The FDA Meets – Greater clarity or More Confusion
Tomorrow the Food and Drug Administration (FDA) will begin two days of meetings which according to the agency “will discuss the role of cardiovascular assessment in the preapproval and post approval settings for drugs and biologics developed for the treatment of type 2 diabetes mellitus.” While Diabetic Investor suspects the meetings will produce some heated discussion and good theater, one has to wonder if the meetings will have any positive long term impact?
Unfortunately, the members of the panel won’t be helped any from the results of the three major studies presented at ADA conference. As we reported from the conference and in our most recent issue the results of Advance, Accord and VADT did little to clarify anything. It could be argued that the conflicting results of these three studies only added to the confusion. Which begs the question; How will the members of this panel be able to offer clear guidance when respected researchers cannot agree and their studies offer different answers to the same question?
Looked at collectively there is no question that poorly controlled diabetes and adverse cardiovascular events go hand in hand. It is also a well known fact that the majority of patients with type 2 diabetes are not achieving control no matter how control is defined. (The fact that the ADA defines control as an HbA1c of 7% or below and AACE and EASD defines control as an HbA1c of 6.5% or below just adds to the problem.) Truly complicating matters is the FDA, ADA, AACE and EASD ignore one of the biggest problems of all; patients with diabetes don’t receive the education they need to help them better manage their diabetes.
Watching all this are the drug companies who have invested millions in diabetes compounds. Will the FDA require companies to perform more detailed clinical trials? Will companies be asked to prove that their drugs do more than lower the patients glucose levels? Is it even possible with new standards to conclusively prove that a drug has no long term adverse events? (Keep in mind that Avandia and Actos were on the market for nearly seven years before we learned of a new adverse event an increased incidence of bone fractures.)
What’s needed here is clarity, consistency and compromise. Drug companies will not risk millions to develop new and potentially better drugs when they aren’t sure how these drugs will be evaluated. Patients and the physicians who treat them would benefit if the various groups put their petty differences behind them and agreed on just what is good control. It would equally beneficial if these same groups would agree on treatment standards. What this means is that everyone must agree to disagree on some points so that we can have some clarity and consistency. Put simply compromise is the order of the day. Unfortunately compromise has been in short supply when it comes to diabetes.
With diabetes growing at epidemic rates, becoming a healthcare and economic crisis compromise is not just required but imperative. The stakes here are high and can be best summed up by something Herbert Bayard Swope, a noted journalist, said during a speech back in 1950; “I cannot give you the formula for success, but I can give you the formula for failure, which is: Try to please everybody.”