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This is, to be quite clear, a violation of the human subjects research protections that emerged out of World War II https://twitter.com/npr/status/1248946409556062208
Since 08/20/1947, the day U.S.A. v Karl Brandt, et al* was decided, there has been absolutely no legal question that the voluntary consent of human subjects is absolutely essential – human medical experimentation without consent is unlawful
*you may know the case by another name, "The Doctors Trial."
The USA tried 20 Nazi medical doctors for the atrocities they committed. Out of the horrors of that regime, and the trial of those doctors, came the Nuremberg Code – a set of ethical precepts to ensure 'never again'
The USA tried 20 Nazi medical doctors for the atrocities they committed. Out of the horrors of that regime, and the trial of those doctors, came the Nuremberg Code – a set of ethical precepts to ensure 'never again'
There are some lines you do not cross.
And there are other more terrible lines that you do not consider even approaching, because those lines are drawn in the blood of far too many of our siblings to count.
And there are other more terrible lines that you do not consider even approaching, because those lines are drawn in the blood of far too many of our siblings to count.
We know, of course, that the United States failed to follow the Nuremberg Code.
It wasn't until 1972 that the unethical experimentation on Black men in Tuskegee, an experiment that denied proven medical treatment through deceit, was finally halted
https://www.cdc.gov/tuskegee/timeline.htm
It wasn't until 1972 that the unethical experimentation on Black men in Tuskegee, an experiment that denied proven medical treatment through deceit, was finally halted
https://www.cdc.gov/tuskegee/timeline.htm
So in 1978, the "Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research" was issued
https://en.wikipedia.org/wiki/Belmont_Report
https://en.wikipedia.org/wiki/Belmont_Report
The official report lays out three key ethical precepts that MUST be adhered to when using human beings as 'research subjects'
The first of which is "respect for persons." In sum, people are autonomous and you must have their informed consent before using them as subjects
The first of which is "respect for persons." In sum, people are autonomous and you must have their informed consent before using them as subjects
This echoed the 1964 Helsinki Declaration, a set of ethical precepts published by the World Medical Association, that was revised in 1975
It says: "Concern for the interests of the subject must always prevail over the interests of science and society."
https://history.nih.gov/about/timelines/helsinki.html
It says: "Concern for the interests of the subject must always prevail over the interests of science and society."
https://history.nih.gov/about/timelines/helsinki.html
And this fundamental ethical precept was operationalized into American law via what has come to be known as "The Common Rule" (found at Subpart A of 45 CFR part 46)
The Common Rule *requires* informed consent. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
The Common Rule *requires* informed consent. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
Some may say, "this is a catastrophe, in LA County alone, 28% of deaths from COVID19 have been people in nursing homes. Surely it's better to try an unproven treatment, rather than doing nothing."
Let's talk about why that's wrong... https://patch.com/california/redondobeach/28-las-coronavirus-deaths-stem-nursing-home-outbreaks
Let's talk about why that's wrong... https://patch.com/california/redondobeach/28-las-coronavirus-deaths-stem-nursing-home-outbreaks
First, it's important to note that FDA has *NOT* "approved" Hydroxy/chloroquine for #COVID19.
What FDA did do? Grant an "Emergency Use Authorization" – importantly, it is extremely limited in scope.
What FDA did do? Grant an "Emergency Use Authorization" – importantly, it is extremely limited in scope.
From the EUA:
"The [hydroxy/chloroquine] may only be used to treat adult and adolescent patients who weigh 50 kg or more and are hospitalized with COVID-19, for whom a clinical trial is not available, or participation is not feasible."
"The [hydroxy/chloroquine] may only be used to treat adult and adolescent patients who weigh 50 kg or more and are hospitalized with COVID-19, for whom a clinical trial is not available, or participation is not feasible."
Nursing homes ARE NOT hospitals. The EUA didn't apply to the setting Robin Armstrong is responsible for... https://www.npr.org/2020/04/10/830348837/covid-19-patients-given-unproven-drug-in-texas-nursing-home-garnering-criticism?utm_term=nprnews&utm_source=twitter.com&utm_campaign=npr&utm_medium=social
https://www.npr.org/2020/04/10/830348837/covid-19-patients-given-unproven-drug-in-texas-nursing-home-garnering-criticism?utm_term=nprnews&utm_source=twitter.com&utm_campaign=npr&utm_medium=social
Second, even in a hospital setting to which the EUA applies, there's still a duty to first pursue a clinical trial – an actual, legitimate, clinical trial, subject to the oversight of an Institutional Review Board charged with protecting human subjects.
