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| Medicines out of Control? Antidepressants and the Conspiracy of Goodwill,
July 3, 2004 |
Medicines out of Control? Antidepressants and the Conspiracy of Goodwill
Charles Medawar, Anita Hardon. Amsterdam: Aksant Academic Publishers, 2004. Pp 258. ISBN 9 05260 134 8.
Medicines out of Control? Antidepressants and the Conspiracy of Goodwill is beautifully written, painstakingly researched, thoroughly referenced, powerfully and persuasively argued, and eerily up to date.
The authors, Charles Medawar and Anita Hardon, are established and successful agitators, commentators, and lobbyists on health policy issues, and their co-authorship works wonderfully well. This book tackles the medicines regulatory business, concentrating on how the authorities (especially those in the USA and the UK), and the multinational pharmaceutical companies behaved over the introduction and marketing of the selective serotonin reuptake inhibitor (SSRI) antidepressants.
Using the SSRIs as an exemplar, Medicines out of Control? argues that the relationship between "the pharmas" and the regulatory authorities is far too close; that the pharmas are influential, manipulative and secretive; that they sell their products using unethical methods; that their excesses have become more marked as their profit margins have been threatened by a failure to invent new products; and that US pharmas are influencing the conduct of those elsewhere. It also argues that the regulatory authorities, the one formal defence against the pharmas'
influence, are out of touch, overly secretive, and oblivious to the views of consumers. Moreover, the position of industry and regulators has been reached with the collusion of governments, which have either passively allowed public health to become secondary to the health of industry, or have actively introduced personnel, practices, or legislation that further industry's interests.
Ten years ago, neither the SSRIs nor any other drug class could have served in the same way. Increasingly, patients want more information about their medicines, the public wants details of how multinationals and governments work, the culture of secrecy is being eroded, and information technology permits greater access to data and its easier communication. We also have increasing insights into the regulatory process, the politics of science, and the behaviour of the big multinationals. And by virtue of these very developments, we have unmatched insights into the drugs themselves--about their development, pharmacology, claimed value, and unwanted effects. And all this is set against a background in which regulatory controls are creaking in their antiquity, with attitudes and procedures reflecting more the paternalistic alliances of the 1960s, rather than embracing the inquisitive (and demanding) position of today's society.
Nowhere does Medicines out of Control? touch a more sensitive nerve than when it describes how pharmas and regulators deal with patients and the public. It shows how industry, when it so wishes, creates diseases, promotes ill health, withholds evidence, endangers patients (doses too high), and distorts terminology (using words that obscure ideas of dependence or suicidal ideation in those on SSRIs). It also describes how regulators seem unwilling or unable to do anything about it, as they give little priority to public health. The Medicines Healthcare Regulatory Authority (MHRA), for instance, insists on communicating in "medicalese" when patients are explaining their problems in ordinary language. Ironically, insights into how the MHRA deals with reports of unwanted effects could not have been gained if Medawar, working with his colleague Andrew Herxheimer, had not been given raw data about Yellow Card reports by the MHRA itself. Is this a sign that some in positions of authority want a breakup of the old order?
The problems exposed by this book suggest that in the UK, we cannot go on without an overhaul of the regulatory system, or at the very least, an independent review. Tinkering at the edges is not an option. Nor is it reasonable to ask regulatory authorities to put their own houses in order. Those working in the system are mostly well-meaning and more than competent in their work as they analyse and interpret data at breakneck speed with little time to think. But they are working in an environment that is essentially closed, where the ethos is to be reactive rather than proactive and where there has been no appetite for assessing how their policies affect those they serve. It is also an environment where accountability to industry seems to have a greater priority than responsibility to public health. These problems are compounded because in many respects the authority has taken on the functions of government.
Because regulation is so specialised, democratically accountable Ministers have delegated key decision-making to the regulators, thus ultimately favouring technocracy over democracy.
There are moves afoot to change much in the UK Regulatory Authority, and while they will improve process and might increase transparency, I fear that they will not get to the roots of the problem. It will be interesting to see what the House of Commons Health Select Committee recommends following its forthcoming inquiry on the influence of the pharmas on medicines policy and prescribing practice. Were I asked, I would certainly suggest to the inquiry team that they read Medicines out of Control?, advice I would give unreservedly to everyone interested in this area.
Joe Collier
St George's Hospital Medical School, London, UK
e-mail:jcollier@sghms.ac.uk
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