Doctors are currently dealing with a shortage of an essential drug that is used to treat cancer in children. After a key manufacturer withdrew from the market for vincristine earlier this year, the entire supply chain has been thrown into chaos as the remaining manufacturer has experienced manufacturing issues. This has caused panic and uncertainty for children who are being treated for cancer and their parents. While the shortage should be alleviated by the end of the year, parents and hospitals are still having to alter treatments in the meantime.
Vincristine is an irreplaceable and vital drug in the field of pediatric oncology. It is a type of chemotherapy that is used to treat a variety of pediatric cancers. In fact, Vincristine is used in the treatment of nearly half of the cases of pediatric cancers. When this drug becomes unavailable, there are outsize impacts on these children’s treatment.
Vincristine Role in Treating Patients
Vincristine is a critical part of treatment for childhood leukemia. Its use has since been expanded to a number of other cancers. The drug has been credited with an increase in survival rates in certain pediatric cancers. When vincristine is used to treat a cancer, there are no ready replacements that physicians can turn to if the drug becomes unavailable. If physicians do switch treatments, they are not assured that the alternate course of treatment will be successful.
Vincristine is not a new or revolutionary drug. It has been available on the market since 1963 and does not rely on any new medical advances. Instead, its endurance as the staple treatment acute lymphoblastic leukemia is simply because the drug is effective.
Thanks in part to vincristine, the success rate of treatment for acute lymphoblastic leukemia has reached nearly 90 percent. In this case, success means that the patients are cured of the disease after being in remission for ten years or more. After beginning treatment with vincristine, approximately 98 percent of children will go into remission of the disease within several weeks. Children will usually undergo treatment regimens with vincristine for two to three years to ensure that the cancer stays in remission.
Previously, there were two manufacturers who sold the drug; Pfizer and Teva Pharmaceutical. Teva informed the FDA earlier this year that it had stopped making the drug for profit reasons notwithstanding its lifesaving abilities. Some have cited the very low reimbursement rates that the drug companies receive for this medication since a previous law capped the reimbursements for certain intravenous cancer drugs. The reimbursement for Vincristine can be as low as $5. Teva’s withdrawal left the country with only one supplier of the medication. When Pfizer experienced a production glitch, vincristine virtually disappeared from the market.
Pfizer had been trying to ramp up its production to respond to what was already a shortfall when the production glitch occurred. The manufacturing issue occurred in part because Pfizer was struggling to increase production. The company has been working to resolve the production glitch, which was expected to be fixed by the end of October. By the end of the month, Pfizer indicated that shipments of the drug had been sent to physicians.
Pfizer had warned that the shortage could still persist through December while it worked to increase its production. There have been no suggestions that Pfizer is at fault for the shortage since it was already making significant efforts to make up for an existing shortfall. Pfizer has worked closely with the FDA and the health care industry in an attempt to resolve its production difficulties.
In the meantime, hospitals have been scrambling to get their hands on critical supplies of vincristine. The controversy about vincristine has called attention to the issue of drug shortages in the system. While this is far from the only drug shortage, this is an acute case given the criticality of this particular drug and the lack of producers in the marketplace. Simply stated, this drug shortage has had extreme consequences for children who are suffering from cancer and undergoing chemotherapy.
There are no known alternatives to vincristine. When the drug is unavailable it means that patients are forced to alter their treatment as a result. This can mean that children must put treatment on hold or live with reduced dosages of the drug. At the same time, hospitals also incur costs and delays due to drug shortages.
The controversy has involved ethical issues of whether drug makers should stop making critical drugs that they feel does not live up to their profit margin requirements. Many people view lifesaving pharmaceuticals as a public utility that drug makers have an obligation to the public to produce no matter what. Vincristine is one of an older generation of injectable chemotherapy drugs that have a lower profit margin for their makers. In any event, companies that withdraw vital drugs due to the profit motive face a serious public relations debacle with customers. In Teva’s case, the company faced protests and petitions regarding its withdrawal from the vincristine market.
Teva claims that its decision to leave the market was the result of its low market share as Pfizer was the market leader. The company argues that this means that it was not to blame for the shortage since it supplied so little of the drug anyway. According to Teva, its share of the market ranged between three and 15 percent depending on the month. Still, when there are only two producers of a given drug, even slight changes in the supply chain can have large ramifications for patients and physicians.
As a result of some fierce backlash that it experienced as a result of the shortage, Teva has announced that it will resume production of vincristine. After beginning production again, Teva’s drug is expected to be available to U.S. patients in early 2020. In the meantime, the vincristine shortage is one more issue in a nationwide debate about drug pricing and shortages.
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