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Bad Pharma: A Manifesto to Fix the Pharmaceutical Industry

“There is no medicine without medicines” write Ben Goldacre in his new book Bad Pharma. To Goldacre, an author, journalist and physician, this cause is personal. The title, a reference to both his first book, Bad Science, as well as the pharmaceutical industry’s nickname Big Pharma, is a bit of a misnomer. While the focus is pharmaceutical companies and their actions, there are a number of enablers in the health care system – medical journals, regulators, and even medical professionals, all of whom have put the industry’s needs ahead of good medicine. According to Goldacre, the damage is pervasive and deep, right to the roots of modern medicine. These problems know no borders, and affect us all. Despite the different health care systems that exist worldwide, we all depend on for-profit pharmaceutical companies to develop and market new medicines. These companies collectively wield enormous clout, due in part to the remarkable success of medicines over the past several decades. The global pharmaceutical market will probably top $1 trillion (yes, 12 zeros) this year. And Goldacre argues the industry is not only compromised, it is broken. And over 400 pages, he defends the following paragraph:

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 that 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 ad hoc, from sales reps, colleagues and 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 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 party they have failed; so all of these programs persist, but worse than ever, because now people can pretend that everything is fine after all.

We all have our own biases, and I should disclose mine. I’m a pharmacist who has seen HIV go from a death sentence to a chronic disease, thanks to newly developed drugs. I’ve watched cancers like leukemias be effectively cured, thanks to medication. And I’m amazed that surgeries like double-lung transplants, impossible in the past, are now a reality, thanks in part to drug treatments. Yet I’ve also spent more than a decade reviewing the efficacy and safety of prescriptions drugs. Regrettably few are truly innovative. Many are approved with lingering questions about long-term safety and effectiveness. The value some offer can be questionable. I’ve also seen tremendous harms caused by drugs – from individual patients who have suffered horrible adverse drug reactions to population-level disasters like the Vioxx (COX-2) debacle. And I haven’t ignored the countless fines levied on pharmaceutical companies for bad, and sometimes even criminal, behavior. With its repeated capacity for self-sabotage, the pharmaceutical industry is its own worst enemy. My colleagues who work in the pharmaceutical industry agree. They’re smart, honest people that genuinely want to help get good treatments to patients. They’re embarrassed by what they see. So while I have no doubts about the astonishing track record of innovative new drugs that have transformed medicine, I also have no illusions that drug companies always behave in ways that support science-based medicine. And I think there is the potential for the industry to do much better. So how do we get this?

Goldacre, a medical doctor by training who is still in active practice, has been writing a column on science and evidence for The Guardian for almost a decade. He hasn’t pulled any punches, calling out bad reporting, taking on media personalities who spout pseudoscience, and even even getting sued for libel by a vitamin purveyor. (Goldacre won.) He compiled many of these themes into his first book Bad Science, one of the best resources for non-scientists interested in learning the practical application of the scientific method. From homeopathy to media nutritionists, Goldacre effectively demystifies scientific inquiry and exposes the tricks that can be used to spin and obfuscate the facts. The pharmaceutical industry makes an appearance in the book as well, which Goldacre uses to point out how it can also manipulate good science, using the same tactics (though perhaps with more sophistication) than alternative medicine purveyors. In his discussion of the industry, he foreshadows the thesis of Bad Pharma:

Whatever our political leanings, everyone is basically a socialist when it comes to healthcare: we all feel nervous about profit taking any role in the caring professions, but that feeling has nowhere to go. Big pharma is evil: I would agree with that premise. But because people don’t understand exactly how big pharma is evil, their anger and indignation get diverted away from valid criticisms—its role in distorting data, for example, or withholding life-saving AIDS drugs from the developing world—and channelled into infantile fantasies. ‘Big pharma is evil,’ goes the line of reasoning, ‘therefore homeopathy works and the MMR vaccine causes autism.’ This is probably not helpful.

