It’s not the how but the why
The question isn’t whether Medtronic has a problem, the question is just how big is this problem, can they fix it before serious damage is done or are they even prepared to acknowledge they have a problem at all. We say this as yesterday we finally spoke with Medtronic, more specifically we spoke with Alejandro Galindo VP & BU President, Intensive Insulin Management (who by the way acknowledged during the interview has a total of 5 yes 5 years in the diabetes world) and James Dabbs Vice President of Quality Assurance.
While Mr. Galindo and Mr. Dabbs attempted to explain how things are done, we on the other hand were concerned with why things are happening. Mr. Dabbs spent a great deal of time explaining that as medical device company which is regulated by the FDA they have certain reporting responsibilities, no kidding. However when asked why things were happening, both Mr Dabbs and Mr Galindo became a bit confused. Please allow us to explain-
We asked specifically about all these adverse event reports related to reservoirs. Keep in mind that the reservoir has basically one function it holds insulin. When we noted that several of these reports related to high glucose levels we asked how a reservoir could cause this issue. As Mr Dabbs correctly noted should the reservoir have a leak or be cracked or not function properly it can lead to high glucose levels. However as we then noted the reports we were referring to made no mention of leaks, cracks, etc. so again how can a reservoir cause a high glucose level.
Mr. Dabbs then went into a lengthy explanation of how they report these events, unfortunately neither he nor Mr Galindo could address WHY these events are occurring or why they are being classified as reservoir issues when they really are system issues.
As we suspected Medtronic is playing very fast and very loose with semantics, that rather than acknowledge they have a problem they are trying to conceal they have problem. What they are hoping for is that the FDA doesn’t see what they are up to. That by calling some problems reservoir related, others sensor related and still others pump related that the FDA will not see a pattern, that they agency will ignore what is a deeper much more serious problem with the system itself.
Well we’ve got some news for our friends in Northridge time has run out and soon they will have to face the music. Diabetic Investor has learned the FDA has begun a preliminary investigation into the issues we have noted, but this is just the beginning. We have also learned that another group of investigative journalists are looking into reports that Medtronic has under reported deaths related to their insulin pumps. Simply put the problem and issues which are evident to everyone but Medtronic will soon become a huge issue for the company.
While Mr. Galindo and Dabbs want to talk about how things are done they fail to grasp why these things are happening. They fail to grasp that these events they classify as reservoir issues have nothing to do with the reservoir and is merely a smoke screen designed to cover up a bigger problem with the system itself. They fail to acknowledge they have a major problem with the sensor, a sensor which delivers inaccurate readings or worse no readings at all. They are focused instead on how they should report these problems rather on how they should fix them.
Worst of all they have fail to grasp the serious nature of these problems. That when their product fails or malfunctions it transforms from a living sustaining device to a killer. Mr. Galindo who as we noted has all of 5 years of experience in diabetes seems to care more about the process than the fact that this way cool whiz bang toy could be killing people.
What is becoming painfully obvious here is that Medtronic could care less about fixing these problems. They are clearly placing profits before patients and could care less who gets killed. They have brought in a bunch of corporate drones who know nothing about diabetes. People who care about two things – advancing their careers and avoiding any responsibility whatsoever. They think their diversionary tactics will fool the FDA. That the FDA won’t notice there are some serious issues with this way cool whiz bang which could become a serial killer.
Well we’ve got some news for our friends in Northridge you can run but you cannot hide. The FDA is now onto your game and they will not be kind. Diabetic Investor is not the only publication looking into your criminal behavior. See this is the funny thing about the truth, those pesky facts Medtronic chooses to ignore, they always come back to bite you in the behind.
Once again Medtronic has become their own worst enemy. Rather than deal with issues they made the decision to put profits ahead of patients. That the next quarterly earnings report was more important than whether someone died because their system did not work as intended. What they banked on was no one would notice, that they could divert attention with fancy semantics.
This is not just shameful or immoral it’s criminal and quite frankly the most despicable behavior we have seen since we began covering this company some 20 years ago. Medtronic has always owed the outstanding team that built MiniMed a debt of gratitude. A team that NEVER put profits ahead of patients a team that made boatloads of money by putting the PATIENT first. The current team at Medtronic should not just be ashamed of themselves, they should be held accountable for this inexcusable behavior.
Thank goodness the FDA has begun their inquiry and others are taking a deeper look at how this company operates. As Momma Kliff used to say; you can dance all you want but at some point you are going to have face the music and when that happens it won’t be pretty.