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Comment by yokaze | Hacker News Reader

> They insist on not using other treatments outside clinical trials. The argument that running experiments would cost lives doesn't seem coherent.

Clinical trials are structured experiments which follow a certain protocol, ethical review, etc...

> It's not like we have this 100+ yrs practice of dealing with SARS-CoV-2 epidemic with well established protocols

We do have 100+ years of practice in dealing with various diseases, circumstances, including pandemics, etc... In that sense SARS-CoV-2 is nothing special. Protocols have been developed to ensure that we actually gain knowledge, and not at the expense of the patients.

Should we skip on ethical review boards? Or patient confidentiality? Which part of a clinical study are you suggesting are superfluous?

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> Protocols have been developed to ensure that we actually gain knowledge, and not at the expense of the patients.

If medicine could be reduced to protocols, we wouldn't need the doctors.

You can rest assured right now many MDs are prescribing off-label meds, diagnostics tests, making non-protocol judgement calls etc all around the world. And I am glad they are doing that, because front-line medicine is more engineering than science and their job is ultimately to heal, not being protocol-only automatons.

> SARS-CoV-2 is nothing special

It is special in that everything about it has been very high profile, and in this day and age of hyper-connectedness, when expert institutions mess things up it is harder to cover up and their authority is at a greater risk.

Let's be honest that is why they are being very iron fisted about out-of-band covid treatments, not because of a proportional threat to life.

> You can rest assured right now many MDs are prescribing off-label meds, diagnostics tests, making non-protocol judgement calls etc all around the world. And I am glad they are doing that, because front-line medicine is more engineering than science and their job is ultimately to heal, not being protocol-only automatons.

Well, yeah. One important point about health policy is that it's designed with the knowledge — the assumption — of some level of non-compliance.

Health policy design is game-theoretic, like overbidding in a negotiation: rather than choosing rules that are logically correct, you pick optimal rules to get your own population — a portfolio of people with different feelings toward authority — to on average do the thing you want them to do, or a set of different useful things you want them to do.

When regulating doctors, that means that you take into account that the doctor "on the ground" always has more knowledge than the regulator, and so you can phrase the regulations as absolutes to not do X, Y, or Z, knowing that the doctor will still do X/Y/Z anyway if they have information you don't that leads them to know better in a specific situation.

This is very different from actually making a recommendation to do X/Y/Z in those situations, because such a recommendation can be interpreted out-of-context to imply that doing X/Y/Z might be helpful, and may mislead some doctors into doing X/Y/Z in situations where it wouldn't be helpful — especially in situations where they don't have enough information, but are just falling ever downward on a flowchart of things-to-try.

Basically, when the regulations say "don't do X/Y/Z", what they mean is "if you do do X/Y/Z, we consider you to be taking a heterodox-to-the-medical-establishment position and will discourage others from giving you a platform to promote doing X/Y/Z, lest others not-as-informed as you hear from you and try X/Y/Z themselves without the same justified niche situation. But you can go ahead and keep doing X/Y/Z yourself; we'll turn a blind eye to that. Just do it quietly."

Re: a now-deleted comment about how doctors elsewhere in the world suffer strict consequences for their actions, rather than getting "turned a blind eye":

That still happens in the US regulatory environment as well! Implicit to "we'll turn a blind eye" is the context "as long as you do the due diligence of creating an alternative above-board explanation for what you were doing, so that there's no official record of your heterodox practice."

The most serious and flagrant example of this effect occurs in assisted suicides. It is malfeasance to knowingly kill a patient, and even if no criminal charges occur, you'll have your license to practice permanently revoked if it can be proven that that was your intent.

So no doctor who sets out to assist a patient in suicide ever has the words "assisted suicide" come out of their mouths in a provable way. Instead, they talk about "optimizing quality of life" and "mitigating suffering", through the mechanisms of large doses of drugs that can coincidentally, potentially cause death.

