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Some scientists are taking a DIY coronavirus vaccine, and nobody knows if it's legal or if it works:
Preston Estep was alone in a borrowed laboratory, somewhere in Boston. No big company, no board meetings, no billion-dollar payout from Operation Warp Speed, the US government's covid-19 vaccine funding program. No animal data. No ethics approval.
What he did have: ingredients for a vaccine. And one willing volunteer.
Estep swirled together the mixture and spritzed it up his nose.
Nearly 200 covid-19 vaccines are in development and some three dozen are at various stages of human testing. But in what appears to be the first "citizen science" vaccine initiative, Estep and at least 20 other researchers, technologists, or science enthusiasts, many connected to Harvard University and MIT, have volunteered as lab rats for a do-it-yourself inoculation against the coronavirus. They say it's their only chance to become immune without waiting a year or more for a vaccine to be formally approved.
Among those who've taken the DIY vaccine is George Church, the celebrity geneticist at Harvard University, who took two doses a week apart earlier this month. The doses were dropped in his mailbox and he mixed the ingredients himself.
Church believes the vaccine designed by Estep, his former graduate student at Harvard and one of his proteges, is extremely safe. "I think we are at much bigger risk from covid considering how many ways you can get it, and how highly variable the consequences are," says Church, who says he has not stepped outside of his house in five months. The US Centers for Disease Control recently reported that as many as one-third of patients who test positive for covid-19 but are never hospitalized battle symptoms for weeks or even months after contracting the virus. "I think that people are highly underestimating this disease," Church says.
Harmless as the experimental vaccine may be, though, whether it will protect anyone who takes it is another question. And the independent researchers who are making and sharing it might be stepping onto thin legal ice, if they aren't there already.
(Score: 5, Insightful) by ledow on Thursday July 30 2020, @12:17PM (26 children)
Making it? No problem.
Administering it to themselves? No problem.
Sharing it with the intention for others to administer? That's a problem.
You'd be hard-pressed to convict based on available evidence, I imagine, but if a team of researchers work on a vaccine and decide to administer it to themselves, that's their business. Without it, several quite famous medical solutions would be unavailable to you - because their inventors did exactly that. It's when they administer it to each other, or share it around, then it becomes legally tricky.
(Score: 1, Informative) by Anonymous Coward on Thursday July 30 2020, @12:44PM (3 children)
probably the most famous case is that of Barry Marshall, who gave himself ulcer on purpose: https://www.discovermagazine.com/health/the-doctor-who-drank-infectious-broth-gave-himself-an-ulcer-and-solved-a-medical-mystery [discovermagazine.com]
just in case people demand a citation for the "famous medical solutions" wording.
(Score: 0) by Anonymous Coward on Thursday July 30 2020, @01:52PM (1 child)
There would, however, be a difference between infecting oneself to prove something medically and treating oneself to cure something without proper control studies.
The former may pave a way to understanding something. Marshall and Warren certainly deserved their Nobel. But it took much more work and many more studies than Marshall infecting himself for the information to be accepted. Accepted it did become, after the finding was properly verified.
This story is an example of pure selfishness and reckless experimentation even if it is self-experimentation. No control and no ability to be accepted. Without verifiability and acceptance, which only comes from controls, there is no science here. Kind of like the people who insist HCQ is good, despite all the evidence that control studies have provided that the benefits (if any) are outweighed by the already-known risks of using HCQ.
Put even more simply: There are damn good reasons one has to wait for a therapy or a vaccine. (And in cases where one cannot wait because of death likelihood there are acceleration procedures which help streamline the process further.) This is stupidity at work, not science.
(Score: 0) by Anonymous Coward on Thursday July 30 2020, @04:28PM
We aren't waiting for a vaccine, its being warp drived.
(Score: 2) by driverless on Friday July 31 2020, @03:36AM
There's an endless number of cases of both doctors and non-doctors trying various miracle cures on themselves going back centuries if not millennia. This is just more of the same, with nothing but the Covid19 connection making it newsworthy.
(Score: 1, Funny) by Anonymous Coward on Thursday July 30 2020, @12:48PM (3 children)
I've seen zombie movies.
Epidemic often starts in labs with researchers fooling around with chemicals.
(Score: 2) by Booga1 on Thursday July 30 2020, @01:34PM (2 children)
Don't forget the ones that start with viruses in labs that lose containment.
(Score: 1, Funny) by Anonymous Coward on Thursday July 30 2020, @05:45PM
Don't forget the ones that start with immune systems in vessels that lose containment.
There, FTFY.
(Score: 0) by Anonymous Coward on Friday July 31 2020, @04:38AM
Don't forget the one where Hilary Clinton ordered Fauci to create a killer virus in China to subvert the 2016 election.
(Score: 3, Disagree) by ikanreed on Thursday July 30 2020, @01:52PM (16 children)
And of course, self administered vaccines with no control group or blinding yield no science.
