Some additional details on the latest Exubera trials are here. A few comments:
The decline in lung function as a result of inhaled insulin appears to resolve itself after awhile, but never entirely go away. Quote:
In a 226-patient safety study of Pfizer's Exubera, inhaled insulin was associated with an early decline in pulmonary function that appears to peak by week two, then declines but doesn't completely disappear, reported Richard Dumas M.D. of Recherche Clinique de Laval, in Quebec City.
No one denies the attractiveness of inhaled insulin, but as I said earlier, tight control is critical:
There is no denying the attractiveness of the inhaled products, because injections remain a barrier to increased insulin use, said Satish Garg, M.D., of the University of Colorado Health Sciences Center in Denver.
Dr. Garg, who also presented data on an investigational inhaled insulin, predicted a renewed interest in inhaled insulin and other non-injectable formulations because "we've just learned that tight glucose control, which often means increased use of insulin, can reduce cardiovascular events in type 1 diabetics."
Lastly, this is really scary:
A third inhaled insulin, preprandial human insulin inhalation powder (HIIP) delivered by the Lilly/Alkermes Inhaled Insulin System, demonstrated equivalence to injectable insulin in a study of 259 patients with type 1 diabetes.
Dr. Garg, who reported the HIIP data, said there was about a threefold increase in both cough and anti-insulin antibodies among patients in the HIIP arm. "But interestingly, when asked, four of five patients in the HIIP arm chose to stay on HIIP for mealtime insulin -- and this is in a group that is used to injection."
This is nuts. Patients using the Lilly/Alkermes system develop cough and anti-insulin antibodies, yet they prefer this over injection. The fact that a patient prefers a little cough over the pain of a daily injection is not surprising. But, I am concerned that patients are developing antibodies against insulin. Note that these are Type I diabetics (also known as juvenile diabetes), which tend to be children/young adults at the time of diagnosis. What are the long-term implications for developing anti-insulin antibodies? I don't know, but I find it troubling...
Again, to be clear, I am supportive of the development of any delivery system which does away with the multiple injections of insulin. Conceptually, inhaled delivery is a great way to do this. However, I'm seeing a lot of yellow flags here.
Note how Wall Street spins this stuff...
Interesting posts. I learned a lot. I have a friend at Pfizer who used to work in the Diabetes group. Will make me a bit more educated to talk with him now.
Posted by: Steve Shu | June 15, 2005 at 11:48 PM
Thanks, Steve. Warms my heart to know someone read this and learned something from it.
Posted by: Carlos N Velez | June 16, 2005 at 09:19 AM