I listened to a few interviews from RFK jr. One story that he tells is that during the Trump administration he sat in a meeting with Fauci and claimed "The vaccines we use didn't go through placebo-blind trials". In RFK recounting Fauci claimed that the vaccine were placebo tested and promised to send Fauci studies showing so.

It turns out, that they frequently are not placebo tested and RFK was right with that claim. When looking at the claim at skeptics.stackexchange, the establishment answer is basically "Running placebo-blind trials would be unethical and we know that the vaccine are safe". The question whether or not you really need placebo blind trials is complex and not easy to answer.

Factual issues like that seems complex enough that Peter Hotez and other people in the field are afraid of actually debating RFK on the issues. 

One point RFK makes for both nuclear energy and for vaccines is that if those technologies are completely safe, then the companies that deploy them should have no problem with being liable for negative consequences and buy insurance policies to shield themselves from the risk. There would be no need for the government to have laws that limit the liability.

Asking vaccine companies to accept liability for their vaccines is basically asking them to make a bet that their vaccines are safe or to let an insurance company make a bet that they are safe.

If someone would want to increase trust in vaccines, a good step would be to write a law that says: "Because of the advance in vaccine technology, the 1986 vaccine act that declared vaccines unavoidably unsafe is outdated, and from now on vaccine producers are responsible for significant side-effect resulting from vaccines."

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Max H

1413

Asking vaccine companies to accept liability for their vaccines is basically asking them to make a bet that their vaccines are safe or to let an insurance company make a bet that they are safe.

Isn't it actually asking them to trust that juries and judges will rule that vaccines are safe, and not award outsize damages in cases where they are potentially wrong about that? That's a different question from whether the vaccines are actually safe or not.

I don't think the legal system is particularly good at evaluating vaccine safety or efficacy, and there are well-known problems with jury awards.

So a better question is: is the legal system reliable enough that we can outsource evaluation of safety on technical questions to it, and rely on juries to award damages fairly? And the answer to those questions is pretty clearly no.

 

KingOfMadPistoleros

110

I'd like to register how WEIRD this is as regards my previous model of the world. The existence of protection from liability was a known fact, but the INexistence of obligations for basic placebo tests wasn't.

I'd also like to register how much this looks to me like an inadequate equilibrium and how little chance it seems to me there would be of a competent society choosing to create a system where products are produced by companies with such low demands of validating tests, under oversight by government agencies funded by their contributions and whose personnel is regularly the same as theirs, give or take a few years of career, and then administered to a population who are regularly under legal obligations to use these products and who are legally prohibited from seeking reparations from damages incurred if said products end up being unsafe.

I'd finally like to register the fact that neither of the other two comments currently posted seem to have had such red alarm bells pop up in their mental processes or did not even notice when said alarm bells rang. I understand seeking reasons for the current equilibrium, but I'd like to think you start off by noticing it seems broken rather than searching for reasons to rationalize it. Of course, it may simply be that nothing said in the post was news to the other responders.

I'd still like to ask, "would you agree that, at the very least, this seems like a very broken system, even if there may exist very good reasons why it is broken in such ways?"

I think that matches a lot of how I relate to the topic. There seem to be red flags raised but finding out what's the best way to deal with the issue is a lot harder.

I would add to the things that you already listed, that it seems there are strong cultural pressures to justify the status quo. People who deeply question the establishment narrative get ostracized for it. Krystal Ball who would not see Joe Biden warmongering for the Iraq war or for him prosecuting Assange argued that RFK Jr. position on vaccines is a red line for her. And as she said she's no... (read more)

1KingOfMadPistoleros
Thanks for your response. This is however supposed to be the community founded by a guy who spent two years writing variations on the theme: "do not rationalize away that feeling that something 's off!" and litterally wrote the book on inadequate equilibria. So while social pressure and common human failings explain away some of it, it still seems weird that no one is writing about having the same reaction. I mean, there hasn't even been anyone using the catchphrase: "FDA delenda est!" Has to the non law-abiding nature of said companies. Is it notably more common than in any other highly regulated field? Do car producers get away with cheating more or less regularly for instance?
2ChristianKl
That doesn't mean that it's easy.  Julia Galef, who also advocated that "noticing confusion" is one of the key rationality skills wrote her book about the Scout mindset partly to answer why reasoning so often goes wrong. When we are engaged in relationships that bring us out of approaching a topic with the Scout mindset our reasoning is often bad.  When it comes to car companies, Volkswagen paid a lot of fines for faking the emissions scores in their diesel vehicles. Toyota paid huge fines for lying about the accidental acceleration of their cars.  If you ask yourself how much you should trust Volkswagen on their other claims, then the fact that they so brazenly faked their emission scores should matter. If you are thinking about whether to trust the claims of Toyota about car safety, the fact that they lied about accidental acceleration should inform your views.  There's however a qualitative difference. Car companies just lie about their products which is a bit different than pharma bribing doctors.  Imagine you are talking in polite society, you might say two different things: (1) The official safety data that a car company on how fuel efficient data their car happens to be is misleading and wrong. (2) The official safety and efficiency data that some vaccine company releases for their product is misleading and wrong. You are not going to lose social status for arguing (1) but you might very well lose status for arguing (2).

