BCG is one of more than a 100 drugs listed by the FDA as in shortage this year. It's a persistent issue plaguing the U.S. health system, spanning everything from antibiotics to pain medicines to vaccines and therapies for childhood cancer.
"When the prices of drugs get too low -- particularly drugs that are generic drugs -- then you don't have a market incentive to put the capital up to build facilities like we need for additional amounts of this BCG drug," Frazier said.
To Dr. Gary Steinberg, a urologist at NYU Langone Health who called the BCG shortage his biggest headache, Merck is doing more than its fair share. Some, like UPMC urologist Ben Davies, say the company should be doing more. He pointed to Keytruda, which was approved in 2014 and has dramatically changed the way melanoma and other cancers are treated. It drew more than $7 billion in revenue last year for Merck.
In the case of BCG, "the shortage has definitely led to poor outcomes in bladder cancer patients," 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… the other outcome is you have to have surgery to have your bladder removed."
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