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Letters to the Editor
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The Journal
A marketing wolf in sheep's clothing
From Mr J. Durodie, MRPharmS
On receiving The Pharmaceutical Journal of 20 January I was initially
pleased to see that the PJ was sending out information about National
Institute for Health and Clinical Excellence recommendations for statins.
On reading the document, I became seriously concerned at The Journal’s
decision to send out what was clearly little more than a thinly veiled
marketing brochure under the more “acceptable” title of “The
new NICE guidance on the use of statins”, highly suggestive of
an official document, perhaps even provided by NICE itself or even the
Department of Health.
Let me pick out just a few points of concern.
While the cover page recognises the support by AstraZeneca this could
reasonably be just for the cost of printing. There appears, however,
to be a distinct silence when it comes to the authors and their potentially
conflicting interests and affiliations.
The section on the UK cholesterol story lays things out chronologically
and “conveniently” ends with the JBS II data noting in the
last paragraph that these are the “recommended targets”.
Indeed, the table below is titled “The evidence from guidelines”.
JBS II guidelines are not accepted guidelines for the NHS (at present,
at least) and the authors of the JBS II document actually comment themselves,
early in their report, that the suggested targets are not evidence-based,
but just a suggestion that may be worth considering.
The above is even more disturbing when in the last section extolling
the role of the community pharmacist it is stated that “medication
reviews provide the ideal opportunity to pick up on those patients not
reaching the JBS II targets (of … <4 … and <2mmol/L)”.
These are not the recognised evidence-based targets that the NHS is working
to, nor have they been recognised by NICE (as the leaflet title innocently
suggests). Where, for example, in the leaflet is the reference to Roger
Boyle’s recent letter to all NHS clinicians about cholesterol targets?
This is embarrassingly absent and yet this is what we should be working
to.
On a number of occasions, notably in the summary, it is quoted that there
may be clinical justification for selecting another drug (ie, rosuvastatin,
presumably) where there is “likelihood of failure to reach target
levels”. Again I have to disapprove: another statin might be clinically
relevant where there has been failure to reach targets (dependent on
overall CV risk, risk:benefit ratio for the patient, etc), but certainly
not if there is simply “likelihood” of failure. How could
a patient be assessed for “likelihood” of failure?
The material presented in this rather innocent and nearly official-looking
leaflet is presumably substantially based on the ASTEROID study, for
which there was no control group, no patient-oriented outcomes (morbidity
and/or mortality data), using a high dose statin (above that recommended
for routine practice). And all this on a drug that still has “black
triangle” status.
This publication amounts to little more than a marketing ploy which The
Journal appears content to send out without even the slightest note to
point out that marketing it is. Presumably the PJ is happy to condone
the use of non-evidence based medicines and targets in the face of the
DoH, the government’s cardiovascular disease tsar and NICE, thus
encouraging the undermining of sound work undertaken over many years
by pharmacists in many fields of practice, not least primary care.
I find this apparent lack of care for the profession in the provision
of such materials highly concerning. If I wanted to apply this sort of
data to my daily work I need only look as far as the tabloids.
J. Durodie
Surrey Primary Care Trust
Credibility bestowed that may not be deserved
From Mr A. White, MRPharmS
I am aware that revenue from advertising is essential for the maintenance
of most published journals. For The Pharmaceutical Journal this is an
issue since most advertising is for vacant positions. As many jobs are
now only advertised internally, this will have an inevitable impact on
the revenue of the PJ.
I was disappointed to find the inevitable consequence of this need for
revenue drop from the wrapper on 20 January. Two publications, MeReC
Extra and a document supported by AstraZeneca, were markedly different
in their content.
The MeReC document was brief and informative, and focused on the recent
confirmation of national policy on statin prescribing and a new campaign1 which is focused on achieving the fairly modest national target of 70
per cent generic statin prescribing. If implemented this initiative could
save the NHS at least £85m annually, which could be reinvested
in patient care.
