This morning Johnson and Johnson (NYSE:JNJ) reported 2007 second quarter results and LifeScan continues to show strength. On a worldwide basis sales grew by 14% compared to 2Q 2006. The real question is just where is this growth coming from, meters or pumps? Because the company does not break out results for Animas it is difficult to gauge the impact of Animas on LifeScan sales. Based on our knowledge of the insulin pump market it’s clear that Animas most directly impacts US sales where sales increased just 7%. While Diabetic Investor believes LifeScan continues to gain share in the meter market, the market overall is rather stagnant.
A clearer picture of the BGM market will emerge as Abbott (NYSE:ABT) reports results Wednesday and Roche Thursday. Diabetic Investor suspects that neither Abbot nor Roche will report much in the way of growth for their respective BGM franchises, although it will be interesting to see if either has been able to stop share erosion. Based on what Diabetic Investor is seeing Bayer (NYSE:BAY) is about the only major player in the BGM market gaining share. Once given up for dead it appears by concentrating on the basics Bayer has regained momentum.
More intriguing is the potential impact Medtronic’s (NYSE:MDT) recall of Paradigm insulin pumps will have on future Animas sales. According to the manual for their newest pump the 2020:
“Your Animas 2020 has been designed to operate in the presence of common sources of
electrostatic and electromagnetic interference, including airport and store security systems.
However, like all portable electronic devices, the pump should not be exposed to very
strong electromagnetic fields, such as in MRI’s, RF welders or magnets used to lift
automobiles. Very strong magnetic fields, such as in an MRI, can re-magnetize the portion
of the motor that regulates insulin delivery. If you plan to undergo an MRI, remove your
pump beforehand and keep it outside the room during the procedure.”
It should be noted that the Animas 2020 manual provides a wealth of information on just under what situations the pump should be disconnected. The manual makes no reference whether or not the pump has a built in fail safe system that would prevent the pump from over-infusion of insulin.
The manual for the Accu-Chek Spirit Insulin pump states
Electromagnetic Fields and Hazardous Areas
Do not use your pump around electromagnetic fields such as radar or antenna
installations, high-voltage sources, X-Ray sources, MRI, CAT scan, and all other
sources of electrical current as they may cause your pump not to work. Insulin
delivery may stop and an error E7: ELECTRONIC ERROR may occur.
Always stop and remove your pump before you enter these areas.
It’s interesting to note the difference between the Animas and Accu-Chek warnings. Animas states that “Very strong magnetic fields, such as in an MRI, can re-magnetize the portion of the motor that regulates insulin delivery.” Accu-Chek states “Insulin delivery may stop and an error E7:ELECTRONIC ERROR may occur.” Accu-Chek also mentions radar or antenna installations in their warning. Based on this it would appear that the Animas 2020 may have the same over-infusion issue that prompted the FDA to issue the Class II recall of the Paradigm pumps. It appears Accu-Chek has taken the safest route as the pump stops working rather than over-infusing insulin. Given the choice between the possible over-infusion of insulin and a complete system shut down, the complete system shut down is preferable as it will not lead to severe hypoglycemia. While patients may not like it when their pump shuts down, they can at least go back to injections to control their levels.
Looking over the manual for the OmniPod it states
“The OmniPod and PDM may be affected by strong radiation or magnetic fields. Before having an X-ray, MRI, or CT Scan (or any similar test or procedure), remove your pod and PDM and put them outside the treatment area.”
What concerns Diabetic Investor most here is why the FDA has not taken a closer look at this issue and required insulin pump manufacturers to build a fail safe mode into their systems that would prevent over-infusion of insulin. A problem that appears to be unique MiniMed Paradigm pumps. Diabetic Investor went back to the FDA’s adverse event database and could not find one report that mentioned MRI, X-ray or CT Scan for Animas, OmniPod or the Accu-Chek Spirit. Granted even the combined number of pumps in use of all three companies pales in comparison to MiniMed’s installed user base, still the fact the only company with adverse events related to this issue is MiniMed begs the question, why?
Diabetic Investor has requested further information from Medtronic but has yet to receive a response. Stay tuned.