So you really want to be in the insulin pump business – Part Two
This morning the American Association of Clinical Endocrinologists (AACE) released their consensus statement on insulin pumps. This document can be found at http://www.aace.com/pub/pdf/InsulinPumpManagement.pdf and should be required reading for companies already in the insulin pump market and the many who seek to enter the market.
Since Diabetic Investor subscribers can download the statement Diabetic Investor will highlight some areas worthy of additional commentary.
One of the most telling comments reinforces something Diabetic Investor has been saying for years, albeit the AACE authors we’re more delicate than Diabetic Investor. The author’s state; “Too often, patients have only support from the product manufacturer and their own efforts to initiate and advance this demanding therapy. Not surprisingly, because inappropriate candidates with inadequate training and without expert guidance have been allowed to manage their DM using CSII, some unfortunate outcomes have occurred.”
For years Diabetic Investor has outlined the numerous examples where insulin pump patients received either poor training or subpar support. As this statement clearly demonstrates insulin pump therapy, as effective as it can be, is a very complex therapy. Readers of the document should also pay very close attention to the adjectives the authors used, a lay person who knows little about insulin pumps or insulin pumps therapy after reading this statement just might wonder why physicians would prescribe insulin pump therapy or why any patient would risk using an insulin pump.
What the authors are trying say delicately is that insulin pump companies, in their zeal to promote profits over patient care, have hired inexperienced people for a critical job. Back when Diabetic Investor was reviewing FDA documents for the Medtronic (NYSE:MDT), the insulin pump market leader, MRI issue, the FDA noted a major problem was the low quality of the personal hired by Medtronic.
Just ask anyone in the field and they will tell you that Medtronic, once known for outstanding sales people and equally outstanding customer support, has fallen from grace. To help boost profits the company has basically laid off their experienced sales people and replaced them with younger, cheaper sales reps who basically know nothing about insulin pumps or insulin pump therapy. To make matters even worse they have pursued a similar strategy with their once great customer support personal. Things have become so bad that several physician offices have banned any Medtronic insulin pump rep from entering their office.
Medtronic, again in their zest for even greater sales, has also placed unrealistic demands on their reps with equally unrealistic sales quotas. Understanding where their bread is buttered it’s not surprising that these reps are spending more of their time trying to sell even more pumps and less and less on pump training and patient support.
Diabetic Investor actually has a great deal of sympathy for insulin pump sales reps as this is the most difficult job in diabetes. 80 hour work weeks are common and it’s not unusual for these reps to receive phone calls at all hours of the day. And it’s not just patients who call but physicians and nurse educators. As we noted before the insulin pump business is a 24x7x365 day business with no days off.
The authors also state; ““Hard-core” data from randomized clinical trials published in peer-reviewed journals that provide evidence for the benefits of insulin pump therapy are lacking.” Diabetic Investor isn’t sure which journals the authors are reading or which conventions their attending but there is an abundance of evidence documenting the effectiveness of insulin pump therapy. Later in the statement the authors appear to contradict themselves when they state; “On the basis of this evidence and other currently available data, CSII appears to be justified for basal-bolus insulin therapy in patients with type 1 DM that is inadequately controlled with MDI.”
The authors did get it right when they stated “Successful CSII implementation depends to a large extent on patient and clinician selection, since both insulin pump candidates and providers must have the knowledge, skills, and resources to use this complex and time-consuming therapy safely and effectively.” Insulin pump therapy is not for everyone and while Diabetic Investor strongly believes in this therapy option, we would not go as far to state that insulin pump patients always achieve better outcomes then patients following multiple daily injection (MDI) therapy. In the real world, the choice between MDI and insulin pump therapy is really a lifestyle choice. For every patient who’s comfortable with their pump, there is another who doesn’t want a machine to be in control of their diabetes.
