Trial data unreliable and uninformative

When your doctor diagnoses a problem and recommends one or more drugs that advice is based on guidelines, which in turn depend on results from randomised clinical trials. This, in theory,  ensures that your treatment will be safe and effective. Unfortunately several studies just published suggest that the evidence can be far from watertight.

One reason is that academic tradition of impartially and carefully studying data and reporting on it accurately it had been replaced by a “secretive business environment where quality not quantity is rewarded” according to a recent study. That’s similar to the conclusion that David Healy reached in his recent book Pharmageddon, which talked about a ruthless commercial “can-do approach” where getting favourable results that would aid marketing was the major concern.

The study found  that since 1977  the number of medical articles published in journals has gone up four times while the number that have had to be later withdrawn because of fraud or fudged results has skyrocketed – increasing 30 times. The research was done by two editors of medical journals -Dr Ferric Fang of Infection and Immunity Journal and Dr Arturo Casadevall editor in chief of mBio –  whose work was written up in the  New York Times last month (April).

They concluded that the rise was due to the competitive business culture now dominating universities which created enormous pressure not only to publish but to get the results into a top rated journal . They described this drive to get the results that now underpin evidence based medicine as “a symptom of a dysfunctional scientific climate”.

The ironic result has been that the top rated journals, the ones that doctors take most seriously, are also the most likely to be targeted by ambitious researchers with fraudulent papers. Between 2001 and 2009 they found  there were 740 retractions in 17 journals. Those with the most included such prestigious publications as the New England Journal of Medicine , Cell, Science and Nature.

The damage done when such articles get published isn’t limited to the reputation of the journals. Another study that came out last year analysed 180 of the retracted papers and found that before they were withdrawn they were mentioned by scientists writing in other journals 5000 times in all – the more often a paper is referred to – “cited” – the more highly regarded it is. A number of clinical trials were set up following up on these faked finding which involved a total of 400,000 patients.

The best way to keep the risk of fraud to a minimum is for researchers to have access to the raw material gathered during the course of any trial but as the Tamiflu saga has shown there is at the moment nothing legal to stop companies hanging on to data claiming commercial confidentiality.

But fraudulent results is actually a minor problem when it comes to the reliability of clinical trials. The much more serious issue, covered in the next post, is that far too few are actually good enough.

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