The chemotherapy medication cytarabine was first approved by the Food and Drug Administration in 1969. For four decades, it has been the backbone of AML treatment.With cytarabine combination chemotherapy, the cure rate in AML is 40 percent to 50 percent. Without cytarabine, there is no cure.
In December, it was added to the FDA’s drug shortage list. There is no therapeutic equivalent to cytarabine, and optimal treatment starting on Day One is critical to the cure. Simply put: No cytarabine, no cure. Never in my 30 years of treating patients with leukemia has such a drug shortage occurred, resulting in inadequate therapeutic options for patients.
Take, for example, the 43-year-old Kentucky father who got a substandard dose of cytarabine because his doctor used all the doses he could find but still didn’t have enough. “I don’t know what I’ll do next,” the doctor told me.
Or the 45-year-old retired Air Force lieutenant colonel from Colorado, father of an incoming Air Force Academy cadet, whose leukemia came back after six months. His doctor looked all over the state for cytarabine with no luck and so was forced to give his patient second-line therapy.
Or the 15-year-old boy from Florida who is in remission but can’t get the therapy that will cure him.
Recently I sent out a plea on this national crisis to 8,000 oncologists who subscribe to a monthly e-mail newsletter published by the leukemia department at the MD Anderson Cancer Center. Within 12 hours, my in-box was jammed with replies from doctors in more than 25 states, each with his or her own horror story.
One works for a large California provider that cares for several million members. “As of this morning, the entire inventory of cytarabine in our system was 30 grams,” he wrote. “We are prioritizing the little remaining drug to go first to pediatric patients requiring cytarabine. . . . Patients will inevitably die as a result of this tragedy.”
A colleague from Wisconsin wrote, “We have been forced to form a panel of physicians, pharmacists and nurse practitioners to make difficult decisions regarding . . . this drug (i.e. who can receive it and who can’t).”
A doctor at a large center in Nebraska wrote, “We are completely out after the end of the week and no cytarabine in sight. It is like we live in a Third World country!”
Cytarabine used in the United States is manufactured by three companies: Bedford Laboratories, Hospira and APP Pharmaceuticals.
“We are currently facing manufacturing capacity constraints that are resulting in back orders of some products and we are working diligently to prioritize and expedite manufacturing for all current orders,” wrote Bedford spokesman Jason Kurtz in an e-mail in which he blamed Bedford’s shortage largely on increased demand as supplies from others were squeezed. He said Bedford expects to release more cytarabine in late May or early June. Hospira notified the FDA last week that it had begun releasing new supplies of the drug. And APP will begin releasing newly manufactured cytarabine this week, according to a company spokeswoman.