The AZ-supported document, which is entitled “The new NICE guidance
on the use of statins in practice — considerations for implementation”,
focuses on the ability of rosuvastatin to achieve JBS II and EAS guidelines,
which are neither national policy nor proven to reduce patient-oriented
outcomes (POOs), such as reduction in myocardial infarction, stroke or
death. JBS II recognises this in its own guidance: “There are no
clinical trials which have evaluated the relative and absolute benefits
of cholesterol lowering to different total and LDL-cholesterol targets
in relation to clinical events.”2 The document does not mention
that NICE will be publishing its own guidance on lipid lowering in December
2007.3 It also fails to acknowledge the draft NICE post-MI guidance,4 for those patients at highest risk of further vascular event, has chosen
to use 5 and 3mmol/L as the target lipid levels.
The health economic data are somewhat irrelevant if one considers that
LDL-C reductions with rosuvastatin have not yet been proven to be indicative
of reductions in POOs. However if one accepts the cost per percentage
LDL-C reduction is valid and relevant, it is important to point out what
the authors did not illustrate, namely that generic simvastatin at 40mg
and 80mg would cost 9.5p and 26.3p, respectively, compared with 39p and
47p for the cheapest doses of rosuvastatin and atorvastatin (a drug which
has POO evidence), respectively.
So, logically, the most cost-effective drug is simvastatin 40mg that
will get a 37 per cent reduction in LDL. This is certainly sufficient
for primary prevention patients and provided the patient’s LDL-C
is below 3 should be sufficient for most secondary prevention patients.
One should then discuss with the patient the relative benefits of aiming
for ever lower targets as many are not convinced of their merit.5
It pleases me that The Journal distributes such well produced and referenced
inserts like MeReC publications, yet it concerns me that by distributing
any insert for a fee, The Journal may be bestowing on these documents
some credibility they may not deserve.
Andrew White
Clinical Effectiveness Pharmacist
Bolton Primary Care Trust
References
1. NPC support campaign on statins (available at www.npc.co.uk/statins.htm).
2. JBS 2: Joint British Societies’ guidelines on prevention of
cardiovascular disease in clinical practice. Heart 2005;91:1–52.
3. NICE clinical guideline in development: Lipid modification (available
at www.nice.org.uk).
4. NICE clinical guideline in development: MI: Secondary prevention (available
at www.nice.org.uk).
5. Hayward R et al. Narrative review: lack of evidence for recommended
low-density lipoprotein treatment targets: a solvable problem. Annals
of Internal Medicine 2006;145:520–30.
6. Minhas R, Statin utilisation — recognising the role of the invisible
hand. International Journal of Clinical Practice 2007;61:3–6.
Profoundly depressing
From Ms M. Weatherstone, MRPharmS
I found the inclusion of the AstraZeneca document masquerading as National
Institute for Health and Clinical Excellence guidance with the PJ of
January 20 profoundly depressing. This is a time where hard working pharmacists
and pharmacy technicians are striving to improve the cost-effectiveness
and evidence base of statin prescribing through change programmes and
advice to patients and prescribers, saving millions of pounds of NHS
money to be channelled into other services.
Yet here we have our own professional journal distributing a document
which advocates JBS targets, which are not national policy and are usually
unachievable for the average patient, and the use of a statin which has
no evidence to demonstrate that it saves lives or reduces cardiovascular
events, and which is not even licensed as such.
The NHS statin of first choice for most patients is simvastatin, based
on a wealth of evidence well known to all who read the detail of the
actual NICE guidance, and the targets to reach are those of the National
Service Framework for Coronary Heart Disease, affirmed by the cardiovascular
disease “tsar” himself in November 2006.
Let us hope that the majority will also take heed of the advice given
on the back page of the MereC Bulletin distributed with the same issue.
It was smaller and less glossy, but independent.