Goldacre’s comment captures the trepidation I had before reading the book. Constructive criticism of the pharmaceutical industry is surprisingly difficult to find. Many critics have a clear bias. Big Pharma is evil…and…that’s where it ends. There’s no acknowledgment of the value medicine offers, or the recognition that industry can do better. Big pharma’s failings are a blunt instrument that drive home an unsophisticated, and demonstrably incorrect, point: Medicine itself is bad. Some critics seem to have given up entirely on improving the system: It’s hopelessly rigged and even corrupt, they argue. Lest you think this is solely the domain of CAM providers or advocates like Joe Mercola or Mike Adams, it’s not hard to find academics, and sometimes even medical doctors, whose pharmaceutical industry criticisms are not driven by a desire for better science, but rather reflect a rejection of it. In short, they become cranks.

Reassuringly, Goldacre doesn’t get into black helicopter, medical-industrial complex, conspiracy theories with crank objections to industry. He’s a practicing physician who acknowledges the benefits of drugs but laments a system which has even compromised his own treatment decisions. One of his early anecdotes describes how the publication bias of trials for reboxitine, an antidepressant, gave a skewed perspective of the evidence:

I did everything a doctor is supposed to do. I read all the papers, I critically appraised, them, I understood them, I discussed them with the patient, and we made a decision together, based on the evidence. In the published data, reboxitine was a safe and effective drug. In reality, it was no better than a sugar pill, and worse, it does more harm than good. As a doctor I did something which, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.

Goldacre’s passion and palpable outrage at the fact this has occurred, and continues to occur, are written with a call to action: The situation can can be fixed. And there’s a larger cause – we can all benefit:

However rich you are, if you are sick you can’t innovate new medicines overnight, because that takes time, and more money than even you have. And you can’t know the true effects of the medicines we have today because nobody does, if they’ve not been properly tested, and if some results go missing in action.

Certainly, compared to Bad Science, this is a much longer, much more detailed read. Goldacre recognizes the need for meticulous accuracy but also strove to make the book readable and understandable to the lay reader. It is a tough balance, but I think it largely succeeds. There are only six chapters, of which the first chapter, on missing data, and the final chapter, on marketing, take up almost two thirds of the book. Each chapter provides some illustrative anecdotes, summarizes the overall evidence base, and then proposes a number of possible solutions – some for individuals, and some calling for system-level change. An afterword sums up his detailed prescription. I’ll take the chapters in the same order.

Missing Data
Goldacre starts with missing data, the basis of his thesis and one of the most fundamental problems in medicine today. As I noted in a recent post on on clinical trials transparency, missing data compromises our evaluation of the evidence base,  prevents science-based care, wastes resources, and ultimately, does a disservice to patients. If trials are conducted that don’t support efficacy claims, yet are never published, the evidence base becomes biased in favor of treatments and interventions. Goldacre summed up the issue concisely in a recent interview in The Economist:

If I were to run a study, and then just remove half of my data points so that my results looked much better, well, you would laugh in my face. It would be obvious to anyone that it was research misconduct. You might even call it fraud. And yet we tolerate the results of entire clinical trials—a huge proportion of them—being withheld from doctors and patients. In medicine, we rely on summaries of evidence, we collate the results from many different trials. So withholding the results of whole trials is exactly the same insult to the data as fraudulently deleting data points from within individual studies.

There is ample evidence that the evidence base we are currently using in medicine is distorted exactly as Goldacre describes. However, the extent to which this has harmed our treatment evaluations is probably impossible to discern. Goldacre points out that this isn’t just pharma’s fault – research ethics boards, universities, regulators, and medical journals have all failed to follow-through on new standards for data transparency and access. Goldacre calls these “fake fixes”, such as the requirement from the world’s top medical journals to ensure that all published trials are registered before they commence – but the requirement isn’t subsequently enforced. These fake fixes extend to regulators who offer lip service on  transparency, and even block access to the evidence they have used to determine if a drug should be approved for sale. Instead there is a “yes” or “no” decision, with little public sharing of the evaluation process and information considered. Goldacre makes an important point about regulatory decisions versus those made by health care professionals:

Contrary to what some regulators seem to think, a drugs is not either ‘good’ and therefore on the market or ‘bad’ and off it. A regulator makes a decision about whether it’s in the interests of the population as a whole that the drug should be available for use, at all ever – even if only is some very obscure circumstance, infrequently and cautiously.  The bar is set pretty low, as we shall see, and lots of drugs that are on the market  (in fact, the overwhelming majority) are hardly ever used.

