The untimely withdrawal of diabetes drug Mixtard 30

Until very recently, an estimated 90,000 people in the UK used a form of insulin called Mixtard 30 to help control their diabetes. By the end of this month, these people will no longer have access to this treatment, so they will need to have switched to another type of insulin.

Why has this happened and does it matter?

Mixtard 30 is being withdrawn from the UK market by the drug company Novo Nordisk. It would be nice to believe that this removal is based on sound clinical grounds, for example, because Mixtard 30 is ineffective or unsafe, or because the alternatives are undeniably better for patients.

If only things were that simple. In fact, as a type of ‘human biphasic insulin’, Mixtard 30 is among the first-choice treatments recommended for diabetes by the National Institute for Health and Clinical Excellence (NICE).

It’s an effective treatment, with a long track record of use. Also, hard evidence indicates that, for most people, the widely used forms of insulin known as ‘insulin analogues’ offer no compelling advantages over Mixtard 30 in terms of controlling diabetes or preventing complications of the disease. What’s more, the analogues tend to be more expensive.

So why is Mixtard 30 being withdrawn?

The reason appears to be largely commercial; Novo Nordisk is open about its aim to withdraw its range of older, non-analogue insulins (including Mixtard 30) over time and to promote its analogue insulins instead.

You might think none of this is that important. After all, if there are alternatives to Mixtard 30, surely it’s a simple job to switch patients to one of these options?
Unfortunately, diabetes isn’t quite like that. Switching 90,000 patients to other types of insulin is fraught with difficulty. These people will have needed additional clinical reviews, first to discuss and choose between alternatives and then to monitor the effects of any selected new treatment.

And it can take months to find the right insulin for someone and for that person to become confident in using it. These requirements will have created extra costs and resource burdens for the NHS at a time of acute financial restraint.

And let’s not forget the human dimension here. The switching of insulin therapy can be very frightening and unsettling for people with diabetes, not least because it increases the chances of experiencing hypoglycaemic episodes (low blood sugar attacks), related to the change in treatment. What’s worse, of course, is that they can expect no added benefit from this enforced disruption to their lives.

As if all this wasn’t enough, there’s another problem. One of the great advantages of Mixtard 30 is that it can be injected using a very popular ergonomic device known as InnoLet. This has allowed many people with visual or manual dexterity problems to self-administer their insulin.

With the removal of Mixtard 30 from the market, many of these individuals will now have to rely on other people to give them insulin.

In my and many others’ opinion, the withdrawal of Mixtard 30 is bad for patients, healthcare professionals and the NHS. Over 1,300 have signed a petition against the change: try telling them it doesn’t really matter.

Dr Ike Iheanacho is the editor of the Drug and Therapeutics Bulletin http://dtb.bmj.com/

Novo Nordisk told Channel 4 News:

"Whenever new generations of products that provide benefits in efficacy or safety compared to older generations are made available and become widely used, manufacturers must consider ceasing production of older versions.

For example, reductions in the risk of hypoglycaemia seen with Levemir® versus NPH insulin and the decreased propensity for weight gain with this insulin provide two very tangible clinical examples of why a company would elect to cease distribution of an older generation of insulin.

"Indeed, when this is coupled with the increased unit costs of producing smaller and smaller quantities of a previous generation of products, the business model becomes unsustainable. This in turn erodes the basis for funding of research and development of even better products to address the huge unmet needs that still exist within diabetes care."