The great QOF fiasco. The untold story of the biggest public health experiment ever and how its failure was ignored.

By Jerome Burne

The results of the largest ever trial testing the effectiveness and safety of using drugs to cut the risk of developing chronic diseases were published in the Lancet two years ago. They were astonishing and revealed a massive failure of a major plank in public health policy. Yet they have remained effectively secret.

Conducted in Britain, the trial ran for 15 years, cost 30 BILLION pounds and found no benefits. The expectation was that it would save around 10,000 lives a year, cut admissions to hospital and increase life expectancy. It didn’t do any of those. (Read)

What is even more remarkable (if not surprising) is that unless you are a medical professional or working in the NHS bureaucracy, it is very unlikely that you will have heard of it or what it found.

Actually, I have slightly misrepresented what was involved for effect. It wasn’t a proper trial, but it was certainly the largest-ever uncontrolled public health experiment which, irresponsibly and unscientifically, was done without being tested in a pilot. It wasn’t possible to have a control group because it was conducted on the entire UK population.  

The data the report was based on is something known as QOF (Quality and Outcomes Framework) which was a system set up in 2004 that started paying GP’s for checking such biomarkers as blood glucose, triglycerides and cholesterol and then prescribing drugs to bring them down if they were over the official healthy level.

Too many drugs damaging out health

The story of the QOF disaster and its implications for our medical system is told in a fascinating and alarming new book by GP and Telegraph medical columnist Dr James Le Fanu called ‘Too Many Pills: how too much medicine is endangering our health and what to do about it’.

It’s about polypharmacy – prescribing an increasing number of drugs to most of us but to old people especially as they develop the conditions and disorders that are a common part of ageing.

The result is that by their 70’s many people are on 5 or more drugs, some for markers such as raised cholesterol and some to deal with their side-effects. Most GPs agree it is a problem but, for reasons we’ll come to, feel powerless to stop. It’s a direct result of the same approach to medicine that lay behind the QOF fiasco.

At the start QOF was perfectly logical, if untried. The drugs, such as statins, blood pressure pills and diabetes drugs – had all been run through large RCTs (randomised controlled trials) which, it was widely accepted, showed they were effective and safe. It was believed that many people had undiagnosed risk factors, such as too much blood sugar or ‘dangerously’ raised cholesterol, so encouraging GPs to test and treat would inevitably improve the health of the nation and cut costs by reducing the number of people numbers with diseases that needed expensive treatment. Wouldn’t it?

Creating a synthetic UK

Apparently not according to the analysis of the results published in the Lancet. This involved some fancy statistical constructions to get around the absence of a control group which I can’t evaluate but I trust Dr Fanu. This is what they did.

Researchers from Michigan School of Public Health in the USA and from Manchester and York Universities in the UK gathered data on mortality and chronic disease in similar western countries without a medical pay-for-performance system.

Then they used that to create a ‘so-called synthetic UK as a weighted combination of comparison countries.’ The synthetic UK – the results that could be expected without QOF – were then compared with the result in the real UK and found almost no improvement. ‘Our results show that the introduction of the QOF was not associated with significant changes in mortality for the diseases targeted by the program.’

Initially I assumed that the implication of this devastating report was that treating the whole population with drugs for prevention wasn’t an effective strategy.  This however was not the message the researchers took away. Instead it was that: ‘Pay-for-performance might not be an effective method for improvement of population health’.

Really? It was certainly very effective at increasing drug consumption, as Dr Le Fanu makes clear. From its start in 2004 to 2010 when the data gathering stopped, the number of prescriptions for statins, blood pressure pills and diabetes drugs doubled and those for antidepressants went up by 60%.

More drugs and rising hospital admissions

About half the 30 billion spent on the experiment went on payments for the additional drugs. Meanwhile hospital admissions, rather than falling as expected, continued to rise at a steady rate of 5% a year. So, if the increased drug consumption wasn’t allowing people to live longer or stay out of hospital, what was it doing?

The whole project has certainly been wrapped in a very unhealthy secrecy. One effect of ‘pay-for-performance (notice, not ‘pay for prescribing for drugs’) was that patients were rarely told about it and when they discovered it they usually disapproved; not only because it provided an incentive to offer drugs that might not be needed but also because it discouraged taking other lifestyle steps to keep them well. Many doctors objected that such tick-box medicine marginalised their clinical judgement, but the increase in income seems to have muted criticisms.

Even worse, patients are still being kept in the dark. I spend far too much time following medical research and reports and although I knew about QOF, I knew nothing about this analysis of the results. A look at the Lancet paper explains why. Thanks to a system known as PlumXMetrics – which shows up as an icon on research papers online – it is possible to tell how many have responded to it Rather than being headline news prompting investigation by Parliamentary committees, this bombshell had been read 45 times, saved 19, and mentioned once in a blog and once in a newspaper.

