Last week in Australia – a 2 part documentary on the Catalyst program (ABC1) raised a lot of questions about the use of statins for the management of low-risk patient’s cholesterol levels. This letter is addressed to my trainees.
By now you have probably had a few patients come through your door with a lot of questions about their statins, cholesterol level and risk of serious side-effects from these drugs. This concern has been generated by a recent ABC documentary which aimed to “blow the whistle” on the evils of big pharma when it comes to statins.
In case you missed the program – it is available free online ["Matters of the Heart" part 1, and part 2]. I would encourage any doctors reading this to watch the programs – not so much for personal education, but so that you know what it is that your patient is asking you when they arrive in the coming weeks to discuss their cholesterol therapy.
Now, I imagine a few patients will be feeling somewhat concerned, others downright irate about all of this. Some may even be under the impression that you have actively harmed them, that you have been conned by a drug rep into poisoning them with statins. So I wanted to put a few thoughts down in writing for you so that you might be able to answer their concerns in a rational and accurate manner.
Don’t be defensive – this is a great opportunity for you to engage motivated patients in their own health care. Nothing has changed here – this is relatively old data, it is simply that now the public are more informed on this topic than they were last month.
Let me start way back in 2002, as an old bastard I invoke my right to tell anecdotes about “when I was a boy” as if you really want to hear them .
In 2002 I was a bright-eyed GP registrar in the Goldfields. And back then I really got a kick out of women’s health! This may be news to you:- back then pretty much every woman that developed signs of menopause was offered and encouraged to go straight onto HRT. I was taught this in medical school. It made sense, the physiology and endocrinology all added up in my head. Oestrogen and progesterone were ‘natural’, when your ovaries clapped out it made sense to prescribe replacements – not only did it give great relief from the hot flushes, mood swings, vaginal dryness – it probably helped with a whole heap of long term problems e.g.. cardiovascular risk, dementia, osteoporosis, wrinkles, cold intolerance…… it was a win, win situation. These women had a symptom, a problem. It was easy to diagnose – a quick history and a simple blood test. Then whammy – a week later I had a script pad and “knowledge”. I could help them with the simple flick of a pen. Everybody was happy!
But then things changed… the Women’s Health Initiative Investigators published their game-changing paper in JAMA, July 2002. Suddenly, where there was once black and white – we were seeing light and shade, or at best a haze on an overcast day. The stats were complex, one had to consider things like baseline risk, relative risk data and individually tailor each and every patient’s individual profile. Some women were worried about the risk of HRT, others clung onto it despite the evidence suggesting they were going to be worse off in the long run. It was a mess!
The most confronting realisation for me back then was that I had been ‘wrong’, maybe mistaught? I believed that I was doing the best for my patients – when clearly this was in error. There was cognitive dissonance – I thought I was “a good doctor” and yet I had been peddling horseshit for years. For me the data was incredibly disempowering – I believed that I was making a big difference with my advice – yet the data showed really very marginal benefits and harms when you looked at all the outcomes measured.
WHI outcomes, JAMA 2002. Figure
2 from WHI
The risks and benefits were small, tiny in some places – these were not the confidence intervals of heroic medical deeds!
OK, I know what you are thinking – what on earth does all this have to do with statins and the queue of patients asking me awkward questions all day long?
Well my friends I think we are back to 2002 when it comes to statins and cardiovascular risk. Lipid therapy and statins are little different to HRT.
Let me be clear whom we are talking about here: asymptomatic, low-risk patients. Those with no known cardiovascular disease. This is primary prevention – the bread-and-.. “salt-reduced, Ultra-light butter substitute” of GP land.
