Why Do Terminally Ill Patients Have to Ask for Permission to Take a Live-Saving Drug?

Idiopathic pulmonary fibrosis is the scarring of lung tissue over time with no known cause, cure or approved therapy. Patients survive on average for only two to five years after diagnosis, and about 40,000 die of fibrosis-induced respiratory failure every year — roughly the same number as from breast cancer.

A drug called pirfenidone has been shown to delay the decline in lung function and even prolong life. But the FDA refused to approve pirfenidone when it was last reviewed in 2010 because the regulators claimed the evidence was insufficient, and now a new clinical trial shows how careless that decision really was. (WSJ)

Comments (3)

Trackback URL | Comments RSS Feed

  1. Chamberlain says:

    I am curious about the reason behind. Does FDA assume pirfenidone has an unanticipated by-effect?

  2. Linda Gorman says:

    Because in the minds of regulators and many academics, statistical results trump observation, common sense, and all other clinical data.