Bad Science

by Ben Goldacre

  Clearing the decks

  Firstly, we need full disclosure, and I don’t say this out of some waffly notion of truth and reconciliation. Medicine today is practised using drugs that have come onto the market over several decades, supported by evidence that has been gathered since at least the 1970s. We now know that this entire evidence base has been systematically distorted by the pharmaceutical industry, which has deliberately and selectively withheld the results of trials whose results it didn’t like, while publishing the ones with good results.

  A vague admission that this happened is no more than a weak gesture: it’s the very beginning of a journey back to being an ethical industry. For the sake of patients, we need every single hidden trial to be made available, now, today. There is no way that we can practise medicine safely, as long as the industry continues to withhold this data. It’s not enough for companies to say that they won’t withhold data from new trials starting from now: we need the data from older trials, which they are still holding back, about the drugs we are using every day.

  This material is held in old salt mines, in secure dry storage archives, on ageing disks, in huge clunky 2002 laptops, and in cardboard boxes. Every moment that the pharmaceutical industry continues to hide it from us, more patients are harmed: this is an ongoing crime, against all of humanity, and it is happening under all of our noses.

  What’s more, there is no safe alternative to full disclosure. Doing more trials won’t help: trials are expensive, and small, and when their results become available, we combine them with the existing results of all the trials ever conducted, to get the most robust answer, to iron out random error and fluke results. If we do more trials, we simply add these to a pool of data that already exists, and has already been polluted.

  In fact, there is only one way we could work around the industry still withholding trials: we would have to throw out everything, every single trial that predates this imaginary moment when companies stop hiding results (which still hasn’t yet come, in any case), and then start again. This is an absurd suggestion, but its absurdity is eclipsed by the men and women who sit in offices in the UK and around the world, knowing full well that their companies have trial results that they are still deliberately withholding. Their choice to continue withholding that data, right now, distorts prescribing decisions and harms patients every day. They sleep in their beds, just like you and me.

  But the need for an amnesty does not end with trial data.

  What are we supposed to do, for example, with the ghost-written papers of the past? Commercial medical writers now admit publicly that this practice was rife (when I ask them, in conversation, ‘How can it not have seemed wrong, when you were paying academics to put their names on papers?’, they smile sheepishly and shrug). The pharmaceutical companies, too, have been forced to admit that they did this, after endless embarrassing revelations from leaked documents and humiliating court cases on individual drugs. But these are islands: we have no idea of the full scale across the whole of medicine, and, crucially, we have no idea which academic papers were corrupted, because so much of this behaviour went undeclared.

  These industries now accept that they rigged the academic literature, and that this practice was widespread. That’s only partially useful: now, please, we need a list of the papers that were rigged. Some may need to be formally retracted, but at the very least, let us go back, annotate the literature, and see which academic papers were covertly written by paid industry staff. Let us see which were the product of undeclared publication plans. At the very least, tell us which academics were ‘guest authors’, who contributed nothing but their name, the illusion of independence, and the reputation of their university, in exchange for a cheque. Tell us how much money they were paid; but most importantly, tell us their names, so we know how to judge their other work.

  Because the medical academic literature isn’t like a newspaper: it’s not a transient first draft of history, or tomorrow’s chip wrapper. Academic papers endure. Many of the studies affected by ghostwriting will still be regarded as canonical, they will be widely cited, and their contents will be used to inform practice five, ten and twenty years from now. This is how evidence-based medicine works, and it’s how it’s supposed to work: we rely on the research that has been published in order to write textbooks and make decisions. It’s not enough to say that you won’t use dishonest ghostwriting practices in the future: we all need to know which papers you rigged in the past, right now, to prevent your actions from causing more harm. Patients deserve to know too.

  So, if we’re to make any sense of the mess that the pharmaceutical industry – and my profession – has made of the academic literature, then we need an amnesty: we need a full and clear declaration of all the distortions, on missing data, ghostwriting, and all the other activity described in this book, to prevent the ongoing harm that they still cause. There are no two ways about this, and there is no honour in dodging the issue.

  But going forward, separately, we need to be sure that these practices will not be repeated. The details of how to do this are set out at the end of each section throughout this book, but the basics of the wish list are clear.

  We need to prevent badly designed trials from ever being run in the first place. We need to ensure that all trials report their results within a year at the very latest; we need to measure compliance with that; we need extremely stiff penalties for companies who transgress; and we need doctors and academics who collaborate in withholding trial data to be held personally responsible, and struck off. When it comes to disseminating evidence, we need to make sure this is done cleanly, so that doctors, patients and commissioners of health services have easy access to unbiased summaries of information. It is clear from the evidence presented in this book that the pharmaceutical industry does a biased job of disseminating evidence – to be surprised by this would be absurd – whether it is through advertising, drug reps, ghostwriting, hiding data, bribing people, or running education programmes for doctors. There is much to fix.

