Are statins overused? - WOMEN IN MEDICINE LTD

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Are statins overused?

‘In 2005, the sales of statins • There is evidence from animal studies that
worldwide were very nearly statins cause cancer, and some disturbing
trends are emerging that this may also be a
US$40 billion.’ long-term risk in humans.

Malcolm Kendrick I believe that, currently, statins are overused. Over-hyping of benefits
This is a view that places me in a distinct minor- When I speak to patients, they have often heard
24 Prestwick Close, ity. Indeed, rather than leading a counter-revolu- that taking a statin will reduce their risk of a
Tytherington, Macclesfield, tion, I feel more like King Canute trying, heart attack by up to 40%. The press release for
Cheshire, SK10 2TH, UK without any discernible effect, to stop the tide the Heart Protection Study (HPS) claimed that
Tel.: +44 1625 502 001; from coming in. 50,000 lives a year could be saved by increased
Fax: +44 1625 500 906; prescribing of statins [102]. Information presented
[email protected] For example, there have been recent calls to in this way sounds incredibly impressive, and
place all men over 50 years of age on statins [101]. leads to the view that statins are unparalleled life-
part of And this would only be the start. A review of the saving drugs.
latest European Society of Cardiology guidelines
compiled in Norway, suggested that, were the However, the question most people should ask
guidelines to be followed, more than 50% of – but do not – is this:
men aged 25 or over would require statins [1].
‘How much longer will I live, if I take a statin for,
This move towards, what can only be say, 30 years.’
described as mass medicalization, would be a
grave error. Even today I think that the benefits The answer, if you are a women, is:
of statins are heavily outweighed by the costs –
financial, medical and societal – and the seem- ‘Not one day.’
ingly inexorable pressure for even greater pre-
scribing of statins can only unbalance the And this is true for both primary and second-
equation even further towards the negative. ary prevention. Even in the HPS study, which is
hailed as universally positive, there was no signif-
My main objections to statins are as follows: icant benefit on overall mortality in women [103].

• I think the benefits of statins have been over- And the same is true for men without exist-
hyped through the selective use of terms such ing heart disease, because the primary preven-
as ‘relative risk’, ‘lives saved’ and a focus on tion trials in men have not demonstrated any
cardiovascular outcomes alone, rather than benefit on overall mortality in this group
looking at overall mortality; either [2]. I have been told that the trials were
not powered to demonstrate such a benefit. Pos-
• The cost of statins is enormous. In 2005, the sibly, but if a series of 5-year long, and longer,
sales of statins worldwide were very nearly trials involving tens of thousands of patients are
US$40 billion. This would be enough, I not big enough, or long enough, to demonstrate
believe, to send a manned mission to Mars. To a benefit, then any such positive effect must be
be more pragmatic, I think this money could vanishingly small.
be better spent on medical interventions of
greater value. In short, the ‘opportunity cost’ ‘There is evidence from animal studies
of statins is unjustifiable; that statins cause cancer, and … this
may also be a long-term risk in humans.’
• I think that statins create more side effects in
the general population than have been Other people have argued with me that pre-
reported in the clinical trials. Some of these venting nonfatal strokes and myocardial infacr-
side-effects can be very serious indeed. Often tions (MIs) has a major benefit on the quality
they go unreported; of life, so I should look beyond overall mortal-
ity. However, in those trials that have reported

10.2217/17460875.2.5.481 © 2007 Future Medicine Ltd ISSN 1746-0875 Future Lipidol. (2007) 2(5), 481–483 481

EDITORIAL – Kendrick

such things, serious adverse events (SAEs) were which makes it even more important that they
the same in the placebo as the statin arm. take their statin. I call this the ‘double-
whammy’ effect.
If a SAE in the statin was, for example,
rhabodomyolysis with subsequent renal failure, Perhaps more worryingly, some of the side
then this would have a more impact on the qual- effects of the statins seem to be permanent, for
ity of life than a nonfatal MI. I can only use a example, peripheral neuropathy [4]. More worry-
speculative example because the Cholesterol ing still is the fact that the WHO is picking up a
Treatment Trialists (CTT) collaborators have high signal noise associated with statins and
not, indeed will not, release the data on SAEs amyotrophic lateral sclerosis [5], which is just
from the major statin trials, despite being asked about as unpleasant and deadly a side effect as
repeatedly if they would do so [104]. can be imagined.

