WSJ takes the FDA to task

fdadrugapprThe reality is all too familiar for the 200,000 or so Americans suffering from a terminal lung disorder as they wait, and wait, and wait for the FDA to approve a good drug that can slow the progression of their disease.

An editorial in yesterday’s Wall street Journal really holds the FDA’s foot to the fire on drug approvals.  Key points..

…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.

…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.


…More details are being prepared for peer-reviewed publication, but the top-line numbers show that the drug reduces decline in a proxy of lung function called forced vital capacity by 47.9% compared to a placebo.

…The humane option for an irreversible disease that is not well understood would have been to allow the drug to come to market and ask for a follow-on study, especially since affluent patients can and continue to obtain treatment overseas.

The WSJ tends to be business first and consumers/patients second so I’m sure we’re not hearing the whole story but their article does raise some questions.

2 thoughts on “WSJ takes the FDA to task

  1. Just imagine to die slowly, very slowly from ASPHYXIA… even if breathing high % oxygen. Law-makers should see the ICU of a Respiratory Unit of a big specialized Hospital. A short film (informed-consent) of these patients should be made available to them, to see how is this kind of die… and meditate about.

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