Goldacre

George Walkden : Clinical trials and tribulations: a role for Europe

It’s hard to imagine a better fairy-tale villain than a big pharma company. There’s something undeniably sinister about these vast, faceless titans with their unfathomable methods and international reach; so much so that it’s sometimes an effort to remember that, actually, they’re the ones who develop and mass-produce the drugs we use to stay alive. For that we owe them thanks – but let’s not get sentimental about it. These companies are still companies, and they have their own agendas and priorities, which often end up in conflict with those of the average mortal.

One instance of this conflict is the pharma companies’ vice-like grip, via patents, on the production of newly-developed drugs. This can put heavy financial pressure on health services, particularly in developing countries. Another conflict, which is the focus of this article, involves the publication of clinical trial data. Clinical trials are carried out on a massive scale as part of the process of bringing a new drug onto the market: the trials are meant to determine whether the drug is effective and safe, and whether patients would benefit from being prescribed it.

The problem, as Ben Goldacre clearly demonstrates in his excellent book Bad Pharma, is that the decision whether or not to publish the results of a given trial is determined by factors that are anything but scientific. Most worryingly, there is a strong bias towards publishing only positive results: if a trial’s results are negative, or inconclusive, there is a much higher likelihood that they will be stuffed into someone’s desk drawer and never see the light of day. This isn’t a problem that’s unique to industry-sponsored studies, but it certainly seems to be much worse there: a 2006 review found that 78% of industry-sponsored studies showed positive results for the drug in question, while only 48% of independently-funded studies came up with a favourable outcome. Hardly surprising given that pharma companies stand to gain from presenting their drug in the best possible light, but deeply worrying.