Here’s the foreword to my new book.

September 25th, 2012 by Ben Goldacre in bad science | 19 Comments »

My new book Bad Pharma is out today. It describes how drug companies harm patients, around the world, by distorting evidence on an industrial scale. More  than that, it shows how doctors, academics, and regulators have all failed to fix these problems. Bad practices have been perpetuated, because the public have not understood the true scale of the disaster. If this book is not ignored, it will make certain current public positions from industry, and from regulators, untenable. That will be the beginning of fixing the problem, and for the rest, I need your help.

But first, with kind permission of the publishers, here’s the introduction. I hope you like it.

 

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Intro

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Medicine is broken. And I genuinely believe that if patients and the public ever fully understand what has been done to them – what doctors, academics and regulators have permitted – they will be angry. On this, only you can judge.

We like to imagine that medicine is based on evidence, and the results of fair tests. In reality, those tests are often profoundly flawed. We like to imagine that doctors are familiar with the research literature, when in reality much of it is hidden from them by drug companies. We like to imagine that doctors are well-educated, when in reality much of their education is funded by industry. We like to imagine that regulators only let effective drugs onto the market, when in reality they approve hopeless drugs, with data on side effects casually withheld from doctors and patients.

I’m going to tell you how medicine works, just over the page, in one paragraph[1] that will seem so absurd – so ludicrously appalling – that when you read it, you’ll probably assume I’m exaggerating. We’re going to see that the whole edifice of medicine is broken, because the evidence we use to make decisions is hopelessly and systematically distorted; and this is no small thing. Because in medicine, we doctors and patients use abstract data to make decisions in the very real world of flesh and blood. If those decisions are misguided, they can result in death, and suffering, and pain.

This isn’t a simple story of cartoonish evil, and there will be no conspiracy theories. Drug companies are not withholding the secret to curing cancer, nor are they killing us all with vaccines. Those kinds of stories have, at best, a poetic truth: we all know, intuitively, from the fragments we’ve picked up, that something is wrong in medicine. But most of us, doctors included, don’t know exactly what.

These problems have been protected from public scrutiny because they’re too complex to capture in a soundbite, or even 3,000 words. This is why they’ve gone unfixed by politicians, at least to some extent; but it’s also why you’re holding a book of three hundred pages. The people you should have been able to trust to fix these problems have failed you, and because you have to understand a problem properly in order to fix it yourself, this book contains all that you need to know.

So to be clear, this whole book is about meticulously defending every assertion in the paragraph that follows.

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in its life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion. In their forty years of practice after leaving medical school, doctors hear about what works through ad hoc oral traditions, from sales reps, colleagues or journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are even owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all. These are ongoing problems, and although people have claimed to fix many of them, for the most part, they have failed; so all these problems persist, but worse than ever, because now people can pretend that everything is fine after all.

That’s a lot to stand up, and the details are much more horrific than this paragraph makes it sound. There are some individual stories that will make you seriously question the integrity of the individuals involved; some that will make you angry; and some, I suspect, that might make you very sad. But I hope you will come to see that this is not just a book[2] about bad people. In fact, it’s possible for good people, in perversely designed systems, to casually perpetrate acts of great harm on strangers, sometimes without ever realising it. The current regulations – for companies, doctors and researchers – create perverse incentives; and we’ll have better luck fixing those broken systems than we will ever have trying to rid the world of avarice.

Some people will say that this book is an attack on the pharmaceutical industry, and of course it is. But it’s not only that, and it’s not unbounded. I suspect that most of the people who work in this industry are fundamentally good-hearted, and there is no medicine without medicines. Drug companies around the world have produced some of the most amazing innovations of the past fifty years, saving lives on an epic scale. But that does not allow them to hide data, mislead doctors and harm patients.

Today, when an academic or doctor tells you that they are working for the pharmaceutical industry, they often do so with a look of quiet embarrassment. I want to work towards a world where doctors and academics can feel actively optimistic about collaborating with industry, to make better treatments and better patients. This will require big changes, and some of them have been a very long time coming.

