Joe DeRisi is a biochemist at the University of California—San Francisco (UCSF). In the early 2000’s, DeRisi developed a new technology he called the Virochip, which revolutionized the identification of viruses by reducing the time of discovery from months to hours. In his recent book The Premonition, Michael Lewis describes how the invention of the Virochip means we no longer need expert virologists to do extensive lab work with animals to pinpoint viruses. Anyone familiar with the new technology can wash the unidentified genetic material across the glass microscopic slide, which contains the genetic sequences of every known virus, to see how it binds with the matter on the slide. This extraordinary tool was instrumental in identifying the SARS virus in 2003.
Surprisingly, outside of a small circle of clinical colleagues, DeRisi’s innovative chip technology has remained on the periphery of the medical establishment because, as Lewis recounts, the government health bureaucracy has shown little interest in DeRisi’s new technology or how it could advance medical practice. Consequently, DeRisi’s Lab does not have a medical certification from the CDC. This presented an ethical dilemma when DeRisi received a desperate call for help from a neurologist colleague who was treating a teenage boy dying in the ICU from a mysterious brain disorder. It took less than a day for the Virochip to identify the culprit: Leptospira bacteria, which, in rare instances, causes a disease known as leptospirosis.
The good news was that there was a highly effective cure: pennicillin. The bad news was that, because the DeRisi Lab and its innovative technology was not medically certified by the CDC, there was a law that prevented DeRisi from reporting his results to the neurologist.
What would you do? Would you follow the rules and appeal to the CDC, knowing that by the time the agency responded, the boy would be dead, or would you break the rules, knowing for certain that it will save the boy’s life? Real life choices are not always easy.
To resolve his quandary, DeRisi sought the advice of UCSF’’s bioethicist, and after careful thought, he made the decision to tell his colleague what he had found. Within a week of receiving the penicillin, the boy was released from the hospital, fully recovered. Lewis closes the story by relating how the boy was so grateful he sent the DeRisi Lab a video of him walking out of the hospital entitled Hey, you guys, thanks for saving my life.
Sometimes You Have to Break the Rules
The interchange between the key players in this story is interesting because it helps explain anomalies in the current management of the Covid-19 pandemic. For well over a year, we have been engaged in a massive social effort to save the lives of those most vulnerable to the coronavirus. Saving lives is a core mission of the medical profession, and as we saw with the teenager in our story, time is often an unwelcome constraint. Nevertheless, it’s a constraint that’s an everyday reality for front line doctors. The ability to make sound judgments and decisions in right time is the key skill that distinguishes the highly competent front line physician. And, as we see in the story above, highly competent doctors know when to reach out to others for help and they also know sometimes you have to break the rules to save a life.
Breaking rules isn’t easy because it requires courage in the face of risk. Both DeRisi and his neurologist colleague took a risk in relying on a technology that was not certified by the rule maker, the CDC. However, the combination of the certainty of the teen’s impending death and the north star of the medical oath to do no harm provided the clarity for both of these courageous players to do the right thing.
Breaking rules shouldn’t be done lightly. Rules are important because they serve as guideposts for reliable social interaction. Rules are practical tools for maintaining order in complex societies. Imagine how difficult driving would be if there were no rules of the road. But there are times where the rules should be superseded by a higher principle. For example, if a police officer stops a car for speeding and discovers that the driver is rushing his pregnant wife to the hospital because she’s in labor, the officer will almost certainly escort the driver to the hospital rather than write a ticket.
Breaking rules should only be done when you are reasonably sure that it’s the right thing to do and where there’s a clear principle at stake that would be harmed if the rule was followed. In DeRisi’s case, few of us would argue for following a rule that would result in a clearly preventable death, especially if it were your child. The principle of preventing a certain death should always supersede the blind application of bureaucratic rules.
The Rule Making Process Is Not Perfect
Rules serve an important purpose by being focused on doing things right. Accordingly, one of the core responsibilities of the CDC is to make sure we do things right in supporting the safety and efficacy of public health practice across the general population. Given the nature of its mission, the agency often needs time to establish rule making procedures that are deliberate and well-thought out. Rule makers are generally more motivated by a sense of surety than a sense of urgency. That’s why they insist upon a high standard of proof before establishing a rule.
However, despite this disciplined approach, the rule making process is not perfect because rules are usually established by bureaucratic bodies that are inherently biased toward one-size-fits-all guidance. It’s an occupational hazard that goes along with the “50,000 foot view” that is the usual purview of a national agency. From this perspective, rule makers are often blind to the circumstances of individuals on the ground. Their focus is on what they believe is the general welfare for the whole population. This explains how the health bureaucracy became singularly focused on a strategy of total population vaccination as the singular way to manage the pandemic.
Innovation Often Challenges Bureaucracy
For the front line doctors, managing the health of patients inflicted with Covid is an entirely different challenge. They are focused on immediate treatment, which often entails experimenting with the use of existing drugs to see if they can be repurposed. Accordingly, the front line is often where innovation happens in healthcare and, as we saw in the case of Dr. DeRisi and his neurologist colleague, innovation doesn’t always comport with the existing guidance of bureaucrats.
As long as bureaucrats respect the challenges of the front line doctors and are willing to listen and learn from what they are finding on the ground, these two different perspectives can form a symbiotic partnership that expands the expanse of our total knowledge. However, when the bureaucrats dismiss—or worse yet, censor—the innovations emerging from front line practice, the bureaucrats are enabling the inherent blindness that is their occupational hazard. And when they leverage their position to block front line doctors from sharing their knowledge because they want to remain myopically focused on a one-size-fits-all strategy, they are behaving like the officer who would write a speeding ticket for a man driving his wife in labor to the hospital.
The most fundamental principle of medicine is to do no harm. Let’s hope that when this pandemic episode is all over we don’t discover that the CDC’s inattention to treatments and singular focus on vaccinations inadvertently resulted in a higher level of hospitalizations and deaths because the agency thwarted the application of innovative early home treatments that could have arrested the virus in a matter of days for many of those who succumbed to the virus. Only time will tell.
Excellent insight into why the singular focus on vaccinations has been so sticky when complex issues like a pandemic require a broader multi-pronged approach.