Unclear. I wouldn't want to get into a debate with RFK Jr about it, even with lots of time to prepare. The man is mocked here on HN but is extremely well informed and can easily win debates with any normally read person.
It's going to boil down to what you mean by "safe". The way the word is used in vaccine approvals doesn't match how any normal person expects it to be used. If you go into a debate without being extremely well versed in the technical details, a guy like RFJ will crush you.
For example: most people assume vaccines are tested against an inert placebo like water, and will only be approved as safe if it doesn't cause more problems than the placebo does. This isn't what happens. The "placebo" in vaccine trials is usually another vaccine. This leads to the question of what happens if both are unsafe? The answer is the safety problem isn't detected and the FDA will approve the new vaccine as safe, because it didn't create a higher rate of problems than the older one did. And how was the older one approved? Well, by comparing it to yet another vaccine and so on.
One might assume this chain bottoms out somewhere against a real placebo, but not necessarily! There have been cases where two vaccines were tested against each other, and then both sides were declared safe based on comparisons with the other "placebo" meaning they end up selling the "placebo" as an effective vaccine in its own right. At no point is the vaccine tested against an actually neutral baseline. This is a very basic logic error that makes the evaluations unscientific, but public health officials accept it.
Did you know all the above already? If not then you have no chance at winning over a neutral audience against a guy like RFK Jr. He will argue no vaccines are safe, you will protest that such a belief is insane and preposterous, and then he'll do something like cite US law or Supreme Court judgements where the systematic unsafety of vaccines is taken as a legal axiom. Or pick a specific example and he'll cite specific studies off the top of his head showing you were wrong.
Watch the interview with Lex Fridman if you don't believe me he can do these things. Don't underestimate the guy!
why is this so heavily focused on the supposed merits of rfk as a debater? that kinda sounds tangential at best to the yes or no question that you're responding to
Before HN posters can get to the point of actually debating the issues motivating this kind of decision, they have to accept that there actually are issues and that RFK Jr isn't just deciding things randomly.
As an example of what can go wrong, CNN failed to understand the point I was making here and screwed up very publicly. They tried to use "crowdsourcing" to gather counterpoints to an argument RFK Jr made, in fact, the one about trials not using inert placebos. In other words they gish-galloped him. In return they got a 1,330 word rebuttal that goes through their list showing, that none of the studies they claimed used inert placebos actually did (except a few that weren't used by the US anyway):
No you could just answer the question. You keep acting like you're getting ready to do that and then not doing it. I think you feel compelled to fill the space with something and aren't all that concerned about the substance of what you fill the space with.
Like when he said SARS-COV-2 targets some ethnicities or that Lyme is a bioweapon?
>For example: most people assume vaccines are tested against an inert placebo like water, and will only be approved as safe if it doesn't cause more problems than the placebo does. This isn't what happens. The "placebo" in vaccine trials is usually another vaccine. This leads to the question of what happens if both are unsafe?
That doesn't happen because if you get to how that "another vaccine" was tested, it was against a placebo - or another, even more ancient vaccine, etc... Until you get a test against a placebo.
And because all along the chain, every new treatment was proven to be better than the previous one, the latest can only be better than a placebo.
And no, re-testing against a placebo now isn't going to show anything revolutionary: what you will only manage to do is denying children any standard of care and expose them to death and injury. All because "most people assume vaccines are tested against an inert placebo" instead of educating themselves on statistics and the history of medical testing.
Everyone understands the reasoning behind it. The reason lots of people view it as surprising and stupid is that it implicitly assumes (a) no mistakes are made that would then be propagated, (b) that you also don't accumulate unsafety by doing a chain of relative comparisons and (c) there are no downsides from playing word games with people.
None of these assumptions is sound. The assurance people want from the medical system isn't "taking this is only slightly less safe than taking that", it's "taking this is safe relative to doing nothing", because doing nothing is the default state.
> All because "most people assume vaccines are tested against an inert placebo" instead of educating themselves on statistics and the history of medical testing.
The FDA itself defines a placebo as an inert substance and tells people vaccines are tested against placebos, even though they aren't by their own definitions. They don't get to play games like that and then tell people they should have "done their own research" to catch them in the act.
> For example: most people assume vaccines are tested against an inert placebo like water, and will only be approved as safe if it doesn't cause more problems than the placebo does. This isn't what happens. The "placebo" in vaccine trials is usually another vaccine.
First, please consider from where and whom you received this information. It was probably RFK Jr. or someone on social media or maybe a news article, right? Did you bother to scrutinize that information? Because it's not true. All vaccines (like other medications) are tested against the standard of care. For a first-in-class vaccine, that's going to be a saline placebo because there is no standard of care yet; for subsequent vaccines, it will whatever is the current vaccine. This is completely sensible. The idea that the vaccines on the market now were never tested against saline placebo is mis/disinformation promulgated by a lawyer whose name escapes me; some of those saline placebo-controlled trials for vaccines are listed [here](https://docs.google.com/document/d/1pUMNBewb0kgTU7g3augmOtPG...).
If you have a passing understanding of common anti-vaxx talking points, RFK Jr.'s arguments are easy to debunk.
> it's not true ... [the placebo] will be whatever is the current vaccine. This is completely sensible ... [it] is mis/disinformation
Or rephrased, "that's not happening and it's good that it is". This kind of thing is called the Law Of Salutary Contradiction [1] and originates in confused, ideological thinking. If you want to argue with RFK Jr about something you need to decide if what he's saying isn't true, or if it is true but you disagree it's a problem. You can't pick both.
