The interplay between medicine and the economy is hard to ignore in this era of health care reform, but sometimes the boundary that separates the two is as vague as the edges of Unger’s clouds.
At the Interscience Conference on Antimicrobial Agents and Chemotherapy in Boston this week, Dr. Bienvenido G. Yangco of the Infectious Disease Research Institute in Tampa, Fla., presented new data from a small retrospective study demonstrating the efficacy of single-dose intravenous immunoglobulin (IVIG) as an adjunctive therapy in patients with severe C. difficile colitis who didn’t respond to standard treatment with metronidazole, vancomycin, or other agents (See story).
Although passive immunotherapy with IVIG in refractory C. difficile colitis patients has been used since 1991, the doses in the published case series and observational studies in which efficacy has been demonstrated range from 200-1,250 mg/kg for up to 5 consecutive days or once every 3 weeks for 2-3 doses, Dr. Yangco said. In contrast, the patients in his clinic who were included in the retrospective analysis received a single 200-400 mg dose of IVIG.
The decision to go with the small-dose, shorter-course treatment was, primarily, an economic concession, Dr. Yangco said. “Our study started in the beginning of 2009, when we were starting to experience the worst economic crisis facing our country, when banks and other companies going down the tubes were being bailed out by the government,” he explained. “At the same time, we started seeing these very sick patients with C. difficile, and I wanted to treat them with IVIG like I’d read in the literature, but I knew that using a 3-5 day course would not put me on the good side of the payers, and the administration would probably call me on it,” he said. “I told the pharmacy department that my patients needed a ‘stimulus package,’ and I tried the idea of single-dose IVIG to bail them out.”
In a nod to the science behind the decision, Dr. Yangco noted that single-dose IVIG is an effective maintenance therapy for patients with hypogammaglobulinemia, “and I thought it might work for my patients.”
The single-dose approach did work, and most of the very ill patients in the study recovered. Even so, the clouds seem a little more gray.