Time to set the record straight
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 professional 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 form 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 issues effects 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 on here but the point should be obvious this issue affects a miniscule percentage
of the patient. 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?
Is it really worth telling half truths or worse to gain such a small number of
customers? Are AgaMatrix and Bayer so hard up that they would rather add fuel
to a fire that should have gone out long ago?
As
Diabetic Investor has said before while even one death is too many this issue
can be easily solved. While it took the FDA too long to get this right they
eventually did the right thing by making it easy for patients and healthcare
professionals to see which meters should and should not be used. The fact Bayer
and AgaMatrix would try and exploit this tiny issue for their own benefit is
beyond shameful. This type of behavior is inexcusable from companies of Bayer
and AgaMatrix caliber. As Christopher Hitchens stated in a Vanity Fair article
back in 1996, “There is a good reason the words “shameful” and “shameless”
define the same conduct. You know you’ve behaved shamefully if you have exposed
other people to needless annoyance or embarrassment. You don’t know you’ve
behaved shamelessly if you don’t get this point.”
