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GPs and patients 'misled on statin harms' claim top researchers

GPs and the public have been 'misled' by exaggerated claims about the harms of statins based on flimsy research, a team of leading international academics has claimed.

The team, led by Professor Rory Collins at the Oxford Clinical Trials Unit, have released a new review of statin data in The Lancet, which they said showed the drugs' benefits have been underestimated, while the side effects have been overstated.

Professor Collins' team said their new findings should help GPs and patients make 'informed decisions' about the pros and cons of statins.

But leading GP critics said the report would not allay their concerns that the drugs’ harms may outweigh their benefits as repeated calls for an independent study of all the evidence from statins trials, including adverse event data that have not been forthcoming. 

Professor Collins had been in a row with the BMJ over two articles that claimed muscle side effects were much higher than reported in randomised trials, while the BMJ has been blamed for stoking negative reports resulting in patients stopping the drugs.

The latest review, co-authored by an array of international cardiology and epidemiology experts, claims the observational studies about the effects of statin therapy - including those cited by the BMJ papers - are unreliable, and re-analyses all the randomised trials evidence published to date.

The re-analysis showed that for every 10,000 people taking the equivalent of atorvastatin 40mg daily  – lowering LDL cholesterol by about 2 mmol/L or 77 mg/dL – for five years:

  • 500 taking it for primary prevention would be spared a first ever cardiovascular event such as a heart attack, stroke or coronary intervention;
  • 1,000 with a history of vascular disease would be spared a further cardiovascular event;
  • The number of events avoided would be even greater with longer treatment.

Importantly the team said the benefits were much greater than commonly taken from many earlier randomised trials, where the average reduction in cholesterol was 1mmol/L.

Meanwhile, these benefits would be at the cost of just five additional cases of myopathy and between 50 and 100 new cases of diabetes.

Professor Collins conceded the review did not include the full 'hidden data' on adverse events, but said his team are continuing to seek from trials investigators.

However, the study claims that the ‘large-scale evidence available from randomised trials also indicates that it is unlikely that large absolute excesses in other serious adverse events still await discovery’ and is 'unlikely to materially alter the balance of benefits and harms’.

Professor Collins commented: 'Our review shows that the numbers of people who avoid heart attacks and strokes by taking statin therapy are very much larger than the numbers who have side-effects with it.'

He added that, given the side effects were reversible, ‘there is a serious cost to public health from making misleading claims about high side-effect rates that inappropriately dissuade people from taking statin therapy despite the proven benefits’.

But Dr Martin Brunet, a GP trainer in Surrey and member of the RCGP overdiagnosis group, who has previously questioned the value of statins in primary prevention, said the new analysis would not reassure concerned GPs.

Dr Brunet said: 'You can’t have a good debate about how much good and harm statins do if commercial companies are still holding back data.

'What I would really like is for something like a Cochrane review from an independent group, someone who doesn’t have their career based on this and can see all the data – that review, I might change my practice on.'

Dr Kailash Chand, retired GP and former deputy chair of BMA council, who is an outspoken critic of expanding statin use, said: 'If they want this paper to have any credibility they have to release the full data.'

Lancet 2016; available online 8 September

How the statin debacle unfolded

The controversy around statins in 2013 and 2014 coincided with widespread criticism of NICE’s decision to recommend millions more people take the drugs for primary prevention of cardiovascular disease, by lowering the 10-year risk threshold for primary prevention from 20% to 10%.

Leading UK doctors had urged NICE to backtrack on that decision warning it risked losing the confidence of the GP profession without better evidence to justify such widespread statin use, and the GPC called on NICE to pull back until full data on side effects from all industry trials were made publicly available for independent scrutiny.

Pulse revealed at the time that most GPs disagreed with NICE's decision - a survey showed nearly six out of ten rejected it outright and a similar proportion said they would not take a statin themselves at that level of risk, nor recommend a family member do so.

Around the same time Professor Collins publicly called on the BMJ to retract two papers that claimed the true rate of side effects could be as high as 20%, based on incorrect interpretation of previous observational research. The BMJ refused to retract the articles but corrected the cited side effect evidence - actually that around 9% of people may have discontinued therapy because of a statin-related event - and convened an independent panel that subsequently ruled the journal had acted appropriately.

The NICE guidelines were published unchanged albeit with some nods to greater emphasis on shared decision making and prioritising lifestyle advice. However, a recent study - ironically published in the BMJ - found all the controversy had led to some 200,000 people stopping their statins - potentially leading to an additional 2,000 heart attacks or strokes over the next 10 years that would otherwise be avoided.

