In1717, Lady Mary Montagu was living in Turkey as the wife of the British ambassador. There, she witnessed Turkish women practicing variolation, a method of smallpox inoculation that involved transferring fluid from an infected person’s smallpox pustules into an uninfected person’s open wound. Though the practice was common throughout Africa and Asia, it was uncommon in Europe. Before moving to Turkey, Lady Montagu was disfigured by smallpox, and the disease killed her brother. When she learned that she could potentially prevent her young son from suffering the same fate, she had him inoculated before she traveled back to England. A few years later, she inoculated her daughter as well.
Upon learning about variolation, Lady Montagu wrote,
I am patriot enough to take pains to bring this useful invention into fashion in England; and I should not fail to write to some of our doctors very particularly about it, if I knew any one of them that I thought had virtue enough to destroy such a considerable branch of their revenue for the good of mankind.
She then persuaded British royals to further test the safety of inoculation and to inoculate their children. This further promoted the practice of variolation. Variolation was widely practiced by the end of the eighteenth century, and Lady Montagu’s advocacy for the practice helped lay the scientific groundwork for the development of a smallpox vaccine.
Smallpox was one of the deadliest, most harmful diseases in human history, but it was eradicated through a worldwide vaccination program. No one has naturally contracted smallpox since the 1970s.
Since Lady Montagu’s time, citizen scientists have continued to contribute to medical advances outside of the conventional pathways of industry and academia. For example, in the 1980s AIDS activists and citizen scientists contributed to the development of better treatments for the disease. And patients and parents who suffer from rare diseases also develop and advocate for innovative new therapies when few others do.
Today we face a new pandemic. Though COVID-19 is not nearly as deadly as smallpox (which killed 30% of people who were infected) it has already infected about 22.6 million people worldwide and killed about 800,000. And as in the case of smallpox, a vaccine is necessary to stop COVID-19’s destructive effects in the long-term.
Today, some large pharmaceutical companies are developing a COVID-19 vaccine and conducting clinical trials. But the FDA has not yet approved a vaccine for public use, and there is very little information available to the public about how to manufacture or administer a COVID-19 vaccine.
In the absence of publicly available information about how to prevent the transmission of COVID-19, some citizen scientists are following Lady Montagu’s lead and participating in vaccine R&D and production outside of conventional pathways. Like Lady Montagu, these tactics are controversial, and established medical gatekeepers may be wary of DIY approaches to public health during a global pandemic. On the other hand, every month of delay in the development of a vaccine is a month that people suffer and die of COVID-19. If citizen scientists produce useful medical knowledge or promote more widespread access to information about COVID-19 prevention, they could speed the development of an effective COVID-19 vaccine and potentially save lives.
Consider, for example, the non-profit organization RaDVaC, comprised of citizen scientists who are developing a COVID-19 vaccine outside of existing commercial and regulatory pathways. Members of RaDVaC do not file patents and their work is all shared under open licenses. Their goal is to develop an intranasal vaccine that anyone with the technical knowledge to follow the instructions can produce and self-administer.
One advantage of RaDVaC’s approach is that they are not subject to the same regulatory barriers and delays that slow the pace of commercial vaccine development. The RaDVaC group did not seek IRB approval or FDA permission to distribute information about a COVID-19 vaccine, and because they do not themselves manufacture, sell, or administer vaccines they are beyond the FDA’s jurisdiction.
Skeptics of citizen science may worry that medical research that develops outside the traditional pathway is unsafe. But many of the citizen scientists at RaDVaC are trained scientists, some of whom work or have worked for biotech companies. And delaying access to information and innovation that could prevent the transmission of COVID-19 is dangerous too.
In any case, the claim that DIY COVID-19 vaccine development is unsafe is not a scientific claim. It is a moral claim. To say that using a DIY vaccine is unsafe is to say that the risks exceed the benefits. But regulators at the FDA are not in the best position to judge whether the risks of using a DIY vaccine exceed the benefits — vaccine users are. Many people may judge that they lack the scientific knowledge to make a competent decision about self-administering a homemade vaccine, so they might either refrain from taking the vaccine or they might consult a trusted advisor to better understand the risk. But others may judge that they are capable of assessing the risks, and they may further decide that the risks of remaining unvaccinated exceed the risks of a vaccine. For people in this position, self-administering a DIY vaccine may be the safer choice.
Another concern about citizen science is that distributing or testing an unapproved vaccine is unethical because people cannot consent to the risks associated with treatment if they do not know about the risks and potential side effects. This worry was plausible during Lady Montagu’s time when the earliest European tests of variolation were conducted on children and prisoners. But citizen scientists today only distribute untested treatments to willing adults who are informed of the risks and capable of consenting to the potential benefits. Moreover, if people were unable to consent to the risks associated with using a DIY COVID-19 vaccine, due to a lack of information, then tens of thousands of patients each year would also be unable to give meaningful consent to participate in a registered clinical trial. After all, commercial researchers also lack comprehensive information about the safety and efficacy of their products during the testing stage, which is why they perform tests.
When eighteenth-century Europeans first learned about variolation and people more widely accepted the practice, physicians sought to limit access to the procedure and knowledge of the procedure. Often, physicians performed the procedure with worse results than the Turkish women that Lady Montagu witnessed because they paired it with bloodletting or because they used an inferior technique. Additionally, limiting people’s access to variolation and knowledge of variolation prevented it from being more widely adopted. In this way, institutional gatekeepers undermined public health because they had professional incentives to limit access to preventative care.
Today, regulatory and professional gatekeeping can also cost lives, either by imposing unnecessary delays or by impeding the free and open sharing of scientific knowledge and technology. In these circumstances, it’s a mistake to only focus on the risks of using new technology, we must also consider the risks of delay.