For the approx 1/2 million US Covid vaccine trial volunteers that stood up and said "Stick ME!" approx 1/2 got the placebo. Now that the results of these trials are coming in and looking very good, do we, as a thankful nation owe it to the 1/2 that got the placebo to ensure they get the real deal among the first folks that receive the mass immunizations? (1st, after nursing home workers and patients and healthcare workers)
I understand the whole double blind thing that needs to carry on for some months in order to look for longer term problems, but hey, they stood up above the crowd and said, "Yeah, I'll do it". I personally think they deserve and earned some kind of 'line cutting' privilege's, tho most would probably not ask for it. Your thoughts? (regarding the above question)
If you remember 3 years ago, I volunteered to go thru MRI's and have my brain hooked to a computer for neural feedback.
It worked. I've still got a scan of my brain under pressure sitting in the filing cabinet. Broken nose and all.
I didnt do it for money. I got some healing out of it, and what the docs learned will go miles to help heal those "tough guys" who think they can do everything on their own, only to find out they are human after all.
My experiences with volunteering for medical are still free for the asking. Just takes a phone call, no insurance required.
As for this vacine....I trust Gates and Zuker about as far as I can throw am AC500 with one arm......thats not very far.
I think it makes a lot of sense. To position the clinical trial volunteers who were placebo'd towards the front of the line, in terms of priority of receiving a vaccine.
Maybe it's not a no-brainer, but it certainly seems like a reasonable idea to consider.
"Now that the results of these trials are coming in and looking very good, do we, as a thankful nation owe it to the 1/2 that got the placebo to ensure they get the real deal among the first folks that receive the mass immunizations?" You owe them Nothing. People got the placebo may have gotten lucky months or more later.
I've been thru many studies and won't do drug and other tests no matter if they pay you or not. Why? 1. Most studies including drug and other med studies have "fine print" in the contract etc. that often say you're on your own if have major problems. Most people never read before signing. Most studies I've taken have about same risk as mowing grass and "normal" things people do anyway even if I'm in safety gear to do them. Several have me in harness similar roofers and other hanging off small cranes or beam tied to ceiling.
I get flu shot and others but Not in a hurry getting any New vaccine by any maker. I'll wait to see the Real results of 10's of Thousands and month later at minimum.
Many of health staff and others won't take a rush FDA approval for anything because many FDA approvals even done the "slow way" have big problems. Like Many Dr's won't proscribe Lyrica now because so many side effects, allergic reactions and worse then you have to get off the drug having more issues.
------------------ Dr. Ian Malcolm: Yeah, but your scientists were so preoccupied with whether or not they could, they didn't stop to think if they should. (Jurassic Park)
"Now that the results of these trials are coming in and looking very good, do we, as a thankful nation owe it to the 1/2 that got the placebo to ensure they get the real deal among the first folks that receive the mass immunizations?" You owe them Nothing. People got the placebo may have gotten lucky months or more later.
I've been thru many studies and won't do drug and other tests no matter if they pay you or not. Why? 1. Most studies including drug and other med studies have "fine print" in the contract etc. that often say you're on your own if have major problems. Most people never read before signing. Most studies I've taken have about same risk as mowing grass and "normal" things people do anyway even if I'm in safety gear to do them. Several have me in harness similar roofers and other hanging off small cranes or beam tied to ceiling.
I get flu shot and others but Not in a hurry getting any New vaccine by any maker. I'll wait to see the Real results of 10's of Thousands and month later at minimum.
Many of health staff and others won't take a rush FDA approval for anything because many FDA approvals even done the "slow way" have big problems. Like Many Dr's won't proscribe Lyrica now because so many side effects, allergic reactions and worse then you have to get off the drug having more issues.
I have great difficulty getting my mind around those placebo folks wanting to "wait to see the Real results of 10's of Thousands and month later at minimum." I doubt they were of a risk aversion mindset to begin with and probably aren't going to be when the vaccines come available.
An interesting question... Edited: After putting some thought into this, I do believe those “guinea pigs” should be allowed some “line cutting” opportunities but , I doubt most would take advantage of it. Personally, I’d wait until others with greater needs than myself. But, I will eventually get the vaccination when my turn comes. Health care workers (those frequently exposed), the elderly and those with weaker immune systems should be first inline.
