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

Robert59

Robert59

Well-known Member
Location
Now I live in Tennesee. Did live in Michigan.
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Keesha said:
Crazy. It says ‘some of the participants got placebos yet it wasn’t always clear whether the person suffering the adverse reaction received a placebo or the treatment!’

Are these people doing this clinical trial not taking notes on this?
That in itself is scary!
Wow! Well that was reassuring! Not!
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I am seething with anger over knowing placebo effects are being toyed around with at this time!
 

Aunt Marg said:
I am seething with anger over knowing placebo effects are being toyed around with at this time!
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They're not doing it for placebo effects.


The placebo is given for the control group in the study.

https://www.scribbr.com/methodology/control-group/

Excerpt:

Control groups are essential to experimental design. When researchers are interested in the impact of a new treatment, they randomly divide their study participants into at least two groups:​
​
  • The treatment group (also called the experimental group) receives the treatment whose effect the researcher is interested in.
  • The control group receives either no treatment, a standard treatment whose effect is already known, or a placebo (a fake treatment).

Control groups help ensure the internal validity of your research. You might see a difference over time in your dependent variable in your treatment group. However, without a control group, it is difficult to know whether the change has arisen from the treatment. It is possible that the change is due to some other variables.​
​
If you use a control group that is identical in every other way to the treatment group, you know that the treatment–the only difference between the two groups–must be what has caused the change.​
 
AnnieA said:
They're not doing it for placebo effects.


The placebo is given for the control group in the study.

https://www.scribbr.com/methodology/control-group/

Excerpt:

Control groups are essential to experimental design. When researchers are interested in the impact of a new treatment, they randomly divide their study participants into at least two groups:​
​
  • The treatment group (also called the experimental group) receives the treatment whose effect the researcher is interested in.
  • The control group receives either no treatment, a standard treatment whose effect is already known, or a placebo (a fake treatment).

Control groups help ensure the internal validity of your research. You might see a difference over time in your dependent variable in your treatment group. However, without a control group, it is difficult to know whether the change has arisen from the treatment. It is possible that the change is due to some other variables.​
​
If you use a control group that is identical in every other way to the treatment group, you know that the treatment–the only difference between the two groups–must be what has caused the change.​
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Agree with everything you said BUT should they not be keeping records of this to know who got what?
 
Keesha said:
Crazy. It says ‘some of the participants got placebos yet it wasn’t always clear whether the person suffering the adverse reaction received a placebo or the treatment!’

Are these people doing this clinical trial not taking notes on this?
That in itself is scary!
Wow! Well that was reassuring! Not!
Click to expand...
 
They know who took what.

When there is an adverse event, it has to be investigated by an outside firm to maintain objectivity. That takes a while. There are 60000 people in the study so one adverse event shouldn't be too surprising.
 
From the article:

"It would have to be a serious adverse event. If it was something like prostate cancer, uncontrolled diabetes or a heart attack — they wouldn't stop it for any of those reasons," he said.
"This is likely to be a neurological event."
 
AnnieA said:
They're not doing it for placebo effects.


The placebo is given for the control group in the study.

https://www.scribbr.com/methodology/control-group/

Excerpt:

Control groups are essential to experimental design. When researchers are interested in the impact of a new treatment, they randomly divide their study participants into at least two groups:​
​
  • The treatment group (also called the experimental group) receives the treatment whose effect the researcher is interested in.
  • The control group receives either no treatment, a standard treatment whose effect is already known, or a placebo (a fake treatment).

Control groups help ensure the internal validity of your research. You might see a difference over time in your dependent variable in your treatment group. However, without a control group, it is difficult to know whether the change has arisen from the treatment. It is possible that the change is due to some other variables.​
​
If you use a control group that is identical in every other way to the treatment group, you know that the treatment–the only difference between the two groups–must be what has caused the change.​
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Thanks, Annie, clear as mud.
 
Keesha said:
it wasn’t always clear whether the person suffering the adverse reaction received a placebo or the treatment!’
Click to expand...

I definitely agree, unless they are not allowed to reveal which the particular participant was taking.... to the general public.....
I dont know, of course, whether the reasoning is good enough or not, for the confusing reporting or the stoppage, etc..... just adding the thought I had, regarding that there might be an explanation we are not being completely informed of.
 
Aunt Marg said:
I wasn't making a joke.
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Sorry. I guess I'm not quite understanding your earlier post:
Aunt Marg said:
I am seething with anger over knowing placebo effects are being toyed around with at this time!
Click to expand...
The article says:
"Johnson & Johnson declined to elaborate on the illness due to privacy concerns. It did say that some participants in studies get placebos, and it was not always clear whether a person suffering a serious adverse event in a clinical trial received a placebo or the treatment."

My take is that J & J paused the study while it sorts out (among other things) whether the person involved received a placebo or a vaccine. Since it's a double blind study, that information isn't always immediately available. Therefore the study gets paused until there's certainty.

If said person was receiving a placebo, then the trials will likely proceed apace.
 
StarSong said:
Sorry. I guess I'm not quite understanding your earlier post:

The article says:
"Johnson & Johnson declined to elaborate on the illness due to privacy concerns. It did say that some participants in studies get placebos, and it was not always clear whether a person suffering a serious adverse event in a clinical trial received a placebo or the treatment."

My take is that J & J paused the study while it sorts out (among other things) whether the person involved received a placebo or a vaccine. Since it's a double blind study, that information isn't always immediately available. Therefore the study gets paused until there's certainty.

If said person was receiving a placebo, then the trials will likely proceed apace.
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I must be missing something. I have always understood placebo studies weren't the real thing.
 
