And the hits just keep on coming
Just when you thought things couldn’t get worse for the blood glucose monitoring market, word comes from the FDA that soon the agency could require glucose monitors to become more accurate. According to a story published in the New York Times, the agency is pressing for higher standards from the International Organization for Standardization, who currently sets the standard.
Most patients believe their glucose monitors are accurate just by the fact that the monitor has been approved by the FDA. Few realize that international standards allow monitors to be off by as much as 20%. This really isn’t much of a problem for non-insulin patients as they don’t use this information to make dosing decisions. However, this can be a real problem for insulin using patients who use this information in combination with other variables when deciding how much insulin to take. Too much insulin and the patient risk hypoglycemia, a possible life threatening event. Too little insulin and the patient risks hyperglycemia which contributes too many of the complications associated with diabetes.
The story in the Times sights several examples of how different monitors can deliver vastly different results. And quotes Dr. Alberto Gutierrez, the FDA’s deputy director of the agency’s in vitro diagnostics office who stated, “We think this technology is not up to par for some of the protocols we see out there.” Adding “We feel passionately that this is an important issue.”
The real question is why after all these years has the agency all of a sudden looking into an issue that has been well known for years. While it is true that the agency receives hundreds even thousands of reports regarding glucose monitors the majority of reports are for relatively minor issues. According to the MAUDE database from January 1, 2000 to June 30, 2009 there have been 33 deaths reported associated with various glucose monitors. Reading through many of these reports it would be difficult to draw a straight line between the performance of the monitor and the patient’s death.
Granted even one death is one too many yet it would be foolish and irresponsible to place the blame directly on the glucose monitor. About the only case where this may be true is for the maltose issue Diabetic Investor covered early this spring. Even there it is possible to avoid the situation entirely if the FDA would simply put a list of monitors on their web site which are affected by this issue. The agency could also follow up with a letter to healthcare professionals making them aware of this situation and directing them to the web site for more information.
Once again Diabetic Investor sees the agency following their standard policy of killing a house fly with a nuclear weapon. The fact is glucose levels are just one factor in determining how much insulin a patient should administer. It is also a well known fact that many insulin using patients do not receive an adequate amount of education regarding insulin therapy. While Diabetic Investor has no problem with monitors having a narrower error range we doubt this will have much impact on serious adverse events associated with monitor usage.
Where this issue could become a major problem is the quest for a closed loop insulin delivery system. Just how in the world could the agency approve any such system which relies heavily on the accuracy of a continuous glucose monitor? While it’s true we have seen great strides in the performance of these systems, the FDA has yet to approve any of them to be used a replacement for a conventional monitor. Diabetic Investor is one of the few who believes that dosing decisions should never be made by a machine. We see nothing wrong with providing the patient with more information and making dosing recommendations, however allowing a machine to completely control dosing decisions ignores the many complexities and individualities that are encountered by patients.
Realistically this whole issue could be much to do about nothing given the way things are going in the BGM market. Sales are down, average testing frequency remains unchanged and the majority of patients still don’t check their levels on a regular basis. Should meter accuracy become an issue this would only add to the many reasons patients don’t monitor their glucose.
For anyone out there who believes this could create a marketing opportunity time to step back into the real world. Just suppose for a moment that the FDA did require monitors have a lower error range. Do you think for one moment with billions of dollars at stake that each company wouldn’t meet this new standard?
The fact of the matter is this issue will only make matters worse for BGM companies and will do little to improve patient outcomes or prevent serious adverse events. BGM companies are already struggling with unfavorable market dynamics and any mandate by the FDA to improve accuracy will only hasten the move towards further industry consolidation. As Diabetic Investor has said on many occasions that light at the end of the tunnel is actually a freight train which is headed straight at the BGM market. This latest move by the FDA merely adds fuel to the train.