UPDATE: Because vincristine is such a lifesaving medicine, Teva has decided to re-introduce the product and plan to manufacture it in their U.S. plant, which provides the fastest route to market. This drug will be available for patients in the U.S. as early in 2020 as possible. Thank you, Teva, for listening to our concerns and making childhood cancer a priority. Read their full statement here.
If your child is currently fighting a childhood cancer diagnosis, the last thing you want to hear is that one of the drugs required to beat that cancer is currently unavailable. Yet that is exactly what many families are being told, due to a nation-wide shortage of a critical chemotherapy drug known as Vincristine.
This is a frightening situation for childhood cancer families across the country. Together with the Alliance for Childhood Cancer Drug Shortages Working Group and the Children’s Oncology Group, ACCO is working with the U.S. FDA to find an immediate resolution to this crisis, as well as develop long-term solutions to prevent future shortages. Because no child should have to go without the critical medications they need to survive childhood cancer.
What is Vincristine?
If your child has been in treatment for childhood cancer, it is likely that the sterile generic injectable Vincristine played a role in that treatment; this critical chemotherapy drug has been included in nearly every treatment protocol for childhood cancer, as well as some adult cancers, for the past five decades.
Cancer starts when abnormal cells in the body grow and divide too quickly. Vincristine is so effective in the fight against childhood cancer because it slows or stops this abnormal replication. Unfortunately, there is no alternative or recommended substitute for Vincristine available on the market today, making the current shortage of this important drug a true crisis.
Why is there a shortage of the Vincristine drug?
The current shortage of Vincristine has its roots in two specific events:
- The pharmaceutical company Pfizer, the primary manufacturer and distributor of 97% share of Vincristine for the U.S. market, encountered a quality control issue in its production line, forcing the company to curtail, at least temporarily, its production of Vincristine.
- Earlier this year, Teva, the second of the two manufacturers of Vincristine decided to stop distribution of the generic drug to the U.S. due to their small 3% market share. They communicated with the FDA at the time and were assured that their leaving the market would not result in a shortage of the drug. Generic drugs have a very small profit margin as compared to patented name-brand drugs making it not always possible to continue production. Teva has stepped back in to help reduce the shortage as quickly as possible.
How will this shortage affect kids with cancer currently being treated?
The COG guidance is that if a site does not have sufficient drug available, then children should not be enrolled onto a study. For children who were already participating, sites were given guidance as to how best to manage the research component of care due to the shortage. At some centers, this has led to the rationing of Vincristine and some children had their doses delayed or were possibly missed.
What should I do if my child is currently using Vincristine?
If your child is currently undergoing chemotherapy that includes Vincristine, talk to your child’s oncology team about how this shortage could impact his or her treatment. Although there is relatively little specific data about how missed and/or skipped doses may impact outcomes, your child’s oncology team is best suited to help you understand the implications of this crisis in terms of your child’s specific diagnosis and treatment plan.
Recently, the FDA released a report Drug Shortages: Root Causes and Potential Solutions where they discuss underlying factors contributing to ongoing drug shortages (not just Vincristine) and potential solutions. Find the full report at this link.
We also encourage you to contact the FDA at email@example.com and cc ACCO’s Director of Government Affairs and External Relations, Jamie Bloyd at firstname.lastname@example.org. The FDA will use the information you provide to track the shortages and distribute available resources. Only those impacted by this issue should use this email; it should NOT be used for calls to action or for general complaints about the shortage.
How can I help?
Without changes to our current healthcare system, we fear that this crisis will not be the last. We need your help to ensure that no family ever has to learn that the medicine they need to treat their child is simply not available. We are working with representatives in government, as well as with our allies in the childhood cancer community, to push towards comprehensive federal legislation designed specifically to prevent this type of shortage in the future.
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