Mary Weatherstone
Norwich
Concerns over “promotional brochure”
From Mr P. D. Burrill, MRPharmS
I have some concerns about the document included with the 20 January
issue of The Pharmaceutical Journal. Rather than being a useful publication
covering the evidence base for the use of statins and practical issues
on cost-effective implementation of national guidance, it would appear
to be nothing more than a promotional brochure for rosuvastatin.
The brochure appears to support the JBS II lipid targets of 4 and 2mmol/L.
Are these targets set by JBS II evidence-based? Unfortunately they are
not. JBS itself recognises this in its statement: “There are no
clinical trials which have evaluated the relative and absolute benefits
of cholesterol lowering to different total and LDL-cholesterol targets
in relation to clinical events.”1 The vast majority of statin trials
used fixed doses and were not chasing any particular lipid level.
The Heart Protection Study provides us with strong evidence that treating
high-risk individuals (coronary heart disease, cardiovascular disease,
peripheral arterial disease, people with diabetes over 40 years of age)
with simvastatin 40mg/day for five years significantly reduces their
chance of having a serious vascular event, irrespective of their lipid
level.2 Rosuvastatin does not have this sort of patient-oriented evidence
to support its use. It is patient-oriented evidence that matters.
The NICE guidance referred to in this brochure deemed it cost-effective
to extend access to statins on the NHS.3 Its cost-effectiveness analysis
assumed that half of the prescriptions for statins would be simvastatin
20mg/day and half simvastatin 40mg/day. Arguably, more expensive statins
will not be cost-effective and will waste scarce resources.
A policy of simvastatin 40mg/day for all those at high-risk, irrespective
of lipid level, is simple to implement, evidence-based and cost-effective.
The bottom line is find the high-risk patients, offer them simvastatin
40mg/day, strongly encourage them to take it, and do not worry too much
about non-evidence-based targets.
Peter Burrill
Specialist Pharmaceutical Adviser for Public Health
Derbyshire County Primary Care Trust
References
1. JBS 2: Joint British Societies’ guidelines on prevention of
cardiovascular disease in clinical practice. Heart 2005;91:1–52,
2. 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.
3. NICE Technology Appraisal 94. Stains for the prevention of cardiovascular
events. London: NICE; 2006.
Perturbed by Journal's distribution of AstraZeneca document
From Mr M. I. Hird, MRPharmS
I was interested to receive the AstraZeneca-supported document on the
National Institute for Health and Clinical Excellence guidance on use
of statins with my Pharmaceutical Journal of 20 January.
Although numerous elements of this document could be tackled at length,
including the lack of clinical evidence that rosuvastatin prevents heart
attacks and strokes and the significant scientific debate about whether
the degree of lipid lowering does actually directly correlate to clinical
outcomes as implied, two points perturbed me the most.
The first point is that the document, although purporting to be a summary
of the NICE guidance, was in fact a marketing case for AstraZeneca’s
product and argues heavily for lipid goals of 4 and 2mmol/L. Yet in no
place did the document state that confirmed national health policy is
for targets of 5 and 3mmol/L, in simple terms.1 In this way the document
is undermining the NHS approach to managing this important risk factor.
The second is that the company’s own health economic data show
us that if we were aiming for the 4 and 2mmol/L goals nearly 40 per cent
of patients would end up on rosuvastatin 40mg per day, a dose restricted
to specialist use only due to safety concerns.2
I wonder if the requirement for specialist care and the costs this brings
has been factored into the economic analysis, never mind whether patients
would actually want to use this therapy option if presented with the
balanced
data.
It concerns me that since this document was distributed with The
Pharmaceutical Journal, it may have been lent an air of credibility that it does not
warrant.
Magnus Hird
Pharmacist Practitioner, Bloomfield Medical Centre
NPC Trainer, National Prescribing Centre
References
1. Boyle R. National policy on statin prescribing. London: Department
of Health; 2006.
