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Letters to the Editor
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Statins
Best interests of patients, not influence from pharmaceutical industry
From Dr S. Jarvis, FRCGP
Our article on statin use distributed with The Journal of 20 January
makes it abundantly clear that simvastatin should be the first line treatment
for all patients. What seems to have aroused
the wrath of so many of your readers (PJ, 3 February, pp129–31) is the suggestion that
any guidance other than National Institute for Health and Clinical Excellence
guidance should be used by health care practitioners. It is implied that
my failure to include reference to either the draft NICE guidance on
secondary prevention of myocardial infarction1 or the circular from Roger
Boyle to NHS clinicians2 is a deliberate attempt to mislead readers.
The explanation is much simpler. I wrote my part of this document before
the publication of either the draft NICE guidance on secondary prevention
of MI, or the circular from Roger Boyle. Had I written it after their
publication, I would, of course, have included both. I would also have
included details of the cost-effectiveness analysis of the “Heart
protection study”, published more recently still,3 which demonstrated
that statin use is cost-effective for a much wider range of patients
than those for whom it is recommended in the UK, even if non-generic
statins are used.
I would have reminded readers that both Dr Boyle’s letter and the
NICE guidance on secondary prevention of MI recommend that doctors in
England and Wales should use guidance which fails to take into account
any evidence less than six years old, including the landmark “Heart
protection study” (which used simvastatin).4
The NICE guidance on statins, published in 2006,5 recommends that statins
should be used for a much wider section of the population than that recommended
by the National Service Framework for Coronary Heart Disease of 2001.6 Thus, the NICE guidance on statins accepts that enough new research on
the effectiveness of statins has emerged since 2001 for the NSF on CHD
to be out of date — yet the draft NICE guidance on secondary prevention
of MI recommends that we continue to work to these outdated guidelines
in some of our highest risk patients.
The replies to the article suggest that the JBS-2 guidance7 is not evidence-based.
Interestingly, its recommendations were drafted before the publication
of the Cholesterol Trialists’ Collaboration meta-analysis of 164
clinical trials,8 which, by showing a clear and predictable
negative correlation between reductions in low density lipoprotein cholesterol
and mortality, provides ample evidence of the continued benefits of lower
cholesterol targets.
In introducing the concept of NICE,9 its chairman Sir Michael Rawlins
outlined the need for a national body to counter, among other problems,
the “too frequent failure to provide patients with optimum care
for the treatment of common diseases”, and the fact that “health
care professionals in the UK are sometimes too slow to introduce effective
new treatments”. Yet the circular from Dr Boyle and the draft NICE
guidance on secondary prevention of MI, in asking us to continue to use
guidance which is six years out of date, are effectively instructing
us to perpetuate, rather than to resolve, these potentially serious deficiencies
in care.
When NICE was introduced it was stipulated that its guidance would be
just that — guidance. This guidance would not be mandatory, and
clinicians would continue to have the freedom to exercise their clinical
judgement based on the best interests of their patients.
I take seriously my duty to use the resources of the NHS efficiently.
I also take seriously my duty to provide my patients with the highest
quality of care. The article was part of my ongoing attempt to reconcile
these two duties. Your readers, however, imply that my failure to work
to national guidelines which I consider, for the reasons above, to be
contrary to the best interests of patients must be motivated by undue
influence from the pharmaceutical industry. I find such accusations offensive
in the extreme.
Sarah Jarvis
Richford Gate Primary Care Centre
London
References
1. NICE
clinical guideline in development: MI: secondary prevention
2. Boyle R. National policy on statin prescribing. London: Department
of Health; 2006.
3. Heart Protection Study Collaborative. Lifetime cost effectiveness
of simvastatin in a range of risk groups and age groups derived from
a randomised trial of 20 536 people. BMJ 2006;333:1145.
4. Heart Protection Study Collaborative Group. MRC/BHF heart protection
study of cholesterol lowering with simvastatin in 20,536 high-risk individuals:
a randomised placebo-controlled trial. Lancet 2002;360:7–22.
5. National Institute
for Health and Clinical Excellence. Statins for the prevention of cardiovascular
events. NICE technology Appraisal 94.
London: NICE; 2006.
6. Department of Health. National Service framework for Coronary heart
Disease. London: The Department; 2001.
7. JBS 2: Joint British Societies’ guidelines on prevention of
cardiovascular disease in clinical practice. Heart 2005; 91:1–52.
8. Cholesterol Treatment Trialists’ (CTT) Collaborators. Efficacy
and safety of cholesterol-lowering treatment: prospective meta-analysis
of data from 90,056 participants in 14 randomised trials of statins.
Lancet 2005;366:1267–78.
9. Rawlins M. In pursuit of quality: the National Institute for Clinical
Excellence. Lancet 1999;353:1079–82.
Making the most of NHS resources
From Mr N. J. Wicks, MRPharmS
In response to the correspondence in last week’s Journal (3 February,
pp129–31), I would like to add my comments to those of Sarah
Jarvis (above). First, throughout our document we advocated simvastatin as the
first-line initiation therapy. This was based on a low acquisition cost.
Secondly we acknowledged that there were different sets of guidance that
could influence the lipid levels to which prescribers may wish to treat.
Indeed I need look no further than my own health board to see one part
of the NHS which has decided to set the lower target of 4mmol/L for total
cholesterol.1
Following on from this we went on to discuss the budget impact, using simvastatin
first line, of treating to reach either the 5mmol/L or 4mmol/L total cholesterol
levels. This discussion was aimed at making the most of NHS resources should
patients fail to reach either target using simvastatin. I do not believe
the comments of your correspondents reflected these points but sought to
stifle debate by suggesting that we had tried to pass the document off
as something it clearly was not.
The issuing of guidelines by anyone, be they the NHS or professional bodies,
are exactly that — guidelines. Indeed we can expect to see the latest
set of guidelines from the Scottish Intercollegiate Guidelines Network
issued this week. No doubt these will further serve to inform decisions
on how best to deploy NHS resources.
Noel Wicks
Community Pharmacist
Larbert,
Stirlingshire
Reference
1. Forth
Valley Formulary, November 2006 |
The
Pharmaceutical Journal