The bladder cancer drug Bacillus Calmette-Guerin is in shortage, forcing thousands of patients to receive rationed treatments instead of a full regimen, CNN reported Feb. 15.
In a survey spanning 20 medical centers, health systems and physician practices, plus 4,000 patients, 100 percent of respondents said they had to "use at least one mitigation strategy during the BCG shortage," according to the End Drug Shortages Alliance.
The drug has been in shortage since 2019, and the alliance said that's partly because drugmakers are not prioritizing efforts to boost supply of the lifesaving treatment. BCG has been used to treat bladder cancer patients since 1976, and in the 1990s and early aughts, Sanofi Pasteur and Merck both produced it, according to the alliance.
Then, Sanofi experienced production hiccups and discontinued it in 2017.
Merck — now the world's sole maker of BCG — increased the drug's production by 200 percent between 2012 and 2019 and has produced it "to the full extent of manufacturing capacity over the past several years," a company spokesperson told CNN. Merck is building a new facility that will expand BCG supply, but that won't be completed for another five to six years.
For years, Merck's BCG live intravesical product has been on allocation, according to the American Society of Health-System Pharmacists.
In the meantime, bladder cancer patients who rely on BCG are implementing mitigation strategies, including switching to other products, reducing their doses and splitting vials.
BCG is also a 100-year-old tuberculosis vaccine that some researchers are testing as a potential COVID-19 treatment, a respiratory syncytial virus vaccine and a diabetes vaccine. The supply issue is because of money — or really, the lack of it, according to CNN: The market is relatively small even as bladder cancer cases increase; BCG is a complicated biologic drug and easily falls into quality control issues; and there are few motivations for pharmaceutical companies to begin making it.