Doctor and writer Ben Goldacre has upset the ABPI with his claims about the ‘corruption’ of evidence-based
medicine – yet he’s been credited with influencing GSK’s new policy on clinical trial data. In an exclusive interview, Goldacre tells Pf about the good, the bad and the dodgy in pharma.
There’s no getting away from Ben Goldacre. He’s the fast-blogging front man of the AllTrials campaign, which seeks to make the publication of all clinical trials (new or old) relating to drugs in current use an industry and medical norm – in practice, not just in theory. His book Bad Pharma accuses the industry of exploiting weaknesses in medical practice and regulation to distort the evidence base of medicine through biased trials, ghostwritten papers, selective publishing and use of KOLs. He’s calling for a rebuilding of “the information architecture of evidence-based medicine”.
Industry critics in the UK and the US have accused Goldacre of focusing on “historic” issues, failing to back up his assertions with evidence, and “cherry-picking” extreme cases. These claims misrepresent a measured and coherent book that is by no means a hatchet job on the pharma industry. Indeed, Goldacre makes it clear that “there is no medicine without medicines”. His first book, Bad Science, defended the principles of modern medicine against the claims of ‘alternative’ therapies. He describes himself as a “critical friend” of pharma – and GSK might well agree, having signed up to the AllTrials campaign this month.
Goldacre himself is no web-dwelling misfit. He’s a doctor with an M.A. in philosophy and research fellowships in psychiatry and epidemiology. He’s also won the Association of British Science Writers award for best feature, twice. Pf readers may also be interested to note that his father is a professor of public health at the University of Oxford, while his mother is the enigmatic vocalist of proto-Goth 1970s
Pf will review Bad Pharma on its website. Meanwhile, we interviewed Ben Goldacre on his view of the industry. Without pausing to comb his hair, he gave us an entertaining and pointed account of a situation in which “people know that there’s something a little bit wrong”. Can you honestly disagree?
GSK has announced that it will publish all trial data relating to its current products, with older data being released over several years. Goldacre tells us that he met Andrew Witty, CEO of GSK, before the announcement. “He’d obviously thought very carefully about the practicalities of it, and that reassures me – he’d thought about how to do it, what the costs would be, and I think it’s to his enormous credit.”
None the less, Goldacre says, “what we really need is meaningful structural change where everybody is incentivised and induced and, to an extent, cajoled into doing the right thing. The basics of evidence-based medicine require that we have all of the evidence in order to make informed decisions, and we need that for doctors, not just for regulators.” Still, he notes, even one major company signing up poses the question: “Why is it that GSK are happy for doctors and patients to be able to see all of the evidence on their treatments, whilst other companies aren’t happy with that?”
Bad Pharma did not ‘reveal’ any hidden things, Goldacre insists: “It took very well documented problems in medicine from the academic literature and offered the general public an accessible explanation of those problems, because I feel very strongly that there are various ongoing structural problems in medicine which go way beyond just the pharmaceutical industry. And these problems have not been fixed behind closed doors by the professions, so I think we need the public’s help.” By “the public”, he means the many professionals – lawyers, civil servants, campaigners – who “can bring about structural change”.
The industry’s initial reaction to the book was defensive. “The ABPI put out various things saying that I was a fringe maverick who wasn’t taken seriously by anyone in medicine or academia or by regulators, and I think seeing that led various people to conclude that it was worth creating a more well-structured campaign.”
Stressing a key point, Goldacre notes: “When the public are made aware that drug companies and academics are still entitled to withhold results on medicines that we currently use from doctors and patients, they are amazed and appalled. The ABPI’s press release about my book said that all of the issues in it were historic and had all been long addressed, which is obviously untrue. I think policy makers have to be very concerned about an organisation that is willing to make such sweeping dismissals of legitimate and well documented concerns.
“For the ABPI to state that they were refusing to engage with the concerns that I raised in the book was an extraordinary thing, and it has been well noted throughout the medical and policy communities. I think my views are ultimately reasonably well aligned with those of industry. I would regard myself as a critical friend: I’m talking about problems that need to be fixed.”
But surely, and leaving pious pharma rhetoric aside, the industry has to do what it does to get new medicines out there? Goldacre’s response is milder than you might expect. “Medicines work, there’s no question about that. But if you work in the pharmaceutical industry, you might miss how many criticisms of doctors, academics and regulators there are in the book. We invented evidence-based medicine very recently, only three or four decades ago, and since then we’ve all run around pretending that we have instantiated it already. But the reality is, we haven’t.
“I don’t think it’s unreasonable or unrealistic to say that we can manage profit incentive in the pharmaceutical industry in such a way that their goals are more closely aligned with the goals of patients. If you have an incoherent information architecture, lots of opacity around evidence, and regulatory
frameworks that are undoubtedly very onerous for industry, but still fail to achieve very simple objectives like getting doctors all of the evidence on whether drugs work or not, then companies are competing with each other across terrain that actively rewards bad behaviour.
“I’d like to see a world in which companies are all competing across terrain that actively rewards ethical behaviour like sharing all of the data on how well their treatments work. I think it should be perfectly possible to make lots of money out of the best drugs in a class, and if that means that you may not be able to profit from the third best drug in a class to the extent that you can today by obfuscating around the evidence – well, so be it, because I think overall, industry would benefit from clearer information, as doctors and patients would.”
Goldacre sums up the issue: “Industry does one thing that’s really great and one thing that’s not so great. Industry creates new medicines, and that’s fantastic and really important, and it’s obviously to the benefit of doctors and patients. But then there’s this second issue of how doctors and patients make decisions about which treatment is best. And in that arena, the pharmaceutical industry is obviously very conflicted. Each company wants you to use their products, so in an environment where we accept that you can withhold the results of clinical trials and put spin on their results when they’re published in academic journals, it’s inevitable that people will try and do that.”
Much of the blame rests with regulators for decades of underachievement, he argues. For example, “there’s this bizarre idea that it is satisfactory for the EU Clinical Trials Register to be a register of all the clinical trials conducted in Europe. Now that is not actually a very useful list. The Register, were it to be genuinely useful, would be very simply a list of all of the trials ever conducted on all of the medicines that are currently licensed for use in Europe.” That “failure of vision”, he says, speaks volumes about the culture of medicine.
What’s needed, he argues, is for “doctors, governments, healthcare payers and academics” to be “better at creating systems for synthesising evidence, disseminating it to decision makers, and then implementing best practice”. If that were the situation, he says, the “biased dissemination of evidence” that is marketing – and as he fairly points out, that is what marketing has to be – could not weaken clinical outcomes.
Goldacre offers no support to those who dismiss modern medicine in favour of mystical alternatives. “Just because there are flaws in aircraft design, that doesn’t mean magic carpets exist. The fact that there are problems in medicine doesn’t mean that magic sugar pills work.” However, he argues, the antimedical conspiracy theories “are a kind of poetic response to the obvious regulatory failure in medicine and in the pharmaceutical industry. People know that there is something a little bit wrong here.”
He also separates himself from leftwing critiques of corporate culture. “I don’t have a sense that there’s anything wrong with companies making money from making medicines. I think this is actually a really uncomplicated area: we’ve failed to adequately manage the risks around biased dissemination and withheld clinical trial results, and we should manage those.”
At the heart of it all, Goldacre maintains, is a self-evident truth: “You’ve just got to publish all the results of all of your trials. You wouldn’t choose a car based on only the positive results in a world where industry was allowed to delete half the reviews. It’s a very strange situation that we’ve allowed to emerge.”