Nice insulins, pity about the evidence

Abstract

In February 2006 the German Institute for Quality and Efficiency in Healthcare (IQWiG), an independent body with a mandate to assess the evidence for medical interventions, released its final report on the use of short-acting insulin analogues in the treatment of type 2 diabetes. The report found no advantage over soluble (regular) human insulin. Given that analogues cost more than soluble insulin, the report concluded that there was no evidence to support their use in patients with type 2 diabetes [1]. A subsequent report concluded that the benefits of shortacting analogues in type 1 diabetes were marginal at best [2], and a report on the long-acting analogues is on its way: many suspect that this will be almost equally negative. Although some have taken issue with the way in which the analysis was performed, for reasons to be discussed later, the conclusions of the initial report were not unexpected. It was not so much the advice that provoked controversy as the fact that it was acted upon: healthcare purchasers decided that they would no longer reimburse the costs of short-acting analogues prescribed for patients with type 2 diabetes. The response from some industry representatives, patient bodies and clinicians was one of predictable outrage. From the point of view of industry, the German pharmaceutical market is worth 37.8 billion euros per year [3], third only in importance to those of the USA and Japan, and analogues have a larger share of insulin sales in Germany than anywhere else in the world. Patients were affected at a more personal level, for many link their safety and well-being to an insulin formulation that suits them, and feel threatened if someone proposes to take this away. Some physicians were equally displeased, for clinicians notoriously dislike challenges to their autonomy and judgement. Add to this volatile mix the fact that some (but by no means all) patient organisations and clinicians are well-funded by industry, and you have a recipe for trouble. Most of the anger was directed towards IQWiG, and the debate that followed was loud and sometimes ugly. Peter Sawicki, Chairman of IQWiG, had his name dragged through the media. A petition to the government protesting at the withdrawal of the analogues was signed by 180,000 patients, and ‘independent’ commentators duly appeared in the media to discredit the report [4]. The outcome was revealing. The insulin manufacturers denied the evidence, but they did not dispute it. Instead, they simply opted to reduce the price of their quick-acting analogues to match that of human insulin, and the concerns of the healthcare providers melted away. Story over? Not quite.