by Craig Klugman, Ph.D.
Since 1927, the agency now known as the Food and Drug Administration became the federal agency responsible for the safety of food for human consumption, drugs, and therapeutic devices. Started in 1946, the Centers for Disease Control & Prevention opened to fight communicable diseases (starting with malaria) in the U.S. and around the world. Together, these two agencies are among the most respected scientific institutions in the world. At least they were until the last few weeks.
On August 23, FDA commissioner Stephen Hahn announced emergency approval for convalescent plasma as a treatment for COVID-19. This concept is an old one—harvest the plasma of people who have recovered from an infection to capture the T cells and antibodies their bodies created and infuse those into a sick person to give their immune system a jump start on fighting the virus. The problem is that there is very little scientific evidence that this treatment works in COVID-19 patients. On September 1, a panel of NIH scientific experts determined that “There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19…Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19 to support the conclusion of efficacy.”
If science did not support an emergency use approval, then why did Hahn push for it? The answer may be found in the timing of the announcement: The day before the beginning of the Republican National Convention. One of the main criticisms against Mr. Trump has been his lack of response to the pandemic. But with this announcement, Mr. Trump was able to walk on stage and explain that there was “a power therapy” with “an incredible rate of success” that his administration had just approved. However, the science shows that neither part of that statement is valid. While lying and making up statements is nothing new to Mr. Trump, they certainly are new to the FDA. The agency has been criticized for being too friendly to pharmaceutical companies (who often hold powerful positions on agencies and review boards), but decision-making has mostly been based on the science. When the world’s premiere agency for protecting human health can no longer be trusted to undertake its fundamental mission, we are in trouble.
In a similar storyline, on August 24, the CDC changed its testing guidelines: “If you have been in close contact (within 6 feet) of a person with a COVID-19 infection for at least 15 minutes but do not have symptoms: You do not necessarily need a test… If you do not have COVID-19 symptoms and have not been in close contact with someone known to have a COVID-19 infection: You do not need a test… If you are in a high COVID-19 transmission area and have attended a public or private gathering of more than 10 people (without widespread mask wearing or physical distancing): You do not necessarily need a test”. In other words, where the CDC had previously stated that everyone at risk even if asymptomatic (since people can be infected and shedding virus without having any symptoms) should be tested, their new guidance was that that the asymptomatic were not recommended to go for testing. This message flies in the face of the known scientific evidence, but aligns nicely with the President’s RNC speech that the pandemic is no longer a problem. Trump has repeatedly pushed for less testing since he seems to think it is testing that makes the increasing spread real (not the virus spreading). In reality, the pandemic is still a very big problem that is getting worse. This guidance issued against scientific evidence is so problematic that two Nobel laureates are now saying that we have to ignore the CDC and hope the states can take up the mantle.
One of the newest members of the President’s COVID response task force is radiologist Scott Atlas who is advocating that masks may not be helpful, that children cannot infect others with COVID, and that we should pursue a course of herd immunity. None of these are true. Masks are helpful, in fact, essential in preventing spread of the virus. Multiple scientific students have demonstrated how masks and face coverings mitigate the spread of the virus in airborne excretions. Studies also show that children may have higher viral counts in their noses than adults, meaning they can infect just as effectively as adults. The idea behind herd immunity is that when enough people have had the infection and are immune, then the virus will stop because there aren’t enough hosts. This notion has several problems: (1) The evidence that having been infected imparts long term immunity is scarce and some recent cases have shown reinfection in a handful of patients; (2) Epidemiologists hold that herd immunity can only be reached when 58-65% (depending on the calculation) of people have been infected (and survived). In the U.S. (population of 330 million), that would require 191-214 million infections. Even if we consider a conservative death rate of 1% (low end of the range), that would mean 1.9 million to 2.1 million deaths. If the death rate is 2%, then the number is actually double. For no individual, community, or nation is it acceptable to sacrifice 2 million people to further a single person’s political career or to cover up a failure to take effective action.
In all three cases, institutions that we are supposed to trust and that have historically been among the most scientifically sound organizations charged with protecting the nation’s (and often the world’s) health have told lies, mistruths, and unscientific information to support unsubstantiated political statements. If we can’t trust the most trustworthy, then we are in trouble. In the practice of bioethics, we know that “good ethics begins with good facts”. How do we have ethical policy when the facts are denied, distorted, and hidden? We can’t. The result cannot be anything other than unethical responses. In the long term, the destruction of these institutions will have far reaching consequences to damage the quality and reputation of American medical and biological research around the world. Even if a new administration takes over in January 2021, trust will be slow to be earned again because now that the precedence has been established, we can never trust that politics is not driving guidance from these agencies. In the world of bioethics, the worst violation one can make is causing harm to others whether deliberately or for not having the foresight to have seen the high likelihood of harm. This applies in medical care and in research. We have been harmed. This harm will be seen in the increased morbidity and mortality of COVID-19 now, and in future responses to disease and drug approval. When it comes to protecting the nation’s health, protecting the nation’s health is the only primary value. Expediency, convenience, bending facts to one’s will, and scoring political points have no place in science or the practice of health care. Those who do use our lives and our health in these ways have blood on their hands, and there is no getting that spot out.