What a Vincristine Shortage Means for Childhood Cancer Patients and How Parents Can Help
The names of chemotherapy medications sound scary. When my daughter was in treatment for a rare form of lymphoma when she was 6 years old, I was acutely aware of translating the cold, grown-up medical world we found ourselves in into age-appropriate chunks of need-to-know information. I thought of the names of meds as characters or places in children's stories. Etoposide, for instance, could be a slime-like substance used to win a game—always beating "Ebottomside." Zofran sounds like the name of an evil robot king in a sci-fi fantastical world. In reality, Zofran is the king of anti-nausea medications. But the most lovely sounding chemo name to me was vincristine. Vincristine—ah. A crisp, futurist princess. A heroine. A true "bad-cells" killer. Vincristine, in real-life, is one of the heavy hitters in the pediatric cancer arsenal. However, now vincristine is missing, and its once hopeful story has turned into a nightmare.
As reported in the New York Times, a vincristine shortage has hit the pediatric cancer community. Nearly every cancer family I know has had vincristine in their child's protocol. Because very few new medications have been created over the last several decades to treat pediatric patients, vincristine is considered tried and true—even though it's neurotoxic for growing bodies and can have intense side effects. Far from perfect, believe me when I tell you that parents would prefer their child getting it, to not getting it.
How the Chemo Shortage Affects Families
Jase Canales, 9, is approaching the end of his three-year treatment protocol for Acute Lymphoblastic Leukemia. When he arrived for his maintenance dose of vincristine at El Paso Children's Hospital, his mother Jessica Rivera, "was told that he would not be receiving his medication (vincristine) as scheduled due to the nationwide shortage and children in maintenance would be skipping a dose." Rivera was told that missing the dose "would not affect his health or outcome as he is close to finishing."
As explained to me by a source within the medical community, children who are in the induction phase, the initial and often most intense phase of chemotherapy treatment which begins quickly after diagnosis, are considered a high priority for receiving vincristine. Basically, these children can't afford to miss a dose. Timing is everything. But chemo protocols are established for a reason and if a dose is called for—even if it's during the maintenance phase—it would be ideal for children to get it. Or why would it be in the protocol?
As a member of a peer-to-peer resource for cancer parents called Momcology, the concern on the message boards was palpable. Some hospitals appear to be more impacted than others. Worried parents and caregivers are scrambling to try to find connections to hospitals that may have stock.
How the Medication Shortage Began
I want to scream as I'm writing this. I understand that things happen. Sure, the world is an imperfect and curious place. No one understands that better than a medical parent who is haunted by why. Why my kid? Why this cancer? Why!? The answers to those questions will never have suitable answers. But why the shortage? That might be something we can find answers to. A confluence of factors have left the most vulnerable high and dry without their medications. As reported in the NYT, Teva Pharmaceuticals made a "business decision" to stop the production of vincristine in July 2019. According to a Teva spokesperson, "When the company decided to stop manufacturing vincristine in the U.S., the company was only supplying 3 percent of the market. Based on lack of demand for the Teva product at the time, and to enable us to re-adjust our limited resources to make other life-saving products needed in the market, Teva decided to discontinue vincristine and alerted FDA of its decision in March 2019. With the data that was available, there was no indication of a possibility of a shortage if the company left the market and availability of Teva product has not contributed to the shortage that is being experienced today."
Teva's decision to stop making vincristine did not sit right with Liliana Haas, a pediatric oncology nurse at Willett Children's Hospital at Memorial Health University Medical Center in Savannah, Georgia, who started a Change.org petition to Teva. For Haas, Teva's "business decision" was personal. "I am a childhood leukemia survivor and vincristine helped to save my life...as a pediatric oncology nurse, I see it save the lives of my patients almost every day," says Haas. "Vincristine is used to treat so many childhood cancers, most of my patients battling cancer have received it and depend on it for a cure. As a nurse, it's my job to advocate for my patients who cannot speak up for themselves. That's why I started the petition." At the time of publication, the petition has had more than 135,600 signatures.
That is only one small piece of the puzzling shortage. According to the FDA, Pfizer, the maker of the other 97 percent of vincristine has been having "manufacturing delays" which is what has caused the shortage. Pfizer also was responsible for the EpiPen shortage in 2018.
According to a statement from Pfizer, "Pfizer is now the only supplier of vincristine and is committed to providing this important medicine to patients. We have scaled up production to fully meet the need for vincristine over the long term. We have also expedited additional shipments of vincristine, which are now in transit to healthcare providers so they can treat patients." Pfizer did not respond to my questions about what caused their manufacturing delay. The FDA and Pfizer both say they expect production to catch up within a week or two.
What Parents Can Do
When I wrote to both Teva and Pfizer's spokespeople, I personally thanked their companies for making vincristine—a medication that helped save my daughter. I mean it, truly. Thank you. Now, please don't stop making it! And please keep your ducks in a row so that you don't have manufacturing delays when people's babies depend on it! It feels like a cruel game of connect-the-dots. There are people along this supply chain and my kid is one of the dots on the far end of it. So is Jase Canales. So are the patients of Liliana Haas.
In a recent letter the childhood cancer community, Peter C. Adamson, M.D., chair of the Children’s Oncology Group (COG), strongly urged for action. “In the upcoming days and weeks, I am hopeful we can arrive at focused action items for advocacy solutions that have the goal of guaranteeing cancer drug supplies for children in the United States." Dr. Adamson called for proposals including suppliers establishing and maintaining a national stockpile of key cancer drugs and the U.S. government helping to stabilize the market. The letter urged any family currently having difficulty obtaining vincristine for their child’s cancer treatment to contact the FDA at email@example.com.
Currently, several organizations are working together in a grass-roots all-hands-on-deck fashion. The Coalition Against Childhood Cancer, Momcology, and the Alliance for Childhood Cancer are reaching out to the pediatric cancer community to document the impact of the shortage. "This will allow regulators, physicians, policymakers, and advocates to gain a better understanding of the impact of the shortage within our community," according to a collaborative statement from these organizations. If your family has been impacted by the shortage, please reach out to one of these organizations.
Cancer parents now have to explain to their children why they aren't getting a magical sounding treatment after having already explained the importance of chemo to justify the ongoing medical trauma. There is already such a buildup of the hope that the medicine will make them better. Can you imagine telling your child, "Oh, actually, they ran out of the medication that is supposed to save you!" If a parent is expected to do that, then folks on the other end of the supply chain should be held accountable to Step. It. Up.
Update November 8, 2019: After the publication of this article, the author was in contact with a Teva Pharmaceuticals spokesperson who shared that as of today, the company has decided to re-introduce vincristine in its production plant in the United States. "Because vincristine is such a lifesaving medicine—and there is no reliable single supply anticipated in the near term—we have decided to re-introduce the product and plan to manufacture it in our plant in the U.S., which provides the fastest route to market," says the Teva spokesperson. "Product will be available for patients in the U.S. as early in 2020 as possible."