Late yesterday Diabetes Technology & Therapeutics published an outstanding editorial “Insulin Glargine and Cancer – An Unsubstantiated Allegation” by Satish K. Garg, M.D., Irl Hirsch M.D. and Jay Skyler, M.D., M.A.C.P. The editorial points to the many flaws in the studies that lead to this controversy and should be required reading for everyone in the diabetes community. You can access the editorial at http://www.liebertpub.com/mcontent/files/dia_2009_1705_Garg_3P.pdf.
Diabetic Investor commends the authors for properly putting into perspective not just the flaws in the research but how once this information became public the problems created for patients and the physicians who treat them. We can only hope that the FDA reads this editorial as they move forward with Byetta LAR and Victoza.
As we have seen with the recent news surrounding Tylenol even over the counter medications which everyone assumes are safe have risk factors. However these risk factors must be weighed against the benefits provided by the drug. This is especially true when it comes to diabetes medications. Should the FDA continue along their present path where it seems as if they are looking for any reason not to approve new medications the diabetes epidemic will move from bad to worse.
The facts speak for themselves as everyone, with the possible exception of the FDA, understands that patients need more tools to fight their diabetes. This is particularly true with Byetta LAR and Victoza, two drugs that have the potential to change the paradigm for treating patients with type 2 diabetes. Based on all available data both drugs do an outstanding job of controlling glucose with the additional benefit of weight loss. It is also true that both drugs do carry some risk factors. However these risk factors must be balanced against the numerous benefits these drugs provide.
As the editorial states;
“Although patient safety is of paramount importance in the treatment of any disease, we do not think there is any reason to sensationalize unproven risks of a treatment, which might unwarrantedly deter patients from its use, as in the case of insulin glargine discussed here. All treatments carry some risk. Yet, risk must always be balanced with benefit. The benefits of good glycemic control in patients with diabetes are clearly established, particularly with regard to acute complications, microvascular complications, and neuropathy. Insulin glargine has proved to be an effective agent in helping achieve glycemic control while minimizing hypoglycemia. Our view is that insulin glargine should continue to be used, and certainly should not be discontinued on the basis of unsubstantiated allegations.”