The history of progress is a history of setting up systems where there are incentives to invent and produce products and services, clean the environment, and be just with our fellow humans. Failed societies occur when incentives are maladaptive. Where there is no incentive to produce, we get Third World poverty. Where there is no incentive to protect the environment, we get mega-disasters like the destruction of the Aral Sea.
Unfortunately, the U.S. medical and public health system has a lot of built-in bad incentives. The FDA is forced to declare treatments “safe” and approved or “not safe.” That’s not how reality works. There are different levels of certainty for every drug, vaccine or gene therapy, and the probabilities are constantly changing. And they work differently on different people. Many therapies work well on some patients but can harm others. The current approve-or-ban process allows for no nuance.
At the beginning of the coronavirus pandemic, the FDA banned all hospitals, even the highest-tier research institutions such as Mayo Clinic and John Hopkins, from using their own PCR labs or commercial PCR tests until February 29th, 2020. Everyone was forced to use the CDC-produced PCR test, which didn’t work. This one order could have devastated the U.S. population, had SARS-CoV-2 turned out to be as bad as smallpox. Fortunately, Dr. Chu in Washington state broke the rules and used her own lab’s test to detect the coronavirus entering the country. But depending on someone risking their career is hardly a good system.
This is not to say we don’t need drug safety and PCR-test effectiveness information. Obviously, it is critical. But there is a categorical difference between “information” and “we’re shutting down all the experts until we can think of more orders to give.” Doctors and hospitals can be trusted to try to give their patients good treatment. Their incentives are far more closely aligned with patients than revolving-door bureaucracies that are always integrated with the industries that they regulate.
Another incentive issue related to the incestuous relations between regulators and industry is that treatments are biased toward newer and therefore profitable drugs. This is the opposite of the logical bias, doctors should (and do, when they can) prefer older, more studied chemicals, preferably ones that cells already know how to process. But the financial incentives work against this.
Here’s an example. Remdesivir was pushed into approval by the FDA in October 2020, only a month before the WHO recommended against using Remdesivir at all. Unfortunately, the WHO has been proved correct, in spite of promising preclinical studies — Remdesivir has little effect on coronavirus in patients.
But when there are conclusive results from non-pharma molecules, our system ignores them. A Phase 3 trial in Istanbul by the Swedish Scandi Bio corporation reported in February that they had reduced recovery time in COVID-19 cases by 36%. Their protocol uses four natural nutrient molecules (l-serine, N-acetyl-l-cysteine, nicotinamide riboside, and l-carnitine tartrate). The peer-reviewed paper on the results was published in June.
The Turkish regulatory agency has taken the Scandi Bio protocol into their approval process, and hopefully in a few months Turkey and then the EU will be using these supplements to prevent and mitigate COVID-19 cases. The FDA response was to force GNC and other companies to pull N-acetyl-cysteine off U.S. retail shelves.
The Swedes designed their protocol using results from preclinical experiments done at University of Iowa in April 2020. How is it that U.S. doctors are banned from using U.S. science? There are two U.S.-based human trials now using nicotinamide riboside vs. coronavirus, one on “long COVID” in Boston and another on coronavirus kidney damage. But it will be years before U.S. patients can use these safe supplement treatments in hospitals.
Even the very successful mRNA vaccines suffered. Vaccine companies weren’t allowed to pay incentives for the highest-risk (and representative of the population) subjects to be in trials. They had to take whatever volunteers they got. The Pfizer Phase 3 trial only found 96 virus cases out of 35,000 (mostly white and female) volunteers and the trials lasted most of the year. Imagine if vaccine trials had been done in hot-zone nursing home staff and patients. They would have had enough cases for statistical validity in a month. Vaccination might have started in mid-2020.
It’s time to rethink our incentive systems in medicine and public health. We need to allow doctors, research hospitals and biotech companies to use all their expertise, especially in emergencies. The FDA’s role should be to provide information, not to shut down the parts of our system that have better-aligned incentives.
(Bill Walker recently retired from medical-imaging database company M2S to spend his time following advances in biotechnology. Previously he worked as a research technician at UTSW and Mayo Clinic Rochester. He lives in Plainfield.)