As long as the death can be justified with the above-board explanation ("the patient's pain was so great that they needed this amount of narcotics to rest; and then this dose of narcotics ended up stopping their breathing during the night, and by the time a nurse responded, they were already gone") then the medical establishment — who 100% knows what the doctor was really doing — lets it go.

But if the doctor doesn't bother to hide their approach behind a justification like this? Then they get the book thrown at them.

> But you can go ahead and keep doing X/Y/Z yourself; we'll turn a blind eye to that. Just do it quietly."

This is not true; the only MD in the discussion mentions he was strong-armed out of his personal off-label use, which is also contrary to the non-compliance slack you've mentioned.

> This is very different from actually making a recommendation to do X/Y/Z in those situations, because such a recommendation can be interpreted out-of-context to imply that doing X/Y/Z might be helpful

I don't know if you've seen the video in question, but they are not trying to make a medical recommendation at all. It is more of a meta-discussion, e.g on several institutional games (in the sense of game theory) including the implications of finding out a cheap off-patent drug that could contend with multi-billion-if-not-trillion-dollar global-scale vaccination drive.

> can be interpreted out-of-context to imply that doing X/Y/Z might be helpful, and may mislead some doctors into doing X/Y/Z in situations where it wouldn't be helpful

Youtube should not be in the business of assessing this risk, because they don't have the competence for this. I bet they don't even have one person with a medical degree in their policy team that made the takedown decision. When they take down an on-topic video of an MD and a PhD Biology, however unorthodox their expert position might be, it has the contrary effect of promoting folk medicine, not advancing scientific medicine.

> > Protocols have been developed to ensure that we actually gain knowledge, and not at the expense of the patients. > If medicine could be reduced to protocols, we wouldn't need the doctors.

They are called protocols and not algorithms for a reason.

> You can rest assured right now many MDs are prescribing off-label meds, diagnostics tests, making non-protocol judgement calls etc all around the world.

Sure, sometimes for good reasons, others for less so. Every patient is different and the doctor has incomplete knowledge, and the protocols are in the end just that: Guidelines.

I would be happy, if I get a doctor, which is critical of guidelines in the sense of being aware of their limitations and won't follow them like they are written in stone (on a case by case basis).

However, as I understand it, we are talking here about deviating from the guidelines without good evidence or without a procedure to gain knowledge from it in a structured manner, not a case-by-case basis, but on principle. Quite frankly, I would stay the hell away from such doctor, which thinks that is a good idea.

>It is special in that everything about it has been very high profile, and in this day and age of hyper-connectedness, when expert institutions mess things up it is harder to cover up and their authority is at a greater risk.

>Let's be honest that is why they are being very iron fisted about out-of-band covid treatments, not because of a proportional threat to life.

I had limited contact with the expert institutions, but do have direct contact to people who did work in an ICU with Covid-19, (and a below average mortality rate).

Whenever the topic of, as you call them "out-of-band" treatments arose, the look on their faces would silence the topic. So, if you feel adventurous, I would suggest to cross-check your opinion with someone in the field.

> Whenever the topic of, as you call them "out-of-band" treatments arose, the look on their faces would silence the topic. So, if you feel adventurous, I would suggest to cross-check your opinion with someone in the field.

Let's agree that "the field" is not exclusive to US medicine with all the associated malpractice litigation risks. That might be an explanation for faces turning sour in your personal sample of acquaintances.

> They are called protocols and not algorithms for a reason.

> Every patient is different and the doctor has incomplete knowledge, and the protocols are in the end just that: Guidelines.

> we are talking here about deviating from the guidelines without good evidence or without a procedure to gain knowledge from it in a structured manner

I think you are taking a very elastic view on what protocols are. They either demand adherence or they are mere guidelines. Either evidence is required before straying out of protocol or doctors are expected to operate under incomplete knowledge.