Costs Statins & cancer
There is no doubt that a lower cholesterol level is
The costs of prescribing statins are extraordinary, strongly associated with an increased risk of can-
and rising. In the UK, where I work, statins cost cer [6]. Statins lower cholesterol levels. In animal
the National Health Service (NHS) approxi- studies, statins at doses comparable to those now
mately $1.2 billion in 2005 [105]. But the drug used in humans, caused cancer [106].
cost is only a fraction of the total costs incurred
in ancillary activities such taking extra blood A recent meta-analysis demonstrated a small,
tests, added consultations, prescribing fees, pre- but significant, increased risk of cancer [7]. The
scription charges, and so on. only study performed in older people, the Prav-
astatin in Elderly Individuals at Risk of Vascular
Consider the area of consultations. On aver- Disease (PROPER) study, found an increased
age, a patient on a statin will see a doctor for risk of cancer [7], and the Japan Lipid Interven-
review twice a year. In the UK, around four mil- tion Trial (J-LIT) performed in Japan warned
lion people take statins currently. So, there is a that statin ‘hyper-responders’ had a greatly
need for eight million consultations, which is the increased risk of dying of cancer [8].
entire workload of 2000 general practitioners,
costing $200,000/year to the NHS. A grand So far the risk appears relatively small. How-
total of $4 billion/year. ever, it has been pointed out by some other cho-
lesterol skeptics (yes there are others), that
This is a massive cost to a health service that is carcinogens, for instance those found in cigarette
currently having trouble funding drugs for smoke, can take many years to produce a clear
Alzheimer’s, leukemia and breast cancer. In fact, effect. My worry is that statins could cause can-
last year the NHS went into such severe debt cer with long-term use. Yet there is no study in
that thousands of staff had to be made redun- place (that I know of ) to monitor this possibility.
dant. Every single one of them could have
remained in work, using only a small percentage ‘ … some of the side effects of the statins
of the money spent on statins. seem to be permanent, for example,
peripheral neuropathy’.
Side effects
Summary
It is generally stated that statins have very few I think that statins have been over-hyped and
side effects. In many trials, these have been consequently over-used. This situation has
reported as less than 1%, exactly the same as occurred for a number of reasons, but the net
placebo. My personal experience is that a signif- effect has led to a massive over-prescribing of
icant number of people suffer side effects, usu- these drugs, something that seems likely to get
ally muscle weakness and pain, and often worse.
problems with cognition.
I believe that statins do not provide significant
Unfortunately, these are frequently not overall health benefits – if you look outside pure
mentioned by the patients, or if they are, they cardiovascular disease prevention. I think they
are downplayed or dismissed by their own have many more side effects than is generally
doctors [3]. One problem, impotence, I believe accepted. The costs are huge, and rising, and
is very common. The problem here is that car- they may – in the long term – significantly
diovascular disease is associated with impo- increase the risk of cancer.
tence, as is diabetes. So the patients are often
told that their impotence is a sign of underly-
ing cardiovascular disease – or diabetes –

482 Future Lipidol. (2007) 2(5) future science group

Are statins overused? – EDITORIAL

Financial & competing interests disclosure employment, consultancies, honoraria, stock ownership or
The author has no relevant affiliations or financial involve- options, expert testimony, grants or patents received or
ment with any organization or entity with a financial pending, or royalties.
interest in or financial conflict with the subject matter or
materials discussed in the manuscript. This includes No writing assistance was utilized in the production of
this manuscript.

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