Thursday, 7 June 2012

Pharmageddon

James Le Fanu

Bitter Pills to Swallow

Pharmageddon
By David Healy (University of California Press 302pp £27.95)

http://www.literaryreview.co.uk/lefanu_06_12.php

The everyday practice of medicine is much the same as ever - diagnosing what is amiss and, with luck, putting it right. But recent years have witnessed, or so it seems to many, a profound shift in the nature of the 'clinical encounter', in favour of doctors staring at their computer screens, filling in protocols, checking everyone's cholesterol levels and showing an almost indecent enthusiasm for prescribing drugs. So it is that in just fifteen years the number of prescriptions issued by doctors in Britain has increased a staggering threefold. It is now not unusual for those in their seventies and beyond to be taking half a dozen different medications.
The driving force, and substantial beneficiary, of this mass medicalisation is of course the pharmaceutical industry, or Big Pharma as it has pejoratively become known. Its devious methods of marketing its drugs has rightly attracted much criticism. David Healy's cleverly titled Pharmageddon captures the moral dimensions of what is at stake. Certainly drug companies, like any investor-owned enterprise, have a fiduciary responsibility to increase their shareholder stock by 'growing the business' and maximising their market share. But, Healy alleges, they have done so by systematically subverting the intellectual apparatus of science and its methods of distinguishing truth from falsehood, thus exposing the sick, and indeed healthy, to the hazards of potent and unnecessary treatments.
That subversion now touches every aspect of medicine, starting with its all-important diagnostic criteria. Big Pharma has redefined the symptomatology of medical conditions in such a way as to expand enormously the market for its drugs. This corruption of the nosology of medicine, as it is obscurely known, takes many forms; Healy's account of the curious metamorphosis of manic depression into bipolar disorder illustrates the process well. The former, a relatively rare condition affecting about ten people in a million of the population, is marked, as we all know, by sharp fluctuations in mood from the depths of despair to (inappropriate) euphoria that may warrant admission to hospital for supervision and treatment. Then in the mid-Nineties manic depression simply dropped off the diagnostic radar, displaced by the more benign and vastly more common 'ups and downs' of bipolar disorder.
Fortuitously, or not, this transition coincided with the rebranding of a new class of tranquilliser drugs as 'mood stabilisers' and prominent 'disease awareness' campaigns encouraging people to consult their doctors about this seemingly ubiquitous disorder. Meanwhile the launch of a flurry of new drug company-sponsored specialist journals (The Journal of Bipolar Disorders, Clinical Approaches in Bipolar Disorders) and professional organisations (the European Bipolar Forum, the International Society for Bipolar Disorders, and so on) conferred a reassuring sense of scientific legitimacy on this new diagnostic formulation. Thus within a decade, Healy notes, one of the most serious of mental illnesses became almost fashionable. The ingenuity, foresight, planning - and financial investment - involved must have been phenomenal but would be amply rewarded as the sales of those mood-stabilising drugs soared upwards, generating annual revenues of billions of pounds.
Still, the practicalities of developing new drugs is notoriously costly and time-consuming, leading to the next logical step in the process of subversion - hijacking the methods for evaluating the efficacy and safety of new treatments. Naively, one might suppose that a drug only receives a product licence following rigorous and independent testing by the gold standard of the controlled clinical trial. And indeed for many years that situation prevailed. But now, as Healy points out, 'Pretty well all the trials that a new drug has to go through for approval are designed, and implemented, by the pharmaceutical companies.' They recruit the investigators, analyse the data, decide what it shows and then arrange for its favourable findings to be written up for publication in a prestigious medical journal.
By itself this tight, almost seamless control of the clinical trial data obviously provides numerous opportunities for portraying drugs to be much more effective than they really are. But it is also indicative of the hegemony that the industry now exerts on the whole medical enterprise, coopting all those institutions - government, the regulatory approaches and the medical profession itself - that might stand in its way.
This is the crux of Pharmageddon that Healy illustrates, drawing on his own personal experience as a professor of psychiatry at Cardiff University. He recounts in considerable detail the almost unbelievable obstacles he encountered in exposing how the antidepressant drug Paxil, claimed in the marketing copy for an article published in a prominent medical journal to show 'REMARKABLE Efficacy and Safety in the treatment of adolescent depression', was in reality associated with a threefold increased risk of suicide compared with those on a comparison antidepressant or on placebo.
The final twist of Big Pharma's stranglehold is its role in determining the clinical guidelines for treating raised cholesterol and blood pressure levels - the single most potent factor in mass medicalisation, requiring millions of people to take drugs indefinitely. The composition of the expert committees drawing up those guidelines, when scrutinised, invariably reveals their close involvement in those drug company-sponsored clinical trials demonstrating their efficacy.
Pharmageddon is a powerful and passionate book. Certainly there is no novelty in being sceptical about the activities of the pharmaceutical industry. But this is the first truly comprehensive account of a web of deceit so skilfully spun that few properly appreciate the gravity of the threat Big Pharma now poses to the nation's health and wellbeing.

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James Le Fanu writes a weekly medical column for the Daily Telegraph. His most recent book is Why Us? (HarperCollins).

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