This doesn't address all of your comment but specifically with patient confidentiality – Israel agreed to share more data with vaccine manufacturers in order to get quicker access to the vaccines. There are obviously problems with bilateral dealmaking and Israeli distribution (the article below points them out), but Israel almost certainly saved lives by weakening confidentiality. I think that was the right call.

https://www.pbs.org/newshour/science/israel-trades-pfizer-va...

Ivermectin is not a newly-discovered drug. There were hundereds of millions of courses administered world wide (it even got a Nobel prize). It has been used for decades. [1]

The only unknown right now is the long term effect of ivermectin in patients with covid. It seems to me that it's the same unknown as with the vaccines. You don't have a clinical trial for effects of the vaccines after 5 years, do you? Why don't we wait for it, just to make sure? And it's even worse for the mRNA vaccines, which have not been around for decades and only got the emergency authorization.

Btw the emergency authorization can only be granted by the FDA if there are no alternatives. [2]

> For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition.

I'm not sure if "approved" (as a treatment for covid) would have applied to Ivermectin at the time the EUA was granted but it's not like there were trials to decide that.

[1] https://en.wikipedia.org/wiki/Ivermectin#Cost [2] https://www.fda.gov/regulatory-information/search-fda-guidan...

> mRNA vaccines, which have not been around for decades and only got the emergency authorization

This is mostly true, but mRNA vaccines have gone through human trials before covid.

Yep, but these are completely different scales.

> There were hundereds of millions of courses administered world wide

Except that the doses involved are way lower than what's being speculated about (on flimsy evidence) as a possible COVID-19 treatment. And this drug has severe side effects at such higher doses. There's no way in hell that this stuff is ever going to be safer than mRNA vaccines, let alone more effective.

That's not true.

Here is a 12 min clip with Bret and Pierre Kory about Ivermectin use for Covid / safety record: https://youtu.be/4O7uy4tzI8A

>Btw the emergency authorization can only be granted by the FDA if there are no alternatives. [2]

Bingo. If there was a treatment for covid they couldn't administer the vaccines anymore. There are a lot of entrenched positions and people in power who stand to lose lots of dollars.

And such hypothetical alternative would also only have EUA under your argument. But that then wouldn’t stop them from administering the vaccine, as many of the various not-hypothetical vaccines work well and are cheap, so your overall statement seems a non-sequitur. E.g. it may have been true 6-12 months ago, but the available information has changed.

We also have decades of experience with Ivermectin, Hydroxychloroquine, and other repurposed drugs out of patent. Ivermectin in particular looks like it's working quite well in practice. Isn't it funny that we will hold those to ridiculously high standards, and devote resources to get much newer interventions like Remdesivir, the upcoming Molnupiravir [2] and others, that are still under patent, through requirements? Especially when every second counts, and when people are actively dying?

[1] https://www.nakedcapitalism.com/2021/05/india-just-became-la... [2] https://news.yahoo.com/merck-says-u-govt-buy-110024197.html

Yes. Ethical review boards, patient confidentiality, and modern clinical studies did not exist during any other pandemic comparable with SARS-CoV-2. Like in wartime, when the threat is to society as a whole not just individuals, individual rights take a back seat.

And yes we had experimentation on all sorts of minorities, general exploitation, and in some cases into infliction of harm.

What good old days those were.

You're not protecting anyone from the next Tuskegee Experiment by witholding potentially lifesaving medications from them. You're _repeating it_.

According to Worldofmeters: At the moment the United States has 1848 deaths per million people. Thailand has 21. Cambodia has 20. Taiwan 18. Vietnam 0.6. Laos 0.4.

You’re stopping the Mendel’s and the Tuskegees.

Tuskegee wasn’t an experiment in “we don’t know if this drug works” it was explicitly intended to study the progression of syphilis - they weren’t withholding drugs because they didn’t know if they worked, they were withholding them because black people weren’t human to them.

ERBs and the FDA both exist to protect people from becoming victims.

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