How evidence based medicine is failing patients. What needs to be done to fix it

By Jerome Burne

It’s no secret that there are serious problems with the practice of scientific evidence based medicine (EBM). It’s obviously a good idea to have a system for ensuring treatments are safe and effective. But as a defence against dangerous or poor drugs, the working of our current one makes the pre-crash banking regulation look rigorous. 

Even EBM’s most energetic defenders are eloquent about its failings. Recently Lancet editor Richard Horton wrote an editorial about a symposium held in London on the ‘reproducibility and reliability of biomedical research’.  

“The case against science is straightforward,’ writes Horton ‘much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest … it has taken a turn towards darkness.”

But there is a more serious flaw. Even if tightened regulations could improve the testing, that does nothing to address another growing problem.  More drugs are not the solution to the rise in chronic diseases that’s threatening to bankrupt health services. However, demanding the same large randomised controlled trials (RCTs) used for drugs, to assess the benefits of lifestyle changes will simply reinforce the drug-driven status quo.

Why better RCTs are not the answer

Ben Goldacre energetically catalogued the failings of evidence based medicine as it related to drugs companies in his book Bad Pharma in 2012. Three years on there is still major problems. Last month he wrote in the BMJ:  “Well documented problems exist in the funding and prioritisation of research, the conduct of trials, the withholding of results, the dissemination of evidence, and its implementation with patients.”   (Link behind a firewall)

Goldacre among many others believes that fixing this litany of failings would deliver a true scientific system that could do the job. But the elements of heathy lifestyles that need researching don’t carry anything like the same risks and are not dominated by the marketing pressures that distort drug research. Relying on very expensive RCTs to test them is both unnecessary and impractical since only drug companies have the resources to pay for them so they won’t be done.

Even if charities or the government dug deep into their pockets and began to run many more RCT’s on lifestyle changes, they are the wrong tool to use. The lifestyle approach we need to integrate much more effectively into medicine doesn’t involve just changing one thing – drug or no drug – it involves doing lots of things at once – for example: different diets and more exercise combined with psychological techniques such as stress reduction. RCTs have difficulties with such multiple interventions. Yet when they are tested they often turn out more effective than drugs.

Recently I visited the surgery of a pioneering GP and had a glimpse of how patients’ experience could be transformed when a doctor spots some of EBM’s absurdities  and begins taking lifestyle changes seriously.  There was a big difference between the protocols demanded by EBM and his approach. He gets his patients involved in their health by finding out what life style changes they feel they need to make.

Disenchanted with evidence based medicine

Dr David Unwin is a GP in the Liverpool area who has become increasingly disenchanted with what he calls the “religion” of EBM. ‘When it was first arrived I bought right into it,’ he says. ‘Thought it was absolutely what was needed to prevent drug disasters like the claim that HRT protected against heart disease rather than causing it.’

But increasingly he feels it has less and less relevance to what is actually going on in his surgery. GPs prescribing options are constrained by the supposedly EBM guidelines which tell doctors which RCT-approved drugs to prescribe for each condition, often when a biomarker reaches a certain level.

But this number is an average and takes no account of the individual differences.  ‘If your blood pressure goes above 120/80, I’m supposed to put you on hypertension pills,’ says Unwin. ‘But I can measure your blood pressure on three different occasions and get three different values. Which one should I treat? And it gets even less clear. A placebo study found that blood pressure  could vary a lot depending entirely on whether the patient had been told  his level was fine and healthy or too high and he needed treating. What’s also needed is clinical judgement.’ 

It’s worth pointing out that Unwin is no isolated maverick. He’s an advisor to the Royal College of GPs on setting guidelines and last year his surgery was shortlisted for BMJ awards for both Diabetes Team of the Year and Primary care Team of the Year.

Drugs tested on the wrong people 

Another factor that makes the guidelines far from scientifically precise is that RCT trials are usually done on people who only have one disease. But as Unwin says: ‘Almost none of my older patients have just heart disease or just diabetes they often have both and some more. So how are those trials relevant to the patients I see every day?’

