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Inhaled Insulin: EBM (Evidence-based medicine) or IDM (Industry-driven medicine)?
- H Alberti (13 May 2006)
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Inhaled insulin. Concerns remain
- Niamh M Martin, Karim Meeran, Consultant (14 May 2006)
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H Alberti, Academic General Practitioner Tunis, Tunisia
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Dear Editor, Morton-Eggleston and Barrett (1) give a useful, timely description of inhaled insulin to coincide with the recent NICE recommendations (2). However, firstly, why issue an editorial by authors from the United States, a country not known for its wise use of health resources? And secondly, why from an author heavily involved with Pfizer, the makers of the first inhalable insulin preparation (see Competing Interests)? A more balanced and less promotional editorial was published in the BMJ only 2 years ago (3) and the questions raised at that time – concerning lack of additional benefit, long-term safety, lung complications, questions regarding patient preference and the cost implications for the care of our other patients – remain unanswered. In the same recent issue of the BMJ, questions were raised regarding the worrying and increasing influence of the pharmaceutical industry in the academic research agenda (4). Should we not have the same concerns regarding IDM (Industry-driven medicine)? Those doctors actually working in the UK and striving hard to continue the, arguably, best health service in the world, tend to agree with the NICE recommendations and would be concerned with any change of opinion without further, non-industry-based, evidence. Hugh Alberti 1. Morton-Eggleston E, Barrett EJ. Inhaled Insulin. BMJ 2006;332:1043 -4. 2. National Institute for Health and Clinical Excellence. Inhaled Insulin for the treatment of diabetes (type a and 2): appraisal consultation documents. 2006. www.nice.org.uk/page.aspx?o=305474 (accessed 12th May). 3. Amiel SA, Alberti KGMM. Inhaled Insulin. BMJ 2004;328:1215-6. 4. Delaney B. Is society losing control of the medical research agenda? BMJ 2006;332:1063-4. Competing interests: HA has never, knowingly, received money from any pharmaceutical company for any reason (consulting fees, speaking fees, travel expenses, research grants, skiing holidays, etc.). |
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Niamh M Martin, Specialist Registrar Metabolic Medicine Unit, Hammersmith Hospital, London. W12 0HS, Karim Meeran, Consultant
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EDITOR – Morton-Eggleston and Barrett conclude that the adverse effects of inhaled insulin are ‘not clinically worrisome’.1 Insulin is a potent mitogen and growth factor within the lung, leading to concerns that repeated inhaled delivery of insulin results in supraphysiologic alveolar insulin deposition which may result in adverse local effects.2 Several studies of the efficacy of the inhaled insulin Exubera ® in type I and type II diabetes patients have demonstrated a reduction in lung diffusing capacity (DLCO).3,4 Since lung function has not been altered in other studies of inhaled insulin, the manufacturers of Exubera have concluded that inhaled insulin is not associated with pulmonary dysfunction.5 Significantly, only one of these studies was of greater than two years duration, whilst the remainder were limited to three months. The chronicity of diabetes means that patients will require treatment with inhaled insulin for much longer than two years. Although Exubera is currently only licensed in adult diabetes patients, concerns regarding the long term effects of inhaled insulin are particularly relevant in young adult type I diabetes patients, in whom inhaled insulin will be potentially administered for many years. Until long-term safety data regarding the effects of inhaled insulin on pulmonary function is available, we should remain cautious. REFERENCES: 1 Morton-Eggleston E, Barrett EJ. Inhaled Insulin. BMJ 2006; 332: 1043-4 2 Hsia CW, Raskin P. The diabetic lung: relevance of alveolar microangiopathy for the use of inhaled insulin. Am J Med. 2005; 118:205- 211 3 Quattrin T, Belanger A, Bohannon NJV, Schwartz SL. Exubera Phase III Study Group. Efficacy and Safety of Inhaled Insulin (Exubera) Compared With Subcutaneous Insulin Therapy in Patients With Type 1 Diabetes. Diabetes Care 2004; 27:2622-2627 4 Skyler JS, Weinstock RS, Raskin P, Yale JF, Barrett E, Gerich JE. et al. Exubera Phase III Study Group. Use of Inhaled Insulin in a Basal/Bolus Insulin Regimen in Type 1 Diabetic Subjects. Diabetes Care 2005;28:1630- 1635. 5 Teeter JG, Becker R. The Clinical Relevance of Inhaled Insulin in the Diabetic Lung. Am J Med. 2006; 119:184-190 Competing interests: None declared |
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