2. New prescribing advice for the 40mg dose of Crestor (rosuvastatin).
London: Medicines and Healthcare products Regulatory Agency; 2004.
Disappointed
From Mr T. J. D. Donaldson, MRPharmS
I was disappointed to see that a pharmaceutical industry-supported document
on statins was included with the January 20 issue of The Journal. While
these are encountered not infrequently with journals which rely heavily
on advertising revenue, such advertorials are entirely promotional and
should be clearly declared as such. Should the readership choose to contest
the validity of the document’s conclusions, as I think they should,
will The Journal take any editorial responsibility for its content?
I would like to prompt a debate within The Journal and among its readership
as to whether they consider it right for The Journal, paid for largely
by the membership through the annual retention fee, to seek to generate
income for itself by distributing such material. I hope they will join
me in concluding that it is not.
Tim Donaldson
Newcastle-upon-Tyne
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Provided independently produced inserts are legal and decent, The
Pharmaceutical Journal has no grounds for rejecting them. It has
no control over their contents, the validity of which readers should
be able to assess for themselves.
Mr Donaldson is wrong to suggest that The Pharmaceutical Journal is funded through members’ retention fees. The PJ is entirely
self-funding and in fact contributes to the funding of the Royal
Pharmaceutical Society, thus helping to keep retention
fees as low as possible.
See Leading article (p120).
— EDITOR
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Where is the guidance for advertisers?
From Mrs H. M. Marlow, MRPharmS
I am proud to be a pharmacist and a health care professional. I am also
a strong advocate of evidence-based medicine and and have a strong sense
of professional integrity. However I cannot fail to be disappointed by
the standards set by The Pharmaceutical Journal when it distributes documents
such as the one on statins, supported by AstraZeneca, as it did on 20
January.
In my view, this is advertising for rosuvastatin in disguise, but no prescribing
information is included in the document as required by medicines advertising
legislation. I asked myself how could the professional journal for pharmacy
allow this sort of material to be sent out. What sort of governance processes
does it have? On investigating the PJ website all I can find is some information
for advertisers on advertising rates including rates for inserts distributed
with the PJ. There are no explicit standards for advertisers or more general
guidance on governance.
In contrast a search of the BMJ website reveals explicit and extensive advice
to advertisers on their advertising policy including the high ethical standards
advertisers are expected to adhere to, including guidance on supplements. BMJ
Publishing group requires these “advertorials” to
have the words “Advertisement feature” prominently displayed between
the top of the box and the top of the page. At least the BMJ requires openness
about this form of advertising.
Good governance and high ethical standards should be an integral part of any
organisation claiming to represent professionals. Yet the PJ, the official
journal of the Royal Pharmaceutical Society, falls far short of the standards
we should expect in the 21st century. For example, when will it start to require
authors and contributors to declare competing interests? How does it ensure
fair and independent reporting on conferences when the authors have been funded
to attend by a pharmaceutical company?
The Royal Pharmaceutical Society is updating our professional standards and
Code of Ethics; surely The Pharmaceutical Journal should be following suit.
Helen Marlow
Guildford,
Surrey
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Mrs Marlow is right to point out that there are no explicit guidelines
for advertisers currently available. We intend to rectify this soon.
However, The Pharmaceutical Journal’s policy on advertising is in line with
that outlined on the BMJ’s website, including its policy on supplements
and advertisement features. However, the document Mrs Marlow refers
to was neither a PJ supplement nor an advertisement feature, but an
independently
produced insert. But if she believes that the document was an advertisement
and that prescribing information should have been included then the
Medicines and Healthcare products Regulatory Agency complaints procedure
is open
to her.
We have always required authors to declare any financial, commercial, personal
or occupational interest that readers should know about. (This requirement has
appeared on our website for many years.) And when PJ staff are funded by organisers
to attend conferences, this fact is stated in the published report.
See Leading article, p120.
— EDITOR
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Pharmaceutical Journal