And this brings up the ironic fact that the logical result of applying evidence based guidelines to patients as they get older and sicker – the group that consume most of the drugs – is that they are soon being treated in a way that has no evidence underpinning it at all. The term for this is polypharmacy. No trials have ever or will ever be done on people with four conditions getting a total of 12 or more drugs.

What’s missing from the stack of guidelines, Unwin suggests, is one for ‘de-prescribing’ – how and when to take patents off some of their multiple drugs. ‘But who’s going to run large RCTs on giving fewer drugs?’

But the problem is not just that EBM doesn’t deliver what it promises. Rather than being a scientific way to discover what benefits patients, whatever the form it comes in, EBM has resulted in drugs becoming the main focus of medical research, with RCTs the tool for licencing them.

For years researchers and doctors when asked what research they would like to see say more investigation and testing of non-drugs treatments. This has simply been ignored. Not because there is something unscientific about it, but because non-drug treatments rarely make as much money.

Trials don’t test for things patients want to know

A recent study found that over the last decade 86 percent of commercial trials registered in the UK involved drugs. When doctors and clinicians formed partnerships, a project organised by the James Lind Alliance, just 18 percent of the research they initiated was drug based.

In a genuinely scientific system the lack of good trial evidence for nutritional and other lifestyle approaches to prevention would be a cause for outrage not a justification for usually paying them lip service before issuing the drugs. The idea it is safe to assume it can be largely ignored is absurd

Dr Unwin’s growing scepticism about guidelines meant he was increasingly prepared to trust himself. ‘I realised that if chronic diseases such as heart disease diabetes and cancer are the greatest health problem facing us, then  handing out pills according to guidelines was increasingly irrelevant. Chronic diseases, as everyone acknowledges, are largely caused by unhealthy lifestyles. We don’t need more pills we need to get a lot smarter about the way we go about changing people’s behaviour.’

A couple of years ago he began to apply these ideas to the treatment of diabetics. Having become impressed by the evidence  that a high fat low carb, Atkins-type diet was a more scientifically based way of treating diabetes than the official advice to eat little fat and lots of carbs, he faced the challenge of persuading his diabetic patients to switch and start eating lots of the long demonised saturated fat.

A level playing field between doctor and patient

‘I realised there had to be more of a level playing field between me and my patients. We had to balance evidence based medicine – you come with a problem; I give you a solution – with evidence based practise. That means drawing on my years of clinical experience, rather than just relying on guidelines, and applying it to patient’s own experience. They are the expert on their lives, what they need and what works for them. Without taking that into account you are not going to change anything.’

More details of Dr Unwin’s project can be found here

The results were remarkable. Patients who had been following the evidence based guidelines for years and had remained obese and diabetic not only lost a lot of weight but also either significantly cut their drug intake or stopped taking them altogether.

A crucial element in the project was a psychological technique called ‘Solution Focused Practice’. Essentially this means rather than concentrating on the patient’s problems and then offering a solution – usually a pill – the doctor asks the patient what would make the situation better.

This then opens the way to talk about what they could do to achieve that goal. That was combined with the option of joining a group for weight loss and or diabetes held in the surgery. ‘I used to go along with some of the other surgery staff,’ says Unwin.

 ‘I was surprised at how powerfully effective it was. Until then I had totally given up on trying to get patients to lose weight. It never worked. Now I have a way that does. I’ve used it on 100 patients who are obese and have at least one other condition. The average weight loss over a year is 9 kg.’

So thinking outside the EBM tick box achieved impressive results in the treatment of obese and diabetic patients using by using multiple interventions:  offering a diet that was the opposite of the recommended one, finding out how they wanted to change their lives and then supporting them to make them.

Cancer drugs get an easy ride

Does Dr Unwin’s radical approach, which just looks like good medicine, really need large RCT trials to prove it works? And even if there were and they did, how widely would it be used? Trials of the sort demanded by EBM show that the Mediterranean diet protects the heart better than one that cuts out fat, cognitive behaviour therapy is more effective for depression than anti-depressant drugs and better and safer for insomnia than sleeping pills. Yet which treatments are more widely used?