The "first in class" approach isn't illogical but it's an ultra-high risk strategy. If just one unsafe vaccine gets through the systerm that will lead to a chain of erroneous approvals that result in dangerous substances being labelled as safe. In other words it only seems completely sensible if you have absolute and total faith in the entire testing and regulatory infrastructure. Anyone who lacks your iron-clad faith will view this practice as obviously crazy.
Given that the medical profession have routinely lied as a group about many things in the past, it is unreasonable to use practices that demand quasi-religious faith in them. They refused to accept this and are now paying the price.
1. We used known safe and effective vaccines as placebos. Keyword KNOWN. We're not gonna debate the efficacy of the fucking polio vaccine, just be for real.
2. The reason we do this is because it's very unethical to deny medication that we currently administer and know works to human subjects. That would be treating people worse than we treat the general population. That's unethical.
3. We don't just do this vaccines, but ALL medication. When we make new drugs to treat cancer, we don't compare them against saline. Because that's evil. We compare them against known effective chemotherapy regimes.
4. All of this is besides the point, because using an inert placebo wouldn't help anything. How does using an inert placebo make a new medication more effective or more safe? It doesn't.
5. We DO use inert placebos all the time - just not in human trials. Because we want to give humans real medicine so they don't fucking die.
Known safe according to who? The panel of people RFK Jr just fired, or the other credentialed experts he replaced them with who say the safety wasn't actually known at all?
People who are given placebos in trials aren't "denied medication". They can always take it after the trial has ended and they're unblinded, if the trial succeeds.
> How does using an inert placebo make a new medication more effective or more safe?
Imagine - bear with me here - imagine that an unsafe vaccine got approved. It uses some technology that's unsafe. We know this happens because vaccines are sometimes pulled from the market for being unsafe after approval.
Now imagine you have a second vaccine in trial, which shares some technology with the first, and it gets tested against the first before it's realized that was unsafe. People suffer or even die but the FDA declares it to be perfectly safe because the control group are suffering at the same rate, and for the same reasons.
Now consider what happens when it's discovered by the population that the government claimed a vaccine was safe but it was actually hurting people, and those who never took it at all were better off. It destroys their trust in the system of course.
That's why you have to use inert placebos. There's nothing unethical about this. It's a standard safety precaution. The alternative, as you are now discovering, is that the entire system is torn down and one day there may be no vaccines at all - banned by constitutional amendment - because the sort of people who are pro-vaccine kept making false claims about safety due to dangerously optimistic testing practices.
> That's why you have to use inert placebos. There's nothing unethical about this. It's a standard safety precaution.
This isn't true.
We do use inert placebos, but for some medications, we are not going to be doing that in human trials for obvious safety and ethical concerns. Keep in mind: we do NOT just jump to human trials. We also do cellular trials and animal trials.
Again, if we're trying out a new cancer drug, we're not going to give the control group saline - we're going to give them a chemotherapy regime that we know works. I don't understand what's not clicking for you because it's actually very simple and intuitive.
And, as an aside: the government has not recommended any vaccines that are unsafe. You may feel the COVID vaccines were not safe. That doesn't mean they're unsafe. In addition, there are numerous reasons why a medication might be pulled, and it's quite rare that the reason is safety in absolute. Some medication may be less safe than another so we obsolesce said medication - but even that does not mean that it is unsafe. Just inferior.
With any medication, or in fact any substance, including even water, there are risks. We're generally very aware of the risk before the medication is administered and we work to minimize them in various ways. The simple reality is that dozens have vaccines have worked together to eradicate many diseases in the US, and these health initiatives have been very successful. Other countries are not so lucky, so they are dealing with diseases that we haven't touched in decades.
Please bare in mind that viruses and bacteria are not risk-free, nor are they necessarily the type of thing you can just recover from. For example, about 2% of people who contract Polio will develop paralysis. 2% is extraordinarily high. Just because you might be fine, or you know people who are fine, doesn't mean that the disease is low-risk. With COVID specifically, we're still uncovering long-term effects of infection. With viruses like HSV, we're also uncovering long-term effects like increased risk of cancer and potentially dementia.
Just because you get sick and seem to recover, doesn't mean that what happened was safe and done.
Nah, that's is just an artifact of an conflated claim made by RFK Jr. and others and the more complex reality that needs to be underlined to refute it. If the claim is "no vaccine products on the market were tested against a saline placebo", that is untrue because new first-in-class vaccines were. If the claim is "no vaccine classes on the market were tested against a saline placebo", that is untrue because as far as I can tell all classes were tested against a saline placebo at some point. If the claim is "some vaccine products on the market were not tested against a saline placebo", that would be true and it would not be a problem if those vaccine products were of vaccine classes that were previously tested against saline placebo.
How are you qualifying this strategy as "ultra-high risk"? How well do you understand the new drug and vaccine regulatory process in the US? An "unsafe" (vague) vaccine will be discovered via postmarketing surveillance (e.g. Rotashield). If two unsafe vaccines are trialed comparatively and the adverse event rate is unusually high for both groups than what was previously reported, that's not going to go unnoticed even if it appears like there's no significant difference between the two statistically. Your concern also assumes that because the first approval was erroneous that all subsequent ones will be too, which is an unfounded assumption.
If you want to claim that the medical profession have "routinely lied as a group about many things in the past", you'll have to back that up because I don't agree and will not accept your assertion at face value.
