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Tuesday 11 December 2012

Bad Pharma - "Medicine is broken, as Ben Goldacre explains with laser-sharp clarity in his new book." Courtesy of the New Humanist Magazine Website

Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients by Ben Goldacre (Fourth Estate) - by Martin Robbins

Medicine is broken, as Ben Goldacre explains with laser-sharp clarity in his new book Bad Pharma. The tools we have to investigate new drugs are woefully misused. Drug companies use their financial clout to put a stranglehold on the channels through which evidence is passed to the doctors and policy-makers who need to make decisions on treatments. Information is routinely concealed from the medical profession and wider public through a combination of bad practice and deliberate deceit.
“That’s a lot to stand up,” Ben admits, but in 400 pages he does just that, meticulously picking apart not just drug companies, but researchers, regulators, even patient groups. This isn’t simply a book about badly behaved corporations, but a dissection of a drug research culture so corrupted that it no longer serves the public it is supposed to protect.
Tackling that culture is where the book feels less satisfying. Bad Pharma is written in a data-driven, academic style that eschews personal testimony: great for laying out the raw facts of the situation, but less helpful when it comes to building a picture of the human culture that allowed this mess to develop, in the way that, say, Andrew Sorkin’s superb Too Big to Fail did for the institutions of Wall Street.

The book is essentially a manifesto: each section concludes with detailed recommendations describing what can be fixed, and how. But will anyone listen? For a bit of fun I put a few of Ben’s recommendations to two of the regulators named in the book – the British MHRA and the European Medicines Agency. Did they accept the industry had a problem with open access to data? Should drug companies be required to compare new drugs against the best available treatment? Should regulators force companies to produce better evidence for approving medicines? Should all information seen by regulators be in the public domain? Could regulators communicate risks more clearly?
Speaking to the MHRA is always a chore, and their response failed to address a single one of my questions – not even “have you got a copy of the book?” Instead I learned that trials were “essential” and that companies should report adverse reactions. Whoop-de-do. Their only substantive response was to point to the European Union Clinical Trials Register, which, as Ben pointed out to me, “was kept in secret for many years, and although parts of it have been opened up much of it is still secret.” As ever, I find it bewildering that an agency supposedly dedicated to giving the public clear information is so unresponsive to even the most basic questions.
The EMA were at least willing to admit they’d seen the book, and were keen to point to recent and future progress. “Guido Rasi, the Executive Director since November 2011, has made a very clear policy statement that no clinical trial data is commercially confidential per se. We released over 1 million pages of clinical trial data in 2011 and so far in 2012 have released about 600,000.” Of course this is only a start: the real proof will be in the pudding, and, as Bad Pharma details, these changes were forced on the EMA against huge initial resistance.
My questions were pretty basic, but few journalists seem to ask any at all. “The stories in the book should be frontpage news, they always should have been,” Ben claims, and I tend to agree. “We waste endless time on shrill stories about individual killer drugs. The system’s flaws are infinitely more important, and affect all drugs.” Even those who have engaged with the book have done so in a pretty shallow fashion, perhaps because of the skills required. “More journalists need to learn the basics about how trials work, how doctors make decisions, how regulators work, and watch the journals for stories.”
The great achievement of Goldacre’s 2009 bestseller Bad Science was the rabble of nerds it inspired to continue the work – bloggers, activists and vocal supporters who backed Simon Singh and fought chiropractors and homoeopaths. This is a more complex field though, and I’m not convinced we can crowd-source the skills and resources needed for this particular fight.
“I think these issues need a coherent campaigning organisation, like Liberty or the ACLU,” Ben told me, “to draw attention to important stories, put stories into context, build bridges with stakeholders like patient groups, and encourage them to challenge problems in industry, produce lobbying tools, and so on. This is not a job I can do alone, and it can’t be done effectively in anyone’s spare time.”
Who, if anybody, will step up?

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