For reasons Diabetic Investor cannot understand the GDH-PQQ issue facing some blood glucose monitoring companies just won’t go away. One might have thought that this issue was over when the FDA back on August 14th issued a statement that outlined the problem and provided a link for patients and healthcare professionals that covered which monitors should not used.
Diabetic Investor speculated that the companies who have meters that don’t use this enzyme would try and take advantage of the situation in attempt to gain market share. Clear evidence of this came from a press release issued by Bayer that implied EVERY patient was affected by this issue and that Bayer monitors were superior to the competition. As horrible as this press release was, Diabetic Investor thought no one else would follow Bayer’s lead of playing fast and loose with the true facts of the situation.
Unfortunately we were wrong as this morning, privately held AgaMatrix issued a release which stated the following;
"AgaMatrix, Inc., the makers of WaveSense blood glucose meters, announced today their continued commitment to educate health care professionals and patients on the importance of blood glucose meter (BGM) accuracy for all patients. WaveSense BGM’s uniquely employ WaveSense technology which personalizes each test to provide world class accuracy. They detect and correct for errors caused by different environmental conditions and blood samples.
According to an industry whitepaper, nearly 90,000 people use drugs or solutions (1), which put them at risk of death if they use some BGM’s that use different technology and give inaccurate results because they use the enzyme system GDH PQQ (glucose dehydrogenase pyrroloquinoline quinine). All WaveSense BGM’s employ a unique, patented technology, including a different enzyme, thus are not affected by this issue.
Products representing over 30% of the BGM market could be affected (2), spanning 18 different brands. The FDA has developed a complete list of these products: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm177189.htm
To their credit AgaMatrix at least noted that this issue is limited to a very small, almost miniscule percentage of the diabetes population. However, just as Bayer did, the implication is AgaMatrix monitors are superior and this problem is bigger than it really is.
Let’s assume for the moment that numbers from this "industry whitepaper" are accurate and that "nearly 90,000 people use drugs or solutions (1), which put them at risk of death if they use some BGM’s that use different technology and give inaccurate results because they use the enzyme system GDH PQQ." According to the American Diabetes Association there are approximately 16 million patients diagnosed with diabetes which means that this issue affects 0.006% of the patient population.
Let’s say you eliminate all non-insulin using patients because the deaths caused by the issue come from insulin using patients over-correcting for an inaccurate glucose reading. By most industry estimates there are 4 to 5 million patients taking insulin, taking the mid-point of 4.5 million, this means 0.02% of the insulin using population is affected by this issue.
Taking this one step further, according to the National Kidney and Urologic Disease Information Clearinghouse (NKUDIC) in 2006 there were 26,114 patients undergoing peritoneal dialysis. According to the FDA statement issued back on August 14th, "Non-glucose sugars contained in some therapeutic products such as peritoneal dialysis solutions and certain immunoglobulins can falsely elevate glucose results, which may prompt excessive insulin administration. These therapeutic products, which are labeled to indicate that they may interfere with this particular glucose monitoring technology, are mostly used in patients with serious medical conditions, including kidney failure and moderate to severe rheumatoid arthritis." Never mind that this "industry whitepaper" AgaMatrix cites in their press release states that nearly 90,000 patients are affected by this issue and there are less than 30,000 undergoing peritoneal dialysis which is cited in the FDA statement. Guess there’s another 60,000 patients who are using immunoglobulins.
We could stop here but the point should be obvious that this issue affects a miniscule percentage of the patients. Let’s assume for a moment that all 90,000 patients cited in this now famous "industry whitepaper" switched to either an AgaMatrix or Bayer glucose monitor — would this is any way change the dynamics of the BGM market?…