Wednesday, October 24, 2012

Book Notes: Bad Pharma by Ben Goldacre

Ben Goldacre, who's newspaper column and book "Bad Science" has done so much to expose myth posing as science; has now turned his attention to the pharmaceutical industry. While his previous works have mentioned pharmaceuticals many times (he is after all, by trade, a medical doctor), "Bad Pharma" is his book-length expose of what he believes is wrong in this multi-billion dollar global industry. The results are quite shocking.

The basic thesis of the book is that the prescribing of drugs that takes place in clinics and hospitals is based on faulty evidence, and so is untrustworthy. The body of literature, of published peer-reviewed research, which are reviewed to produce drug liscencing and prescribing formularies has been (by a legion of distortions) systematically skewed by the trade in order to protect their profits and make their products appear to be more beneficial and less harmful than transparently fair trials could ever claim.

A major chunk of the book is given over to the problem of "missing data". That is the practice of simply hushing-up any trial result that does not produce a commercially beneficial result. The flip side of that is the selection of odd bits of trial data that look good (weird anomalies, or from unrepresentative sub-groups) and publishing just this data as if it were a whole trial. Goldacre explains and exposes this practice, with some poignant examples. He also demonstrates the ways in which this problem has been identified but not addressed by governments and regulators. Promises to open-up future research are, he argues, totally inadequate - as prescribing practice is based on the whole body of published research, accumulated over a few decades. He is demanding that drug companies, and regulators immediately release the results of all unpublished trials...

The rest of the book follows the steps a drug must go through in order to become licensed, marketed, and finally prescribed by doctors and then swallowed by us. These include research articles getting published in journals, regulators assessing the published evidence and issuing guidelines, and the process of marketing to doctors (and patients where countries permit this). What Goldacre alarmingly demonstrates is that the smallest distortions and biases at each stage of this process produce outcomes which are far-from the evidence-based prescribing to which all the Drs I know aspire and strive. So, journals funded by advertising from drug companies, or even owned by them, allow misrepresentations and publish selectively. New drugs which "work" gain headline status and influence prescribing, while serious head-to-head trials to demonstrate which is best are neglected. Regulators, say Goldacre, set the bar too low for approving medicines - in many cases only demanding that they beat placebo in trials, not demanding that they represent any advance on previous medicines. The scam of almost identical drugs being manufactured in order to basically renew copyright on older products is exposed; as is the manipulation of both doctors and patients through the billions spent on "marketing" products and "educating" doctors. Goldacre comprehensively explains these processes and how they should work, demonstrates the ways in which they have been distorted, and suggests ways in which these can be corrected. So, for example, he suggests that GP's do not allow drug-reps into their buildings as evidence shows that despite the rules and best intentions in practice they demonstrably influence prescribing.

Most disturbingly in all this, Goldacre shows that these distortions to process, openness and proper regulation have not simply kept doctors and patients in the dark; not even merely allowed us to be recipients of "less than best" medicines, not merely cost health services unnecessary millions; but in several documented cases have actually caused harm. One example involves a pain killer which had an unfortunate side effect (unusual numbers of people taking it died), the drug company knew this - but buried the research for years until the product was withdrawn.

At each of these stages, Goldacre shows that various governments, politicians and industry whistle-blowers have identified the problems he describes, and attempted to fix them. To cite one example; in theory all trials should be published now - whether or not the results suit the industry. However - he continues by showing that these 'fixes' have been illusory, the data-bases of trials being conducted are hopeless, and there is no effective policing of the industry to enforce compliance, he argues. At each stage, he shows that while the problems he highlights are recognised across the world; the fixes in place are failing.

One of the most extraordinary things has been the reaction to the book from the industry. A spokesman from  the Bristish Pharmaceutical Industry issued a rebuttal of the book which was demonstrated primarily that he hadn't actually read it. Goldacre in at least three instances anticipates the industry excuses, and answers them in detail; only for the industry just to trot them out as if they were convincing and final. So for instance, Goldacre details some of the huge fines levied on Glaxo-Smith-Kline in the USA for malpractice. He goes onto show that they are a British based company, whose drugs, practises and personnel involved in the American scandal are involved in, and affect their European operations; arguing that it is no-use for GSK to say in the UK that the American situation was nothing to do with them. So - when they pop and say, "nothing to do with us" they are using an excuse which has not only been anticipated but answered.

It is clear that if even half of what Ben Goldacre has so meticulously documented here is true - then there is a huge scandal as big or bigger than the banking crisis going on all around us every day. This isn't an ideological rant against big-business- this concerns the health and well-being of anyone who takes medicines and whether they can do so with confidence that the chemicals they are putting in their bodies really are the best treatment for them; or whether the choice of what  drug they are taking has actually shaped by selective or mis-information, advertising budgets, dubious education programmes for doctors, all undetected by poor and secretive regulation. Frankly, the pill I have to take every morning for a minor stomach-complaint: to what extent has my long term well-being been in tension with the share-price of its manufacturer, and to what extent has the flow of information from lab to journal to regulator to doctor been distorted by that tension?

Bad Pharma suffers in places from being over-long, and is a little repetitive in places. These flaws should not stop anyone from getting it, and being appalled. Goldacre suggests various responses that should be made, which are directed at researchers, drug companies, doctors, regulators and us patients too. Many of these are no more than robustly enforcing the kind of regulation which has long-been promised but never delivered.  The most urgent call for the public though is to start campaigning for an end to the scandal of missing data. That means, not to promise to details all future trials and publish all results; but to release all the hidden data from the buried trials which skew the systematic reviews of research on which prescribing formularies are based. It seems clear to me that the only way that the industry can prove that it has nothing to hide, is to hide nothing. 

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