Just when it looked like the FDA was living in the 21st century the agency issues new guidance for …wait for it …. Blood Glucose Monitors. Now we know that BGM is dying a slow and profitable death, but it is dying and there is no hope for long term survival. So naturally it makes perfect sense that the agency spends valuable time and resources to come up with new guidelines when in place will be meaningless as the industry, they were designed for will be dead.
We shouldn’t be too hard on the FDA as they are making progress when it comes to diabetes devices however, they may be having second thoughts. First and foremost, the FDA’s goal should be to protect the patient. As we have stated consistently insulin is not just a life sustaining drug it’s also lethal when dosed improperly.
The issues with 670G show how sometimes and we can’t believe we are writing this the agency moved too fast. It would be nice to believe that the FDA does not bow to outside pressures that they do not approve something to make a group happy, it would also be extremely foolish. Let’s be honest nearly everyone in the diabetes community – the JDRF, the ADA, the West Coast Mafia and the we’re not going to wait community – wanted the FDA to approve a closed loop insulin delivery system.
These active and very vocal groups wanted something to cheer about, they wanted to prove they had the muscle to make the FDA move in their direction. They wanted this so bad they made a deal with the devil. Privately and sometimes publicly these active and vocal groups were active and very vocal about how they see Medtronic as the evil empire. Keep in mind these same people were ripping Medtronic a new one when the company signed their exclusive deal with UnitedHealthcare. A deal which they said would limit patient choice and stifle innovation.
Yet they wanted a closed loop system so bad they hopped into bed with the evil empire. Some of these groups not only hopped into bed with empire they did so knowing full well the 670G was not ready for primetime. This is like having unprotected sex knowing full well that other person has an STD. But when you are whoring yourself out to make a point you do what whores do.
Over the past three months according to the MAUDE database 42 Deaths are attributed to Medtronic – over that same time frame there were 6 for Tandem 7 for Insulet and 4 for Dexcom. Now Medtronic will try and explain away this discrepancy given their huge installed user base. They will attempt to divert attention away from the real problem by using fancy semantics. They will claim that the MAUDE database is not a perfect system and is open to wide interpretation.
More like manipulation if you take a deeper dive as we have done. Someone still needs to explain to us how the hell a reservoir can cause a death. But let’s no go there again today.
When the 670G was approved, faster than even Medtronic thought it would be, these groups jumped for joy hailing this approval as milestone for every person with diabetes. These hypocrites who were ripping Medtronic one day showed the other of their two faces and were hailing Medtronic for their innovation. Heaping praise on the company when it wasn’t that long before they were shoveling manure on them.
Yet what is truly stunning and shows the level of their hypocrisy is their silence. These groups which claim to care about patients, who screamed long and loud for the approval of this system where are they now. Listen it’s no secret to any of these hypocrites that the 670G is a flawed system. Yes, when the damn thing works it is pretty awesome however it does not work often enough or well enough and as the MAUDE reports note it can and does kill the patient using it.
The fact is these groups not only sold their souls to the devil by their continued silence they are complicit with empire. Their continued silence shows they too are putting profits over patient safety. They too think whiz bang way cool is more important than systems that not only work but work consistently.
In the movie Star Trek 3: The Search for Spock there’s a scene where the Genesis planet is self-destructing, and Lt Saavik asks David (Kirk’s son) what went wrong. David basically states he took some short cuts to make Genesis work short cuts he knew which might come back to haunt him. Looking at the planet self-destructing Saavik states;
“How many have paid the price for your impatience? How many have died? How much damage have you done? And what is yet to come?”
There is no question a closed loop system could be of great benefit to patients with diabetes. However, it’s important to remember that only 35% of Type 1 patients even use a pump and less than 5% of insulin using Type 2’s. Millions have spent on this quest and look where we are today. It’s bad enough that Medtronic is trying to sweep this problem under the rug it’s even worse that these groups who claim to be patient centered are helping push the broom with their continued silence.
As Spock himself said in the Star Trek 2: The Wrath of Khan – “The needs of the many outweigh the needs of the few or the one.”: Listening to these groups one would think the needs of the few outweigh the needs of the many. It’s time to take a stand and end the silence