COVID-19 And Beyond: How FDA Commissioner Hahn Can Immediately Speed-Up Medical Discovery With A Simple Stroke Of His Pen By Creating A Two-Tier System

WESTFIELD, N.J., April 24, 2020 /PRNewswire/ -- Congress made welcomed legislative attempts in the past to increase medical discovery such as enacting the Orphan Drug and Translational Research Acts, but they are very limited in scope; and the same holds true with, due to the COVID-19 pandemic, the Administration's new rules regarding relaxation of regulations to enter clinical trials in national emergency situations.

The good news is that the pandemic and associated national pandemic fear generated by COVID-19 has created a general awareness and wake-up call for the urgent need to significantly reduce the barriers for volunteers to enter promising clinical studies. But there is no practical doable, effective and speedy way yet offered except that proposed in Dr. DeFelice's book that physicians be permitted to volunteer for clinical research studies much more easily than others. Who would object? More potential therapies would be tested and, pari passu, more breakthrough therapies and cures discovered. He then coined the term, "doctornauts", to describe such altruistic physicians.

In his first book, Drug Discovery: The Pending Crisis, published in 1972, physician Stephen L. DeFelice, the founder of FIM, The Foundation for Innovation in Medicine in 1976, correctly predicted that there would be fewer cures in the near future. Ask yourself, "When was the last cure?" The reason? Medical discovery of new therapies can only be discovered in clinical studies. Penicillin and insulin were discovered when administered to patients with bacterial infections or diabetes. For a variety of reasons, such as the thalidomide tragedy, we became excessively concerned with safety, including the exaggerated dangers to volunteers in clinical research but puzzlingly ignoring the value of this critical step. As a result, we established highly costly and risk-averse ponderous rules and regulations which, unnoticed, eliminated our huge reservoir of creative, underfunded physicians and scientists as well as our major research institutions such as our pharmaceutical companies.

This message went unnoticed until Dr. DeFelice met with the physician and then Senate Majority Leader, Bill Frist, who, as a previous researcher, quickly understood the concept and circulated a draft of the Doctornaut Act. Unfortunately, it met with little interest.

But, to repeat, COVID-19 has sparked a dramatic cultural wake-up call to the fundamental role of clinical research in attacking disease. This awakening is fueled by the alarming reality that the only remedy that we had in our medical armamentarium was quarantine; and, due to genetic bioengineering, we can expect more lethal viral and also bacterial pandemics in the near future. One core message is that speed is the key and doctornauts provide that.

To immediately and legally establish doctornauts, FIM proposes a path that the FDA Commissioner and physician, Stephen Hahn, already has authority to implement. He, with a single stroke of his pen, can issue a simple addition to already established regulations which regulatory language is described in the FIM proposal. It creates a Two-Tier system with Institutional Review Boards or IRBs, committees which oversee clinical trials, to help the already swamped FDA created by a single virus. The educational FIM proposal deals with the history and rationale regarding physician volunteers or doctornauts which can be helpful to spur the Commissioner to action.

Now consider the following: if the doctornaut or physician volunteer venture is successful, dramatic medical advances discovered in them can also be readily applied to children with diseases and disabilities. And finally, it will substantially help in reducing health care costs within the near term.

For more information about Dr. DeFelice and FIM, please contact Patricia Park at [email protected] or 908- 233- 2448.

https://fimdefelice.org/covid-19-and-beyond-presents-an-historic-opportunity-for-the-fda-commissioner-to-create-a-two-tier-system-to-accelerate-the-discovery-of-cures-and-breakthrough-therapies-for-diseases-and-disabilities

SOURCE The Foundation for Innovation in Medicine (FIM)