Thursday, 15 November 2012

Bitter pill to swallow

Debashish Munshi & Priya Kurian

The bestselling author of Bad Science and physician-turned-writer Ben Goldacre has taken the gloss off the sugar-coated world of pharmaceutical research with his latest tome Bad Pharma. Goldacre’s sensational expose of the suppression of negative data from drug trials hit the news when a chapter from his new book was published in The Guardian in September this year. Since then, the mediasphere and the blogosphere have been agog with commentaries on and reviews of the book, including in The Telegraph and the New Statesman.

So what are the key charges Goldacre levels at pharmaceutical companies? According to him, they publish and publicise only positive results from trials; cover up results they don’t like; carry out tests on relatively small samples of what he calls “unrepresentative patients”, analyse data with flawed techniques statistical analysis, and “exaggerate the benefits of treatments”. What is perhaps worse is that, as Goldacre alleges, such practices have gone unchallenged by regulatory bodies and academic journals, leaving frontline physicians none the wiser.

In a letter to the New Statesman, the Association of the British Pharmaceutical Industry, on its part, denies that negative trial data are deliberately hidden and insists that 90 per cent of medicines now in use have been developed by the pharmaceutical industry through “incremental innovation”. The industry does acknowledge though that there is “still work to be done in ensuring the publication of negative trial data within journals, and in ensuring greater transparency all round within the industry”.
The ongoing controversy has of course put question marks around the integrity of drug trials and the vulnerability of physicians and patients alike to risks associated with real or perceived distortions of trial data. But it has also raised some red flags on the culpability of academic journals in the dissemination of such data.

Goldacre takes academia to task in the chapter excerpted in The Guardian  saying: “Finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies”. This charge echoes the charges made in the award-winning documentary Inside Job against some business school academics, economists, and state officials who knowingly or otherwise condoned the practices that led to the catastrophic financial crisis in the world.

Connected to this issue of appropriate communication of research results, a recent study in France published in PLOS Medicine found that around half the press releases on randomized controlled trials contained “spin” that inaccurately represented the findings of the actual trials, and were subsequently reproduced in media coverage. A significant finding of this study was that such spin in the press releases and media coverage, which distorted the actual findings of the research, reflected the spin in the published journal articles, namely in the abstract conclusions. The study called for journal editors and reviewers to take greater responsibility to ensure that research findings were accurately presented in article abstracts and press releases.

It seems clear that without open access to raw data, and given the continued conflict of interest between some researchers and those sponsoring the drug trials, it will be difficult for journalists to ask hard questions of the press releases that come their way.

1 comment:

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