The worsening shortage of a bladder cancer drug solely manufactured by Merck has undoubtedly led to deaths, Pittsburgh urologist Ben Davies, MD, told CNBC.
The shortage of Tice BCG, a biologic drug that is remarkably effective against bladder cancers, is being felt across the nation, as hospitals find it harder to obtain.
Smaller clinics already have run out of the drug, while hospitals such as New York City-based Memorial Sloan Kettering Cancer Center have changed their policies on administering the drug to prioritize newly diagnosed patients.
In the case of BCG, "the shortage has definitely led to poor outcomes in bladder cancer patients," UPMC urologist Dr. Davies said. "You just get more recurrences. So that means you have to have more surgeries, you have to come back to the doctor to be screened more. It's not a question that [the shortage has] caused deaths."
The shortages started several years ago when Sanofi and Merck were both manufacturing the drug. The FDA cited quality problems at the Sanofi plant that made the drug in 2012, and a few years later Sanofi left the market.
Since 2016, Merck has been the only supplier of the drug.
Merck told CNBC it is working "around the clock to get Tice BCG to as many patients as we can."
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