Johnson & Johnson pauses COVID-19 vaccine trial after participant experiences unexplained illness

Vaccine trials (placebo and actual vaccines) are given only to perfectly healthy, uninfected patients.
Control groups are a well-established, crucial component of clinical trials.

The Britannica Encyclopedia can explain this far better:

Control group, the standard to which comparisons are made in an experiment. Many experiments are designed to include a control group and one or more experimental groups; in fact, some scholars reserve the term experiment for study designs that include a control group. Ideally, the control group and the experimental groups are identical in every way except that the experimental groups are subjected to treatments or interventions believed to have an effect on the outcome of interest while the control group is not. Inclusion of a control group greatly strengthens researchers’ ability to draw conclusions from a study. Indeed, only in the presence of a control group can a researcher determine whether a treatment under investigation truly has a significant effect on an experimental group, and the possibility of making an erroneous conclusion is reduced. See also scientific method.

A typical use of a control group is in an experiment in which the effect of a treatment is unknown and comparisons between the control group and the experimental group are used to measure the effect of the treatment. For instance, in a pharmaceutical study to determine the effectiveness of a new drug on the treatment of migraines, the experimental group will be administered the new drug and the control group will be administered a placebo (a drug that is inert, or assumed to have no effect).

Each group is then given the same questionnaire and asked to rate the effectiveness of the drug in relieving symptoms. If the new drug is effective, the experimental group is expected to have a significantly better response to it than the control group. Another possible design is to include several experimental groups, each of which is given a different dosage of the new drug, plus one control group. In this design, the analyst will compare results from each of the experimental groups to the control group.

This type of experiment allows the researcher to determine not only if the drug is effective but also the effectiveness of different dosages. In the absence of a control group, the researcher’s ability to draw conclusions about the new drug is greatly weakened, due to the placebo effect and other threats to validity. Comparisons between the experimental groups with different dosages can be made without including a control group, but there is no way to know if any of the dosages of the new drug are more or less effective than the placebo.

It is important that every aspect of the experimental environment be as alike as possible for all subjects in the experiment. If conditions are different for the experimental and control groups, it is impossible to know whether differences between groups are actually due to the difference in treatments or to the difference in environment. For example, in the new migraine drug study, it would be a poor study design to administer the questionnaire to the experimental group in a hospital setting while asking the control group to complete it at home. Such a study could lead to a misleading conclusion, because differences in responses between the experimental and control groups could have been due to the effect of the drug or could have been due to the conditions under which the data were collected. For instance, perhaps the experimental group received better instructions or was more motivated by being in the hospital setting to give accurate responses than the control group.

A control group study can be managed in two different ways. In a single-blind study, the researcher will know whether a particular subject is in the control group, but the subject will not know. In a double-blind study, neither the subject nor the researcher will know which treatment the subject is receiving. In many cases, a double-blind study is preferable to a single-blind study, since the researcher cannot inadvertently affect the results or their interpretation by treating a control subject differently from an experimental subject.
 

I'm convinced all of the nonsensical placebo studies are the route-cause and hold-up to cancer cures, along with other life-threatening and terminal illnesses, account drug makers and researchers frittering away valuable time, resources, and monies on asinine studies instead of applying their efforts towards actual cures.

If I'm not mistaken, it's referred to as - "job creation" or "job security".
 
StarSong said:
Vaccine trials (placebo and actual vaccines) are given only to perfectly healthy, uninfected patients.
Control groups are a well-established, crucial component of clinical trials.

The Britannica Encyclopedia can explain this far better:

Control group, the standard to which comparisons are made in an experiment. Many experiments are designed to include a control group and one or more experimental groups; in fact, some scholars reserve the term experiment for study designs that include a control group. Ideally, the control group and the experimental groups are identical in every way except that the experimental groups are subjected to treatments or interventions believed to have an effect on the outcome of interest while the control group is not. Inclusion of a control group greatly strengthens researchers’ ability to draw conclusions from a study. Indeed, only in the presence of a control group can a researcher determine whether a treatment under investigation truly has a significant effect on an experimental group, and the possibility of making an erroneous conclusion is reduced. See also scientific method.

A typical use of a control group is in an experiment in which the effect of a treatment is unknown and comparisons between the control group and the experimental group are used to measure the effect of the treatment. For instance, in a pharmaceutical study to determine the effectiveness of a new drug on the treatment of migraines, the experimental group will be administered the new drug and the control group will be administered a placebo (a drug that is inert, or assumed to have no effect).

Each group is then given the same questionnaire and asked to rate the effectiveness of the drug in relieving symptoms. If the new drug is effective, the experimental group is expected to have a significantly better response to it than the control group. Another possible design is to include several experimental groups, each of which is given a different dosage of the new drug, plus one control group. In this design, the analyst will compare results from each of the experimental groups to the control group.

This type of experiment allows the researcher to determine not only if the drug is effective but also the effectiveness of different dosages. In the absence of a control group, the researcher’s ability to draw conclusions about the new drug is greatly weakened, due to the placebo effect and other threats to validity. Comparisons between the experimental groups with different dosages can be made without including a control group, but there is no way to know if any of the dosages of the new drug are more or less effective than the placebo.