To that end, because the stories I am telling you are so worrying, I’ve tried to go beyond simply documenting the problems. Where there are obvious fixes, I’ve set out what they are. But I’ve also included, at the end of each chapter, some suggestions on what you can do to improve things. These are tailored to whoever you might be: a patient, a politician, a researcher, a regulator or a drug company.

More than anything, though, I don’t want you to lose sight of one thing: this is a pop science book. The tricks and distortions documented in these pages are beautiful, and intricate, and fascinating in their details. The true scale of this murderous disaster only fully reveals itself when the details are untangled. Good science has been perverted on an industrial scale, but this has happened slowly, and evolved naturally[3], over time. This has all been perpetrated by ordinary people, but many of them may not even know what they’ve done.

I want you to find them, and tell them.

What’s coming
This book follows a simple trajectory.

We start by defending our central claim: industry-sponsored studies are more likely to produce results that flatter the sponsor’s drug, which has now been demonstrated, beyond any doubt, by current research. In this section we also encounter the idea of a ‘systematic review’ for the first time. A systematic review is an unbiased survey of all the evidence on a given question. It is the best-quality evidence that can be used, and where they exist, systematic reviews are used for evidence throughout this book, with individual studies only described to give you a flavour of how the research has been done, or how mischief has been made.

Then we look at how the pharmaceutical industry manages to create all these positive trials for its drugs. Our first stop is to review the evidence showing that unflattering trial data can simply be withheld from doctors and patients. Companies are perfectly entitled to conduct seven studies, but only publish the two positive ones, and this behaviour is commonplace. What’s more, it happens in every field of science and medicine: from basic laboratory research, where selective publication fills the literature with false positive findings, wasting everyone’s time; through early research trials, where evidence that drugs might be dangerous is hidden from view; and on to major trials used to inform everyday clinical practice. Because so much trial data is witheld from doctors and patients, we can have no clear idea of the true effects of the treatments that we use every day in medicine. The stories in this section go from antidepressants, through statins, cancer drugs, diet pills, and right up to Tamiflu. Governments around the world have spent billions of dollars to stockpile this flu drug, in fear of a pandemic, and yet the evidence on whether it reduces the rate of pneumonia and death is being witheld right now, to this day.

Next, we take a step back, to look at where drugs come from. We cover the drug development process, from the moment someone dreams up a new molecule, through tests in labs, on animals, the first tests in humans, and then the early trials necessary to show that a drug works on patients. Here you will find, I suspect, some surprises. Risky ‘first-in-man’ drug tests are conducted on homeless people; but more than that, full clinical trials are being globalised, a new development that has arisen very suddenly, in only the last couple of years. This raises serious ethical problems, because trial participants in developing countries are often unlikely to benefit from expensive new drugs; but it also raises interesting new problems for trusting the data.

Then we look at regulation, and the hoops you must go through to get a drug onto the market. We will see that the bar is very low: that drugs must only prove that they are better than nothing, even when there are highly effective treatments on the market already. This means that real patients are given dummy placebo pills for no good reason, but also that drugs appear on the market which are worse than the treatments we already have. We will see that companies break their promises over follow-up studies, and that regulators let them do this. We will also see how data on side effects and effectiveness can be withheld from regulators, and that regulators, in turn, are obsessively secretive, withholding the data they do have from doctors and patients. Lastly, we will see the harm done by this secrecy: ‘many eyes’ are often very powerful, to spot problems with medicines, and some of the most frightening harms have been missed by regulators, and only identified by academics who were forced to fight hard for access to data.

Then we take a tour through ‘bad trials’. It is tempting to believe that a simple clinical trial is always a fair test of a treatment: and if done properly, it is. But several tricks have been introduced, over the course of many years, which allow researchers to overstate and exaggerate the benefits of the treatments they are testing. When you get here, you might think that some of these are innocent mistakes; in all seriousness, while I doubt that, I’m more interested in how clever they are. More importantly, we will see how obvious these tricks are, and how people who should know better at every step of the chain, from ethics committees, through to academic journals, have allowed companies and researchers to engage in these shameful, outright distortions.

