So we never said that we thought that inhaled insulin was the end-all, be-all, and we've always been concerned about long-term safety ... it takes a long time to build a 20-year database, which is what some patients would want to see before they started inhaled insulin.
On the other hand, I always liked that inhaled insulin had the opportunity to change the population A1c. There are patients who already have A1cs that are quite poor that refuse to take traditional insulin, for a variety of reasons. Although you can say that safety isn't absolutely open and closed until tens of thousands of patients have taken it over a long period of time, on the other hand, maybe lung safety isn't the most important concern when the 8-year safety data looks good (as it did at EASD) and when you have an A1c of 8 or 9 or 10 or 12, like so many patients in the US and globally do.
Pfizer announced this morning it was pulling the plug on inhaled. We can understand this decision as a business decision - sales hadn't been at all promising and there were many problems associated with Pfizer's launch. We think a key question, however, is how they educated healthcare providers, how easy they made it for patients AND doctors, how they decided to proceed with the launch. Maybe they should have waited for the second generation device, which had many practical improvements over the first generation (very common in medical devices) and looked very impressive to us as a second generation device.
These were some of the problems that we think Pfizer could have addressed differently had it made sure to research what being a patient with diabetes is really like, day in and day out, 24/7, to say nothing of what it's like to be a healthcare provider in today's world, treating diabetes. They could have addressed differently:
-- hassle factor with pulmonary testing (help make sure the doctors/educators have good access)
-- hassle factor with learning how to use the device, cleaning, etc. (resistance to insulin is about more than just the shot - it's also about learning carb counting, learning the intricasies of the device)
-- dosing complexity (3 +3+3 doesn't equal 8 - dosing was complex and the teaching didn't address all the complexity)
-- educating endos and educators and PCPs (not all the same)
-- education for patients on hyperglycemia and hypoglycemia associated with insulin - and other side effects like weight gain (see above, it's not just about the shot)
-- understanding better than resistance to insulin is not always about the patient, often it is about the healthcare system and the healthcare provider and all the frustrations about working in today's system, with reimbursement at the top of the list.
Therapy is, of course, only as good as the treatment regimen and that's a process - it's not formulaic and with insulin, especially mealtime insulin, it's often not simple. To underestimate or to not even address that these challenges exist is a difficult road.
From a patient perspective, it's key to know "what's the threshold above which they're willing to put up with the hassle?" For most patients and providers, that threshold was never met, and we wonder how much it was even considered.
We are happy to hear Pfizer has a commitment to diabetes and we hope to see evidence of that soon. We were surprised and disappointed to hear that its partner Nektar heard about this news only this morning, with everyone else - we also think that's a shocking way to treat a partner, particularly a company so committed to diabetes as Nektar. We hope to see its second generation device further developed and for a range of companies to learn from the mistakes of Pfizer. There's a lot to learn! As long as safety holds out, we think creating more alternatives for patients are possible - we're sorry that this has to go down as one of the biggest failures in pharmaceutical history.
Yes, business is business, but diabetes remains the biggest public health crisis of our time, and we think patients, doctors, nurses, and families deserve better in terms of research and execution. Here's hoping we will never see an exit so spectacular in this field again ...