By Andy Xu (PO ’24)
The Race for a Vaccine
Imagine you’re asked to be among one of the first recipients of the FDA approved COVID-19 vaccine. You might consider refusing and, as of now, that decision wouldn’t be uncommon. In fact, over two-thirds of Americans say that they intend to forgo such a vaccine in its early stages of release. The findings suggest a growing mistrust of the Trump administration’s attempt to expedite vaccine development. In addition, they amplify an already growing contingent of Americans who scorn immunizations of any kind. Simply put, the research and deployment of a conventional vaccine won’t be easy.
That’s where fringe groups like the Rapid Deployment Vaccine Collaborative––or RaDVac––come in. Unlike Pfizer and Moderna, two large pharmaceutical companies, RaDVac isn’t benefiting from federal investments like Operation Warp Speed, a public-private partnership created by the Trump administration to allocate billions of dollars towards vaccine research. Instead, it’s origins as an example of citizen science (public participation in scientific research) are more humble. RaDVac began with just four researchers: Preston Estep, Don Wang, Alex Hoekstra, and Ranjan Ahuja. Since then, over 40 listed collaborators have joined them, including Harvard geneticist George Church. Unhampered by ethical review panels, board meetings, shareholder concerns, or FDA oversight, the team represents an unconventional party in the race for a vaccine.
Remarkably, it appears that RaDVaC’s efforts have actually come to fruition. Since July, the group has been regularly updating its summarized findings along with instructions on how to produce its nasal spray vaccine prototype yourself. One specific research strategy, however, has put RaDVac into the spotlight: self-experimentation.
A History of Self-Experimentation
A glance at history yields several biomedical advancements stemming from scientists willing to risk it all. In fact, 12 researchers have won Nobel Prizes for work conducted with the aid of self-experimentation.
The most recent of such recipients, Barry Marshall (2005), willingly ingested a Helicobacter culture to demonstrate its ability to cause gastrointestinal disease.
Werner Forssman, a German physician awarded a Nobel for pioneering cardiac catheterization, placed himself under local anesthesia and successfully inserted a catheter into his own heart (he survived).
Charles Nicolle’s Nobel journey saw him combine the blood of recovered typhus patients with lice, a suspected transmitter of the illness, to (unsuccessfully) produce a typhus inoculation.
There is a historical context to this kind of experimental risk-taking, one that the scientific community has even rewarded. With COVID-19, the stakes are even higher. Unlike Marshall, for instance, RaDVaC scientists are not trying to produce scientific discoveries, they’re trying to save lives. That said, what is the FDA doing to oversee that lifesaving?
A Look at What Food and Drug (FDA) Regulations Exist
Although RaDVac has explicitly stated that it’s not anti-FDA, that doesn’t mean that their relationship should be under any less scrutiny. Currently, FDA jurisdiction doesn’t prohibit individuals from inhaling the prototype vaccine, nor does it frown upon the open sharing of DIY vaccine research. Moreover, RaDVac contends that it has duly disclosed the risks and side effects of its prototype while ensuring consent from all of its participating scientists.
Nevertheless, the consequences of initiatives like RaDVac can be significant. At the most basic level, individuals risk getting sick if they incorrectly prepare a DIY vaccine. Also, those who partake in untested vaccinations are often disqualified from being test subjects for actual potential vaccines developed by pharmaceutical companies. Worse, the bifurcation of vaccine development into formal and informal channels poses a serious risk to the public perception of such inoculations.
Suppose, for example, that a bevy of health issues are linked to the premature usage of a single DIY vaccine. If society increasingly adopt such vaccines into the fold of accepted research and development, such a hypothetical would harm the legitimacy of all vaccines––conventional and unconventional. Granted, this wouldn’t be a problem if RaDVaC, and companies like it, had to endure a comparable process of ethical review and rigorous testing. As the distinction between conventional and unconventional suggests, they unfortunately don’t.
