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RFK Jr. to require placebo-controlled studies for new vaccines

npr.org

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Re: RFK Jr. to require placebo-controlled studies for new vaccines

#11

Post by jljljl »

giraffe_lady wrote: post #9
jljljl wrote: post #3

What would be the benefit of a placebo study vs studying the differences between vaccinated and unvaccinated populations? Is the hypothesis that there is some kind of psychosomatic/placebo effect to vaccines, where just the process of getting injected changes outcomes? I find that hard to believe.

Vaccines are already double blind tested with a placebo, but the yearly updates for seasonal vaccines based on a previously tested mechanism are not. The goal of this new requirement is to create delays making it effectively impossible to create annual flu & covid vaccines within these constraints. The reason the updates aren't currently tested this way is because medical research ethics perspectives on the balance o…

Yeah that makes sense. If there was an update of MMR, and there was a 50/50 chance that your child does not actually get vaccinated against MMR, you’d refuse to participate in the trial.

Re: RFK Jr. to require placebo-controlled studies for new vaccines

#12

Post by giraffe_lady »

nailer wrote: post #8

Regardless of what you think of RFK, there's no good reason to think more testing of medicine is a bad thing.

Medical research ethical standards disagree:

> An ethical dilemma arises in a clinical trial when the investigator(s) begin to believe that the treatment or intervention administered in one arm of the trial is significantly outperforming the other arms. A trial should begin with a null hypothesis, and there should exist no decisive evidence that the intervention or drug being tested will be superior to existing treatments, or that it will be completely ineffective. As the trial progresses, the findings may provide sufficient evidence to convince the investigator of the intervention or drug's efficacy. Once a certain threshold of evidence is passed, there is no longer genuine uncertainty about the most beneficial treatment, so there is an ethical imperative for the investigator to provide the superior intervention to all participants.

> https://en.wikipedia.org/wiki/Clinical_equipoise

Re: RFK Jr. to require placebo-controlled studies for new vaccines

#14

Post by KeepFlying »

nailer wrote: post #8

Regardless of what you think of RFK, there's no good reason to think more testing of medicine is a bad thing.

If we had infinite time and resources and pecpuld pause disease for the duration of the trial, then I'd agree with you.

Without that we delay treatment, increase costs, and slow research. And people die while we wait.

Test what's most likely to be a problem, and avoid wasting resources proving what we already know.

Re: RFK Jr. to require placebo-controlled studies for new vaccines

#15

Post by add-sub-mul-div »

nailer wrote: post #8

Regardless of what you think of RFK, there's no good reason to think more testing of medicine is a bad thing.

What if what you think of RFK is that he's clearly throwing up roadblocks to delay or prevent vaccines (ideologically) that the actually legitimate medical community is already on top of testing appropriately?

Re: RFK Jr. to require placebo-controlled studies for new vaccines

#16

Post by nailer »

KeepFlying wrote: post #14
nailer wrote: post #8

Regardless of what you think of RFK, there's no good reason to think more testing of medicine is a bad thing.

If we had infinite time and resources and pecpuld pause disease for the duration of the trial, then I'd agree with you. Without that we delay treatment, increase costs, and slow research. And people die while we wait. Test what's most likely to be a problem, and avoid wasting resources proving what we already know.

> Without that we delay treatment, increase costs, and slow research. And people die while we wait.

This is for new vaccines: we're not halting administration of existing vaccines. And the time taken for testing new vaccines seems reasonable for safety purposes, as it would be for any other medicine.

Re: RFK Jr. to require placebo-controlled studies for new vaccines

#18

Post by clipsy »

nailer wrote: post #16
KeepFlying wrote: post #14

Earlier quoted context omitted.

If we had infinite time and resources and pecpuld pause disease for the duration of the trial, then I'd agree with you. Without that we delay treatment, increase costs, and slow research. And people die while we wait. Test what's most likely to be a problem, and avoid wasting resources proving what we already know.

> Without that we delay treatment, increase costs, and slow research. And people die while we wait. This is for new vaccines: we're not halting administration of existing vaccines. And the time taken for testing new vaccines seems reasonable for safety purposes, as it would be for any other medicine.

"New vaccines" in this case includes, as an example, influenza vaccines that use the same mechanism that has already been proven safe and effective and which need to be developed and deployed in the (short) time between determining the most likely influenza strains for the year and the beginning of flu season.

If annual influenza vaccines cannot be approved in time for flu season and flu deaths increase significantly over the years to come, would you consider that justifiable?

Re: RFK Jr. to require placebo-controlled studies for new vaccines

#19

Post by nailer »

clipsy wrote: post #18
nailer wrote: post #16

Earlier quoted context omitted.

> Without that we delay treatment, increase costs, and slow research. And people die while we wait. This is for new vaccines: we're not halting administration of existing vaccines. And the time taken for testing new vaccines seems reasonable for safety purposes, as it would be for any other medicine.

"New vaccines" in this case includes, as an example, influenza vaccines that use the same mechanism that has already been proven safe and effective and which need to be developed and deployed in the (short) time between determining the most likely influenza strains for the year and the beginning of flu season. If annual influenza vaccines cannot be approved in time for flu season and flu deaths increase significantly…

That’s a good question. No I wouldn’t consider it justifiable. I think newer versions of existing vaccines shouldn’t qualify as ‘new vaccines’.

The article mentions ‘ four years ago is unacceptable so it sounds like they want to retest new versions every four years, rather than every new version.

Re: RFK Jr. to require placebo-controlled studies for new vaccines

#20

Post by jmye »

nailer wrote: post #8

Regardless of what you think of RFK, there's no good reason to think more testing of medicine is a bad thing.

What, specifically, is your experience in medicine, and specifically epidemiology and current vaccine testing?

Given the answer is clearly and obviously “none”, why do you think you’re qualified to have any opinion at all?

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