The madness of Big Pharma

The madness of Big Pharma

http://entertainment.timesonline.co.uk/tol/arts_and_entertainment/the_tls/article6013955.ece

The new enfant terrible of psychiatry and the pharmaceutical companies' abuse of clinical trials
Andrew Scull
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David Healy is the new enfant terrible of psychiatry. Unlike the previous occupant of the role, Thomas Szasz, he has not declared mental illness a myth and attacked psychiatry as a sham and a confidence trick. On the contrary, in company with most of his professional brethren, he asserts that madness is a form of brain disease (though he is more circumspect than some about the nature of that disease). Nor does he reject the primary treatment modalities of modern psychiatry. He has held prominent positions among those promoting and practising cognitive-behavioural therapy, the pragmatic, results-oriented psychotherapy that has largely supplanted the so-called depth psychologies of a now vanished Freudian era. He is an enthusiastic proponent of electroconvulsive therapy (ECT), and he regularly dispenses the miracles of modern psychopharmacology – antipsychotics and antidepressants – in his clinical practice, albeit not so cavalierly and freely as many of his fellow professionals.
Yet he has vaulted to prominence as a fierce critic of standard professional practice; of the role of Big Pharma – the collective name for large pharmaceutical companies – in reconstituting the very terms in which we as a culture understand and respond to mental illness; and of the biobabble that these days has replaced psychobabble as the verbal camouflage for our ignorance about the aetiology of mental illness. Along the way, he has exposed the extraordinary venality of many leading academic psychiatrists; the widespread ghostwriting of what purport to be cutting-edge publications in major journals (apparently produced by eminent scientists but actually concocted by public relations flacks for the pharmaceutical houses); the routine suppression or gross misinterpretation of data on the effects of psychoactive drugs along lines which maximize the profits of the huge multinationals (who thereby extract obscene sums from the sufferings of the mentally ill); the heightened risk of suicide and other untoward events that, perversely, may accompany the ingestion of antidepressants; and the fraudulent “science” on which many contemporary understandings of mental disorder rest. Small wonder that for many Healy has become a professional pariah, and that he plausibly reports being hounded, menaced and attacked by the enormously powerful corporations whose profits he threatens.
Much of Healy’s critique has emerged in a series of books on the history of psychopharmacology, a discipline and an approach to treating mental illness that emerged on the scene only a little more than a half century ago with the introduction of the first “major tranquillizer”, Thorazine. Mania constitutes the latest salvo in his continuing assault on professional sacred cows, and appears as a contribution to a new Johns Hopkins series of biographies of individual diseases. The title of the book is somewhat misleading. Mania was one of the standard varieties of mental disturbance, already recognized by the ancient Greeks. But while the book’s early chapters provide a quick (and not always accurate) survey of developments through the late nineteenth century, Healy’s primary interest and contribution lie elsewhere. His central subject is the emergence over the past century and a little more of the entity we have learnt to call manic-depressive psychosis, or bipolar disorder, a disease (if such it be) that afflicts a large and growing segment of the population from the smallest children to the ranks of the now ageing baby boomers.
Healy contends that “modern authorities on manic-depressive disorder make a gross error when they try to effect a link between modern presentations of a disease they call bipolar disorder and ancient precedents”. On the contrary, “few if any” mental patients in the Western world were held to be suffering from manic-depressive disease before 1920, and in the United States, the epidemic did not begin to emerge until as late as the 1960s, when drug companies began to market the disease. Even more significant, in Healy’s view, was the advent of new imaging technologies from the late 80s onwards (CT scans, MRIs and PET scans), which produced the first images of the brain, first in black and white, and then in “living” (or rather simulated) colour – not, he hastens to add, because these images uncovered the roots of madness, as claims to link dopamine deficiency and schizophrenia, or serotonin and depression, have been thoroughly discredited; but because they were so useful as marketing copy, for selling the public on the notion that mental illness was the product of faulty brain biochemistry.
As Healy duly recognizes, the term “manic depressive psychosis” had been constructed by the late nineteenth-century German psychiatrist Emil Kraepelin. But it existed “more as a foil to dementia praecox [schizophrenia, as it would shortly come to be called] than as a condition developed in its own right”. Dementia praecox (early dementia) was a disease that by definition had an implacable downward course, clinically and cognitively, so a different label was needed for patients who managed to get better. But while the diagnosis of dementia praecox was enthusiastically embraced internationally, its counterpart was largely ignored. If that situation has changed drastically over the past half-century – and most emphatically it has – for Healy that transformation can only be understood in terms of a larger transformation, not just of psychiatry, but of modern medicine more generally.
It was from the 1930s and 40s, on his account, that the change agent emerged, producing shifts in the cognitive, organizational and therapeutic dimensions of modern medicine that have only intensified down to the present – changes that mark a revolution at least as profound as the advent of germ theory in the late nineteenth century. It was the discovery of the sulphonamides, and then of penicillin and other antibiotics, mass produced by chemical companies that then set up pharmaceutical subsidiaries, that ushered in a brave new world of commercialized therapeutics, one increasingly dominated and controlled by a multinational industry now made up of “the most profitable corporations on the planet”. And among the largest and most profitable territories farmed by Big Pharma has been the treatment of an ever-expanding array of mental disorders, and creation of an ever-larger population of mental patients taking their magic potions.
