The article by Home et al. (1) in the May issue of Diabetes Care prompted us to respond and comment on the current practice of reporting on clinical trials when insulin analogs are concerned. While a cure for type 1 diabetes has not yet been achieved, comprehensive, multidisciplinary treatment strategies have lead the way to offer patients and their families a near-normal life and affected children a near-normal life expectancy. Multiple injections, insulin pump therapy, and frequent blood glucose measurements have provided the basis for better quality of life and good metabolic control in people with type 1 diabetes. However, the value of insulin analogs is still in question (2). There is no doubt that industry has invested vast resources to develop new insulin types for safety and efficacy reasons. However, at present, there is no doubt that insulin analogs are more expensive, and in view of the rising tide of financial problems in healthcare systems globally, this in itself can potentially pose an additional threat to the free availability and affordability of insulin treatments for patients with type 1 diabetes worldwide. The Diabetes Control and Complications Trial (DCCT) research group showed the importance of strict metabolic control for the delay and/or prevention of diabetes complications (3,4). The indiscriminate use of terms such as “conventional” and “intensified” insulin treatment has been abandoned, and “simplified” therapies should not be recommended (4). Pre- or even postprandial administration of rapid-acting insulin analogs, especially in very young children, has been reported by some authors (5) to be safe and even advantageous. Multiple injection regimens allow greater freedom in daily routines and are therefore clearly the standard of insulin-replacement therapy. However, reports on the advantages of insulin analog therapy have very often been published only in abstract form and as supplements to company-organized meetings (1).
In their original article, Home et al. included an example of another misleading way of reporting on insulin analog treatment and its alleged advantages; their investigations were setup mainly to study safety and suitability issues. In the title, and in some key passages of the article, it is suggested that the insulin analog was superior in terms of achieving glycemic control and reducing hypoglycemic episodes when compared with NPH insulin. The data from their article, however, do not support this over-optimistic view and clearly show that HbA1c levels for each of the detemir groups were not different from those of the NPH group. In addition, and probably most importantly, the reduction of hypoglycemic episodes so enthusiastically reported was seen exclusively for “minor events,” specifically during the night, while “major” hypoglycemic events were not reduced or eventually even greater in their IDetmorn + bed group when compared with their NPH group. While we do not suggest that Home et al. have failed to carry out a useful and carefully executed study, we very much regret to see that the interpretation of their data is far from careful and not at all balanced. Since co-authors have industry affiliations and their interpretations may naturally reflect company interests. However, such reports as the article by Home et al. influence clinical decision making in daily practice and are based on individual beliefs and personal interests rather than on solid data when it comes to conclusions and decision making. A much more responsible attitude and more careful interpretation of data is clearly warranted and should guide clinical scientists when interpreting their data and writing articles for reputable peer-reviewed journals. As such, wording and biased phrasing in scientific papers is often more powerful than the actual data and scientific work. The scientific community should therefore behave responsibly when writing the results from clinical trials in order to not tarnish its reputation and most importantly to not lead the public and ultimately the patient to untimely and probably incorrect conclusions.
References
The authors of the original article did not wish to respond to this letter.