The Freedom to Choose Medicine Is a Civil Right

Pandemic policymaking has a sit tight and assess problem. We should empower citizens by ending policies that treat vaccines like Schedule II narcotics

I originally posted this article on Medium in August 2022. It’s good background for next week’s post, which will propose broader legislative strategies

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In the dark satire Don’t Look Up, the President is told there’s a 99.78% chance an approaching comet will wipe out civilization. Rather than taking immediate action to deflect the comet, she declares the information a state secret and decides to do nothing until after the midterm elections. Although the screenplay was originally written as an allegory for climate change, the satire is shockingly applicable to pandemic policymaking.

Just look up!

In the ancient Hippocratic treatise “Of the Epidemics” physicians are advised to “either help or do no harm to the patient.” In the 19th century, the growing realization that bloodletting was dangerous and ineffective led to a stronger medical focus on the problem of inadvertent harm — and the pledge to first try to help regrettably went missing from standard medical oaths. Under the modern harm-avoidance philosophy, if there is insufficient proof of the risks and benefits of a given treatment, then it may be safer to passively accept the status quo until clearer evidence can be found. Although insisting on the highest standards of scientific proof might seem virtuous at first glance, in some situations “cautious” inaction may be like demanding comprehensive documentation for a flotation device before throwing it to a drowning man. Preliminary evidence of the possible risks and likely benefits of various courses of action should be weighed against the risks of refusing to help.

My postdoctoral research was led by the National Cancer Institute scientists who invented the HPV vaccine. When the vaccine first came to market in 2006, I encouraged all my loved ones to ask for it at their next physical. Most of them expressed a willingness to pay for the vaccine out of pocket. Anyone who didn’t meet arbitrary age and gender recommendations was denied the vaccine, based on the rationale that there was insufficient proof it would help. One family member developed HPV-induced anal cancer in 2019. Without diving too far into the murky realms of molecular virology, it’s scientifically reasonable to imagine that receiving the HPV vaccine would have prevented the HPV-induced cancer. Although I didn’t recognize it in 2006, denying the right to choose a safe and effective medicine — supposedly for my relative’s own good — now strikes me as morally indefensible. Wrestling with the ethically challenging hindsight primed me recognize a similar pattern of botched paternalism unfolding over and over again during the course of the Covid pandemic.

In the summer of 2021, I found myself in my relative’s shoes when preliminary evidence convinced me a better safe than sick third dose of Covid vaccine might be helpful. I knew expiring vaccine doses were being discarded across the country, so I lied to a provider to divert the safe and potentially effective medicine away from the landfill and into my arm. It took a huge amount of effort to convince my friends and family that lying to healthcare providers to get a third dose was the moral and proper thing to do at the time. One friend declined to lie and then caught Covid during the Delta wave. With hindsight, it’s clear that the third dose would have offered my friend a good chance of resistance against Delta. Denying honest Americans third doses is what I thought about while watching the sit tight and assess scene in Don’t Look Up.

Since the beginning of the pandemic, it has been clear that SARS-CoV-2 testing is a key weapon in our fight against the virus. In the first months of the pandemic, friends of mine at a small biotech company called Aperiomics heroically pivoted their business model to develop one of the first commercial Covid test kits. I was surprised to learn that only a physician would be allowed to collect the kit’s simple throat swab. For reasons that have not been made public, the requirement for physician supervision of Covid testing was eventually abandoned. Meanwhile, Aperiomics went bankrupt.

In the past couple months, many of my friends, family, and colleagues caught Covid. I’ve urged everybody to consider the widely available antiviral drug Paxlovid. Nearly all my friends were denied Paxlovid because they didn’t meet arcane eligibility requirements. After a day and a half of bureaucratic struggle, one friend joked that he considered taking up smoking but then decided it would be easier to get the medicine he needed by lying about his body weight — thereby enabling the healthcare worker carrying out his mandatory $40 tele-health pre-screening to wink, nod, and arbitrarily check the “obese” box. A loved one with brain cancer recently caught Covid and was denied Paxlovid because brain cancer isn’t an officially designated high-risk category for Covid complications - even though Covid is known to cause immunosuppression and certain types of brain cancer are known to progress more rapidly in immunosuppressed individuals, such as people living with HIV. [Update: my cousin didn’t survive as long as the average HIV-positive person does.] At about the same time my friends and family were being denied Paxlovid, Tony Fauci wisely chose to try a second five-day course of the drug for the off-label goal of treating Covid rebound.

My lab is leading the development of a vaccine against a group of cancer-causing viruses called polyomaviruses. The polyomavirus vaccine is designed to protect organ transplant patients against kidney and bladder damage. In parallel, our current work has been helping to reinforce the emerging idea that HPVs and polyomaviruses can cause bladder cancer. If the polyomavirus vaccine proves safe in clinical trials, I would be interested in taking it because it might offer me some protection against a common form of cancer. Unfortunately, the same regulatory framework that denied my family the HPV vaccine and Paxlovid will presumably deny me the polyomavirus vaccine I’m helping develop because it will only be approved for use in transplant patients.

How did we slide into these “first do no help” public policy traps? In my experience as a civil servant, I’ve noticed that institutional committees tend to spend an inordinate amount of time worrying about the possibility of attracting near-term blame for authorizing unproven approaches while worrying too little about the possible long-term consequences of passively accepting the status quo in the face of a looming calamity. There’s also a general reluctance to publicly confess scientific uncertainty, based on the mistaken belief that issuing categorical guidance will avoid public confusion and help preserve institutional trustworthiness. This is faulty thinking. Public health agencies aren’t chartered to be infallible oracles of absolute truth — and government agencies are currently suffering massive reputational damage for “cautiously” refusing to take action, for a lack of transparency about areas of scientific uncertainty, and for unilaterally denying access to “unproven” medicines that turned out to be lifesaving.

Error-prone regulatory bureaucracies could be subjected to a democratic check-and-balance simply by more clearly acknowledging individual freedom of choice. Safe and potentially effective medicines could simply be made available for consumer purchase on demand. Some consumers would undoubtedly ignore known risks and might use on-demand medicines unwisely. We need look no further than the complex cases of ivermectin, over-the-counter Tylenol, marijuana, and alcohol to see the potential dangers. But the fact that some people might behave foolishly is not a reasonable justification for abridging everybody’s right to make informed choices about which medicines we put in our own bodies.

Our country’s founding documents declare that it’s better to risk erring on the side of too much individual liberty rather than risk drifting into unchecked authoritarianism. During the pandemic, regulations that denied my friends and family access to safe, authorized, widely available, potentially effective, non-psychoactive, and non-addictive medicines drifted into death-by-inaction paternalism. It’s time to recognize the individual freedom to choose medicines as a basic civil right.