That said, there are steps that the FDA can take to adopt a proactive approach towards citizen science. First, the FDA can be unequivocal in its jurisdiction over any and all vaccine research, manufacturing, and deployment efforts (including that of groups like RaDVaC). This would greenlight a simple, yet effective punitive measure: criminal fines. After all, unregulated DIY vaccines typically emerge from individuals or groups who don’t represent large pharmaceuticals. Thus, the threat of paying up big time can be especially effective in ensuring compliance.
Now, none of this is to say that citizen science should be completely abandoned. As RaDVaC likes to point out, they’ve shared all their findings online so that anyone can learn from them (that includes researchers all around the world). This highlights the opportunity of shared knowledge, transparency that citizen scientists actually pride themselves on. Therefore, a better tack would be for the FDA to channel the potential of these researchers towards their mutual aims: a workable vaccine. As the Harvard Medical School roots of RaDVaC imply, there are legitimate citizen scientists with extensive experience. This proactive stance is the most appealing; it not only ameliorates the issues of citizen science altogether, but also engenders collaborations that benefit society.
Past Attempts to Guide the Ethics of Research
Ethically speaking, self-experimentation lies in an opaque state. A big reason is that many ethics offices simply don’t have an exact policy. In a survey of North American universities and national health services, seventeen of twenty-five respondents admitted that they had no guidelines whatsoever for self-experimentation.
Even the Hippocratic Oath (c. 5th-century B.C.E), perhaps the oldest and most famous ethical pledge, speaks little of the topic. Let’s refer to the 1964 edition (written by Louis Lasagna) that is commonly used by medical schools today.
One line espouses the following: “I will respect the hard-won scientific gains of those physicians in whose steps I walk.”
Another demands that physicians promise to “prevent disease whenever [possible].”
Unfortunately, in our context, the two appear diametrically opposed. Does respecting “hard-won scientific gains” mean avoiding informal biomedical research, research that contradicts the rigorous standards of those fruitful gains? If so, then that is seemingly at odds with “preventing disease” whenever possible because it discontinues projects like RaDVaC that aim to prevent COVID-19 transmission.
The Nuremberg Code (1947), perhaps, holds the answer. It was created in response to the absolute cruelty and exploitation of concentration camp prisoners at the hands of Nazi scientists.
The only pertinent point to our discussion is number five: “No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur, except, perhaps, in those experiments where the experimental physicians also serve as subjects.”
The “except” is a crucial modifier––it implies conditional support for consensual self-experimentation. The definitive nature of this implication is short lived, however, when considered in conjunction with the troublesome interpretation of the Hippocratic Oath.
The Helsinki Declaration (1964) and Good Clinical Practices (1996) followed suit. Unfortunately, both mainly codified and, in some instances, merely encouraged ethical review boards to revisit the Nuremberg Code, a set of principles already unhelpful concerning the topic at hand.
In essence, although a veritable collection of ethical considerations do exist, they fall short in dealing with self-experimentation. One may argue that this is simply because the practice hasn’t been too common, and they would be right. A National Center for Biotechnology Information (NCBI) study found just 465 documented instances over the last two centuries (and eight deaths). However, the incidence of something happening is arguably immaterial when the consequences involve injury or death.
Media speculation around RaDVaC speaks to the glimmer of hope it provides amid uncertainty. Unfortunately, hope is not a plan, but neither is a lack of regulations combined with outdated (or even absent) ethical considerations.
This conclusion was reached by introducing RaDVaC and its reliance upon self-experimentation. Next, an overview of how scientists have long subjected their own bodies to said practice followed suit. That led to observations about the practice today, its dangerous lack of regulatory oversight, and potential ways FDA supervision can be employed. Additionally, the ethical considerations are still not well-defined, with existing policy and precedent leaving plenty of room for interpretation.
Joseph Salk––developer of the polio vaccine––famously tested the prototype on himself and his family. He declared that “It [was] safe, and you can’t get safer than safe.” With polio nearing eradication, Salk has a lot to be proud of. Nevertheless, citizen science is here to stay. That means momentous achievements like Salk’s will inevitably be met by mistakes, mistakes that international regulators and the FDA should be prepared to face.