Pinker Bioethics: What Should We Learn?

Julian Savulescu 
Twitter @juliansavulescu

Steven Pinker has recently written an op-ed questioning the contribution of bioethics to the safe and efficient regulation of research. This has been widely misinterpreted and criticised, though Alice Dreger has written a recent accurate blog in support of Pinker. Pinker provocatively said that bioethics should get out of the way of research. This has been interpreted to mean that we should give up ethics review of research. Nobody, not me, and not Steven Pinker, thinks we should abandon ethical review of research. He actually says, ” Of course, individuals must be protected from identifiable harm, but we already have ample safeguards for the safety and informed consent of patients and research subjects.” Pinker is objecting to the unnecessary, unproductive obstruction that much bioethics represents to good research and regulation.

I largely agree with him and have said as much myself over the years. I recently wrote a piece for the anniversary issue of the JME arguing as much. I applaud him for trying to generate some self-reflection in the field.

Two of the cases which are held up as showing the need for bioethics are those of gene therapy death victim Jesse Gelsinger and Asthma study death victim Ellen Roache.

That is exactly right – they show the need for good bioethics. However it was bad and sloppy bioethics that failed to prevent their deaths. I have previously argued that it was a mistake to enrol patients with the mild form of the disease Gelsinger was suffering from, rather than babies with the lethal form of disease. It is either because ethics committees do not understand the concept of expected risk or because they prioritise getting consent (their obsession in my experience) over reduction in expected harm

Ellen Roache died because the researchers did not do a systematic review of the literature. I argued with Iain Chalmers and Jennifer Blunt about 5 years before that systematic review of the literature was necessary to prevent harm, that researchers were continuing to repeat placebo controlled studies and harming patients. This was an opportunity for bioethics and ethics committees to do prevent harm and do some good – they failed.

These are just two examples of how the ethics review system fails. Following these deaths, I wrote an Editorial in the JME: Two deaths and two lessons: Is it time to review the structure and function of research ethics committees?

But as I wrote recently, it fails in another way – by obstructing good research. As Sokol acknowledges, huge amounts of bureaucracy and red tape delay research and raise it costs.

I have recently written on the moral imperative to conduct gene editing research. This is yet another example of where bad bioethics threaten to retard important research.

Imagine there is a disease killing 100,000 people per year. For every year a cure is delayed, 100,000 people die. Time in medical research is money, but it is also human life. The massive delays which unnecessary and inefficient ethics review causes costs lives – we just cannot see whose lives. To be sure there are many promising lines of research that have not resulted in lifesaving cures so far, such as stem cell research. But enormous progress has been made in medical research overall, with the saving of millions of lives. While one of line research may lead to a dead end, overall it contributes to knowledge that together does save lives, as Pinker says, millions of lives. Delaying participants in this race literally has life and death consequences.

Has bioethics done more good than harm? Or more accurately, does the harm it has prevented outweigh the harm it has failed to prevent? It is not at all obvious what the answer is in relation to research.

There is one thing I would qualify about Pinker’s critique: we don’t have “ample safeguards for the safety and informed consent of patients and research subjects” because bioethics is frequently focussed on the wrong targets. I recently said in a heavily edited letter to Nature that we have ethics review processes to protect people in any future gene editing research. In principle, that is correct. But as the Gelsinger gene therapy death shows, these processes need to be improved.

The moral imperative for bioethics is to get out of the way when it should get out of the way (even stronger, it has a duty to facilitate and support ethical and beneficial research); but it is also imperative to stand up when it should stand up. The problem is, we often don’t know when. What we need is less obstruction of good and ethical research, as Pinker correctly observes, and more vigilance at picking up unethical research. This requires competent, professional and trained bioethicists and improvement of ethics review processes.

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6 Responses to Pinker Bioethics: What Should We Learn?

  • Timothy Murphy says:

    Bioethics out of the way, for sure.

    Not only is ‘bioethics’ not a unitary theory, neither is it a unitary practice.

    So, Steven Pinker has called on bioethics to get out of the way, when it comes to obstructing biomedical research.

    Who can argue w/ that? The main problem seems to be regulatory ‘creep,’ namely the impulse to extend over All Research the standards that apply to the Most Sensitive and Most Risk-Intensive research.

    In a sense, the burden of proof seems to be right now: Prove that your study doesn’t involve poor study design, inequitable subject selection, and unjust distribution of risks. And if your study does not go anywhere near these thresholds of harm, well, you still need to prove ahead of time that it does not. It will take just as much time to fill out the paperwork, thank you very much.

    In the 1980s, Yale prof Robert Levine was alert to the problem of regulatory oversight. In Ethics and the Regulation of Clinical Research, he proposed that oversight bodies get out of the business of reviewing low-level research risks. Put that burden on journals and universities, etc. I couldn’t agree more. In addition to the well-worn Georgetown standards of bioethics, why is there no acknowledged principle to relieve the regulatory burden So Far As Possible?

  • michael says:

    I take issue with excluding self-interest from the realm of morality and suggesting that by definition morality is other-caring. I would argue that morality is determined by reference to the pursuit of values and not by the fulfillment of duty. Also the talk about restricting freedom for the public interest is a dubious argument. You rightly talk about the dangers of moral relativists and subjectivists yet this so-called balance between individual rights and public interest is pretty meaningless.

  • Julian Savulescu says:

    Thanks for these comments – I agree Tim. Michael, moral behaviour might promote self-interest. But there has to be some other-regarding component otherwise it is just prudence, not morality. It is true we are “one” in “all to count for one and none for more than one” which means our interests have to be taken into account, even by ourselves, from a moral perspective. But they have to be considered from some partly impartial, not purely self-interested standpoint

  • michael says:

    Julian I will comeback to comment on your last comment but for the meantime you mgiht find this interesting

    http://www.ipscell.com/2015/08/stevenpinker/#st_refDomain=www.facebook.com&st_refQuery=/

  • herbalist healer says:

    Moral behavior might promote self-interest but I would argue that morality is determined by reference to the pursuit of values and not by the fulfillment of duty.

  • herbalist healer says:

    Moral behavior is something that i guess is hard to comment on because What we need is less obstruction of good and ethical research

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