---
product_id: 53272062
title: "Bad Pharma: How Medicine is Broken, and How We Can Fix It"
brand: "ben goldacre"
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---

# Bad Pharma: How Medicine is Broken, and How We Can Fix It

**Brand:** ben goldacre
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Bad Pharma: How Medicine is Broken, and How We Can Fix It

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## Customer Reviews

### ⭐⭐⭐⭐⭐ 5.0 out of 5 stars







  
  
    A devastating blow to the structure of medical knowledge
  

*by D***S on Reviewed in the United Kingdom on 28 November 2012*

This is a magnificent and brave book. It demands full support, and I am bold enough to express this. It brings together knowledge which many of us in medicine have known for some time, but it makes clear that the problem is worse than we have realised.This book strikes a fundamental blow to medical epistemology. We used to joke that "Half of what you learn in medical school will be of no use to you in practice- the problem is just that we don't yet know which half; After reading this book you realise the problem is deeper- too much medical knowledge is suppressed from the start- and so as doctors we do not even know what we don't know. It just never crosses our consciousness. We don't even know the half of it.The flaws in medical knowledge Goldacre describes run wide and deep.Too much medicine is simply never published or recorded.Negative results "This does not work" are just as important to medical practice as "this does work." Yet routinely negative studies are ignored, filed away, unpublished, maybe never even written up. There is no journal of failed treatments and other false starts. Authors and researchers don't get promoted for showing such results. Share prices don't rise on such news.Too much pre-selection and pre-editing goes on so that what reaches large journals and is then available to be incorporated into guidelines is rather over-optimistic, and based on a biased sample. (Most of the times a drug hasn't worked in a clinical trial the information simply vanishes into "internal company files") Goldacre points out how unethical this is- patients have been taking part in clinical trials to advance medical knowledge- and then the trial goes unpublished so no one can learn from it. Worse still some patients are at risk of harm as a result of this omission.The way information is presented to and by journals is biased. Large positive results are welcomed by drugs companies and journals alike- good for sales of both of them. Good for authors too. (Kudos/promotions) Some doctors put their names to articles they have barely even reviewed.Many trials are stopped too soon- so long term treatments are assessed over unrealistically short time scales. Many trials stop too soon so that later complications are missed out of the analysis.Many trials are set up against false or misleading comparators, rather than against best current treatments.Many journals are not robust in their peer review processes, and the possibility of obviously misleading flawed papers reaching publication (and so the credibility that goes with that) is huge. Peer review is touted as a gold standard of academic accuracy yet in reality it shows that fools seldom differ, and that great minds think alike. The misuse of reviewing by some competitive scientists to advance their own views, and to do down competition, rather than quality assure scientific results, is a blot on science's copy book. (I do peer review for some journals and sign my name to reviews- and try to be fair about a paper's merits)National Regulators are not given the full information about candidate drugs, and have no means to compel its production. So they make their assessments of a drug's merit on partial and positively skewed information. Bodies like NICE then have incomplete information on which to base their recommendations. All the way through the deletion and distortion of the published record of medicine is weakening our ability as doctors to make good treatment recommendations to our patients. We do not know either the positive results or the negative results properly, and so no one can get a proper overall view of which drug is good for which patients. The potential for harm by ignorance is huge here- whether by missed benefits or unrecognised side effects.All this means that the medical information data base is skewed, distorted and misleading. As a doctor I try to practice evidence based medicine, and act in accordance with current assessments of best practice. What this book confirms is that my efforts are undermined before I start- all the information I need is not available at any stage of the process. I could be superbly read and up to date- and yet because of the flaws in the medical evidence base simply be moving deeper into misleading myself, and consequently my patients.This is not a comfortable realisation. The medical information base, that can then be consolidated into reviews, guidelines, the BNF, and text books is utterly flawed. The prevalence of deletions (missing information) and distortions (spin, misleading presentations of data) mean that my personal and our collective knowledge is inaccurate right from the start.And that's before my own prejudices and misunderstandings can even get going. Some years ago a post graduate tutor asked me to lead an EBM workshop and describe the process whereby we as doctors come to understand the evidence and then digest it and present it fairly to patients. I said I very much doubted that doctors do understand evidence very well themselves- we are easily misled by presentation effects- just as everyone else is. Ultimately the analysis of medical evidence is largely by means of detailed statistics, and few doctors understand these well. A patient of mine who was a statistician told me that his first question to a client was , "what do you want these statistics to show?" He could then work to their wish. Numbers do not speak for themselves, but can be made to sing sweetly if played right.This book shows that the current systems of discovering new medical knowledge, and of using existing knowledge well, are severely flawed. This is not a good state for my profession to find itself in. We have grand edifices of knowledge, and this book shows that many of them are built on sand. For a profession that prides itself on being based on accurate, well defined and described knowledge this is a very poor performance.Goldacre's book is important and raises significant questions about what we are doing as doctors, and about how we get the information we need to practice medicine well. This book shows that there are currently very widespread deep problems at every stage in the generation and distribution of medical knowledge.His book is well written, well exampled and accurate. It should compel action by many people in medicine, the pharmaceutical industry and by those around medicine who regulate knowledge generation.This is an important book, and it is vital for doctors to read it, no matter how uncomfortable its implications are for us.

