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THE GREAT CHOLESTEROL CON
Author: Malcolm Kendrick
Reviewed by ANDRE BEAUMONT
Dr Malcolm Kendrick is a prince of cholesterol hypothesis sceptics. He has written a book that is broad in scope and which invites even broader discussion.
Cholesterol hypothesis adherents are not unfamiliar with headlines of the Wonder Drug Does Everything type on their side of the argument.
The lead story in the Daily Express of 21 May 2010, though, is Statins Can Be Risk To Health and goes on to quote research published in the BMJ:
Known side effects include insomnia, bowel problems, headaches, loss of appetite and loss of sensation or pain in the hands and feet.
It goes on to quote a lead researcher:
We found four outcomes with increased risk - for kidney problems, liver problems, cataracts and muscle problems.
For these, risk worsened over the first year and persisted but then reversed once they had stopped the medication. When you stop taking it, the risk goes down, which does suggest an association.
For someone of a political mindset, a number of questions requiring yes or no answers might present themselves:
- Has the previous government left a problem best addressed now rather than later?
- Are statins being foisted on people without proof of disease?
- Are any other medications prescribed to millions without proof of disease?
- Do statins have any significant disbenefits?
- Do statins have any significant benefits?
- Has cholesterol much to do with cardiovascular disease anyway?
This is the reverse order to which most researchers would ask questions.
Or one can address the questions that arise from research (Treatment of Cholesterol Abnormalities. American Family Physician Vol 71 / No.6; 2005):
Statin medications are indicated to decrease cardiovascular events in patients with elevated cholesterol levels, although a decrease in cardiovascular and all cause mortality has not been demonstrated.
Because cholesterol-lowering drugs have been shown to affect cardiovascular mortality more than total mortality, concern has arisen that these agents might increase mortality from other causes.
Or, maybe, one can address the questions arising from common sense.
If 88% of women aged 55-64 are said to have high cholesterol (a recently quoted statistic) has it not occured to anyone that cholesterol rises in middle age because it is protective of something?
Might it not be that the limits have been set too low, and the conclusions drawn from the science erroneous, as there are not widespread cardiac events occuring in this segment of the population?
Why is it that nature has left only homo sapiens at the mercy of this blood component, cholesterol?
Should we not also be dosing racehorses over seven years old with statins or might possible muscle cramps not be a good thing?
Around 600 people without cardiovascular disease need to be dosed with statins for one cardiovascular event to be prevented, and any decrease in cardiovascular mortality has not been demonstrated, so how is it beneficial to 599 of the 600?
If segments of the medical establishment are concerned that elevated cholesterol might be an indicator of present or future cardiovascular disease, why not ultrasound the major blood vessels of those with elevated levels to ascertain whether there is sign of disease? (Though trying to image the coronary arteries presents a problem because the ribcage is in the way).
This may be beyond the resources of a public health service in an economic downturn but the cost is not high.
(Britain is well behind the U.S. in imaging; 75 million C.T. scans are undertaken there a year. A difference is that most of those carried out in Britain are without cost to the patient. There is little doubt, though, that they save the NHS a lot of money in the long run so a significant increase in the number of imaging devices is needed. Medicine should not be disproportionately about rationing but about giving people what they need or want at reasonable cost, perhaps through greater throughput. The marginal cost of a C.T. scan is around $120. Old techniques and mass medication do, to some extent, need to make way for better diagnostics).
Dr Malcolm Kendrick has the advantage over nearly everyone in having read most of the papers on the subject. He describes his prose style, as used in the book, thus: 'despite my apparent joviality, I am deadly serious'.
For instance, he writes:
A low cholesterol level, especially after the age of 50, significantly increases your risk of dying. One massive long-lasting study that looked specifically at cholesterol levels and mortality in older people, was carried out in Honolulu and published in August 2001 in The Lancet.
And the findings thereof:
Our data accord with previous findings of increased mortality in elderly people with low serum cholesterol, and show long term persistence of low cholesterol concentration actually increases the risk of death. Thus the earlier that patients start to have lower cholesterol concentrations, the greater the risk of death.
Perhaps you would prefer a British study? This from the BMJ in 1995:
Low serum cholesterol concentrations (<4.8 mmol/l), present in 5% of men were associated with the highest mortality of all causes, largely due to a significant increase in cancer deaths.
