The Volokh Conspiracy
Mostly law professors | Sometimes contrarian | Often libertarian | Always independent
Zach Weissmueller here at Reason has the details:
On Monday, YouTube sent Reason an automated takedown notification for a March 13, 2020, video titled "Biohackers Are on a Secret Hunt for the Coronavirus Vaccine." The message said our video violated the company's spam, deceptive practices, and scams policy.
YouTube denied Reason's appeal, informing us that the video violates the company's "medical misinformation policy."
Did this 16-month-old video really promote "medical misinformation"?
Speaking as the journalist who produced it: absolutely not. While YouTube, as a private company, is within its rights to decide what to carry, the decision to remove this video illustrates a disturbing, censorial trend that has accelerated in the age of COVID.
You can view a non-YouTube copy of the video at that article, so you can judge for yourself; and here's the auto-generated transcript:
The following is an interview in the Southern California home of a biologist whose company is fundraising and effort to construct, test and distribute a DIY coronavirus vaccine out of synthetic DNA reason. Granted his request for anonymity due to a legitimate fear of retribution from the FDA, but has verified his identity, that of his business partner and of a potential Silicon valley funder. The proposal under discussion is available in a link below this video. And those interested can contact the team by emailing Corrine, firstname.lastname@example.org.
I'm a biologist I've been working in the field for about 10 years in molecular biology, biochemistry, mostly in industry, making proteins, making DNA, all the kinds of things that people want to pay you to make. And also been involved in the DIY bio community since near its inception
By DIY bio community. He means a grassroots movement comprised of professionals and amateur biologists who experiments with genetic engineering in their homes and community labs. People like Josiah Zaner founder of the Odin, which distributes kits, allowing anyone to experiment with CRISPR gene editing tool members of this community have created glowing yeast by inserting jellyfish genes, injected themselves with homemade vaccines, attempted to reverse engineer patented pharmaceuticals tried to genetically engineer dogs, and there are even efforts to create designer babies by modifying human embryos, all without seeking FDA approval.
The FDA, despite people's, uh, usual perception of them as fairly friendly. I mean, they, they are looking out for the consumer, but, um, if somebody is trying to develop, um, and distribute unapproved medicine, uh, they, they will come down hard and they have, and um, for someone like me that doesn't have, um, you know, lawyers on retainer and for our group in general, uh, it's a severe risk to our livelihoods outside of this project, if we were to be de anonymized.
So you've put together this proposal and a document titled, CoroNope. Could you give us an overview of what's in that document and what your proposal is,
Outline of how vaccines are made, how DIY vaccines could be made since so far? No one has really had to DIY a vaccine and kind of a grief, uh, scientific and technical background on how it would be designed and then how we would go about manufacturing it and distribute it. Yeah.
Why do you see the need for this? What is the purpose of a day?
Why a vaccine at this point in a pandemic situation, obviously there's a bit more leniency on the part of the FDA and various other regulators to push things through as fast as possible, but especially after the swine flu vaccine scandal where the vaccine was developed, rush through and distributed, and then a few hundred people, at least in the U S developed a very rare neurological disorder. Since that time, they've not taken too many more liberties, even during pandemics companies that are developing vaccines nowadays, they have to go through several months of testing and then final approval, and then watching out for side effects. And we feel that there might be a niche there, at least for us
Experts like Anthony Fowchee, director of the national Institute of allergy infectious disease have said a vaccine will likely not be available to the public for about 18 months, even with a fast track testing process,
The method that we're using, it's very minimal risk, uh, in terms of, uh, the patient safety, there is much more of a risk that it simply won't work, but we prefer to err on the side of it not working rather than it potentially harming people
Other than using the sample of the novel Corona virus and killing it, or recombining it with a less harmful virus to create the vaccine, which would be prohibitively expensive and dangerous. His team is attempting to create a vaccine built from synthetic DNA attached to bacteria, which would then either need to be injected in conjunction with an electrical pulse or combined with a chemical allowing for better penetration of cell membranes.
How confident are you something like that could actually work given that there's nothing on the market like that at this point, the company that we are, shall we say cribbing the most off of they have phase one phase two clinical trial using the, basically the exact same approach for a Merz middle east respiratory syndrome. They found that they got significant antibody responses in these clinical trials. Now, obviously they can't test it in a epidemic or pandemic scenario. They would have to actively infect people with this virus. So for now that's as close as they can get to approval. It's quite promising. Um, it seems that having an antibody response against the particular protein that we're targeting, the spike protein, uh, is enough to neutralize it, uh, for most Corona viruses. What exactly is the path that you would see this taking? How would it be distributed?
How would people get their hands on it? Well, there be two separate stages. At the first point, we have maybe a few hundred or a few thousand doses that we can distribute to people and they would go ahead and do the injection, uh, monitor themselves. And then after a few weeks or months, um, ideally we could test their, um, antibody titers against the, uh, the virus. And at that point it would be considered as close to tested as we can get. Um, I don't think we'll have the stage where we're doing a double-blinded placebo controlled trial for this. That's not in our budget and not really in the, uh, the timeline I'm still trying to grasp how this would be distributed. Is this like a Dallas buyers club situation where people are, you know, going to their local community lab and collecting a bunch of needles or is this like online black markets?
