The Pharmaceutical Journal
Vol 278 No 7458 p774
30 June 2007

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• Veterinary pharmacy
• Antibiotic resistance
• Community pharmacy
• Opiate addiction
• Clinical trials
• Retention fees (3)

Letters to the Editor

Clinical trials

Scepticism is healthy

From Mr J. P. Miller, MRPharmS

I read with interest your news item referenced from PLoS Medicine that stated “head-to-head drug comparisons are more likely to favour a sponsor’s drug than its comparator” (PJ, 9 June, p666). Large pharmaceutical companies clearly have a vested commercial interest in setting up randomised controlled trials. Because of the huge costs involved they are often the only people able to conduct these, and larger outcome-based trials, where huge patient numbers are often needed to demonstrate significant benefits.

RCTs are usually set up to prove or disprove a hypotheses and to generate data, which are often produced by pilot studies or from secondary/tertiary endpoints in other trials. This, in effect, means that companies have a good idea of the expected outcome based on these data, power the trials accordingly and are able to back the right horse. Why does it come as a surprise that a commercial organisation would fund trial work that has a good chance of being positive for that organisation? Few chief executives would last long in an organisation that continually conducted work showing no benefit or little commercial return.

A degree of scepticism is healthy. However, to suggest that the positive outcomes favouring a sponsor’s drug are due to unfair bias does a disservice to the huge amount of robust work conducted by the pharmaceutical industry. Perhaps in days gone by trial work was less rigorous. However initiatives like Good Clinical Practice, the Helsinki Declaration and web postings of studies from the Medicines and Healthcare products Regulatory Agency make this highly unlikely today.

J. P. Miller
Leeds

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