You can compare that with the demographic table of the US. Looks like they don't quite align, but are presumably within the guidelines. FWIW, all the comments I saw from people more familiar with medical data were pretty positive about the demographic spread.
https://en.wikipedia.org/wiki/Race_and_ethnicity_in_the_Unit...
I’m not saying anything for or against this, but I bet it was in the first phase where the concerns for equity were brought up.
Edit: the difficulty becomes the argument between recruiting equitably vs recruiting quickly, both are going to have downsides. Ideally you would do both at once, the question becomes why is this so hard in the US, and there are lots of reasons.
A lot of studies also recruit people who have a connection to the study (maybe friends/family members, students at the local university, etc...). If there is less diversity in the company and people running the study, I think this would also lead to less diversity in the participants. Again, I have no knowledge of how this one was done.
It's not hard to imagine a patient noping out of an experiment if he's the token black guy in a room full of white doctors poking and prodding at him.
I work for a company that makes medical devices for people with diabetes, (a disease which disproportionately affects people of color), and we go out of our way to ensure that we have a diverse cast of people who interact with the patients in our studies.
I am just guessing a fairly small people asked about Tuskegee would know what it is but maybe it's just me. I am just suggesting maybe asking black people why they don't want a covid vaccine for example and address those issues.
That said, I recently read that most black people (falsely) believe that the Tuskegee subjects were deliberately infected with syphilis, but I can't find the source right now, and it's kind of splitting hairs anyway.
Phase 1 is essentially to test "will this drug cause terrible harm to people who receive it in a reasonably short time frame?" In terms of dosage guidelines, phase 1 studies often don't have variable dosing, or if they do, not an awful lot - because the question around optimal dosing is the target of phase 2.
(Sometimes you can roll 2 and 3 up together, for instance, if the difference in dosing is in duration of therapy rather than an actual difference in drug administered per unit time.)
Phase 1 usually has terribly small samples, because it's only looking for terribly large effects. Seeing homogeneity there, of any stripe, is neither unexpected nor problematic.
(A lot of the vaccine studies rolled up phase 1/2 together because we already have a pretty good understanding of what these delivery mechanisms do to people, and so while you'd be cautious in administering to the initial study participants, it really didn't merit a "test it on five people and hold your breath" approach.)
All this to say nothing of how the medical establishment generally under serves minorities. There's quite a bit of writing on why it might be so hard for these major pharma corps to find volunteers from these communities.
These things are all so well known, it isn't even worth the effort to track down citations for them, and you still trust them?
https://www.quora.com/We-all-know-the-evil-that-Hitler-did-W...
Edit: Well, since people are obviously not even reading the link, I'm going to quote the bullet points from the first answer in nearly their entirety:
> Nazi regime was the first to introduce animal rights and limited hunting seasons. Hitler had outlawed animal testing (who needs animals when you got thousands of Untermenschen).
> Nazis had the first public anti smoking campaign at a time when smoking was not linked to cancer.
> Hitler had authorized extensive research on cancer and various venereal diseases and abundance of medicine for public.
> Nazi labour laws were best in contemporary world. Reduced work hours, periodic breaks, paid holidays and sponsored trips to Italy as perks.
> Promoted sports culture among youth which led to Germany being a sports power house.
> Hosted the 1936 Berlin Olympics.
> Hitler had announced loans of 1000 Reichsmark (10 month salary in 1939) for married couples at minimal interest and waivers for birth of first child.
> Volkswagen - people's car. Personalized Cars for average germans was laid out in 1937. Volkswagen is an extremely popular brand now.
> German Autobahn(super highways) was introduced in Hitler's era.
> Hitler had forbade German army from using mustard gas or any sort of chemical weapons on enemy forces because of the trauma he suffered in WW1 from mustard gas. As a result, deadly gas warfare of WW 1 was never seen in WW 2.
> Nazis were pioneers in rocket science. America's space programs were guided and led by former Nazi scientists like Werner von Braun and Arthur Rudolph.
They got sponsored trips to a lot of places in Europe: Poland, France, Russia...probably best to avoid that last one though.
Are you saying corporate structure in the law causes these actions?
The things I mentioned previously did not involve any lapse of judgement at all. Saying that is just being an apologist. I'm not saying you're suggesting lapses of judgement are responsible for these things, merely that actually suggesting so would make one an apologist. They are all done with eyes open, focusing on the dollar signs at the end of the road, public interest be damned.
I'm simply stating that they are negative actions by some. If that didn't come across, here it is.
