Letter from David Dickinson, to the Clerk
of the Committee (PI 127)
I am writing to you as Clerk of the Committee
because my attention has been drawn to proceedings last year of
the 3rd Health Committee session taking evidence on the influence
of the pharmaceutical industry. Evidence about the quality of
patient information leaflets and consent information sheets was
given, and I understand that Mr Hinchliffe challenged witnesses
to provide a leaflet so that it could be understood by all patients,
suggesting that an example might be submitted at a later date.
I wanted to reassure the Committee that effort
does go into making documents user-friendly; to show that there
is some good practice in the UK (which leads Europe in this field);
and to demonstrate that it is possible to produce information
that puts complex truths in simple language and helps ordinary
people to make sensible everyday judgements about risk.
We may not quite have achieved a universal leaflet,
but I and my colleagues (in particular Suzy Gallina and Jane Teather)
have worked hard over the last few years to make patient information
more accessible, and I annex the resulting model of a patient-friendly
patient information leaflet, based on aggregating more than 250
interviews with patients.
We are an information design consultancy, working
with both patients and the pharmaceutical industry to improve
the quality and user-friendliness of patient information. In fact
it was we who worked with the British offshoot of Novartis, to
modify their clinical trial information sheetscited in
evidence to the Committee by Dr Richard Nicholsonso that
their consent documents are now something that patients want to
read, and taken up by the regulators in their templates.
Although the model leaflet is recognisably similar
to current leaflets, it is better designed, more clearly worded
and closely focused on four areas which patients consistently
express concern: what the medicine does, the dos and don't of
taking it, how to take it, and clear information on side effects
(including how likely they are and how serious they are). It does
not quite meet the regulatory requirements as they are currently
drafted, since the relevant legal guidance does not quite allow
such a conversational style.
7 February 2005