Under EBM’s current regime RCTs are not often run on non-drug treatments and when they are and are shown to be safe and effective, they are commonly ignored. So when patients, worried at the prospect of a life-time on drugs, ask if there is anything else that works they will be told – not any evidence based treatments. That’s why EBM in its present form is not fit for purpose, which should be to test any treatments that look safe and effective.

Instead what it does very well is keep them out by making a distinction between supposedly scientifically tested drug medicine and unscientific non-drug treatments which can then be dismissed as “quackery”, relying on anecdote and the placebo for any apparent effects.

And nowhere is the scientific/quackery boundary policed more vigorously than in the field of cancer where RCTs costing £100 million-plus provides the stamp of scientific approval for a new drug. But just how rigorously scientific is the testing? A lot less than drugs in other fields according to a recent BMJ article titled: ‘Why do cancer drugs get such an easy ride?’.

EBM not delivering

A review that looked at nearly 9000 trials of cancer drugs, run between 2007 and 2010 found that compared with drugs for other conditions, they were  nearly 3 times more likely not to be randomised, 2.6 times more likely not to be compared with any other treatment and 1.8 times more likely not to be blinded. 

‘The result,’ writes the author Donald Light, professor of comparative health care and an economic and organizational sociologist at Rowan University School of Osteopathic Medicine in New Jersey, ‘are cancer drugs that offer few significant benefits for patients.’ Between 1995 and 2005 the 71 drugs licensed for solid tumours in Europe improved survival by a mean and median of 1.5 and 1.2 months respectively.’ That is the kind of results that EBM is delivering.

Now of course showing that it’s drug companies, rather than patients, who benefit hugely from this light touch regulation does not show that cancer treatments without RCTs are effective and safe. But what it does suggest is that dividing cancer and other treatments into scientific and non-scientific is misleading and not beneficial to patients since the system ensures that however promising the  ‘non-scientific’ ones (which also happen to be the ones lacking the  commercial potential needed to trigger a large trial) stay on the shelf.

We need ways to test treatments but EBM in its present form isn’t delivering.  One final example: Statin drugs have been used for over 20 years, they are the most widely prescribed drugs ever, they have been subject to a vast number of RCTs and yet last month the Chief  Medical  Officer called for a committee to be set up to decide if they were safe and effective or not.

Twenty years and still no answer?

The James Lind research shows people want something different, so does the massive use of the internet to track down information on health. What’s needed is a move away from the sterile debate: scientific vs. not-scientific, greater non- commercial involvement in testing and investigations to discover techniques besides RCTs that can deliver reliable information about lifestyle change. 

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.

15 Comments

  • Bravo what a really good article thank you thank you. I think something else needs to be checked into and that is the fact that over the last 40 years the definition of illnesses has been lowered and lowered. typically by panels of members where in the vast majority have direct financial ties to the pharmaceutical industry. these members directly benefit financially when they can bring down a guideline. For instance high blood pressure now it is 1:15 whereas over 40 years ago it used to be 100 plus your age: semicolon I’ve read that blood sugar I eat fasting blood sugar if it were below 200 you were not considered diabetic. now it has to be under 100 for doctors to not push pills on you. I don’t understand why doctors don’t understand that most heart medications damages your body in so many ways and one of the main damages is the body’s ability to metabolise sugar. so it is not a coincidence that somebody who is labeled with high blood pressure, then takes medications for add many times will eventually develop diabetes. or should I say quote unquote diabetes. Because that number keeps getting lower as to what is really defined as diabetes doctors need to stop fear mongering their patience. I myself was placed on high amounts of high blood pressure medications and developed various symptoms which were tested out to be diabetes. I asked my doctor whether or not the blood pressure medication had anything to do with the high blood sugar I got silence. later through internet searches I began to see that this was true . I later kept forgetting to take the high blood pressure medication not meaning to blood sugar at that time with an average of 50 3 it fell to an average of 145. got off the diabetic medication and it fell further to 142. I have read on another medical page that doctors 40 50 years ago for happy if your a1c was below 9.0. I no longer take medication of any type. And I’m having a really hard time trusting doctors but wish to push that on me. I had also developed rheumatory arthritis later I found natural ways to get rid of it. it took over a year for me to get my health back. one should not go to a doctor and fear that their health is being placed in jeopardy.

