6 ms·

Pfizer trial demographics are on page 31 of this PDF: https://www.fda.gov/media/144246/download https://www.fda.gov/media/144246/download You can compare that

by Exmoor 6y ago

Pfizer trial demographics are on page 31 of this PDF: https://www.fda.gov/media/144246/download https://www.fda.gov/media/144246/download You can compare that with the demographic table of the US. Looks like they don't quite align, but are presumably within the guidelines. FWIW, all the comments I saw from people more familiar with medical data were pretty positive about the demographic spread. https://en.wikipedia.org/wiki/Race_and_ethnicity_in_the_United_States#Racial_categories https://en.wikipedia.org/wiki/Race_and_ethnicity_in_the_Unit...

Herodotus38 6y ago
Notably, specifically look at the phase 1 demographics. It was 100% white. I’m not saying anything for or against this, but I bet it was in the first phase where the concerns for equity were brought up. Edit: the difficulty becomes the argument between recruiting equitably vs recruiting quickly, both are going to have downsides. Ideally you would do both at once, the question becomes why is this so hard in the US, and there are lots of reasons.
- KKKKkkkk1 6y ago
  Is that why African Americans don't trust the US medical establishment? Phase 1 is meant to select the safest dose. If Black people did not take part in Phase 1 and were only added in Phase 2, that means that folks in Phase 2 were exposed to unnecessary risk.
  - Herodotus38 6y ago
    I have no insight into how volunteers were recruited in the study but I would imagine that it is partially a cycle of African Americans being less likely to volunteer due to a history of mistreatment by medical community. A lot of studies also recruit people who have a connection to the study (maybe friends/family members, students at the local university, etc...). If there is less diversity in the company and people running the study, I think this would also lead to less diversity in the participants. Again, I have no knowledge of how this one was done.
  - rrrrrrrrrrrryan 6y ago
    It's still very difficult to convince black people to partake in medical trials, largely because their trust in the system was so thoroughly violated in the not-so-distant past: https://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study https://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study It's not hard to imagine a patient noping out of an experiment if he's the token black guy in a room full of white doctors poking and prodding at him. I work for a company that makes medical devices for people with diabetes, (a disease which disproportionately affects people of color), and we go out of our way to ensure that we have a diverse cast of people who interact with the patients in our studies.
    - spoopyskelly 6y ago
      Is diabetes racist?
    - runamok 6y ago
      I see the Tuskegee example trotted out pretty often and frankly I was ignorant of it. Is this a well known and discussed thing among black people or might it be more about a general distrust of the government, etc. and as you pointed out, being historically under represented in medicine. I am just guessing a fairly small people asked about Tuskegee would know what it is but maybe it's just me. I am just suggesting maybe asking black people why they don't want a covid vaccine for example and address those issues.
      - rrrrrrrrrrrryan 6y ago
        Yes, the Tuskegee study is well known among black Americans, and it's been written about extensively. They've even shown that the study might be responsible for as much as half of the life expectancy gap between white and black American men today, because it directly led to mistrust of the medical establishment and caused black men to avoid going to the doctor. That said, I recently read that most black people (falsely) believe that the Tuskegee subjects were deliberately infected with syphilis, but I can't find the source right now, and it's kind of splitting hairs anyway.
  - wittyreference 6y ago
    That's not what phase 1 is for. Phase 1 is essentially to test "will this drug cause terrible harm to people who receive it in a reasonably short time frame?" In terms of dosage guidelines, phase 1 studies often don't have variable dosing, or if they do, not an awful lot - because the question around optimal dosing is the target of phase 2. (Sometimes you can roll 2 and 3 up together, for instance, if the difference in dosing is in duration of therapy rather than an actual difference in drug administered per unit time.) Phase 1 usually has terribly small samples, because it's only looking for terribly large effects. Seeing homogeneity there, of any stripe, is neither unexpected nor problematic. (A lot of the vaccine studies rolled up phase 1/2 together because we already have a pretty good understanding of what these delivery mechanisms do to people, and so while you'd be cautious in administering to the initial study participants, it really didn't merit a "test it on five people and hold your breath" approach.)

by Exmoor 6y ago

Herodotus38 6y ago

Notably, specifically look at the phase 1 demographics. It was 100% white. I’m not saying anything for or against this, but I bet it was in the first phase where the concerns for equity were brought up. Edit: the difficulty becomes the argument between recruiting equitably vs recruiting quickly, both are going to have downsides. Ideally you would do both at once, the question becomes why is this so hard in the US, and there are lots of reasons.

KKKKkkkk1 6y ago
Is that why African Americans don't trust the US medical establishment? Phase 1 is meant to select the safest dose. If Black people did not take part in Phase 1 and were only added in Phase 2, that means that folks in Phase 2 were exposed to unnecessary risk.
- Herodotus38 6y ago
  I have no insight into how volunteers were recruited in the study but I would imagine that it is partially a cycle of African Americans being less likely to volunteer due to a history of mistreatment by medical community. A lot of studies also recruit people who have a connection to the study (maybe friends/family members, students at the local university, etc...). If there is less diversity in the company and people running the study, I think this would also lead to less diversity in the participants. Again, I have no knowledge of how this one was done.
- rrrrrrrrrrrryan 6y ago
  It's still very difficult to convince black people to partake in medical trials, largely because their trust in the system was so thoroughly violated in the not-so-distant past: https://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study https://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study It's not hard to imagine a patient noping out of an experiment if he's the token black guy in a room full of white doctors poking and prodding at him. I work for a company that makes medical devices for people with diabetes, (a disease which disproportionately affects people of color), and we go out of our way to ensure that we have a diverse cast of people who interact with the patients in our studies.
  - spoopyskelly 6y ago
    Is diabetes racist?
  - runamok 6y ago
    I see the Tuskegee example trotted out pretty often and frankly I was ignorant of it. Is this a well known and discussed thing among black people or might it be more about a general distrust of the government, etc. and as you pointed out, being historically under represented in medicine. I am just guessing a fairly small people asked about Tuskegee would know what it is but maybe it's just me. I am just suggesting maybe asking black people why they don't want a covid vaccine for example and address those issues.
    - rrrrrrrrrrrryan 6y ago
      Yes, the Tuskegee study is well known among black Americans, and it's been written about extensively. They've even shown that the study might be responsible for as much as half of the life expectancy gap between white and black American men today, because it directly led to mistrust of the medical establishment and caused black men to avoid going to the doctor. That said, I recently read that most black people (falsely) believe that the Tuskegee subjects were deliberately infected with syphilis, but I can't find the source right now, and it's kind of splitting hairs anyway.
- wittyreference 6y ago
  That's not what phase 1 is for. Phase 1 is essentially to test "will this drug cause terrible harm to people who receive it in a reasonably short time frame?" In terms of dosage guidelines, phase 1 studies often don't have variable dosing, or if they do, not an awful lot - because the question around optimal dosing is the target of phase 2. (Sometimes you can roll 2 and 3 up together, for instance, if the difference in dosing is in duration of therapy rather than an actual difference in drug administered per unit time.) Phase 1 usually has terribly small samples, because it's only looking for terribly large effects. Seeing homogeneity there, of any stripe, is neither unexpected nor problematic. (A lot of the vaccine studies rolled up phase 1/2 together because we already have a pretty good understanding of what these delivery mechanisms do to people, and so while you'd be cautious in administering to the initial study participants, it really didn't merit a "test it on five people and hold your breath" approach.)