So, millions of UK citizens were involuntarily enrolled in a vast, long-running drug experiment, begun without any evidence that it might be effective, which they also unknowingly paid for out of taxes. And then when then the policy it was, in effect testing, turned out to be a failure, patients still weren’t told about it, denying them the chance to make more informed decisions about how best to stay well. Meanwhile doctors are still handing out prescriptions and being paid for it.

Revelations of a whistle blower

The book is like a wonderfully readable release of data by a whistle-blower – revealing the internal workings of an industry that are normally shrouded in secrecy. Dr Le Fanu is no big-pharma basher but a firm fan of modern medicine, itemising the benefits it has brought in treating what was untreatable and ‘vanquishing (or mitigating) the trials and tribulations of the elderly’.

But as his book says on the cover, we are all getting far too many pills and the reason is intimately connected with the way medicine is organised. In just fifteen years the number of prescriptions written by GPs has gone up three times, a rise which is implicated in the 75% increase in hospital admissions for adverse drug reactions between 1999 and 2008.

The majority of these are elderly because they are more likely to be diagnosed as needing treatment – as we age, markers of ill-health such as cholesterol and blood pressure naturally rise – as well as being more likely to suffer ill-effects because their resilience naturally declines.

Over several chapters Dr Le Fanu burrows into the evidence, normally brushed out of sight and rarely discussed with patients, of just how small the benefit is from drugs for prevention. Evidence that, had it been routinely in the open, should have warranted much greater caution in the great QOF experiment.

I’ve written a lot here about the unreliability of statin data – the raw material from the trials is still being kept secret – but Le Fanu has one very simple chart that illustrates why the massive rise in stain prescribing stimulated by QOF had little or no impact on heart disease.

Heart disease deaths dropping long before statins

There are two lines. One showing number of deaths from heart disease in the UK between 1950 and 2015. The other shows number of statin prescriptions from when they were licensed in 1990.

Deaths went up from 35 to 50 (per 100,000) from 1950 to 1970 and then started a steady decline down to 10. When statins arrived the death-rate had already halved from its peak. When the lines crossed in 2000, statin prescriptions had hit 15 million. In the following decade they soared to nearly 70 million. It’s hard to see what protection they offered from heart disease.

Blood pressure pills emerge as a bit more effective – treating 2400 people will prevent 50 strokes – which makes it worthwhile but there are no fewer deaths, most likely because of the rate of damaging side effects, such as badly damaging falls and an increased risk of diabetes.

The combination of drugs of limited effectiveness and a range of unpleasant, sometimes deadly, side effects being prescribed to everyone with biomarkers above a level that officially put them at raised risk for a chronic condition, has created a perfect storm for the elderly.

‘The current medical practise of fetishizing numerical goals for blood pressure and the like,’ writes Le Fanu ‘has led to an onslaught of drug treatments aimed at bringing people aged 60 and older into line with someone 30 or 40 years younger.’

Devastating effects of a prescribing cascade

Between 1995 and 2010, the proportion of adults getting five or more drugs doubled to 20% . Le Fanu describes how this ‘prescribing cascade’ can happen. How in a matter of months a fit 70-year-old man put on a statin simply on the basis of his age, could be on six drugs.  

Following the statin, he begins to suffer muscle pains. So an anti-inflammatory is prescribed to help. One effect of these drugs is to raise blood pressure, which shows up at his next doctor’s appointment. This leads to a blood pressure pill (diuretic). A few months later a very painful case of gout develops which is a known effect of diuretics. Weeks later raised blood sugar shows up (another side effect of diuretics) so he is put on the diabetes drug metformin which leads to a diarrhoea and another drug prescribed to help with that.

This of course exaggerated but elements of this cascade are happening all the time. Doctors are aware of it and even have conferences to discuss it. One practical solution is to develop a skill for which there are no payments – unprescribing, which my spellchecker tries to correct to ‘prescribing’.

And there is promising evidence for it. Ten years ago, a year-long study on 100 nursing home patients found that stopping 320 of their drugs cut the yearly mortality rate from 45% to 21 % and dropped hospital admission from 30 % to 11%. ‘A better result than achieved by any drug treatment anywhere,’ Le Fanu comments.

But that’s not really an option for individual doctors. Not only does a huge weight of the evidence they rely on say these drugs are tested, effective and safe, but diagnosing a condition and prescribing a pill for it is what they do.  Breaking ranks and ‘unprescribing’ could make them vulnerable to professional and financial penalties if a patient died or had a severe reaction. Prescribing these drugs may have modest to no benefits for patients; they are more reliably protective for the doctor.  

This is an important, compassionate and carefully researched book that shines light on policies kept in the dark for too long. In a properly evidence-based system focused on patient needs it would prompt extensive discussions and a major re-evaluation. It certainly makes a powerful case for shifting to lifestyle medicine as fast as possible.  

Conflict of interests: James is an old friend of mine and I am mentioned in his list of acknowledgements. I am not entirely uncritical though. I think he is far too soft on antidepressants which he puts in the good medicine camp. They are just as ineffective and over-hyped as his other targets.

