As if we needed any more evidence

As if we needed any more evidence

It seems with each passing day more evidence is uncovered which proves a point that has been made by Diabetic Investor over and over, in that we are no closer to a true artificial pancreas today than we were when this quest began. It also seems that the benefits Diabetic Investor had hoped would come from this quest, namely better insulin pumps are not materializing either. This past Friday Animas, the insulin pump unit of Johnson and Johnson (NYSE:JNJ), issued a Class 1 recall for their 2020 insulin pump. According to the notice on the FDA’s website:

“Animas identified a component issue affecting Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following:

  • “Loss of prime”
  • “Occlusion”
  • “No Cartridge detected”

If you receive any of these alarms, the pump may prompt you to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump’s safety instructions and disconnect your infusion set from your body before the “rewind, load and prime” steps can lead to unintended delivery of insulin, placing you in danger of potential serious health risks, such as hypoglycemia.

The Animas 2020 Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this date, the pump will no longer deliver insulin and will generate a “Call Service Alarm.”

This recall follows another a notification sent by Medtronic (NYSE:MDT) which noted some issues with their Paradigm insulin pump. Not to mention that LifeScan, the glucose monitoring unit of JNJ, also had to recall their newest monitor the Verio®IQ as it too had some issues.

Now Diabetic Investor doesn’t want to say we told you so but it’s about time the diabetes device industry and the JDRF acknowledge what is becoming painfully obvious, that this quest to develop an artificial pancreas is still several years away and NOT right around the corner as they imply whenever they are interviewed about the project. Diabetic Investor also believes the JDRF owes an apology to the many who have donated to the organization to help fund this quest.

Keep in mind this is the same organization that stated we would see a true artificial pancreas in just four years, a statement we’re sure the organization now regrets. Given the way things are going we’re not sure which will happen first; the Chicago Cubs winning a World Series (something that hasn’t happened in over a century) or seeing a true artificial pancreas come to market. At the moment we’d say that Cubs stand a better chance which says something about how many obstacles remain for the artificial pancreas.

Let’s be clear here Diabetic Investor is not necessarily against the development of an artificial pancreas IF there was tangible evidence that this project is providing benefits to existing patients. Is it possible that after all these years and the millions invested the artificial pancreas is turning into a another bridge to nowhere? Please show us the benefits and do not insult our intelligence and state that patients will soon see something spectacular. We’ve heard this before from the companies who tried to  con everyone into believing they could develop a non-invasive glucose monitor, another system that even had it been successful would have done nothing to increase testing frequency.

Where are the better, more patient friendly, more reliable insulin pumps? Where are the new short-acting insulin’s? Where are continuous monitoring systems that don’t require calibration and  come with sensors that last longer than 7 days?

Looked at from another perspective think if the artificial pancreas was being developed by a publicly held company rather than the JDRF, would this company based on its track record be worthy of further investments. Now given this is the wacky world of diabetes where companies like MannKind (NASDAQ:MNKD) continue to find investors dumb enough to buy their shares anything is possible. Something that wouldn’t even be possible if Al Mann had not personally invested nearly a billion dollars of his own money into the company. The truth is had Mann not invested his once considerable fortune into MannKind this company would have died long ago.

Could it be history is now repeating itself with the artificial pancreas? Is it possible that the good folks who donate to the JDRF will continue to buy into the dream, investing with their hearts and not their heads? Could it be that these donors will remain silent and not demand that the JDRF be held accountable? As we have said before many positive benefits COULD come from this project, but so far all we’ve seen so far are promises made and promises broken. How long will it take before everyone begins to wake up and realize that this project, however well intentioned, has failed to live up to the hype.