And two studies later:
Enough already, I hear you cry. OK, enough already, I shall merely summarise the data on overall mortality:
- Under the age of 50 your cholesterol level doesn't really make much difference to your risk of dying. However, if your cholesterol level starts falling, watch out. You are at terrible risk - a 429 per cent increased risk of death per 1mmol/l cholesterol drop according to the Framingham Study.
- After the age of 50, a low cholesterol level is associated with a significantly greater overall mortality. The older you get, the more dangerous it is to have a low cholesterol level.
Later he writes:
The point I want to make is that there is a complete and utter dissociation between cholesterol levels and heart disease.
SHOULD THE NATIONAL HEALTH SERVICE BE DIVIDED IN TWO?
By the early nineties, for those who had something to compare it with, the NHS had identified itself as the British Leyland of European health systems - it just about did the job, it covered the waterfront in terms of range, it had a tendency to disregard what the customer (in other words, the patient) wanted or needed, it communicated poorly and was prone to supplying an outdated or defective product.
Contemporaneously, in another European country where patients made a contribution to costs, I noticed that a blood test centre was going out of its way to frighten people with perfectly normal test results about their cholesterol.
So the cholesterol hypothesis was put to a friendly cardiologist in the same country who proved dismissive of the idea that cholesterol caused cardiovascular disease.
This accords with what Dr Kendrick reports:
At first, doctors weren't all that keen on statins. Many of them didn't believe in the cholesterol hypothesis, and were far from certain that lowering cholesterol levels would do much good.
Other than where cardiovascular disease was present, the NHS didn't appear to trouble itself about cholesterol either.
The conclusion drawn at the time was that although frightening people about cholesterol would be a profitable line for more than a few, the NHS, known to be mean with its drugs budget, would be leaving people alone about cholesterol.
The prospect of some statins coming off patent changed things for the NHS.
Now it teaches its students that Britain is superior in preventative healthcare despite this being an area in which it has had, historically, virtually no moral authority to make claims.
The problem with the NHS is that almost anybody who has had any power to influence its direction has been brought up with a NHS background or knows no better healthcare tradition. Those who do know better have no influence.
Outcomes for many diseases are amongst the worst in northern Europe.
It is hard to be sure, but the NHS obsession with record keeping may be making things worse. Locums, newly qualified doctors, those with lesser qualifications in hospitals and the incompetent can pull an illness out of the record and attribute it to the patient without going through the discipline of doing their own thorough diagnosis.
Outcomes in northern European countries where the patient is custodian of his or her own records appear to be better.
Patients take responsibility for their own health more. If a doctor produces inadequate diagnoses a few times in a row, the patient goes elsewhere.
This is as it should be. Healthcare should be like other professional services, with the customer in charge. Accessing it should be little different to employing an accountant or, for something more rarified, a structural engineer - you usually defer to their superior knowledge but they don't run your life.
Many of the NHS's problems arise because it is a near monopoly. (Britain also has a private healthcare sector which is overly costly to access compared with its European competitors).
It is home to bizarre orthodoxies that find no credence elsewhere and which would dissolve under competitive pressure.
It has been subject to top down targets and layers of bureaucracy that limit the exercise of clinical judgement.
Too much time is spent on record keeping and talking about cholesterol rather than addressing the issues at hand because one solution fits all policies are imposed from above.
The NHS is heading for a crisis before the decade is out not because any party is seeking to change the free at the point of use principle or because it will be other than well funded but because its internal capacity to change over a short period is currently so slight.
Splitting the NHS into two could provide the necessary impetus for change. The two parts need not be of precisely equal size.
At present, those who use NHS hospitals are offered the choice of two hospitals. Instead, where geography allows, they should be offered the choice of two organisations, each seeking to be patient responsive.
Freely consulting GPs of either organization in a locality, or nationally, should be allowed.
Some competition in each locality is better than none.
The Big Society ideology currently encourages the near monopoly of education by local authorities to be broken by new free schools. New academies also represent a rejection of the one solution fits all approach of comprehensive education.
In healthcare, fewer people feel competent to intervene and the stakes are higher.
So it is interesting to speculate whether in a future parliament the Big Society ideological envelope could accommodate a two-part NHS.
Dr Kendrick also gives space to his own explanation of heart disease.
Throughout, the book is always an entertaining read given the complexity of the way the science is written up.
