6 ms·

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

by yokaze 5y ago

> 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?

zackees 5y ago
All these protocols for treating disease was changed for this virus. Patients were banned from taking HCQ in the state. I know several this happened too. Pretending the system is working as intended is a farce.
saddlerustle 5y ago
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.
- olliej 5y ago
  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.
  - cheaprentalyeti 5y ago
    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.
    - olliej 5y ago
      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.
acituan 5y ago
> 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.
- derefr 5y ago
  > 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."
fireflies_ 5y ago
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-vaccine-doses-for-medical-data https://www.pbs.org/newshour/science/israel-trades-pfizer-va...
micouay 5y ago
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 https://en.wikipedia.org/wiki/Ivermectin#Cost [2] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities#criteria https://www.fda.gov/regulatory-information/search-fda-guidan...
- LegitShady 5y ago
  >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.
  - manwe150 5y ago
    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.
- dehrmann 5y ago
  > 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.
deleted 5y ago
[deleted]
briefcomment 5y ago
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-latest-country-to-approve-use-of-ivermectin-to-treat-covid-19.html https://www.nakedcapitalism.com/2021/05/india-just-became-la... [2] https://news.yahoo.com/merck-says-u-govt-buy-110024197.html https://news.yahoo.com/merck-says-u-govt-buy-110024197.html

by yokaze 5y ago

zackees 5y ago

All these protocols for treating disease was changed for this virus. Patients were banned from taking HCQ in the state. I know several this happened too. Pretending the system is working as intended is a farce.

saddlerustle 5y ago

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.

olliej 5y ago
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.
- cheaprentalyeti 5y ago
  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.
  - olliej 5y ago
    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.

acituan 5y ago

> 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.

derefr 5y ago
> 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."

fireflies_ 5y ago

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-vaccine-doses-for-medical-data https://www.pbs.org/newshour/science/israel-trades-pfizer-va...

micouay 5y ago

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 https://en.wikipedia.org/wiki/Ivermectin#Cost [2] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities#criteria https://www.fda.gov/regulatory-information/search-fda-guidan...

LegitShady 5y ago
>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.
- manwe150 5y ago
  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.
dehrmann 5y ago
> 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.

deleted 5y ago

[deleted]

briefcomment 5y ago

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-latest-country-to-approve-use-of-ivermectin-to-treat-covid-19.html https://www.nakedcapitalism.com/2021/05/india-just-became-la... [2] https://news.yahoo.com/merck-says-u-govt-buy-110024197.html https://news.yahoo.com/merck-says-u-govt-buy-110024197.html