How dare you criticise me. Translational research and the infallibility threshold.

Translation is the process we use to describe the transition of a (scientific) innovation from conception to deployment. The different stages of translation raise different normative questions (and the exact movement from one normative translational stage to another is extremely interesting and worth looking at for a life sciences lawyer). Magic things happen to the innovation along that path – benchside, critical reviewing and harsh attacks on a concept’s validity are highly desirable and indeed necessary to prove the concept and make it ready for its journey towards bedside. Seemingly, at some stage this rigorous review of a concept’s validity, and more importantly – safety, turns from necessary mechanism to a measure impeding the business interests of third parties. One of the reasons behind this odd transition is that the innovation leaves the hands of scientists and academics and is handed into the care of a commercial enterprise, who views it as a product which must generate profit. The product’s value hinges on its core characteristics not being in doubt, scientific validity or patient safety are no longer interesting issues.

If I sell toasters and they produce lovely toast, the product may well sell. If someone comes along and suggests that instead of merely producing lovely toast, the toaster turns slices of innocuous bread into carcinogen slabs, and that consumers ought to be careful, my business interests are impacted by that statement (people are unlikely to invest in my toaster or my business). If the statement turns out to be wrong and the person making the allegation knew the statement to be wrong, it seems fair enough that I am compensated for the loss. It is probably even legitimate (and, in respect of limiting my loss, my duty) to try to prevent the person from making the statement in the first place. So far, so good.

In the context of health products and therapeutic interventions, matters are slightly more complex. I am sure the translational life span of a toaster is very interesting, but the translational process of a new therapeutic intervention is riveting. Occasionally, boffins in labs come up with crazy ideas, such as using autologous adipose stem cells to treat back pain (just one example, but I get back to it below). They try this ad nauseam, probably in some hapless animal model. After interviewing enough rats to find out whether their backs have got better, they move on down the translational process. At every step of the way, the idea is harshly criticised: within the group developing the innovation, in journal articles responding to the publication of the innovation, in journal articles presenting the attempt to replicate the innovation, in institutional review board hearings, at conferences, in the pub, etc. It would be unheard of if the group developing the innovation were to try to silence those who criticise the innovation – this is part and parcel of the scientific process that gives us societal progress.

At some stage, commercial entities spot this idea (probably because they have their own, much better paid, boffins scanning the scientific literature and going to the conferences to listen to the criticism) and they snap it up. Once it has become their intellectual property, it is no longer an innovative scientific idea, but a product. Something fundamental has changed at this translational stage. The commercial entity is trying the get the innovation into routine clinical application and I acknowledge that it’s absolutely necessary that someone does, and that the state is not in a position to effectively do so. At the same time, the commercial entity has invested money into the acquisition and development of the innovation and the investors are entitled to expect some sort of return on investment. Hence, the value of the innovative product must be preserved, if not improved. The commercial entity does this in the only way it knows – by launching lawyers at third parties who allege a defect or problem with the product.

To put it slightly colourfully: On Monday, Prof. X (yes, yes) goes to a conference and criticises stem cell therapy as being underresearched and potentially unsafe (“more research needs to be done”, ouch) and he only has a lively debate on his hands. The group presenting their stem cell therapy may well seek Prof. X out at the conference hotel bar that night, shake his hand, thank him for his feedback and, quite possibly, agree to provide him with the raw data for their experiments (it would be so nice, wouldn’t it). On Tuesday, the group sells their innovation to a commercial entity. On Wednesday, Prof. X repeats his criticism and his concern for about the safety of the innovation and suddenly, he has lawyers sending letters to him and his employer, trying to get him to shut up and keep his concerns to himself lest he be litigated against. They don’t have a hope to actually win any litigation unless they can prove that he knew his concerns to be false and that he voiced them purely to harm their interests. But they don’t have to – litigation is expensive and they are loaded, it’s only a matter of time until Prof. X folds for financial reasons.

This has, unfortunately, become quite fashionable. The most recent example I am aware of is the fracas involving, Leigh Turner, a University of Minnesota professor of bioethics who had serious concerns about a stem cell therapy being offered by a company called Celltex. He wrote to the US Food and Drug Administration expressing his concerns. Celltex responded by writing to the University of Minnesota requesting that the university distance itself from Turner (divide and conquer – once the prof is on his own, it’s much easier to bully him into retracting his comments because Celltex in all likelihood have at least a seven-figure annual litigation budget that they have written off already. I don’t know how much colleagues at Minnesota get, but if it’s anywhere near what I am getting then a lawsuit would last approximately ten seconds). The university responded in a legally impeccable fashion: as he is not an official representative of the University, he of course spoke for himself but they left no doubt about the fact that his statements have an overwhelmingly strong footing in academic freedom. The fact that he is not only entitled to speak on his own behalf in the context of his academic work, but expected to do so, is – in any case – the other side of the coin of academic freedom. It would be unthinkable that the University of Minnesota would let this academic stand on his own if it came to litigation as this would be a clear attack on all academics in all universities, which explains why I am taking the time to write about this. Any academic who has a sufficient understanding of how the system works that has brought us to this best of all possible callings should feel offended.

I should acknowledge that there are people who seem to feel otherwise but are struggling to engage meaningfully with those who do (it pains me to see exchanges such as those sustained by an individual claiming to be Laurence B. McCullough in response to a call for solidarity with Leigh Turner; the style is unhelpful on an epic scale and quite embarrassing to read (see the comments on that article)).

The whole problem seems preposterously unnecessary. Turner works in bioethics. There is an ethical issue with making potentially unsafe or insufficiently tested treatment available to individuals. Turner had a moral and professional obligation to voice these concerns (“Professor of bioethics withheld concerns about stem cell therapy. Harm could have been avoided.”). Celltext could have responded by saying “let’s talk and see what we can do to make this work”. Instead, they went on the legal attack. What Celltex and others fail to realise that in trying to protect their commercial interests, they attack – and possibly damage beyond repair – the very system they are dependent on to generate the type of innovation they need to have anything to sell. It’s as dim-witted as a dairy farmer interfering with his livestock’s food and water intake and then moaning about the low milk yield. (I do realise that a lot of colleagues will not like that comparison at all, but I have a feeling that it’s an analogy with a level of complexity that a biotech CEO will be able to put on a PowerPoint slide). At the same time, these companies woefully underestimate that the academic community is so incredibly well-connected, that their plan to shut up one academic will soon be the subject of a world-wide debate. Before you know it, when you google “Celltex” you will not find glowy-faced pictures of healed, happy patients but contributions like this one and unhelpful repetitive chants such as the ones purportedly by McCullough. So you achieve the exact opposite – by trying to protect your commercial interests in an old-fashioned way, you do more harm to them.

It probably boils down to this: once the commercial cost of causing a public academic debate outweighs seven figure biotech litigation budgets, we have corrected the imbalance caused by abusive utilisation of litigation to silence colleagues. So let’s keep discussing this.

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