You say "if I were a black man", as if you have any idea of what it means to be a black man in America
[1] https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=RP
why not run the trial in the country where the vaccine is going to be sold?
/s
Most trials were run in countries where a large number of new cases were expected over the trial period. Government measures in almost all first world countries brought the R rate right down, which is disastrous for a trial looking for results.
That's a bit sus
They talk about how fast this vaccine was delivered. We could have done it a lot faster. An incredible number of lives and livelihoods could have been saved.
Take 1,000 diverse volunteers from the US military, start an isolated challenge trial (if something very unexpected happens, they're contained). Then expand it after those first thousand show success. Done in half the time that this took. We'll send those soldiers to die in pointless foreign wars, and then we won't do something so obvious as this to actually save American lives. The US would have had as many volunteers as you could handle for a challenge trial, hundreds of thousands of volunteers would have been trivial to get.
https://www.england.nhs.uk/coronavirus/wp-content/uploads/si...
See also the press release from the regulatory agency specifically about anaphylaxis: https://www.gov.uk/government/news/confirmation-of-guidance-...
It's also rather surprising to me (as a relative layman) that this wasn't picked up during safety trials. I get anaphylactic reactions to some food and medicines and carry an EpiPen. There are a few vaccines which have been counterindicated for me due to this so I have always thought it's a relatively well-known potential side effect from at least some vaccines (and other medicines of course). As such I would have expected it to be looked/checked for during safety trials.
Or "anyone with a history of anaphylaxis to a medicine or food should not get"? Do you have a source for anyone with any allergy being denied the vaccine?
It's still reasonable that the federal government would be reluctant to fund such a vaccine, though.
There's no excuse for bad testing demographics. If only whites are tested then we'd only find out in the wild if it works on non-whites or has adverse effects on non-whites, which is obviously hideous.
We'd also flat out reject a vaccine that only works on non-whites because we'd never know it.
It's fine to say that a vaccine that only works on some known part of the population is a good thing. It's better than no vaccine. But we have to know who it works on. That's what testing does, and that's what's being discussed.
There never is a "bad testing demographic". The testing demographic can only be "good" or "bad" in relation to the population the vaccine is going to be certified for.
> If only whites are tested then we'd only find out in the wild if it works on non-whites or has adverse effects on non-whites, which is obviously hideous.
That's absolutely correct, if a vaccine is tested on a specific demographic, it should only be certified for that demographic, and only be given to other people after additional tests. In this context, if the FDA notices that there are not enough non-white people in the testing group, the FDA should not certify the vaccine for non-white people. White people can already start being vaccinated, and additional tests need to be performed on non-white groups. The role of the FDA is precisely to notice these stuff, react accordingly, and keep phrama companies in check.
It's already what we are doing for people suffering for immunodeficiency. We develop a vaccine explicitly without including them in the trials - because it's harder to make a vaccine considering them. We certify the vaccine for the non immunodeficient people - as fast as possible. Then we will start looking for a vaccine for immunodeficient people at a later stage. First by testing the already developed vaccine - or by looking in another way if that does no work.
What Pfizer exec decided to do, is put speed above all. And they were absolutely right to do so. They published they trial sampling details and it's up to the FDA to certify the vaccine for the part of the population the FDA think the sample was good enough for. And require additional tests for the others.
The FDA does not certify vaccines as being safe for particular races, for one simple fact -- races are a social construct, not a biological reality. What we call "races" are actually mishmashes of a large variety of different ethnic groups, many of which have little to nothing in common with each other genetically.
Vaccines are certified by age and by gender and that's it. There will never be a "whites-only" vaccine and the very idea is morally repugnant and biologically ridiculous.
I do agree with you, but then what should anyone care about the distribution of ethnic groups in a medical trial if those ethnic groups have absolutely no impact on the result of the trial.
Either it makes sense to differentiate the vaccine according to $variable and testing groups as well as certifications need to reflect that. Or it makes no biological sense to care about $variable, then we should have no requirements about making sure that $variable is correctly sampled in the test groups.
In this case, ethnicity probably has 0 impact on the effectiveness of the vaccine, therefore why does anyone care about the distribution of ethnic groups in the sample ?
The FDA is supposed to issue EUA if the "benefits likely outweigh the risks". That bar was crossed after phase I trials, frankly, definitely after phase II, and is 1000x safer after a phase III trial (even if you don't love everything about it). The FDA is clearly not abiding to this standard, and is instead going with "almost no conceivable downside" standard. That has cost many lives.
There's no need to imply it's the GP's own opinion, and sotto voce that the GP is a racist.