Some doctors, patients oppose insulin inhaler

Blockbuster or bust.

Those are the stark outcomes facing Pfizer Inc.'s Exubera, the first inhalable insulin that will arrive on most pharmacy shelves as early as next month.

Pfizer and some industry analysts have said they believe inhaled insulin -- delivered through a small pump about the size of a flashlight and filled with dry powdered insulin packages -- will be quickly adopted by some of the nation's 14.6 million diagnosed diabetes and could account for up to $2 billion a year in sales. That would make it a blockbuster drug at a time when the pharmaceutical industry is having a hard time finding new medications.

The treatment might coax those who resist taking insulin because of their discomfort with needles to get treated. Up to a fifth of diagnosed diabetics do not take insulin or pills as they should, the American Diabetes Assn. estimates. But there's evidence of mounting resistance among doctors and some patients to the new diabetes drug.

The main reason: some doctors worry that the long-term effects of inhaled insulin on the lungs hasn't been studied sufficiently. Research has shown that inhaled insulin causes slight declines in air capacity in the lungs.

Those findings led the Food and Drug Administration to recommend that smokers and asthma sufferers not take the drug. The agency has requested Pfizer to conduct additional research that isn't expected to be completed for several years. It also has not yet approved the medication for children.

"There are still questions about the long-term safety of this product," said Dr. Anastassios Pittas, an endocrinologist and assistant professor of medicine at Tufts University School of Medicine in Boston who was part of Pfizer's initial rollout to a small number of doctors last fall. Pittas said he had prescribed the drug to only two of his patients who requested it and that many of his colleagues also weren't widely prescribing the drug.

Another potential hurdle for wider uptake of the drug: its price. The pump and insulin packets cost about $2,100 a year, a third more than injectable insulin alone and slightly more than the oral medications used by those with a less severe form of the disease.

Many insurance plans are paying for the drug, said an Exubera spokesperson, but some are holding out because they aren't convinced the convenience is worth the higher cost. British and German regulators have recommended against insurance coverage on the grounds that Exubera doesn't treat an unmet medical need.