Ouch.
I’ll offer a few thoughts on this, and by the end of it, it may sound like I’m actually defending the drug researchers in that article.
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An attempt to discern a better treatment protocol between Group A & Group B of children who all have a terrible disease is fundamentally different than an institutional policy (fictitious in the sense in which I brought it up) of dispensing daily benzodiazepines to children, presumably to keep them more docile. So I guess we can start w/ that point.
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All medical scientific research carries with it additional moral & ethical burdens vs. scientific research of most other types. If you & I both have hypertension, and we consent to participate in a new drug study, we are both effectively agreeing that either (a) we may not have our blood pressure treated at all for some period of time (ie, we’re in the placebo group, with its associated risks), (b) we’re receiving a drug that may turn out to not be beneficial, or © we’re receiving a drug that may prove to have harmful side effects (eg, liver toxicity) when studied in a larger patient population.
The other physicians in the crowd will be familiar with papers in the medical literature where patients had been randomized into a particular treatment protocol vs. an effective placebo group. At some point, the investigators took an early peek at their outcome data so far, and to their horror, discovered that the treatment group had a higher mortality rate than the placebo group. So they had to abort the study before it’s originally planned conclusion. What that would mean for me as an investigator would be that the treatment protocol that I designed and asked patients to put their trust in me as a treating physician…well, that treatment protocol instead killed some folks compared to placebo. That’s an enormous moral burden to shoulder. And it’s happened.
The stakes arguably get raised even higher when the question under investigation involves cancer, or children, or highly-charged diseases such as HIV/AIDS, especially going back to where that disease was in the 1990’s. But in any case, the moral & ethical considerations are far greater than those of killing a fruit fly, or an E. Coli, or smashing two perfectly good protons into each other. The additional layer of oversight by institutional review boards and the like becomes really important.
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Clinical research on children carries with it the compounding factor that the patients are minors, and in most (if not all) states cannot consent for themselves. Thus, consent must be provided by a parent…or (as in that article) whatever other legal authority is involved.
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In broad medical terms, children are not just miniature adults. Many things about them are quite different. We’re seeing one example these days, as — mercifully — COVID-19 infection in children seems (thus far) to be much less serious. Other disease processes are likewise different.
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Again, HIV/AIDS in the 1990’s was much different than what we see today. AZT was the mainstay of treatment until at least the mid-‘90’s. I had a couple needle stick incidents as a resident back then. My recollection is that the first time I took AZT for a few days, but the second time it was something else. There were newer drugs by then.
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A sizable number of children born w/ HIV in the 1990’s would sadly have been orphans. Far too many of their HIV-infected mothers would have succumbed to the disease in those days. And some number of those children would have been institutionalized as wards of the state.
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It’s a perfectly reasonable moral position to hold that, under no circumstances, should a state agency be allowed to provide consent to experimental medical treatment of any kind on behalf of a child who is a legal ward of that state. It’s one thing if the kid needs his appendix out, and consent is necessary for that. But experimental medical protocols would be excluded from such consent processes. I’ll say it again: that’s a perfectly reasonable moral position for anyone to stake out.
So all that’s a bit of a run-up to this hypothetical. Suppose that we have a group of children w/ HIV/AIDS circa 1995, and the only approved treatment at present is AZT. Somebody’s come along and developed Drug X, and the data’s been promising in animals and perhaps in human adults, as well. But we don’t have any data for children. So let’s say we propose a study design where the children are randomized into three groups, where all kids continue to receive their AZT at an equivalent per-kg dose:
A. AZT + Drug X at 10 mg/kg per day
B. AZT + Drug X at 20 mg/kg per day
C. AZT + Vitamin C
All three groups have their CD4 levels and other labs checked (let’s just say) every six weeks for the (let’s say) 24 weeks of the study, with parameters for what would trigger the investigators to abort, for either positive or negative findings. The kids in Group C are obviously the placebo group, but they’re no worse off than they would have been otherwise; they were getting their usual dose of AZT before the study began. And they may be better off — Drug X may have some nasty side effects and may not confer any discernible benefit. But we also cannot say that the kids in Group C are being denied optimal treatment, either, because we don’t know that yet. That’s why we’re doing the study.
Is it an experiment? Yes. Are the kids “guinea pigs?” Well, yes…one could say that. Could any of them be harmed? Possibly…the most likely group would presumably be Group B, taking the new drug at the higher dose. It could prove to have toxic effects there, but we don’t know. But it might also be a huge breakthrough treatment for HIV in children. That’s what we’re hoping for. But like it or not, this is how we learn stuff in medicine. In the New England Journal article a few weeks back previewing the Pfizer COVID vaccine, their data shows that in the trials, 162 of 2200 folks in the placebo group got infected w/ COVID, vs. 8 of 2200 in the vaccine group. So when you get your own vaccine here one of these days, raise a glass to those 154-ish people who agreed to be a guinea pig, only to get COVID anyways. (Thankfully, there were no COVID-related deaths in either group.)
So again, anyone can still take the position that the state is morally wrong under any circumstances to allow for anything like my hypothetical experiment. And I won’t argue. But even so, this is hardly Nazi Germany level stuff. Nobody’s deliberately giving people syphilis without their knowledge. And if you don’t subscribe to that moral absolute, did the state really sign off on anything so bad here? And is the drug company up to something inherently evil for funding a study that may show that they’ve developed a breakthrough in the treatment of children w/ a terrible disease? How else will anyone figure this out? Some kids’ parents or guardians are gonna have to consent to some kind of study for the knowledge to be advanced.
All that’s a hypothetical, of course. The Guardian’s not gonna tell us the specifics. The way they can make this look is just too juicy. And it’s certainly possible that if I knew the specifics of the study protocols, who knows, I too might recoil w/ horror. Whatever specific field of science you guys are in, you’re likely used to lazy reporting on it in the lay press. All nuance just falls by the wayside. Well that’s really true when it comes to reporting on medical stuff.
And yes, I realize that I’ve now steered my own thread in an entirely new direction. You know…the thread about the TV show about the orphaned girl who gets addicted to Librium and still becomes a world champion chess master. Oh, well.
My colleague at work (in fact the guy who turned me on to the show) & I were just talking about this issue the other day after I had finished the series & we were talking about it in general.