For those companies seeking to enter the insulin pump market Diabetic Investor strongly encourages them to read and reread the following two statements made by the authors when they write about insulin pump usage in various patient populations. The authors state; “Once the patient is successfully transitioned from MDI to CSII, frequent (i.e., daily) contact with the pump trainer is mandatory; a return visit with the endocrinologist/diabetologist is advised within 3 to 7 days to begin fine-tuning the insulin infusion parameters on the basis of initial glucose data provided by the patient. Educational consults (e.g., clinic visits, phone calls, e-mail communication) should be scheduled weekly or biweekly at first and then periodically as necessary.” (Highlighting added by Diabetic Investor.)
They go onto to state; “As with any sophisticated device, the ability to use more complex pump features (e.g., adjustment of bolus “wizard” settings, configuration of different basal settings depending on expected daily routine, exploration of different modes of bolus delivery, temporary basal settings, adjustments for periods of physical activity) depends on each patient’s knowledge; skills; motivation; and ability to obtain sufficient data related to glucose levels, carbohydrate intake, insulin administration, and level of physical activity. This incremental process may take months or years, with the speed of progress depending on both the patient and health care team’s assessment of the overall benefits of pump therapy. “ (Highlighting, bold and underlining added by Diabetic Investor.)
For any company out there who believes they can successfully train and support their patients using a web site and that somehow they can save money through less human interactions with the pump patient, their physician and educator READ THESE TWO STATEMENTS OVER AND OVER.
We also suggest that these newbie’s, all the current pump companies and anyone who believes we’re close to developing an artificial pancreas read the following passage from the authors; “According to a March 5, 2010, report published by an FDA panel established to examine insulin pump problems, the agency received 16,849 adverse event reports between October 1, 2006, and September 20, 2009, including 12,093 injuries (72%), 4294 pump malfunctions (25%), and 310 deaths (1.8%) (3). Analysis of the 16,640 discrete events reported for pumps made by the 5 top manufacturers revealed that that the most commonly reported patient related problems were hospitalization (21%), high blood glucose (17%), DKA (8%), hyperglycemia (8%), treatment with medication (6%), and low blood glucose (5%), while the most frequently identified device-related problems included “unknown”(20%), “replace”(9%), “audible alarm”(6%), “use of device issue”(5%), “device displays error message” (5%), and “failure to deliver”(3%). Event reports for the 310 mortalities were frequently incomplete, but causes of death included diabetic coma, hypoglycemia, hyperglycemia, DKA, unresponsiveness, respiratory infection, alcohol consumption, and motor vehicle crash. For cases in which a device problem could be identified, reported malfunctions included infusion set failure, disconnection, device issue, pump alarming, over infusion, bent cannulas, pump not working properly, failure to deliver, suspected electromagnetic interference, display failures, and issues with infusion sets.”
AN INSULIN PUMP IS A MACHINE USED BY HUMANS, MACHINES MALFUNCTION AND HUMANS MAKE MISSTAKES! Does anyone seriously believe we can develop a commercially viable artificial pancreas that will successfully navigate the FDA, be reimbursed by insurers and be successful in the real world? Is it even realistic to state, as some have, that we can do this in just four years? Diabetic Investor isn’t sure what these people are smoking, but we want some as it will help us leave the real world and believe the fantasy.
Diabetic Investor wants to thank AACE and the authors of this statement for reinforcing what Diabetic Investor has been saying for years, the insulin pump business is one tough nut to crack and proceed at your own peril. Just because you can make a pump cheaper does not take away the fact that it is very expensive to run an insulin pump company. As we have said on these pages before any idiot can build an insulin pump but it takes real talent to run a successful insulin pump company.
Yet even with this statement from AACE and all the data available Diabetic Investor knows this won’t stop companies from trying. The reality is there is always someone out there who believes they can build a better mouse trap and can run an insulin pump company better than everyone else. Many falsely believe the key to this market is lower cost of goods. Others share the fantasy that the internet will somehow make pump training and pump support cheaper. There others who have totally left the reservation, believing an artificial pancreas is right around the corner.
What all these folks have in common is they are living the dream and as Sigmund Freud once said; “A dream …. is a psychosis, with all the absurdities, delusions and illusions of a psychosis.”