Diabetes Day held last Friday had its priorities all wrong. Rather than calling for more innovative drug treatments its goal should have been to explore why diabetics continue to be treated by a system that ignores patients’ wishes and allows ineffective and dangerous treatments to proliferate, while safe and effective ones languish for lack of earning potential.
If that sounds mad and harsh consider the case of two treatments; one actual and the other currently just a twinkle in the eyes of a few visionary doctors but of great and growing interest to hundreds of thousands of diabetic patients.
The relatively new licensed drug – Farxiga (dapagliflozin) – uses a new mechanism to lower blood glucose – blocking a process in the kidneys – but it is not particularly effective. It does cause a small amount of weight loss, usually beneficial for diabetics, but its other side effects include a couple of cancers, a form of dehydration that can require rapid hospitalisation, kidney problems as well as considerably raising your chances of developing a genital fungal infection.
Almost no damaging side effects
Contrast that option with a very low carbohydrate high fat diet which is more effective at getting blood sugar down and keeping it controlled, and which also has a number of beneficial side effects such as impressive weight loss, lowered cholesterol and better liver function. Damaging side -effects are virtually non-existent and many patients are able to cut their drug use after a few months and some say they have become diabetes free.
The obvious question this prompts is: Given that almost everyone would prefer to be treated with the diet, why are only drugs regularly available at your local GP? Why in fact is the NHS spending just over a million pounds on this particular one and around 600 million on all of them?
Of course medical treatment shouldn’t be decided by popularity polling but there are good reasons for thinking that a genuinely evidence based system wouldn’t result in 17 or more expensive trials being run on Farxiga , while the diet is essentially ignored as a treatment or as a topic for research. This in turn allows claims such as the ones I have just been making to be dismissed as anecdotal, unproven or conflicting, followed by a call for more research which is unlikely to ever be funded.
More fat but less cholesterol
A good example of the sort of promising small scale studies that have been done is one run by a pioneering GP called Dr David Unwin that was published last year. There is an account of it in a new post on HealthInsightUK (http://healthinsightuk.org/2014/11/13/high-fat-low-carb-diet-for-diabetes-a-gps-tale/). It involved 19 type 2 diabetic patients being treated in Dr Unwin’s practice who were put on a low carb diet plus regular educational and support sessions. After 7 months only one had dropped out, of the rest all had significant weight loss (average 8.63 Kg) and the average HbA1c was down from 50.68 (6.7%) to 39.9 (5.7%).
What’s more even though the patients were eating much more fat than they had been previously, their cholesterol levels dropped, which is curious given that a lot of fat is supposed to raise cholesterol. Also interesting was that liver function improved for nearly all participants; that is generally considered something that is principally affected by alcohol. (For more details why the low carb diet makes sense with diabetes see http://healthinsightuk.org/2014/08/31/twelve-reasons-why-diabetes-charities-should-ditch-the-low-fat-diet-and-recommend-low-carbs/)
So lots of boxes ticked for diabetic patients and many of them reduced their intake of the regular diabetes drugs. By way of contrast and to support my tirade it is worth going into a bit more details about what is involved with the drug Farxiga.
The independent drug evaluation web site “Worst Pills, Best Pills”, which has an impressive record of spotting problems with drugs, advises against using Farxiga , saying: ‘Patients should not use the drug because it poses serious risks including possible risks of cancer, which outweigh its modest benefits.’ (http://www.worstpills.org/ but it needs a subscription)
Trials don’t deliver what patients want to know
Many of the problems stem from the fact that it blocks a mechanism in the kidneys that allows beneficial substances – such as the important energy source glucose – to be recycled rather than being peed out with the urine.
It was approved solely on the basis that it lowered blood glucose. (This is similar to licencing requirements for other drugs such as those that bring down cholesterol. That’s all they have to show they can do.)
However there are a number of things other than the ability to bring down blood sugar that diabetic patients want to know about when deciding whether to go on a new treatment. For instance, does it improve or reduce diabetic complications (blindness, heart disease, kidney failure and amputation of the feet)? But as ‘Worst Pills’ points out: None of the randomised control trials that evaluated dapagliflozin were designed specifically to measure such clinically meaningful outcomes.’
So why do we put up with a system that claims to be delivering evidence based medicine but doesn’t test many of the things patients want to know about a drug? What’s more, most of the drugs it licences have side effects that are more or less damaging – from cancer to genital fungal disease, while those it excludes or ignores often have side effects that are beneficial such as weight loss or improved liver function.