How would an unapproved vaccine like this even get out into the world? Yeah, it's a complicated question because if you're not selling it, which we don't plan to, then it becomes less clear. It's not quite self experimentation, but if you have tens of thousands, people injecting this thing, you, you can't claim that they're all just self experimenting. If it does end up needing an electroporation device, um, yes, it would be centered around community labs. So the plasma itself can be shipped, uh, dry to wherever it's needed and reconstituted quite easily. So, um, that side of it isn't quite as difficult, but I don't see us going with some sort of dark web black market distribution stuff. I don't know if we could make, um, data reporting a precondition of getting a dose in lieu of payment, something like that. But, um, I think people hopefully will understand that it is still experimental, which means we're doing an experiment. Um, so they will become in a way Guinea pigs, which sounds a little bad, but it will be Guinea pigs as well. So at least we'll all be in the same boat.
And what makes you believe that anybody would inject an untested vaccine?
Well, people inject black tar heroin every day, and I don't think they have quite as much quality control data available as we'll have, but all joking aside, uh, we can provide as much data as we can generate. Um, it's up to people to be able to give their, as it were informed consent about these things. We appreciate them, most people aren't biologists. Um, ideally we could get some biologists who were okay with staking, their reputation, at least a little on saying, yes, this test data looks correct. Having been in the DIY bio community where people will inject plasmids into themselves on a dare or after a couple of drinks. Maybe it seems a little less crazy, but at a certain point not doing something that seems pretty safe in the face of a disease that could kill you or loved ones. Um, it depends on where everyone's particular risk threshold is. I think, and I don't, I don't blame them for, uh, waiting for an FDA approved vaccine.
Do you worry that you could make things worse by if you release a vaccine that hasn't gone through the official process and then it does end up injuring people that then that's going to just create more distrust and, you know, the approved vaccine when it eventually comes
The other advantage of DNA vaccines aside from, uh, not having to work with live viruses really at worst, they just do nothing. They're extremely well tolerated. That's the one thing we've learned from all the previous clinical trials and various, uh, papers over the years is that yeah, the worst you get is a, a minor rash at the injection site. I think our biggest risk is something that would be true for any vaccine that's developed. Sometimes having antibodies against a virus can do more harm than good.
What is the scenario that you're imagining where this actually would be useful and fill in gaps,
The company developing a vaccine that we're currently closest to in terms of methodology, uh, there'll be spending the next, at least four, probably six to eight months, uh, doing their testing. Uh, once they get initial confirmation that it's at least safe. Um, but possibly before manufacturing can scale up, we will have at least some manufacturing capacity. And depending on the level of the pandemic at that time, there might be situations where they're only handing out, um, vaccine to going by, uh, like last name or depending on how much money you have or first-world countries. All of these could be preferential distributions that leave plenty of people underserved. And even if it's only a matter of weeks or months, um, before they would get access to the vaccine, those can be life or death. I know it seems like with Italy completely unlocked down, it's nearing maturity, but it's still very early stages.
And, uh, especially in the U S I would say it's a safe bet that this is the, uh, the worst since the 1918 Spanish flu, I don't think will be nearly as bad as that, but I think we'll quickly see that hospitals are very often operating at or near capacity even without a pandemic on the loose. And, uh, especially considering the amount of, um, oxygenation ventilation that's being needed. Uh, you're going to see a lot of people start being triaged and then the medical services get overwhelmed, and it's hard to get the data. Um, a lot of the numbers out there right now, aren't reliable. They come from say an authoritarian country that has their best interests in at least calming their population and looking good on the international stage versus providing reliable data. So we can hope for the best there. But I think some of the worst case scenarios of 4% case fatality rate, um, could be possible, especially again with overloaded hospitals. Uh, it just depends. And that's assuming it doesn't mutate into something more virulent. Um, Italy's the best case study we have right now, and it's getting, uh, pretty bad. So
No I've gotten verification from one Silicon valley investor that he is interested in supporting your project. What level of interest have you gotten so far and what do you need to actually proceed at the time?
One of the advantages of a DNA vaccine as that, um, unlike with a regular inactivated attenuated virus where you're injecting it into chicken, eggs, and waiting for these cells to grow mammalian cells or AVM cells divide once every, roughly 24 hours, whereas bacterial cell divides every 20 minutes. So when you're looking at exponential growth, you can get a lot more bacteria. I would say with 25 to $50,000, we could set up a solid buyer, reactor. It's all a purification set up all the chemicals and plastic ware and testing kits that we would need to get again, a few thousand doses at that point. And from there, it's pretty much an economy of scale and you can produce 20 times more bacteria for definitely not 20 times the price.
How hopeful are you that you can actually succeed in this endeavor?
The most basic level we can get the plasmid synthesized, which also will probably be a few thousand dollars in terms of avoiding getting shut down by the FDA or any other regulatory agencies who knows we'll see whether or not the vaccine itself works. Um, definitely less than 50% chance. We don't want to get anyone's hopes up if they're putting this in. They're not going to be going out the next day or even six months after and believing they have it.
I mean, anyone who sees this, who's interested in either following what you're doing or helping in some way, what are ways that they can do that?
Uh, we have a Bitcoin address. If you send us an email, um, get in touch with us. We can forward that on to you, uh, for the funding side. Uh, otherwise if you want to weigh in, um, on the technical aspects, uh, or even the regulatory aspects or societal aspects, any of that, uh, please do feel free to get in touch with us. Um, if you're interested in joining our team, uh, again, if we do end up scaling up, uh, getting enough funding for that, we would need, um, skilled hands. Do you think,
Is that what you're doing is going to become more common in the future? Not necessarily for vaccines, but people's ability to kind of develop DIY medications or gene therapies. Like where do you see the future of that going?
Well, frankly, I thought we would be there by now. This was not the future I was promised, but sometimes you've just got to make that future, I suppose.