The BCG Shortage

In 2014, I was on the Board of Directors of the Society of Urologic Oncology (SUO) when Merck announced having shortages of Tice strain Bacillus Calmette Guerin (BCG), a critical “drug” for treating intermediate and particularly high risk non-muscle invasive (NMI) urothelial cancer (UC) of the bladder, including carcinoma-in-situ (CIS) and high-grade (HG), stage Ta and T1 disease after transurethral resection. This was the second time in three years that a shortage of BCG had occurred, the previous one occurring when Sanofi announced a shortage of Connaught strain BCG. Particularly with the Merck shortage, I became a de facto spokesman for the SUO, the American Urological Association (AUA) and the Bladder Cancer Advocacy Network (BCAN) on this matter, which greatly affected all urologists in the Americas and Europe (and more importantly, our patients with bladder cancer). I was in contact with representatives of the manufacturer (Merck) of Tice strain BCG, manufacturer (Sanofi) of the competing product – which had not yet gone back into production, the Food and Drug Administration (FDA) and of course, the SUO, BCAN and the AUA. During the shortage, the use of BCG, when one could obtain it, was primarily restricted to patients with CIS and HG NMI UCs – rather than for intermediate risk disease for which intravesical chemotherapy could be an “almost as good” substitute. Maintenance courses and repeat induction courses of BCG were curtailed, and urologists experimented with administering lower dosages of BCG (so that vials could be used on more than one patient). After six months the Tice strain BCG shortage eased but was still felt by some practices for several more months (four months