Woke Trial - Ethics

This forum made possible through the generous support of SDN members, donors, and sponsors. Thank you.

neglect

1K Member
20+ Year Member
Joined
Sep 2, 2003
Messages
9,011
Reaction score
4,725
There is a PET scan trial called ‘New IDEAS,’ which looks at amyloid PET imaging. This is a follow up on the IDEAS trial, which showed that doctors marginally change mgmt after amyloid PET scans (no surprise, to get a patient a PET scan in the trial one had to attest the scen could change mgmt). It also showed a slight reduction in $ for PET + patients, but this might have been due to the fact they had AD.

Here’s the summation. Results from IDEAS Study Published | ALZFORUM

The bottom line, IMO, is much ado about nothing. So now comes the next trial. This next trial explicitly calls for ethnic categorization: 2 African Americans, 2 Hispanics, and 3 Others. Is this ethical? I’m not so sure. If there’s a reason to study ethnic differences, like ethnic responses to tPA, I’d probably be in favor. Just getting PET scans on Black patients? Seems like we’d be treating one group differently than another. THere are pressures to participate here, particularly if you work for a huge hospital: you’ll get PET center referrals. But is it actually ethical?

So far I’ve heard that Blacks and Hispanics have greater vascular contributions, so might have more amyloid negatives. Is this a meaningful outcome? Is THIS worth studying, rather than, say, trying to address these discrepancies?

If I had more confidence in the phenotypes getting into this trial, I’d probably say sure - let’s validate Amyloid PET in URMs. Since there’s very little standardization, that won’t happen. I’m also bothered by the absence of Asians. No-one seems to give a **** about the Vietnamese and Cambodian urban poor with terrible vascular disease and social-economic disadvantages. Tagging overlapping wise people from the SDN forum: @Nutmeg @MOHS_01 @Hernandez @jdh71 @gostudy @Homer J. Simpson @Fireman Thoughts?

Edit: summation of the New Ideas trial here: New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study - Full Text View - ClinicalTrials.gov

Members don't see this ad.
 
Last edited:
I have mixed feelings about these issues. We obviously need to do better in terms of including racial and ethnic minorities in clinical research for a variety of reasons: ensuring our results are generalizable not just within the US but worldwide, ensuring that evidence-based practice is as sound for minorities as it is for the majority, etc.

Using race as a substitute for biology is problematic. Racial groups are not only internally heterogenous, they mix freely and definitions about who fits into what race differ tremendously by culture. But it's not quite as simple as saying that race is a social construct as some would like to, as there are medical problems with a clearly genetic basis that affect people along racial lines. Sickle cell and cystic fibrosis are diseases that exist, no matter how inconvenient those diseases are for sociologists. But the simple classifications ingrained into our society and that many of us learned in school are basically phrenology-level pseudoscience.

In my mind, our emphasis in studying racial minorities should not be to tailor medicine on a racial basis, but to ensure that our research population is representative of our treatment population.
 
  • Like
Reactions: 2 users
Members don't see this ad :)
I have mixed feelings about these issues. We obviously need to do better in terms of including racial and ethnic minorities in clinical research for a variety of reasons: ensuring our results are generalizable not just within the US but worldwide, ensuring that evidence-based practice is as sound for minorities as it is for the majority, etc.

Using race as a substitute for biology is problematic. Racial groups are not only internally heterogenous, they mix freely and definitions about who fits into what race differ tremendously by culture. But it's not quite as simple as saying that race is a social construct as some would like to, as there are medical problems with a clearly genetic basis that affect people along racial lines. Sickle cell and cystic fibrosis are diseases that exist, no matter how inconvenient those diseases are for sociologists. But the simple classifications ingrained into our society and that many of us learned in school are basically phrenology-level pseudoscience.

In my mind, our emphasis in studying racial minorities should not be to tailor medicine on a racial basis, but to ensure that our research population is representative of our treatment population.

To my feeble mind there's a contradiction above. We need to ensure "minorities in clinical research" so results can be generalizable. But race is "heterogenous" and can't be used as a "substitute for biology." So serious question: which is it? Do racial differences make trial results done on 93% Caucasian populations useless when applied to African Americans, or Africans, or Indians, etc? Or are racial/ethnic groups so heterogeneous that it doesn't matter? These two ideas appear to be antitheses of each other.

You kinda answered it, I think, because after you said "using race as a substitute" for biologic difference is idiotic - I liked that - you point out there ARE genes that happen to be concentrated/diluted within some racial groups. Do they matter for a kinda-junky imaging trial? So. Much. Overlap. When the CHANCE trial came up, I remember someone I admire very much quipping, "I don't think Chinese platelets are different than mine." (I think the issue was more mistrust, but that trial was replicated with POINT). In the same vein, I don't think Latinx amyloid is different than mine.

So the bottom line: why do this trial?



Read the replies, later today probably tonight, you should bring alcohol.


So painful. Demanding JAMA retract a study that actually shows a genetic expression difference that's highly germane? It is as anti-science as you can get. Like flat earthers, they demand science conform to their idea that race/ethnic differences are 100% social constructs and have nothing to do with random clustering in human lineages and unknown genetic selection.
 
