Dubai, United Arab Emirates (CNN) — Dino Carlon was terrified when he was diagnosed with bladder cancer three years ago. However, his spirits were lifted when he learned of a highly effective drug with a proven track record.
Carlon was supposed to have his medication for several years, but said he only got it for a few months because his urologist told him there was a shortage of the drug, and its name is Bacillus Calmette-Guérin, or BCG.
A new report estimates that more than 8,300 US patients annually do not receive full doses of medication for bladder cancer.
“This is a horrific crisis,” said Laura Bray, a board member of the End Drug Shortages Alliance. “We must do everything we can to give each of these patients the best chance of survival. It’s heartbreaking, and it needs to do better.”
A spokesperson for Merck, the only manufacturer of BCG worldwide, wrote in a statement sent to CNN that the company increased production of the drug by 200% between 2012 and 2019.
It, in turn, is building a facility to expand BCG’s throughput, but it could take five or six years to build, inspect and obtain regulatory approvals, according to the statement.
There are a number of factors contributing to this drug shortage, which began in 2019.
BCG is a biologic drug, which uses bacteria and is therefore more complex to make than many other types of medication. It is particularly vulnerable to quality control issues.
Sanofi, the other company that once made BCG, began having production problems in 2012. In 2016, it announced it would stop making the drug the following year.
While cases of bladder cancer are slowly increasing, it is still a relatively small market, and manufacturing the drug requires a significant investment.
Carlon said he was supposed to receive the BCG shots over a period of about two years. But the urologist told him he wouldn’t be able to get his remaining doses due to a shortage.
The recurrence rate for bladder cancer ranges from 30% to 40%, said Dr. Benjamin Davis, a spokesman for the American Urological Association.
“This recurrence rate is very high. It’s a bad disease.”
There are about 82,920 new cases of bladder cancer in the United States each year, and 16,710 deaths, according to the American Cancer Society.
Because of the significant shortage, the American Urological Association recommends that it be given priority to patients at higher risk.
It is reported that BCG is one of several drugs that are in short supply, including other cancer drugs, for adults and children.
Carlon wonders why the FDA can’t convince companies to make drugs that aren’t necessarily very profitable.
According to the FDA’s statement, the agency cannot order a specific drug from any manufacturer even if it is medically necessary.
You also can’t control how much medication is distributed, or which buyers are given priority.
Marta Wocieska, a former official with the Food and Drug Administration, said the federal government could offer financial incentives to companies to manufacture drugs that are in short supply, as the government has paid to make COVID-19 vaccines and treatments.
“Pharmaceutical companies can continue to be profitable while ensuring access to essential medicines,” said Dr. Yoram Ongoro, a core faculty member at the Johns Hopkins Berman Institute of Bioethics.
He added that the government is obligated to fix this shortcoming.