Dagon

107

I don't think the modern world's liability system works well enough for this.  More importantly, I don't think the cost-benefit of when and how to release medicines matches the revenue-risk of sales and liability well enough for this to be a useful incentive scheme.

Vaccines, even for non-pandemic serious diseases are literally life-changing.  The calculus of any individual, or a population, reducing the risk of any major viral disease (pick any one - tetanus, shingles, hepatitus, HPV, even seasonal flu) in exchange for some risk of side effects is NOT something that maps cleanly to corporate liability.  It does map pretty cleanly to doctors and patients (and governments, in case of attending public schools) publishing information and making the best decisions they can.

That's pretty close to just legislating that "vaccines are unavoidably unsafe".  I wish more things were acknowledged to be so - the attempt at 100% safety at any cost is extremely harmful to the world.  Driverless cars are another example where the bar should be closer to "safer than humans on average" than "safe".

Some sort of aggregated liability for fraudulent claims about the impact (effectiveness or frequency/severity of side-effects) is absolutely necessary, and already exists - that's a crime, and breaks the immunity.  Likewise very severe regulatory penalties for manufacturing process failures.

BTW, I object to the framing "if it's X, then why not accept unlimited liability"?  "If you've not committed a crime, you shouldn't need to keep secrets from the state" is the same form, and it's bullshit.

[-][anonymous]64

Or a simple analysis: if you ask "what do they know and how do they know it", obviously a judge and jury are going to have a high error rate on something like a low probability event involving complex medical information. Likely giving judgements that are not better than noise.

The liability system "worked" when it was obvious things like manufacturers bolting the bumper to the gas tank (though some studies show the pinto wasn't actually less safe than similar cars of that era) or really more blatant things like coal mines without safety railings. When th... (read more)

A further problem with a liability model for vaccines is that they must be relatively cheap to be useful. They usually have large measurable public benefits, but highly variable and invisible private benefits. So any given person doesn't know whether or how much they benefited from a vaccination, but can easily attribute problems to it (correctly or not).

Under a product liability model the producer is getting only a small fraction of the positive value of vaccination to society, but is being stuck with costs plus penalties for most of the problems and lega... (read more)

2ChristianKl
So any given person doesn't know whether or how much they benefited from a vaccination, but can easily attribute problems to it (correctly or not). I don't think that negative side effect attribution is easy.  The more than doubling in infant deaths of DPT-vaccinated girls in Guinea-Bissau was not easily picked up. If the side effect of a childhood vaccine would be a 5-point drop in IQ, it's very unlikely that this would be picked up by current processes but it would still be a very clinically significant effect. In general, most people who have head-trauma-induced depression don't know about the causation as it takes months to develop afterward.  If the mercury that gets into the brain as a result of a thimerosal-based vaccine would produce inflammation that has effects similar to head-trauma in some patients it would likely be very hard to pick up given that it's not an effect you would see directly after the vaccine is given. For most patients who decide whether or not to vaccinate, the price is zero because someone else pays for the vaccine. The price is paid by the government or health insurance companies. Giving manufacturers liability would however make the vaccines more trustworthy for those people who are on the edge and thus likely increase vaccination rates. 
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On the safety question I have just written a post on aluminum adjuvants here. I was unable to confirm safety, but we'll see what others say.

Should we actually do this policy change, or operate with the existing system?
Generally, I think the social deadweight losses associated with these types of lawsuits are enormous.

Pharma companies would bear the losses for harms, but not be rewarded for the health gains of vaccines.  Seems infeasible to maintain current incentives for innovation. Unless we are saying they will charge lots for the vaccines - but we are also having a discourse about paying them too much money!

Add to this, court systems are very, very bad at dealing with probabilistic harms. Judges and juries lack statistical literacy. The main beneficiary of this system would be the lawyers.

This policy is only sensible to consider in combination with other policy to drastically reduce the role of the FDA as the blocker of market access (on the theory that with insurance bearing the load it would be less needed, and we can now afford a faster and less formalized process)