The first chemical weapon to be tried for the treatment of mania in the modern era was in many ways an exception to this pattern, for it used an existing salt that no one could patent or use to make obscene profits. An Australian psychiatrist, John Cade, claimed in 1949 that lithium carbonate had a specific anti-manic action. It was an assertion that was largely ignored, until it was taken up by a Danish psychiatrist, Mogens Schou, nearly two decades later. Healy provides an entertaining and sobering account of the vicious disputes that then emerged between Schou and Michael Shepherd at the Institute of Psychiatry in London, centring on Shepherd’s contention that the enthusiasm for lithium was a therapeutic bubble, the product of poorly designed clinical trials. Controlled studies, he insisted, would soon puncture the bubble.
For Shepherd, the Randomized Controlled Trial, or RCT, was a method par excellence for curbing therapeutic enthusiasms (the sorts of enthusiasms that had earlier led psychiatrists to pursue surgical evisceration, frontal lobotomies and insulin comas as cures for psychosis). And so we have all been brought up to believe. Healy will have none of it. The “lithium wars”, as he calls them, accomplished one very important change: the rise of the concept of “mood stabilization” and its link to the notion of securing this altered state by chemical means. As the tide of enthusiasm for lithium receded – the original American lithium clinic, at Columbia University, closed its doors in 1995 – a host of designer chemicals from the drug companies began to flood the marketplace. Mood disorders had become highly profitable. These drugs all had “evidence-based medicine” behind them, an array of RCTs that purported to show their significant effects in bringing disturbances of affect under medical control.
Statistical significance has a very different meaning from clinical significance, of course, though it is a distinction the marketing departments do their best to obscure. Besides, Healy argues, by far the largest source of improvement in the clinical trials of these drugs is attributable to the placebo effect, the drugs themselves contributing but small marginal increments to this effect, and at the cost of major side effects. In fact, “in any sample of ten patients, with drugs like the mood stabilizers, the clinical trial data suggest one responds to the drug while nine do not”.
Yet even were one to accept this sobering line of argument, one would have missed a still larger set of problems associated with chemical “cures”. For Healy goes on to describe how Big Pharma has captured almost total control over the research process, to say nothing of buying up academic experts and turning them into marketing shills. It is drug companies that assemble, pay for and manage large-scale clinical trials. They own the data, and they use and manipulate them for their own purposes, suppressing damaging information wholesale, massaging outcomes and manufacturing new “diseases” whose primary function is to serve as marketing vehicles for new varieties of psychotropic pills. With an ever-expanding array of problems being medicalized and added to psychiatry’s Diagnostic and Statistical Manual, “diseases have all but become commodities and are as subject to fashions as other commodities, with the main determinant of the fashion cycle being the patent life of a drug”. Big Pharma controls the trials, and controls the reporting of the trial results. In consequence, instead of serving as a check on therapeutic enthusiasms, “RCTs have become the primary marketing tools of pharmaceutical companies. They are the fuel that powers bandwagons, helped by the fact that company trials in which the drug fails to beat the placebo commonly do not see the light of day”.
Except when there are lawsuits. Class action lawsuits in the United States, with their elaborate pre-trial discovery process, have done something to bring unsavoury drug company practices into the light of day, and to bring forth some of the suppressed data. Increased risk of suicide, of diabetes and other metabolic disorders, of massive weight gain, of the reduction of life expectancy, and the existence of an array of trials where drugs had no discernible therapeutic effect – these are just some of the findings belatedly beginning to surface. And then there is the buying up of academic talent – payments in the hundreds of thousands of dollars, even the millions, to “opinion leaders” to promote off-label uses of a whole spectrum of pills – consultation fees, free trips to desirable locales, to say nothing of the increased flow of research dollars to particular laboratories that reliably report the findings their commercial masters are seeking. Futilely, universities and academic journals have put in place requirements that researchers disclose the financial interests that might contaminate their findings, only to find such rules flouted, with minimal consequences for the offenders.
What particularly arouses Healy’s ire is the manufacture of bipolar disorder among infants. Cocktails of drugs are given to children as young as one or two. Diagnostic criteria are relaxed to allow more and more children into the mix. Foundations are established for parents of such children to assemble and lobby on behalf of fixing the alleged biochemical imbalances that produce their children’s misbehaviour. Stories of epidemics of teenage depression are planted in the mass media. Rating scales are manipulated, and used to demonstrate that the pills have behavioural effects – something it is difficult not to demonstrate. Meantime, the sequestering of data allows a situation where the published scientific literature is all too often at odds with what the scientific data themselves would show, were they actually allowed into the public arena.
Mania ends with a series of pessimistic pronouncements. In studies of psychotropic drugs, “the publicly available data are close to worthless”. We do know, however, that “the quality of life of patients in whom treatment is deferred or not instituted is better than those treated immediately”; and that, “uniquely among major illnesses in the Western world, the life expectancy for patients with serious mental illness has declined”. Big Pharma “increasingly appears to jeopardize the health and well-being of our friends, relatives, and children” in its manic pursuit of profit (a phenomenon that afflicts – as Healy rightly notes – all of medicine, not just the benighted psychiatric borderlands). And it observes no ethical limits, ruthlessly extending its grasp to include the youngest and most vulnerable, even though “giving major tranquilizers to children is little different from giving children cancer chemotherapy when they have a cold”. David Healy is indeed an enfant terrible – and a very brave man. Either way, he can expect a lot of hate mail. I doubt he is on Eli Lilly’s or Pfizer’s Christmas card list.


David HealyMANIAA short history of bipolar disorder320pp. Johns Hopkins University Press. $24.95; distributed in the UK by Wiley. £16.50.978 0 8018 8822 9


Andrew Scull’s new book, Hysteria: The biography is due to appear in the autumn. He has written widely on the history of Anglo-American psychiatry.