After a brief detour to discuss how some of the problems around bad evidence, and missing evidence, could be addressed, we move on to marketing, which is where most previous books on drug companies have focused their attention.

Here we will see that the pharmaceutical industry spends tens of billions of pounds every year trying to change the treatment decisions of doctors: in fact, they spend twice as much on marketing and advertising as they do on the research and development of new drugs. Since we all want doctors to prescribe medicine based on evidence, and evidence is universal, there is only one possible reason for such huge spends: to distort evidence-based practice. All of this money comes directly from patients and governments, so we ourselves are paying for this privilege. Doctors spend 40 years practising medicine, with very little formal education after their initial training. Medicine changes completely in four decades, and as they try to keep up, doctors are bombarded with information: from adverts that misrepresent the benefits and risks of new medicines; from sales reps who spy on patients’ confidential prescribing records; from colleagues who are quietly paid by drug companies; from ‘teaching’ that is sponsored by industry; from independent ‘academic’ journal articles that are quietly written by drug company employees; and worse.

Finally, we will see what can be done. While the deceit of a marketing drive can be ignored by an ethical doctor, the problems caused by distorted evidence affect everybody, without exception. The most expensive doctors in the world can only make decisions about your care on the basis of the evidence publicly available to them, and nobody has a special inside track. If this evidence is distorted, then we are all exposed to avoidable suffering, pain and death. The whole system needs to be fixed, and until then, we are all, very truly, in this together.

To an extent, this is a field where you need to know everything, to understand how it impacts on everything else. I’ve bent over backwards to introduce the ideas in the best order, but if all this material is completely new to you, then you might spot some extra connections – or feel greater outrage in your belly – reading it a second time. I have not assumed any prior knowledge. I have, however, assumed that you might be willing to deploy a little intellectual horsepower here and there. Some of this stuff is hard. That’s precisely why these problems have been ignored, and that’s why I’ve had to explain it to you here, in this book. If you want to catch people with their trousers down, you have to go into their home.

Enjoy.

Paperback:

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Kindle:

amzn.to/Uhr0p4


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If you like what I do, and you want me to do more, you can: buy my books Bad Science and Bad Pharma, give them to your friends, put them on your reading list, employ me to do a talk, or tweet this article to your friends. Thanks! ++++++++++++++++++++++++++++++++++++++++++

19 Responses



  1. briantist said,

    September 25, 2012 at 11:07 am

    Thanks Ben.

    Excited to see that my pre-ordered “Bad Pharma” downloaded today onto my Nexus 7’s Kindle App. Looking forward to a good read.

  2. kbarrington said,

    September 25, 2012 at 11:34 am

    Ahh but what to do about it. I am lucky, as a neonatologist there isn’t enough money in my field for the drug companies to be interested in our studies in general. The main exception being with inhaled nitric oxide, which was cheap when the original publicly-funded trials showed that it worked. But then we were hijacked by a drug company who were given the exclusive rights to produce this previously readily available gas, and they jacked up the price by about 10,000%. They told us it was unfortunately necessary because it is so expensive to develop a new drug, but in fact they had spent next to nothing developing this treatment. The real reason that they could screw the system like that was that we showed that inhaled nitric oxide reduced the need for ECMO (for every 5 babies treated 1 fewer needed ECMO). ECMO, which is prolonged heart-lung bypass, is very expensive, costing in the region of 100,000$ per patient. So you can see how their minds worked, the dollar bills in their eyes were easily visible!
    But as I asked before, what to do about the situation that you describe? We have to take medical research out of the hands of the drug companies.
    When a patient volunteers for a drug trial they have the right to know that their data will contribute to the well-being of society, and not just the bottom line of a drug company.
    Why do we allow drug companies to do medical research at all? They will never be able to avoid conflicts of interest. Ban them from performing human research, tax them enough to fund clinical trials which will be run by publicly accountable bodies organized and controlled by patients, doctors, clinical trial specialists, other health professionals and lay persons. That way we might get reliable research, which answers questions that we really want the answers to. We would avoid millions of dollars being wasted to promote ‘me-too’ drugs in questionable trials, and might be able to find out how best to treat sick people, and babies!

