Social Audit Ltd
P O Box 111 London NW1 8XG
Telephone/Fax 44 (0)171 586 7771
socialaudit@gn.apc.org   http://www.socialaudit.org.uk

 

Mr. Roy Alder, Head of Executive Support
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

12 May 2000

Dear Mr Alder,

RE: DIRECT TO CONSUMER ADVERTISING

Thank you for your letter of 20 April in response to my requests of 14 and 25 February for information about the MCA's thinking on Direct-To-Consumer-Advertising (DTCA).

Please would you let me know on what date, earlier this year, the Medicines Commission requested the MCA "to highlight the issues surrounding DTC". I should also like to know the date on which the MCA's report was completed and sent to the Medicines Commission, and whether or not they have yet discussed it, or scheduled it for discussion and, if so, when?

Could you please also let me know if the Medicines Commission made a written request asking the MCA for information about DTCA and/or whether the request arose from any minuted discussion in a meeting of the Medicines Commission? If it was either, please supply a copy of the precise terms of the request to the MCA to prepare this report. I ask partly because an invitation "to highlight the issues surrounding DTC" sounds very much like something murmured in a corridor, even over a sherry. It also made me wonder if the proposal to look into DTCA in fact came from the MCA itself.

I do not mean to be personal, but should also like to know the qualifications or position of the principal author of the report prepared for the Medicines' Commission. It's not that I equate seniority with better performance. I certainly don't. It's just that I want to get some idea of how seriously and in what depth this issue is being considered.

Apropos of this, please could you also let me know whether or not the principal author in any way consulted consumer or patient interests in preparing this report? If so, which bodies were consulted, and why was Social Audit not?

Perhaps you would also let me know whether or not the MCA report specifically suggested that any sort of public consultation might usefully inform the Medicines Commission's deliberations?

Your letter said nothing about the scope or content of the MCA report, only that it contained no cost estimates and no conclusions. Please would you let me know whether the report addressed any of the following questions/topics and, if so, which. If all else fails, even a 'yes' or 'no' response would be helpful:

1. The relevance of the precautionary principle in deciding whether or not to permit DTCA: where and to what extent should the burden of proof lie in establishing either substantial evidence of the health benefits of DTCA and/or in providing sufficient evidence to exclude the possibility of harm?

2. The adequacy or not of the presently available evidence relating to the risks, benefits and costs - and/or the need for any further research?

3. The nature and extent of the influence of the international pharmaceutical industry in promoting the introduction of DTCA in Europe and beyond, and in informing the debate about benefits, risks and costs?

4. The extent to which the NHS might be able to meet the increased demand likely to result from increased volumes and frequency of product and "disease awareness" advertising, on target and non-target audiences?

5. The likely effect of DTCA in promoting (or not) effective and appropriate drug use - taking into account the influence in this respect of drug advertising and promotion to health professionals?

6. The extent to which DTCA might promote inappropriate intervention over non-intervention, use of drug therapies over possibly better alternatives, and/or less effective (including cost-effective) medical treatments?

7. The likely effects of DTCA on people's health - taking into account the possibility of unnecessary concern over their state of health, their perception of health and health needs and their dependence on health-care providers?

8. The possibility that DTCA might give some unfair competitive advantage to major multinationals, at the expense of smaller companies and national producers?

9. The probable impact of DTCA on production and use of generic drugs?

10. The likely overall effect of DTCA on product prices and national drug budgets?

11. The range of indirect effects of DTCA on health - including its influence on the dependence of consumer and patient groups on commercial funding, and the editorial independence of the press and media, and their coverage of health issues?

12. The extent to which experience in the USA (since DTCA began in earnest in 1997) might be relevant to its impact in the UK, given the commitment in the USA to private rather than public health?

13. The relevance of US experience, taking into account also the unusual range of protections available in the USA, such as rigorous law enforcement by the FDA, freedom of information laws which guarantee much more openness than in the UK/EU, and opportunities for redress and other consumer rights?

I fear it may irk you to see all these questions, not to mention the forthcoming request for yet another internal MCA review, but I think you will also understand that I have no alternative but to ask. Any time anyone from the MCA wants to discuss matters intelligibly, they have only to pick up the telephone. I've been waiting for nearly three years and am quite prepared to wait another three, relying in the meantime on your considerable patience, appetite for process, and gift for meticulous imprecision.

We do request an internal MCA review and, if appropriate, would definitely seek a referral to the Ombudsman. Moreover, any appeal to the Ombudsman would be based not simply on an alleged breach of the Code, but on substantial evidence of diminished leadership in upholding its spirit, and of conspicuously awful organisational public relations. Meanwhile, the grounds on which we request an internal appeal are as follows:

1. The MCA seeks exemption from disclosure merely on the grounds that this was "internal opinion, advice, recommendation, consultation and deliberation". These are not, on their own, sufficient grounds for withholding information - and we've been here before. To justify non-disclosure, the MCA has to be clear that this is "information whose disclosure would harm the frankness and candour of internal discussion". No evidence of the possibility of harm is given.

2. Nor is any evidence offered that "any harm or prejudice arising from disclosure is outweighed by the public interest in making information available". We have been here before too. See Guidance on Interpretation: "In those categories which refer to harm or prejudice, the presumption remains that information should be disclosed unless the harm likely to arise from disclosure would outweigh the public interest in making the information available" … "In each case the harm that would arise from disclosure should be weighed against the public interest in making the information available …" and "there is less need for confidentiality … where the availability of the assessment will enhance public debate and understanding of an issue …"

3. The exemption claimed by the MCA rests, in part, on the assumption that the Medicines Commission may give advice to Ministers. However, our request for information should in no way inhibit the Medicines' Commission's deliberations, and the document prepared by the MCA for the Medicines Commission would be far removed from such advice, since it lacked conclusions and served only to "highlight the issues surrounding DTC".

4. Given the topicality of this issue and the blanket nature of the exemptions claimed, the response to this letter could and should have been more prompt - but was, typically, way beyond the time limits proposed in the Code. The terms in which Mr Bagwell wrote on 16 March suggest, at best, that he appreciates that endless apologies for delay can become exceedingly tedious.

5. No attempt was made to describe the scope or focus of the MCA report, nor to justify not doing so. Even if non-disclosure of the whole report were justified, the decision not to identify any shred of it, after a two-month delay, seems questionable, if not absurd.

6. The MCA reply failed to mention that it is represented in the EC working group on this issue, though I made it clear "I would be grateful for any information you are able to provide".

7. The MCA failed to respond to my request for "citations to any data not generated by the MCA/CSM, but on which it relies"

8. Notwithstanding a succession of refusals to disclose requested information to Social Audit, over the past 2-3 years - and the consistency of findings on appeal that its secretiveness is unjustified - the MCA has again failed to uphold the aim of the Code of Practice: "to improve policy-making and the democratic process by extending access to the facts and analyses which provide the basis for the consideration of proposed policy."

As the relevant European Commission working party convened to discuss DTCA and related issues has already had its first meeting, you will appreciate there is now some urgency behind this request. In the circumstances, I hope you will feel able to respond in the very near future. Thank you for your attention; I look forward to hearing from you.

Yours sincerely,
Charles Medawar

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List of correspondence with MCA/CSM