Eli Lilly just paused their antibody trials because of potential saety concerns.
https://www.nytimes.com/live/2020/1...s-paused-because-of-potential-safety-concerns

A government-sponsored clinical trial testing an antibody treatment made by the drug company Eli Lilly has been paused because of a “potential safety concern,” according to emails that government officials sent on Tuesday to researchers at testing sites, and confirmed by the company.

The news comes just a day after Johnson & Johnson announced the pause of its coronavirus vaccine trial because of a sick volunteer, and a month after AstraZeneca’s vaccine trial was halted over concerns about two participants who had fallen ill after getting the company’s vaccine.

The Eli Lilly trial was designed to test the benefits of the therapy on hundreds of people hospitalized with Covid-19, compared with a placebo. All study participants also received another experimental drug, remdesivir, which has become commonly used to treat patients with Covid-19. It is unclear how many volunteers were sick, or any details about their illness.

In large clinical trials, such pauses are not unusual, and illness in volunteers is not necessarily the result of the experimental drug or vaccine. Such halts are meant to allow an independent board of scientific experts to review the data and determine whether the event may have been related to the treatment, or occurred by chance.

Enrollment for the Eli Lilly trial, which was sponsored by several branches of the National Institutes of Health and the Department of Veterans Affairs, among others, had been ongoing. But emails sent Tuesday from multiple officials told researchers to stop adding volunteers to the study out of an “abundance of caution.”

In a statement sent over email, Molly McCully, a spokeswoman for Eli Lilly, confirmed the pause. “Safety is of the upmost importance to Lilly,” she said. “Lilly is supportive of the decision by the independent D.S.M.B. to cautiously ensure the safety of the patients participating in this study.”

The N.I.H. and the V.A. did not immediately respond to requests for comment.

Eli Lilly is one of several companies pursuing experimental treatments for Covid-19 that use monoclonal antibodies — mass-produced mimics of immune molecules the human body produces in reaction to the virus.

Eli Lilly’s product is similar to a treatment designed by drug company Regeneron, which developed an antibody therapy given to President Trump after he was diagnosed with Covid-19 earlier this month. Mr. Trump has promoted the treatments, without evidence, as a “cure” for his condition, and has suggested that their approval and widespread distribution could be imminent. The week after the president was treated, both companies applied for emergency clearance for their products from the Food and Drug Administration.

Antibodies can block the coronavirus from infecting cells, and preliminary data from Eli Lilly and Regeneron have hinted they may be able to tamp down the amount of virus in an infected person’s body and reduce their symptoms.
 
Aunt Marg said:
I must be missing something. I have always understood placebo studies weren't the real thing.
Click to expand...
During drug trials, half of the people being tested get the real drug, half get a placebo (basically a sugar pill). Testing subjects don't know which they're getting, nor do the people who interface with them (because they might unwittingly tip their hand). Thus the term, "double blind."

A completely separate group of researchers knows which patients are receiving which. They look at reported symptoms, incidence of related and unrelated disease (did someone who received the actual vaccine happen to catch Covid during the trial?), possible complications, etc.

That's why it might take a little time to figure out what's actually wrong with this person, whether he/she got the vaccine or the placebo, and if so, whether anybody else is exhibiting similar symptoms.
 
StarSong said:
During drug trials, half of the people being tested get the real drug, half get a placebo (basically a sugar pill). Testing subjects don't know which they're getting, nor do the people who interface with them (because they might unwittingly tip their hand). Thus the term, "double blind."

A completely separate group of researchers knows which patients are receiving which. They look at reported symptoms, incidence of related and unrelated disease (did someone who received the actual vaccine happen to catch Covid during the trial?), possible complications, etc.

That's why it might take a little time to figure out what's actually wrong with this person, whether he/she got the vaccine or the placebo, and if so, whether anybody else is exhibiting similar symptoms.
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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.
 
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@Aunt Marg, they wouldn't test her afterwards. People receiving placebos are part of a control group.

For instance, for the sake of argument let's say that 1% of the people in the study have strokes during the course of trial.

If it turns out that roughly half of those strokes occurred in the control group and half in the vaccine group, it will need to be watched further, but isn't necessarily a red flag. However, if it turns out that 3/4 of the strokes occurred in the vaccine group, that would demand serious attention.
Going further with it, if it turned out that 3/4 occurred in the placebo group, the researchers would likely look into whether the vaccine had an unexpected happy effect on stroke incidence.
 
Maybe I have it all wrong.

There are two patients in the intensive care unit at the same hospital, patient A, has Covid-19, is near death, on a ventilator, and not improving, patient B, is also infected with Covid-19, and exhibiting the same near death state.

Let's inject patient A or B with a bogus empty syringe (doesn't matter which patient, as both are on their death beds), and miraculously, by the next morning, the patient that received the magical, make-believe drug through an empty syringe, will jump out of bed fully cured, and exhibit zero trace of ever having been infected with the Covid-19 virus.

Amazing, simply amazing.
 
Aunt Marg said:
Maybe I have it all wrong.

There are two patients in the intensive care unit at the same hospital, patient A, has Covid-19, is near death, on a ventilator, and not improving, patient B, is also infected with Covid-19, and exhibiting the same near death state.

Let's inject patient A or B with a bogus empty syringe (doesn't matter which patient, as both are on their death beds), and miraculously, by the next morning, the patient that received the magical, make-believe drug through an empty syringe, will jump out of bed fully cured, and exhibit zero trace of ever having been infected with the Covid-19 virus.

Amazing, simply amazing.
Click to expand...
That's not how drug trials work. When someone is dying, placebos are off the table.
 
StarSong said:
That's not how drug trials work. When someone is dying, placebos are off the table.
Click to expand...
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?
 

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