The race to develop the first Covid-19 vaccine is on! In some ways, it’s like the dog team relay sometimes called the “race of mercy”. In 1920, the people of Nome, Alaska were stricken with diphtheria. A supply of life-saving serum was hundreds of miles away. Teams of sled dogs ran in high winds and -50 F. temperatures to get the serum to Nome. Six days, 20 sled-mushers, 700 miles. This feat inspired the Iditarod, the famous Alaskan sled dog race that continues to this day.
(Priscilla du Preez, Unsplash)
With the Covid-19 vaccine effort, we are still racing against the odds, struggling against the equivalent of fifty degrees below zero. The sobering facts are that only six percent of vaccine projects succeed. In the world of vaccine development, ten years is considered a speed record. We’re not guaranteed success; a Covid-19 vaccine that works is as yet a hope and a prayer. The Trump administration has created “Operation Warp Speed”, whose goal is to have 300 million doses of vaccine ready for the U.S. come January.
A few days ago, two ethicists – one a professor of philosophy and the other of bioethics – published an op-ed in the Washington Post entitled “Pandemic Ethics: The case for experiments in human volunteers.” Their essay begins: “The pandemic has thrown previous moral assumptions into disarray.”
Let’s put speed aside for a moment and consider American-style “previous moral assumptions”. Through much of the 20th century, Americans had a tug of war going on about the ethics of medical experimentation. On the “let’s not abuse human beings” side, we have the Hippocratic Oath, the Nuremberg Code (1947), the Declaration of Helsinki (1964), and the Belmont Report (1979), all intended to protect vulnerable human subjects from harmful exploitation. The 20th century codes contain detailed guidelines about how to conduct research as safely as possible. The National Institutes of Health tells researchers: “Our society values the rights and welfare of individuals. It is not considered ethical behavior to use individuals solely as means to an end.”
On the other side, we have our checkered history of eugenics-related legislation and widespread exploitation of prisoners, the disabled, people living in state institutions, and people of color as subjects of medical experiments. A remarkable amount of harm was done by the federal government and justified by Cold War ideology. Substances used ranged from radiation to pathogenic bacteria to LSD. Up until the 1970s, when the Tuskegee syphilis experiment provoked national outrage, those in power felt fairly free to exploit those who lacked it.
Fast forward to now. The Washington Post writers state that current medical research ethics prohibit “exposing human subjects to significant risk”. In reality, ethical precepts are one thing, and actual practice is another. Phase I drug and device clinical trials – even when they follow in the wake of lab animal trials – do sometimes expose human subjects to significant risk. That’s because we can’t establish safety until we’ve tested something on humans, which is what Phase I trials do. Much of the time, animals are not effective proxies for humans, and scrutiny of research on animals often reveals poor scientific methodology. There’s no such thing as perfectly safe interventional clinical trials.
To add to the issue of imperfect safety for vaccine trial participants, there is a debate in the media right now about whether we should follow our usual safety protocols or whether we should take emergency measures instead. Many people are arguing that we have to speed things up, take more risks, and forego some of our usual protections of human subjects because of the dire need and the vast potential benefits.
The normal way to do vaccine clinical trials takes years. Let’s call it the slow way. Researchers spend years developing vaccine candidates in the lab, test them on animals, and then compare human volunteers (experimental arm of the trial) to unvaccinated controls (who may get a placebo). Both groups, for it to be a true experiment, would need to be living with the same degree of risk.
Then there’s the fast way. There’s a new organization called “1 Day Sooner”, for people who want to volunteer themselves as guinea pigs for experimental Covid-19 vaccine testing. They want to volunteer to be infected with Covid-19 so experimental vaccines can be moved through the process as quickly as possible. This is known as a challenge study – you challenge your body with the actual disease and see if the vaccine or treatment can prevent or cure. There’s a lovely spirit behind this effort, for which thousands from all over the world have signed up on a website, but it exposes thorny issues.
An ethical question immediately arises: can volunteers give true informed consent for such an experiment, especially since we know that even young, healthy people can die from Covid-19 or suffer complications such as respiratory failure and strokes caused by blood clots? We don’t even know what long-term – perhaps permanent – organ damage may result in survivors of the virus.
In addition, challenge studies are traditionally carried out when the disease is self-limited or there is effective treatment available, so the life of the volunteer can be saved. We don’t have that condition met for Covid-19. Is your conscience at ease letting volunteers risk their lives in this way? If you say yes, you are part of a long tradition. Historically, when it comes to drug and medical device safety and efficacy research, the majority of us have benefitted from the sacrifice of the few. To make the question harder, would you be okay with your child or mate being intentionally infected with the virus in order to test an experimental vaccine?
Another ethical rub: informed consent. Some ethicists argue that healthy challenge study volunteers can be “fully informed” about the risks of research and, since they sincerely want to help fight the pandemic, we should let them. This argument has been used for a long time in our country to abuse the vulnerable. There is sobering research on how often people giving “informed consent” misunderstand the risks, misconceive their odds of being benefitted, and may even feel pressured to participate.
Vaccine developers in the U.S. worry the Covid-19 pandemic might subside and they won’t have a ready supply of people to experimentally vaccinate in a hotspot of infection. And if they don’t have that, how will they get quick and helpful results?
Here’s my proposed solution: global cooperation. There is every likelihood that there will continue to be hotspots of infection around the world until we get a reliable vaccine in place. If we test vaccines where they are most urgently needed internationally, we won’t need to ask for challenge study volunteers. We’ll have volunteers either here or abroad who are already at substantial risk of getting sick with the virus and we’ll be able to study results in various living laboratories. Of course, this approach requires cooperation and agility, but we’re good at that.
As part of the testing effort, the successful vaccine developer needs to make the vaccine available and affordable to people and nations who need it most. This is exactly what global consortiums such as the Center for Epidemic Preparedness Innovation (CEPI) and members of the G20 are planning. It is short-sighted to opt out, as the U.S. federal government is doing. Do we really want to run the Iditarod all by ourselves? Or do we want to join a pool of teams that plan to share the prize if any of them wins the race?
