Drug killing 10,000 in UK every year. How could you tell?

by Jerome Burne

Last week an email containing what looked like a great story arrived in my inbox – drug kills 800,000 in Europe in 5 years! A quick check revealed that that this was no wild or dodgy claim. It was based on research by a cardiologist at Imperial College Professor Darryl Francis, just published in the European Heart Journal.

What’s more it had been covered in a blog on the site of top business magazine Forbes; the icing on the scandal cake was that within an hour of Francis’ paper going up on the website of the journal that published the paper, it had been removed on the grounds that due to an oversight it hasn’t been peer-reviewed. A cover-up getting underway?

So here, it seemed, were all the hallmarks of a big new drug scandal. And the more I dug into it, the more solid it became. The drug involve was a beta-blocker – a type of drug prescribed in large numbers to heart patients and people suffering from anxiety because it slows the heart rate and lowers blood pressure.

Drug making things worse

Used in this way they are generally considered safe, but when used during an operation to cut the risk of subsequent heart problems – a well-known side effect of surgery – evidence dating back years strongly suggested they make things worse. In fact according to the Imperial College research, this use kills 10,000 people a year in the UK alone.

The key evidence that they were dangerous came from a controlled trial involving 10,000 patients, published five years ago in the Lancet by Canadian researcher Professor Philip Devereaux. In an interview he told me that although the drugs did cut the number of heart attacks, they pushed up the death rate by considerably more and so shouldn’t be used for prevention in surgery.

However guidelines saying that, taking other evidence into account, they should be used for precisely that purpose from the prestigious European College of Cardiology (ECS) were still an official recommendation.

And as if this wasn’t enough to constitute an ongoing scandal, the final part of the story, as set out in Professor Francis’ paper, was that the research supporting the use of beta-blockers in surgery was discovered, in 2011, to be either partially missing or obviously fraudulent.

Conflict of interests?

This was deeply embarrassing for the ESC because the favourable research had been done by Dr Don Poldermans of the Erasmus Medical Center in Rotterdam, who was the Chairman of the ESC’s Committee that had drawn up the guidelines.

Under Poldermans’ leadership the committee had decided that his research – finding the drug cut the death rate – cancelled out Devereaux’s paper finding that it increased it, leaving an agreement by both papers that beta-blockers reduced non-fatal heart attacks and so they were worth taking.

So the big scandal was – once the only bit of research showing that beta-blockers were worth it had been totally discredited nearly four years ago – why were the ESC guidelines still advising medical teams to use the drugs during surgery? It looked as if as many as 50,000 people in the UK alone could have died in the intervening period as a result of these highly misleading guidelines remaining unchanged.

But after getting all my ducks lined up in this way, the following day I decided not to write the story. Not because any of the facts I have set out were found to be wrong but because I couldn’t prove that the drugs were being used in this way in the UK. What I was left with was a story that showed just how unreliable supposedly evidence based medicine could be.

When doctors are personally liable

There was one more thing I discovered that, at first, seemed to make the story even stronger. It turned out that using beta-blockers to cut heart attack risk during surgery is not a licenced use in the UK. What this means is that the doctor who does this has to have reasonable evidence it could help and is personally responsible if something goes wrong.

(Drugs are licenced to treat particular conditions – pain, seizures– and if doctors use them to treat a different condition – a seizure drug to treat pain – they are then using the drug “off-label”. It is done quite often and there is a good clinical case for it but it means that the drug watchdog – the MHRA doesn’t collect any data on reported side-effects, so if there’s a problem, it’s very hard to detect it.)

So if beta-blockers were being regularly used in this way based on the unchanged ECS guidelines that could mean that large numbers of doctors could be personally liable for those 10,000 extra deaths a year. This was a prize-winning investigation!

But that only mattered if doctors in the UK were actually using the drugs in this way and I couldn’t prove they were. Several top cardiologists told me that while American and Europeans clinicians do it, UK doctors, having looked at the evidence, had decided not to.

Decision that could kill patients

They could of course be lying or simply wrong but because use of the drugs would be “off-label it wouldn’t be centrally recorded. That left no realistic way to check the extent of use, which killed it as a UK newspaper story. Who cares if a drug could be dangerous if no one is actually using it?

What was left was a big question mark over the way that evidence based medicine actually works. What about the role of bodies drawing up guidelines? Are there millions of people still getting treatment with a drug that raises their risk of heart problems because no one has changed the guidelines for years? Whose responsibility is it to alter guidelines when evidence changes? Surely not a UK clinician analysing the latest evidence?

In response to my queries the ESC claimed it had acted as fast as it could. But then during the two years between Polderman’s dismissal and publication of Francis’ paper last year, what was the evidence-based course of action? To give beta blockers and so saving lives according to guidelines or not to?

From what the UK physicians told me they look like the good guys. But it’s not that simple. They said they had decided not to use beta-blockers about ten years ago. But how could they have done that? Back in 2003 Polderman’s work looked like a strong reason to give the drugs. From evidence based perspective the UK physicians’ decision was going to kill patients by withholding the drug.

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.
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3 Comments

  • “They said they had decided not to use beta-blockers about ten years ago. But how could they have done that?” Just speculation, but could there already have been doubts about Poldermans’ integrity?

    • Editorial

      Well sure it is certainly a possibility but that is my point. Either you have a sort of informed free for all with experienced clinicians (and presumably some not so bright ones) saying don’t think this work is very sound, going to ignore these guidelines or, as we supposedly have.an evidence based system where people run proper trials, experts study them and on that basis draw up guidelines that everyone is supposed to follow. I may have missed something but my understanding is that that is supposedly the difference between the evidence free world of complementary medicine where people do make their own decisions without any proper evidence and real medicine where is all tied down and based on evidence. The point of the piece as to say that at times it looks as if the decision making process in proper medicine looks remarkably evidence free.

      I think that is inevitable, that you can’t legislate for every eventuality in biology, that you have to say we will take what we can from studies and then use our judgement to do what we think is best for individual patients. The point being that that is precisely what clinicians using CAM medicine also do.So could certain cheer leaders for “evidence based” medicine stop claiming the scientific high ground and acknowledge this reality.

  • They nearly killed my uncle with a drug for his Arthritis infection. He then got really bad lung/kidney damage and nearly died.

    I was also at 39 told I did not have a serious chest infection, “go home and stop whining”, (lol my words, Doc pretended he cared). I don’t run to surgery at every opportunity, had not had out of hrs doctor for 25 yrs, my mum worked IN This surgery for 15+ yrs so they KNEW I did not malinger etc. On trying the anti biotics, they did not work, I got unable to breathe, dragged myself to surgery with a friends Oxygen bottle as was unable to drive myself, walk 20 feet without a breathing attack. So he checked lung, temp and said nothing really wrong, go home relax take more anti biotics ( I was also being sick/trots & had not drunk for 3 days, eaten for 8 days). On returning home as was too weak to argue, I collapsed, and emergency ambulance was called, admitted to hospital told I had lung infections/pneumonia and had irreversible lung damage.

    Does anyone think I should sue my doctor, as was unable to climb stairs, when I was a 38-39yr old fit guy when this happened. Now I use a salt inhaler/silver colloidal water/High VIT C, Good natural Vits/Minerals and a decent diet, getting better quality food all the time as it IS Working. I’m getting less than 6-7 Chest infections every year, and don’t need 5-6 courses of steroid (prednisolone) and anti-biotics every month/6weeks.

    I was truly dying and none of the medical ppl really cared, they are so demoralised by the corruption/budget cuts, poisonous drugs they have given up, but still take the Cash.

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