Doctors warn of possible rationing on critical childhood cancer drug

by Rachel Frazin - 10/15/19 8:56 AM ET

Doctors are warning that shortages of a drug used to treat childhood cancer may force them to start rationing the medicine.

The New York Times reported that there is not an adequate substitute for the drug, vincristine, which is used to treat most childhood cancers including leukemias, lymphomas and brain tumors.

{mosads}“This is truly a nightmare situation,” said Dr. Yoram Unguru, a pediatric oncologist at the Herman and Walter Samuelson Children’s Hospital at Sinai in Baltimore, told the Times.

“Vincristine is our water. It’s our bread and butter. I can’t think of a disease in childhood cancer that doesn’t use vincristine,” Unguru added.

He told the newspaper that shortages of the drug could affect kids across the country and force doctors to make difficult decisions.

“There is no substitution for vincristine that can be recommended,” Unguru said. “You either have to skip a dose or give a lower dose — or beg, borrow or plead.”

The drug used to be supplied by two companies, Pfizer and Teva Pharmaceutical Industries, until Teva “made a business decision” to discontinue it in July, according to the Food and Drug Administration (FDA).

Pfizer is now the only supplier and has experienced some manufacturing difficulties, according to The Times.

Vincristine is used to manage the most common childhood cancer, acute lymphoblastic leukemia, and to treat Wilms tumor, a rare kidney cancer.

The Children’s Oncology Group, an organization of researchers, is recommending changing clinical trial treatment procedures for vincristine, considering using half-doses, skipping doses or not using the medicine in some cases, the Times reported.

“Pfizer has experienced a delay, and we are working closely with them and exploring all options to make sure this critical cancer drug is available for the patients who need it,” the FDA told the Times in a statement.

Pfizer spokeswoman Jessica Smith told the newspaper the company would expedite more shipments of vincristine over the next few weeks to “support three to four times our typical production output,” to compensate for Teva leaving the market.

Teva spokesperson Kelley Dougherty told The Hill in a statement on Tuesday that its discontinuation did not contribute to the shortage.

“Availability of Teva product has not contributed to the shortage that is being experienced today,” Dougherty said.

“Teva evaluated data from 2017 to assess the market need for vincristine. At that time, the market share split was on average 85 percent brand and only 15 percent generic/Teva,” she added. “Based on this information about usage and availability and an annual business assessment, Teva decided to discontinue the product, and alerted FDA of its decision in March 2019.”

Tags Cancer FDA Food and Drug Administration Pfizer Teva Pharmaceutical Industries