text: bad pharma bad pharma : how drug companies doctors and harm patients is a book by british physician and academic ben goldacre about the pharmaceutical industry , its relationship with the medical profession , and the extent to which it controls academic research into its own products . it was published in the uk in september 2012 by the fourth estate imprint of harpercollins , and in the united states in february 2013 by faber and faber . goldacre argues in the book that " the whole edifice of medicine is broken , " because the evidence on which it is based is systematically distorted by the pharmaceutical industry . he writes that the industry finances most of the clinical trials into its own products and much of doctors ' continuing education , that clinical trials are often conducted on small groups of unrepresentative subjects and negative data is routinely withheld , and that apparently independent academic papers may be planned and even ghostwritten by pharmaceutical companies or their contractors , without disclosure . describing the situation as a " murderous disaster , " he makes suggestions for action by patients ' groups , physicians , academics and the industry itself . responding to the book 's publication , the association of the british pharmaceutical industry issued a statement in 2012 arguing that the examples the book offers were historical , that the concerns had been addressed , that the industry is among the most regulated in the world , and that it discloses all data in accordance with international standards . in january 2013 goldacre joined the cochrane collaboration , british medical journal and others in setting up alltrials , a campaign calling for the results of all past and current clinical trials to be reported . the british house of commons public accounts committee expressed concern in january 2014 that drug companies were still only publishing around 50 percent of clinical - trial results . author after graduating in 1995 with a first - class honours degree in medicine from magdalen college , oxford , goldacre obtained an ma in philosophy from king 's college london , then undertook clinical training at ucl medical school , qualifying as a medical doctor in 2000 and as a psychiatrist in 2005 . as of 2014 he was wellcome research fellow in epidemiology at the london school of hygiene and tropical medicine . goldacre is known for his " bad science " column in the guardian , which he has written since 2003 , and for his first book , bad science ( 2008 ) . this unpicked the claims of several forms of alternative medicine , and criticized certain physicians and the media for a lack of critical thinking . it also looked at the mmr vaccine controversy , aids denialism , the placebo effect and the misuse of statistics . goldacre was recognized in june 2013 by health service journal as having done " more than any other single individual to shine a light on how science and research gets distorted by the media , politicians , quacks , pr and the pharmaceutical industry . " synopsis introduction goldacre writes in the introduction of bad pharma that he aims to defend the following : 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 a drug 's 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 . chapter 1 : " missing data " in " missing data , " goldacre argues that the clinical trials undertaken by drug companies routinely reach conclusions favourable to the company . for example , in a 2007 journal article published in plos medicine , researchers studied every published trial on statins , drugs prescribed to reduce cholesterol levels . in the 192 trials they looked at , industry - funded trials were 20 times more likely to produce results that favoured the drug . he writes that these positive results are achieved in a number of ways . sometimes the industry - sponsored studies are flawed by design ( for example by comparing the new drug to an existing drug at an inadequate dose ) , and sometimes patients are selected to make a positive result more likely . in addition , the data is analysed as the trial progresses . if the trial seems to be producing negative data it is stopped prematurely and the results are not published , or if it is producing positive data it may be stopped early so that longer - term effects are not examined . he writes that this publication bias , where negative results remain unpublished , is endemic within medicine and academia . as a consequence , he argues , doctors may have no idea what the effects are of the drugs they prescribe . an example he gives of the difficulty of obtaining missing data from drug companies is that of oseltamivir ( tamiflu ) , manufactured by roche to reduce the complications of bird flu . governments spent billions of pounds stockpiling this , based in large part on a meta - analysis that was funded by the industry . bad pharma charts the efforts of independent researchers , particularly tom jefferson of the cochrane collaboration respiratory group , to gain access to information about the drug . chapter 2 : " where do new drugs come from ? " in the second chapter , the book describes the process as new drugs move from animal testing through phase 1 ( first - in - man study ) , phase 2 , and phase 3 clinical trials . phase 1 participants are referred to as volunteers , but in the us are paid $ 200 – $ 400 per day , and because studies can last several weeks and subjects may volunteer several times a year , earning potential becomes the main reason for participation . participants are usually taken from the poorest groups in society , and outsourcing increasingly means that trials may be conducted in countries with highly competitive wages by contract research organizations ( ) . the rate of growth for clinical trials in india is 20 percent a year , in argentina 27 percent , and in china 47 percent , while trials in the uk have fallen by 10 percent a year and in the us by six percent . the shift to outsourcing raises issues about data integrity , regulatory oversight , language difficulties , the meaning of informed consent among a much poorer population , the standards of clinical care , the extent to which corruption may be regarded as routine in certain countries , and the ethical problem of raising a population 's expectations for drugs that most of that population cannot afford . it also raises the question of whether the results of clinical trials using one population can invariably be applied elsewhere . there are both social and physical differences : goldacre asks whether patients diagnosed with depression in china are really the same as patients diagnosed with depression in california , and notes that people of asian descent metabolize drugs differently from westerners . there have also been cases of available treatment being withheld during