E-DRUG: Lancet: Medicines out of Control?
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[Lancet's book review of this "must read" book about the uneasy triangle of pharmaceutical industry, drug regulators and patients. Thanks to Andy for spotting. Copied as fair use. WB]
http://www.thelancet.com/journal/vol363/iss9427/full/llan.363.9427.dissecting_room.30053.1
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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