Rams
[This message has been edited by blackrams (edited 12-03-2020).]
I have some very outdated experience in this area of study.
Yes I think it would be a thoughtful "thank you" to the study population that got placebo. Owed, maybe not unless written in to the protocol...but probably the right thing to do. I know that this is in the protocol for one of the studies (probably Oxford one).
It may be a little more complicated, as subjects are normally monitored after a study is unblinded for further data and health monitoring. Once you have jabbed all of the placebos with vaccine you have lost your control group for any further study.
I think they should have the opportunity to get the vaccine whenever they'd like. I understand they signed waivers and maybe got paid to take part in the guinea pig olympics but they were still willing to take big risks. Front line workers, elderly first. Test subjects (who got the placebo) 2nd, high risk folks (such as myself) next then the masses.
Were the trial volunteers, in reality, trying to "line cut" by volunteering for the trial? They are plainly not worried about the vaccine, and more worried about the virus. So half got the placebo instead of the real thing. They were told their odds were 50-50, so they have no right to complain. Now they're being asked to sign a consent form asking them to wait two years for the real vaccine? And your answer is "I am owed that vaccine."?
No. No, you're not owed anything. That's what "volunteer" means. Whether you volunteered for altruistic or selfish reasons, you volunteered. So don't sign the form. Quit the trial. Nobody's going to jail over this. It looks like the lady wanted to go to the front of the line. She was offered a 50-50 chance of getting there, and lost. Now, like Hudini, she's peeved. I've no sympathy for her. Get in line with the rest of us.
Now, Don, you are the kind of person who will volunteer because it's the right thing to do. But you're honest enough to know that you may get the short end of the stick, and accept that risk. You'd only expect what you were promised on the paper you signed. That's what volunteer means.
It also bothers me that we're, again, expanding the definition of "hero" to include these people.
Were the trial volunteers, in reality, trying to "line cut" by volunteering for the trial? They are plainly not worried about the vaccine, and more worried about the virus. So half got the placebo instead of the real thing. They were told their odds were 50-50, so they have no right to complain. Now they're being asked to sign a consent form asking them to wait two years for the real vaccine? And your answer is "I am owed that vaccine."?
No. No, you're not owed anything. That's what "volunteer" means. Whether you volunteered for altruistic or selfish reasons, you volunteered. So don't sign the form. Quit the trial. Nobody's going to jail over this. It looks like the lady wanted to go to the front of the line. She was offered a 50-50 chance of getting there, and lost. Now, like Hudini, she's peeved. I've no sympathy for her. Get in line with the rest of us.
Now, Don, you are the kind of person who will volunteer because it's the right thing to do. But you're honest enough to know that you may get the short end of the stick, and accept that risk. You'd only expect what you were promised on the paper you signed. That's what volunteer means.
It also bothers me that we're, again, expanding the definition of "hero" to include these people.
I never really bothered much with the paperwork I had to sign anywhere.
I'm of the opinion, that the medical frontline workers and 1st responders, AND that .16% of our adult population that volunteered to step up and take the risk that so many others were afraid to, are owed something more than what a contract may stipulate., whether they expect it or not.
Were the trial volunteers, in reality, trying to "line cut" by volunteering for the trial? They are plainly not worried about the vaccine, and more worried about the virus. So half got the placebo instead of the real thing. They were told their odds were 50-50, so they have no right to complain. Now they're being asked to sign a consent form asking them to wait two years for the real vaccine? And your answer is "I am owed that vaccine."?
No. No, you're not owed anything. That's what "volunteer" means. Whether you volunteered for altruistic or selfish reasons, you volunteered. So don't sign the form. Quit the trial. Nobody's going to jail over this. It looks like the lady wanted to go to the front of the line. She was offered a 50-50 chance of getting there, and lost. Now, like Hudini, she's peeved. I've no sympathy for her. Get in line with the rest of us.
