October 27, 2014 | John Fauber and Elbert Chu examine the pharmaceutical industry's growing reliance on surrogate endpoints, like "progression-free survival," to gain approval of new drugs, particularly in cancer. They argue that the FDA has become too permissive of endpoints that do not demonstrate meaningful benefits to patients, especially in the absence of strong postmarket studies that could later establish efficacy in extending survival or quality of life. They also question whether perverse incentives may have been set up in the FDA review process that place a disproportionate emphasis on quick decisions and early patient access. MedPage Today