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

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 Yet routinely negative studies are ignored, filed away, unpublished, maybe never even written up.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this is- patients have been taking part in clinical trials to advance medical knowledge- and then the trial goes unpublished so no one can learn from it.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.

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.

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

I rarely give five stars but this book deserved it. While criticism can be ideological and philosophical, in this book it's based on scientific evidence. Drugs are all about science and decisions have to be made purely based on evidence. The author has tried to highlight the usual but hidden practices used by drugmakers to game the system. On the top of that, he tried to bring home the point that ignoring this directly affects people and poses threat to people's lives; even leading to death. He also focuses both on U.S. and Europe, thus improving our understanding of worldwide practices. The author's solution is clear: TRANSPARENCY. Regulators can't completely be relied upon on matters of life and death and we need more independent eyes to call out the fake data. This book is a must for every journalist as well as a doctor who rely on pharma companies to treat their patients.

Evidence based medicine is a term held near and dear, but evidence based research, studies etc. are not based on anything positive- all the so-called evidence is distorted in dozens of crucial stages including drug regulation and laws supposed to protect people. 1) New drugs are not needed, just more expensive and/ or replacements of less new dangerous drugs, or don't work well. 2) Data is purposely skewed to favor benefits. Bad trial data is lost or unreported. 3) Tests on humans are done in third world countries with less than ideal patients for the purpose of the drug 4) Regulators do not do their job as there is a big financial conflict of interest. 5) Doctors are either fooled or paid to push these drugs 6) Most doctors don't even know the difference between Relative Risk and Absolute Risk- big problem as this is the main way that drug's benefits are falsely increased and risks reduced- but it is all just distortion or statistics.The big problem is that nobody in the industry wants to do anything about it. And if they try then they will be lambasted and thrown out of their medical society. We see the same thing happening with politics today- speak up and you are finished.There are many more 'tricks of the trade' that are either deliberately used or become convenient loopholes in every stage of a drug's production and marketing that get used by scientists, regulators, academics and doctors either knowingly, knowingly with the acceptance of money or increased job status to further their interests.Medical journals, for example are not published or edited by the serious scientific minds that we are led to believe- these magazines are either literally owned by the pharma companies themselves or bought with different forms of bribery.The process from a drug's invention (usually a "me too" copy of a molecule) to it's marketing is filled with loopholes that have zero concern for the health or well being of the patient. In fact most drugs since the 1970s are only "invented" as a means to make more profit.This book more than confirms my fears, doubts, and criticisms of medicine I've had my whole life, experienced and studied. And it is a very good reference for all the claims. As the author states, the main reason why people are so impressed and willing to be herded like cattle to slaughter when it comes to trusting medicine, is due to the fact that most people hate effort, especially when it comes to dry material and understanding statistics and systematic review. If it can't be explained in one sentence then most people are not interested.The bottom line is that health is your main concern and drugs will never ultimately save you- only your diet and lifestyle can do that. Yet I am all too convinced that most people do not want to be helped- they just want to remain either helpless victims or they are just too stubborn to put the change and effort in to at least help their own situation, but becoming more aware of their own body and health,. Just like alternative medicine-another group of dubious individuals- people love to swallow a miracle pill and just let their faith guide them without ever gaining any genuine awareness of reality. That is fine with me- this is a free society to so what you please- just that the drug and supplement industry are not transparent, so that the majority of effortless people will unfortunately be misled and as a result suffer much harm, as we see with this health crisis.At best we can look forward to the missing data becoming published in the public domain so that people can at least look at it. But few will do this. And, sadly, even IF the pharma system corrects the dozens of problems that mislead doctors and harm patients, most of the drugs that people take are based on the old system anyway.I have little faith is any system, and am committed to helping people yes, but as Jesus said, "You have to save yourself".2000 years later George Carlin added, "Ya gotta wanna"

Completo e de linguagem acessível e atraente! Informações pertinentes e consistentes! Um livro que deveria ser lido por todo estudante de medicina!

After reading this magnificent work (you have to pay attention, that's for sure) I felt two things: (1)What a bunch of crooks and snake-oil hucksters the drug peddling industry is, and (2)how do I get this to my doctor without jeopardizing my standing with her. After all, this revelatory book should be read my every doctor whether or not they have a "No drug reps beyond this point" sign on the wall.Way back when the FDA lowered by half (repeat: by half; i.e. by 50%!!) their estimate of how much blood cholesterol was dangerous and needed to be lowered with widespread use of statins, I became a thorough going skeptic of the FDA and the industry as a whole. Goldacre took a detailed look at the industry, the doctors who are (unknowingly, or unthinkingly, or otherwise) co-opted by pharmaceutical companies with big budgets, and the shoddy and sometimes intentionally misleading "studies" that purportedly prove the effectiveness of the drugs they are shilling to the unsuspecting public and the "look the other way" FDA and other agencies which are supposed to protect us from this charlatinism. Nobody comes out of this analysis clean and lilly white. Quite the opposite.Goldacre is not a doomsayer, but he is certainly a whistle blower. Whether this has any effect on doctors in England, Europe, the States, or here in Canada is an open question. My gut feeling is: No, it will have little effect. But we patients might be able to have some influence. We can give our doctors this book and encourage them to read it. The tough job is to convince them that you are NOT inditing them by giving them the book. Many doctors are likely to take offense my your doing this. So... send it to them by mail with no (or a bogus) return address.Even if 75% of what Goldacre says is wrong, it is still a big concern, and getting bigger. Everyone who cares about their health should read this, and then take extra precautions when doctors suggest drug treatments. Look more closely. It's up to us.