Category: 2021

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2021 COVID-19 Science

The FDA and Its EUAs

We have learned that science is a method, not a product.  Science begins with an educated guess which is proven true by a series of experiments designed to show that the guess is false.  If the hypothesis cannot be proven false, it is accepted as true by the community of scientists.  Now that we’ve waded up to our armpits in philosophy of science, let’s move back into shallow waters and consider the process by which our FDA approves new drugs, medical devices, and laboratory tests in the United States.

First, I am going to reveal a personal bias.  I believe that the United States has the safest healthcare system in the world for individual patients.  Notice I did not say most efficient, cost effective, or optimized for populations.  But if I am sick or injured, I want my healthcare delivered by U.S. trained doctors in U.S. hospitals using drugs, devices and tests approved by the U.S. FDA.   

The FDA has been disparaged for being too slow to approve new therapies and methods. True enough, the FDA’s priority is not speed.  Instead, the FDA’s mandate is safety.  The FDA conducts a thorough, time-consuming review of all details of science supporting an application for approval, granting approval only after all questions have been answered satisfactorily.  The FDA conducts post-market surveillance of approved drugs, devices and tests, mandating reporting of adverse outcomes.  The FDA’s slow, methodical pace keeps Americans safe.

The FDA does not conduct science.  Rather, the FDA performs quality control for science, validating the logic, analytics and data supporting the claims of products submitted for approval.  Therefore, FDA approval implies a level of trustworthiness akin to science.  But like science, FDA approval takes time.  Time is something we do not have in a pandemic.

Enter the Emergency Use Authorization, known as EUA.  When time is short, the FDA may allow unapproved medical products to be used to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.  All SARS-CoV-2 tests have been made available by EUA.   Convalescent plasma is transfused under EUA.  Antibody treatments for COVID-19 are prescribed under EUA.  Remdesivir, Baricitinib and the their combination are first line treatments for severe COVID-19, available for use by EUA.  And COVID-19 vaccines released by Pfizer and Moderna have been made available by EUA.  None have been approved by the FDA.  The trust conferred by FDA approval should not be transferred to the tests, treatments, or vaccines we are using in the fight against COVID-19.

Are there reasons to believe that the vaccines are safe and effective?  Yes, and good ones too.  But as with any experimental treatment or product, risks of adverse outcomes are elevated.  Individuals must evaluate whether the risks–both known and unknown–are outweighed by the potential benefits of the vaccine. In a recent article published in the New England Journal of Medicine, Dr. Mariana Castells and Dr. Elizabeth Phillips articulately summarize the outstanding questions about the vaccines currently available:

“In the world of Covid-19 and vaccines, many questions remain. What are the correlates of protective immunity after natural infection or vaccination? How long will immunity last? Will widespread immunity limit the spread of the virus in the population? Which component of the vaccine is responsible for allergic reactions? Are some vaccines less likely than others to cause IgE- and non-IgE–mediated reactions? Careful vaccine-safety surveillance over time, paired with elucidation of mechanisms of adverse events across different SARS-CoV-2 vaccine platforms, will be needed to inform a strategic and systematic approach to vaccine safety.”

Some may criticize me for suggesting that the vaccine is not risk-free and that it may be better for some to wait before receiving their shot.  However, honesty is one of the foundational characteristics of science.  We must be willing to follow the data where it leads, even if it leads to a place we do not want to go.  It is dishonest to say that any COVID-19 vaccine has FDA approval; to say that possible adverse effects—short term and long term–have been fully evaluated by the scientific method; to say that the protective immunity imparted by vaccine has been fully studied scientifically; to say that vaccine will alter the course of the pandemic or any infected person’s disease.  I am not saying the vaccines will cause harm, but likewise we cannot say the vaccines will not cause harm.  

The vaccines available now are associated with the risks of the unknown.  For some that risk is worth taking; for others it is not.  Whether you decide to take the vaccine or to wait, keep doing what we know slows the spread of disease: mask up, keep apart, and isolate when exposed.

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2021 COVID-19 Science Vaccine

The Science of COVID

Spoiler alert: This essay contains an unpopular conclusion, and you may disagree.  It’s okay if you do, because you’ll probably be in the company of many of my colleagues who disagree with me too.  Today I’m going to talk about when we can trust science.  To do that, I’m going to pretend to be a scientist and a philosopher.  This is dangerous because, as I have said before, I am neither a scientist nor a philosopher.  Instead, I am a practitioner, applying science to the problems of diagnostic medicine.  As a practitioner, I must know when science is applicable and when it is not.  I know just enough about science and philosophy to be dangerous.

Our experience tells us to trust science, and the explosion of technology during our lifetimes tells us we can.  But science is a process, not a product.  Not everything labelled as science is science.  To understand the difference, let’s consider how science works.

The scientific method begins with a hypothesis.  A hypothesis is just an educated guess about some aspect of reality.  It is proposed by a scientist as a fact of the world, something that can be relied on to be always true within certain conditions.  If the conditions are true, the hypothesis can be used to predict the future and tell us about the past.  

Once formed, the hypothesis is communicated to other scientists, who test the hypothesis by experiment.  The objective of an experiment is not to prove the hypothesis true; rather, the objective of an experiment is to prove the hypothesis false.  If successfully proven false, the hypothesis is rejected.  This is the fate of most hypotheses.  The path of science is littered by the half-truths of discarded hypotheses.  On the other hand, if the hypothesis survives the challenges of repeated experimentation, it becomes elevated by the community of scientists to the status of theory, and its predictions become part of scientific knowledge.  This is a relatively rare phenomenon.  

The falsification objective of the scientific method is a commonly misunderstood aspect of the process, but it is fundamentally important.  It gives science its power over other means of understanding reality, but it also gives science its pace.  It takes time to test hypotheses.  The proof of a hypothesis can be shortened by increasing the number of simultaneous experiments, but only to a point.  Science, like fine wine, requires adequate aging.  

For all its power, the elevation of hypothesis to theory illustrates another weakness of the method: theories are created by scientists.  Scientists are people, and people make mistakes. Scientists have made many.  We can review examples of the most spectacular blunders of scientists later.  The point is that the mistakes of science are the mistakes of people, not fallacies in the method.

So why do we trust science?  Because, despite its flaws and weaknesses, science has increased our understanding of the world exponentially.  But can we be misled by science?  Of course we can, and we are most vulnerable when products labeled as science are not developed with strict adherence to the scientific method.

This brings us to the controversial part.  Most of everything we have learned and developed in the war against COVID-19, including the tests, the treatments, and the vaccines, should not be trusted as science.  In the middle of this emergency, there has not been enough time to fully study the virus and the disease by the scientific method.  Rather, what we have so far are merely hypotheses: the best guesses of the smartest and brightest people in the land.  To be sure, these hypotheses are our best hope in this fight against pandemic, but they should not be labeled science.  There has not been strict adherence to the scientific method.  So, what should we trust, what should we view skeptically, and how can we tell the difference?  We will address these questions next time.