As you enter the vast conference centre – half a mile or more end to end – hosting the 79th Scientific Session of the American Diabetes Association in Philadelphia, your first sight on the left is a Dunkin’ Donuts store. Up the escalator brings you to the ADA’s mission statement which reads in part: “to prevent and cure diabetes”. So only two minutes in and the disconnect between what would be a sane way to deal with diabetes and the reality couldn’t be plainer.
It seems laboured to spell it out but diabetes is a life-style disorder to do with food and exercise and metabolism with probably a bit of genetic influence thrown in. So if you are dedicated to preventing, let alone curing it, lifestyle would seem a good place to start. But a fairly careful scan of the scores of sessions and papers presented on each of the four days revealed about five that were devoted to preventing it with diet or treating it with nutrition.
Drugs added value
Of course this is not surprising, diabetes is big business, just a few pharmaceutical companies dominated the exhibition hall, funded a good proportion of the research and made the attendance of many of the 14,000 or so delegates possible. In the run up to the meeting the financial press was full of speculation about which companies were muscling into whose territory, whether any of the new drugs had any added value features that would propel them into the billion dollar-plus annual sales league.
And none of the companies would deny that diet and lifestyle were absolutely key to successfully living with diabetes, many of the presentations nodded to its importance but like prayers before going into battle the aim was to get them out-of-the-way before getting down to the real business – drugs.
The bulk of the sessions were concerned either with reporting new research identifying pathways that could lead to new drugs or running trials of new combinations that would build an evidence base and lead to marketing authorisation. The event was a powerful illustration of the invisible blinkers worn by evidence medicine.
I have no doubt that many even most of the trials were properly conducted, they ticked all the EBM boxes, according to the rules they were certainly scientific. Some for instance involved huge numbers – one of a brand of insulin was a randomised controlled trial involving 12,500 people in forty countries followed for six years. That is huge and hugely expensive.
A hundred million for what?
It’s three main aims were to prove that the drug didn’t raise your risk of cancer – it didn’t – that keeping your blood sugar well controlled cut your risk of developing heart disease – it didn’t either which was a disappointment and that if you were at high risk of developing diabetes starting on the drug early could cut your chances of developing it –– it did, by just over 30%.
So there is now an evidence base for starting insulin injections before you even have diabetes, you needn’t worry about cancer – at least not for 6 years but you won’t be any less likely to have a heart attack – one of the major problems that come with diabetes. But is it really all that useful for the hundreds of millions it must have cost?
Evidence based medicine is blind to what it tests and more importantly it is also unconcerned about what it doesn’t test – in this case, by and large, any possible treatments that don’t involve drugs. Interestingly one of the few dietary intervention studies, done in China, also looked at how effective a treatment was in reducing cardiovascular mortality over 6 years. The treatment was a low-fat diet.
A remarkable result
The result especially in light of the failure of insulin to have an effect, was remarkable. It reduced risk by about 30%. It was clearly underfunded and the result was odd in that the effect only occurred in women. Even the researcher didn’t seem to have much faith in it. Possible explanations were that the men all smoked heavily and weren’t very good at following the diet. So the chances more people are going to be put on a Chinese style low-fat diet when their diabetes risk is rising rather than being offered evidence-based insulin injections is slim
There are plenty of uncertainties about the dietary study that will allow for calls for more studies to be done while access to funds will be very limited. We will probably never know the reason for the huge male/female difference let alone ways of getting round it or whether using a different diet might have a different outcome.
Money is a major reason but there is more to it. Diabetes is a very clear example of how all sorts of other factors besides personal responsibility make people ill. The drug companies, underpinned by evidence based medicine is not concerned about that and that’s fine, why should they? They aren’t charities. But is that really all there is? Is it right or sensible to hand the increasingly important business of “preventing and curing” diabetes to a system that simply requires that you can pay for hugely expensive placebo controlled trials?
Tomorrow I intend to talk about the pharmaceutical approach to this lifestyle problem on display at the conference in light of the ongoing TV investigation into the obesity – The men who make us fat.