Watchdog setback for inhaled insulin

PUBLISHED: 09:00 21 June 2006 | UPDATED: 11:03 22 October 2010

The manufacturer of a new form of insulin which allows patients to inhale rather than inject the drug has today hit out at the government's health watchdog.

The manufacturer of a new form of insulin which allows patients to inhale rather than inject the drug has today hit out at the government's health watchdog.

The drug, Exubera, developed by Pfizer, is designed to offer adults with diabetes an alternative to daily insulin injections.

King's Lynn-based Bespak, where about 550 people are employed, has designed the inhaler for the drug, one of the company's most important projects for many years.

Bespak had hoped that Exubera would be given the go-ahead by government health watchdog, the National Institute for Health and Clinical Excellence (Nice), after being approved for use by authorities in the US and Europe.

Diabetes UK backed the firms asking Nice to "take account of the patients' perspective and meet individual needs and preferences."

But Nice has published draft guidance saying it does not believe the benefits of using an inhaler to deliver insulin were worth the money.

A Nice report published today will recommend the product be restricted to patients with "a proven injection phobia diagnosed by a psychiatrist or psychologist".

Dr Olivier Brandicourt, managing director of Pfizer, said: "Introducing a requirement to obtain a diagnosis of phobia from a psychiatrist will clearly discourage patients.

"The proposed approach will add the stigma of mental illness to the burden of diabetes.

"Patients with diabetes deserve a better quality of life. A more prudent approach would be to trust the expert clinicians' judgment to manage this debilitating condition effectively."

Pfizer noted that the waiting list to see an NHS psychiatrist currently can be up to five months.

If this guidance became final and people with diabetes were forced to seek psychiatric diagnosis, it would add to the burden of the already overstretched NHS psychiatric services and would increase the cost of diagnosing and treating diabetes.

Dr Kate Lloyd, medical director of Pfizer, added: "Currently people often delay initiating or intensifying treatment for as long as four years due either to fear of injection or to the pain and discomfort they experience as a result of multiple injections.

"By adding a formal requirement for a psychiatric diagnosis of phobia before inhaled insulin can be given, Nice risks compounding this delay and consequently heightening the incidence of complications including heart disease, amputation, blindness and kidney failure."

A spokesman for Nice said the revised recommendations are now available on its website and the public can submit comments until July 12.

Andrea Sutcliffe, deputy chief executive of Nice and executive lead for the appraisal, said: "The evidence on inhaled insulin shows that it is no more clinically effective than injected insulin or other methods for controlling diabetes, however it is more expensive.

"During the consultation on the first draft of the guidance it was suggested that there might be a sub-group of people with diabetes in whom the use of inhaled insulin would be cost effective and an approach was suggested to help identify this group that persuaded the independent advisory committee to reconsider their initial recommendations.

"Consultees suggested that inhaled insulin would be a good use of NHS resources in people who find it difficult to control their blood sugar levels through the use of injected insulin because they have severe needle phobia or other serious problems with injection sites."


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