RFK will require placebo controlled trials for vaccines

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I was shocked to find out that vaccines weren't double blind with placebos.

How in the F would you possibly administer placebo for horrific infectious disease in an ethical manner? How is science education m the US so bad?

I'm an engineer, I just was surprised that was what was not done in the past when the first vaccines came out.

They were. They just don’t do it for the tweaked or reformulated vaccines. Then they only compare the tweaked version against what came before to see if it’s better. They don’t make people forego any measles vaccine at all in order to trial a reformulated one. That would be unethical and quite frankly, a public health disaster.

You might consider that unethical, but this is *not* the approach followed for pharmaceutical therapeutics. It is 100% not the case that the control arm in a trial for a new cancer drug is the standard of care.

I don’t consider it unethical. I can recognize that different circumstances call for different approaches. Vaccines aren’t treatment drugs.

At some point, the new treatment’s efficacy is compared against the current treatment’s. Sometimes a new drug can be both safe and effective compared to placebo, but not more effective or safer than the presumably cheaper and better studied standard of care, so it dies on the vine.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I was shocked to find out that vaccines weren't double blind with placebos.

How in the F would you possibly administer placebo for horrific infectious disease in an ethical manner? How is science education m the US so bad?

I'm an engineer, I just was surprised that was what was not done in the past when the first vaccines came out.

They were. They just don’t do it for the tweaked or reformulated vaccines. Then they only compare the tweaked version against what came before to see if it’s better. They don’t make people forego any measles vaccine at all in order to trial a reformulated one. That would be unethical and quite frankly, a public health disaster.

You might consider that unethical, but this is *not* the approach followed for pharmaceutical therapeutics. It is 100% not the case that the control arm in a trial for a new cancer drug is the standard of care.

I don’t consider it unethical. I can recognize that different circumstances call for different approaches. Vaccines aren’t treatment drugs.

At some point, the new treatment’s efficacy is compared against the current treatment’s. Sometimes a new drug can be both safe and effective compared to placebo, but not more effective or safer than the presumably cheaper and better studied standard of care, so it dies on the vine.

This response doesn't make sense to me. Your point is that it's okay for therapeutics to be compared to a placebo control group because they'll die in development if they're not better than the standard of care? I don't think that's true at all. A drug can be a success for reasons other than it's safety and efficacy profile (e.g., its dosage form). Also, even if that were true, I'm not sure why it would have any implications for what the control group should be in a study.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I was shocked to find out that vaccines weren't double blind with placebos.

How in the F would you possibly administer placebo for horrific infectious disease in an ethical manner? How is science education m the US so bad?

I'm an engineer, I just was surprised that was what was not done in the past when the first vaccines came out.

They were. They just don’t do it for the tweaked or reformulated vaccines. Then they only compare the tweaked version against what came before to see if it’s better. They don’t make people forego any measles vaccine at all in order to trial a reformulated one. That would be unethical and quite frankly, a public health disaster.

You might consider that unethical, but this is *not* the approach followed for pharmaceutical therapeutics. It is 100% not the case that the control arm in a trial for a new cancer drug is the standard of care.

Yes it is standard of care most of the time, exceptions being if there is no standard or the standard of care has been exhausted.

[Anonymous]

When I was a part of the Pfizer covid trial, there was a placebo group. Which confused me at the time since I thought, isn't the general population the placebo group?? Mostly I was annoyed that I might not actually be protected and had to wait to find out.

I was also pregnant at the time and badly wanted protection for my unborn as well. All turned out well, but I was under the impression that new drugs already have a placebo group either designated or via the population.

[Anonymous]

Anonymous wrote:When I was a part of the Pfizer covid trial, there was a placebo group. Which confused me at the time since I thought, isn't the general population the placebo group?? Mostly I was annoyed that I might not actually be protected and had to wait to find out.

I was also pregnant at the time and badly wanted protection for my unborn as well. All turned out well, but I was under the impression that new drugs already have a placebo group either designated or via the population.

There was a true placebo for COVID vaccines among other medical treatments because there was no established "standard of care" - novel disease and no existing vaccine nor treatment.