Now, Don, you are the kind of person who will volunteer because it's the right thing to do. But you're honest enough to know that you may get the short end of the stick, and accept that risk. You'd only expect what you were promised on the paper you signed. That's what volunteer means.
It also bothers me that we're, again, expanding the definition of "hero" to include these people.
I really like this post. The liberal in me might find it a bit cold-hearted, but the conservative in me definitely recognizes the truth of it.
That being said, it would be a nice gesture to offer it to them in some kind of expedited manner.
On a side note: I have never gotten a flu shot in my life. It's not that I don't believe in their effectiveness, I have just been programmed (raised) to "tuff it out". So I don't know exactly how I expect that programming to just simply disappear this time around.
Will I take the shot? If anyone should know the answer to that question shouldn't that be me? Because I have absolutely no idea if i'm going to or not.
I hope they (DeepState, Democrats, The Machine, whatever) make us*. Save me from throwing a fit defending a belief (anti-whatever) I don't even necessarily believe in.
Now they're being asked to sign a consent form asking them to wait two years for the real vaccine?
I guess I'm a little puzzled why this wouldn't have all been agreed upon to prior to the testing. These people already all signed consent forms at the start of the trial. Did the researchers bang their foreheads with the palms of their hands after the testing was done when they realized... "Damn, the volunteers who got the placebo now need to wait two years for the real thing, otherwise our trial is not 100% kosher. Get them to sign another waiver!" This would seem like one hell of an oversight.
If this potential two year wait wasn't made clear to every volunteer from the get-go, then that's on the researchers, not the volunteers. And if it was made clear, then I'd say that the volunteers who received the placebo should not receive any special consideration to jump the cue if they now refuse to wait the two years as part of the study.
I have some very outdated experience in this area of study.
Yes I think it would be a thoughtful "thank you" to the study population that got placebo. Owed, maybe not unless written in to the protocol...but probably the right thing to do. I know that this is in the protocol for one of the studies (probably Oxford one).
It may be a little more complicated, as subjects are normally monitored after a study is unblinded for further data and health monitoring. Once you have jabbed all of the placebos with vaccine you have lost your control group for any further study.
Cheers PK
According to Dr. Fauci, The way to continue the study (with all participants being vaccinated) would be to give the study participants another round or two of shots. Those who received the placebo would receive the vaccine and those who got the vaccine would get the placebo. The participants would still not be told who got what in the beginning. That way, the study could continue with the two groups (different dates of vaccination) and provide even better data.
It might make the study continue but would not help for any further long term post trial safety data.
Please enlighten me as to what safety data you're referring to.
The vast majority of the population has not received any vaccinations which is precisely where the placebo participants are. Any long term post trial data of non-vaccinated people would be available in the general population I would think. Having two different groups with separate vaccination dates would provide significantly more safety data reference the actual vaccine.
Maybe I'm simply not understanding your point. Please enlighten me.
Please enlighten me as to what safety data you're referring to.
The vast majority of the population has not received any vaccinations which is precisely where the placebo participants are. Any long term post trial data of non-vaccinated people would be available in the general population I would think. Having two different groups with separate vaccination dates would provide significantly more safety data reference the actual vaccine.
Maybe I'm simply not understanding your point. Please enlighten me.
Rams
I'll give it a shot. 1. The 'double blind' aspect would no longer be valid if the general population was used and there would be questions whether the placebo, the vaccine or the virus in the wild (and think perhaps, mutation) caused the problems that might would arise. 2. the months already invested in the trials would be lost if the general population's reaction (or lack thereof) was suddenly to be used as bellweather for the efficacy or any side effect.
This trial protocol is not a new one. It was pretty much used for the Salk 'killed' polio vaccines 60+ yrs ago, tho it also included a portion of the volunteers as a no placebo observed group that all got the real thing. Salk was adamantly against a placebo, claiming it would b on his shoulders if a placebo patient contracted the dreaded polio while involved in the trial, and it was a responsibility he and others took very seriously. In Salk's words: "a ‘beautiful’ ... experiment over which the epidemiologist could become quite ecstatic but [which] would make the humanitarian shudder.” Many researchers at the time were concerned about the Salk vaccine because it was the first big inactivated vaccine to be introduced by trial in the US and about 1/2 the medical establishment thought a modified live (attenuated) form was the only proper way to go. Sabin introduced one later which was also a resounding success.
