The United States of America completely lost control of the COVID-19 pandemic. The wonder drug hydroxychloroquine doesn’t work outside of President Trump’s Twitter feed. No other medicine emerged as a miracle solution, and there is of course no vaccine. Yet, but scientists came up with a clever way to speed up the vaccine research: human challenge trials, i.e. deliberately infecting people with the coronavirus to test experimental vaccines. Even bioethicists and Nobelists are all for it.
US President Donald Trump started the Operation Warp Speed, which consist basically of giving gazillions of dollars to any pharma company making the biggest vaccine promise, because the wannabe dictator would like to approve a coronavirus vaccine soonest, before elections later this year. As it happens, Moderna is one of the race leaders, and their mRNA vaccine already entered phase 3 clinical trial. [Correction 3.02.2022: I was proven to be wrong in the following section, Moderna COVID-19 vaccine does work, and I received it myself.] Which is a bit weird, because even the biggest RNA vaccine enthusiasts admit there is not a single vaccine of this kind available on the medicines market, for no condition. Apparently the logic is: having failed so often with all other diseases, the mRNA-based vaccine must work for the coronavirus because of the statistical probability. Or something like that. Plus, Moderna is a very secretive company with a shady history and a shady founder. Plus their coronavirus vaccine apparently is not entirely convincing and has adverse effects. Yet all this is still nothing compared to what the coronavirus can cause.
And this is what our science elites want to do: infect so-called “human volunteers” with the coronavirus in order to faster test experimental vaccines like those of Moderna. There is an Open Letter, signed by 153 top scientists, including 14 Nobel Prize winners. I admit being a bit later reporting on it, but unlike proper science journalists, I am not ecstatic.
The organizer of the Open Letter is “1Day Sooner“, as the website says “Founded in April 2020, 1Day Sooner is an organization that advocates on behalf of COVID-19 challenge trial volunteers.” No, it is not a union of healthy volunteers who routinely do phase 1 clinical trials, there is no such union. It is a movement fronted by some students with who knows who behind them, recruiting volunteers to human challenge trials with the coronavirus. You don’t even need to confirm your email to get enlisted. It is not clear if any of the already enlisted “volunteers” every participated in a phase 1 clinical trial, and what is even less clear is how serious they mean it. Signing up to things on internet is not the same as entering an actual clinical trial as human volunteer. Normally, such trials are rather safe. But this is about a human coronavirus challenge trial, where your ending up disabled or dead is not a hypothetical, but a very real probability.
The Open Letter is addressed to “Dr. Francis Collins, National Institutes of Health, 9000 Rockville Pike Bldg 10. Bethesda, MD 20892“. This is how it starts:
Challenge Trials for COVID-19
Dear Dr. Collins,
The COVID-19 pandemic must be fought urgently on many fronts, but it is hard to picture robust economic and social recoveries in the absence of a vaccine. We are writing to underscore the vast importance of human challenge trials as a method to help develop vaccines.
In April, thirty-five members of the US House of Representatives called upon U.S. regulators to consider allowing volunteers to be infected with the pandemic coronavirus to speed vaccine testing—in so-called human challenge or controlled infection trials. In addition, over a hundred vaccine candidates are already under development around the world, at least ten of which have moved into the clinical trial phase. In May, the World Health Organization published guidance supporting trials of that form, if done ethically, and in June published a draft laying out a practical roadmap for their implementation.
The undersigned urge the U.S. government (including, but not limited to the Coronavirus Task Force, the Department of Health and Human Services, the Food and Drug Administration, Centers for Disease Control and Prevention, National Institutes of Health, and Congress), its allies, international funders, and world bodies (e.g. the World Health Organization), to undertake immediate preparations for human challenge trials, including supporting safe and reliable production of the virus and any biocontainment facilities necessary to house participants.“
So who shall be used? The volunteers who signed up? I don’t believe it for a second.
We all know by now that COVID-19 is not an old people disease as initially we all believed. Many young and otherwise perfectly healthy men and women, even children died from the coronavirus infection. Most of these victims happen to have been among the healthcare personnel, and especially in USA the victims are way too often Black or LatinX. The reason being their poverty, which forces them to continue doing their high-exposure low-pay jobs and to live in cramped conditions where social distancing is impossible, while wealthy white people lock themselves inside their houses and order everything online. It is apparently the dose, or the viral load, which apparently makes the coronavirus deadly, and in a human challenge trial the dose must be high enough to notice a vaccine effect.
