Update on vincristine shortage
Recent alarming press reports described a disturbing shortage of the chemotherapy drug, vincristine -- an essential component in the treatment of most childhood cancers, including leukemias, lymphoma, brain tumors, bone tumors, neuroblastoma, Wilms tumor, and rhabdomyosarcoma.
Faced With a Drug Shortfall, Doctors Scramble to Treat Children With Cancer (New York Times)
‘Complete Disruption’ of Supply of Essential Pediatric Chemo (Medscape)
Parents of Children with Cancer Speak Up About Critical Drug Shortage (Today)
Drug shortages are a somewhat common occurrence in the United States. However, a vincristine shortage represents a true crisis with no alternative or recommended substitution for the drug. Childhood cancer doctors providers must now make the gut-wrenching decisions on whether to ration vincristine among equally deserving children and how to limit trial enrollment. This is an unacceptable situation for children with cancer and their families.
Currently, just one manufacturer (Pfizer) is responsible for the entire US vincristine supply, and it has faced quality control problems that limited production.
NOVEMBER 13 UPDATE: Teva Pharmaceuticals announced that they will re-introduce vincristine to their supply line “as early in 2020 as possible.” We thank Teva for re-evaluating their previous business decision to discontinue producing vincristine.
Above info is a slide presented in the 10/23 community webinar.
Children’s Cancer Cause is an active part of two coalitions responding to the issue and evaluating policy solutions. The Alliance for Childhood Cancer and the Coalition Against Childhood Cancer (CAC2) have convened a working group on the situation.
This joint coalition working group offered a webinar on October 23rd, where we learned from COG Chair Peter Adamson, MD, that Pfizer had received shipment of vincristine and has a team in charge of controlled distribution “to ensure that every child who needs vincristine receives it.”
The webinar recording is now available here.
This COG letter provides more information on the issue and the government’s response thus far and reports that Pfizer now expects vincristine distribution to resume by the end of October. Of note, the COG letter references previously published guidelines to help physicians who may be forced to ration drug about approaches to consider, along with steps hospitals can take to minimize the impact of a drug shortage.
If a family is being immediately impacted, they should contact the Food and Drug Administration (FDA) at drugshortages@fda.hhs.gov and work with their physician on a care plan. Only those impacted by this issue should use this email. Do not use this email for any calls to action or general complaints about the shortage. We want them to be able to respond to all the physicians, patients and families as rapidly as possible.
According to COG, proposals that could be enacted in a reasonable time frame for today’s children that merit consideration include (1) establishment and maintenance of a national stockpile of key cancer drugs used for the treatment of children with cancer, and (2) US government purchasing contracts that provide a guaranteed buyer to help stabilize a fragile market.
In addition, a drug shortages task force established in 2018 by the former F.D.A. Commissioner Scott Gottlieb just submitted a report with findings and recommendations. The drug shortage issue is complicated and involves multiple factors such as aging manufacturing facilities overseas and a consolidation of suppliers. However, most experts believe the US is impacted by shortages more than Europe and payment polices are the root of many of the shortages.
Children’s Cancer Cause will continue to monitor the situation, provide advocacy solutions as appropriate, and work with families and providers that are facing treatment decisions related to the vincristine shortage currently. For the most up-to-date news and alerts, please be sure you're following us on Facebook and Twitter.