Research Ethics and Ethical Problems

Noted on Ben Goldacre’s twitter feed a couple of weeks ago was this article in Slate about the recruitment of pregnant women into drug trials.

Essentially, there’s a situation in which there’s a dearth of information about the impact of drugs during pregnancy.  According to the article,

[p]harmaceutical companies are not willing to navigate the legal and ethical minefield of testing drugs on pregnant women, especially because pregnancy lasts only nine months, a short window in which the tests could pay off in additional sales.  As a result, drugs are often prescribed to this population off-label, meaning that they haven’t been specifically approved for pregnant women.

Of course, that doesn’t explain why testing is an ethicco-legal “minefield” to begin with.  Still, it’s not all that hard to come up with at least a skeletal explanation: the whole point of trials is that the effect of a drug is unknown, and this might mean that it’s not safe.  When we’re talking about a volunteer, then it’s important that they know the risks before enrolling; but when a woman is pregnant, another dimension is added: she’s effectively volunteering her unborn child as well.  And it might be problematic to expose another human – even a foetus – to an unknown risk.

But this leaves us with a paradox: some treatments might be dangerous for pregnant women or their unborn children, but it’s hard to find out which, because that would require enrolling them in research – which is ex hypothesi problematic precisely because it might be dangerous for them or their unborn children.  Upshot: pregnant women who need treatment are left to choose between using drugs that might be unexpectedly dangerous (to them or their children) or useless by virtue of their pregnancy, or not accessing potentially vital medicines at all; and their doctors are forced to rely on anecdote and educated guesswork when it comes to prescribing.  So the outcome is really no good for anyone – even if it is with the best intention.

Anne Drapkin Lyerly and Ruth Fadden are cited as

argu[ing] that pregnant women are often seen as just vessels, with their own health regarded as secondary to the health of their unborn child.

That may often be the case – it wouldn’t surprise me in the slightest, and it shouldn’t need spelling out that treating the pregnant as “mere” vessels is probably morally indefensible, for more or less the same reasons that treating any person as a mere lump of meat would be.  Still, it pays to be careful.  What may be the case isn’t necessarily what is the case.  Partly this is because, though persons are not just lumps of meat, they are at least partially so; and pregnancy is, at least biologically, the state of being a vessel for a foetus.  So while we oughtn’t to treat pregnant women as only that, it is at least arguably a relevant consideration – it’s something that we have to assign a weight, even if it’s not a great one.  Much will turn out to hinge on what we think of the status of the foetus.

On that matter, I’m happy to accept that the status of the mother is vastly higher.  The mother is – at least usually – a person; and the foetus isn’t.  Assuming that personhood gives an entity inherently high moral value, this means that the mother has an elevated moral status that the foetus simply lacks.  That’s why comparing foetal and maternal interests as equals is a crock, and why maternal desires are important.

Nevertheless, I wouldn’t want to head too quickly to the idea that the foetus has no moral standing at all.  It’s possible to say that it has some without sacrificing the claim that it’s not high, and not inherent, and usually highly discounted.

It seems to me that what matters in respect of enrollment in trials is that a pregnant woman probably does assign some positive value to her foetus – after all, she’s decided to stay pregnant.  And so it would seem to follow, straightforwardly if not quite analytically, that she is not indifferent (and maybe shouldn’t be indifferent) about the welfare of that foetus and the child that it will be – and that, in turn, means taking a position on the acceptability of exposing it to unnecessary risks.  Participation in drugs trials is, unless one thinks that there’s quite a strong duty to research, an unnecessary risk.  And if the mother-to-be takes that seriously, then so should the researchers.  This isn’t because the woman is a mere vessel for the foetus, but precisely because she isn’t: she’s the kind of thing that can and does assign the foetus, and her role as gestatrix, a significant positive value.

The point is this: it seems possible to construct an argument about research participation being morally iffy for the pregnant that doesn’t commit us to any claim about the woman having a low moral status in comparison to the foetus.  Saying that participation and/ or recruitment is problematic is compatible with thinking that the mother’s moral status is unassailably higher than the foetus’.

I don’t know whether this argument would be powerful; but it’s not obviously insane.  Note, too, that I use the word “problematic”.  I’m not saying that participation would be wrong – only that there’re questions that could be asked, and maybe should be asked.  They might be answerable.

While I’m at it, the bit about it being problematic leads me to something that interested me about the sub-headline: “It isn’t unethical to test drugs on pregnant women.  It’s unethical not to.”  I’m instinctively suspicious of any claim that x is “ethical” or “unethical”, because… well, I don’t know what it means.  That is: I accept that in this kind of context the word “ethical” is meant as a synonym for “permissible” or “required”, and “unethical” for “wrong”.  But my worry is this: it’s tempting to dismiss something as “unethical” too easily – as though it’s self-evident what should be done – and, implicitly, that people who do the opposite are either moral failures, or acting in bad faith.  That’s frequently not the case.

Testing drugs on pregnant woman is a nice example of this.  When considering such trials, there seems to be three options available: either positive recruitment of the pregnant, positive avoidance of recruiting them, or indifference about whether participants are pregnant or not.  That is, we either ought, or ought-not, or not-ought, to recruit them.  To say that not to recruit them is unethical implies that we should either recruit them positively, or, at least, be indifferent about whether a participant is pregnant.  Let’s stipulate that it probably means the former of these options.  That would mean that, in the end, the reasons for recruiting them outweigh the reasons for not recruiting them and the reasons to be indifferent.  (I’m assuming that there might be a positive reason for indifference, rather than just a methodological blind spot.)

Well – OK: but what’s important here is that there would, all the same, be a reason not to recruit.  A desire not to put the unborn at unnecessary risk might well furnish this.

Now, suppose that this desire motivates a researcher to exclude pregnant women from a study.  Would we really want to say that the motives were “unethical” – that is, blameable?  All else being equal, that seems to me to be hard to sustain.  Our researcher might well be acting in good faith, based on reasons that are, in their own terms, perfectly good – indeed, praiseworthy.

It might be that, when we’re wondering about the constitution of a cohort of trial participants for a new drug, the reasons to recruit actually outweigh the reasons not to.  They might outweigh them in every case.  But it doesn’t follow from that that the reasons not to recruit are not reasons after all, and not good ones at that.  When we talk about moral problems, we aren’t really talking about whether or not to do the right thing – we’re talking about whether to do prima facie right thing A, or prima facie right thing B.  And if we decide that we should A, it seems to me not really to be quite right to call B unethical.  The moral difference between the two might be quite narrow.

Yes, for some, this is likely to be dismissed as an instance of terminological hair-splitting.  But I think it’s more than that: it tells us something about what’s at stake in moral debate, and reminds us that showing the difference between the one thing we ought to do and the alternatives demands nuance.  And that’s a nuance that can’t be provided by a binary “ethical”/ “unethical” distinction.

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