Fighting Back Against A Critical Shortage of Vital Pediatric Drugs

Berman Institute of Bioethics faculty member Yoram Unguru, an assistant professor at the Johns Hopkins School of Medicine and a pediatric hematologist/oncologist at The Children’s Hospital at Sinai, has spent years sounding the alarm about the skyrocketing number of drug shortages in the United States.

But even he wasn’t prepared for the notice he received one Sunday evening last month. Unguru, along with pediatric oncologists across the country, were notified of an imminent national shortage of vincristine, the single most widely used chemotherapy agent in childhood cancer.

“This was truly a nightmare situation.  Vincristine is utilized by children with nearly every type of cancer, including leukemias, lymphomas, brain tumors, bone tumors, musculoskeletal tumors, neuroblastoma, and more,” said Unguru.

“In 2016, colleagues and I published a paper in the Journal of the National Cancer Institute about the ethical allocation of childhood cancer drugs during a shortage. We came up with two hypothetical worst-case scenarios to set the stage – the primary case was a vincristine shortage and now was coming true.”

Unguru swung into action that evening, contacting a New York Times reporter who had interviewed him previously about drug shortages. A story in the next morning’s paper, “Faced With a Drug Shortfall, Doctors Scramble to Treat Children With Cancer,” followed by an appearance on NPR, helped launch a news cycle that created national awareness of the impending shortage and its potential impacts.

“This will inevitably result in many difficult decisions in the coming weeks as nearly every child with cancer in the United States will be affected by this shortage,” said Unguru, who traced the origins of the shortage to earlier in 2019 when Teva, one of only two pharmaceutical companies manufacturing vincristine sulfate injection, made a business decision to discontinue production. Afterward, the other and sole producer of vincristine, Pfizer, faced manufacturing delays.

Teva immediately faced a major backlash. A petition calling upon the company to resume manufacturing gathered more than 215,000 signatures. Another petition sent to the White House asking the government to intervene in the shortage gathered more than 100,000 signatures. In the face of public pressure, Teva announced last week that it will resume production of vincristine.

“I was pleasantly surprised to see the announcement, and it’s the right decision. Patients are going to benefit but it won’t help immediately,” Unguru told Forbes in an interview. “The cynic in me says that this will be one more story that people forget about. But I’m hoping that through advocacy work, the recent federal Mitigating Emergency Drug Shortages Act that Senators Collins and Smith have introduced might make a difference. I don’t believe drug shortages will be resolved until the government steps in.”

Dr. Unguru is a pediatric hematologist/oncologist with joint faculty appointments at The Herman and Walter Samuelson Children’s Hospital at Sinai and The Johns Hopkins Berman Institute of Bioethics, where he is a Core Faculty member. He is also an Assistant Professor in the Johns Hopkins School of Medicine. Dr. Unguru is a member of the Children’s Oncology Group, and leads a multidisciplinary, transnational working group examining the ethical and policy implications of chemotherapy shortages in childhood cancer.