The Bioethics of DIY Vaccine Projects: The Case of Radvac
Abstract: The public’s trust in science, and in particular in the vaccines produced by science, is troublingly low. Much of this lack of trust is the result of doubts about the integrity of the conventional path to medical treatment development and approval. In “The Danger of DIY Vaccines”, Caplan and Bateman-House sharply criticize Radvac (Rapid Deployment Vaccine Collaborative), a citizen-science SARS-CoV-2 vaccine initiative, on the grounds that it deviates in significant ways from a conventional treatment development path. Yet by adopting an unconventional approach, one that involves openly sharing all aspects of the vaccine design with the public, along with initial, if still tentative data from their own self-experimentation, Radvac is likely to increase trust in science. It can do this precisely by overcoming some of the perceived shortcomings of standard paths to medical treatment development, such as financial conflicts of interest and a lack of transparency. To assess bold, unconventional initiatives such as Radvac, bioethicists themselves need to become bold and less wedded to convention.
The current pandemic is the worst peacetime health crisis the world has faced in generations. The entire planet has mobilized to try to solve this crisis, and thus we wake each day to a flurry of new ideas about preventing or treating COVID-19.
Now more than ever, we need public intellectuals – scientists and doctors, but also bioethicists – to help us learn to distinguish useful treatments from dangerous nostrums, whether the proposed remedies are brought forth from within or without the realm of conventional medical treatment development.
One project with a foot outside the realm of conventional medical treatment development methods is Radvac (Rapid Deployment Vaccine Collaborative), a do-it-yourself citizen-science SARS-CoV-2 vaccine effort started by scientists connected to Harvard and MIT.
Science has recently published two articles on Radvac. While I happen to disagree with most of its conclusions, “Self-Experimentation, Ethics, and Regulation of Vaccines”, by Guerrini et al. (1), is a reasonable example of much needed serious analysis. “The Danger of DIY Vaccines”, by Caplan and Bateman-House (2), on the other hand, ultimately comes across as a scholastic vendetta rather than a serious attempt to engage with its stated concern: the public’s relation to science. Here I’ll address Caplan and Bateman-House’s article in some detail.
The thesis of “The Danger of DIY Vaccines” is that trust in science is needed if vaccines, in particular vaccines against SARS-CoV-2, are to prove useful, and that Radvac is an obstacle to establishing this trust.
The evidence adduced for the claims about Radvac is sparse and often factually incorrect, manifests a fundamental misunderstanding of the goals of Radvac, and does nothing to prove the article’s thesis.
First, we have a specious yoking together of Radvac with the goals of an unpopular leader and his “Warp Speed” vaccine program. Nearly everyone, of course, including the Radvac group, would like to see people vaccinated quickly, but beyond that, there aren’t any significant similarities between Radvac and Operation Warp Speed. Indeed, the Radvac team everywhere stresses that their vaccine is highly experimental and will remain so for some time to come, and that caution with the vaccine should be exercised, now and always – however much the vaccine design emphasizes safety above all else. When it comes to claims of actual proven safety, present or imminent, the Radvac effort is thus not even on impulse engines. Vaccines under development under the Warp Speed effort, on the other hand, may or may not be safe, yet many officials connected to Operation Warp Speed seem not to be urging caution about these vaccines at all, but are in fact urging quick approval. Guilt by association with presumptively incautious White House efforts won’t fly here (at any speed).
Then we have a paragraph lamenting the ways in which the Radvac DIY project doesn’t follow the standard procedures of modern clinical trials. The use of different procedures from those of modern trials is of course a feature of any DIY project. In assessing Radvac or any other DIY effort, we must recall that while the notion of “do-it-yourself” experimentation may seem new, “DIY” is simply a new moniker for a very old attempt to establish and adhere to ethical standards, not avoid them. One key, centuries-old standard is: experiment on yourself first before experimenting on others. It should be noted, further, that nowhere do we have evidence that the Radvac group is uninterested in creating, at some later point when the immediate crisis is more under control, a traditional clinical trial to test the vaccine.
The next gripe is particularly puzzling:
The research is rife with conflicts of interest in that those making the vaccine are recruiting friends to try it while promoting their actions in the media. They are not selling their vaccine but stand to benefit from attention in the media and any resulting philanthropic support.
First, no evidence is given that any “recruitment” is taking place. (I know friends of members of the Radvac team who, on the contrary, took the initiative themselves to contact Radvac, and were then told by the group to study the Radvac white paper carefully before even considering taking the vaccine.) Second, when does the possibility of philanthropic support not attend any significant effort to offer help to the world? How can this possibility of media attention and support constitute the basis of a criticism, as opposed to being a universally present, largely benign consequence of interesting philanthropic efforts?
As if connecting Radvac to Trump via Operation Warp Speed wasn’t enough, the authors trot out another issue from the politics of the day, diversity, in an attempt to portray the Radvac team as politically incorrect or insensitive. The suggestion is made that Radvac members are uninterested in the diversity of vaccine users. Despite what Caplan and Bateman-House would have us believe, what characterizes Radvac’s position on diversity is not an absence of concern, but, on the contrary, a stark – and indeed unusual – presence of concern: The Radvac white paper notes explicitly the importance of taking into account ethnic and genetic differences in the design of localized versions of the vaccine. (3) It is also worth pointing out that the core Radvac team is itself ethnically diverse.
The penultimate paragraph of the article goes into the real reasons why the public is skeptical of vaccines, reasons that are of course well known: perceived financial conflicts of interest, a lack of independence of reviewers, and so on. Yet in the paragraph that concludes the piece, where the authors describe their own remedy for the problem of vaccine skepticism, we have what amounts to an injunction to stay the traditional course – but without, somehow, the named unfortunate elements of that course. This recommendation simply states an obvious, already widely affirmed goal. With no ideas presented about how to solve the problems with the status quo of vaccine development and approval, the authors do nothing to contribute to the achievement of a change in that status quo for the better.
Indeed, by not offering any concrete solutions to the ills of the conventional path to vaccine development and approval, but instead simply listing widely affirmed, anodyne notions like “transparent assessments”, “carefully controlled trials”, and “independent experts”, the impression could be given to a skeptical reader that the function, if not purpose of the article is to maintain the status quo, precisely by confirming that nothing revolutionary is needed, just the status quo made “more perfect”.
In sum, yes, we do indeed need to increase trust in science. But we also need to increase trust in public intellectuals, in particular bioethicists, for it is they who can help translate the complicated results of science into concrete, trusted improvements in healthcare.
I fear that “The Danger of DIY Vaccines”, which sinks so low as to call the hard-working, well-intentioned people at Radvac “rogue scientists”, fails doubly: it fails to increase trust in science, but also fails to increase trust in bioethics, by fueling the otherwise generally unjust, though regrettably widespread view that bioethicists are rigid, conventional, at times even mud-slinging, close-minded thinkers whose ultimate role in society is to keep alive the very dysfunctional regulatory apparatus at the root of public distrust of the fruits of medical science.
References and Notes:
1. C. J. Guerrini, J. S. Sherkow, M. N. Meyer, P. J. Zettler. Self-experimentation, ethics, and regulation of vaccines. Science. DOI: 10.1126/science.abe1963
2. The danger of DIY vaccines A. L. Caplan, A. B-H. The danger of DIY vaccines. DOI: 10.1126/science.abe4440.
3. https://radvac.org/white-papers