Exclusive NICE has made substantial changes to its draft diabetes guidelines after its initial proposals were described as ‘bonkers’ and threatened to make the institute a ‘laughing stock’.
A number of pressure groups, led by the Primary Care Diabetes Society (PCDS), have called on NICE to re-consult on the changes to the guidance, expressing concern that final guidelines are still due to be published in the summer ‘without further consultation with the major stakeholders’.
But Pulse has discovered that NICE will not put the revised guidelines out to consultation because no new analyses have been undertaken since the draft guidelines were published.
As revealed by Pulse, the draft guidelines were heavily criticised in particular over updates to the management of glycaemic control, with one expert describing the draft recommendations as ‘bonkers’, while others warned they risked making ‘a laughing stock’ of NICE.
The criticisms were particularly focused on the use of repaglinide as an alternative first-line therapy in people who cannot tolerate metformin, with experts pointing out that this has not been widely used since its launch in the 1990s.
But NICE has told Pulse that it has made changes, although there is little indication around what these changes entail.
Professor Mark Baker, director of clinical practice at NICE said: ‘We thank our stakeholders for taking part in the consultation on the management of type 2 diabetes in adults NICE guideline update. The NICE Guideline Development Group has carefully considered the comments received on the draft guideline, and has made changes as a response to the consultation.’
According a letter from the Association of British Clinical Diabetologists (ABCD) and the Royal College of Physicians this month, these revisions were ‘substantial’.
The letter stated: ‘As registered stakeholders that responded to the draft update to the guidelines, the Association of British Clinical Diabetologists and the Royal College of Physicians of London were encouraged to learn that the GDG had subsequently made “substantial changes” to the draft recommendations.’
However, they called upon NICE to give relevant groups the opportunity to see the changes, and comment on them before they are published.
The letter continued: ‘We are writing to ask whether NICE intends to give stakeholders an opportunity to comment on the revised guideline before it is published in August. If not, we would urge you to consider doing so, to ensure the maximum possible support for this important document.’
This followed a letter sent by Primary Care Diabetes Society (PCDS) chair Dr David Millar-Jones, which was backed by the ABCD and patient groups, also called for further consultation on the guidelines before publication.
It said: ‘The original draft guideline has caused considerable concerns and was felt to be cumbersome and likely to cause confusion in non-specialist care. It was felt that this guideline would put patients at risk and lead to errors in their management.’
It added: We are concerned that the final guideline is due for publication without further consultation with the major stakeholders. We are keen to support a guideline that reflects current, safe and prudent health practices and feel that further consultation should be sought before final publication.’
NICE’s manual on developing guidelines states that a second, four-week consultation on proposed guidelines may be undertaken under ‘exceptional circumstances’ – for example if ‘information or data that would significantly alter the guideline were omitted from the first draft, or evidence was misinterpreted in the first draft and the amended interpretation significantly alters the draft recommendations’.
However, Professor Baker told Pulse that a second consultation was ‘not required’ because no new analyses had been undertaken in order to revise the draft document.
‘As no new systematic reviews, modelling or analyses have been performed as a result, a second consultation was not required.’