3 ms·

It seems there has to be some amendments to rules about releasing raw, anonymized trial data when the state is sponsoring development of the drug. Also, how ca

It seems there has to be some amendments to rules about releasing raw, anonymized trial data when the state is sponsoring development of the drug. Also, how can Pfizer claim that their "study" ends in 2023? Several hundred million people have already received their vaccine, unaware that it's part of a study where the clinical data is not even accessible to their doctors...

ceejayoz 5y ago
> Also, how can Pfizer claim that their "study" ends in 2023? Long-term studies are common. We still study Tylenol to this day, for example, to monitor for things like "does it interact with newly approved drugs".
foolyvaxxed 5y ago
dragonwriter 5y ago
> Also, how can Pfizer claim that their "study" ends in 2023? Because it does. https://beta.clinicaltrials.gov/study/NCT04848584 https://beta.clinicaltrials.gov/study/NCT04848584 > Several hundred million people have already received their vaccine, unaware that it's part of a study Because it's not. Use under the EUA and subsequent approval is separate from and in parallel with continuing studies.
- fsociety999 5y ago
  > 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.

ceejayoz 5y ago

> Also, how can Pfizer claim that their "study" ends in 2023? Long-term studies are common. We still study Tylenol to this day, for example, to monitor for things like "does it interact with newly approved drugs".

foolyvaxxed 5y ago

dragonwriter 5y ago

> Also, how can Pfizer claim that their "study" ends in 2023? Because it does. https://beta.clinicaltrials.gov/study/NCT04848584 https://beta.clinicaltrials.gov/study/NCT04848584 > Several hundred million people have already received their vaccine, unaware that it's part of a study Because it's not. Use under the EUA and subsequent approval is separate from and in parallel with continuing studies.

fsociety999 5y ago
> 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.