|Social Audit Ltd|
|P O Box 111 London NW1 8XG|
|Telephone/Fax 44 (0)171 586 7771|
|Mr Roy Alder, Head of Executive Support|
|Medicines Control Agency|
|Market Towers, 1 Nine Elms Lane|
|London SW8 5NQ||
27 September 1998
Dear Mr Alder,
Thank you for your letter of 8 September, responding to my 8 August enquiry about the relationship between the MCA and CSM. I appreciated the rapid response, though the information provided covers old ground and steers grindingly clear of the point. The point was to ask about the CSM's evasion of public accountability, and to question why it is thought to be in the public interest. I can't see that it is.
1. Open, honest communication has to be a sine qua non, if the Committee is to honour its terms: "to give advice with respect to safety, quality or efficacy" of medicines and "to promote the collection and investigation of information relating to adverse reactions for the purpose of establishing such advice to be given".
Your letter, incidentally, says something rather different. You wrote that the CSM "advises the Licensing Authority on questions of safety, quality or efficacy of new medicines for human use." I can find no reference to these restrictions in Section 4 of the Medicines Act. I thought the CSM could offer drug safety advice to anyone, and about new medicines or old (subject to s118, discussed below). Have I missed something?
2. "It is our aim that the Commission should become in due course the accepted source of information on all matters concerning the use of medicines". This is how the Sainsbury Committee envisaged the CSM (as a sub-committee of the Medicines Commission) - as a powerhouse, an interface between the bureaucracy and the real world which would become a real driving force for good medicine. Over 30 years later, the CSM seems to cower at the prospect of openness, cannot accept even the modest discipline of a voluntary Code on disclosure as does its secretariat, and has no policy on disclosure of its own. Given the rituals of self-congratulation, I feel angry as well as sad that this original vision has been corrupted to such an extent.
Again I draw a distinction between what your letter said (and didn't), and what came from the horse's mouth. You wrote that the CSM actions "are covered" by s118 - but then so are yours or mine. What Professor Rawlins actually wrote on 3 July was that that the Committee's "arrangements for disclosure are determined by s118 of the Medicines Act" (emphasis added) - as if to suggest that that its refusals to disclose were properly justified by law. In the light of the Chairman's professed personal reservations about s118, why is the CSM deferring so readily to an omnibus secrecy clause (s118) as its guiding principle on communication?
The only sense I can make of the CSM's present posture is that it is invoking the especially pernicious s118(b) of the act - and seeking to justify this discretionary, blanket secrecy by not disclosing "any information obtained by or furnished to (them which) was made in pursuance of this Act." As this covers virtually everything the CSM does, it occurs to me that we might just be playing this preposterous game of hide-and-seek because the CSM is relying on this appalling piece of law. How else could they credibly claim unchallengable power to say absolutely nothing if they don't want to? Promise me this isn't happening.
3. For all the solemn regard to the public interest, and expressions of proper compliance with statute and clause, the MCA/CSM does seem capricious and self-serving when it comes to the crunch. Thus, Professor Rawlins was quite happy to give me a summary lecture on the merit of the Montgomery & Dunbar study, but immediate pleads exemptions when asked to explain what on earth he means. Then, when the point is further pressed, the MCA decides - as if magnanimously - to make an exception, and to treat the matter as a Code request after all (your letter of 11 September). The CSM refuses to answer straight questions on the grounds it is not bound by the Code but then, to spare them embarrassment, the MCA wheels out the Code to use as a vehicle for providing answers which fall disgracefully short of the honest scientific assessment I was seeking - and am still due.
Your letter makes legalistic distinctions between the CSM and MCA, which do not in any way explain the justification for the present state of affairs. The MCA/CSM are integral and interdependent parts of the medicines control system, two sides of the same coin. I shall continue to question why one part of the system is subject to some sort of discipline of disclosure, the other transparently unaccountable.
This is not a Code request, but our website is of course available for any comments on these points that the MCA/CSM may wish to make. I hope I'm not barking up the wrong tree here, and rely on you to tell me if you think I am. Thank you for your other two letters (8 and 11 September); I'll reply to these soon.
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