(Score: 2, Disagree) by The Mighty Buzzard on Thursday July 30 2020, @02:07PM (14 children)
Er... Don't they have the rest of the planet as a control group? In any case, all the folks getting their panties in a wad saying "this won't prove anything"? Yes, it will. It is quite possible to prove whether the vaccine is worth a serious and immediate closer look or not.
My rights don't end where your fear begins.
(Score: 4, Informative) by ikanreed on Thursday July 30 2020, @04:20PM (12 children)
No, that's not how control groups work.
If you don't bring the control group in to check for matching examation, you've learned nothing about comparable infection rates(not that a sample size of fucking 1 would tell you anything on the intervention group either). You've learned nothing at all.
Which is consistent with a mightybuzzard worldview in general at least.
(Score: -1, Offtopic) by Anonymous Coward on Thursday July 30 2020, @06:11PM (10 children)
Obviously you don't know the difference between effectiveness and efficacy.
(Score: 2) by ikanreed on Thursday July 30 2020, @06:19PM (9 children)
Hey look, you're testing neither of those. Wow! So impressive!
No controlled laboratory experiment. No longitudinal population data with matched measurements. A complete absence of useful information! Hooray!
We should do a controlled experiment to see if it's possible to differentiate your brain from a bowl of banana pudding.
(Score: 0) by Anonymous Coward on Thursday July 30 2020, @06:49PM (7 children)
Legacy medicine had its time, but it is on the way out: https://www.nature.com/news/personalized-medicine-time-for-one-person-trials-1.17411 [nature.com]
(Score: 0) by Anonymous Coward on Thursday July 30 2020, @08:33PM (6 children)
N-of-1 trials are not the same thing as giving yourself an untested, unproven, and experimental vaccine.
(Score: 0) by Anonymous Coward on Thursday July 30 2020, @08:55PM (5 children)
It is the exact same thing.
Am I immune?
Take antibody test: No.
Take untested, unproven, experimental vaccine.
Wait 2 weeks.
Am I immune?
Take antibody test: Yes.
Now vaccine is tested and proven to work in one person. If the last answer was "no", then you would need to try again.
(Score: 2) by Mykl on Thursday July 30 2020, @10:24PM (1 child)
A shame you were one of the 1 in 20 people that the vaccine doesn't work for. You've just thrown out something that's effective for 95% of the population.
Oh well.
(Score: 0) by Anonymous Coward on Thursday July 30 2020, @11:19PM
You do your own n = 1 experiment if you want to make sure you get one that works for you. Doing an experiment taking the average is imprecision medicine, you never know if you are the 1/10 the treatment works for or the 9/10 it is a waste of time and money (or even dangerous).
(Score: 0) by Anonymous Coward on Friday July 31 2020, @02:54AM (2 children)
No, they are not the same thing. There is no general efficacy data necessary to do a Bayesian analysis. The large number of confounding variables that are not controlled for also breaks your repeated-measures design. Further more you small sample size kills any statistical power or significance you have overall even if you attempt to factor those in.
(Score: 0) by Anonymous Coward on Friday July 31 2020, @04:17AM (1 child)
Sounds like someone who has no idea what they are talking about would type into the internet.
t0: Do not have antibodies
t1: take vaccine
t2: Have antibodies
Either it was the vaccine or you got exposed somehow else. So stay home between t1 and t2.
(Score: 0) by Anonymous Coward on Friday July 31 2020, @08:50PM
Or you were exposed before t0 and developed immunity even though the vaccine was no help. Or you were already immune at t0 but the false negative said otherwise. Or you were exposed despite staying at home and developed immunity that way. Or the t2 test was a false positive. Or the reporting was incorrect. Or you were exposed in the vaccine but not its antigen payload. Or you could have antibodies but not enough for an immune response. Or a number of other things.
Like I said, there are tons of confounding variables and you don't have the sample sizes or probabilities necessary to discern those things, which is why this design isn't close to being a proper repeated-measure N-of-1 trial.
(Score: 1, Insightful) by Anonymous Coward on Thursday July 30 2020, @08:48PM
A great saying you should learn (as in embrace and act on): "Perfect is the enemy of good". https://en.wikipedia.org/wiki/Perfect_is_the_enemy_of_good [wikipedia.org]
(Score: 2) by The Mighty Buzzard on Thursday July 30 2020, @11:15PM
The rest of the world are already being monitored as closely as they'll allow. If you want them monitored any more closely you need to wait for the water to heat some more to boil that particular frog.
My rights don't end where your fear begins.
(Score: 0) by Anonymous Coward on Thursday July 30 2020, @04:33PM
The only thing is proves is that it isn't absolutely fucking lethal.
(Score: 2) by ledow on Thursday July 30 2020, @02:33PM
No. But they are a small shortcut to prove that it's not immediately fatal or injurious.
(Score: 2) by wisnoskij on Thursday July 30 2020, @03:05PM
I would suspect that legally it might work identically to guns. As long as you had no part in making it, you are free and clear. But these people are likely to be fired, and maybe they would run afoul of the doctor licencing board or even the legal system for practicing medicine without a licence.