Put patients on drug company boards

Your risk of developing Alzheimer’s could be increased by having high levels of glucose and insulin in your blood – one of the results of a diet high in sugar and refined carbs that’s linked with insulin – see my feature in the Daily Mail on Tuesday.  But how likely is that to be the subject of a major clinical trial?

 It’s going to be a while before the link is firmly grounded in research but it comes with convincing pointers. In fact it’s especially active in the hypothalamus where memories are laid down. When our brains response to insulin gets messed up by a constant high carbohydrate diet, plaques can start developing.

If further research supports this idea it’s yet another reason to eat the kind of Low Glycaemic Diet we advocate in the 10 Secrets of Healthy Ageing. Meanwhile bodies that fund research would be setting up a large scale program to refine the diet and find how best to combine it with exercise to keep insulin in the brain at a healthy level. Wouldn’t they? The answer of course is almost certainly not.

The reason is drearily familiar  – most clinical trials are run by drug companies and their interest in lifestyle and non-drug treatments is about as keen as Bob Diamond’s interest in the Co-op bank. But just possibly the intellectual climate may be changing. I was struck by an article that appeared in Nature last month entitled “Therapy Deficit”  complaining about exactly the same scenario at work in psychiatry. A massive concentration on brain and genetic research aimed at generating new drugs at the expense of anything else.

New treatments psychiatry, diabetes and Alzheimer’s are badly needed but psychiatry already has proven non-drug treatments available – psychotherapy and CBT (cognitive behavioural therapy). However, as the Nature paper points out, there is a relatively easy research project that could improve them, possibly dramatically, but at the moment it is not going to be done.

There is a big database that records who has had various forms of therapy and what the outcome was. Analysing it could provide valuable clues to what elements make the treatment most effective. In this case it’s not the drug companies but the government that has blocked using funds for that purpose. The good news is that such a blinkered approach is becoming less acceptable.

When it comes to diet and life style approaches to diabetes (and possibly down the line to Alzheimer’s  drug company supporters might argue that trials are done and this approach keeps failing. That’s was it initially looked as if had happened last week when a big study designed to show that lifestyle changes could cut the risk of heart disease in diabetics was stopped early because no benefits were showing up.

Called “Look AHEAD” it ticked all the evidence based boxes. It was big – 5000+ people – long term (especially for a diet study) – four years – and randomised. However although those getting “intensive lifestyle intervention” lost a bit of weight and got fitter (they had to exercise) it had no effect on risk of cardiovascular problems such as non-fatal heart attacks and strokes or having to go to hospital for angina.

But far from showing trying to treat diabetes with lifestyle was a waste, it was actually yet more evidence that the low fat diet is a busted flush. Like the monster in a horror movie it seems indestructible. Here’s an editorial from five years ago calling for it to be abandoned in a “paradigm shift”  . In the summer a study found that low-glycemic-index diet is was more effective than low fat for weight loss and cardiovascular disease prevention.

What it does show is just how little research is done into building on the benefits of the low glycaemic approach which keeps on showing up as successful in relatively small trials. Just as fine tuning CBT gets little support. In “10 Secrets of Healthy Ageing”, the book I did with Patrick Holford, there is an account of the impressive results from a small trial involving 21 people on a low glycaemic diet (basically cutting down refined carbs) for 12 weeks. They all had metabolic syndrome and their doctors reckoned they were on route for diabetes.

The results are detailed on page 143 but essential point is that their health markers – weight, blood glucose, cholesterol and fats in the blood  – were all dramatically down. Could that approach be improved? Undoubtedly, Maybe there is something to be learned from the Spanish Mediterranean Ketogenic diet . It’s even more low carb and higher in fat but a trial last year found similar large drop in metabolic markers. But is anyone doing serious big trials to test out the variations?

This is not a situation that is going to be solved by appeals to evidence based medicine. It’s essentially a political issue. The notion that banks and other financial institutions have to be prevented from simply pursuing their own interests even when they are at odds with their customers is no longer radical lunacy.

This week GlaxoSmithKline promised to support the BMJ’s call for more transparency about the side-effects that show up in clinical trials, but what we really need more focus on are the trials of treatments that aren’t patentable but are highly likely to benefit patients with a  far lower risk of side effect but which just aren’t being done. Time for patients on drug company boards?