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The Drug Pushers (2012)

by Ben Goldacre(Favorite Author)

4.07 of 5 Votes: 4

ISBN

0771036299 (ISBN13: 9780771036293)

languge

English

genre

Nonfiction

publisher

McClelland & Stewart

review 1: I was walking around Notting Hill with my buddy Elias, who runs a biotech company. “How’s work?” I asked, as one does. He disappeared for a second in the famous bookstore from the Hugh Grant movie and emerged with this thick tome.“Read this and then we can talk,” he said.The book is a full-on attack on the pharmaceutical industry. No part of it escapesThe author starts with testing. In short, negative trials (the kind that say a new treatment did not work) disappear more often than they don’t. This is horrible on a number of levels: 1. It’s like rolling the dice a thousand times but only discussing the five hundred best outcomes. The result won’t be representative. 2. People who participate in trials and risk their health to do so deserve better. 3. ... morePeople who might participate in a similar trial in the future really really deserve better. Ben Goldacre was not the first to think that this is a problem, and manifold “cures” have been sought/recommended to the problem: medical journals have committed to only publish papers if they can prove they did not “gag” negative results; patients could be warned ahead of participation that the results of the experiment conducted on them might be gagged (though this avenue has not been pursued); professional bodies and regulators have committed to the dissemination of data. The author proves that in practice none of the promises are being kept. He gives names and addresses. If he was wrong about the slightest fact he’d be in jail now. The bottom line is that the pharmaceutical companies carry on with this practice because “he who pays the piper calls the tune” but also because the regulators are both “captured” and highly secretive by nature. He leaves out a further reason I once read about in another book called “Reasonable Rx,” namely that pharmaceutical companies would not under any circumstances want to prevent their competition from going down the same blind alley they just did. But of course, given how combative the author is and given how many times he points the finger at specific companies he cannot include this criticism, since it is an unprovable allegation.From the “gagging of negative results” problem he then moves on to the horror of the “Stage 1,” “Stage 2” and “Stage 3” trials that bring a molecule from its discovery to the point where regulatory approval (FDA approval in the US) is first sought. Stage 1 is the business of trying a new drug on people who get paid something like twice the minimum wage to subject themselves to the new molecule. At this stage the point is merely to find if the drug is harmful, not to see if it cures anything. The book describes these awful communities of people for whom this can be their sole profession, who more often than not have no medical cover if something goes wrong and who sign their life away before participating, though this is still an improvement on the previous prevalent practice of conducting these tests in jails. Famous criminal Whitey Bulger was exposed to LSD this way, I seem to recall...The next two stages are about finding out about how the body absorbs the drug, if it does what it’s meant to do with sensible dosage, and of course if it is effective. Oh, and increasingly many of these trials now take place in super-poor countries around the world, among populations that not only should never be our guinea pigs, but might actually differ significantly in how they absorb drugs. My wife’s from Japan and I’ll tell you her body absorbs alcohol very differently than mine does. CROs (Clinical Research Organizations) are described in some detail too. These are the companies that conduct the trials. Once upon a time it was universities, but these days it’s private companies, who are in the business of selling the results to the pharmaceutical industry. No bonus points for guessing what their incentives are. The laundry list of dirty tricks used in trials by these industry-dependent CROs is breathtaking. Outright fraud aside (which happens a lot) the tools of the trade include 1. testing on ideal, super-healthy patients, rather than real-world patients who will be often carrying other ailments 2. benchmarking against wrong dosage in the alternative treatment 3. benchmarking against invasive procedures such as surgery over too short a period of time, which will always favour the drug 4. carrying on with catastrophic trials in case they turn 5. trials that are merely large enough to prove something is better than placebo masquerading as trials that are big enough to prove a drug is better than another existing drug, 6. again, typically small trials that are not truly trialling anything and are just marketing ploys to get doctors to prescribe a drug, 7. bundling of outcomes in a way that highlights improvements in the extreme rather than the average 8. scratching from the outcome what happened to patients who dropped out of the trial (when in reality this behaviour can be a good predictor of patients subsequently dropping a drug) if that makes the result look better 9. fishing in the data of failed trials to find out if the drug worked on a (by definition, not statistically big enough) subgroup and, most insidiously, 10. changing your mind ex-post on what you were looking to cure. Every trick comes with an example from real life. This is a veritable catalogue of largely legal but ethically highly objectionable behaviour, and if you are remotely human you will be enraged to read about it. And if one small detail was wrong, Ben Goldacre would be serving hard time.Regulators also come under the microscope and they don’t scrub up too good either. Quite often, the burden of proof they impose on new drugs is that they must merely beat a placebo rather than the currently “best in class” drug. Head-to-head tests are as rare as hen’s teeth. Mankind today actually has no idea what the best statin is, for example; no pharmaceutical company has an incentive to run one and no regulator has ever done the work to find out, a fact that statistically speaking has led to millions of premature