  So what have the great and good of British medicine done to help patients, in the face of this endemic corruption, and these systematic flaws? In 2012, a collaborative document was produced by senior figures in medicine from across the board, called ‘Guidance on Collaboration Between Healthcare Professionals and the Pharmaceutical Industry’. This document was jointly approved by the ABPI, the Department of Health, the Royal Colleges of Physicians, Nursing, Psychiatrists, GPs, the Lancet, the British Medical Association, the NHS Confederation, and so on.

  It contains no recognition of the serious problems we have seen in this book. In fact, quite the opposite: it makes a series of assertions about them that are factually incorrect.

  It opens with a reassuring statement: ‘Opportunities may be missed or even rejected because of misconceptions stemming from historical practices that are no longer acceptable, or the actions of a few individuals that are not typical of the working relationship between healthcare professionals and the industry.’ But as we have seen, trials that are ‘disappeared’, ghostwriting, and distortions in marketing are all systemic problems, and they have not been fixed.

  It goes on to state that all trials are subject to rigorous scrutiny, and that their results are made available in the public domain. Again, we know that this is simply not true: even with the new FDA legislation from 2007 demanding publication within a year, on pain of $10,000-a-day fines, the current best estimate is that only one in five report within a year (and no fine has ever been levied, ever).

  It states that drug reps ‘can be a useful resource for healthcare professionals’. Again, I’m not sure why the Royal Colleges, the BMA, the Department of Health and the NHS Confederation felt the need to reassert this to the doctors of the UK, on behalf of industry, when the evidence shows that drug reps actively distort prescribing practices. But that is the battle you face, trying to get these issues taken seriously by the pinnacle of the medical establishment.

  Even the de
tails are peculiar. The document claims – to encourage a favourable view of industry – that it costs £550 million to bring a new drug to market. This mythical and overstated figure comes from an industry-sponsored study, a decade old, which made so many bizarre assumptions that it spawned a vast critical literature, and even a popular book, The $800 Million Pill, in 2004. To give you a flavour of how this number was produced: they only looked at a narrow range of unusually expensive drugs; they ignored the fact that research investment is tax deductible; and most bizarrely, they even factored in an ‘opportunity cost of capital’ (meaning: ‘we missed out on earning money by not investing our R&D budget in shares from other companies that would have gone up in value’). This amounts to what economists – even local small business accountants – would call ‘double counting’, because R&D brings financial rewards too. People have estimated the true cost at a tenth of that figure of £550 million, or a quarter; but also, in more industry studies, five times as much. I’m not telling you this to open up another complex issue: I’m just saying, it’s a weird industry figure for all these bodies to casually sign off on.

  But I digress.

  Most troublingly, this document, signed by the great and the good of UK medicine, says: ‘Industry plays a valid and important role in the provision of medical education.’ It says this, citing no evidence, in the face of everything we know about industry-funded marketing.

  Here, I should be clear once again: I think it is great that doctors and academics and people from industry should work together on research projects. Medicines are made by commercial organisations, that is the reality, and they often produce good medicines. Sharing research knowledge, and research needs, and insights, and patients, is all great, within a meaningful and audited regulatory framework.

  The statement: ‘industry plays a valid and important role in the provision of medical education’ is in a completely different ballpark. But I am outgunned by the great and the good of UK medicine, who all signed off on this document in 2012, and I will list them again: the Department of Health, the ABPI, the Royal Colleges of Physicians, Nursing, Psychiatrists, GPs, the Lancet, the British Medical Association, and the NHS Confederation.

  This is how far we are from people in my own profession developing insight into what has happened, and what needs to be done. This is why I need your help. But before we get to what you can do, there is one final oddity for you.

  In 2012 it was announced that GPs will be expected to work with drug companies to work out how to treat their patients. The ABPI has drawn up a guide to ‘joint working agreements’, with the support of the Department of Health,6 and the vision is clear: ‘Popular areas for joint working you may wish to consider include identification of undiagnosed patients, reviewing uncontrolled patients, improving patient adherence to medicines and treatment pathway redesign.’

  To place this in context, it comes at a time when the structure of the NHS is being dismantled, and the job of planning health services is being given to local groups of family doctors, the vast majority of whom are very smart, but have little or no training and experience in commissioning services for whole populations (under plans opposed even by the Royal College of GPs). Whatever your views on the new NHS policy, one thing is clear: inviting drug companies in to design care pathways, at the very time when those are in flux, and suddenly being managed by people with limited commissioning experience, seems very dangerous.