  • That is a great article, but unfortunately the very first paragraph of the Guardian article to which you linked, gives the game away:

    “The chief medical officer, Sally Davies, has requested an expert review to shore up public confidence about the safety and effectiveness of medicines, in the wake of controversy around statins and Tamiflu.”

    Anyone who has been burned by statin drugs knows just how insane it is to use these on well patients for prevention – so a review, no-doubt chaired by the same people that insist that statins are safe, isn’t going to help – or am I being too cynical?

    Furthermore, that review will certainly not probe the deeper scandal – that there is no worthwhile evidence that levels of blood cholesterol (or LDL/HDL) has much to do with cardiovascular disease!

    I wish everyone would read Malcolm Kendrick’s book, “Doctoring Data”, because rather than shoring up up confidence, I feel medical research will only change after it is totally shamed.

    • Editorial

      Agree my point about the review was that it was a sign of the systems failure not that it would produce a sensible conclusion. Also great fan of malcolm k.

  • Great article.

  • It is so heartening to see that skepticism is alive and well in Medicine. I have been spending most of my consultation time focusing on food and lifestyle. I now have over one thousand patients on a low carb/ high fat diet and the results have exceeded anything any drug regimen could do.

    Seeing the reversal of T2D has been the most gratifying, meaning that not only was there weight loss but the patients typically can dump 3 or 4 drugs as well. The fact that this is not our FIRST approach to all patient non-surgical care is an indictment on the Eminences and their strict adherence to their EBM RCT banks of data: er, money

    • do Dr I am so pleased to hear that you are reversing diabetes with your patients. please forgive grammar and spelling errors this is being done on a phone. when I asked my doctor how can I get rid of type 2 diabetes she laughed hysterically at me. I was left on my own and that’s result suffered a great depression. the only thing that got me out of it was reading books and doing internet searches at finding out that type 2 diabetes could possibly be reversed. my diet and exercise lifestyle has never been very bad not very good but also not very bad. so I wondered why in the world did I get this. The only thing that I could look upon was to see that I was taking a high dose of high blood pressure medication. When I looked at the side effects every symptom related to diabetes was listed on the side effects of the high blood pressure medication. my fasting blood sugar prior to taking high blood pressure medication was 91 after about 6 months of taking high blood pressure medication it went up to 394. I knew something I knew that this had to be the link but my doctor was reluctant to confirm that with me when I asked whether or not perhaps the high blood pressure medication has anything to do with my height I got silent.what’s really met mean about this is that now I have to my research I come to find out that most likely my doctor knew that there was a connection but would not speak of it. Instead I was given another high blood pressure medication and was told that it was necessary to take the metformin for my kidneys. However I was not told it was high blood pressure medication I did not know this. what got my blood sugar back down to what I consider a normal range because as you know normal keeps getting be defined as a much smaller and smaller parameters. maybe, was that I kept I kept forgetting to take the high blood pressure medication I just kept forgetting to take it I didn’t forget to take the metformin but I kept forgetting to take the high blood pressure medication my blood sugar dived down from 503 a1c I mean 16.5 a1c 26.3 which is 145 blood sugar count.s

      what’s infuriating to me about this is that the metformin most likely caused me to develop rheumatory arthritis. drugs for that are very dangerous to the body. may remedy the arthritis but causes almost every other thing to go wrong with you. I have sent found a natural way of dealing and getting rid of the arthritis. But for the first time in my life I understood why piano players you have arthritis stop playing the piano it was painful for me to type at work. Now I’m back to normal and that’s gone but it took about a year to get rid of that.

