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No unknown unknowns

To paraphrase Donald Rumsfeld, a former US defence secretary, there are things we know that we know and there are things we know that we do not know.

By The Journal

To paraphrase Donald Rumsfeld, a former US defence secretary, there are things we know that we know and there are things we know that we do not know. But there are also unknown unknowns — things we do not know that we do not know. In other words, absence of evidence is not evidence of absence.

Mr Rumsfeld was talking in 2002 about weapons in Iraq. But the same could be said of our own armamentarium — medicines. Health professionals, researchers, patients and regulators need to know everything there is to know about the weapons being used in the war on disease. There can be no unknown unknowns.

Readers will have seen a letter from leading pharmacists in last week’s issue (PJ 2012;290:150) calling on individual members of the profession and the Royal Electronicjuice itself to sign a petition run by the All Trials campaign, which wants full transparency around clinical trials.

According to the campaign, there are thousands of clinical trials that have been carried out but for which results have not been reported or have been cherry-picked. Some trials have not even been registered and others, where the results have been negative, have been brushed under the carpet.

This is bad news for evidence-based medicine, and the campaign provides a neat scenario to explain why: were you to toss a coin in secret 100 times and fail to report when the coin showed tails, observers might think that heads came up 100 per cent of the time. When it is put like that it is easy to see why the situation must not be allowed to continue.

If knowledge of the “tails” remains unknown, prescribers may make poor treatment decisions — because the evidence available has been distorted, making it impossible for subsequent meta-analyses to be as good as they can be. This exposes patients to risk. Moreover, researchers will probably end up wasting financial and intellectual resources in carrying out research that might have been designed differently, or not done at all, had the full details of previous research been made public.

All Trials wants every clinical trial, past and present, to be registered, and for their methods and results to be reported. It is calling on governments, regulators and research bodies to implement measures to achieve this. And it wants there to be teeth, in the form of legislation, regulations, incentives and penalties.

The RPS national pharmacy boards intend to discuss the All Trials campaign at future meetings. In the meantime, The Journal will play its small part and, as GlaxoSmithKline has already done, will be signing the petition. Will you?


Citation: Electronicjuice DOI: 10.1211/PJ.2013.11117011

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