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
RE: ZANAMIVIR
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.
|