      for diabetes personally I do a lot of organic green smoothies with little bit of fruit I also try to keep up my exercise I’m no longer feeling depressed I feel great now God felt as if I was being given a lifelong sentence with diabetes and it does not have to be that way I am so happy to hear the doctors like you are becoming more MORE the more more doctors are doing this. I belong to Kaiser well that won’t happen there they receive way too much money from the pharmaceutical industry really want to make anyone well.this is evident to me and the fact that premium switch were under $60 an early 80s have more than 10 times increase my premiums are nearly $800 a month. I’ve read that the higher ups and Kaiser pay themselves double-digit million-dollar salaries. thank you for your good work thanks to hear the doctors out there like you

  • Karen,
    Eat a Paleo Diet (vegan Paleo is best)
    Walk 3-5 miles everyday
    Drink 3ltrs of water everyday
    Do not sit down for more than 3 hrs in total over the day (walk, stand or lie down)
    Make sure you get at least 3 teaspoons of unprocessed rock salt or unprocessed sea salt everyday
    And your health troubles will be over within 60 days. You only need a Doctor to confirm they are gone.

  • Dear dr.thank you for the advice. whenever I have heard of Paleo I have always associated with a lot eating of meat. once again forgive my phone it makes very weird mistakes. the story I told you was approximately 4 years ago. I was able to remedy my problem within a six month period. I thank you for your encouragement. I’m writing this after having walked in Griffith Park for about an hour and a half.

    Idid have a very intense conversation with my doctor once I saw her another 6 months after I was much better.I basically told her that I could not believe that a doctor would prescribe heart medications knowing full well that these medications damage the body’s ability to metabolise sugar. and that also the net effect or rather the net positive effect of taking blood pressure medication only lowers your chances of having heart disease find absolute value of 1%.

    anyway I don’t wish to rattle on about that topic I wanted to advise you to look into intermittent fasting. in my religion we try to fast at least one day a week. I began to notice that of course my numbers would be down the day of fasting but they were also still down the next day with eating food. I have read that fasting increases I’m sorry rather decreases insulin resistance. there are two doctors who highly recommend intermittent fasting and they are Dr Mark Hyman and dr. Joseph Mercola.

    I currently try to exercise every day a little bit at least a half an hour and several times a week exercise much more intensely. I have also increased the good fat in my diet such as coconut oil and I do use salt that’s the Himalayan salt. I highly recommend green smoothies with a little bit of fruit. this drink makes me bright eyed and bushy tailed meaning that it gives me a lot of really good energy and I find I don’t get coffee to do that for me. also I noticed that I don’t get colds and flus as often as I used to and when I do they’re not as severe or as long as they used to be. let food be thy medicine and medicine be thy food. Live long and prosper and keep up the good work thank you

  • also Dr what scares me about going to a doctor is that you can so easily be labeled as being sick.the parameters of being well keep getting better over and over. I really don’t like getting into arguments with doctors regarding this. some of the older doctors to remember but blood pressure used to be 100 plus your age, fasting blood sugar was great as long as it was below 200, and cholesterol was 200 plus your age. I’m not going to try to hit a number but I will try instead foritfy my diet an exercise routine. as long as I am not feeling symptoms I am NOT going to be concerned.

    doctors have in the past get the hell out of me and it cost me to go into great and deep depression which I’m afraid to even tell him that because then they’ll try to shove and a depressant drugs on me. as I tell people this is not a healthy planet and we are given difficulties in order to grow and become better person more humane towards each other. planet Earth is not a pleasure cruise.

    I also meditate and it helps both to lower stress and find appropriate solutions to life’s problem s. it also helps to understand what’s going on and from that understanding you develop a better way of handling it. I am more healthy and happy tonight then before been denounced as being sick. and receiving a life sentence with no view of parole. once again thank you for the good work that you are doing.

  • some corrections: the parameters of health are being lowered down lowered or rather it’s a shrinking target. when I said healthy planet I meant happy planet. it’s hard to proofread on the cell phone.

  • One factor the skews the political influence on what is researched and how the research is done is the institutionalised lobbying by the pharmaceutical industry at the heart of Government. As it says on the Gov.UK website

    ‘The Ministerial Industry Strategy Group (MISG) brings together government and the research-based bio-pharmaceutical industry to promote a strong and profitable UK-based bio-pharmaceutical industry.’

