by Brian Trench

In the four months between its UK and US publication this book has left indelible marks. Ben Goldacre’s case for comprehensive reporting of drug trials has been cited in British parliamentary debates, national newspapers and medical journals. He has become a central figure in a new campaign to change the regulation of trials, requiring all results to be made public. Most remarkably, considering the vigor of Goldacre’s critique of the pharma-ceutical industry and of medical journals, that All Trials campaign has won the support of British drugs firm GSK and the British Medical Journal. The latter has announced it will refuse to publish research papers unless all the trial data is made available for independent scrutiny.

GSK announced in February their commitment to release all clinical study reports online, going back to 2000. “I couldn’t be any happier,” blogged Goldacre in response. “This is huge, and internationally huge.” Indeed, these recent initiatives make the response to Bad Pharma of the British pharmaceutical industry body, ABPI, that the book is out-of-date and that the industry has moved on, look decidedly silly. Starting with a North American promotional tour for the book from February 17th in Portland, Oregon, Goldacre is taking his crusade to the homeland of the biggest pharma firms and of a regulatory agency, FDA, which is the target of some of his strongest criticisms for failing physicians and their patients.

Epidemiologist and popularizer Goldacre already went global with his first book, Bad Science, which was translated into more than twenty languages. Despite the title, this was much more a critique of how science is (mis)represented in media and other public spaces than a critique of how science is done. Goldacre’s TED talk on the issues in Bad Science has had over 1.1 million views in 18 months; the talk based on Bad Pharma is more than keeping pace with over 670,000 in six months.

But Bad Science had a much easier case to make, with much softer targets, than does Bad Pharma. The media’s misuse of statistics or the unsupported claims made for crank diets are of a quite different order from the argument that the multi-billion drugs industry and the multi-billion medical practice that depends on this industry are “broken.” Goldacre claims that drugs trials are too short, that they often test drugs against the wrong comparator, that reports of trials showing negative results routinely go missing, that participants in drug trials are lied to, that drugs are marketed for uses other than those for which they have been tested, that drugs regulators conceal data informing their decisions, that published studies on drugs trials downplay side-effects, that drugs companies resist carrying out studies of drugs’ efficacy with ‘real-world’ patients, that ‘new’ drugs are often copies, that academics have papers on drugs trials written in their name by contractors for drug companies, and much, much more.

Repeatedly, Goldacre says that the many deficiencies in the testing, regulation and prescription of drugs are causing harm to patients. “Bad pharma”, in Goldacre’s account, causes “avoidable suffering and death”. None of the interests involved is spared his denunciation, though I don’t fully grasp how in specific terms university ethics committees (or, in US parlance, institutional review boards) have “failed us”. As a former chair of such a committee, I may be too sensitive but it seems to me he is arguing for extending the scope of ethics committees’ operations more than identifying failures in how they do their work.

He refers several times to the failure to test two widely prescribed statins for treatment of high cholesterol against each other in “real-world” trials: “If one of these turned out to be just two per cent better than the other at preventing heart attacks and deaths, this knowledge would save vast numbers of lives around the world”. And, just in case, the reader has missed the point, he adds: “Failing to know the answer to this question could be costing us lives, every day that we continue to be ignorant.”

Goldacre’s hand-holding technique is the same as in Bad Science, only more so: he says what he is going to say, he says it, and he says what he has just said, and then he says it again in the form of remedies. He takes the reader firmly – and sometimes a little patronisingly – through complex procedures. For those who need to dig deeper, there are over 360 footnotes, many with references to published studies. But the arguments are likely to be clear to the reader who sticks only with the main text. Anyway, Goldacre claims with characteristic immodesty, that for someone who wishes to understand the problem and how to fix it, “this book contains all that you need to know.”

The hundreds of references demonstrate that concerns about the drugs system are widely shared and many of the issues have been extensively researched. As this book was being completed for publication in the UK last fall, a paper was published in the open-access journal, Trials (www.trialsjournal.com/content/13/1/100#B3), that presented seven public-interest arguments against non-disclosure of trials data for commercial reasons. Goldacre acknowledges in particular the many contributions of Iain Chalmers, founder of the Cochrane Collaboration that promotes evidence-based medicine, and now a leader with Goldacre of the All Trials campaign. Contributors and editors of medical journals have in recent years been much concerned with “publication bias” (preference for positive results), access to trials data and conflicts of interest. Journals have required increasing disclosure from contributors of any relationships that may affect their assessments.

Goldacre acknowledges a little begrudgingly some of these changes but also denounces “fake fixes” – including the FDA Modernization Act and the associated data resource at www.clinicaltrials.gov – and insists that much more needs to be done to repair the system. Most of us know or at least suspect that doctors are targeted by drugs companies with various incentives to favor their products. But Goldacre also takes us behind the scenes at medical conferences and into the planning of marketing campaigns. Hidden information and missing data are where he starts and finishes and where he is gaining most traction. Transparency and disclosure are Goldacre’s main remedies. In one of his most apt medical metaphors he insists that “sunlight is a very powerful disinfectant”.

Brian Trench is a researcher and trainer in science communication, retired from Dublin City University, Ireland, where he was Head of the School of Communications, 2002-2007.