Good riddance to bad pharma: GSK’s historic commitment to transparency

Charlie Ashford looks at what the pharmaceutical industry has been getting wrong, and how they can get it right.

“Medicine is broken”.

So begins Bad Pharma, the latest book by doctor-turned-writer Ben Goldacre.

From poorly-designed and missing trials to gigantic marketing budgets, Goldacre describes the various ways in which drugs companies, in his words, “mislead doctors and harm patients”.

Perhaps the most shocking chapter of the book concerns missing data. It’s impossible to say exactly how many drugs trials have gone “missing” – in other words, left unpublished because of unflattering results. According to the most recent systematic review, though, half of all conducted trials have never been published in academic journals, and trials with positive results are twice as likely to be published as others.

Take the case of reboxetine, an antidepressant. In 2010, researchers conducted a systematic review of all the data available on the drug, including the results of unpublished trials obtained, with difficulty, from manufacturers and regulators. The results were shocking, revealing that the drug was in fact no better than a sugar pill at treating depression, and also had more side-effects than its competitors. Goldacre, who had prescribed reboxetine, was incensed: “I did everything a doctor is supposed to do,” he says. “I read all the papers, I critically appraised them, I understood them, I discussed them with the patient… As a doctor I did something which, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.”

How has the pharmaceutical industry responded to Goldacre’s criticisms? Not well. The Association of the British Pharmaceutical Industry (ABPI) issued a statement dismissing all of its arguments as “long documented and historical”. The Pharmaceutical Research and Manufacturers of America (PhRMA) stated that the current system is “scientifically rigorous, tightly regulated and working well”.

Rather than burying its head in the sand, a responsible pharma company should recognise that problems exist, and look for ways to fix them. Luckily, Goldacre has some suggestions. Central to these is the creation of a registry for all clinical trials, for companies to publicly declare the studies they are planning and the methods they intend to use, and afterwards publish the results.

This is not a new idea – existing initiatives include the European Medicines Agency’s clinical trials register, and the US Government’s ClinicalTrials.gov. For various reasons, none have been successful. In January, Ben Goldacre, along with Sense About Science, the British Medical Journal, the James Lind Initiative and the Centre for Evidence-based Medicine, launched the latest attempt: AllTrials.net.

The take-up has been impressive, with a large number of high-profile organisations signing up. Less than a month after AllTrials’ launch, GlaxoSmithKline (GSK) became the first major pharmaceutical to join, committing to publish full clinical trials reports for all drugs dating back to 2001. For Goldacre, this is nothing short of “historic”.

This month, I attended an event in London called Pharmabate, to see Ben Goldacre joined by representatives from industry, regulators, law and medical ethics. All had interesting things to say. Andrew Powrie-Smith of the ABPI traded blows with Ben Goldacre, while admitting that there were important issues to be addressed. Meanwhile, Dr. Miran Epstein presented a radical view, arguing that the only solution is the nationalisation of all pharmaceuticals.

Perhaps the most memorable comment of the night came from the back of the room. Sir Iain Chalmers, founder of the nonprofit Cochrane Collaboration, gave a view from a long career in evidence-based medicine. It was, he said, nearly a quarter of a century since he had first pointed out the problem of missing clinical trials. Now, for the first time, it seems that the public are finally interested in the issue.

So far, none of the other major pharmaceuticals have followed GSK’s lead. But they should be worried. Attention is increasing in the media, government and industry. The longer they fail to confront the issue, the more they risk.

According to Iain Chalmers, pharma companies now face a choice. They can either find themselves on the right side of history, or the wrong one.

Charlie Ashford is a Researcher at Corporate Citizenship