But of course COVID-19 is not a binary live or die issue. Many of those who survived suffer prolonged and even permanent damage, to their lungs, hearts, blood vessels, kidneys, even brains. All organs can be affected, healthy young people who caught COVID-19 ended up on dialysis, received lung transplant or ended otherwise indefinitely ill and disabled. Once the after-effects manifest themselves after virus clearance, there is basically nothing medicine can do, except of palliative measures of one kind or another. Is it ethical to run such a clinical trial? The signatories think that of course it is. They elaborate:
“Trial participants should be relatively young and in good health. The mortality risk of the coronavirus to 20-29 year-olds, healthy and unhealthy, is similar to that of living kidney donors , a relatively common procedure, similarly justified by the donor’s informed consent and the benefits to society. […] no children, no prisoners […] Decades of psychological research on highly altruistic behaviors has demonstrated that a large, and likely growing, fraction of the general population is willing to undergo meaningful risks to benefit others due to genuinely altruistic motivation rather than insensitivity to risk, psychopathology, or other ethically concerning motives.“
That is completely outside of all reality. In truth ALL phase 1 clinical trial healthy volunteers in USA are financially destitute people who do it for money, either desperate to make ends meet or hoping to achieve the most modest of life goals or joys, attainable to everyone but the very poor. The vast majority of these Phase 1 trial participants in USA is Black or LatinX, often illegal immigrants or former prison inmates whom nobody wants to employ. While many are generally mindful about the risks, they have little choice, and everyone will weigh their risk perception against the financial reward, which in the case of coronavirus challenge trials would be high, which fits neatly to the current disastrous economic situation in USA where masses suddenly ended up unemployed and in poverty.
These real-life “healthy volunteers”, as opposed to the armchair virtue-signalers signing up forthe 1Day Sooner call, explicitly do not care about altruism, and why should they. Their war and its dangers are real, not on television. It is also likely true that none of the esteemed academic signatories of that Open Letter would ever participate even in the safest phase 1 clinical trials themselves, and would prevent all their family and friends from doing so. Never mind the coronavirus challenge trials.
If you wish to learn about the sociology of “healthy volunteer” clinical trial research, I highly recommend the new book by University of North Carolina professor Jill Fisher “Adverse Events“, here a review by Carl Elliott, and
I intend to write my own review soon. Update 20.08.2020: here is my own review.
The academic elite signatories of the open letter know all of that of course. You can assume everything about their motivation, but never a naive ignorance about who the phase 1 clinical trials are done upon, in reality. There is no other way to put it but: they must think that the Black and the LatinX precariat is expendable, especially when the goal is to save the freedom and the privileges of the wealthy white elites which the pandemic has curtailed. In fact, the only way for this human underclass to redeem themselves is to sacrifice their health and even lives for the White American wealth economy.
Let me now introduce you to some of the signatories. The “initial signatories of the the Open Letter organizers include next to 1Day Sooner people the COVID-19 star epidemiologist Marc Lipsitch, eminent vaccine researcher Stanley Plotkin, then the TED Talk CEO, heads of philanthropy foundations, think tank and capital investment group affiliates, a computer scientist, and several of ethics experts, including:
Arthur Caplan, Drs. William F. and Virginia Connolly Mitty Professor of Bioethics, Department of Population Studies, NYU Langone Health
A bioethicist who coauthored some medical ethics paper with the murderous trachea transplant surgeon Paolo Macchiarini. Caplan featured on my site calling for retraction of “all” Macchiarini papers. Except of those Caplan coauthored, those remain largely untouched (Taylor et al 2014, Lim et al 2013, the third Caplan-Macchiarini coproduction Badylak et al Lancet 2012 was retracted on explicit order from the Karolinska Institutet). When challenged on Twitter about this human challenge campaign, Caplan called me a “liar” and blocked me.
Then there are 14 Nobel Prize Laureates who signed the Open Letter. Including
Lou Ignarro, Professor Emeritus, UCLA School of Medicine
Other academic elites who signed:
Kim Nasmyth, Professor of Biochemistry, University of Oxford
Mentor of the infamous Maria-Pia Cosma. Their joint papers clearly contain photoshopped gels, but the journal Cell announced not to care, while the Vienna Institute of Molecular Pathology (which Nasmyth used to be director of) proclaimed that the “allegations were dropped”, and blocked me on Twitter.
