Open letter raises concerns about NICE guidance on statins
BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3937 (Published 11 June 2014) Cite this as: BMJ 2014;348:g3937All rapid responses
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Concerns about conflicts of interest (COI) in NICE guideline groups have been raised in the recent statin proposals. But this is the norm not the exception for authors of NICE guidelines who are often steeped in COI, for example, Hypertension, Diabetes and Depression.[1,2,3] These of course are chronic incurable common conditions that is the financial life blood of the Pharma Industry balance sheets.
Regrettably institutions like NICE dismiss these COIs, claiming that as long as these are declared, they do not impact on the advice given. This of course is a nonsense and those looking from outside are bemused that experts with COI are allowed to be involved in such important guidance. Experts on the take from Pharma companies believe that medication “works” , so have a closed therapeutic mindset, never questioning the current paradigm of medical care. Medications are always the solution to all problems medical or social .
Indeed there other conflicts of interests that are non financial. Academics have their own careers to carve out, empires to build and pet theories to disseminate. Being on NICE gives credence and status. So even expert academics without links to Big Pharma are by no means truly impartial. So we have the known knowns of academic bias; the known unknowns of academic bias but also unknown unknowns, the ones we don't know we don't know! The road to medical truth is barricaded by squat-set-balaclava- -bowtied thuggish experts touting professorships and heavy biases! And we don’t really need experts, for most medical research at its core is so basic that having O level statistics would make you over qualified.
NICE is over complicated, flat-footed, bureaucratic, opaque and addled by conflicts of interest, financial and otherwise. Big Pharma and vested specialist interests lurk malevolently in the shadows of many a guideline. Yet these guidelines directly affect our families' medical care, everywhere and everyday. Is NICE fit for purpose? We need to tear it down and start again with a system that actively prohibits all conflicts of interest and is less reliant on a select few experts.
[1] NICE Diabetes Group http://www.nice.org.uk/nicemedia/live/11983/40804/40804.pdf
[2] NICE Hypertension Group http://www.nice.org.uk/nicemedia/live/13561/56027/56027.pdf
[3] NICE Depression Group http://www.nice.org.uk/nicemedia/live/12329/45896/45896.pdf page 600
Competing interests: No competing interests
Re: Open letter raises concerns about NICE guidance on statins
Statins for All?
The debate about extending the use of statins to those with an (unreliably) estimated 1% annual risk of cardiovascular disease [1,2] is in danger of degenerating into an unseemly row about the burden of side effects, largely promoted by the tabloid press on one side and the drug companies on the other. This is a dispute which the medical profession, having only recently come to terms with the need to base its recommendations on objective evidence, would do well to keep out of, at least until the relevant evidence is available. The “statins for all” question has become too big to be settled by limited and potentially biased trial data and needs a society-wide effort. Why not organise a nationwide campaign for the “One Percenters” to volunteer for individual “n-of-1”, placebo-controlled, randomised, cross-over trials of statins (and other proposed Polypill components), with web-based self-reporting of symptoms and “brain games” to assess cognitive performance? The only involvement of the drug companies would be to provide placebo pills in the expectation of opening up huge new markets, and participants themselves, having seen their own results, would choose whether or not to continue on a statin long term.
What Goes Up Must Come Down…
Although the survival curves in the statin trials diverge for the first few years, they must eventually meet at the bottom. Another yawning evidence gap concerns how long treatment should continue and what should happen near the end of life. Does preventing fatal heart attacks in old age benefit individuals or society, if they then go on to die of something worse? Even in someone with advanced dementia, it can be difficult to stop what may be seen as life-prolonging treatment, without appearing to dismiss the value of that continued life. It is one thing to extrapolate from trial populations to those with lower baseline risk but quite another to claim that the predicted benefits of a few years on statins can justify lifelong treatment.
Lifelong controlled trials in low-risk populations are unlikely to be practical, but randomised trials of stopping or continuing statins offer the best chance of settling key questions, such as whether or not they reduce the risk of late life dementia [3,4] and whether they affect the quality of life in old age. The same approach could be used with many of the myriad other “preventative” drugs that older people are now burdened with.
Until we have evidence from such studies, NICE should confine itself to pronouncing on clinical issues and doctors should stick to treating patients, not society.
1. National Institute for Health and Care Excellence. Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. NICE guideline draft for consultation. 12 February 2014. http://guidance.nice.org.uk/CG/WaveR/123
2. NICE.org.uk. NICE statin letter: concerns about the latest NICE draft guidance on statins. 10 June 2014. www.nice.org.uk/media/877/AC/NICE_statin_letter.pdf.
3. McGuinness B1, Craig D, Bullock R, Passmore P. Statins for the prevention of dementia. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003160. doi: 10.1002/14651858.CD003160.pub2.
4. Wu C-K, Yang Y-H, Lin T-T, et al. Statin use reduces the risk of dementia in elderly patients: a nationwide data survey and propensity analysis. J Int Med 2014. doi:10.1111/joim.12262.
Competing interests: No competing interests