Clinical trials may have uncovered a possible link between inhaled insulin and lung cancer. In testing its blockbuster manque Exubera, Pfizer said six of the 4,740 Exubera-treated patients versus one of the 4,292 patients not treated with Exubera developed lung cancer. One lung cancer case was also found after Exubera reached the market. However, all those affected were smokers, so connections are still somewhat unclear, although Pfizer is adding to warning labeling for whatever product might still be out there. More from a news brief issued this morning.
What might be clear, though, is the role that a true Quality by Design approach could have played in developing this product. Pfizer's "Right First Time" appears to have failed, utterly, in this case. This is not playing Monday morning quarterback but pointing to a case where pharma lost billions by failing to connect more closely with customers and with its own work force. There's another case playing out right now, which shall remain nameless, with huge implications for industry professionals , particularly those based in New Jersey.
The Exubera product concept was brilliant, from the stabilization process that allowed its active ingredient to be manufactured to the delivery device itself. But nobody wanted a large device with complicated dosing instructions, so Exubera violated Toyota's "customer focus" rule. (Not to mention the fact that Pfizer transferred some manufacturing folks from its Brooklyn location to a fairly remote site to make the product. In the end the company only wound up laying them off...so it wound up violating Toyota's "respect for the worker" rule, too.)
Both Lilly and Novo Nordisk have reportedly stopped inhalable insulin development, and Nektar has suspended discussions with other potential partners. A shame because, if the kinks were worked out, inhalable insulin could solve a great many problems and be much easier for patients to take, particularly in parts of the world where needle availability and safety might be in question (assuming its costs went down, of course).
So perhaps it's time to go back to the drawing board. But, this time, maybe with the right tools (and many more physician and patient customer focus groups) in place? (And an eye to "right sizing" staffing requirements for the next blockbuster, up front)
