Social Audit Ltd P O Box 111 London NW1 8XG Telephone/Fax 44 (0)171 586 7771 [email protected] http://www.socialaudit.org.uk
|C W Kelly, Permanent Secretary|
|Department of Health|
|Richmond House, Whitehall,|
|London SW1A 2NS||
22 September 1999
Dear Mr Kelly,
Many thanks for your letter of 27 August. I'm sorry not to have replied sooner, but I have been away for the past three weeks. I also wanted to wait until I'd had a chance to see the Ombudsman's report.
I appreciate your writing and of course accept the Department's apologies for the delay that arose in handling our requests for information. I'm sure you would have wanted it otherwise, and also accept that the MCA was acting in good faith in consulting members of the CSM before disclosure.
The exchange of some 150 letters over two years clearly makes this a frustrating experience for all parties concerned. Indeed, it would have been to the advantage of the CSM/MCA to have released much sooner some of the information that has now been disclosed, because it does them credit.
But I also think this case illustrates problems beyond the scope of the Ombudsman's report. These relate to: 1. The role of the Committee on Safety of Medicines; 2. The management of the Medicines Control Agency; 3. The safety of antidepressant and other drugs; and 4. The sustainability of the medicines control system and the relationship between medicine and health. The evidence on our website points to real big problems. The gist is this:
1. The main significance of the 16 months delay is surely what is says about the sensitivity of conflict of interest issues for the CSM. The reluctance to disclose suggest that commercial pressures are indeed huge, even if the MCA/CSM should be congratulated for the efforts they makes to avoid rank abuse. This case otherwise reveals the CSM's very marginal leadership role in the medicines control system - halfway between bishop and pawn - and this seems very disappointing.
The CSM emerges as an almost uniquely unaccountable quango. Far from being some stalwart, independent, competent guardian of the public interest - as people have been led to believe - the CSM "provides advice to the licensing authority" (Ombudsman, para 3). If on top of this, the CSM is not prepared to allow its scientific standards to be fairly challenged, and baulks even at the prospect of disclosure to Citizen's Charter standards, it has no credible claim to a leadership role in the control system.
2. The long delays cannot possibly be explained in terms of the wheels of due process turning too slowly. The scores of letters that passed between the MCA and us are overwhelmingly the product of a clash of two obsessions - one with secrecy, the other disclosure. This case illustrates much more than the MCA/CSM's zealous determination to enforce tight anti-disclosure laws. It reveals a system deeply out of touch with the public and apparently oblivious to its ineptness in communication. The MCA appears to have little grasp of the fundamentals of public relations and has real problems distinguishing between the trees and the wood; its letters repeatedly reveal the triumph of tired process over good common sense.
I'm still wondering why no-one thought to suggest a meeting or even pick up the telephone, when it could have saved reams of paper and months of tiresome work. Some of the points made in the enclosed memorandum1 from disaffected MCA staff reinforces my instincts to think in terms of cock-up rather than conspiracy - though I wish I could discount the thought that long delays suited the pharmaceutical companies and that they pay the MCA's bills.
3. Social Audit's complaint to Ombudsman came nowhere near resolving the substantive issues - namely that SSRI antidepressants are not only far less specific and effective than claimed, but also carry far greater risks. An important reason for this is the MCA/CSM's reliance on lack of evidence of harm as a prime indicator of safety, its tolerance of scientifically unacceptable evidence, and reference to alien standards and definitions which the public (and many doctors) are bound to misunderstand. For all the secrecy, obfuscation and double-talk, there clearly is a problem of therapeutic dependence with antidepressants, to compare with benzodiazepine tranquillisers. The fact is that many people find it extremely hard to stop taking these drugs, therefore many will get stuck on them. The nub of the problem is rotten communication - starting with so called "warnings", formally approved by the MCA/CSM, which barely describe some serious side effects quite likely to arise. The problem is nicely illustrated in the attached short report from the Chief Pharmacist at the Maudsley Hospital, published in the current issue of Open Mind.
I hope this will help you to understand why I think the CSM/MCA response to this problem is lamentable. Yes, they did go to a lot of trouble making enquiries - but never quite the right enquiries and not directly of users, only to ranking members of the cartel. The quality of warnings shows the CSM/MCA to be remote from the public it claims to serve, incapable of keeping their eye on the ball. The net result will be that a lot of people end up feeling very ill and very let down - all the more worrying because history is repeating itself yet again.
4. The impact of new technologies and of commercial, national and supranational interests have transformed the cultures of medicine and health - yet the present medicines control system fails to meet even some of the main challenges recognised by the Sainsbury Committee, over 30 years ago. What is essentially a steam-age control system cannot be adequate now that medicine has something analogous to nuclear power in its hands. Nor is the present system much to rely on when medicine is becoming increasingly guided by commercial imperatives, some of which have clearly damaging impacts on personal and public health.
I pursued this complaint to the Ombudsman not because of the delay or any frustration, but because I am convinced that medicine translates as health only when it operates within a framework of honest science and decent democratic values. The starting point in developing a better system - something more fit for our grandchildren - has to be control of the abuse of secrecy. In my experience in this case and in many others, secrecy makes medicine dangerous: it inhibits essential feedback and constructive criticism and the opportunity to learn from mistakes. It encourages ignorance and lack of understanding, obstructs effective public participation, promotes excessive and damaging dependence on medicines and leads to profound lack of confidence and trust.
Thank you again for writing and for considering these wider points.
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