    Role of group
    The MISG is co-chaired by the Secretary of State for Health and the Chairman of the British Pharma Group, and aims to promote a strong and profitable UK-based bio-pharmaceutical industry capable of sustained research

    Membership
    Rt Hon Jeremy Hunt (Co Chair)(Secretary of State for Health)
    Rt Hon Earl Howe (Parliamentary Under Secretary for Health Quality)
    Rt Hon David Willetts (Minister of State for Universities and Science, Department for Business Innovation & Skills)
    Lord Deighton (Commercial Secretary to the Treasury)
    Stephen Whitehead (Association of the British Pharmaceutical Industry)
    Tim Edwards (BioIndustry Association)
    Deepak Khanna (Association of the British Pharmaceutical Industry)
    Haruo Naito (Japanese Pharmaceutical Group and Eisai)
    John Young (American Pharmaceutical Group)
    Dr Pascal Soriot (AstraZeneca)
    Steve Bates (BioIndustry Association)
    Patrick Vallance (GlaxoSmithKline)
    Ulf Wiinberg (H Lundbeck A/S)

    Terms of reference
    The Ministerial(Bio-pharmaceutical)Industry Strategy Group (MISG) will bring together government and the research-based bio-pharmaceutical industry to:

    promote a strong and profitable UK-based bio-pharmaceutical industry capable of sustained research, development and manufacturing that should lead to the future availability of new and improved medicines
    lead on the strategic development of the UK environment and foster a transparent relationship between the NHS and bio-pharmaceutical industry that will facilitate joint working for the benefit of patients and improve public health, and support the appropriate use of innovative medicines
    provide a forum to discuss how the UK Government can be a leader in promoting the health and economic benefits of a strong biopharmaceutical industry in Europe and the rest of the world and also attract inward investment to the UK
    to monitor progress of the above and ensure that resources are deployed by Government and industry in a timely manner to realise the dual goals of maximising healthcare outcomes for patients and stimulating economic growth
    The MISG will be co-chaired by the DH Secretary of State and the chairman of the British Pharma Group. It will include standing membership from ministers at BIS, HMT and industry members, largely in above-country roles, representing the research-based sector. The trade bodies ABPI and BIA are also represented and other ministers, government officials or industry personnel can be invited to attend as a guest.

    MISG will meet at least once a year. The secretariat will be provided jointly by the Department of Health and the British Pharma Group.

    The membership of the MISG, and its terms of reference will be reviewed every 2 years.’

    To read the minutes of their meetings go to:
    https://www.gov.uk/government/groups/ministerial-industry-strategy-group

    In other words the political direction of healthcare research is skewed in fave of anticipated drug company profits.

    • Editorial

      Fascinating/alarming to see in detail just how warm the government/pharmaceutical embrace is. Does seem all of a piece with current critique of industry in general being developed by likes of Will Hutton (see observer today) who highlights the massive increase in percentage of profits going to shareholders in recent years. Companies become vehicles for enriching shareholders and short-term profits – and in in the case of this relationship for achieving targets in employment, exports etc. Not much of a patient or indeed medical voice in there. Allowing in the development of treatments that are not going to do much enhance shareholder value, whatever they may do for patients, does seem a steep mountain to climb while these high level lobbying get togethers set the direction of travel.

  • Typo: fave in last line should have been favour

  • Does rock salt lower blood pressure. On meds for high blood pressure but want to come off them. What can I do. Take various supplements and do low carb but nothing is working. Stopped the meds but went back on them because blood pressure went up and got a really fast heart beat and felt unwell. Thanks

    • Editorial

      See earlier answer. Following a non-drug approach is not like doing drugs – i.e. taking a couple of pills of a different sort to fix the problem – it is about doing a number of things that improve the way your system works in general, which are likely tol help with a specific issue (blood pressure) and may very well clear up some other problems as a bonus. Any competent nutritionist will help. I would recommend a clinical nutritionist rather than a dietitian.

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