How NICE may be outflankedBMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7552.1268 (Published 25 May 2006) Cite this as: BMJ 2006;332:1268
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Response to How NICE may be outflanked (R E Ferner, Sarah E McDowell)
2 June 2006
Ferner and McDowell (How NICE may be outflanked – 27 May 2006) raise
some important points about the influence of interested parties on NICE,
which plays a critical role in the availability of treatments, but let’s
not forget that there is still a post-code lottery of healthcare in the
UK. While it exists, patients and patient groups will rightly continue to
fight for equality of access. As you point out, NICE now has a fast
track approval process – the result of campaigning by patient groups.
I would also like to clarify the context of the quote attributed to
me. My comment that “fast track appraisal of drugs by NICE is to be
welcomed but we need to ensure that once approved, guidance is implemented
fully and that cancer patients receive the drugs recommended” was used in
this paper to imply that patient groups like Breakthrough view the
licensing and NICE approval of trastuzumab for early stage breast cancer
as a foregone conclusion. My original point, and Breakthrough’s
position, was to welcome the new NICE fast track process, and to highlight
that once any approval for any treatment is given, steps need to be taken
to ensure that the NHS can and does implement guidance. It is important
that patients gain the benefits of these decisions as quickly as possible.
In the case of trastuzumab it is the view of many clinicians, who are
experienced medical professionals, that this particular drug offers
significant potential benefit to some women with breast cancer. Patients
and patient groups would not have felt so passionately about the treatment
if the medical world hadn’t been so excited by it. The effectiveness and
safety of treatments are just as important to patients as to clinical
experts and it is not the case that patient groups try to push for every
new drug that appears on the horizon. Patients understandably want access
to treatments that will potentially benefit both their survival and
quality of life.
Ferner and McDowell might argue that in the ideal world the appraisal
process for new drug treatments would be insulated but we live in the real
world where real people’s lives are directly affected by the decisions
that NICE makes, and these people want to be involved.
Breakthrough Breast Cancer
Competing interests: No competing interests
In their analysis ‘How NICE may be outflanked’ Ferner and McDowell
highlight the direct marketing of product messages via the media1. This is
important but it is obvious, unsophisticated and has begun to attract
Subtler techniques are available. ‘Specialist societies’ and ‘disease
interest groups’ play an important role. These are often dependent on
pharmaceutical sponsorship and their leadership is heavily targeted by the
marketing arm of the drugs industry. The grey market of ‘satellite
symposia’ and ad hoc promotional meetings provides fertile ground where
self interest, disease promotion and marketing combine. Opinion leaders
can be provided with soft research grants, included as investigators in
phase III or IV trials or invited to author ghost written articles.
Specialist societies may nominate them to provide expert submissions to
NICE where discrimination between their personal interests and their
professional interests may be difficult.
‘Guidelines are an ideal vehicle for gaining rapid market
dissemination particularly if they avoid mention of cost altogether”3 and
are well suited for providing a niche for on-patent drugs – the lifeblood
of the pharmaceutical industry. The potential for a positive bias towards
pharmacotherapy with guidelines both based on industry sponsored trials
and written by those who undertake them is considerable. Considerable
interaction between the pharmaceutical industry and authors of clinical
guidelines has been documented4. Specialist society guidelines are still
not invariably accompanied by a clear declaration of the nature or extent
of any relevant conflicts of interest– a quality requirement within the
AGREE Collaboration framework5. Recent cardiovascular guidelines are one
obvious illustration of this reticence. The full and uninhibited
disclosure of conflicts of interest within a recognised framework is
Journal editors are culpable when bypassing peer review through the
publication of industry-sponsored supplements and not rigorously enforcing
disclosure of conflicts of interest in other papers. Journals are
obviously subject to conflicts of interest resulting from advertising
revenue and the desire for large reprint orders that are used for
promotional purposes including those for guideline statements. Ensuring
the integrity of professional guidelines remains a challenge to both the
medical and publishing fraternities.
None of these factors are new. In this context, the establishment of
a process that is open, transparent and accountable is a major step
forwards for the NHS, can only improve the quality of decision making and
encourage a more effective use of resources across the health service –
resources misallocated represent benefits foregone. Specialist groups are
not primarily concerned with the impact of their recommendations for other
parts of the health service or patients in general though this remains an
important consideration for GP’s with their ‘gatekeeper role’. For this
reason, if the NHS is to survive, NICE will have a vital role in ensuring
that the ‘tragedy of the commons’ does not continue to be the tragedy of
the health service.
1. Ferner R E, McDowell S E.
How NICE may be outflanked
2. Schachter M, Wierzbicki A S
Spinning stars: ASTEROID's impact on atherosclerosis
The Lancet 2006; 367:1655-1656
3. Haycox A, Bagust A, Walley T
Clinical guidelines-the hidden costs.
BMJ. 1999 Feb 6;318(7180):391-3.
4. Niteesh K. Choudhry; Henry Thomas Stelfox; Allan S. Detsky
Relationships Between Authors of Clinical Practice Guidelines and the
JAMA 2002 287: 612-617
5. Cluzeau FA, Burgers JS, Brouwers M, et al for the AGREE
Collaboration. Writing Group.
Development and validation of an international appraisal instrument for
assessing the quality of clinical practice guidelines: the AGREE project.
Quality and Safety in Health Care 2003; 12(1): 18-23.
1. Over the past 12 months I have attended advisory boards for Novartis and Pfizer.
2. Over the past 10 years I have attended educational meetings, received travel grants, honoraria for lectures and advisory boards from a number of pharmaceutical companies including AstraZeneca, Bayer, Fournier, GlaxoSmithKline, Pfizer, Merck, MSD and Sanofi-Aventis.
3. I am a member of the British Cardiac Society and Primary Care Cardiovascular Society, and Chair of Cardiovascular Working Group of the South Asian Health Foundation which receive funding from a variety of donors (pharmaceutical and non pharmaceutical).
4. I am Primary Care Section Editor for the International Journal of Clinical Practice.
5. I am an Appraisal Committee Member within NICE and member of 2 NICE guideline development groups.
The opinions expressed in this letter are mine and not in any way intended to represent any of the organisations with which I am affiliated.
Competing interests: No competing interests