Will someone do the math

Will someone do the math

According to the World Health Organization (WHO) globally 347 million have diabetes. According to the International Diabetes Federation (IDF) 10% of the global diabetes population are classified as Type 1 diabetics, or about 35 million. By most industry estimates on a global basis there are less than 1 million patients following insulin pump therapy, or approximately 2.9% of the global type 1 population. Put in clearer terms less than 1% of the global diabetes population follows insulin pump therapy.

Even with all the advances in insulin pump technology, the introduction of “smart pumps” and continuous monitoring systems which communicate with an insulin pump, insulin pumps are not a popular therapy option. Diabetic Investor has long maintained that insulin pump therapy is no longer a better therapy than multiple daily injection (MDI). For every study that shows insulin pump patients achieving better outcomes there is another that concludes patients following MDI are doing just as good.  The way we see it insulin pump therapy is a lifestyle choice NOT a better therapy option.

Now before everyone goes off half-cocked, yes there are situations where insulin pump therapy is clearly better than MDI. However, when it comes to managing diabetes there aren’t and should never be any absolutes.  Put more simply different strokes for different folks. The goal after all is not how a patient achieves better outcomes rather that they achieve better outcomes. Listening to some in the insulin pump world one just might come away thinking that the only way a Type 1 can do this is by using a pump and that clearly is not the case.

While there are several benefits to insulin pump therapy it is also the most difficult therapy option to master. Patients must understand concepts such as insulin time to action, duration of insulin action, insulin to carb factors, etc. Diabetic Investor has long maintained one reason pumps were not more popular is what we call the calibration factor. Keep in mind that an insulin pump is really nothing more than a computer which needs to be programmed to match the needs of the patient. For this programming to be effective the patient needs to acquire a fair amount of data. In the days before CGM this meant checking glucose levels at all hours of the day and night, thankfully this task has been made much easier with CGM. Still insulin pump therapy is not the first choice, even for Type 1 patients who must have insulin.

A contributing factor to this lack of popularity is that most physicians hate patients on pump therapy, not because the therapy is not effective, it is, rather these patients require a high level of education and support. It’s no accident that 80% of pump placements come from 20% of endocrinologists, or as we call them pump warehouses. These offices are set up to handle the patient demands of insulin pump therapy. They not only believe in the therapy option but aggressively promote it. Yet these practices are few and far between.

Next there is the issue of cost and the fact is insulin pump therapy isn’t cheap by any measure. Patients new to pump therapy typically have first year out of pocket expenses ranging from $3,000 to $5,000. This is followed by annual pump supplies out of pocket costs of $400 or so, even more for those using CGM.

Finally there is what we like to call the pump fear factor, ask patients why they don’t want to be on a pump and a surprising number will say straight out they don’t want to be hooked to a machine. A machine that can and does malfunction, a machine which when it does malfunction can and has killed patients.  There is no question that today’s pumps are vastly better than those from years past but they are a medical device.  Yet anyone who has reviewed the FDA’s MAUDE database knows that insulin pumps fail and patients using a pump have been killed because pumps have malfunctioned.

Frankly these are things Diabetic Investor thinks about every time we hear about the “bionic” pancreases, better known as the artificial pancreases. This came to mind when we read an article posted on Australian web site which stated; “Australian researchers believe they have built a smartphone-linked “bionic pancreas” for diabetics that is more accurate than other artificial pancreas in development.”

The article goes on:

“For more than a decade scientists in Australia and around the world have been working to develop a bionic pancreas that could free those with type 1 diabetes from the daily ordeal of managing their disease.

Now a team of engineers from University of Newcastle and diabetes researchers from Hunter Medical Research Institute (HMRI) have made a portable artificial pancreas that they say is smarter than other competing devices.

Professor Graham Goodwin, of University of Newcastle, said the device uses a highly sophisticated algorithm to calculate and deliver precise insulin dosages.

If a clinical trial planned for 2015 works as well as the approved simulator, it could be a breakthrough for the lives of those with type 1 diabetes who have to inject insulin daily, they say.

“It’s early days but we think we have a chance of building a world-beating system with smarter technology and better blood glucose management than other therapies have offered,” said Prof Goodwin.”

Now we all know that this isn’t the only effort to build an artificial/bionic pancreas. It’s also true that the JDRF has made this the cornerstone of their research efforts. Millions, hundreds of millions, have been spent on this quest.   Yet no one has bothered to ask do  we need a bionic pancreas.

Has anyone at Medtronic (NYSE:MDT) the world’s leading insulin pump company, bothered to do the math? While all the insulin pump companies are involved in this quest to one extent or another, Medtronic has been at it the longest and has been the most vocal proponent. In fact, it would not be an overstatement to say that their entire insulin pump strategy is built around this quest.

Yes we know to bring this subject up in public is considered taboo and yes we’ve heard how Diabetic Investor is traitor to the cause because we don’t believe in the bionic pancreas. As Rhet told Scarlet; “Frankly my dear I don’t give a damn.”  The fact is no matter how many times we say that we’re not against the development of a bionic pancreas that we truly hope this effort is successful as we believe the effort should yield better pumps and better CGMs, nope we’re a traitor to the cause.

What we’re against is living in a world of absolutes. Living in a world where no one has bothered to ask if this effort would lead to a sustainable business, notice we did not say profitable business.  To all those who support the bionic pancreas blindly we ask; given the time and money spent what is there to show for the countless man hours and millions spent. Are insulin pumps better, likely; however this would have happened anyway as the technology has evolved over the years. Are CGM systems more accurate, for sure, but like pumps this was inevitable as well.  Perhaps the best question of all is when will the bionic pancreas get here, two years, five, 10 – when?

Think about this for a moment all this money and man hours have been spent to develop a system that benefits 10% of the world’s diabetes population.  Yet that’s actually an overstatement, as does anyone seriously see the bionic pancreas being available in emerging markets or even advanced markets like India? Does anyone believe that cash strapped governments in Europe will pay for this system? With cost containment being the order of the day does anyone seriously see payors providing adequate reimbursement for this system?  Has anyone bothered to do the math?