It is important that every aspect of the experimental environment be as alike as possible for all subjects in the experiment. If conditions are different for the experimental and control groups, it is impossible to know whether differences between groups are actually due to the difference in treatments or to the difference in environment. For example, in the new migraine drug study, it would be a poor study design to administer the questionnaire to the experimental group in a hospital setting while asking the control group to complete it at home. Such a study could lead to a misleading conclusion, because differences in responses between the experimental and control groups could have been due to the effect of the drug or could have been due to the conditions under which the data were collected. For instance, perhaps the experimental group received better instructions or was more motivated by being in the hospital setting to give accurate responses than the control group.

A control group study can be managed in two different ways. In a single-blind study, the researcher will know whether a particular subject is in the control group, but the subject will not know. In a double-blind study, neither the subject nor the researcher will know which treatment the subject is receiving. In many cases, a double-blind study is preferable to a single-blind study, since the researcher cannot inadvertently affect the results or their interpretation by treating a control subject differently from an experimental subject.
Click to expand...
The way I see it... a controlled waste of time conducting mickey-mouse experiments.

Rubbish (the bold highlighted portion)! If I'm going to get a headache, it doesn't matter if I'm in a hospital setting, in a home setting, or out for a walk around the block, I'm getting a headache. What a crock of (you know what).
 

Aunt Marg said:
So where is the benefit in subjecting a perfectly healthy and uninfected percentage of participants with imaginary, make-believe drugs and medicine?

A cure for Covid-19 will be found feeding Aunt Marg (who's perfectly healthy) a few Smarties or M&M's each day? The same Aunt Marg that doesn't have Covid-19? The same Aunt Marg who has never had Covid-19?
Click to expand...

The people who volunteer for studies know in advance they won't know which group they're in. They know there's a 50/50 chance they'll get an injection of plain saline while the other group gets the vaccine in their shot. There's risk both ways since the vaccine being studied may turn out to be horribly unsafe.

You have to have a control group that gets nothing in order to compare results to the vaccine group.
 
Aunt Marg said:
So where is the benefit in subjecting a perfectly healthy and uninfected percentage of participants with imaginary, make-believe drugs and medicine?

A cure for Covid-19 will be found feeding Aunt Marg (who's perfectly healthy) a few Smarties or M&M's each day? The same Aunt Marg that doesn't have Covid-19? The same Aunt Marg who has never had Covid-19?
Click to expand...

Here's how the vaccine would be tested: Two groups, of equal age and approximately equal health status, get a shot. Group A gets the vaccine; Group B gets plain water or whatever they use for these placebos.

Then, both groups get a mild dose of the coronavirus. If a lot more people in Group B (the placebo group) get symptoms, while more people in Group A feel just fine, that would prove that the vaccine is at least somewhat effective.

At least, I think that is how it works. They would probably not get enough of the virus to make them really ill.
 
AnnieA said:
The people who volunteer for studies know they won't know which group they're in. They know there's a 50/50 chance they'll get an injection of plain saline while the other group gets the vaccine in their shot. There's risk both ways since the vaccine being studied may turn out to be unsafe.

You have to have a control group that gets nothing in order to compare results to the vaccine group.
Click to expand...
I'm glad there's folks like yourself Annie, who feel confident and support what goes on in clinical studies and trials.

If a percentage of people develop salmonella poisoning, and are throwing-up violently, let's conduct a study with perfectly healthy people.

Well take 100 test subjects (100% perfectly healthy people), inject half with salmonella (the real thing), while injecting the other half with a make-believe drug, and we'll split the test subjects/volunteers up into two categories, the A category, or experimental group, and the B category, or controlled group.

After everyone is injected and 50 out of the 100 test subjects start heaving their guts out immediately, it should be safe to conclude that the study was a success, that being those who were injected with the real salmonella bug got sick, while those who received the placebo effect remained perfectly healthy.

Conclusion, salmonella makes people sick.

Later that day in the lab... researchers are seen sitting and standing around scratching their heads as to what to do about finding a cure or remedy for salmonella poisoning.
 
Sunny said:
Here's how the vaccine would be tested: Two groups, of equal age and approximately equal health status, get a shot. Group A gets the vaccine; Group B gets plain water or whatever they use for these placebos.

Then, both groups get a mild dose of the coronavirus. If a lot more people in Group B (the placebo group) get symptoms, while more people in Group A feel just fine, that would prove that the vaccine is at least somewhat effective.

At least, I think that is how it works. They would probably not get enough of the virus to make them really ill.
Click to expand...
So far as I've heard, none of the vaccine trials are intentionally infecting people with the virus. Since there's no cure, infecting people could endanger their lives, their long term health, and the lives and health of others because it's so contagious.
 
Last edited:
Aunt Marg said:
Does that make sense to you?

If I have a serious illness or disease and require medication, and start on an experimental drug, then so be it, but why have my sister participate (who is perfectly healthy) and give her a sugar pill or make-believe injection, and then test her after?

