The Weak Correlation Between Antibiotic Action and Mortality

At the recent FDA workshop on narrow-spectrum antibiotic development[1], the concept of using bacteriological response (BR) as an efficacy endpoint was flat-out rejected. The reason given is the purported lack of correlation between BR and survival/mortality which FDA considers the Continue reading The Weak Correlation Between Antibiotic Action and Mortality

FDA Needs Radical Reform

The nomination of Dr. Scott Gottlieb for FDA commissioner, a political appointee, has created the usual bipartisan furor. He is called unqualified, a renegade, not committed enough to FDA orthodoxy, an industry darling by some and a maverick by others. All Continue reading FDA Needs Radical Reform

The CDC and Spectinomycin

Pfizer discontinued US distribution of spectinomycin (Trobicin®) in November 2005; remaining inventory expired in May 2006 [1]. Nonetheless, at the FDA website we still find a Package Insert for Trobicin updated as late as Aug 2012, a thin 6-page leaflet which Continue reading The CDC and Spectinomycin

GC Therapy –  Shooting for the Stars

Besides ceftriaxone (CTRIAX), cefixime and spectinomycin we have no other highly effective single-dose treatment regimens for urogenital GC. Failures of all 3 drugs have been described but remain rare, can be overcome with higher doses of CTRIAX (1 g instead Continue reading GC Therapy –  Shooting for the Stars

QIDP, a Liberal Hand-Out from FDA

On our blog site, ‘QIDP’ stands for “Qualified Infectious Diseases Product” but when you look up ‘QIDP’ on the internet, you will find that it also stands for “Qualified Intellectual Disabilities Professional”. Looking at the more recent crop of ID Continue reading QIDP, a Liberal Hand-Out from FDA