Monday, June 30, 1997
About once a year or so, a particular clinical disaster induces
us to pause and take the pulse of our clinical thinking, and to ask if we need
to revise our own internal models of how things should get done. While there
was enough bad news last week to float a ship on tears, the specific event that
raised our antennae was the failure of The Liposome Co. Inc.'s Ventus liposomal
prostaglandin E1 in patients with acute respiratory distress syndrome (ARDS).
And the tidbit that raised questions was the fact that LIPO went straight into
Phase III studies after a single, small Phase II trial.
The perennial problem for biotech, of course, is that investors
want to get something for their money within their lifetimes. That argues for
pushing compounds through the clinic fast, and taking a chance on the home run
in Phase III. On the other hand, one can justifiably wonder if the sector will
continue to be able to attract funds if it can't show some greater degree of
reliability in its clinical results - especially as companies mature and can
presumably afford to follow a more conservative clinical path.