The two faces of the FDA

The two faces of the FDA

We’re all used to politicians talking out of both sides of their mouths but when it comes to hypocrisy the FDA takes the cake. On June 6th the FDA issued a Class I recall for Bayer Ascensia® Contour® Blood Glucose Monitoring System. The reason for the Class I recall –
“The meters reported the wrong units of measure for Canadian users. Instead of mmol/L, which is the appropriate measurement for Canadian users, the meters were reporting mg/dL. Contractors change the meters to the appropriate units of measure before they are packaged. The contractor shipped 32 meters to Canada that were distributed with the wrong unit of measure (mg/dL – units used in the U.S.) instead of mmol/L. Consumers may misinterpret the blood glucose results displayed by the meter and adjust treatment according to the misinterpreted result. They may overestimate the glucose value by 18 times what they actually are and over treat themselves. Consumers may have a reaction of hypoglycemia but its symptoms may prevent them from self- treatment. Also, some consumers may lack the classic signs of hypoglycemia to receive proper treatment.”
Apparently the FDA considers hypoglycemia a risk for people who use a blood glucose meter but those that wear an insulin pump. Searching through the FDA’s MAUDE database Diabetic Investor could not find one adverse event report where death resulted from use of a glucose meter. Yet, the FDA somehow sees this problem with the Contour which affected a whopping 32 meters a more serious risk than a product that has over 330,000 units being used. (Diabetic Investor has attached a copy of the recall with this email.)
This year alone there have 29 reported deaths for patients using a Medtronic (NYSE:MDT) insulin pump, 7 of which were directly tied to hypoglycemia.
How can it be that FDA classifies the Bayer recall as Class I and the Medtronic recall as Class II? There is no reasonable explanation which is fitting since the FDA appears to have lost any sense of reason.
Read the attachment and you will see Bayer went above and beyond in their attempt to correct this issue. According to the recall
“The firm began calling its Canadian customers on or about June 6, Comments: 2007 to
inform them of the problem, to tell them that a meter with the correct measurement units
will be sent to them, and to request that they return the meter currently in their
possession. Canadian health officials were notified via email on June 12, 2007 and
reportedly informed Bayer that a press release was not necessary due to the limited
number of units involved.

Bayer determined that only 16 of the meters had been further distributed beyond the
distribution facility in Canada, although 32 correct meters had been shipped to Canada.
As of June 11, 2007, the 16 distributed were accounted for as follows: 2 were returned by
customers, 7 were located in Canada at distributor or retailer warehouses, 2 were located
with customers using the warranty database and the remaining 5 are presumed sold but
have not been located.

On June 11, 2007, the contractor added a verification check to its software. Bayer is
verifying that all stock on hand have been configured properly for units that were
supposed to have been reconfigured before the controls went into affect.”

What did Medtronic do, they claim to have sent out 210,000 letters to inform patients, physicians and distributors of the issue with the Paradigm line of insulin pumps. A letter that obviously didn’t get to many customers as of the 9 adverse event reports that specifically mention MRI, 7 occurred well after the letter was supposedly sent out.

Medtronic is doing their best to try and sweep this issue under the rug hoping no one will notice. They did not even take the time to educate their technical support personal about the problem nor is there any mention of the issue that is easily accessible on their web site. No press release was issued and the company is incorrectly telling anyone who asks this isn’t a recall but a field correction. The fact of the matter is there is a design flaw with the Paradigm line of insulin pumps and Medtronic is risking the lives of patients to fatten their bottom line. This is outrageous.

David Kliff
Diabetic Investor
847-634-4646 fax
224-715-3761 mobile