[Anonymous]

Placebo use in vaccine trials: Recommendations of a WHO expert panel
https://pmc.ncbi.nlm.nih.gov/articles/PMC4157320/

Randomised, placebo-controlled trials are widely considered the gold standard for evaluating the safety and efficacy of a new vaccine.

[Anonymous]

^^Randomized, placebo-controlled trials are still being used in the development of vaccines. Not always -- sometimes the comparison is current standard of care. But it's not like immunologists have a fit of the vapors at the very idea of it.

[Anonymous]

Anonymous wrote:When I was a part of the Pfizer covid trial, there was a placebo group. Which confused me at the time since I thought, isn't the general population the placebo group?? Mostly I was annoyed that I might not actually be protected and had to wait to find out.

I was also pregnant at the time and badly wanted protection for my unborn as well. All turned out well, but I was under the impression that new drugs already have a placebo group either designated or via the population.

Had it not been for RFK there would not have been a placebo group. As deeply flawed as it was. Baby steps…

[Anonymous]

Lets expose RFK to polio and give him the placebo. This man is a stupid, delusional, ignorant, nutcase.

[Anonymous]

Anonymous wrote:

Anonymous wrote:I was shocked to find out that vaccines weren't double blind with placebos.

Most vaccines go through placebo testing already. Usually happens in Phase III for new vax. Something already cleared say chicken pox, new versions do not need to go through a placebo testing phase because they use the data from the first trial. Just more expense nothing new here.

He wants placebo trials for everything, including vaccines we already know are effective, because he has no science education!

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I was shocked to find out that vaccines weren't double blind with placebos.

Most vaccines go through placebo testing already. Usually happens in Phase III for new vax. Something already cleared say chicken pox, new versions do not need to go through a placebo testing phase because they use the data from the first trial. Just more expense nothing new here.

He wants placebo trials for everything, including vaccines we already know are effective, because he has no science education!

Vaccine expert Paul Offit from Children's Hospital of Philadelphia has a great post on placebo testing. Worth noting that RFK twists his meaning of placebo when he states existing vaccines have not been tested against placebo.

https://pauloffit.substack.com/p/the-casual-cruelty-of-placebo-controlled

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:I was shocked to find out that vaccines weren't double blind with placebos.

How in the F would you possibly administer placebo for horrific infectious disease in an ethical manner? How is science education m the US so bad?

I'm an engineer, I just was surprised that was what was not done in the past when the first vaccines came out.

They were. They just don’t do it for the tweaked or reformulated vaccines. Then they only compare the tweaked version against what came before to see if it’s better. They don’t make people forego any measles vaccine at all in order to trial a reformulated one. That would be unethical and quite frankly, a public health disaster.

You might consider that unethical, but this is *not* the approach followed for pharmaceutical therapeutics. It is 100% not the case that the control arm in a trial for a new cancer drug is the standard of care.

I don’t consider it unethical. I can recognize that different circumstances call for different approaches. Vaccines aren’t treatment drugs.

At some point, the new treatment’s efficacy is compared against the current treatment’s. Sometimes a new drug can be both safe and effective compared to placebo, but not more effective or safer than the presumably cheaper and better studied standard of care, so it dies on the vine.

You can just use the standard of care as the control and directly compare safety and efficacy against that to get the relative difference

[Anonymous]

Europe requires double blind placebo controlled clinical trials. Aren't you all trying to move to Europe? I hate to be the one to tell you, but you're going to encounter the same regulations there.

[Anonymous]

Anonymous wrote:Europe requires double blind placebo controlled clinical trials. Aren't you all trying to move to Europe? I hate to be the one to tell you, but you're going to encounter the same regulations there.

People are going to figure out how to get vaccinations to protect their families from measles, from the flu and from other infectious diseases. Will it be as robust as the herd immunity we have managed to achieve? Absolutely not. We voted to throw that away.

But people will do what they need to do to protect their families. They always have and they always will.
People sought out and pursued the first inoculations.... The vaccines did not come to them.

[Anonymous]

Anonymous wrote:Europe requires double blind placebo controlled clinical trials. Aren't you all trying to move to Europe? I hate to be the one to tell you, but you're going to encounter the same regulations there.

RFK Jr redefined placebo to make it sound like we don't do them. We are not different from Europe on vaccine testing with placebo in practice.