Jerome Burne

Jerome Burne

Jerome Burne is the editor of HealthInsightUK. He is an award-winning journalist who has been specialising in medicine and health for the last 10 years and now works mainly for the Daily Mail. His most recent book “10 Secrets of Healthy Ageing” was written with nutritionist Patrick Holford. He blogs at “Body of Evidence” – jeromeburne.com. 2015: Finalist for 'Blogger of the Year' award from Medical Journalists' Association.

7 Comments

  • “Meanwhile hospital admissions, rather than falling as expected, continued to rise at a steady rate of 5% a year”.

    Obviously because the treatment being studied had little or no effect. So what did? My guess would be the consumption of the food and drink recommended by government – and indeed imposed on patients in hospital, if necessary against their will. Today’s high-carbohydrate, high-sugar diet, full of “food-like substances” rather than nutrients, is so harmful it is surprising more people don’t get sick and die young. I suspect that if, somehow, the entire population could be put on a healthy diet, the cost of the NHS could be halved in 10-20 years.

    “So, if the increased drug consumption wasn’t allowing people to live longer or stay out of hospital, what was it doing?”

    What it was meant to do: making vast profits for the people who own and run the pharmaceutical industry (and the medical industry, and the insurance industry).

    If proof were needed that homo sapiens collectively is not intelligent, this would suffice. One industry (the manufacture of “food”) piles up vast profits by making people sick. Other industries then pile up vast profits by trying, ineffectually, to cure them.

    Many experts have testified that “primitive” people, who ate their traditional diets and lived traditional lifestyles, simply never got any of the “diseases of civilization”. Despite never cleaning their teeth, they rarely or never got dental caries or gum disease either.

    But no one was very interested in those facts. As Upton Sinclair pointed out a century ago, “It is difficult to get a man to understand something when his salary depends upon his not understanding it”.

  • Today’s Times report there are 1200 hospital admissions a week linked to prescription drugs!

    It is very odd that issues so much smaller get so much more coverage. The medical cull has somehow become accepted.

  • Tom, you said ” Other industries then pile up vast profits by trying, ineffectually, to cure them.”

    That’s not what they’re doing, or even trying to do. What they’re doing is treating symptoms, not causes, thus ensuring lots more of that lovely money.

    You can’t, really, really, can’t, drug people healthy. And that ought to be a fundamental principle of medicine. By all means, address symptoms for the patients comfort but don’t stop there; seek the cause & address it. Unfortuntely, curing people doesn’t generate nearly the income that treating symptoms does.

  • QOF was well-intended and not unreasonable. However what was unreasonable was the failure of the NHS (or rather the Department of Health)to explain clearly that the project has been completely ineffective and that we must stop further interventions in people who are well. We have also seen recently a lively debate on the value versus the danger of the breast screening programme. The Department of Health is uniting to state that a policy has turned out to be wrong and should be stopped. Politicians: please note that we require more transparency.

  • Not just over-drugging for insignificant outcomes.
    The Cardiology Universe has been discombobulated by recent studies such as ORBITA which finally showed that an elective stent for single-vessel occlusion was no better than a Placebo – procedure.
    – After FORTY years of Best Practice. Oops!

    Then there is CABANA which rocked the foundations of catheter ablation to treat AF, compared with appropriate medication. Oops again.

    And we won’t go into ‘Renal Denervatin’, zapping a renal arterial wall to control BP.
    But guess what a suitable comment on latest results might be?
    Oops, again.

    Forsooth, the Patient needs to inform himself before falling into the grasp of these ‘Witch-doctoring Barber-Surgeons’ !

  • Fascinating and horrifying … and potentially illegal given it involves a clear conflict of interest (GPs being given payment to prescribe more) AND the lack of explanation and publicity AND given that all drugs have side-effects, the clear causing harm for no benefit.

    A cynic might suggest this is one way to shorten lives and so reduce the public pension liability!

    Meanwhile Prof. Sir Rory Collins continues to hide data on statins safety that would confirn whether they do any harm or good.
    As Ben Goldacre pointed out several years ago in “Bad Pharma”, hiding data on drug side effects leads to patients being harmed, maybe dying. These is NO EXCUSE for hiding this data now that many of these drugs are off patent.

    • Editorial

      Yes indeed. Re Ben Goldacre it is woderfully ironic that having pointed out so many sensible things that need to be done to make drug testing and marketing benefiocial to patients that he is one of the authors of a study that concludes that the widespread concern about the level of statin side effects is due to a reverse placebo effect – people expect problesms becasue of all the publicity abotut them that they start having them. The material that he relies on to come to this “no need to worry about statin side- effects” conclusion is one of the infamous statin trials the raw data for which is still firmly hidden away. Never rely on such trials, he cautioned and then went and did just that. Oh well, falling off the moral high ground in common in many professions. Catholic priests? For more details put Ben’s name into the search engine here

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