The GOP nominee for president has been talking about the burden of regulations on business, and screamed about the four thousand plus drugs that are currently undergoing the regulatory mandated clinical trial process. He has a simplistic view that if these drugs were sped through a simpler process this would in some way save lives. How does he know?
How does he know that these drugs are going to do what is hoped? How can he know that a new cancer drug won’t actually have some dramatic unexpected effect that could make the situation worse? How does he know that fixing one symptom won’t create other deadly symptoms for the patient, or worse for other people?
Does he understand the historical record of drugs that created unexpected (unintended) consequences, some of which were horrific?
Does he understand the historical record of drugs that had absolutely no effect, but were marketed as cures for everything, causing people to die earlier or less comfortably than they otherwise would have?
The answer (of course) is that he doesn’t know these things, but does know that people desperate for new drugs to help terminal or painful conditions may vote for a candidate who creates fear of regulations.
He also knows that drug companies looking to reduce their costs of development (and their costs of indemnification) would in some cases love to see the time required to meet regulations reduced.
Reducing costs is a good idea, but not by removing scientific rigor.
There are no simple answers to complex questions, history has shown that people who promote simple one dimensional answers are always dangerously wrong.
The science being done today in the fields of medicine and food creation are incredible. The knowledge that scientists have curated on how the mechanisms of life work has opened up entirely new avenues of research that is leading to incredibly complex solutions to previously untreatable conditions. But there is always a “but”. How do we know for sure that one change, or a series of changes that a treatment makes won’t create a situation that will be dangerous in other ways. The answer is we need to be very careful. Being careful means agreeing on a rigorous scientific process to confirm the validity of an idea through careful peer reviewable testing that always errs on the side of doubt. That is exactly what todays regulations aim to do.
The regulatory bodies in existence are always looking to improve their processes, but improving the rigor, efficiency or effectiveness of a scientific process, does not mean reducing regulations.
The scientific process may seem frustrating, but a non-scientific process is not just dangerous it’s would also be vastly less effective.