us know it as Lou Gehrig disease, and it involves creeping paralysis, certain death, horrible disability, confinement to a wheelchair, and many people wind up only able to operate a computer screen to message. It is just a miserable disease. People have been trying to find ways to intervene, to fix it, to cure it, and to slow it.

Unfortunately, some patients, families, and some others believe that the biggest obstacle to getting the answer to ALS is the FDA and regulations. They believe that regulations are causing bureaucrats to slow down potentially beneficial interventions.

They believe that regulations and the FDA are indifferent to the suffering of patients, paying more attention to data analysis, wondering more about the certainty with which a particular claimed cure or intervention really can help, and not letting patients who are desperate make or take a risk-benefit choice, given their dire straits, that they are willing to try things and to gamble that something might help them.