Early this year, Hagop Kantarjian, M.D., chair of MD Anderson’s Department of Leukemia, began to hear from oncologists around the country asking for advice:
What do you offer a patient with acute myeloid leukemia (AML) when the drug cytarabine is not available?
Is there a substitute for the generic drug in the lone combination known to cure some patients with AML?
The grim answer — no.
“With cytarabine combination chemotherapy, the cure rate for AML is 40% to 50%,” Kantarjian says. “Without cytarabine, it’s 0%.”
Approved by the U.S. Food and Drug Administration in 1969, cytarabine is used with antibiotics called anthracyclines to treat AML, other leukemias and lymphomas. Alternatives exist for treating the other cancers, but nothing else works for AML.
Cytarabine is one of many mainstay generic cancer drugs that have been in short supply during the past year. There are alternatives for most of the other chemotherapies.
In December, cytarabine went on the FDA’s drug shortage list. Two of the three manufacturers cited production problems or raw material shortages. The third said it could not meet demand alone.
“In 30 years of treating leukemia, I’ve never seen such a critical drug shortage,” Kantarjian says. As the largest leukemia practice in the country, MD Anderson buys enough cytarabine to assure a supply for its patients. The shortage was stressful elsewhere.
Raising awareness to save lives
An appeal to thousands of physicians via the department’s Leukemia Insights email newsletter yielded hundreds of stories from doctors across the country with patients who needed the drug.
Starting with interviews with a Houston TV station and The Wall Street Journal, Kantarjian took every opportunity to draw attention to the problem. He wrote a widely read guest commentary for The Washington Post. Interviews with ABC News, NBC News and Science magazine followed.
Shortages of generic drugs climbed from 58 in 2004 to 211 in 2010, the FDA reports. “The root cause is financial,” Kantarjian says. “This has almost never occurred with brand-name drugs.”
The cytarabine shortage, like most others of generic cancer drugs, is unique to the United States.
Cytarabine supply improved by mid-summer, but the long-term problem is unaddressed, Kantarjian says. Perhaps tax breaks or subsidies might be provided to manufacture crucial drugs, or controls that limit generic drug price increases might be eased.
“In a country as rich as ours, patients should not have the misfortune of contracting a life-threatening disease for which a non-profitable treatment is withdrawn or not available,” Kantarjian says.