  • Like
Reactions: 4 users
In the CHANCE trial, the criticism I most often heard was that the risk factors in the US and Chinese population are so different. Is atherosclerosis in a BMI 19 person due to chain smoking 4 PPD the same as atherosclerosis in a BMI 40 patient due to IV McDonalds TID the same thing? I don't know, but skepticism wasn't necessarily about race here.

I guess I have more problem with the amyloid trial than the JAMA trial. The amyloid trial is using racial subgroups to try to make biological distinctions with the goal of changing practice (PET ordering and interpretation) along racial lines. The JAMA trial is trying to explain a widely-observed difference in a particular minority group by looking for a biological difference among self-identified members of that group. Perhaps the difference is subtle, but I think it's important. There's no problem with the hypothesis that particular subpopulations have different allelic frequencies. Anyone who thinks this is categorically false needs to be referred to the Ashkenazi Jewish population. But for the most part, the fluidity of racial labels means that you can assume very very little about individual biology by someone's identification with a particular minority group. A black person in the US may have far more European ancestry than African ancestry if you trace geneology. HLA types in European Iberia may be much closer to North African populations than Norwegian populations. Giving someone different error bars on a test just because they self-identify as being part of a different racial or ethnic group is unfathomably stupid in 2020, and yet we often do it anyway.
 
  • Like
Reactions: 1 users
There is a PET scan trial called ‘New IDEAS,’ which looks at amyloid PET imaging. This is a follow up on the IDEAS trial, which showed that doctors marginally change mgmt after amyloid PET scans (no surprise, to get a patient a PET scan in the trial one had to attest the scen could change mgmt). It also showed a slight reduction in $ for PET + patients, but this might have been due to the fact they had AD.

Here’s the summation. Results from IDEAS Study Published | ALZFORUM

The bottom line, IMO, is much ado about nothing. So now comes the next trial. This next trial explicitly calls for ethnic categorization: 2 African Americans, 2 Hispanics, and 3 Others. Is this ethical? I’m not so sure. If there’s a reason to study ethnic differences, like ethnic responses to tPA, I’d probably be in favor. Just getting PET scans on Black patients? Seems like we’d be treating one group differently than another. THere are pressures to participate here, particularly if you work for a huge hospital: you’ll get PET center referrals. But is it actually ethical?

So far I’ve heard that Blacks and Hispanics have greater vascular contributions, so might have more amyloid negatives. Is this a meaningful outcome? Is THIS worth studying, rather than, say, trying to address these discrepancies?

If I had more confidence in the phenotypes getting into this trial, I’d probably say sure - let’s validate Amyloid PET in URMs. Since there’s very little standardization, that won’t happen. I’m also bothered by the absence of Asians. No-one seems to give a **** about the Vietnamese and Cambodian urban poor with terrible vascular disease and social-economic disadvantages. Tagging overlapping wise people from the SDN forum: @Nutmeg @MOHS_01 @Hernandez @jdh71 @gostudy @Homer J. Simpson @Fireman Thoughts?

Edit: summation of the New Ideas trial here: New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study - Full Text View - ClinicalTrials.gov
Agreed, uncertain validity as far as yielding actionable information, but I can see some utility to seeking out differences in baseline functional or imaging studies between ethnic or racial groups. In a less politically charged environment, study of such possible variances that may explain observed differences between groups would be welcomed, but today.... any possible difference may be viewed as socioeconomically derived, victim shaming, etc.

We have spent decades saying that race is a social construct; what does this mean for the current emphasis on it? If discernible biologic differences exist, what will that portend? It will be abused, for sure, by those who would seek to drive lines of delineation, preferring the world to line up on opposing sides of any and every conflict.

I don't know... I generally want to study things for knowledge's sake... but politicians and their enablers ruin everything.
 
  • Like
Reactions: 1 user
The amyloid trial is using racial subgroups to try to make biological distinctions with the goal of changing practice (PET ordering and interpretation) along racial lines.

Right, exactly. See below. Could we find people that could help?

A black person in the US may have far more European ancestry than African ancestry if you trace geneology. HLA types in European Iberia may be much closer to North African populations than Norwegian populations. Giving someone different error bars on a test just because they self-identify as being part of a different racial or ethnic group is unfathomably stupid in 2020, and yet we often do it anyway.

Yeah, this is what bothers me.

Agreed, uncertain validity as far as yielding actionable information, but I can see some utility to seeking out differences in baseline functional or imaging studies between ethnic or racial groups. In a less politically charged environment, study of such possible variances that may explain observed differences between groups would be welcomed, but today.... any possible difference may be viewed as socioeconomically derived, victim shaming, etc.

We have spent decades saying that race is a social construct; what does this mean for the current emphasis on it? If discernible biologic differences exist, what will that portend? It will be abused, for sure, by those who would seek to drive lines of delineation, preferring the world to line up on opposing sides of any and every conflict.