A doctor needs to use the same information as that available to the regulator in order to make a very different decision: is this the right drug for the patient in front of me right now? The simple fact that a drug is approved for prescription doesn’t mean it’s particularly good, or the best. In fact, there are complex decisions to be made in each clinical situation about which drug is best.

 Goldacre concludes the chapter with an extended list of fixes, outlining ways to strengthen the checks and balances to ensure that the results of all human trials are made publicly available. Some are major policy issues, others are much more simple to implement. Would they improve transparency? Undoubtedly. Are these new issues? No. But the culture of complacency that exists in the health care system about this issue has so far been remarkably resistant to meaningful change.

Where do new drugs come from?

The second chapter looks at the drug development process, and covers a huge subject in a handful of pages. Consequently the complexity and risk of drug development is simplified, which is unfortunate, as it’s important to keep in mind that we have collectively decided that much of this risk must be carried by these for-profit companies. A later mention of drug development costs is also abbreviated, which again minimizes the financial consequences of development. (See my old post on this issue for a detailed discussion of drug development costs.)

One of the most interesting sections is a discussion on just who is participating in clinical trials. Until the 1980′s, many trials in the United States were being performed on prisoners. Today, it’s increasing likely that the crucial trials supporting the approval of a drug are being conducted overseas, where it’s apparently much easier, and less expensive, to run a trial. The challenges with ensuring effective ethical standards and clinical trials oversight should be obvious. Some of the problems with poor countries accessing these drugs are discussed, and Goldacre explores the ethical issues with studying drugs in patients who will never be able to afford the treatments.

Bad regulators
The overall purpose of clinical trials, from a manufacturer’s perspective, is to collect information to support a drug’s regulatory approval. If you’re a frequent reader of this blog you’ll know that there is no shortage of criticism of regulators for the work they do in evaluating new drugs. One of the biggest is the challenge of obtaining expert opinion on new drugs from individuals who  may have significant conflicts of interest. This is a common problem, where those with the most experience using a drug, are often in direct conflicts of interest, most frequently because of compensation for participation in clinical trials. The conflicts that can exist between regulators and the industry it regulates are real, and probably managed less transparently than we would like.

Another criticism Goldacre raises is the problem with accepting surrogate markers as endpoints in trials. Manufacturers want their drugs approved as quickly as possible (the patent clock is ticking) so often ask to measure what are called “surrogate” indicators, which are proxies for “hard” indicators which are the outcomes we are really interested in. For example, blood pressure, or cholesterol measures may be the endpoint measured in a clinical trial, rather than a more meaningful indicator like heart attack, stroke, or death. Measuring surrogates is easy. Measuring hard outcomes is time consuming and could mean the need to study hundreds more patients. When surrogates are demonstrably accurate predictors of hard outcomes, we’re in a good place – it’s fair to use a short, smaller trial. But assuming a surrogate predicts a hard outcome can lead to bad decisions. The classic example is the CAST trial, which tested a group of heart drugs for their ability to control abnormal heart rhythms – the surrogate. But the trial also measured hard outcomes. And the trial answered the question – the surrogate improved, but the treatments were killing, not helping patients.
Goldacre gets into the problem with so-called “me-to’s” which are variations of a competitor’s drug product. For example, there are several different but similar “statin” drugs on the market, as there are a group of similar drugs for blood pressure called “ACE inhibitors”. The typical pharma criticism is to berate industry for lacking innovation and playing it safe. But this is a view shaped by an ignorance of the pharmaceutical development process. First, these drugs are often all in development at the same time. Once a potential pathway or drug target has been identified, it’s a race to design drugs, complete the trials and be first on the market. And until the trials are done, and the drugs are approved, it’s anyone’s guess which is going to be the “new” drug and which will be the “me-too”. So we may have a dozen or more similar drugs on the market. That’s a consequence of a competitive marketplace. I share Goldacre’s mixed feelings about me-too’s. This kind of variety is useful to patients who may prefer one over another. Yet it’s also true that the pharmaceutical industry really doesn’t compete on price, nor does it regularly conduct head-to-head trials comparing drug A versus drug B. So we end up with markets where there’s little clear information on which drug is best, and worst of all, no price competition, which would at least reduce the costs of treatment. Goldacre points out the pressing need for comparative effectiveness research, studies which compare treatments and help us determine which is superior.
One of the most important roles of a regulator is the requirement to monitor its safety after approving it for sale. Given a drug is usually tested in small numbers of patients who are carefully selected and closely monitored, there can be a number of surprises once a drug is unleashed on a market. I covered a lot of this ground in a prior post on adverse event reporting. Goldacre spends time describing how regulators worldwide do a generally poor job of both collecting safety information, but also sharing it with health professionals and the public. Some of the recommendations he has to improve regulation includes:

  • requiring companies to compare new drugs against the current “standard of care” rather than placebo
  • raising the evidence bar to demand trials that answer more relevant questions useful for patients and physicians
  • dramatically increasing the transparency of drug evaluation process, so that the evidence supporting decisions can be evaluated
  • improving the way we share information on the risks and benefits of drugs

All of these solutions are achievable. Transparency and data access are obvious. There is little cost and tremendous upside. Changing the standards for clinical trials would have a much more profound effect on drug development, possibly delaying new drugs for years. Goldacre argues this is justified – we’re not losing out if there’s no evidence to demonstrate that the new treatment is better than the current standard. It’s an important policy issue which merits discussion.

Trials
Two chapters are devoted to the structure of clinical trials – how they’re often flawed, and how biases can work their way into the evidence. Patients may be carefully selected for a study and they may be largely unrepresentative of the real population that ultimately take the drug. So  new medication that appears to offer a substantial benefit may offer little improvement when it’s used in the real world.  Unfortunately, this happens all the time. Or trials may not even answer relevant questions we might have: Studies may be too short (surrogate markers again) or they compare a drug to something inappropriate (placebo, perhaps, instead of the current best treatment).  The chapters are essentially a quick-and-dirty critical appraisal guide, and Goldacre gives example after example of the spin that can occur. One of the interesting projects that Goldacre describes is his work in promoting real-world evaluations of effectiveness, which have the potential to tell us which drug works best in a representative population. Clearly he’s excited by the possibility of these pragmatic studies to answer questions that have (so far) been unattainable.

Marketing
The last chapter is devoted to marketing in all its guises. Goldacre describes it as a “chaotic and biased” system, which is a fair description. Regrettably most countries rely on pharmaceutical companies to disseminate information on their own products – and they are hardly unbiased sources of information. One of the challenges we have in the way drugs are prescribed and distributed is that we have a set of misaligned incentives that create market failure. These incentives are easily manipulated through marketing. Consider the following:

  • The patient wants the best treatment, and generally trusts the physican’s decision-making. Their opinions may have been influenced by direct-to-consumer advertising. In some cases, they may believe they are ill because of advertising.  Costs of treatment may or may not be a concern, depending on  insurance coverage.
  • The physician prescribes the drug. The decision making process for physicians is not always rational, or evidence-based. They may have been exposed to biased sources of information about a drug’s merits. The cost of the drug may not be known – and the physician may not care.
  • The pharmacist has verify the safety and appropriateness of the drug, but well after the treatment decision has already been made. The question of “who pays” has to be sorted out. There is usually little opportunity to help guide drug selection. The pharmacist may also be a target of direct marketing from pharmaceutical companies.
  • The insurer (private, government, or otherwise) will often know little about the individual patient circumstances. They generally want the same thing as the patient – the most appropriate therapy – but know the cost of each treatment and will have a preference for using more cost-effective treatments first.

Take for example, the now infamous case of the COX-2 drugs (Vioxx and Celebrex) when they were launched. Here were drugs that seemed to offer marginal but promising benefits (fewer gastrointestinal bleeds) in selective patients based on short trials. However, they were significantly more expensive that other anti-inflammatory drugs. Yet massive marketing created both patient demand and physician prescribing, accelerated by manufacturer-sponsored “continuing education” programs, and unbelievably, even fake journals created to give the impression of academic credibility. And insurers, who might have preferred less expensive anti-inflammatory drugs, had to make decisions about whether to restrict funding, or pay a tremendous premium for the potential minor benefits of these new treatments. These drugs went on to be blockbusters – but with tragic consequences.