clinical trials . in 1996 in kano , nigeria , the drug company pfizer compared a new antibiotic during a meningitis outbreak to a competing antibiotic that was known to be effective at a higher dose than was used during the trial . goldacre writes that 11 children died , divided almost equally between the two groups . the families taking part in the trial were apparently not told that the competing antibiotic at the effective dose was available from médecins sans frontières in the next - door building . chapter 3 : " bad regulators " chapter three describes the concept of " regulatory capture , " whereby a regulator – such as the medicines and healthcare products regulatory agency ( mhra ) in the uk , or the food and drug administration ( fda ) in the united states – ends up advancing the interests of the drug companies rather than the interests of the public . goldacre writes that this happens for a number of reasons , including the revolving door of employees between the regulator and the companies , and the fact that friendships develop between regulator and company employees simply because they have knowledge and interests in common . the chapter also discusses surrogate outcomes and accelerated approval , and the difficulty of having ineffective drugs removed from the market once they have been approved . he argues that regulators do not require that new drugs offer an improvement over what is already available , or even that they be particularly effective . chapter 4 : " bad trials " " bad trials " examines the ways in which clinical trials can be flawed . goldacre writes that this happens by design and by analysis , and that it has the effect of maximizing a drug 's benefits and minimizing harm . there have been instances of fraud , though he says these are rare . more common are what he calls the " wily tricks , close calls , and elegant mischief at the margins of acceptability . " these include testing drugs on unrepresentative , " freakishly ideal " patients ; comparing new drugs to something known to be ineffective , or effective at a different dose or if used differently ; conducting trials that are too short or too small ; and stopping trials early or late . it also includes measuring uninformative outcomes ; packaging the data so that it is misleading ; ignoring patients who drop out ( i.e. using per - protocol analysis , where only patients who complete the trial are counted in the final results , rather than intention - to - treat analysis , where everyone who starts the trial is counted ) ; changing the main outcome of the trial once it has finished ; producing subgroup analyses that show apparently positive outcomes for certain tightly defined groups ( such as chinese men between the ages of 56 and 71 ) , thereby hiding an overall negative outcome ; and conducting " seeding trials , " where the objective is to persuade physicians to use the drug . another criticism is that outcomes are presented in terms of relative risk reduction to exaggerate the apparent benefits of the treatment . for example , he writes , if four people out of 1 , 000 will have a heart attack within the year , but on statins only two will , that is a 50 percent reduction if expressed as relative risk reduction . but if expressed as absolute risk reduction , it is a reduction of just 0 . 2 percent . chapter 5 : " bigger , simpler trials " in chapter five goldacre suggests using the general practice research database in the uk , which contains the records of several million patients , to conduct randomized trials to determine the most effective of competing treatments . for example , to compare two statins , atorvastatin and simvastatin , doctors would randomly assign patients to one or the other . the patients would be followed up by having data about their cholesterol levels , heart attacks , strokes and deaths taken from their computerized medical records . the trials would not be blind – patients would know which statin they had been prescribed – but goldacre writes that they would be unlikely to hold such firm beliefs about which one is preferable to the extent that it could affect their health . chapter 6 : " marketing " in the final chapter , goldacre looks at how doctors are persuaded to prescribe " me - too drugs , " brand - name drugs that are no more effective than significantly cheaper off - patent ones . he cites as examples the statins atorvastatin ( lipitor , made by pfizer ) and simvastatin ( ) , which he writes seem to be equally effective , or at least there is no evidence to suggest otherwise . came off patent several years ago , yet there are still three million prescriptions a year in the uk for atorvastatin , costing the national health service ( nhs ) an annual £ 165 million extra . he addresses the issue of medicalization of certain conditions ( or , as he argues , of personhood ) , whereby pharmaceutical companies " widen the boundaries of diagnosis " before offering solutions . female sexual dysfunction was highlighted in 1999 by a study published in the journal of the american medical association , which alleged that 43 percent of women were suffering from it . after the article appeared , the new york times wrote that two of its three authors had worked as consultants for pfizer , which at the time was preparing to launch uk - 414 , 495 , known as female viagra . the journal 's editor said that the failure to disclose the relationship with pfizer was the journal 's mistake . the chapter also examines celebrity endorsement of certain drugs , the extent to which claims in advertisements aimed at doctors are appropriately sourced , and whether direct - to - consumer advertising ( currently permitted in the us and new zealand ) ought to be allowed . it discusses how pr firms promote stories from patients who complain in the media that certain drugs are not made available by the funder , which in the uk is the nhs and the national institute for health and clinical excellence ( nice ) . two breast - cancer patients who campaigned in the uk in 2006 for trastuzumab ( herceptin ) to be available on the nhs were being handled by a law firm working for roche , the drug 's manufacturer . the historian lisa jardine , who was suffering from breast cancer , told the guardian that she had been approached by a pr firm working for the company . the chapter also covers the influence of drug reps , how ghostwriters are employed by the drug companies to write papers for academics to publish , how independent the academic journals really are , how the drug companies finance doctors ' continuing education , and how patients ' groups are often funded by industry . afterword : " better data " in the afterword and throughout the book , goldacre makes suggestions for action by doctors , medical students , patients , patient groups and the industry . he advises doctors , nurses and managers to stop seeing drug reps , to ban them from clinics , hospitals and medical schools , to declare online and in waiting rooms all gifts and hospitality received from the industry , and to remove all drug company promotional material from offices and waiting rooms . ( he praises the website of the american medical student association – – which ranks institutions according to their conflict - of - interest policies , writing that it makes him " feel weepy . " ) he also suggests that regulations be introduced to prevent pharmacists from sharing doctors ' prescribing records with drug reps . he asks academics to lobby their universities and academic societies to forbid academics from being involved in ghostwriting , and to lobby for " film credit " contributions at the end of every academic paper , listing everyone involved , including who initiated the idea of publishing the paper . he also asks for full disclosure of all past clinical trial results , and a list of academic papers that were , as he puts it , " rigged " by industry , so that they can be retracted or annotated . he asks drug company employees to become whistleblowers , either by writing an anonymous blog , or by contacting him . he advises patients to ask their doctors whether they accept drug - company hospitality or sponsorship , and if so to post details in their waiting rooms , and to make clear whether it is acceptable to the patient for the doctor to discuss his or her medical history with drug reps . patients who are invited to take part in a trial are advised to ask , among other things , for a written guarantee that the trial has been publicly registered , and that the main outcome of the trial will be published within a year of its completion . he advises patient groups to write to drug companies with the following : " we are living with this disease ; is there anything at all that you 're withholding ? if so , tell us today . " reception the book was generally well received . the economist described it as " slightly technical , eminently readable , consistently shocking , occasionally hectoring and unapologetically polemical . " helen lewis in the new statesman called it an important book , while luisa , writing in the guardian , described it as a " thorough piece of investigative medical journalism . " andrew jack wrote in the financial times that goldacre is " at his best in methodically dissecting poor clinical trials . ... he is less strong in explaining the complex background reality , such as the general constraints and individual slips of regulators and pharma companies ' employees . " jack also argued that the book failed to reflect how many lives have been improved by the current system , for example with new treatments for hiv , rheumatoid arthritis and cancer . max pemberton , a psychiatrist , wrote in the daily telegraph that " this is a book to make you enraged ... because it 's about how big business puts profits over patient welfare , allows people to die because they don 't want to disclose damning research evidence , and the tricks they play to make sure doctors do not have all the evidence when it comes to appraising whether a drug really works or not . " the association of the british pharmaceutical industry ( ) replied in the new statesman that goldacre was " stuck in a bygone era where pharmaceutical companies wine and dine doctors in exchange for signing on the dotted line . " the issued a press release , writing that the pharmaceutical industry is responsible for the discovery of 90 percent of all medicines , and that it takes an average of 10 – 12 years and £ to introduce a medicine to the market , with just one in 5 , 000 new compounds receiving regulatory approval . this makes research and development an expensive and risky business . they wrote that the industry is one of the most heavily regulated in the world , and is committed to ensuring full transparency in the research and development of new medicines . they also maintained that the examples goldacre offered were " long documented and historical , and the companies concerned have long addressed these issues . " goldacre argues in the book that " the most dangerous tactic of all is the industry 's enduring claim that these problems are all in the past . " humphrey rang of the british pharmacological society wrote that goldacre had chosen his target well and had produced some shocking examples of secrecy and dishonesty , particularly the nondisclosure of data on the antidepressant ( chapter one ) , in which only one trial out of seven was published ( the published study showed positive results , while the unpublished trials suggested otherwise ) . he argued that goldacre had gone " over the top " in devoting a whole chapter ( chapter five ) to recommending large clinical trials using electronic patient data from general practitioners , without fully pointing out how problematic these can be ; such trials raise issues , for example , about informed consent and regulatory oversight . rang also criticized goldacre 's style , describing the book as too long , repetitive , hyperbolic , and in places too conversational . he particularly objected to the line , " medicine is broken , " calling it a " foolish remark . " alltrials following the book 's publication , goldacre co - founded alltrials with david tovey , editor - in - chief of the cochrane library , together with the british medical journal , the centre for evidence - based medicine , and others in the uk , and dartmouth college 's geisel school of medicine and the dartmouth institute for health policy and clinical practice in the us . set up in january 2013 , the group campaigns for all past and current clinical trials to be registered and reported , for all treatments in use . the british house of commons public accounts committee produced a report in january 2014 , after hearing evidence from goldacre , fiona , editor - in - chief of the british medical journal , and others , about the stockpiling of tamiflu and the withholding of data about the drug by its manufacturer , roche . the committee said it was " surprised and concerned " to learn that information from clinical trials is routinely withheld from doctors , and recommended that the department of health take steps to ensure that all clinical - trial data be made available for currently prescribed treatments . publication details bad pharma : how drug companies mislead doctors and harm patients , fourth estate , 2012 ( uk ) . isbn 978 - 0 - 00 - - 2 faber and faber , 2013 ( us ) . isbn 978 - 0 - - 800 - 8 signal , 2013 ( canada ) . isbn 978 - 0 - 7710 - - 3 as of december 2012 foreign rights had been sold for brazil , the czech republic , netherlands , germany , israel , italy , korea , norway , poland , portugal , spain and turkey .