Draft NICE guidance signals blow for inhaled insulin therapy

Exubera (Pfizer) has not been recommended by the National Institute for Health and Clinical Excellence (NICE) in its draft guidelines on the inhaled insulin. ‘The evidence [reviewed] indicated that inhaled insulin should not be recommended because it could not be proven to be more clinically or cost effective than existing treatments,’ said Andrea Sutcliffe, Executive Lead for production of the guidance.

A Diabetes UK spokesperson labelled inhaled insulin a ‘medical breakthrough’ and stated that such new developments ‘should not be restricted on the basis of cost’.

In addition, Pfizer said: ‘NICE has dismissed the robust scientific and medical evidence used by international medical experts in the US and Europe to grant widespread approval for this medicine.

‘The choice here is quite simple: force patients to keep enduring the burden of multiple daily injections and poor compliance, as they have since the 1920s, or give them an alternative.’

A final statement is due to be published by NICE in October and healthcare professionals and the general public can have their say in the meantime.

Benefits seen with self-monitoring in type 2 diabetes
A new study – the RetrOlective Study: Self-monitoring of blood glucose and Outcome in people with type 2 diabetes (ROSSO) – shows that self-monitoring of blood glucose is clearly correlated with improved life expectancy and reduced long-term complications in people with type 2 diabetes.

Head-to-head study carried out in insulin delivery devices
Results of a head-to-head study comparing the insulin delivery devices FlexPen and OptiClik demonstrate that FlexPen is significantly more accurate for both 10U and 30U doses.

The study, which was published in the Journal of Clinical Research, showed that while both the OptiClik and FlexPen devices delivered median doses within specified limits, the variation in dose delivery for the OptiClik pen was much wider than for the FlexPen device.

All FlexPen samples fell within the specified limits, which were based on ISO standards.

Dual PPAR-alpha/gamma agonist development programme dropped
AstraZenca has dropped its development programme for tesaglitazar (Galida), a dual peroxisome proliferator-activated receptor (PPAR)-a/g agonist that was in Phase III of development.

Based on data showing elevations in serum creatinine, among other things, it was decided that the overall benefit–risk profile was unlikely to offer significant advantages over currently available therapy.

Efforts to develop another dual PPAR-a/g agonist, muraglitazar (Pargluva), may also have to be abandoned following a request from the US Food and Drug Administration to see more data on side effects late last year, said its developer Bristol-Myers Squibb.

Disappointment expressed that PAD is still not in nGMS contract
Three groups have expressed disappointment that peripheral arterial disease (PAD) has not been included in the revised new General Medical Services (nGMS) contract, which came into effect in April.

The British Cardiac Patients Association (BCPA) and the Circulation Foundation (previously known as the British Vascular Foundation) have both deemed the omission unacceptable and written to the nGMS contract’s key negotiators to ask for a justification. Target PAD – a multidisciplinary group of GPs, vascular surgeons, vascular nurses, clinicians and patient group representatives concerned with the care of people living with or at risk of PAD – has issued a statement.

It acknowledged the difficulties in the allocation of Quality and Outcomes Framework clinical indicators, but argues that, given PAD’s status as one of three major manifestations of atherothrombosis (along with coronary heart disease and stroke), PAD should have an allocation from the points currently given to cardiovascular conditions.

Majority of European Parliament want diabetes to be a priority
The European Parliament wants diabetes, which affects more than 25million people in the EU, to become a priority in the EU’s new health strategy. Members of the European Parliament made the demand in a ‘written declaration’ that received the rare support of more than half of the Parliament.

The declaration now becomes a formal resolution of the House and the Parliament’s staff will forward the wishes of Parliamentarians to the Council of Ministers and the European Commission.