7 ms·

> The question isn't whether this "may be" a harmful decision (of course it might); it is whether it is likely to be. The statement said there was insufficient

> The question isn't whether this "may be" a harmful decision (of course it might); it is whether it is likely to be. The statement said there was insufficient data to make that calculation definitively. If you want to take a course of action not borne out by the study, the FDA doesn’t go after you or your doctor for off label use. The FDA is clarifying that the unproven route is, well, unproven. The FDA is all about medical risk vs provable results. They can’t intelligently comment on the uncontrolled unknown beyond saying that that you’re entering that territory. If you want odds on rolling the dice outside that space, they’re irrelevant to you. So stop looking there. edit: what you want is a politician with the balls to say whether we should do it anyway and convince other politicians that they should own making that decision even if they turn out to be wrong. But Washington is full of cowards too cowardly to even go to bat for sticking to the studied regime beyond milktoast deference to science so you’re here expecting the FDA to start exceeding their role.

enchiridion 6y ago
This is why I am frustrated by the FDA. It seems like all they are willing to do is read statistics produced by others. The suggested dosing is obviously unproven because it has not had a nice large scale study done. Shouldn't this be where they conduct a few rapid small scale experiments? That data, the existing trials, along with a deep bench of knowledge should be enough to make a well justified determination.
- finnthehuman 6y ago
  FDA is doing exactly what’s in their statutory responsibility and authority. ie: what congress told them to do. (See my edited addendum to the parent comment.)
  - fennecfoxen 6y ago
    When someone observes that a government agency which seems to be doing something nonsensical is actually just following the law perfectly, it always brings to mind H. L. Mencken: "Democracy is the theory that the common people know what they want, and deserve to get it good and hard."
- s1artibartfast 6y ago
  1) The FDA does not run clinical trials. 2) Trials must be large to see results because Covid is rare. The Moderna trial took 30,000 patients 3 months to get to 90 covid cases. 3) This could be a an interesting opportunity for challenge trials, but unfortunately, the key metric for vaccines is reduction in severe cases. Subjecting people likely to have a severe case is unethical when there chance of normally catching it is very low.
  - enchiridion 6y ago
    Why not look for key indicators of immunity in the authorized dosage group, then compare against indicators in the reduced dosage group? This is part of my complaint. Why is a large trial, or even a challenge trial (which I also support), the only way to get results here? There is more to science than reading statistics from trials. They should be able to ask and answer very specific questions based on the working model proven far. Then scale those results to the broader problem.
- bluGill 6y ago
  Running trials takes time. It isn't worth it.
hcknwscommenter 6y ago
It is not about who has "balls." You seem to think this is just a balancing of risks. It is not. It is a balancing of "what do we actually have data to support" versus "what do we hope to be the case but have no actual evidence to suggest it is so."
- finnthehuman 6y ago
  > You seem to think this is just a balancing of risks. No I don’t. I was saying that the kind of balancing you mention is out of scope for FDA to answer. The fact you can’t find anyone to answer the question you want answered is not the FDA’s problem. I said go off-label if you want to (although off-label might be slightly the wrong word in this case). Good luck finding a politician that wants to tie themselves to recommending that, in case it turns out wrong.
- beisner 6y ago
  Sure, but we do have prior probabilities based on other vaccination campaigns and studies. We also have some understanding of the causal mechanism of this vaccine, so there is other evidence. It’s just not a direct randomized control. People fixate on statistical testing under randomized control, but there’s a lot more information out there that can be used to assess probabilities.
  - jschwartzi 6y ago
    Given that we've never before studied an mRNA vaccine, how do any of the numerous other studies apply to either the Moderna or Pfizer vaccine?
mikem170 6y ago
> politician with the balls I wish that these decisions wouldn't need to be deferred to politicians. So many of them are selfish idiots. I'd more trust the vote of relevant medical specialists. I'd rather that these specialist provide the public the best/concise information they have and let people make informed decisions for themselves, or even have a referendum on one dose versus two, and prioritizing. Politicians have already turned the world upside down for something that looks like it will kill two out of a thousand people when all is said and done, mostly older. Half the population is dumbfounded by their lack of perspective, the other half is scared shitless.
- deleted 6y ago
  [deleted]

enchiridion 6y ago

This is why I am frustrated by the FDA. It seems like all they are willing to do is read statistics produced by others. The suggested dosing is obviously unproven because it has not had a nice large scale study done. Shouldn't this be where they conduct a few rapid small scale experiments? That data, the existing trials, along with a deep bench of knowledge should be enough to make a well justified determination.

finnthehuman 6y ago
FDA is doing exactly what’s in their statutory responsibility and authority. ie: what congress told them to do. (See my edited addendum to the parent comment.)
- fennecfoxen 6y ago
  When someone observes that a government agency which seems to be doing something nonsensical is actually just following the law perfectly, it always brings to mind H. L. Mencken: "Democracy is the theory that the common people know what they want, and deserve to get it good and hard."
s1artibartfast 6y ago
1) The FDA does not run clinical trials. 2) Trials must be large to see results because Covid is rare. The Moderna trial took 30,000 patients 3 months to get to 90 covid cases. 3) This could be a an interesting opportunity for challenge trials, but unfortunately, the key metric for vaccines is reduction in severe cases. Subjecting people likely to have a severe case is unethical when there chance of normally catching it is very low.
- enchiridion 6y ago
  Why not look for key indicators of immunity in the authorized dosage group, then compare against indicators in the reduced dosage group? This is part of my complaint. Why is a large trial, or even a challenge trial (which I also support), the only way to get results here? There is more to science than reading statistics from trials. They should be able to ask and answer very specific questions based on the working model proven far. Then scale those results to the broader problem.
bluGill 6y ago
Running trials takes time. It isn't worth it.

hcknwscommenter 6y ago

It is not about who has "balls." You seem to think this is just a balancing of risks. It is not. It is a balancing of "what do we actually have data to support" versus "what do we hope to be the case but have no actual evidence to suggest it is so."

finnthehuman 6y ago
> You seem to think this is just a balancing of risks. No I don’t. I was saying that the kind of balancing you mention is out of scope for FDA to answer. The fact you can’t find anyone to answer the question you want answered is not the FDA’s problem. I said go off-label if you want to (although off-label might be slightly the wrong word in this case). Good luck finding a politician that wants to tie themselves to recommending that, in case it turns out wrong.
beisner 6y ago
Sure, but we do have prior probabilities based on other vaccination campaigns and studies. We also have some understanding of the causal mechanism of this vaccine, so there is other evidence. It’s just not a direct randomized control. People fixate on statistical testing under randomized control, but there’s a lot more information out there that can be used to assess probabilities.
- jschwartzi 6y ago
  Given that we've never before studied an mRNA vaccine, how do any of the numerous other studies apply to either the Moderna or Pfizer vaccine?

mikem170 6y ago

> politician with the balls I wish that these decisions wouldn't need to be deferred to politicians. So many of them are selfish idiots. I'd more trust the vote of relevant medical specialists. I'd rather that these specialist provide the public the best/concise information they have and let people make informed decisions for themselves, or even have a referendum on one dose versus two, and prioritizing. Politicians have already turned the world upside down for something that looks like it will kill two out of a thousand people when all is said and done, mostly older. Half the population is dumbfounded by their lack of perspective, the other half is scared shitless.

deleted 6y ago
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