Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (48 page)

So these are not isolated problems, they are not on distant soil, and they are most definitely not a thing of the past, because many of them happened recently, and the people concerned are all still around, in very senior positions of power.

Now, let me tell you something from my personal life. I know people who work in various drug companies, because I am a nerd, and nerds work in biotechnology. I talk to these friends, and people I trust tell me, when they’re earnestly drunk at parties, that Andrew Witty, the current head of GSK, who took over in 2008, is a lovely and honest man. He wants to do the right thing, they say. He bangs his fist on the table and talks of integrity. And I am entirely prepared to believe that this is true.

But it’s also completely irrelevant: because this is the serious global business of health, affecting every single one of us. We cannot allow the behaviour of the pharmaceutical industry to swing on a pendulum, one moment dismal, one moment acceptable, oscillating wildly in different companies at different times, with our chances of getting proper data forever at the whim of whether the person at the top is
nice
.

We need clear regulations, with clear public auditing, to ensure that compliance is tested, and documented. And we need it to be applied muscularly, to everyone, without exception. We should remember, after all, that drug companies compete against each other, and they play by the rules we set as a society. If the rules permit dodgy practices, then companies are practically compelled to play dirty, even if the personnel know that their actions are morally wrong, and even if they want to do the right thing.

This is particularly well illustrated by a recent episode from Australia. The government commissioned a lengthy review on how to regulate bad pharmaceutical marketing. This review made clear policy recommendations to prevent misleading and dangerous practices, and those new regulations would have brought all companies in line with a best practice code that was already followed by members of Medicines Australia, the major industry body. But in December 2011 the government rejected this review. It was going to leave the industry free to engage in dodgy dealings, and the clearest criticism came, not from campaign groups, but from the drug companies themselves. Why would anyone follow the best practice in their voluntary code now? The press release put out by Medicines Australia was brutally honest: ‘our member companies are [going to be] disadvantaged by doing the right thing’.
⁵

In a moment we will look at what good regulations would look like in practice (it’s not a difficult problem to solve), and what individuals can do to make them happen. We will also, more excitingly, think through the future of medicine, in an age of ‘big data’, when evidence is cheaper and easier to produce than ever before.

But before we get there, we need to remember that this isn’t simply about fixing the problem, starting from now. Because even if we set aside the ongoing failure of industry and regulators to address these problems, patients are still being harmed, every day, by the actions of the pharmaceutical industry over the past few decades. It’s not enough for companies simply to promise change in the future (and they’ve not even delivered on that). If the industry wishes to make amends for past crimes, then it needs to take serious action, today, to reverse the ongoing harm that still results from their previous behaviour.

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 details 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.