This isn't some sort of hidden secret, the EUA document from FDA – a document that clearly lays out the limits of the EUA – is publicly available on the FDA's website:
https://www.fda.gov/media/136534/download
https://www.fda.gov/media/136534/download
Third, there's no reason to believe hydroxy/chloroquine is at all effective against #COVID19.
The evidence was fairly clear from the beginning. #HCQ was largely pursued in the USA initially, as far as I can tell, because of this now-disgraced study https://twitter.com/mattbc/status/1247355590474596353?s=20
The evidence was fairly clear from the beginning. #HCQ was largely pursued in the USA initially, as far as I can tell, because of this now-disgraced study https://twitter.com/mattbc/status/1247355590474596353?s=20
Fourth, hydroxy/chloroquine is NOT an inert placebo. It is a drug that carries *significant* risks. https://twitter.com/mattbc/status/1246991449259941890?s=20
Fifth, this sort of rogue human subject experimentation is serving as an excuse to not do the things WE KNOW would help protect people in nursing homes. The things the disability community has been demanding, particularly, with regard to this pandemic. #WeAreEssential
Physicians are engaging in unethical human experimentation on disabled folks, but almost all y'all media types don't want to platform the disability community. You don't want to hear about #WeAreEssential stories: https://twitter.com/mattbc/status/1248517579964133376?s=20
You don't want to hear about #WeAreEssential disability policy demands from the disability community https://twitter.com/mattbc/status/1247729921239154690?s=20
with the exception of @AliciaMenendez & @JoyAnnReid – who do actually understand nothing about us without us... https://twitter.com/RebeccaCokley/status/1249037836814336000?s=20
This is an interesting point, because the ethics-violator makes a feint towards “compliance” in the NPR piece that seems pretty clearly meant to fake us out
The admission made by Armstrong in this section of the @NPR piece makes it plain that he did not obtain informed consent for his human subjects research:
"Consult with" is not the relevant legal term of art, "obtain informed consent" is.
But let's read these facts in the light most favorable to Armstrong, let's assume that his 'consultations' actually met the standards of informed consent.
But let's read these facts in the light most favorable to Armstrong, let's assume that his 'consultations' actually met the standards of informed consent.
We already know, by the way, that Armstrong considers this human subjects research – that's what "observational study" means
And we already know that Armstrong didn't "consult with" (and therefore could not have obtained informed consent from) several patients that he turned into research guinea pigs:
It's worth noting that an individual research subject lacking the capacity to give informed consent (e.g. because they have dementia) DOES NOT absolve the researcher from the requirement to obtain informed consent.
I am the healthcare proxy for several individuals who lack capacity to provide informed consent. Legally, I stand in their shoes – you want them to participate in human subjects research? You must, as a matter of law, obtain my informed consent. https://twitter.com/mattbc/status/1248517581104910336?s=20
And if you happen to be an unethical physician reading this in a state in which I am admitted to practice, please note: I've never disclosed on this here website a complete list of everyone I represent in this capacity.
Keep that in mind when you're deciding which laws to break
Keep that in mind when you're deciding which laws to break
Because if you harm someone I am responsible for – if you decide to go all aktion t4 on anyone I care about?
I will dedicate the rest of my life to fucking up the rest of yours.
I will dedicate the rest of my life to fucking up the rest of yours.
Yes, I said aktion t4. Yes, my family knows what that means.
Fucking try me. https://twitter.com/mattbc/status/1140810296895975425?s=20
Fucking try me. https://twitter.com/mattbc/status/1140810296895975425?s=20
So we have an admission (against interest) from Armstrong that
1. he's conducting an "observational study" – i.e. human subjects research
2. and that he didn't bother to obtain informed consent from some research subjects before subjecting them to his experimentation
1. he's conducting an "observational study" – i.e. human subjects research
2. and that he didn't bother to obtain informed consent from some research subjects before subjecting them to his experimentation
But did he perhaps obtain informed consent from those other folks he did talk to?
Well, if we're going to assume that he did, he would have had to, as part of the "consultation" disclose ALL relevant information, including the risks of #HCQ.
Well, if we're going to assume that he did, he would have had to, as part of the "consultation" disclose ALL relevant information, including the risks of #HCQ.
Armstrong asserts HCQ "has virtually no side effects"
The truth is HCQ's side-effect profile is so significant, the drug carries a mandated FDA black box warning
The truth is HCQ's side-effect profile is so significant, the drug carries a mandated FDA black box warning
A black box warning is extremely serious: https://twitter.com/mattbc/status/1246992695098302464?s=20
Well, I guess we can't actually read these facts in a way that gets us to the possibility Armstrong obtained informed consent from anyone.
If you're lying to research subjects about the safety risks of the trial? It, definitionally, cannot be informed consent.
If you're lying to research subjects about the safety risks of the trial? It, definitionally, cannot be informed consent.
