Comment by fsociety999 | Hacker News Reader

Comment by fsociety999 | Hacker News Reader

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I understand that, my point is that as part of the EUA, patients are required by law to receive information about the treatment.

See section e-1-A-ii here: https://www.law.cornell.edu/uscode/text/21/360bbb-3

  (ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—

    (I)that the Secretary has authorized the emergency use of the product;

    (II)of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and

    (III)of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.

So I am saying, what percentage of people who got the shot actually received this information? Since the trials are ongoing, that should have been communicated to 100% of people who received the vaccine as part of informed consent.

> So I am saying, what percentage of people who got the shot actually received this information?

That's very different than what you said before, and all of them who got it under the EUA.

> Since the trials are ongoing

The trials being ongoing is immaterial, it's required when under an EUA, not when the intervention is one for which trials are ongoing, which are different things.

> That's very different than what you said before

Well, it is what I _meant_ and what I believe the op meant that you originally responded to.

> The trials being ongoing is immaterial

No, it is not immaterial, because people have to be notified of “the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown”. The fact that the clinical trial is ongoing means that many of those benefits and risks are, in fact, unknown.

You can spin this however you like, but my point is that most people who are receiving and have received shots have NO IDEA that clinical trials are ongoing and the actual data has not been made available to the public (even to their doctors who are likely recommending it). This is the reality whether you would like to believe it or not.

> the clinical trial

This is one of your many points of confusion; it is completely normal for even long approved interventions to have many clinical trials in varying stages. There are currently 92 trials for the Pfizer vaccine listed on clinicaltrials.gov, in stages from “not yet recruiting” to “completed”.

And also 1,761 between “Not Yet Recruiting” and “Active” for the notorious untested drug aspirin.

> many of those benefits and risks are, in fact, unknown

That's kind of expected with an EUA more than a fully approved intervention (but even for the latter it's always the case), and why disclosure of potential unlnown risks is required with EUAs.

You unsupported assertion that this requirement is routinely ignored would be a problem if it was true, but you offer exactly zero reason to believe it is true, surrounded by a lot of irrelevancies that show you don't understand the context.

I received a printed handout with every shot I received and my kids received. Are you asking whether every vaccine clinic handed those out as they were required to?

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