APPENDIX 13
Letter from the Chief Executive, National
Institute for Clinical Excellence to the Chairman for the Committee
(NC 62B)
Further to Mr McShane's request for copies of
correspondence referred to at the Select Committee hearing, we
have prepared the following chronology together with a supporting
statement, which I hope the Committee will find helpful.
Chronology
The Institute's revised guidance on zanamivir
was issued on 21 November 2000.
1. On 23 November 2000 the Financial Times published
an article on the NICE guidance in which the Editor of the D&TB
is quoted as stating, on the 22 November, that "the bulletin
would not be changing its mind" ie it would not be recommending
zanamivir (two pages). [attachment 1]
2. In December 2000 the D&TB contained "Treatment
Notes" which concluded that it would continue not to recommend
zanamivir (one page). [attachment 2]
3. On 11 January 2001, the Chief Executive of NICE responded
to an invitation to comment on the first circulation draft of
the D&T Bulletin on zanamivir being prepared by the D&TB,
entitled "Why Not Zanamivir?" (one page). [attachment
3]
4. On 26 January 2001, the Technical Editor of the D&TB
faxed Professor Sir Michael Rawlins, enclosing a further draft
of this article (three pages) seeking a response by 30 January
2001. [attachment 4]
5. A response to this letter was sent by Professor Rawlins
to Professor Collier on 29 January 2001 (two page letter). In
this letter Professor Rawlins expressed his surprise at the precipitate
way in which the Editor of the D&TB had reached a conclusion
on the Institute's guidance. That such a conclusion could have
been formed in one day without the full evidence base and confirmed
at an internal D&TB meeting chaired by the Editor the following
day, illustrates one of the differences between the Institute's
approach to considering evidence and the approach adopted by the
D&TB. No conclusions are reached or recommendations formulated
by the Institute without reference to its independent Appraisal
Committee and the organisations with which it is consulting. [attachment
5]
6. It was more than two months before the Editor of the
D&TB responded to Professor Rawlins' letter (two page letter
dated April 2001 + report dated 12 February 2001—10 pages).
[attachment 6]
The Institute had, in the intervening period, decided that
given the responses that had already been made, there was little
point in engaging in further correspondence with the D&TB
on this subject. By the time the Editor's response was received,
the Chairman of the Appraisal Committee, Professor David Barnett,
had accepted an invitation to present the Institute's interpretation
of the evidence on zanamivir, at a meeting of the Royal Society,
on 25 April 2001. It was known that Professor Collier, as Editor
of the D&TB, would also be speaking at that meeting. The Institute
considered that this was an appropriate forum in which the two
interpretations of the evidence should be discussed. A transcript
of Professor Barnett's lecture is available if the committee wishes
to see it.
Having considered all the issues we saw no benefit to patients,
the NHS, ourselves, or the D&TB in engaging in a further public
debate, which would have required the Institute to critique the
D&TB's methodology.
For information, the consultees in the appraisal of zanamivir
are listed below. All these groups had access to the full evidence
base and none of them appealed against the guidance that was eventually
issued to the NHS:
— British Medical Association
— British Geriatrics Society
— British Lung Fundation
— British Society for Antimicrobial Chemotherapy
— British Thoracic Society
— Faculty of Public Health Medicine
— Nationa Asthma Campaign
— Public Health Laboratory Service
— Royal College of General Practitioners
— Royal College of Paediatrics and Child Health
— Glaxo Wellcome Ltd.
I can confirm that we will be submitting a detailed
response to the criticisms of our guidance by the D&TB and
others, early next week.
1 February 2002
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