  3. Tom Walker said,

    September 25, 2012 at 12:07 pm

    Looking forward to reading this book.

  4. paul nuki said,

    September 25, 2012 at 2:05 pm

    Nice intro, one copy heading my way…

    v much hoping you properly skewer eminence based medicine

  5. detox girl said,

    September 25, 2012 at 2:10 pm

    Yes, my preordered Bad Pharma downloaded on my iPad this morning too! Gadzooks! The Quacks are lining the pockets of the Quackbusters now! Where will it end? Anyway, good luck with the media feeding frenzy. Go get em cowboy! (as in rugged individualist battling against overwhelming odds, as opposed to “cowboy” in the sense you might use it to describe, err, me….)

  6. Karellen said,

    September 25, 2012 at 2:19 pm

    “Medicine is broken. […] These are ongoing problems, and although people have claimed to fix many of them, for the most part, they have failed; so all these problems persist, but worse than ever, because now people can pretend that everything is fine after all.”

    … but it is still better than the Alternative, yes?

  7. zanzer said,

    September 25, 2012 at 3:00 pm

    Some great feedback from the early Amazon reviews…
    More unicorn pictures, football coverage and discussion around the moral failings of farmers, less tacit denial of climate change and apparently the paperback doesn’t function well as a wheelbarrow.

    I wonder if an expose into the systematic failings of the self regulating book review is on the cards?

  8. reprehensible said,

    September 25, 2012 at 10:39 pm

    Hey Ben,

    Would love to spend tomorrow reading it but I will instead be preparing for an interview for a sales role at GSK. There really is so little PhD funding out there :-(

    Hope your book helps turn the tide.

  9. Rachelle said,

    September 26, 2012 at 11:33 am

    A hugely sarcastic THANKS for putting this up. It was totally awesome, and I can’t read to read the rest!

    I had promised myself that I would wait for the U.S. release, but after reading this, that’s so not going to happen. This is worth international shipping charges for sure!

  10. danielearwicker said,

    September 26, 2012 at 11:37 pm

    Karellen said,

    “… but it is still better than the Alternative, yes?”

    Hmmm.. in what way? Still looking forward to reading this, but the gist of it seems to be that real medicine has been corrupted to the point where it now resembles alternative medicine to a worrying extent.

  11. hemlock said,

    September 27, 2012 at 1:14 am

    danielearwicker, I’d say no to that it resembles alternative medicine. There are regulations and things that mean pharmaceuticals have some basis for use – such as it must be biologically plausible that it could treat a condition, that there must be an effect (the dispute here would be that the evidence for effect is being distorted), and it must have an acceptable safety profile. All of that means that it’s still the polar opposite to something that is essentially made up. It’s unfortunate that’s the message that seems to be coming through, what we actually should take from this is we need improved regulation, not medicine is bad. We have to be realistic that pharmaceuticals, from anaesthetics through to anti-emetics have undoubtedly improved things for people and have made huge differences to our lives and put it into perspective to make things better for doctors as well as patients.

    I’ve not read the book yet, but you’ve also got to take into account that pharmaceuticals are prescribed in the context of a patients condition and that it’s malpractice to give someone something that isn’t appropriate for their condition. The issue would be where marketing and things like hiding unfavourable results distort the picture for the prescriber and mean they are making decisions on incomplete or distorted information. That said, like with the Vioxx saga, I’ve heard patients that were on it (I’m a nurse) say that if they’d had all the information they could have made an informed decision, knowing that there was a risk and accepting that extra monitoring might be needed with their doctor because it worked very well for them. Having the company hide data was detrimental in many ways and I’m hoping that this book will help untease and look critically at the issues. I don’t know, would aspirin, if tested today get through? Maybe not, but that doesn’t mean it’s not a very useful drug.

  12. jocorok said,

    September 27, 2012 at 8:16 pm

    Ben, is there no statistical method to evaluate how much we can trust the published data on a specific subject?

  13. Darren Pearce-Lazard said,

    September 28, 2012 at 1:15 pm

    Bought my copy immediately. Thanks, Ben, for the usual enlightenment. I look forward to reading it.

