After Backlash, Teva Will Resume Production of Vincristine
After facing harsh backlash over a decision to stop manufacturing an essential pediatric oncology drug, Teva Pharmaceuticals has announced that it will resume production of vincristine.
In July, the company announced that it was bowing out of the market because of “business reasons.” This led to severe shortages of vincristine in the United States and sent the oncologic community into a tailspin, because the drug is a vital component of treatment for many childhood cancers
“Because vincristine is such a lifesaving medicine — and there is no reliable single supply anticipated in the near term — we have decided to reintroduce the product and plan to manufacture it in our plant in the US, which provides the fastest route to market,” Teva announced last week.
Teva bowing out of production left only one manufacturer (Pfizer) supplying the US market. While Pfizer had already been supplying the bulk of vincristine to facilities in the US, it ran into some snags while ramping up inventory to fill the gap left by Teva’s withdrawal from the market.
This led to a complete disruption of drug production, and a looming shortage of vincristine, as previously reported by Medscape Medical News,
“We have experienced shortages before but never a complete disruption like now, where there is no supply coming into the country,” Peter C. Adamson, MD, chair, Children’s Oncology Group, Philadelphia, Pennsylvania, told Medscape Medical News last month. “We’ve been worried before, but the supply has never been disrupted like it is now.”
Teva’s decision to stop manufacturing vincristine and Pfizer’s manufacturing woes drew intense media attention and left physicians scrambling, as there are essentially no optimal alternatives for vincristine, which is used to treat several childhood cancers, including leukemias, lymphomas, and brain tumors.
A pediatric oncology nurse, Liliana Haas, who is also a childhood leukemia survivor, started a petition to convince Teva to resume production. “As a childhood leukemia survivor, this drug helped save my life. As a pediatric oncology nurse, I see it help save the lives of my patients every day,” she wrote. Her petition gathered more than 215,000 signatures and comments. A second petition that was sent to the White House asking the government to intervene in the shortage gathered more than 100,000 signatures.
The shortage appeared be more related to Pfizer’s manufacturing issues than to Teva. Adamson explained that Teva only had a relatively small share of the market for vincristine, so when the FDA reached out to Pfizer, they didn’t think it would be a challenge to close the gap left by Teva. “But inevitably they ran into a manufacturing problem, and now Teva isn’t available to help fill that gap,” he said last month.
Drug shortages, unfortunately, have become the “new normal” in US healthcare. A host of drugs used to treat a variety of ailments have periodically been in short supply during the past decade, but there has been a chronic stream of shortages of chemotherapeutic agents essential to combating childhood cancers. Vincristine has been in short supply, on and off, for more than a decade, and as recently as last year.
“The primary difference between the prior vincristine shortage in February 2018 and the current shortage is that now there is now only a single supplier,” said Yoram Unguru, MD, a pediatric hematologist/oncologist at Samuelson Children’s Hospital at Sinai and Johns Hopkins Berman Institute of Bioethics in Baltimore, Maryland. “There is no alternative or substitute for vincristine.” told Medscape Medical News last month.
Teva emphasized in its latest announcement that when it removed vincristine from the market earlier this year there was no indication of a possible shortage. “In fact, the company was only supplying 3% of the market and, without any information to the contrary, anticipated that that volume could quickly and easily be absorbed by the brand manufacturer [ie Pfizer], which was supplying the other 97%.”
According to STAT News, Pfizer says that deliveries were made late last month and the company now believes it is meeting current demand for vincristine and should be able to continue to do so for the rest of the year.
The Problem Is Still Here
However, the underlying issue of drug shortages has not gone away. Spencer Mangum, MD, a pediatric hematologist/oncologist at Nemours Children’s Health System, Wilmington, Delaware, noted that “we have achieved amazing success in childhood cancer, and it wasn’t through the discovery of new drugs but optimization of old drugs.”
Unfortunately, these drugs are older and no longer on patent, and don’t have much use outside of pediatric oncology, he told Medscape Medical News. “They’re not profitable and pharmaceutical companies have been dropping out of the market,” he said. “And then we have shortages like we are facing with vincristine.”
But while vincristine “really hit a nerve” because it is used in so many pediatric cancers, Mangum emphasized that there are other drugs that have been in short supply — and for much longer periods. “They’re not as widely used so there isn’t the same pressure like with vincristine, but for the patient who needs them, it’s really important,” he said.
A variety of potential solutions have been discussed; one is more public awareness of drug shortages. “Some think that the government should guarantee production, and pay for it,” Mangum pointed out, “And others have discussed creating stockpiles.”
He added that although these drugs are not profitable for manufacturers, he thinks drug companies should produce them as a gesture of good will with the public.
“These drugs aren’t very expensive to them to manufacture, and to produce them would show that they care about patients, and aren’t just all about profit,” Mangum said.