I think the NIH just stole one of my titles, which was so innovative and unexpected, that I don’t believe they just had the same idea, they must read this blog. A new perspective article in the PNEJM, from, among others, Francis Collins (the NIH director), is titled ‘In support of SUPPORT’. I am going to call my lawyers to complain about infringement of my intellectual property rights. As for the content, well it is strong statement in support of er.. SUPPORT.

A large group of people, ethicists, pediatricians and neonatologists also signed a letter just published in PNEJM, that was called just ‘OHRP and support’, and, as I was one of the signatories, I can’t really complain about that title. But the letter could be considered auto-plagiarism, as it repeats something that I already wrote elsewhere, i.e. ‘Public citizen are full of shit’- no, not really, some of the authors were reluctant, can’t understand why…

It seems that all the public criticism of the OHRP ruling has made them reconsider their actions. OHRP have now issued  a new letter withdrawing the sanctions against the SUPPORT group, and specifically against the IRB in Birmingham. The letter still states that OHRP were right, but they now think that maybe the details of their response were incorrect. Much easier to write that, than an honest letter that said ‘we messed up, and listened too much to poorly informed detractors’.

One thing in that retraction letter that I really disagree with is this idea:

`Doctors are required even in the face of uncertainty to do what they view as being best for their individual patients. Researchers do not have the same obligation’

I was nearly sick. YES WE DO! And it is an obligation that we take very seriously.

I think this comment is based on a very old fashioned idea of what medicine is all about. OHRP seems to think that doctors somehow know, by their clairvoyant insight, endowed when they pass their final exams, the best course of action for their patient, and they should go ahead and treat according to their ESP. I’d rather treat according to my EBM.

Good modern science based medicine is all about making a decision with your patient (or their family) based on their particular situation, the evidence base which exists, their values and desires, and the final calculation of risk and benefit. ‘In the face of uncertainty’ means that there is no clear answer. So, for example, I have a 3 day old baby at 25 weeks with a large PDA, who is still intubated, and no current clear signs of hemodynamic compromise. The OHRP thinks that I should decide whether or not to treat based on my view of what is best. Very often (as in this situation) my view is that I don’t know what is best, that is the only honest evaluation of that situation. If I don’t know what is best, then I can guess, use prejudice, treat according to what happened the last time, phone a friend, check what day of the week it is, or toss a coin.

Which of those satisfies my obligation to my patient?

They all do to some extent, because I am uncertain. The most ethical approach is the last one. To toss a coin. And to do so in the setting of a prospective experiment, where the data will be collected, the comparison of the different approaches can be made objectively, and the results made available to colleagues around the world. That fully satisfies my ethical obligation to do the best for my individual patient, and also means that sometime in the future I will have the knowledge to make a better decision, that there will be less uncertainty.

Also, at least if I toss the coin, if in the future it turns out that one of the 2 courses of action, giving ibuprofen, or not giving ibuprofen, is proven to be preferable, then at least 50% of my babies will have had the right treatment.  That is better than finding out that maybe 100% of them got the worse treatment!

To suppose that researchers are somehow working to a different ethical standard is entirely mistaken. My first responsibility is to my patient, and if I am reasonably certain that one arm of a comparative trial is not in their best interest, then I am morally obliged to not ‘toss the coin’ but to treat according to that best interest.

There are many ethicists, clinicians and clinical researchers who ‘get it’, the signatories of the letter in the PNEJM for example, why don’t the OHRP?