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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