### ⭐⭐⭐⭐ 4.0 out of 5 stars







  
  
    The Nerd Rampant - great stuff
  

*by G***Y on Reviewed in the United Kingdom on 27 September 2012*

This is an important book, which tackles a problem that affects all of us - the development and use of effective and safe medicines. It's well researched and passionately and engagingly written. He presents a number of tricky topics clearly (I think) without losing their essence.The case he makes for publishing the data from all trials is made in vigorously sugar rush kind of a way. But the calm measured ways have been tried (as he reports) and Ben's entertaining blunderbuss of criticism to whip up public/political pressure seems like a good plan B to me.The section I have to comment on is the area of clinical trials. I've worked with a lot trial designers and a number of trials. You could get the impression from the book that Pharmaceutical companies have many tricks they can pull to pretty well guarantee success. They don't, most drug development project fail and they fail because their trials fail, there's roughly a 80% failure rate after a successful 'first in humans safety study', but that's across all compounds and therapeutic areas. The more novel the compound and the harder the disease is to treat, the lower success rate.On the aspects of trials that Ben criticises many are valid criticisms, but for trials that drug companies have to run to prove that a compound is an effective drug, many of the practices are ruled out by the regulators, in particular post-hoc sub group analysis, bundling outcomes and using uninformative outcomes. I'd also like to say that in my direct experience with the pharmaceutical industry, the clinical trials were designed to elicit the truth about the compound, not make it look good, by people that are smart, honest and diligent.As a client emailed to us today, when we commiserated with a failed trial:  "Thank you ... we believe that the results were credible and while we all wanted a positive study, our job is to uncover the truth."Ben's problem with conducting trials on 'ideal' patients, this does not make it more likely for the drug to be successful, they allow it to be shown to be successful with fewer patients. The trials aren't conducted in subjects more likely to recover and make the drug look good - the patients in the control group will be recruited from the same population and recover too making it hard to show the drug is effective. The ideal patients are those most sensitive to treatment - the `in the goldilocks zone' of neither having so mild a condition that they have a high chance or a good outcome, or so severe a condition that even a good drug is unlikely to improve matters. Being able to study the drug and prove or disprove its effectiveness in fewer patients is also an ethical thing to want to do.Ben's problem is that the medical profession needs to understand the drug in a broader population. The drug developer's problem is that drug development already costs hundreds of millions of dollars and consumed 10+ years of the drug's (nominally 20 years) patent life. Pharmaceutical companies may have been rich in the past but all are now merging, laying off staff and closing sites. So broader medical knowledge needs to come from the things Ben proposes - big simple studies using healthcare data gathered in the community and thorough and well researched meta-analyses.Ben complains at the use of 'surrogate outcomes'. He gives the example of statins and control of cholesterol level. He gives that example because the only two 'surrogate outcomes accepted by regulators are cholesterol level and blood pressure. Perhaps giving up smoking and weight loss are also surrogate markers? Pretty much any other disease where you want to try to prove you have a drug that treats it, you have to show 'clinically meaningful' outcomes.  The regulators are comfortable with cholesterol and blood pressure because of the unanimity of medical opinion that these were causes of heart problems. And studying the reduction of heart problems directly in trials requires studying thousands of patients for years.A suggestion he makes is that trials for Diabetes treatments should be based on reducing deaths from diabetes, but diabetes sufferers also suffer from consequential liver disease, kidney disease, neuropathic pain, loss of fingers and toes and sight loss. Now I assume these are all consequences of the diabetics lack of control over their blood sugar levels, if that's correct and I was a diabetic I'd be happy with a drug proven to control sugar levels and would not want to wait until it was proven to reduce mortality. [Ben elsewhere criticises the UKPDS -trial - a big, long running study in Diabetes that is generally taken to show that stringent control of blood glucose levels and/or blood pressure reduce type 2 diabetes complications. The study is cited by many Diabetes groups. Ben's criticism is of a compound endpoint but I'm not clear if the criticism applies to the original outcome (1998) or the 10 year follow-up (2008) I could find the latter easily and they looked pretty convincing. Learning point: if Ben cites something its worth following it up.]The biggest point I want to dispute is this business of stopping trials early. Looking at the data to in order to adapt the trial, in particular stop it is a very sane, reasonable and ethical thing to do and results in better science. Various statistical approaches to allow this to be done so that it doesn't also amount to cheating have been worked on in academia and industry for the past 25 years or so. The key aspect of all the approaches is that the rules by which decisions are to be taken are pre-specified and the consequences well understood.Ben tells some tales of the worst behaviour by Pharmaceutical companies apart, highlighting the need for regulation and huge punishments in an industry where the rewards can be so great. But I think that is known.More importantly Ben highlights some real and pressing problems that require pretty big changes to bring about. First pharmaceutical companies operate in a highly regulated environment, where those regulations don't always work in our best interest. Companies need to get the data on their drug necessary for licensing; this is already a big and onerous task (and much bigger and more onerous than it was 10 years ago). This data is not a good match for physician's needs - this mismatch Ben documents vividly. The best solution is to better manage drugs and their information after they've been approved, with the access to the full data, meta-analyses and big studies using public healthcare records. To move the requirement to pre-approval without also changing the patent laws will effectively make drug development unaffordable.Secondly - and this is an area where I've no direct experience, the management and analysis of post registration trials needs management - these seem to be essential to broaden the evidence base to patient groups not studied for registration, to amass evidence for rare but serious safety issues, to study other outcome measures (such as quality of life, and long term mortality), to identify sub-population effects. From Ben's tales of clinical trial malfeasance or incompetence it would seem these aren't to the same standard as drug development trials.Lastly this data needs collating and analysing by cool heads, in particular neither swayed by patient advocacy groups funded by the drug companies nor needing a juicy finding in order to justify publication.

### ⭐⭐⭐⭐⭐ 







  
  
    Intense
  

*by E***A on Reviewed in Italy on 27 June 2019*

A great book that gives numerous insights related to the effects of pharma industry on our everyday life.

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