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



## Robert59 (Oct 13, 2020)

Johnson & Johnson says it has temporarily paused its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant, delaying one of the highest-profile efforts to contain the global pandemic.

https://www.abc.net.au/news/2020-10...19-vaccine-trial-coronavirus-illness/12761752


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## Keesha (Oct 13, 2020)

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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## Aunt Marg (Oct 13, 2020)

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!


I am seething with anger over knowing placebo effects are being toyed around with at this time!


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## AnnieA (Oct 13, 2020)

Aunt Marg said:


> I am seething with anger over knowing placebo effects are being toyed around with at this time!



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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## Sunny (Oct 13, 2020)

Well, it depends on what that "not always clear" thing means.  Did it mean that it wasn't made clear in the report (a writing error?), or that the researchers themselves weren't clear about whether this was one of the "placebo" people or not, which would probably invalidate the whole study.


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## Keesha (Oct 13, 2020)

AnnieA said:


> They're not doing it for placebo effects.
> 
> 
> The placebo is given for the control group in the study.
> ...


Agree with everything you said BUT should they not be keeping records of this to know who got what?


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## JimBob1952 (Oct 13, 2020)

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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## JimBob1952 (Oct 13, 2020)

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.


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## StarSong (Oct 13, 2020)

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."*


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## StarSong (Oct 13, 2020)

AnnieA said:


> They're not doing it for placebo effects.


I figured Aunt Marg was making a joke.


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## Aunt Marg (Oct 13, 2020)

AnnieA said:


> They're not doing it for placebo effects.
> 
> 
> The placebo is given for the control group in the study.
> ...


Thanks, Annie, clear as mud.


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## Aunt Marg (Oct 13, 2020)

StarSong said:


> I figured Aunt Marg was making a joke.


I wasn't making a joke.


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## AmberTea (Oct 13, 2020)

>scary<


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## win231 (Oct 13, 2020)

With the previous adverse reaction, they mentioned "Transverse Myelitis," which is neurological.  And devastating.


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## Kaila (Oct 13, 2020)

Keesha said:


> it wasn’t always clear whether the person suffering the adverse reaction received a placebo or the treatment!’



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.


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## StarSong (Oct 13, 2020)

Aunt Marg said:


> I wasn't making a joke.


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!


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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## Keesha (Oct 13, 2020)

Aunt Marg said:


> Thanks, Annie, clear as mud.


Yep!


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## Aunt Marg (Oct 13, 2020)

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*."
> ...


I must be missing something. I have always understood placebo studies weren't the real thing.


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## StarSong (Oct 13, 2020)

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.


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## StarSong (Oct 13, 2020)

Aunt Marg said:


> I must be missing something. I have always understood placebo studies weren't the real thing.


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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## Aunt Marg (Oct 13, 2020)

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.


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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## StarSong (Oct 13, 2020)

@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.


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## Aunt Marg (Oct 13, 2020)

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.


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## StarSong (Oct 13, 2020)

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.
> 
> ...


That's not how drug trials work.  When someone is dying, placebos are off the table.


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## Aunt Marg (Oct 13, 2020)

StarSong said:


> That's not how drug trials work.  When someone is dying, placebos are off the table.


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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## StarSong (Oct 13, 2020)

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.


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## Aunt Marg (Oct 13, 2020)

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".


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## Aunt Marg (Oct 13, 2020)

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:
> ...


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).


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## AnnieA (Oct 13, 2020)

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?



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.


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## Sunny (Oct 13, 2020)

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?



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.


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## Aunt Marg (Oct 13, 2020)

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.


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.


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## StarSong (Oct 13, 2020)

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.


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.


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## StarSong (Oct 13, 2020)

Aunt Marg said:


> 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.


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


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## JimBob1952 (Oct 14, 2020)

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?
> 
> ...



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.


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## Aunt Marg (Oct 14, 2020)

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.


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.


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## gennie (Oct 14, 2020)

There are very few absolutes in medicine.  Most treatment is somebody's best guess.


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## JimBob1952 (Oct 14, 2020)

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.




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.


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## Aunt Marg (Oct 14, 2020)

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.


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!


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## JimBob1952 (Oct 14, 2020)

Yes, it's been great for my wallet.  I get a little dizzy sometimes though....


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## JimBob1952 (Oct 14, 2020)

PS you are a good sport to put up with my snark!


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## Aunt Marg (Oct 14, 2020)

JimBob1952 said:


> PS you are a good sport to put up with my snark!


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.


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## todalake (Oct 14, 2020)

Only 2 reasons to take unproven medicine outside of clinical trials.  One,  your an idiot.   Two,  last resort to prevent possible dying.


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## JimBob1952 (Oct 14, 2020)

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.


Well said!


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## Sunny (Oct 14, 2020)

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


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.


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## StarSong (Oct 14, 2020)

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.


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.


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