deaths. That is not to say there’s no room for multiple drugs. There is, since the statistically most effective drug may have side effects that don’t work for all patients. Regardless, you would have thought there’s a duty to establish what the most effective drug is. It’s clearly not how the regulators see it. Not only that, but regulators allow most new drugs to come to market after proving they can improve a “surrogate outcome” like the cholesterol count, rather than the outcomes that matter like smaller likelihood of heart attack, for example. In many situations that’s the best we can do, of course, but there are circumstances and illnesses where the burden of proof should be much higher. We also find out about the abusive practices of the industry, which drives drugs through the “accelerated approval” loophole that was carved out for very specific situations. Again, all of these arguments are made with concrete examples of drugs. The discussion in this book is NEVER theoretical, it’s always via example. Names and addresses. And the accusation against the regulators can be summed up as follows: on every issue they are happy with relentless drift toward the lowest common denominator: placebo vs. head-to-head, surrogate outcomes vs. real outcomes and accelerated approval for drugs where we really ought to wait.The least surprising but longest and most salacious part of the book is to do with marketing. The author goes quickly over the horrors of direct advertising of drugs to consumers, the websites and fake surveys that invite us to click on to discover if we’re suffering, for example, from anxiety etc. etc. and lists tons of studies that prove direct marketing is financially effective and fundamentally wrong, but saves himself for two biggies: the armies of sales reps who have woven themselves into the fabric of the medical industry and the fabrication of company sponsored “research.” The sales reps bit is easy to understand. It’s a bit how bond brokers take me out to dinner, and I love it. Though of course I would never dream of dealing with them more next morning , needless to say. It’s just the other guys who do that. My mom believes me, even if you don’t. The research bit is chilling. Bottom line, pharmaceutical companies plant most research in periodicals. They employ armies of authors to write the stuff ahead of the launch of new drugs (first a barrage of articles about some new ailment that affects tons of people, then a barrage of articles about promising new medicines) and then literally hire academics to put their name on the ghostwritten research. This is more insidious than it sounds, because academics benefit doubly from having their name attached to research. If you only ever sign stuff you wrote you are in unfair competition for promotion, recognition etc. with other doctors who are happy to sign stuff that was ghostwritten for them by a pharmaceutical company. You obviously miss out on the money too, but that’s the lesser of your problems. Journals turn a blind eye to this, because all the ads they carry are for drugs, of course. There’s nobody watching out here. Again, Ben Goldacre lists names and addresses, none of this stuff has come off the top of his head.Bottom line, marketing is 25% of the costs of a pharmaceutical company, research is half of that and the rest is to do with actually making and distributing the drugs! The author complains that marketing not only is unethical; it also adds a 33% to the price of medicine!The book closes with a long list of proposals; summarising solutions the author has been proposing to the specific problems in every chapter. For example, the NHS has the means to tarck true-world outcomes (not surrogate outcomes) on true-world (non-ideal, superhealthy) patients and has a moral duty to do so, though obviously it needs to overcome the issue of personal data.He even suggests we start with a South-African style general amnesty, subsequent to which we need to go back and find all the missing studies, find out what data we can collect from existing sources and figure out what tests we urgently need to run. And since it’s the second edition I read, the proposals are followed by a long afterword that lists progress on the proposals which actually sounds quite heartening.That said, it’s INCENTIVES people respond to, and this Ben Goldacre does not address. The world of pharmaceuticals and medicine needs its incentives to be restructured, or else it’s difficult to see how we don’t drift back to where we started, and all this after the miscreants have bagged the amnesty!I must say that after reading this book I can see where the authors of “Reasonable Rx” were coming from when they recommended that the industry be split in two, namely companies that only develop drugs and companies that only market them. But I still hate their recommendation that a government-supported agency should stand in the middle. It’s not easy, that’s for sure.And now I know a tiny bit more about what was on my friend Elias’ mind that day in Notting Hill…
review 2: I'm a doctor, so I'm very used to thinking about treatments, weighing up the pros and cons, discussing them with my patients, and generally being rather cynical about how drugs get to the market. I've also been involved in some research studies, including those that Goldacre detests the most; those that fail at the first hurdle and get halted because of negative results. There's no doubt that Goldacre is well-intentioned and no one should accuse him of writing Bad Pharma for self-aggrandisement, but there's just a limit to the number of times one can bear repetition of the same words, phrases and message. By the time I finished even the first 20%, I felt beaten around the head by his nerdy text. And that's a shame, because he has a story and an important message, but frankly, I think there are better ways of getting the message across to those who should take action. It's a bit like that psychology experiment where you expose rats (or people) to increasing amounts of stress: a moderate amount helps learning and recall; above that, rats (and people) simply want to curl up and die...or slip out for a pint. That's just how I felt. Sorry, Ben, but I'd be happy to buy you a beer any time. less

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