Steven Pinker, Johnstone Family Professor of Psychology, Harvard University
Do I have to explain what’s wrong with that one? Pinker’s thinly veiled white supremacism made him a prime candidate to sign such a letter.
These are our highest academic elites, all 153 of the original signatories. They are joined by thousands of “volunteers” who signed up for something entirely hypothetical and non-binding, more power to them. If human challenge trials do happen, it won’t be on these folks, for various reasons. But the elite scientist masterminds of the Open Letter are prepared to see many of much less fortunate human beings maimed and killed, to test some vaccine promise which might very well be unfounded, or fake. I wonder how many of these elites would agree to go first, as healthy volunteers? Oh right, they all are way too old, otherwise of course they would storm the no-man’s land.
Correction 7.08.2020: The article initially listed a scientist as signatory by mistake, due to a similar name. I apologise for that.
COVID-19 pandemic is meanwhile in the second wave which seems to be worse than the first. USA became a pandemic disaster zone and lost control of the virus, thanks to Trump and Republican Party. COVID-19 became a giant field experiment, no need for human challenge studies.
Maybe this is why 1 Day Sooner is being mothballed, quietly. The Open Letter presented above was deleted in the last days, here a backup from 1 November. Its original organisers can now be found on the advisory board of 1 Day Sooner, I stroke through those names not on board or on the team anymore:
Scott Aaronson, David J. Bruton Centennial Professor of Computer Science, University of Texas at Austin Amrita Ahuja, Director of the Douglas B. Marshall, Jr. Family Foundation Chris Anderson, Head of TED Alexander Berger, Managing Director at Open Philanthropy
- Arthur Caplan, Drs. William F. and Virginia Connolly Mitty Professor of Bioethics, Department of Population Studies, NYU Langone Health
- Nir Eyal, Henry Rutgers Professor of Bioethics and Director of the Center for Population-Level Bioethics (CPLB), Rutgers University
Ambassador James Glassman, Founding Executive Director at the George W. Bush Institute
- Kim Krawiec, Kathrine Robinson Everett Professor of Law, Duke University School of Law
- Marc Lipsitch, Professor of Epidemiology, Harvard University
- Abigail Marsh, Professor of Psychology and Neuroscience, Georgetown University
- Josh Morrison, Co-Founder and Executive Director at 1DaySooner
- Stanley Plotkin, Emeritus Professor of Pediatrics, Perelman School of Medicine, University of Pennsylvania
- Sophie Rose, Co-Founder and Director of Research at 1DaySooner
- Nadine Rouphael, Associate Professor of Medicine and Acting Director, Hope Clinic, Emory Vaccine Center
Sally Satel, Resident Scholar at the American Enterprise Institute Peter Singer, Ira W. DeCamp Professor of Bioethics in the University Center for Human Values, Princeton University Kate Wharton, Senior Associate at CrossBoundary Daniel Wikler, Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health, Harvard University
Newly joined COVID-19 experts are Clint Hermes of the law firm Bass Berry & Sims PLC and Joel Lawson of The Lawson Family Charitable Fund.
And in a Twitter exchange, 1 Day Sooner admitted to something really bizarre: that COVID-19 is similar to flu, at least if you talk about designing a human challenge trial.
“You escalate till you infect (or provoke illness depending on the model) about 70-80% of the people exposed to the dose. Here’s an example of a study like this for flu https://pubmed.ncbi.nlm.nih.gov/25416753/“
The idea of 1 Day Sooner is apparently to establish the required coronavirus dose needed to provoke illness (ie, COVID-19) in “70-80% of the people exposed“. That is a dangerous approach, because not everyone agrees that COVID-19 is just like a flu. I approached the board members Lipsitch, Plotkin and Rouphael (all infectious disease experts), but they chose not to reply despite reminder. Plotkin is very old, but the other experts? Probably too busy advocating for human challenge trials.
Anyway, how did 1 Day Sooner (they refused to say who was behind the Twitter account) get to comapre COVID-19 with the flu?