As a conclusion to the issues raised, three further extracts from Dr Kendrick's book choose themselves:
But a high cholesterol level is not a risk factor in the over 70s. If anything, raised cholesterol protects against heart disease in the over 70s, especially in women - for whom, in fact, a raised cholesterol level isn't a risk factor for heart disease at any age.
Despite the complete and utter lack of evidence of any mortality benefits, GPs in the UK are actively encouraged to check cholesterol levels in women, and further encouraged to get the cholesterol level below 5.0mmol/l. If they achieve this in a high enough percentage of their practice population, they are then paid large sums of money.
One critical point about cholesterol levels that I have not mentioned so far is that the level which is considered high has been falling relentlessly. Twenty years ago, GPs in the UK would only get excited if your cholesterol level was above about 7.0mmol/l. Ten years ago, anything above 6.5mmol/l had moved into 'treatment' zone. Today, if your level is above 5.0mmol/l you will be earmarked for 'statination'. Tomorrow, if current trends continue, the level will be 4.0mmol/l. It already is for those who have suffered a heart attack. Some 'experts' believe that the true, healthy level of cholesterol is about 2.5mmol/l. Therefore, no matter what your level of cholesterol, according to the prevailing wisdom, you will benefit from having it lowered.
Postscript 31 October 2011
I remember my second week at university well. A few of my contemporaries and I were invited to have lunch with Lord Adrian, former Master of the College, who had won a Nobel prize in medicine for work on neurons, and who had just relinquished the Chancellorship of the University.
We arrived at 12.30 and enjoyed our lunch and conversation. By 1.30, or a little after, all the other students had said thank you and made their way off to 2 o'clock lectures or other pressing engagements. I, though, had decided that other things could wait - I was with an excellent mind that could go anywhere and I was determined to explore it.
He didn't seem to mind. Indeed, the conversation ranged over many academic subjects and we both enjoyed it. Time passed and he asked if I might like some afternoon tea. He rang up and a college servant brought it the 50 yards from the kitchens. It was past 3.30 before I went.
During the conversation, searching for new subjects to discuss, I remembered that he had qualified as a doctor.
A new test to measure cholesterol had been developed a couple of years before. A broadsheet newspaper had just mentioned a hypothesis that cholesterol caused heart disease, more or less asserting it to be so, in a period when newspapers rarely discussed medicine.
So I mentioned this while also asking him what his research had been about.
To my surprise, all the while anxious that I should understand and remember, he gave me a mini-lecture on the necessity of being very cautious about the way conclusions were drawn from science for use in medicine, before letting the conversation go in the direction intended.
It does seem one of the wonders of life that an 18-year old should be so keen to learn and an 85-year old so keen to impart knowledge, both strangely confident it would bear fruit.
This is, too, another part of the Idea Of The University (a subject a government minister will lecture on in three weeks time) - that you educate yourself, drawing material from where you can.
It did bear fruit, too. My views of how the old should be treated were formed that day. Provide them (it will be us who will be 'them' later) with basic security and accommodation, assistance with things they would find tiring to do (institutions of mediaeval origin, like an Oxbridge college, are sometimes very good at all these), and leave them in charge of things that matter to them, not just in semblance but in reality, and you may find their needs, and call on resources, are very slight.
We have much to learn from them.
Nor has all of the mini-lecture slipped from memory.
We all know there are many kinds of proof. There is the Euclidean kind of proof where the inner angles of a triangle can be proved to add up to 180 degrees. There is proof beyond reasonable doubt. There is proof of the pudding in the eating.
With cholesterol science the standard of proof seems to lie somewhere between proof of the pudding and on the balance of probabilities. It does not attain the standard of beyond reasonable doubt so any aggressive pushing of statins, should it occur, needs now to be discontinued.
[26 October 2012 Re: Liverpool Care Pathway Legal standards of proof must apply to consent, too. The NHS's formulation of 'no decisions about me without me' is like a marketing formulation and not up to scratch. You can be present and play no part in decision making. Informed consent by the patient in all cases is the goal for patients. It should not be salami sliced to just consent, then assumed consent then no consent at all without increasing legal hazard. Blanket consents to the administration of drugs may have to be re-examined. A culture change will do everyone good].
Also, some research money needs to go into exploring an alternative hypothesis - that cholesterol rises in middle age because it is protective of brain function. If it is a false hypothesis it needs to be demonstrated conclusively that it is so.
To promote research all in one direction and not in its opposite can be an unappealing form of gatekeeping.