Bladder cancer drug shortage is stressing patients out
Dire shortages of a crucial drug for treating bladder cancer are hitting patients nationwide for the second time in three years — leaving some fearing for their lives.
Bob Field, a 71-year-old bank officer who lives in Manhattan, was set to begin receiving maintenance doses in February of Tice BCG, a vaccine that’s considered the most effective treatment for his non-muscle invasive bladder cancer, or NMIBC.
The problem: In the US, Tice BCG is manufactured solely by Merck, and — in what experts say looks like a throwback to the EpiPen crisis — the pharma giant is having a major problem producing it.
Just two days before Field’s dosages were slated to begin, his doctor at Memorial Sloan Kettering Cancer Center was forced
to cancel the treatments, citing a sharp curtailment in Merck’s distribution.
to cancel the treatments, citing a sharp curtailment in Merck’s distribution.
Field, who was diagnosed last September and whose wife has also been an MSK patient for nine years, said the delay has him feeling “like I got hit in the head with a sledgehammer.”
“I hold Merck accountable,” Field, who’s also his wife’s primary caregiver, told The Post. “I can’t believe they could not have foreseen the shortage and ramped up production.”
Field isn’t the only outraged patient. The American Cancer Society expects 80,470 new cases of bladder cancer this year — 70 percent of which will be NMIBC.
The Bladder Cancer Advocacy Network, or BCAN, finds Merck’s inability to meet demand troublesome — especially since NMIBC patients are coming off a BCG shortage that lasted from 2012 to 2016.
“We’ve already met with Merck, and we’ll be meeting with the FDA as early as next week,” said Robert Shalett, BCAN’s director of communications. “We want to encourage the FDA to fast-track introduction of BCG strains used safely in other countries — like Tokyo BCG and Danish BCG.”
A spokeswoman for Merck, which first disclosed the shortages on Dec. 31, referred questions to the company’s Web site, which puts the blame on “increasing demand for this medicine globally.”
Merck also claims to have increased production “by more than 100 percent” since the drug’s only other distributor in the US — France’s Sanofi Pasteur — ceased production in 2016 after mold overgrowth ruined its BCG manufacturing facility.
Although Merck said it expects to meet most of the global demand for the drug “over the course of this year,” it stopped short of giving a guarantee.
New Jersey-based Merck says that making BCG is complex because it requires 30 days for the medicine’s bacteria to grow, followed by 45 days of quality testing.
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Those constraints currently limit Merck’s production of BCG to 600,000 to 870,000 vials a year, which are then allocated among wholesalers and distributors rather than directed to individual hospitals or medical practices.
“At no point in determining this allocation process has Merck considered profitability,” the company said.
BCAN’s Shalett agrees that BCG production can be difficult. “It’s not like baking a cake,” he says. But he adds that’s just another reason to have other producers of the only US-allowed strain.
NewYork-Presbyterian/Columbia is already warning that future batches of BCG will be reserved for first-time patients with high-grade Stage 1 cancer.
Shalett knows that’s not what NMIBC victims want to hear.
“Having cancer is stressful enough,” he said. “Something like this just adds to all the anxiety already going on.”
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