  And beyond that: inviting sales representatives in to go through your patient list, and pick out the patients they think should receive their company’s drugs, exceeds almost every problem we’ve documented so far around the dubious activities of drug reps; while reviewing patients’ progress with staff from a drug company raises huge concerns about consent and patient confidentiality. I don’t know if you would be happy for your GP to go through your medical history with the local salesperson from GSK, Merck, Pfizer, Roche, or any of the other companies that have come up over the past few hundred pages. I think you should at least be asked.

  So that is the end of our story.

  This mess has sat, hidden in plain sight, for lack of a clear explanation. It has persisted because it’s complex, and because the people we would normally trust to manage such technical problems have failed us. The government, the great and the good of medicine – the silverbacks of the Royal Colleges, the faculties and the learned societies – know everything that you have just read. They know full well, and they have decided, for their own reasons, that they are unconcerned. In some cases, like the regulators, they have actively conspired in the secrecy.

  It’s hard to imagine a betrayal more elaborate, or more complete, across so many institutions and professions. This is a story of pay-offs, of course, but more than that, it’s a story of complacency, laziness, banal self-interest and people feeling impotent. You have been failed by the people at the very top of my profession, for decades now, on matters of life and death, and as with the banks, we’re suddenly discovering a terrifying reality. Nobody took responsibility, nobody was in control, but everybody knew something was wrong.

  We only have one hope, though it is a small one: you.

  Things you can do

  If you are concerned by what you have read in this book, then here are some suggestions of things you can do.

  There are detailed points on what needs to change at the end of each chapter, which I hope you’ll revisit. Here I have pulled out big-picture points, with something for everyone. Creating change is a complex process, especially when problems are diffuse and deeply embedded in the culture of powerful industries and professions: the people who need to be lobbied are doctors and patient groups, as much as politicians, and this is reflected below.

  Everyone

  The first thing you might do is write to your doctor, or briefly mention your concerns when you see them. To be clear: I don’t think it is helpful to waste valuable individual clinical time on political conflict with your doctor. However, if doctors know that their patients are concerned about these issues, they will be more inclined to take them seriously, and it is enough to do this in passing. Many are already very ethical on these issues anyway, and so they may find your concerns heartening. Here are some things you may wish to do:

  You may wish to ask a question:

  For example, you might want to know if your doctor accepts drug-company hospitality, or sponsored teaching.

  You may wish to make your wishes clear:

  For example, if you do not think it is acceptable for your doctor to go through your medical history with a sales representative from a drug company, you could ensure that they know that, just in case.

  You may wish to make a request:

  For example, you might suggest that they post a list of interactions with industry in their waiting room, as suggested earlier in this book.

  There are also the usual outlets that anyone can pursue for general political activism, and for lobbying politicians. It would be good to raise what you regard as the key concerns with your MP, but there is no clear legislation in the pipeline (in fact, quite the opposite, as you’ve seen).

  If you have time, there is a clear need for organisers. Currently there is no substantial public campaign group on the issues raised in this book. I will maintain a list of involved organisations on the Bad Pharma pages at badscience.net, but as of now, these groups are small, and focused on professions rather than patients or the public. You may wish to offer your support, financially or by cheering from the sidelines, even if you are not a healthcare professional.

  Lastly, since changing laws is complex business, I would like to see work from policy people, wonks who know how government works, with suggestions of how some of the problems raised here could be fixed in legislation, or otherwise.

  At this moment we should take a brief moment to mention quacks: alternative therapists who sell vitamins and homeopathy sugar pills, which perform no better than placebo in fair tests, and who use even cruder marketing tricks t
han the ones described in this book. These business people often like to pretend, with some swagger, that their trade somehow challenges the pharmaceutical industry. If they profit at all from the justified anger that people feel about the problems you have read about here, then it comes at the expense of genuinely constructive activity. Selling ineffective sugar pills is not a meaningful policy response the dangerous regulatory failure in the pharmaceutical industry.

  Patients

  Patients are at the centre of this story, and you are in a strong position. Firstly, I hope that you will be asked to participate in a trial at some stage in your disease: trials are the only way we have of finding out what works, they are generally safe, and they save lives. There are four simple questions you should ask about any trial you’re invited to participate in, and if you’re refused on any count, I would like to hear about it:

  Ask for a written guarantee that the trial has been publicly registered before patients are recruited, and ask where you can see it.

  Ask for a written guarantee that the main outcome of the trial will be published within a maximum of one year after completion.

  Ask for the name of the person who will be responsible for that.

  Ask whether, as a participant in the trial, you will be offered a copy of the report describing its results.