Intended for healthcare professionals

Editorials

Patients’ roles and rights in research

BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3193 (Published 25 July 2018) Cite this as: BMJ 2018;362:k3193

The Dead Hand of Research Committees; More Means Less

Your recent editorial, “Patients’ roles and rights in research” [1] ended with an invitation for comment; here’s mine: the proposals, and the journal’s determination to act on them, would be another nail in the coffin of clinical research and the skills that go with it.

The editorial declares that “including patients and the public as partners in research is accepted best practice in several Western countries…” but by whom and for what reason? It notes the sorry evidence that “The exponential rise in research output has been accompanied by a decline in quality… [with]… high levels of waste, bias, inefficiency, and error”; but the idea that the rot would be slowed by the proposed collaborative effort with patients is nonsense; it runs counter to the way research operates, as I will show by the reality of example, rather than words for comment and death by debate.

In the course of a medical ward round, we reviewed and moved on from an elderly man with a pulmonary disorder. But I remained intrigued by his senile purpura and when the round was over, went back to the patient, asked if I could take and reinject a little blood – and immediately found that a tiny i.d. injection of fresh blood produced a typical lesion of senile purpura on susceptible skin of the extensor forearm; that, in turn, led me on to show it only raised a wheal when injected elsewhere. This critical observation was the key to the explanation of senile [2] and corticosteroid [3] purpura by the shearing and fluid spread in collagen deficient skin; more importantly, it led to a new method for the measurement of skin collagen and the considerable literature on the changes with age [4], endocrine and associated bone disease [5].

But note, it was the initial experimental response that made the sense of my half-baked intuitive idea; I could not have justified a research proposal without it. The logic of a novelty may only become apparent after the pilot experiment is done, but research committees want the logic first. That’s the Catch 22 of research approval by committee, and that’s why they approve proposals for which the outcome is predictable, and put their dead hand on the unknown of novelty. Thus, our study showing that patients with dermatitis herpetiformis have jejunal changes “indistinguishable from coeliac disease” [6], would never have been allowed by a research committee, because it was based on little more than my wild “hunch”; yet the defect it revealed has been confirmed many times by others. Of course, even without our defining studies, that discovery would have been made eventually, just as would have the cause of senile and corticosteroid purpura, and the tissue collagen work that led on from it; but does that justify the exclusion by committee of the creative clinical research that leads to novelty?

The editorial proposal for yet another committee is dangerous; of course it would not harm the dull academic labour that now masquerades as clinical research – the churning out of massive double-blind, case-controlled, randomised studies that mostly confirm what we already know, or don’t need to know, about drugs and disease – maybe, indeed, the extra paperwork would improve things by delaying their approval. But when applied to clinical research that is inspired to find and create new things, the editorial proposal will serve only to kill its few remaining shoots. The BMJ should know better.

Sam Shuster

1 Patients roles and rights in research. BMJ 2018; 362:k3193
2 Shuster, S, Scarborough, H. Senile Purpura. Quart J Med , 1961,30, 33-4
3 Scarborough, H., and Shuster, S. (1960). Corticosteroid purpura. Lancet, i, 93.
4 Shuster S, Black MM, MacVitie E. The influence of age and sex on skin thickness, skin collagen and density. Br J Dermatol . 1975; 93 : 639–643.
5 Shuster S. Osteoporosis, a unitary hypothesis of collagen loss in skin and bone. Med Hypoth. 2005; 65:426-432.
6 Marks JM, Shuster, S, Watson, AJ. Small bowel changes in dermatitis herpetiformis. Lancet 1966, ii, 1280-1282.

Competing interests: No competing interests

28 August 2018
Sam Shuster
emeritus professor of dermatology
Newcastle University
Woodbridge, Suffolk