Pharmaceutical company Teva USA today announced that it will resume production of childhood cancer drug vincristine after a recent shortage which led to patients missing doses of the vital chemotherapy.
“I’m pleasantly surprised to see the announcement and it’s the right decision,” said Dr. Yoram Unguru, a pediatric oncologist at the Herman and Walter Samuelson Children’s Hospital at Sinai in Baltimore and faculty member at the Johns Hopkins Berman Institute of Bioethics. “Patients are going to benefit, but it wont help immediately,” he added.
The company came under intense pressure for the decision to cease production in March 2019 after claiming its product only made up 3% of the market share, with Pfizer producing the remainder. One White House petition asking the government to intervene in the shortage has over 100,000 signatures and another requesting Teva resume production has over 200,000 supporters.
However, the decision to make the drug again will not make any short-term impact on the ongoing shortage with the announcement from Teva stating that production will resume “as early in 2020 as possible,” without specifying a date.
“One of the hardest things in being able to cope with and address shortages, is how long is the shortage is going to last, is it 2 weeks or two months? Knowing this allows you to plan for your expected patients, in those respects I’d like a bit more information from Teva,” said Unguru.
The statement from Teva USA posted on their Twitter page:
Most children with cancer are treated with a cocktail of chemotherapy agents, many of which have no viable alternative. Vincristine, the drug which is in short supply, works by stopping the fast-dividing cells growing by blocking the cell from assembling its ‘skeleton,’ when it attempts to divide, without which it cannot function. Missing doses could have serious implications for treating and preventing relapse of the disease.
“We are relieved to hear that production of vincristine has resumed. We were shocked that such an important drug would ever be unavailable – we know that we all need to do better for our kids moving forward,”said Liz Scott, co-executive director of Alex’s Lemonade Stand Foundation (ALSF), a U.S.-based pediatric cancer charity.
Pfizer, the other manufacturer of the drug also recently reported issues making the drug, but in the middle of October announced it was ramping up production with the hope of meeting demand by the end of the month.
“This shortage is likely a combination of Teva withdrawing and Pfizer manufacturing delays. If you look historically when there are only 2 or 3 producers of a drug, and one of those producers has had a problem – it ends up in a shortage. There’s zero redundancy when there is only one producer. Having two producers is better than one and having three is better than two,” said Unguru.
Despite some deliveries of the drug resuming last month, in November there are still reports by parents of children with cancer that they are missing out on doses.
“I know that what was happening in the last several weeks was that Pfizer stated they had a new US supply of vincristine and centers could individually contact Pfizer with their needs and they would supply that amount. At my hospital, our pharmacy colleagues had contacted Pfizer with their demands for the short term and we were only getting half of what was requested as of last week,” said Unguru, adding that only this morning did the pharmacy at his medical center confirm they had an adequate vincristine supply.
It isn’t over yet and the Teva produced drug won’t hit the supply chain until a currently-unspecified point next year, but will this sobering experience that has undoubtedly harmed many children with cancer actually make any difference to drug shortage issues in the U.S.?
“The cynic in me says that this will just be one more story that people will forget about, but I’m hoping that through advocacy work, recent legislation that senators Collins and Smith have introduced (the Mitigating Emergency Drug Shortages (MEDS) Act) will maybe make a difference. However, I’m not holding my breath until the government steps in,” said Unguru.