It’s the overall issue of misaligned incentives that I would have liked to see explored further in Goldacre’s book. The United States is 45% of the global pharmaceutical market, followed by Japan (9%), Germany (5%) and the United Kingdom, at 4%. For-profit companies will act to maximize their revenue in the biggest market. It’s arguable that the United States has the least cost-efficient health care system in the world. As long as that system continues to allocate health resources in inefficient ways (e.g.,  paying for drugs that don’t offer meaningful new benefits), can we really expect pharmaceutical companies to change on their own? Regulation is important, but incentives drive behavior, and we should reward companies who bring the truly innovative therapies to market.

Again, Goldacre writes a number of prescriptions for improvement. They range from the simple (“Don’t see drug reps”) to bigger policy issues about how we can improve the continued professional development of physicians. All merit consideration. And there’s no question, that if implemented, they would dramatically improve the way we use medications.

Closing thoughts
This is a book with important messages for patients, health care professionals, governments, and the pharmaceutical industry. It may anger, and even infuriate you. It should. Yet Goldacre sketches out a path for reform – one in which transparency is the rule, not the exception, and one in which the pharmaceutical industry can engage with the health care system in ways that will help it do what we all want it to do – bring innovative new medications to market that improve the health and welfare of patients. This change, however, will only come when we demand better – better from pharmaceutical companies, better from regulators, and better from our fellow health professionals. Ultimately, we’ll have the industry we deserve – if we’re not willing to demand better, we’re never going to see any improvements. This book is your call to action.

Bad Pharma hasn’t been published in North America yet. But I’m told some have had success with their Kindle using Amazon.co.uk.

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27 thoughts on “Bad Pharma: A Manifesto to Fix the Pharmaceutical Industry

  1. Jan Willem Nienhuys says:

    I have read the book. It is horrifying. A major part of what is described about the practice of RCTs (setting them up, writing down the results, publishing) is a description of what I would call simply fraud (to be sure, fraud that is probably going on in a much more intense way in SCAM*).

    The only plea that can be used is that in science one is ‘exploring’ and that trying to find out what is going on (what does the drug actually do, for which patients does it work best?) is something entirely different providing a formal proof of effectivity. But this exploring leads to very many dead ends. This is well known in the pharmaceutical industry. I forgot the figures but for every 1000 compounds tried out, only one will be somewhat promising. I think this is basically what Ioannidis has observed: if you do exploration in a field where there thounds or even much more possibilities, then you’ll end up with very many duds.

    In physics people are more careful. In particle physics and astronmy, where enormous amounts of data are handled, p=0.000001 is the norm in exploratory research.

    However, when one presents a proof of effectivity to a regulatory body, then all this exploratory behavior is taboo.

    I guess that the scientists who run experiments for pharmaceutical companies know very well what is proper and what not. But when the company spends twice as much a PR as on research, one can imagine what the scientists will do when the PR department tells them what to do to prevent $100,000,000 or a multiple to be written off ‘because after all the new drug isn’t really that good’. When the sales and PR departments are the actual bosses, you can expect that science takes a back seat.

    * In SCAM one doesn’t have to leave’s one chair to see how the proponents lie and cheat at every turn. If one just reads carefully what the SACMmers write in their own defense one can see the lies and obfuscations. Just a week ago I was confronted with such a blatant lie: the Belgian homeopaths want to be ‘recognized’. They prepared a report to the government, in which they stated that this recognition was already the case in the Netherlands. Actually they more or less copied the membership requirements of homeopathic associations (such as ‘must have 3 years of medical training’) and implied these were government requirements. Then universities get only a few days to comment on this, and if they don’t, it becomes part of an ‘official government report’. A similar farce has been performed in Switzerland.

  2. MarcusGP says:

    Thanks for promoting this sadly important book. Without a doubt the best read of 2012.

    I keep repeating this in sceptical circles, and will do so again; this is a topic many sceptics and quackwatchers really need to read up on. Sure, each case is a hell of a lot more work than SCAMs, but the damage it does is proportional to said work.