    (Incidentally, would be good if could log into your site using Facebook or similar rather than creating yet another account.)

  14. cdhanjal said,

    October 1, 2012 at 11:30 am

    Thanks Ben, the book sounds great and I’d like to purchase the eBook. Will there be a non-DRM version on sale?

  15. zwingenberger said,

    October 2, 2012 at 9:23 am

    Ordered your new book a few day ago, really looking foreward to it.

    …and hope, a German version will be available soon – “Bad Science” (“Die Wissenschaftsluege” – who in the world created that ambiguous title ?!?) was really delightful and holds up a big reputation here in Germany.

  16. Jurjen S. said,

    October 4, 2012 at 7:16 am

    Some choice excerpts from the The Economist’s review:
    “The book is slightly technical, eminently readable, consistently shocking, occasionally hectoring and unapologetically polemical.”
    “The danger with a book like this is that it ends up lost in abstract discussion of difficult subjects. But Dr Goldacre illustrates his points with a plethora of real-world stories and examples.”
    “This is a book that deserves to be widely read, because anyone who does read it cannot help feeling both uncomfortable and angry.”
    www.economist.com/node/21563689

  17. sindestino said,

    October 8, 2012 at 8:52 pm

    I’m looking forward to read your new book. I really enjoyed reading Bad Science and recommended it to a lot of people.

    I prefer the Spanish edition though. Do you know if it will be translated soon?

    Thanks

  18. JeannetteK said,

    November 11, 2012 at 6:58 am

    Don’t get me wrong, I love my GP. She’s very down to earth with no hint of the omniscient complex that seems unfortunately to dominate the medical profession.

    Let’s face it, far too many GP are complicit in the bad medicine and even worse science perpetrated by drug companies. In fact, the pharmaceutical companies couldn’t get away with what they do, if doctors weren’t so amenable. This link is to a radio program in Australia about the noble cause of finding cures – www.abc.net.au/radionational/programs/backgroundbriefing/a-noble-cause/3583670. It exposes the perks for practising doctors who prescribe certain drugs – not just pens and writing pads, but dinners, holidays, and even money. Yet none of the doctors involved in pharmaceutical company bribery (oh, but one can’t call it that), none of them even admits their role in this problem.

    A bigger issue is that people leave medical school without the basic pharmaceutical knowledge to know how to prescribe, let alone what. The even bigger problem is an attitudinal one where the community and doctors collude to pretend that we have ‘evidence-based medicine’. Part of that collusion is that doctors are somehow omniscient – they’re people we trust. They’re people we have to trust. We have to believe they know what they’re doing. Of course there are sceptical practitioners like you, like my GP and like the new generation of doctors. Thank you for telling us loudly and eloquently that the Emperor has no clothes. However, it’s the medical profession, not the big Pharma that’s the biggest part of the problem. Their Emperor is beautifully clad.

    Many years ago I questioned a GP about the safety of a drug I was prescribed for back pain. It’s fine I was told in a tone that suggested I had no right to query the side effects. Got the prescription filled out and as I was leaving the pharmacy with my baby son in the pusher, the pharmacist called after me “excuse me,” he said politely and somewhat tentatively, “are you breast-feeding your son?” Surprised, I answered in the affirmative. “Well, look” says the Pharmacist, “I’ll have to talk to your doctor. The main ingredient in this medication is fat soluble which means it’ll reach your son. It’s NEVER prescribed for pregnant women and you shouldn’t be taking it.” It seems that there had been a study (or two) done that showed negative effects on growing foetuses, and by default breast-fed babies. The Pharmacist was doing his doctorate in the rather esoteric field of lactation and medication. Luckily for me.

    From that day onward I’ve always known that no matter how good, humble and personable our GP are, they’re not pharmacists. They’re as unqualified as I am to judge whatever ‘evidence’ the drug producers provide us about the safety and efficacy of a drug.

  19. joey89924 said,

    November 20, 2012 at 3:28 am

    We would avoid millions of dollars being wasted to promote ‘me-too’ drugs in questionable trials, and might be able to find out how best to treat sick people, and babies!

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