 

Readers' comments (17)

  • As a patient tried on several statins which led to myalgia and joint pains for which I have stopped them myself - I understand why a proportion of patients stop taking them.

    However if no SE - then still believe they should continue as there are clear benefits.

    Just don't put them in the water supply, or insist all should take them - as ever informed patient choice should play a part.

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  • The Lancet paper does not contain any substantially new information or data. Many of the studies used in the analysis had run-in periods, “which means that people who complained of side effects from statins were excluded from the trial. For example, 35% of the statin users were excluded during the open-label run-in in TNT. Thus, the actual adverse events rate are certainly higher than in the trials. None of the CTT(Clinical Trials Unit) data has been made available to other researchers, despite multiple requests. All of this data is from industry sponsored studies, with concern for bias No one has seen these data except the trialists. The Oxford Clinical Trials Unit receives hundreds of millions of pounds of support from the pharmaceutical industry. Adverse events are underreported in these trials, as they do not ask about the common ones and many use a definition of muscle problems which requires a CPK increase, yet many patients have muscle weakness without CPK bumps. It is estimated that closer to 20% of statin users have muscle problems The higher estimate certainly reflects the many patients I saw when I was practicing, who are or were miserable when put on statins. As a matter of fact I have personal experience. My myalgia and fasciculation’s were so severe that I needed neurological and orthopedic intervention. All symptoms eased once I stopped taking Statins. Lancet paper definitely, exaggerates the benefits of primary prevention.

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  • Just release all the data!

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  • I heard Professor Sir Rory Collins being interviewed live on BBC Radio Scotland this morning. He was asked about potential financial conflicts of interest and chose not to answer this directly or fully.

    I remain concerned about the potential for significant biases from this Collaboration. We need full transparency and all data. Even then biases will likely be there.

    When the previous debate arose between Sir Prof Rory Collins and the BMJ I wrote to him to ask politely where I could find any financial declarations. I can share his response if there is wider interest.

    Dr Peter J Gordon

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  • The ABPI disclosure database, which is voluntary, is now open to all. I searched for Prof Rory Collins and had zero returns. One of a number of possibilities for this is that Prof Rory Collins may have no declarations to make.

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  • How many drug companies are paying those leading researchers?

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  • The BBC report suggested that the 30% non compliance was because of the negative pr, but isn't that a fairly normal rate?
    I've had many patients complain of myalgia- Not a controlled trial , just observational

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  • For those who have been around long enough I am sure you do recall young men particularly from the subcontinent dropping dead in their 40s and 50s
    I know we at primary care level have been much more vigilant on BP control, DM control and smoking cessation drives. But I honestly do believe that if I were to mention one drug introduced during my practice life that has made a difference to people's lives, it's the STATINS. I honestly can't remember the last time one of my patients having had a stroke. These were frequent occurrences in my early years in practice in late 70s and early 80s. I have been a strong proponent of statins from Day 1. In my own family with a very strong FH of IHD and we number 1000 over 4 generations spread globally I encourage everyone to start a statin as soon as they reach 50 irrespective of their lipid levels. I bet papers will come out showing the benefits of statins in delaying dementia, preventing ED and many other ailments. Tell me of one drug without a side effect. It's simply a cost/benefit analysis.

    My partners and other doctors at our practice may not share my views

    I have absolutely no interest in any pharmaceutical organisation

    Dr Nizar Merali
    GP Direct
    19,000 list size practice in Harrow

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  • I as a full time senior citizen single handed GP for many years, have seen/ know patients do devolope myalgia or muscle cramps, I do myself get them to a certain extent having taken it for 5yrs or more for primary prevention of CHD & CVA. Having seen relatives (mother CVA, brothers CHD) friends with severe incapacitating CVA I would rather take the statins than suffer a coronary or stroke,I firmly believe this from available evidence. As for funding, no research should be undertaken or published with Pharmaceutical involvement in any way ,let them(pharmaceutical companies) fund research via a central pool of money for research purposes by reputable researchers & publish the same in unbiassed way.

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  • Without"the full revelation of all hidden data, this is a pharma promotion and P-R exercise, - until proven otherwise.
    Trust in the double blind clinical trial continues to deteriorate.
    If the evidence base is manipulated in favour of pharma marketing, then it is inappropriate to assume the "guidelines" have scientific validity and cause greater benefit than harm.
    Reveal the hidden data and if any, reveal conflicts of interest.

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