    In the EBM/EBP-community this is nothing new, but even for people who are reasonably well informed on the topic, Bad Pharma has been an eye-opener of sorts. Just to use myself as an example: sure, I´d read most of the papers Goldacre cites, and have heard my share of anecdotes from friends and acquaintances who have been bullied out of research, prescribed crap drugs or withheld data, but it never really added up until I read Bad Pharma. I blame it on my own lazyness (and the fact that researching research fraud and misconduct in “real” medicine is a lot more time consuming than with SCAMs. To me it is, anyway, though this might be because of the many great resources online).

    Again; thanks for bringing up Bad Pharma, and for the service you keep providing with your posts.

  3. Janet says:

    http://www.guardian.co.uk/science/audio/2012/oct/22/science-weekly-podcast-ben-goldacre-bad-pharma

    This is a podcast I subscribe to from The Guardian. It’s an extended interview with Dr Goldacre on Bad Pharma.

  4. elburto says:

    I agree with the others. This is a terrifying, flabbergasting book. My reading of it was punctuated with so many gasps and muttered profanities that my partner is now reading it out of sheer curiosity!

    Congratulations to Ben Goldacre on striking gold yet again. A truly talented man.

  5. The very first time I heard of SBM was on “Bad Science book” that I bought when I was on Scotland. That inspired me to study about clinical trials, basic science and philosophy. Most of people don’t realize how they are fooled every day because of their lack of this kind of knowledge…

    I don’t really understand why the book is available on Uk but not in USA. That don’t make any sense, since both use english and kindle format.

  6. Robb says:

    It will be published in the US in January 2013 by Faber and Faber.

  7. mho says:

    Being a cancer patient, I dread the publication of this book. I so wish these ideas could be discussed other than through the popular press–since that same press has failed totally in presenting the science and the need for urgent action on climate change. That press has failed to give us accurate financial information, accurate political information, accurate military information . . .and so on.

    The number of patients in my local support group who are using herbs and vitamins and crushed-up-whatevers has tripled. New, for profit hospitals charge MEDICAID patients $3 co-pays for chemotherapy, but they build acupuncture rooms, give away ginger candies and hire art therapists in the cancer clinic.

    However useful it will be as a critique, the sCAM believers will use this book as a pitchfork of fear to drive throngs of ill-informed consumers to their quasi-relgious belief system and away from real medicine–some of which has saved many lives and improved the quality of life for millions.

  8. James Coyne says:

    I managed to get advanced copy of this book on Amazon via an Irish bookstore. It’s fantastic, and if anything, Ben Goldacre pulls his punches when exposing how Pharma hides data and manipulates perception of the efficacy and safety of drugs.,

    Case in point: early in the book Goldacre describes how Pharmacia/Upjohn successfully marketed reboxetine has safe and effective, when it had suppressed data that showed there was neither. This much of the story Goldacre got right. However, what he doesn’t say is that this drug company enlisted gadfly psychiatrist David Healy to promote reboxetine as safer and more effective than SSRIs. Healy conducted the dubious Normal Volunteers study with a handful of his his clinic staff serving as research participants. He claimed that a number of them became suicidal when switch from reboxetine to an SSRI. The article was published without any conflict of interest disclosure. The odds ratio for the link between SSRIs in suicidality in this study is absurdly high.

    http://davidhealy.org/wp-content/uploads/2012/05/2000-Healy-Healthy-Volunteer-Suicide.pdf

    Goldacre is far too cozy with uncritical of David Healy and got defensive when I posted on Twitter my account of David Healy and reboxetine. You can read it here.

    https://dl.dropbox.com/u/23608059/martyrdom%20of%20healy.pdf

    Although not perfect, Bad Pharma is still a damn good book.

  9. geo says:

    Even when a trial’s protocols are published in advance, researchers can still choose to abandon the outcome measures which they had laid out there, and come up with more flattering alternatives. In the UK a group of researchers are fighting against Freedom of Information requests for the outcomes of a trial of behavioural interventions which was funded by public money: http://www.whatdotheyknow.com/request/pace_trial_recovery_rates_and_po

    It seems to me that many of Goldacre’s concerns are even more problematic for psychosocial interventions where things like blinding and the accurate measuring of meaningful outcomes are often much more difficult, even for researchers unaffected by any bias or self-interest.

