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. 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.
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