So I really don’t need to say “I told you so” on the whole Exubera flop business. It was just so darn obvious.

I don’t know if anybody noticed, but an Indy Star article (local newspaper for both the affected Pfizer plant and competitor Eli Lilly) actually quotes me, saying “It’s not just about the funny looks you might get… This is something you need to carry everywhere, to every bathroom, every bedroom, every time you walk out the door. You cannot be separated from it. I don’t think Pfizer made a product suitable for that at all.”

The reporter wanted to know what went wrong. Yeah, he’d read about the inhaler device design not being so desirable and all that… Above is my attempt to clarify the fact that in the case of 24/7 diabetes devices, the design issue is SO MUCH MORE than just a pretty case.

The other issue is of course that only about 10% of the insulin inhaled gets into the bloodstream, raising the question of what long-term effect the other 90 percent might have on your lungs. Ugh.

So it’s pretty darn clear to most patients and doctors alike WHY Exubera bombed. The big question is: WHAT NOW?

Does this mean the end of the inhaled insulin dream? And will its costly repercussions inhibit the pharmaceutical industry moving forward?

Let’s start with the financial side of things. At a $2.8 billion loss, the Exubera bomb is officially one of the most expensive failures in the history of the pharmaceutical industry. (Pfizer spent about $370 million this year on promotion alone, financing everything from CDE and doctor training, to prime-time TV spots. Yikes!)

How could Pfizer, the world’s largest drug maker, be so short-sighted as to forecast Exubera as a billion-dollar blockbuster?! Didn’t they see the writing on the wall? Maybe this whole debacle gives us a little insight into the need for those big blockbuster drugs — to finance the inevitable, enormously costly “experiments” that don’t pan out. How else could a company like Pfizer stay in business after such a spectacular calamity?

The financial review Motley Fool says the one clear winner here is Sanofi-Aventis, “for which Exubera has been a billion-dollar blockbuster. A few weeks before the FDA approved the treatment in early 2006, Sanofi agreed to give up its co-marketing rights to the drug in exchange for $1.3 billion from Pfizer.” Check mate in this game of billion-dollar chess.

Apparently Pfizer went out on a limb cutting its losses here. The Wall St. Journal points out that the company actually “bucked an unspoken industry rule: Products can linger on life support as long as they pose no safety problems.” Good for them, I guess, since long-term patient safety is not only an ethical issue, but could come back to bite them with more losses and lawsuits.

So is inhaled insulin dead?

The NY Times asserts that “the problems that bedeviled Exubera (will) probably plague other inhaled insulin treatments under development.” They even quote a certain Dr. Joel Zonszein of Montefior Medical Center in the Bronx, saying inhaled insulin on the whole is “just not a practical way to treat this population.”

On the other hand, some folks apparently see success in the very essence of Exubera: the accomplishment of safely converting a liquid drug that formerly could be administered only by injection into an inhalable form. Pfizer was the first to break the FDA-approval barrier, which ostensibly could “open the floodgates” on development of other such medications.

Currently developing inhaled insulin:

  • Eli Lilly, working with Alkermes on its AIR product, which could be submitted to the FDA in 2009. (Lilly also just purchased the rights to a molecule that may preserve beta cell function)
  • Novo Nordisk, in late-stage studies with AERx, licensed from Aradigm.
  • MannKind’s Technosphere, in late-stage development.
  • Abbott Diabetes, presumably, since its purchase of the technology from a company called Kos.
  • B&O Medicom, with its Insulair product, presumably in trials now.

From where I sit, the design of every single one of these blasts Exubera out of the water. But here’s what bothers me: Mannkind’s “thorough” marketing research last year included surveying some 425 physicians — 150 general practitioners, 150 internists and 125 endocrinologists about their product. What about the voice of the patient?! Why aren’t these companies spending more time where we live, in order to understand what truly impacts uptake of a new diabetes treatment? Why do they just assume that we’re all so desperate to dump needles that we’ll put our lungs at risk, or risk unreliable dosing, or put up any amount of money for a new needle-free gadget no matter how bulky and inconvenient?

I’ve said it over and over again: the Diabetes Online Community is the cheapest and most accessible focus group any industry could wish for.

Will no one learn from Exubera’s mistakes by engaging with us first?