There was no problem back then getting parents to volunteer their children, probably because it was primarily children that were most likely to get polio.
[This message has been edited by maryjane (edited 12-03-2020).]
I'll give it a shot. 1. The 'double blind' aspect would no longer be valid if the general population was used and there would be questions whether the placebo, the vaccine or the virus in the wild (and think perhaps, mutation) caused the problems that might would arise. 2. the months already invested in the trials would be lost if the general population's reaction (or lack thereof) was suddenly to be used as bellweather for the efficacy or any side effect.
This trial protocol is not a new one. It was pretty much used for the Salk 'killed' polio vaccines 60+ yrs ago, tho it also included a portion of the volunteers as a no placebo observed group that all got the real thing. Salk was adamantly against a placebo, claiming it would b on his shoulders if a placebo patient contracted the dreaded polio while involved in the trial, and it was a responsibility he and others took very seriously. In Salk's words: "a ‘beautiful’ ... experiment over which the epidemiologist could become quite ecstatic but [which] would make the humanitarian shudder.” Many researchers at the time were concerned about the Salk vaccine because it was the first big inactivated vaccine to be introduced by trial in the US and about 1/2 the medical establishment thought a modified live (attenuated) form was the only proper way to go. Sabin introduced one later which was also a resounding success.
There was no problem back then getting parents to volunteer their children, probably because it was primarily children that were most likely to get polio.
While that may be a valid reason, I (personally) believe better and more data reference the vaccine and it's effectiveness and safety would be gained using Dr. Fauci's proposal. I don't pretend to be qualified to make or defend that opinion. Shrug.
Although paraphrased, this is what I heard him say when asked about how to address placebo participants on whatever news I had tuned in this morning.
quote
According to Dr. Fauci, The way to continue the study (with all participants being vaccinated) would be to give the study participants another round or two of shots. Those who received the placebo would receive the vaccine and those who got the vaccine would get the placebo. The participants would still not be told who got what in the beginning. That way, the study could continue with the two groups (different dates of vaccination) and provide even better data.
I'll try to find it. Found it.
quote
Dr. Fauci sketched out one possible way to balance the obligation owed to people who took the placebo against the need for more data from the trials. Vaccine makers could give everyone who got the placebo the vaccine — while also giving everyone who got the vaccine the placebo. None of the trial participants would know which order they got the doses. The trial could therefore continue to be blinded.
In that scenario, researchers would be able to compare the two groups to see if the vaccine’s protection faded over time. The newly vaccinated placebo group would still enjoy a strong immune response, while the people originally vaccinated starting in July 2020 might have a weaker one. If both groups remained at low risk of infection, that would show that the vaccine was long-lasting.
“In my mind, that’s one really good option of fulfilling the ethical constraints at the same time as you get new knowledge,” Dr. Fauci said.
I'll give it a shot. 1. The 'double blind' aspect would no longer be valid if the general population was used and there would be questions whether the placebo, the vaccine or the virus in the wild (and think perhaps, mutation) caused the problems that might would arise. 2. the months already invested in the trials would be lost if the general population's reaction (or lack thereof) was suddenly to be used as bellweather for the efficacy or any side effect.
This trial protocol is not a new one. It was pretty much used for the Salk 'killed' polio vaccines 60+ yrs ago, tho it also included a portion of the volunteers as a no placebo observed group that all got the real thing. Salk was adamantly against a placebo, claiming it would b on his shoulders if a placebo patient contracted the dreaded polio while involved in the trial, and it was a responsibility he and others took very seriously. In Salk's words: "a ‘beautiful’ ... experiment over which the epidemiologist could become quite ecstatic but [which] would make the humanitarian shudder.” Many researchers at the time were concerned about the Salk vaccine because it was the first big inactivated vaccine to be introduced by trial in the US and about 1/2 the medical establishment thought a modified live (attenuated) form was the only proper way to go. Sabin introduced one later which was also a resounding success.
