HIV and ID Observations

From the FDA comes this news:

FDA notified healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)]. In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.

Some quick (and non-scientific) thoughts on these perhaps no-so-surprising turn of events:

• The use of various adjunctive therapies in acute sepsis has a long and mostly checkered history. ACTH-directed glucocorticoids, mineralocorticoids, intensive insulin therapy, disparate antibody treatments (most famously anti-endotoxin antibodies) — none has really worked very well. Now we can add recombinant human activated protein C — Xigris — to the list of disappointing (and sometimes dangerous) therapies. In failure there may be opportunity, but treatment of sepsis is one tough nut to crack.
• I know trade names are frowned upon in academic medicine, but is there anyone who actually said, “drotrecogin alpha (activated)”? What kind of word is “drotrecogin”? Is there a “Drotrecogin Beta (Activated),” and is it a space ship? The use of the parenthetical post-name word — “(activated)” — is particularly cumbersome.
• Finally, how many ID doctors ever literally prescribed this drug? In our institution, the use of drotecogin alpha … oh you know, Xigris … was overwhelmingly in the hands of the intensivists. They would consult us sometimes after giving it to their critically-ill patients for advice on the usual ID issues (choice of antibiotics, source of fever, whether to change the lines). I only remember being specifically asked, “should we give it” a few times, and am certain I never ordered it.

Meanwhile, “Xigris” happens to be a terrific name. Kudos to whatever advertising brainiac thought of that one.

I’m sure he/she cashed the check for these services many years ago.