Can you name a vaccine currently on the market which has not undergone testing in a study with a randomized, double-blind placebo-controlled design? I am not sure why RFK Jr.’s belief on the subject should be taken seriously.
The current establishment position is that it’s unethical to run randomized, double-blind placebo-controlled trials for vaccines if there’s already an existing vaccine on the market that targets a given illness. Instead, new vaccines for illnesses with existing vaccines get tested against an existing vaccine. In practice, most of the commonly used childhood vaccines in the United States fall under that category.
Those are just the basic facts of the issue whether or not you like RFK Jr. The more interesting question is about whether his policy demand of requiring randomized, double-blind placebo-controlled trials for each vaccine is one that should be adopted or not. And if it gets adopted what happens with existing vaccines that fail that standard.
Yes, that’s the standard because the existing vaccine for a given illness that the new candidate is tested against has already undergone randomized, double-blind placebo-controlled trials. Meaning it was proven to be safe and effective against a placebo and, therefore, is the new standard. This makes sense ethically and scientifically.
This isn’t about liking or disliking RFK Jr. It’s about not trusting an anti-vaccine activist to shape vaccine policy using evidence-based reasoning instead of his distrust of scientists.
If you care about evidence, how about starting with acknowledging that the answer to your first question about why one would believe RFK Jr is that because he’s factually correct with the claim that no randomized, double-blind placebo-controlled trials for vaccines are run?
You seem to have had a false belief that needs updating, and if you just gloss over that, that’s not good reasoning.
The key question is about what policy you want. Given what RFK Jr. said, it’s likely that the policy he is going to advocate is some form of a requirement of randomized, double-blind placebo-controlled trials for vaccines.
Currently, the reasoning of why there’s no randomized, double-blind placebo-controlled trials for vaccines has nothing to do with evidence-based reasoning but with a mix of a certain medical ethics and pharma lobbying.
Meaning it was proven to be safe and effective against a placebo and, therefore, is the new standard.
Safe is a relative term and you are using the term “proof” quite losely.
Vaccines are by law unavoidably unsafe, which is the legal justification from the 1986 National Childhood Vaccine Act for giving the producers immunity from lawsuits over the vaccines. The whole idea at that time is that vaccines have some side effects but the benefits outweigh the risks. The vaccines from that era are the one’s that are used in the controlled studies. HHS did not follow the law to report on the progress on how vaccines got more safe after that in the way the act requires.
In medicine, it frequently happens that drugs have side-effects that were not picked up in initial clinical trials, so obviously if you follow evidence-based reasoning, a trial does not proof anything absolutely safe. As a relevant recent example, the increased risk of myocarditis and pericarditis from mRNA Covid-19 vaccines was not picked up by the placebo-controlled trials that they ran.
evidence-based reasoning instead of his distrust of scientists
Distrust of scientist was part of the motto of the Royal Society. When studying bioinformatics one of my professors made a point to say something in every lecture to foster our distrust. The replication crisis of the last decade was inherently about distrust of scientists and one of the greatest things that happened to science in that timeframe.
Saying scientists who are not running enough placebo-controlled trials should be distrusted, is an evidence-based argument. Ideally, there would be meta-science that better tells us when we need to to run placebo-controlled trials and when we don’t but the NIH under past leadership did not like to fund that meta-science.
Policy-wise, I think that focusing on standards of evidence is the most likely choice he could make as HHS secretary because he’s unlikely able to just declare certain vaccines he doesn’t like to be off-the-shelves.
So if you want an evidence-based discussion it makes sense to focus on the merits and costs of placebo-controlled trials.
This last one is not reporting on the vaccine trial, but is a follow-up to such a trial.
So, at this point, it’s difficult for me to feel like you’re having this conversation in good faith. But, nonetheless, ethically and medically, the appropriate and most relevant control is the standard of care—because we need to know if the novel vaccine/medicine/therapy outperforms what we are already doing. And, again, the standard of care is adopted after a randomized, double-blind placebo-controlled trial, or after replacing the previous standard of care that underwent such a trial. So, in reality we should be questioning his reasoning and motivation for making this false claim and using it as a bludgeon to shape vaccine policy.
>Vaccines are by law unavoidably unsafe
Speaking of using terms loosely… I’ll just parrot you and say “unsafe” is a relative term and I think it’s doing a lot of rhetorical heavy lifting here. Sure, they are “unsafe” in the way that any action or inaction is nominally “unsafe”.
>You seem to have had a false belief that needs updating, and if you just gloss over that, that’s not good reasoning.
This is needlessly antagonistic given that you are repeating an outright false claim that “no randomized, double-blind placebo-controlled trials for vaccines are run”.
I’ve never made any claims about “absolute safety”. This line of attack by you feels, at best, like putting words into my mouth when I would prefer you simply ask a question about my position on something instead of assuming. I am aware that medicine comes with risks but it seemed tangential to the conversation at hand and so I made the reasonable assumption that “safe relative to the standard of care” was mutually understood. Apparently that assumption was wrong—but that doesn’t justify your strawmanning.