There was no problem back then getting parents to volunteer their children, probably because it was primarily children that were most likely to get polio.
The FDA has to approve all vaccines in this country for human use.
The FDA's charter is to determine SAFETY and EFFICACY
In order to receive clearance for use from the FDA, the manufacturer MUST BY FEDERAL LAW comply with all regulations under Title 21 CFR (Code of Federal Regulations) which is Federal law enacted by Congress.
Those requirements include submitting a test and clinical study plan to the FDA and having that plan approved. The manufacturer then follows that plan and periodically notifies the FDA if any changes are necessary or if unforeseen problems arise.
Once the clinical study trial is completed the manufacturer submits the results data to the FDA for review and, (hopefully), for clearance to market the pharmaceutical to the public. The data submitted to the FDA must demonstrate that the pharmaceutical is both SAFE and EFFECTIVE.
The act of administering the pharmaceutical to the control, (placebo) group in the clinical trial would INVALIDATE the study and would be cause for the FDA to immediately and lawfully withhold any approval of the product. AS THEY SHOULD
"Operation Warp Speed" obtained concessions from the FDA regarding many things in 21CFR, most importantly in drastically compressing the time usually required to run a pharmaceutical clinical trial.
"Rewarding" clinical trial participants by effectively destroying the already foreshortened trial is foolhardy and dangerous.
Members of the public that wish to receive any of the COV2 vaccines should both be warned that they are knowingly taking a pharmaceutical that has NOT completed a traditional clinical trial AND they should be required to sign a wavier that they have been so advised and hold both the manufacturer and the U.S. government harmless.
[This message has been edited by randye (edited 12-03-2020).]
"Rewarding" clinical trial participants by effectively destroying the already foreshortened trial is foolhardy and dangerous.
Well, there ya have it. I'm not qualified to even go there.
But, my prediction is that MadernaTX and Pfizer will both let those who were volunteers/participants of the study know what they got and then we'll see a mass exodus of the placebo receiving participants from the study so they can get the vaccine. That in itself will basically destroy the placebo section of the study. That's not to suggest that these folks volunteered just to get the vaccine but, I doubt they'll be very happy if denied it either. They can opt out of the study at any point and still received all of the medical surveillance they were promised.
Rams
[This message has been edited by blackrams (edited 12-03-2020).]
Well, there ya have it. I'm not qualified to even go there.
But, my prediction is that MadernaTX and Pfizer will both let those who were volunteers/participants of the study know what they got and then we'll see a mass exodus of the placebo receiving participants from the study so they can get the vaccine. That in itself will basically destroy the placebo section of the study. That's not to suggest that these folks volunteered just to get the vaccine but, I doubt they'll be very happy if denied it either. They can opt out of the study at any point and still received all of the medical surveillance they were promised.
Rams
Yep, there's nothing to prevent any of the volunteers from exiting the study at any time and nothing to prevent them from getting the vaccine once the general public begins receiving it. Extremely unlikely in the real world today, that FDA or any other govt agency would withdraw approval if or because control/placebo folks started receiving any approved Covid vaccine.
[This message has been edited by maryjane (edited 12-04-2020).]
Yep, there's nothing to prevent any of the volunteers from exiting the study at any time and nothing to prevent them from getting the vaccine once the general public begins receiving it. Extremely unlikely in the real world today, that FDA or any other govt agency would withdraw approval if or because control/placebo folks started receiving any approved Covid vaccine.
If the study is still ongoing, how would they even know if they got a real vaccine or not? Isn't a study, typically years long, something like 7 years? Why would the study end just because the product is on the market?
If the study is still ongoing, how would they even know if they got a real vaccine or not? Isn't a study, typically years long, something like 7 years? Why would the study end just because the product is on the market?
This study is supposed to be two years.
Edited: Correction, 25 months.
Rams
[This message has been edited by blackrams (edited 12-07-2020).]
Ok, so,...... why would anyone in the study ask for or receive the "experimental" vaccine so soon? The y are the control group of the experiment? If, for example,... the entire group of "lab rats" get the test stuff, who is tested and what are they compared to? How is this a legitimate research project?