Biologic differences exist, full stop. Not sure how this would be abused, would have to explain that to me. If the test forms a greater understanding of the underpinnings of a patient's MCI or dementia, then I think it COULD help them.

Things make more sense to me when specific, so let's imagine a 72 yo AA man with DM, HTN, and a stroke 10 years ago, now presenting for memory loss. He has a dementia, lives with spouse who is generally overwhelmed by various stressors, doesn't provide a crisp history, but reports 3 years or so of memory and thinking problems. When he became anxious and depressed she finally got him into the doctor.

So he has possible AD now, without good history. If the PET scan is negative, I can imagine turning more attention to vascular protection (although with stroke he should be covered with asa, statin, BP, DM, lifestyle if possible). If it is +, it wouldn't change mgmt. Regardless we'd treat the neuropsych problems.
 
  • Like
Reactions: 1 user
Right, exactly. See below. Could we find people that could help?



Yeah, this is what bothers me.



Biologic differences exist, full stop. Not sure how this would be abused, would have to explain that to me. If the test forms a greater understanding of the underpinnings of a patient's MCI or dementia, then I think it COULD help them.

Things make more sense to me when specific, so let's imagine a 72 yo AA man with DM, HTN, and a stroke 10 years ago, now presenting for memory loss. He has a dementia, lives with spouse who is generally overwhelmed by various stressors, doesn't provide a crisp history, but reports 3 years or so of memory and thinking problems. When he became anxious and depressed she finally got him into the doctor.

So he has possible AD now, without good history. If the PET scan is negative, I can imagine turning more attention to vascular protection (although with stroke he should be covered with asa, statin, BP, DM, lifestyle if possible). If it is +, it wouldn't change mgmt. Regardless we'd treat the neuropsych problems.
So now you have a questionably useful test (which is about par for the course for PET and SPECT in neurodegenerative disorders) and still no basis for making modifications to the interpretation on purely racial factors. Are you going to treat the results of that test differently if the person is black, white, or Asian? If Asian, do we treat a Korean background the same as a Bangladeshi or Tibetan background? If black, do we lump in someone with ancestry going back to plantations in Mississippi with a recent Bantu immigrant from Tanzania?

Where this often gets abusive is when we find that a minority group, usually a minority group with more poverty and less medical access, has different average numbers in some category. Blood pressure, cholesterol, etc. So instead of trying to improve the medical situation of that group, we define normal as different for that population, which implicitly assumes that the difference is biologically driven even when the distinguishing feature of the group is really not very much about biology and the biological differences that exist should really not be lumped together by traditional racial definitions.
 
Last edited:
  • Like
Reactions: 1 users
So now you have a questionably useful test (which is about par for the course for PET and SPECT in neurodegenerative disorders) and still no basis for making modifications to the interpretation on purely racial factors. Are you going to treat the results of that test differently if the person is black, white, or Asian? If Asian, do we treat a Korean background the same as a Bangladeshi or Tibetan background? If black, do we lump in someone with ancestry going back to plantations in Mississippi with a recent Bantu immigrant from Tanzania?

Where this often gets abusive is when we find that a minority group, usually a minority group with more poverty and less medical access, has different average numbers in some category. Blood pressure, cholesterol, etc. So instead of trying to improve the medical situation of that group, we define normal as different for that population, which implicitly assumes that the difference is biologically driven even when the distinguishing feature of the group is really not very much about biology and the biological differences that exist should really not be lumped together by traditional racial definitions.

I'm not used to being this uncertain or equivocal for this long. Because perhaps it is biased to think to oneself, "this person is AA, thus likely a vasculopath, so a negative PET scan will make me really hammer the BP, LDL, HA1C, diet, exercise." But you're exactly right! Korean is different from Tibetan, but both will be lumped as Asian here. And how about people who's ancestors came from Tangier vs. Gibralter? Palermo vs. Tunis? Probably a bit of minor genetic differences, but one is Africa, the other Europe.

Well, much to think about.
 
  • Like
Reactions: 1 user
Right, exactly. See below. Could we find people that could help?



Yeah, this is what bothers me.



Biologic differences exist, full stop. Not sure how this would be abused, would have to explain that to me. If the test forms a greater understanding of the underpinnings of a patient's MCI or dementia, then I think it COULD help them.

Things make more sense to me when specific, so let's imagine a 72 yo AA man with DM, HTN, and a stroke 10 years ago, now presenting for memory loss. He has a dementia, lives with spouse who is generally overwhelmed by various stressors, doesn't provide a crisp history, but reports 3 years or so of memory and thinking problems. When he became anxious and depressed she finally got him into the doctor.

So he has possible AD now, without good history. If the PET scan is negative, I can imagine turning more attention to vascular protection (although with stroke he should be covered with asa, statin, BP, DM, lifestyle if possible). If it is +, it wouldn't change mgmt. Regardless we'd treat the neuropsych problems.
Oh, I agree that biological differences exist; the problem is that not all biological differences will be complimentary to all groups -- and some of these differences will be open to abuse. I was not speaking specifically to the subject matter being studied here, but more broadly.
 
Top