Select Committee on Health Appendices to the Minutes of Evidence

Attachment 5

Copy of a letter dated 29 January 2001 from the Chairman, National Institute for Clinical Excellence to the Editor, Drug and Therapeutics Bulletin

  I am responding to your fax of 26 January, which was accompanied by a draft version of "Why Not Zanamivir?" I have both general, and specific, comments.

  I have long held the view that the Drug and Therapeutics Bulletin has an important place in British medicine. I have equally been supportive of the arrangements for its provision to doctors in England through public funds. Moreover, I have always accepted that as part of the "checks and balances" of a democracy it is to be expected that the Bulletin will on occasions disagree with conclusions by "official" bodies (such as the Committee on Safety of Medicines and The National Institute for Clinical Excellence). I accept, therefore, however irritated I may be (as a member and chairman of the CSM or as chairman of NICE) I would defend your right to publish your views and will continue to do so.

  Despite all this the way in which you have conducted your recent review of Zanamivir has stretched my liberal instincts close to breaking point. This is not because of what you now propose to say (more of this later) but because of the way in which you have conducted this exercise. Very shortly after NICE's guidance was published and before you had an opportunity to look at all of the data, you informed the media (the Financial Times in particular) that the DTB would not be supporting our advice. You reiterated this in a footnote to the next edition of the DTB. It is only after this that you circulated a draft article for consultation. Do you really expect anyone to believe that, following these public statements, you are now prepared to take an alternative view?

  In response to the article, itself, I have the following points:

  1.  It is unclear as to why "the robustness of the pooled analysis is questionable". Unless the DTB has suddenly decided that meta-analyses or pooled analyses are unjustifiable I can see no reason for your statement.

  2.  The fact that Zanamivir shortens the duration of influenza symptoms in at risk patients is evidence that is has biological activity. A comparison of Zanamivir with established symptomatic treatment is not the issue.

  3.  Whether or not "complications requiring antibiotics" are a reliable proxy measure of serious outcomes is a matter of scientific judgement. You might like to reflect on the difficulties of conducting a study that looks at deaths as an end-point. In the case of influenza immunisation, however, I should remind you that very few of these have ever demonstrated reduction in hospitalisation or death. And, as you will be aware, those that are currently used have only been shown to be immunogenic. Nevertheless, we encourage the use of influenza immunisation in very large numbers of people.

  4.  The fact that the current SPC for Zanamivir suggests that the drug has unproven efficacy in at-risk patients does not take into account the more recent evidence available to the Institute.

  5.  The Institute is well aware of the advice from the NHS Executive about including antimicrobials in a Patient Group Direction. It took this into account when drawing up its advice. It was one of the reasons that the Appraisal Committee endorsed the view that Zanamivir should only be used when influenza is "circulating in the community".

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