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… and I could not be more thrilled. Hardly a day goes by without the state of America’s diabetes epidemic weighing heavily on my mind. And then there are days like today when it struck me while procrastinating on the Internet that even though diabetes prevalence is greater than ever, diabetes awareness is also at an all time high.
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 ...
We'd love for you to come walk with us in San Francisco on October 20 to support the JDRF ~ please sign up at the following link! Our team is sponsored by diaTribe and the Capital Group.
http://walk.jdrf.org/index.cfm?fuseaction=walk.walkeradd&chapterid=4057&eventID=3310
This is a pretty long link, and if it doesn't work, just go to www.jdrf.org and choose walks in California and then choose San Francisco and then choose Team diaTribe!
We hope to see you there.... we're walking for all the people who have diabetes and all our hopes that one day we'll wake up and our diabetes will be gone.
http://www.youtube.com/watch?v=49ZCX4oOBDU
Won't you help? Thank you in advance from all of us at diaTribe for your consideration!
Is the cause of obesity increased energy intake or decreased energy expenditure? This question was hotly debated at the Cleveland Clinic Obesity Summit 2007 in late September. At the meeting, keynote speaker Dr. Kessler (the former FDA commissioner) argued that supersizing of unhealthy food – “fat on sugar on salt on fat” as he put it – is the primary cause of the obesity epidemic in America. Portion sizes are on the rise, and the food industry has learned how to make fast food ever more palatable and addicting. Americans, he argues, essentially addicted to the fat, sugar and salt the food industry presents us with.
On the other hand, well-known and highly regarded obesity expert Dr. Stephen Blair argued instead that decreased energy expenditure is the major contributor to the obesity epidemic. He pointed out that there is no evidence that the average number of calories consumed per day has increased, but there is overwhelming evidence that we’re using technology to lazier than ever – escalators have replaced stairs, and we even use remote controls to make the sedentary activity of watching TV just a little more sedentary. It’s a shame that technology isn’t instead used to make us more active – for example, with cell phones, it is now possible to walk and talk, but most people drive and talk instead of walk and talk. (We actually walk and talk a lot at Close Concerns so we took exception to this!)
So who do you believe? Are we overeating or under-exercising? Probably the problem is a combination of both and it would be great bottom line to have more incentives.…
Even at this point, it’s been years since obesity officially has became a hot topic and prevention become a watchword, rates of incidence continue to rise. NPR put together a terrific broadcast on this in late August and we are sad to say that we just got around to listening to it – had we listened earlier, we would have been raving earlier. The sad truth on the obesity front is that things just keep getting worse - since 2003 not one state has shown a decline in obesity rates. Colorado comes out as the leanest state (which it has for many years!) while nearly one-third of all adults in Mississippi are obese, making it the heaviest state in the nation.