For years we have believed that we are making major differences to the life and longevity of our flock by aggressively treating “dyslipidemia” [not sure if that is really a disease?]. The Colleges, the Heart Foundation have all produced smart guidelines and “targets” for therapy to keep the cholesterol under control. And we find this concept really appealing – its a concrete number: ”Mr Smith, your LDL is 5.7 – you need to go onto something….” What could be easier? The patients ‘get it’ – they have been trained by a generation of GPs and TV adds to do so. Sure some of them you might need to beat about the head with the “risks of infarction”. Maybe you have showed them scary pictures of atherosclerotic lesions or, God forbid, even performed exercise-stress tests upon the entirely asymptomatic to make a case for intervention.
Having a high cholesterol is not an illness – there are no symptoms. [ unless you have really nasty familial xanthelasma maybe?] You are treating a number – a blood test. Your patient will not thank you for lowering their total cholesterol by 1.7 points. So beware – in the absence of symptoms and suffering you had better be sure that you are prescribing drugs to your patient that will actually make a difference to them. Otherwise you are simply poisoning them.
Second point. We do not have a consensus. This is probably the reason why journalists are interested in such a dull topic – they can smell the smoke and like reporting on fires. In the last few years there have been large meta-analyses and wholesale recommendations going in both directions. It has gotten a little heated in the “letters to the Editor” sections. Powerful and respected bodies such as the Cochrane group, the Lancet, the Cholesterol Treatment trialists (CTT) etc have all come out with papers, editorials and guidelines which do not really agree on much. For me it is like being an atheist in a Hindu temple… unsure in which God one should disbelieve!
For example, the Abrahamson review of the CTT meta-analysis came out with a completely different conclusion – and in a break from tradition actually looked at individual patient data again to re-analyse the risks and benefits of statins. Hmmm.. something is wrong here. How can 2 groups of scientists look at the same data set and come up with different answers? My suspicion: the benefits and risks are small – close to insignificance – so any effect is going to weak and easily tweaked. We are dealing with marginal numbers – just like we were with HRT. This is not the stuff of modern medical marvel. So my advice – do not get too precious about the guidelines and targets.
On the downside, we area all aware of the potential risks of statins. The two big ones are (1) muscle damage [myalgia, weakness through to rhabdomyolysis] and (2) the development of diabetes. In order to have a meaningful risk : benefit discussion with your patients you need to understand the downsides. This is a balancing act – so you need to be able to measure these reliably. Unfortunately the studies are unable to shed clear light upon the downsides – at best they are hopelessly biased. Side effects are tough to pick up in company-sponsored trials – the initial “wash in period” tends to eliminate a lot of patients with minor side effects, and others may not appear until after the trial is concluded. So you will read papers with rates of myopathy ranging from 0.1% up to 20%. Impossible! Here is my take – if your patient has any side effect – they are 100% at risk. So their balance is clearly in the red given the relatively impotent benefits known for statins in low-risk patients.
And then there is the “Big Pharma- conspiracy” angle. Are any of these guidelines actually based on trails that have not been manipulated by a drug company?… The TV reports and headlines of recent weeks have put this more sexy face upon the ‘controversy’. So remember to keep your LIPITOR pen out of view when your next disgruntled myalgic patient walks into your consult room! Actually, better still – don’t accept drug rep visits, gifts or faux education. I know you think that it doesn’t influence your decision-making or prescribing habits. However, I know for sure that those companies are not employing reps and spending millions of advertising for charity! You need to get your information from somewhere else – this means doing some reading and critically analysing the primary data yourself. There are some really cool, independent FOAMed sites out there.
So my fellows where does this leave us?
We are back in 2002. You need to go back to the classroom and relearn – educate yourself about cardiovascular risk, statins and the like. Realise that we are talking about drugs that have a minor effect if any on the long term health and well-being of your patient. You need to understand the magnitudes of the benefit and risks involved, not blindly follow guidelines.
Here is a starting point: check out theNNT.com - look at the numbers. Read the papers that they use to generate the numbers, read the editorial commentary in the big journals and then read some more.
Then you will be in a great place to have a real discussion with your patients. Forget the hype, know your stuff and understand that you are fiddling around the margins of risk.
Yours in good faith