3 ms·

> Because it's not That is misleading at best. It absolutely is part of an ongoing clinical trial regardless us if it is authorized for emergency use. How man

> Because it's not That is misleading at best. It absolutely is part of an ongoing clinical trial regardless us if it is authorized for emergency use. How many people who were given the vaccine were told that it is part of an ongoing clinical trial, authorized for emergency use, and the data from the trial won’t be available for years? I suspect a very small percent.

ceejayoz 5y ago
My kids were in a clinical trial on bilirubin lights, a technology around since the 1950s. Would it be fair to imply the lights are untested as a result?
mike_d 5y ago
Trial participants sign agreements to be part of the trial and usually receive compensation or free medical treatment in exchange for being part of the trial and continued health monitoring. This is a hard rule from the FDA, and failure to do so is subject to criminal liability. Individuals receiving drug under an EUA are not part of a clinical trial, regardless of what you think of the drug.
- fsociety999 5y ago
  Yes, I am aware of that. I was referring to informed consent related to people who received the drug under the EUA. See here for more context: https://news.ycombinator.com/item?id=30017165 https://news.ycombinator.com/item?id=30017165
dragonwriter 5y ago
> It absolutely is part of an ongoing clinical trial regardless us if it is authorized for emergency use. It is for the people enrolled in an actual clinical trial. It's not for people outside of the clinical trial using it under either the EUA or the subsequent full authorization. > How many people who were given the vaccine were told that it is part of an ongoing clinical trial, 100% of those for whom that was true. Which is a very small percentage of the population who has received it. > authorized for emergency use 100% of those for whom that was true, who aren't the same people.
- fsociety999 5y ago
  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 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.
  - dragonwriter 5y ago
    > 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.
    - fsociety999 5y ago
      > 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.

ceejayoz 5y ago

My kids were in a clinical trial on bilirubin lights, a technology around since the 1950s. Would it be fair to imply the lights are untested as a result?

mike_d 5y ago

Trial participants sign agreements to be part of the trial and usually receive compensation or free medical treatment in exchange for being part of the trial and continued health monitoring. This is a hard rule from the FDA, and failure to do so is subject to criminal liability. Individuals receiving drug under an EUA are not part of a clinical trial, regardless of what you think of the drug.

fsociety999 5y ago
Yes, I am aware of that. I was referring to informed consent related to people who received the drug under the EUA. See here for more context: https://news.ycombinator.com/item?id=30017165 https://news.ycombinator.com/item?id=30017165

dragonwriter 5y ago

> It absolutely is part of an ongoing clinical trial regardless us if it is authorized for emergency use. It is for the people enrolled in an actual clinical trial. It's not for people outside of the clinical trial using it under either the EUA or the subsequent full authorization. > How many people who were given the vaccine were told that it is part of an ongoing clinical trial, 100% of those for whom that was true. Which is a very small percentage of the population who has received it. > authorized for emergency use 100% of those for whom that was true, who aren't the same people.

fsociety999 5y ago
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 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.
- dragonwriter 5y ago
  > 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.
  - fsociety999 5y ago
    > 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.