Millions of us have a problem sleeping; it’s one of the top reasons for GP visits. Unfortunately for insomniacs the way it is generally treated provides a vivid case history of why our current system of evidence based medicine needs a radical overhaul.
The dream of improving medicine with system that would separate good treatments from bad has become a nightmare. If it was being used to regulate the white goods market, the like of Which?, magazine, the BBC radio programme You and Yours and a host of irate consumers would have had it dismantled years ago.
My feature on sleeping pills in the Daily Mail yesterday pointed out the wickedly familiar scandal of the million plus patients addicted to these drugs and then described several of the new risks that have recently emerged – Alzheimer’s, cancer and a raised risk of dying early. I don’t plan to rehash the article here; instead I want to set out four reasons why the system that delivers such a lousy and dangerous solution is in drastic need of a change.
The built-in drug bias
Insomnia – like other psychological disorders such as dementia and depression, along with weight problems and diabetes – is treated with drugs that can cause various nasty side effects. Addiction in the case of insomnia – heart problems, diabetes and suicide for the others.
This would be understandable if they were all acute life threatening conditions needing emergency treatment but with the exception of dementia, which is a special case, they are all chronic and frequently mild. What’s more they all respond well to non-drug therapies that have none of the risks ,such as stress reduction, cognitive behavioural therapy (CBT), specific dietary changes and other lifestyle changes.
A system that is supposedly designed to tell you which treatments are the most effective and safe that delivers such unreliable results is obviously badly in need of an overhaul.
The “there’s nothing else” myth.
In the case of insomnia, NICE has been advocating CBT (Cognitive Behavioural Therapy) for decades with no impact on prescribing. Until very recently a valid excuse was that the waiting lists for CBT were counted in months. So they handed out the pills because they were reluctant to let patients leave the surgery empty handed.
This can be seen as an understandable human response, although it’s not one that carries much weight with those evidence based medicine campaigners who hound practitioners offering CAM treatments that make patients feel better. The same excuse is given for prescribing the drugs when faced with difficult Alzheimer’s patients or when kids are exhibiting oppositional behaviour, despite similar evidence of harm.
The point is that “not having anything else” is a short-hand for “not having a different or better drug”. And this highlights another major failing of the way the evidence based model works in practice. So long as a drug has a licence, doctors are following evidence based principles if they prescribe it.
The fact NICE recommends they try something else that is at least as effective and far safer doesn’t detract from that. And no official body has the responsibility to ensure these guidelines are followed.
The claim that non-drug treatments don’t have the evidence
With a few exceptions, such as CBT for both depression and insomnia, the other non-drug treatments for these psychological conditions aren’t backed up by large scale trials. What this highlights is that if there are drug treatments that are known to be poor and possibly dangerous, there is no incentive in the current evidence based system to develop anything else.
In fact far from there being “nothing else” for insomnia there is a wide range of options and experts in the field agree that used properly and combined in different ways they can be very effective. Besides CBT, relaxation techniques can help promote sleep, as can natural supplements that increase GABBA – the neurochemical that is also targeted by all the drugs because it damps down nervous system activity.
But GABA isn’t all that promotes sleep, so does the neurotransmitter serotonin and that too can be increased using a natural supplement rather than a drug. The mineral magnesium promotes relaxation, while the herb Valerian has some studies showing it promotes sleep.
Could a combination of some or all of these help most people without exposing them to a range of serious risks? Almost certainly. Is research being done to find out what works best? On a tiny scale compared with the spend on new drugs. The current evidence based system comes with virtually no incentive to fund large trials of treatments that are non-patentable.
Benefits outweigh the risks but how can you tell?
When asked about the dangers of insomnia drugs, or any others, doctors will say that all drugs come with side effects but that the licencing system ensures we only get ones where the benefits outweigh the risks.
But even if you assume that twenty or thirty minutes of extra sleep (a benefit which soon fades) is worth chancing the considerable dangers of addiction that equation is now changing. Even with caveats about needing further trials, the latest findings linking the drugs with the likes of cancer and Alzheimer’s pile more weight on the risk side.
However the evidence based medicine system offers no guidance to the intelligent drug user about what a rational response would be. Presumably the right thing to do is to wait for an ex cathedra statement from the drugs watchdog that the risks now outweigh the benefits. But that can take a while. The raised risk of heart disease from the diabetes Avandia drug prompted no action or warning for three years.
Or do you say “enough already” and decide to find out if relaxation, supplements and herbs work for you regardless of the size of the evidence base?
Just jeering at non-drug treatments for their lack of evidence, especially when drug company results are known to be so distorted is no longer credible or in patient’s best interests.
Body of Evidence 
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