>As a relevant recent example, the increased risk of myocarditis and pericarditis from mRNA Covid-19 vaccines was not picked up by the placebo-controlled trials that they ran.
Because it’s an incredibly rare side-effect that nearly invariably self-resolves. And the side-effect was picked up in follow-up, which is exactly why scientists continue to monitor vaccine recipients.
>Saying scientists who are not running enough placebo-controlled trials should be distrusted, is an evidence-based argument.
No. It is not. It is bad science to run a placebo controlled trial when an effective standard of care is already available. The medically relevant question is whether a new drug or therapy is safe and effective relative what what we are already doing.
Okay, my statement as far as “no trials” was imprecise, I did explicitly talk about the COVID-19 trials, so I did grant that there are trials that happen. The just don’t happen for most vaccines as most vaccines are controlled against previously licensed vaccines.
Because it’s an incredibly rare side-effect
A quick search suggests 1/10000 as a current official number. Do you consider 1/10000 incredibly rare?
I’ve never made any claims about “absolute safety”.
People who want to decide whether or not to take a vaccine care about absolute safety and not about relative safety between different vaccines.
Sure, they are “unsafe” in the way that any action or inaction is nominally “unsafe”.
They are unsafe in a way that warrants their producers being held not liable for the damages caused by them to set incentives to minimize damages. The assumption here is that the cost of paying for an insurance policy that adequately pays for the damage is too high to burden the producers of vaccines with it.
There are few cases where we say as a society that things are so risky that we need to shield a company from the harm that their products might produce.
There’s a reason that prediction markets are popular on LessWrong. They are a tax on bullshit. A requirement to have insurance policies is in the same way a tax on bullshit. “Unavoidably unsafe” is about unwillingness to pay that tax.
The medically relevant question is whether a new drug or therapy is safe and effective relative what what we are already doing.
That’s relevant for people who want to decide about whether to take the old or the new vaccine. To the person who wants to make a decision between taking no vaccine at all or the new vaccine, evidence that compares the new vaccine against no vaccine is relevant.
__________
But let’s focus more on the meat of the issue. What makes you confident that the current system is effective at finding all side-effects that exist of vaccines?
Is it that you decided beforehand that “distrust of scientists” is bad and therefore you trust the output of the system? Otherwise, what process did you went through to develop your trust that this particular system works very well?
Can you name a vaccine currently on the market which has not undergone testing in a study with a randomized, double-blind placebo-controlled design? I am not sure why RFK Jr.’s belief on the subject should be taken seriously.
The current establishment position is that it’s unethical to run randomized, double-blind placebo-controlled trials for vaccines if there’s already an existing vaccine on the market that targets a given illness. Instead, new vaccines for illnesses with existing vaccines get tested against an existing vaccine. In practice, most of the commonly used childhood vaccines in the United States fall under that category.
Those are just the basic facts of the issue whether or not you like RFK Jr. The more interesting question is about whether his policy demand of requiring randomized, double-blind placebo-controlled trials for each vaccine is one that should be adopted or not. And if it gets adopted what happens with existing vaccines that fail that standard.
Yes, that’s the standard because the existing vaccine for a given illness that the new candidate is tested against has already undergone randomized, double-blind placebo-controlled trials. Meaning it was proven to be safe and effective against a placebo and, therefore, is the new standard. This makes sense ethically and scientifically.
This isn’t about liking or disliking RFK Jr. It’s about not trusting an anti-vaccine activist to shape vaccine policy using evidence-based reasoning instead of his distrust of scientists.
If you care about evidence, how about starting with acknowledging that the answer to your first question about why one would believe RFK Jr is that because he’s factually correct with the claim that no randomized, double-blind placebo-controlled trials for vaccines are run?
You seem to have had a false belief that needs updating, and if you just gloss over that, that’s not good reasoning.
The key question is about what policy you want. Given what RFK Jr. said, it’s likely that the policy he is going to advocate is some form of a requirement of randomized, double-blind placebo-controlled trials for vaccines.
Currently, the reasoning of why there’s no randomized, double-blind placebo-controlled trials for vaccines has nothing to do with evidence-based reasoning but with a mix of a certain medical ethics and pharma lobbying.
Safe is a relative term and you are using the term “proof” quite losely.
Vaccines are by law unavoidably unsafe, which is the legal justification from the 1986 National Childhood Vaccine Act for giving the producers immunity from lawsuits over the vaccines. The whole idea at that time is that vaccines have some side effects but the benefits outweigh the risks. The vaccines from that era are the one’s that are used in the controlled studies. HHS did not follow the law to report on the progress on how vaccines got more safe after that in the way the act requires.
