Select Committee on Health Appendices to the Minutes of Evidence

Attachment 6

Copy of a letter dated 4 April 2001 from the Editor, Drug and Therapeutics Bulletin to Chair, the National Institute for Clinical Excellence


  I am writing in response to your letter to me dated 29 January 2001; please accept my apologies for the inordinate delay in replying. Almost all of the points you raise were dealt with in our report to the Institute which we delivered on 15 February and which I expect you will have read (I enclose a copy just in case it slipped by). The particular issue I want to address now is your concern about the way in which I conducted myself. You felt that I was too hasty and acted in such a way that might unfairly prejudice the conclusion of a definitive Drug and Therapeutics Bulletin (DTB) article.

  I was contacted by Nick Timmins of the Financial Times immediately he received a copy of the NICE Guidance on zanamivir. He faxed me a copy which I read but made no immediate comment, preferring to discuss the Guidance with my colleagues at DTB at our regular Wednesday editors meeting the next day. You will be aware that DTB had reviewed zanamivir almost a year earlier so we knew much of the data and the surrounding issues. We discussed NICE's position in detail and felt that on the evidence provided in the Guidance there was no compelling reason for us to change our mind as to the value of the drug. I contacted Nick Timmins to tell him of our view and this was reported the next day. It was easy for us to reach our conclusion. On face value:

    —  the data on reduction in antibiotic usage was not statistically significant;

    —  there was no evidence of reduced hospital admission or mortality;

    —  the advice conflicted with important material in the Summary of Product Characteristics and the recommendations on how to use Patient Group Directions, and seemed to ignore recent evidence from the USA on unwanted respiratory effects in patients with lung disease; and

    —  on the basis of our conclusion earlier, symptom-shortening by one day was not sufficient alone to advise the drug's usage.

  With this in mind, we felt that until we had the full report there was no other position available to us. I would imagine you would expect readers generally to read the advice and make up their mind—which is exactly what we did.

  Some four weeks later we received, and closely read, the full assessment and nothing it contained was sufficient to overturn our, albeit internal, position. An article for DTB was then drafted and went through the same procedures as usual (except that I relinquished overall editorial responsibility to my deputy Ike Iheanacho) and the final article was published in February. As it turned out there was no reason for others or me at the DTB to change our minds. However, had there been convincing evidence to the contrary, I can assure you we would have. I have never been afraid of changing my mind when new persuasive evidence has emerged, and often some would see this as to my detriment (you will be well aware that I did so about membership of the NICE Guidelines Committee). Moreover, I believe that others recognise that this is how I behave.

  Be that as it may, I feel the zanamivir issue has raised some very important issues and imagine that, whatever the immediate difficulties, ultimately the NHS will be the stronger for the debate.

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