Secrecy does not serve us well

Dear Editor,

Last week’s BMJ and Channel 4 Dispatches programme “Diet, Drugs and Diabetes” focussed on possible dangers of incretin based therapies and alleged that the pharmaceutical industry is hiding important safety data, putting patient safety at risk (1-3). While drug safety and transparency by all stakeholders are paramount, it is important to remember that no drug is completely safe. Even widely used and well established diabetes treatments, such as metformin and sulphonylureas, may cause lactic acidosis and significant disabling hypoglycaemia respectively. Both clinicians and those with diabetes need to make a balanced decision about the risks and benefits of any treatment and this requires a non-judgemental appraisal of the data. The Dispatches programme and accompanying articles in the BMJ failed in this regard.

We have seen the damage to patient well-being caused by irresponsible reporting in the case of the MMR scare and autism, albeit based on fraudulent research. Such ‘health scares’, when not supported by adequate peer reviewed research, lead to much anxiety with many patients stopping treatment and much healthcare professional time is needed to reassure people about their treatment.

The BMJ articles allege that the issue of pancreatitis and carcinoma of the pancreas was hidden yet these potential side effects have been widely discussed at a variety of specialist forums and in both the general and specialist peer reviewed literature (4-6) and listed as a side effect in such publications as the latest edition of the British National Formula. The current data about the risks of pancreatitis and carcinoma of the pancreas remain inconclusive and at present do not provide a cogent case to stop using the treatments. On the other hand, there are many reasons to continue using incretin based therapies. The commonest cause of death and morbidity in people with type 2 diabetes is cardiovascular disease and two recent meta-analyses have indicated that treatment with DPP-4 inhibitors or GLP-1 receptor agonists during randomised controlled trials are associated with a reduction in cardiovascular events (7;8), a point edited out of my Dispatches interview with Dr Cohen. For many people with diabetes, the risk benefit ratio remains in favour of treatment.

Publishing a highly selective one-sided set of reports not only damages the reputation of the BMJ but does precisely what the BMJ is accusing the pharmaceutical companies of doing. This approach lets down the academic and clinical community as well as people with diabetes who deserve an open and honest discussion about the strengths and weaknesses of these, and all other, diabetes treatments.

Yours faithfully

Richard IG Holt

References

(1) Cohen D. Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed? BMJ 2013;346:f3680.
(2) Gale E. Incretin therapy: should adverse consequences have been anticipated? BMJ 2013;346:f3617.
(3) Montori VM. Helping patients make sense of the risks of taking GLP-1 agonists. BMJ 2013;346:f3692.
(4) Butler PC, Elashoff M, Elashoff R, Gale EA. A Critical Analysis of the Clinical Use of Incretin-Based Therapies: Are the GLP-1 therapies safe? Diabetes Care 2013 May 6.
(5) Nauck MA. A Critical Analysis of the Clinical Use of Incretin-Based Therapies: The benefits by far outweigh the potential risks. Diabetes Care 2013 May 6.
(6) Gier B, Butler PC. Glucagonlike Peptide 1-based drugs and pancreatitis: clarity at last, but what about pancreatic cancer? JAMA Intern Med 2013 Apr 8;173(7):539-41.
(7) Patil HR, Al Badarin FJ, Al Shami HA, Bhatti SK, Lavie CJ, Bell DS, et al. Meta-analysis of effect of dipeptidyl peptidase-4 inhibitors on cardiovascular risk in type 2 diabetes mellitus. Am J Cardiol 2012 Sep 15;110(6):826-33.
(8) Monami M, Cremasco F, Lamanna C, Colombi C, Desideri CM, Iacomelli I, et al. Glucagon-like peptide-1 receptor agonists and cardiovascular events: a meta-analysis of randomized clinical trials. Exp Diabetes Res 2011;2011:215764.