In medicine, it frequently happens that drugs have side-effects that were not picked up in initial clinical trials, so obviously if you follow evidence-based reasoning, a trial does not proof anything absolutely safe. As a relevant recent example, the increased risk of myocarditis and pericarditis from mRNA Covid-19 vaccines was not picked up by the placebo-controlled trials that they ran.
Distrust of scientist was part of the motto of the Royal Society. When studying bioinformatics one of my professors made a point to say something in every lecture to foster our distrust. The replication crisis of the last decade was inherently about distrust of scientists and one of the greatest things that happened to science in that timeframe.
Saying scientists who are not running enough placebo-controlled trials should be distrusted, is an evidence-based argument. Ideally, there would be meta-science that better tells us when we need to to run placebo-controlled trials and when we don’t but the NIH under past leadership did not like to fund that meta-science.
Policy-wise, I think that focusing on standards of evidence is the most likely choice he could make as HHS secretary because he’s unlikely able to just declare certain vaccines he doesn’t like to be off-the-shelves.
So if you want an evidence-based discussion it makes sense to focus on the merits and costs of placebo-controlled trials.
>s that because he’s factually correct with the claim that no randomized, double-blind placebo-controlled trials for vaccines are run
This is factually untrue. Here are just a few recent examples:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00241-5/fulltext
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30843-4/fulltext
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30001-3/fulltext
Or if you’d like one that’s more relevant to recent history:
https://www.nature.com/articles/s41541-022-00590-x
https://www.acpjournals.org/doi/full/10.7326/M22-1300
This last one is not reporting on the vaccine trial, but is a follow-up to such a trial.
So, at this point, it’s difficult for me to feel like you’re having this conversation in good faith. But, nonetheless, ethically and medically, the appropriate and most relevant control is the standard of care—because we need to know if the novel vaccine/medicine/therapy outperforms what we are already doing. And, again, the standard of care is adopted after a randomized, double-blind placebo-controlled trial, or after replacing the previous standard of care that underwent such a trial. So, in reality we should be questioning his reasoning and motivation for making this false claim and using it as a bludgeon to shape vaccine policy.
>Vaccines are by law unavoidably unsafe
Speaking of using terms loosely… I’ll just parrot you and say “unsafe” is a relative term and I think it’s doing a lot of rhetorical heavy lifting here. Sure, they are “unsafe” in the way that any action or inaction is nominally “unsafe”.
>You seem to have had a false belief that needs updating, and if you just gloss over that, that’s not good reasoning.
This is needlessly antagonistic given that you are repeating an outright false claim that “no randomized, double-blind placebo-controlled trials for vaccines are run”.
I’ve never made any claims about “absolute safety”. This line of attack by you feels, at best, like putting words into my mouth when I would prefer you simply ask a question about my position on something instead of assuming. I am aware that medicine comes with risks but it seemed tangential to the conversation at hand and so I made the reasonable assumption that “safe relative to the standard of care” was mutually understood. Apparently that assumption was wrong—but that doesn’t justify your strawmanning.
>As a relevant recent example, the increased risk of myocarditis and pericarditis from mRNA Covid-19 vaccines was not picked up by the placebo-controlled trials that they ran.
Because it’s an incredibly rare side-effect that nearly invariably self-resolves. And the side-effect was picked up in follow-up, which is exactly why scientists continue to monitor vaccine recipients.
>Saying scientists who are not running enough placebo-controlled trials should be distrusted, is an evidence-based argument.
No. It is not. It is bad science to run a placebo controlled trial when an effective standard of care is already available. The medically relevant question is whether a new drug or therapy is safe and effective relative what what we are already doing.
Okay, my statement as far as “no trials” was imprecise, I did explicitly talk about the COVID-19 trials, so I did grant that there are trials that happen. The just don’t happen for most vaccines as most vaccines are controlled against previously licensed vaccines.
A quick search suggests 1/10000 as a current official number. Do you consider 1/10000 incredibly rare?
People who want to decide whether or not to take a vaccine care about absolute safety and not about relative safety between different vaccines.
They are unsafe in a way that warrants their producers being held not liable for the damages caused by them to set incentives to minimize damages. The assumption here is that the cost of paying for an insurance policy that adequately pays for the damage is too high to burden the producers of vaccines with it.
There are few cases where we say as a society that things are so risky that we need to shield a company from the harm that their products might produce.
There’s a reason that prediction markets are popular on LessWrong. They are a tax on bullshit. A requirement to have insurance policies is in the same way a tax on bullshit. “Unavoidably unsafe” is about unwillingness to pay that tax.
That’s relevant for people who want to decide about whether to take the old or the new vaccine. To the person who wants to make a decision between taking no vaccine at all or the new vaccine, evidence that compares the new vaccine against no vaccine is relevant.
__________
But let’s focus more on the meat of the issue. What makes you confident that the current system is effective at finding all side-effects that exist of vaccines?
Is it that you decided beforehand that “distrust of scientists” is bad and therefore you trust the output of the system? Otherwise, what process did you went through to develop your trust that this particular system works very well?