  10. BillyJoe says:

    mho,

    “However useful it will be as a critique, the sCAM believers will use this book as a pitchfork of fear to drive throngs of ill-informed consumers to their quasi-relgious belief system and away from real medicine–some of which has saved many lives and improved the quality of life for millions.”

    I do hope you are not suggesting that the truth be suppressed because if its supposed adverse consequences.

    Besides, it’s unknown what the consequences might be. It might actually result in a complete revamp of the pharmaceutical industry’s marketing arm. And a more ethical pharmaceutical inductry could result in a further marginalising of sCAM.

    It is hardly ever bad move to tell the truth.

  11. MarcusGP says:

    mho, BillyJoe:

    I really can´t see supressing information as being the right way forward here. Mainly because the entire SCAM/Conventional-thing is a useless division (well, not in law). What we need to know is what works, and shoddy trials and literature should be exposed and picked to pieces no matter where it might come from.

    As to the effects on the SCAM-community, I very much doubt anything will change most of their minds. THey´re already throwing around their conspiranoia, and all information like this does is show that the EBM and sceptic communities actually take fraud in the medical industry seriously. In addition it can be a handy way of introducing critical thinking to true believers.
    I had a fellow student who was an acupuncturer and aromatherapist, and who “hated” big pharma and homeopathy (why on earth she chose our profession I´ll never know). I avoided the acupuncture for some time, feeding her with non-conspiranoia criticism of the pharmaceutical industry and gave her information on trials of homeopathy. It only took a term before she was coming to me asking why on earth I hadn´t shown her that acupuncture was bunk, and that her attacks on BP had been misguided. But of course, she was one of very few exceptions in my experience.

  12. jmcohen87 says:

    I’m glad to see that SBM isn’t ONLY bashing alternative medicine.

  13. My bottom-line approach is, it’s the substance that matters, and if it’s not something that is meant to be in our bodies without harm, then, it matters little what clinical trials say, which is what pharmas have gotten more and more away from. It’s “the dose of the poison” was said long before modern meds ventured into all kinds of foreign unnatural substances that were never meant for human consumption. This was said recently on another site…Carletta Casey (Atlantic, Iowa) says:
    October 13, 2012 at 11:12 am

    This is totally unacceptable. I have worked in the health care field for over
    50 years, and back in the 1950′s a drug was tested for 15+ years before put on the market. As years passed the years shortened and now it is out of the
    factory today and tomorrow people are the “testors” not rats or guinea pigs.
    This is ludicrous and must stop. We need to make a statement to congress, who
    by the way get paid to “look the other way”!!!!

    Sorry, to be redundant, but, I just wanted to say also, it’s nice to see SBM actually bringing this out in topic! I wasn’t coming back for a while to give you all and myself a rest :) but, just thought I’d mention this here :)

  14. Harriet Hall says:

    @jmcohen87,

    “I’m glad to see that SBM isn’t ONLY bashing alternative medicine.”

    You could have seen that a long time ago. In fact, my post from 3 days ago doesn’t mention anything about alternative medicine, and there are many, many other examples. We “bash” anything that is not good science, wherever we find it. It’s just that we find so much more of it in CAM!

    Another point: there is less need to criticize mainstream medicine because it is already self-critical: the studies I cited in my article were all from mainstream medical journals. There is more of a need for criticism of CAM because it doesn’t criticize itself.

  15. weing says:

    This book is about valid criticisms of big pharma. Addressing these will improve medical care.

    “now it is out of the factory today and tomorrow people are the “testors” not rats or guinea pigs.” etc. illustrates ignorant criticism.

