Is Exubera the next Vioxx?

The FDA is set to consider approval of Pfizer’s inhaled insulin drug Exubera. A year or two ago it would have been an easy decision –the drug is a convenient alternative to injected insulin. But in the post-Vioxx era it’s being looked at differently. After all, the drug doesn’t work better than injected insulin, and has some safety concerns. The safety issues appear minor –a slight drop in breathing capacity that apparently stabilizes over time– but who knows what will happen in a much larger population once the drug is approved?

So the question becomes: in the post-Vioxx era, how will the FDA weigh the added convenience of inhaled insulin –which is a big deal to some people– with the probably small but less certain risk? Personally, I’d vote for the drug’s approval and put the responsibility in the hands of physicians and pharmacists to help patients evaluate what is best for them.

September 8, 2005

One thought on “Is Exubera the next Vioxx?”

  1. Diabetes is a condition with so much morbidity and mortality that the existence of minor problems and the possibility of unforeseen problems are risks people are willing to take. With diabetes, there is not only danger when glucose gets low or high enough to be acutely dangerous; there is also chronic damage from glucose levels that are mildly but chronically high.

    The greatest potential of inhaled insulin comes from pairing it with continuous non-invasive glucose monitoring. Using this combination a patient could titrate their glucose levels far more tolerably than doing so with previous approaches, which would require many skin punctures each day. The result could be far lower rates of glycosylation of proteins, the molecular damage that is expressed in the chronic problems of diabetes.

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