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J R Soc Med. 2004 July; 97(7): 355–356.
PMCID: PMC1079538

Medicines out of Control

It is easy to imagine—towards the end of the present century—some intellectual descendent of Roy Porter writing a history of medicine in the twentieth century in which the great epidemic of mental distress and chronic unhappiness that characterizes our age will loom very large indeed. But it will also be a puzzle. How did depression and anxiety come to be such a burden on their sufferers, and to make such demands on health services worldwide? In Medicines Out of Control: Antidepressants and the Conspiracy of Goodwill,1 Charles Medawar and Anita Hardon provide an unashamedly partisan account of this history, focusing in particular on a ‘drug crisis in the making’ and an ‘unhealthy dependence on corporate and professional power’. These can be found in the struggles over the nature of depression, the potential for its treatment, and the complex relationship between the great pharmaceutical companies, the medical profession and the various regulatory agencies. Medawar and Hardon's version of these events will make some people in these institutions very angry indeed.

The rise of depression and the antidepressants, the medicalization of everyday mental distress and the iatrogenic consequences of these processes have been dealt with in cooler and more balanced histories of psychiatry and psychiatric illness. For the critics, antidepressants were discovered before the disease of depression was invented in its modern form, and in the second half of the twentieth century the notion of depression and anxiety was steadily extended by the great pharmaceutical companies and their associated clinical researchers to include a plethora of subjective states that were not previously regarded as illnesses at all. Against this view stand those who argue that the invention of antidepressants met the previously unmet needs of many people who suffered chronic mental distress and greatly improved their lives, and that these needs were legitimated by the development of new disease categories. Medawar and Hardon take the first of these views, but in covering the well-worn ground in some detail they also focus on issues of recent political and professional significance. Sadly, they do so unevenly, shifting from partisan to well-argued cases, and from disinterested history to contemporary polemic. The book would have benefited from the attention of a ruthless editor.

To my mind, neither the unevenness nor the unabashed political purpose of the book undermines its call to think hard and clearly about certain aspects of what Edward Shorter has called the Age of Prozac.2 First, there is the question of dependence on prescription drugs. Therapeutic dependence on benzodiazepines has long been recognized.

Selective serotonin receptor inhibitors (SSRIs) were perceived as avoiding these iatrogenic effects; but this, according to Medawar and Hardon, was partly because a redefinition of dependence in DSM IV meant that ‘with-drawal’ symptoms alone no longer permitted such a diagnosis; instead, a new diagnostic category of ‘discontinuation symptoms’ was pushed by the pharmaceutical companies and their associated clinical researchers. At a stroke, ‘therapeutic dependence’ lost its legitimacy and, in the US, its legal standing. Medawar and Hardon summarize this issue in a typically assertive way, declaring that,

‘The 1990s saw “depression” formally redefined as serotonin-deficiency disease and the scourge of millions—a convenient, seductive, and deeply simplistic view. The term, drug “dependence” was redefined, to propose that loss of autonomy could never arise in a therapeutic setting, but only when the behaviour of patients signalled abuse’ (p. 214).

So, concerns about dependence induction and other potential iatrogenic effects of antidepressants have been circumvented—lost to the redefinition of dependence in DSM IV, and to the power of large corporations to control knowledge and shape understanding of their products and the circumstances in which they are used. This hypothesis is further developed by an account of the political contests over other iatrogenic consequences of SSRIs, notably the suggestion that they may have been implicated in the suicides of some people treated with them. Medawar and Hardon are caustic about what they see as the failures of the pharmaceutical industry, drug regulators and clinical communities to respond adequately to this issue. Their version of events is edged with conspiracy theory, and the book is run through with references to ‘big Pharma’ and ‘the powers that be’. Neither of these notions is sufficiently exacting to account for the experiences of Dr David Healy3—whose unhappy encounters with the pharmaceutical industry and its clinical collaborators have been widely reported. In retreading this important ground, Medicines out of Control draws attention to allegations that the pharmaceutical companies have sought to undermine those who threaten their hegemony.

Beyond the mysterious ‘conspiracy of goodwill’ that has formed the antidepressant era, Medawar and Hardon raise important questions about regulation of drugs. Before a drug is introduced, regulators demand controlled clinical trials (on carefully selected homogeneous samples); but, once a drug is widely in service, they fail to engage in systematic monitoring of what happens in everyday clinical practice, with ‘real’ patients. It is this argument, and the way it is subsequently developed, that is the most interesting part of the book. Many of us know little about how drug regulation and surveillance are organized in Britain, because information about these processes is so restricted. Medawar and Hardon tell us important things about how the ‘yellow card’ system of reporting adverse drug reactions works in practice, and about deficiencies that make the monitoring of pharmaceuticals in everyday service unsystematic at best and accidental at worst. They also tell us how these doors can be, if not completely opened, at least kept ajar. There is a second story, about how Medawar and others sought safety information about the SSRIs from the Medicines Control Agency and elsewhere, and how they engaged in contests about its disclosure. They were able to do this because they were assembling other kinds of data that gave them a handle on the dimensions of a problem. Through the internet, they were collecting the accounts of a very large number of people who had observed or suffered ills that they associated with SSRIs. This kind of ‘evidence’ is troublesome for medicine because it is ‘anecdotal’ and lacks the kind of objective structure that fits with population studies and trials, but it is powerful evidence for those beyond the clinical and research communities. Just lately, campaigners on this issue have won a considerable victory, in that patients experiencing unexpected side-effects from a medicine will be enabled to report them directly to the Medicines and Healthcare products Regulatory Agency; but Medawar remains discontent, believing that the scheme should not be run by the drug-licensing agency.4

The print-run of Medicines Out of Control was small, and the authors express a desire for ‘peer review’ of its central arguments. The current version will be followed in 2005 by a popular work for a general readership. This will almost certainly lead to wider public debate and controversy. An important part of the story in this book is the way in which ordinary ‘service users’ have come to take a vocal interest in their treatment and what it means to them. Indeed, the second half can be read as an account of what can now be achieved by way of consumer engagement through the web. It offers some compelling lessons about the power of this medium. Finally, unencumbered by the bureaucratic embrace of the Department of Health's Research Governance Framework for Health and Social Care and the EU Trials Directive, and without having to meet conditions set by NHS Trust R&D governance leads or local research ethics committees, Charles Medawar and Social Audit Ltd can collect whatever data they want and use it how they please. An implicit and important lesson of this book is therefore about the power of the internet to gather and build data that can be converted into political momentum; and how, for NHS and university based researchers, opportunities for innovative and critical research on the provision of healthcare may become more politically restricted.

References

1. Medawar C, Hardon A. Medicines Out of Control: Antidepressants and the Conspiracy of Goodwill. Amsterdam: Aksant Academic Publishers/New York: Transaction, 2004. [258 pp; ISBN 90-5260-134 8 (p/b); £22]
2. Shorter E. A History of Psychiatry: From the Era of the Asylum to the Age of Prozac. New York: John Wiley, 1997
3. Schafer A. Biomedical conflicts of interest: a defence of the sequestration thesis—learning from the cases of Nancy Olivieri and David Healy. J Med Ethics 2004;30: 8-20 [PMC free article] [PubMed]
4. Boseley S. Patients get the right to report drug side-effects. GuardianMay 2004: 7

Articles from Journal of the Royal Society of Medicine are provided here courtesy of Royal Society of Medicine Press