Test my sister for what? To see if the sugar pill affected her? To see if the empty syringe injection made her sick? Reduced her good health? Restored her poor vision back to 20/20? Gave her super-human strength? Allowed her to run twice as fast as any other human being in history?

What benefit is there in treating a perfectly healthy individual with something make-believe or imaginary?

It's my understanding that a cure or a vaccination for the Covid Virus was front and centre, not wasting time and resources on placebo effects.
Click to expand...

All large scale clinical trials use placebos. It's not a waste of time, it's absolutely essential to determining the efficacy and safety of the drug.
 
JimBob1952 said:
All large scale clinical trials use placebos. It's not a waste of time, it's absolutely essential to determining the efficacy and safety of the drug.
Click to expand...
As far as I'm concerned, Jim, there is no safety involved with any drug. It's all about money, and if the drug or vaccine doesn't instantly kill a patient taking it, the drug/vaccine is passed, signed off on, and released for use.

I have zero faith or respect for drug-makers.
 
Aunt Marg said:
As far as I'm concerned, Jim, there is no safety involved with any drug. It's all about money, and if the drug or vaccine doesn't instantly kill a patient taking it, the drug/vaccine is passed, signed off on, and released for use.

I have zero faith or respect for drug-makers.
Click to expand...


That's fine. I hope you don't take any medications. If you check into a hospital tell them not to give you any. You wouldn't want to enrich any of the greedy pharma companies.

I feel the same way about food companies. Food is necessary for life, but food companies are only in it for the money. That's why I don't eat food. I can't stand the idea of someone making a profit off my hunger.
 
JimBob1952 said:
That's fine. I hope you don't take any medications. If you check into a hospital tell them not to give you any. You wouldn't want to enrich any of the greedy pharma companies.

I feel the same way about food companies. Food is necessary for life, but food companies are only in it for the money. That's why I don't eat food. I can't stand the idea of someone making a profit off my hunger.
Click to expand...
Jim, if there's one thing for certain, I'm going to indulge in taking as many medications and drug treatments as I can, providing the side-effects associated with such medicines isn't too severe, and I will continue to question, challenge, and distrust any/all information that drug-makers release, and by no means will I ever compromise and risk my good health by offering my body as a test subject related to research in the name of the betterment of modern day cures or medicine.

As for the trailblazing breakthrough you've happened upon where you were able to completely wean yourself off any/all foods, a big congratulations to you! So envious I am! :)
 
JimBob1952 said:
PS you are a good sport to put up with my snark!
Click to expand...
Jim. Remember a few weeks back where I mentioned in a post of mine that I always try and shake hands after a debate, a disagreement, or even a warm and heated conversation with a member or members afterwards?

Well that's me today, nothing has changed. :)

I respect and appreciate that we all possess strong beliefs and opinions related to certain things, so understandably, we will never all agree, but if we can show up here without calling people names and such and leave the conversations feeling as though we still have a friend or friends on the forum, then in my view, that's a successful day for me.
 
Aunt Marg said:
Jim. Remember a few weeks back where I mentioned in a post of mine that I always try and shake hands after a debate, a disagreement, or even a warm and heated conversation with a member or members afterwards?

Well that's me today, nothing has changed. :)

I respect and appreciate that we all possess strong beliefs and opinions related to certain things, so understandably, we will never all agree, but if we can show up here without calling people names and such and leave the conversations feeling as though we still have a friend or friends on the forum, then in my view, that's a successful day for me.
Click to expand...
Well said!
 
StarSong said:
Which is precisely why vaccine and clinical trials aren't done the way you described.

Perhaps this will help explain it:
https://www.npr.org/sections/health...can-you-tell-if-a-covid-19-vaccine-is-working
Click to expand...
That's interesting, Starsong. I didn't know it worked like that. So they just give either the vaccine or a placebo to a very large number of people, and sit back and see what happens?

But what if the group that received the vaccine is very careless about social distancing, or worse, arrogantly defying the rules of social distancing? Let's say the drug works, and very few of them get sick.

But the placebo group practice careful social distancing, and manage to keep the numbers down to the equivalent of the vaccine group? It would look like maybe herd immunity has finally been reached, or both groups were very lucky. But it would appear to "prove" that the vaccine didn't work at all, even when it did.
 
Sunny said:
That's interesting, Starsong. I didn't know it worked like that. So they just give either the vaccine or a placebo to a very large number of people, and sit back and see what happens?

But what if the group that received the vaccine is very careless about social distancing, or worse, arrogantly defying the rules of social distancing? Let's say the drug works, and very few of them get sick.

But the placebo group practice careful social distancing, and manage to keep the numbers down to the equivalent of the vaccine group? It would look like maybe herd immunity has finally been reached, or both groups were very lucky. But it would appear to "prove" that the vaccine didn't work at all, even when it did.
Click to expand...
People's behavior typically evens out when tens of thousands are being studied. Researchers choose roughly equal numbers of various ages, races, socioeconomic strata, genders, geographic area, etc. in each cohort.

It's not perfect but like with anything that has a margin of error, it works out to be good enough when significant numbers are involved.
 

You must log in or register to reply here.

Back
Top