  16. How is that ‘ignorant criticism’ weing? Just going by the results of meds put out.. the bad effects, lawsuits, deaths, along with other side effects… the short time they’re created, packaged and sold on to the public without effective testing, how is that not valad criticism? Sorry, didn’t want to get into this ;) so if I don’t respond, please don’t think I’m ignoring..see you all hopefully another time :)

  17. BillyJoe says:

    …and, of course, we should pay very close attention to what Carlette Casey says because, you know, it’s anecdotal personal experience and that’s the most reliable evidence ever don’t you know. :D

  18. Harriet Hall says:

    “if it’s not something that is meant to be in our bodies without harm, then, it matters little what clinical trials say”

    Question: are antibiotics meant to be in our bodies without harm? If Rusty’s child were dying of bacterial pneumonia, would she reject antibiotics? If she accepted them, would it matter which one had been shown superior by clinical trials?

  19. Ahriman says:

    I’ve had more than one person lately justify to me the use of acupuncture or CAM generally by pointing to Goldacre’s book. It’s been very helpful to turn around and show that this blog is supportive of criticizing bad science whether in the CAM world or in medical research. It always takes the other person by surprise.

    As has been pointed out, it is simply false to say that CAM works, because these problems exist in the pharmaceutical industry. Or vice-versa. One does not imply the other, even though otherwise very intelligent people that are dedicated to science and truth will seemingly make that leap with very little consideration as to what they are claiming.

    I think it is incredibly important not to compromise ourselves by ever insinuating for a moment that the practice of medical research and the ways of the pharmaceutical industry are without fault. If we do, we commit a similar error to the one I described above, i.e. because CAM is quackery, then medical science is always a clear, unbiased and effective system for the treatment of patients. There are gaps in our knowledge not just because we haven’t made certain scientific discoveries yet. They exist, because of the less than ideal cultural and economic settings in which real practical medical science takes place.

    That doesn’t mean that we give up on science-based medicine any more than it means that we turn to CAM for “cures” when medical science offers none. But I think people like to fit everything within a nice, neat narrative of “how the world works” when the world is simply messy and sometimes there are no good answers, at least not in the present moment.

  20. Narad says:

    How is that ‘ignorant criticism’ weing?

    I’m not weing, but the assertion that “back in the 1950′s a drug was tested for 15+ years before put on the market” is nonsensical. The polio vaccine took about three years from initial testing to rollout. Mycostatin, about four years from isolation to production.

  21. BillyJoe says:

    Sorry, Narad, Carlette Casey said it is true on that cute little blog RH referenced, so that’s the end of the matter. You just haven’t got into the headspace of the congenial CAM consumer yet.
    I bet you don’t even know what a rose smells like.

  22. Narad says:

    I bet you don’t even know what a rose smells like.

    I assure you that I’ve used too much rose in a sherbet in just the past couple of months.

    Oh, and Enovid looks to have taken about two and a half years.

  23. mho says:

    agreed–truth should not be supressed.

  24. Calli Arcale says:

    Though it might not seem relevant, I’ve recently read this lecture by Admiral Gehman at the US Naval Academy and been seeing applications all over the place. Read it. You will not regret it. His central thesis is that organizations may perceive threats, and then people will (not always consciously) act to mitigate those threats, and a wise person understands this and tries to avoid pushing organizations into doing that. He’s specifically talking about how organizational problems can lead to tragedies (specifically, the USS Cole bombing and the loss of the Space Shuttle Columbia), but the lesson has much broader application, I think.

    http://www.usna.edu/ethics/publications/documents/GehmanPg1-28_Final.pdf

    Think of it this way. If you are working for a pharmaceutical corporation, and you know there is this big effort to make this amazing, blockbuster drug, and your data is suggesting that maybe it’s not all it’s cracked up to be, what will you do? Your data may represent a threat to your department. Will you do what, years later, will seem to be the right thing, and tell people? Or do you do what might seem like the right thing now, and keep digging until the data stops looking like a problem? That’s more or less what he describes NASA doing with the information that foam shedding had very nearly destroyed Atlantis on ascent, two flights before Columbia’s final flight, when it missed a critical electronics box on an SRB by just a foot. That should’ve been a “ground the fleet” finding, but somehow good engineers who consider the astronauts family gradually massaged it until it became an acceptable anomaly rather than the very narrow escape from disaster that it actually was. If it happened there, it can happen in any organization. Normalizing anomalies so they go away and stop being a threat to your organization. I’m sure it happens in clinical trials too.

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