On the Leiter report there is an ongoing debate over editorial policies (primarily failures to disclosure significant interests) at the American Journal of Bioethics. For those interested, at the end of this comment, I disclose my potential conflicts of interest.
The discussion on the Leiter report among some of the interested parties is primarily procedural, yet the tone is rather bitter (if I may use that word)--no surprise because the sides in the debate are accusing each other of misconduct and calling each other "unethical" among other things. Intrigued, I read the two pieces that are at the heart of the controversy--they can be found in a single link here (posted by G. Owen Schaefer on Leiter). Rather than rehearsing the two sides of the debate, I want to call attention to three aspects of the McCollough (et al) response that appear to be treated as standard practice among bio-ethicists, and that deserve more scrutiny regardless of the merits of this particular debate. My first two comments are directed against McCullough's arguments, although what I am really after is to raise questions against apparently prevalent norms among some (many?) bio-ethicists.
First, at one point McCullough (et al.) write: "no ethical standard for off-label use of drugs existed when Dr. New began her treatment protocol in 1986. The LoC falsely assumes such a standard has always existed. To avoid this criticism, the LoC could have cited a consensus ethical standard. The LoC does not do so because, as our review of the 68 citations indicates, there is no such standard in the literature. Grant, for the sake of argument, that such a standard has just been created. To apply it to clinical practice from 25 years ago commits the error of presentism, i.e., applying ethical standards of the present as if they applied throughout human history, against which historians rightly warn us (Pernick 2009)." (40)
Two aspects of this argument are troubling: i. a lot gets packed into the so-called "error of presentism". It is one thing to worry about anachronism: to ask Plato what he would have thought about email is silly. But it is not silly to ask Plato what he would have thought of government surveillance of its citizens (or to ask what he would have thought about eugenic practices). If after the fact one can frame a question in such a way as would have been available at some past time, one can certainly debate with past judgment. (A famous case is where Adam Smith takes Plato to task for condoning child exposure even after the economic rationale has disappeared.) ii. More subtly, the authors presuppose that until there is a "consensus" there is no standard of moral right or wrong. But even if one is no enemy of moral relativism or pluralism (as, perhaps, some readers might be) this approach has perverse consequences: a) it gives folk an interest to prevent consensus from developing; b) it means one is an ethical captive to the lowest common moral denominator; c) it makes morality a matter of decision by expert committee, but why should we trust the experts?
Second, throughout the article McCollough (et al) appeal to studies where results that carry the authority of "statistical significance" (and "statistically convincing") are used against their critics' concerns. Now, elsewhere on this blog I have already reported qualms about the over-reliance of statistical significance (here and here). But note something important: it is very dangerous to use "statistical significance" when one is trying to prove a negative (as McCollough and his co-authors try to do--a medical technique is thought safe because the studies show no statistically significant harmful effects). But besides assuming a normal distribution (and a linearity in an effect, etc), this is especially silly when we are dealing with relatively small numbers (N=147) and "low incidence and prevalence, particularly when the effects being studied (neurocognitive behaviors) are affected by a vast array of factors" (40). Rather than claiming vindication, a more honest assessment would probably entail that it is too early to know anything with much confidence. So, the burden of evidence is not on the critics, but on the defenders of the practice. (I may be no bio-ethicist, but I think I know something about evidential arguments!)
Third, The whole argument of McCullough and his co-authors has a very legalese feel. In particular, it appears that there is an authoritative code to which proper bioethical argumentation MUST conform, and if it is NOT then it is deemed to fall short of some base-line "intellectual integrity" (41) The authority is a fifteen page article, cited as "De Grazia, D., and T. L. Beauchamp. 2001. Philosophy. In Methods in medical ethics, ed. J. Sugarman and D.P. Sulmasy, 31–46.Washington, DC: Georgetown University Press." (besides, p. 41, see also 36, and 37). I have not read the piece. Let me grant that it shows superb moral and ethical insight. But who appointed these two the benchmark-guardians of proper ethical conduct among ethicists??? Did some "consensus" develop on this, too?
[Full disclosure: first, one of my esteemed co-bloggers, Mark Lance, is one of the signaturees of the fetaldex.org letter of concern, which is accused of "unethical transgressive bioethics;" second, my partner is a retina surgeon and neuro-science researcher, which occasionally accepts funding from the medical industry for her basic research, which helps cover some expenses of our forthcoming sabbatical. Her research is in no sense related to the current controversy.]
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