Selling the dream

Selling the dream

First to set the record straight Diabetic Investor is NOT against the development of an artificial pancreas (AP) and we do believe some good will come from this work. However, we do believe the Juvenile Diabetes Research Foundation is playing very fast and very lose with the so-called facts of what an artificial pancreas can and cannot do.

Just by way of a quick review the quest to develop a fully automated closed loop insulin delivery system began many years ago but it wasn’t until October of 2005 that the quest became official when the JDRF board approves the launch of the artificial pancreas project (APP). Today the JDRF along with its many partners are fighting their way through the many hurdles between the dream of an AP and the reality of an AP.

Along the way some, including Diabetic Investor, have questioned the wisdom of this pursuit, not from a scientific or lifestyle improvement perspective, rather from a business perspective. Put another way does it really make sense to spend millions on a system on a handful of patients will use or even afford? This does not mean patients with diabetes will not reap benefits from this pursuit, far from it as Diabetic Investor has noted in the past patients will likely see more accurate continuous glucose sensors and better overall insulin pumps are just two benefits that quickly come to mind. Yet these tangible and near term benefits never seem to be mentioned whenever the JDRF talks about the APP, who in their frequent interviews on the subject just love to sell the dream.

Now we aren’t fools and understand that when it comes to raising money for the cause it’s far easier to sell the dream than it is the reality. Yet we also believe the JDRF has a responsibility to their many donors not to raise unrealistic expectations and at least acknowledge that the APP has some issues before it can do all the wonderful things they say it will do.

We mention this because of story we ran across from a local Virginia television station and can be seen at,0,5785123.story. According to the story on the stations web page that accompanies the video is the statement “It could be at least seven years before the artificial pancreas hits the mass market.” Although Diabetic Investor was not surprised by the statement we did remember a time when the JDRF was going around telling everyone that they would have this done in four years. Yes back in January 2010 when the JDRF partnered with insulin pump maker Animas, a unit of Johnson and Johnson (NYSE:JNJ) Alan Lewis, PhD, who at the time was the President and Chief Executive Officer of JDRF stated; “JDRF will provide $8 million in funding over the next three years for this project, with a target of having a first-generation system ready for regulatory review within the next four or so years.”

Later that same month Aaron Kowalski, Ph.D. who’s leading the APP effort for the JDRF gave an interview to Amy Tenderich, who writes the outstanding patient blog Diabetesmine, where the following exchange took place-

Question- “Does the JDRF/Animas team feel confident they can incorporate the sophisticated algorithm into the small form factor of a pump? If not, why will it take FOUR years to get a working prototype to the FDA for review?



There are a number of time-consuming stages here. I imagine much of this will be the clinical trials required for regulatory approval. JDRF partnered with FDA over the past four years to proactively address these issues and the FDA named the Artificial Pancreas a “Critical Path Initiative” in 2007. I would argue the pieces of the puzzle exist or are close, and the goal here is to move forward as aggressively as possible”

Keep in mind both the statement by Dr. Lewis and interview given by Dr. Kowalski happened over four years ago and today the JDRF is telling everyone we might not see the APP for another seven years, please.  Diabetic Investor also calls into question the JDRF’s claim that a true AP will somehow save millions of dollars in healthcare costs. There is no doubt and no price that can put on the improvement to the patient’s life  but these constant claims that an AP will magically save millions in healthcare costs just cannot be substantiated.

The truth is even if a true AP does reach the marketplace all it would take is one error, one malfunction that causes one death and this dream will become a legal nightmare. Just as the sun rises in the east and sets in the west, a lawsuit will follow a lawsuit that would dramatically change how these systems are sold. Say goodbye to the possible savings of millions of dollars and hello to increased costs of what already is anticipated to be a very costly system.

But before we can even debate the possible savings of an AP one has to wonder any system will get through today’s FDA. As we have seen with their recent decision to on Tresiba® and Ryzodeg® the agency remains in ultra-conservative mode. Keep in mind this the same agency who has publicly noted they would be taking a closer look at medical devices and insulin pumps in particular. They may have outlined a path for AP approval but as recent decisions by the agency have shown; having a path is one thing, actually following that path is something completely different. Just ask the good folks at Novo Nordisk (NYSE:NVO) who were literally blindsided by the agency.

Yet as we noted much earlier this does not mean the APP will not yield benefits, Diabetic Investor just believes the JDRF should present a more realistic picture when they talk about this project. The dream remains the same and it can and should be pursued. This pursuit should also be accompanied with the truth and a realistic assessment of not just the good that will come from the quest but also the acknowledgements there are issues to overcome before the dream becomes a reality.

Patients with Type 1 diabetes have been waiting a long time for this dream to become real and the last thing they want or need right now is another series of disappointments based on falsely raised expectations. Whether the JDRF realizes it or not patients with Type 1 diabetes don’t need to be treated with kid’s gloves. These folks understand the burden of managing diabetes as they live it each and every day of their lives. The fact is these patients wanted an AP yesterday but they also know from experience what happens when a device doesn’t work as intended. Although there is no survey we can point to or any record we can find on how Type 1’s feel about the APP, we do know one thing from our many discussions with these patients as they would rather the JDRF gets it done right rather than getting it done fast. Although it’s never mentioned by the JDRF how this is done can make the difference between life and death.