The British Medical Journal (BMJ) published a poll in late-October 2012 asking, “Who is mainly at fault for denying access to negative clinical trial results?” Respondents were able to choose from a list of potential culprits – legislators, universities, ethics committees, the pharmaceutical companies and regulators.
There was only one reason why this poll was being run: the recent publication of Ben Goldacre’s Bad Pharma: How Drug Companies Mislead Doctors, a door-stopping 450-page assault on the misconduct of the pharmaceutical industry.
Goldacre is best known as the author of Bad Science, which started as a column in the UK’s Guardian newspaper. There, he used his epidemiological training to reveal all manner of quackery with a rare ability to explain complicated ideas to non-experts.
In Bad Pharma he repeats this trick, but the headline news is infinitely more disturbing: contemporary medicine is acutely sick and in desperate need of therapy. Usually, it’s naturopaths who run this argument, portraying what they see as contemporary medicine’s de-humanising reductionism.
Goldacre’s perspective is very different: medicine’s evidence base has been undermined by an unscrupulous alliance of the pharmaceutical industry and regulators, which leads to the routine suppression of negative studies revealing many drugs to be either ineffective or less effective than those they seek to replace.
This suppression has been wilful and many academics (the industry’s “key opinion leaders”) have acted as willing partners in the enterprise, putting their names to ghostwritten articles reporting positive trials, while failing to publish negative trials.
Since there’s so much missing data, we can’t really say whether the therapies we use work or not. Thus, according to Goldacre, medicine’s evidence base is irredeemably corrupted and needs reconstruction. Reform, he believes, must be root-and-branch, with pressure exerted by doctors and patients.
Any argument is only as good as the evidence that supports it. And in Bad Pharma, there’s an almost overwhelming amount of convincing evidence. But we would be wrong to think of Goldacre as a lone voice. We’ve been here before. In only January this year, a BMJ editorial described missing trial data as a “threat to the integrity of evidence based medicine”.
In 2009, Irving Kirsch published The Emperor’s New Drugs: Exploding the Antidepressant Myth. Kirsch demonstrated that in trials, SSRIs (a common class of antidepressants known as selective serotonin re-uptake inhibitors) performed no better than placebos, a fact that would have been known had some clinical trial data not been suppressed by pharmaceutical companies. Regulators happily licensed these new drugs in full possession of this knowledge.
Goldacre’s work, then, is a lightning conductor for much that has come before. But more than that, Big Pharma is a campaigning work, designed to catalyse a movement and leverage access to the corridors of power. Goldacre has also taken to social media to reinforce the message of his book, keeping the momentum building.
So far this strategy has worked spectacularly well. The Emperor’s New Drugs was every bit as damning as Big Pharma, but it might as well have been published in Antarctica to an audience of penguins for the impact it had on the general public. Big Pharma, on the other hand, has been unanimously endorsed and promoted by the British broadsheet newspapers.
And Goldacre’s Twitter feed has been running hot. In two tweets on 23 October, he referred to the woeful inadequacy of the European Medicines Agency (the EU drugs regulator) and its desultory attempts to create an adequate and functional trials register. This prompted member of parliament and doctor Sarah Wollaston to ask questions about missing and suppressed data in the British House of Commons. And the UK Health Minister Norman Lamb has agreed to meet academics to discuss this “really important” issue.
It’s clear that Goldacre cares about medicine, patients and science. If he is able to maintain the rage, his efforts might help usher in a new era of truly evidenced-based biomedicine. But there’s also cause for scepticism.
Goldacre himself looks to stronger regulation and legislation to fix the problem. Others are not so sanguine. Veteran economist Harry Shutt emailed Goldacre, saying:
this profit-maximising industry is totally unsuited to being run on profit-maximising lines by conventional shareholders.
Shutt suggests public ownership of pharmaceutical companies may be the solution. While Goldacre maintains that he doesn’t want “a central-command state economy”, this may be the only way to contain greed and corruption within the pharmaceutical industry.