First, they declared support for a coronavirus challenge trial announced in UK. In that project, funded by the UK government with £33.6m to Imperial College London, Royal Free Hospital and the clinical trial service provider hVIVO, healthy volunteers would be infected with the SARS-CoV2 viruse, to literally see what happens. The principal investigators are Imperial College professors Chris Chiu and Peter Openshaw. The was excited BBC coverage in October 2020:
“The UK is pushing ahead to be the first nation to carry out “human challenge” studies where up to 90 healthy people will be deliberately exposed to Covid.The trials, which could begin in January, aim to speed up the race to get a Covid-19 vaccine.”
Other news outlets wrote:
“Chiu said the plan for initial studies – which are aimed at assessing how much virus it takes to infect someone with COVID-19 – is to immediately treat volunteers with the Gilead antiviral drug remdesivir as soon as they are infected.“
The recruitment is already happening while the consortium admitted to me on twitter to have no ethics votes, no approvals from UK authorities, even no detailed plans for the clinical trial which is not registered. They refused to comment on the remdisivir failure.
So where does this PR stint and money grave called UK Human Challenge Consortium come into play with 1 Day Sooner? The latter told me on Twitter:
“The first step before testing vaccines is to establish the proper infectious dose, which is the UK government plan. These studies can also improve knowledge of the immune response.”
Once you establish a required COVID-19-causing dose in 90 humans (with remdesivir at hand), you progress to vaccine testing by infecting even more healthy volunteers. No wonder Lipsitch, Plotkin and Rouphael refused commenting on their publicity stunt 1 Day Sooner. It all makes no sense.
The results of the Great British Human Challenge Trial are in! The 34 young participants (out of 36 recruited) received £4,565 each, and starting early 2021 were exposed to “a very low dose — roughly equivalent to the amount of virus in a single respiratory droplet” of the original SARS-CoV2 strain (i.e., not the more dangerous Delta).
The press release stated:
“Eighteen of the volunteers became infected, 16 of whom went on to develop mild-to-moderate cold-like symptoms, including a stuffy or runny nose, sneezing, and a sore throat. Some experienced headaches, muscle/joint aches, tiredness and fever.”
Here the preprint (we learn it’s under a review in a Nature portfolio journal):
Christopher Chiu , Ben Killingley , Alex Mann , Mariya Kalinova , Alison Boyers , Niluka Goonawardane , Jie Zhou , Kate Lindsell , Sam Hare , Jonathan Brown , Rebeeca Frise , Emma Smith , Claire Hopkins , Nicolas Noulin , Brandon Londt , Tom Wilkinson , Stephen Harden , Helen McShane , Mark Baillet , Anthony Gilbert , Michael Jacobs, Christine Charman, Priya Mande, Jonathan S Nguyen-Van-Tam, Malcolm Semple, Robert Read, Neil Ferguson, Peter Openshaw, Garth Rapeport, Wendy Barclay, Andrew Catchpole Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge Research Square Platform LLC (2022) doi: 10.21203/rs.3.rs-1121993/v1
Nature sums up:
“People developed their first symptoms and tested positive, using sensitive PCR tests, less than two days after exposure, on average. That contrasts with the roughly five-day ‘incubation period’ that real-world epidemiological studies have documented between a probable exposure and symptoms. High viral levels persisted for an average of 9 days, and up to 12.
The most common symptoms were typical of other respiratory infections: sore throats, runny noses and sneezing. Fever was less common, and no one developed the persistent cough that had been used as a hallmark of COVID-19, says Catchpole. 70% of infected participants lost their senses of smell or taste — another COVID-19 signature — to varying degrees. Such problems persisted for more than 6 months in five participants and more than 9 months in one. Some people developed no symptoms at all, but had the same high viral levels in their upper airways that lasted as long as they did for others who exhibited symptoms.”
I am not sure what the point of all that was. What practical use does this data have now? This information would have been old news even a year ago. Maybe society would have been better served if these 36 people received a vaccine instead? Sure it’s fun to experiment on humans thanks to the lax British regulations on human experimenting, especially when you gratuitously cause prolonged damage to your participants and get celebrated for that in the media. Let’s do it again! – says hVIVO. Primum non nocere.
If you are interested to support my work, you can leave here a small tip of $5. Or several of small tips, just increase the amount as you like (2x=€10; 5x=€25). If 1Day Sooner asks for donations why shouldn’t I?