Crucial medicine to treat childhood leukemia is in such short supply

By GARDINER HARRIS

A crucial medicine to treat childhood leukemia is in such short supply that hospitals across the country may exhaust their stores within the next two weeks, leaving hundreds and perhaps thousands of children at risk of dying from a largely curable disease, federal officials and cancer doctors say.

“This is dire,” said Valerie Jensen, associate director of the Food and Drug Administration’s drug shortages program. “Supplies are just not meeting demand.”

The drug is methotrexate, and the cancer it treats is known as acute lymphoblastic leukemia, or A.L.L., which most often strikes children ages 2 to 5.

It is an unusually virulent cancer of white blood cells that are overproduced in bone marrow and invade other parts of the body.

The cancer commonly spreads to the lining of the spine and brain, and oncologists prevent this by injecting large quantities of preservative-free methotrexate directly into the spinal fluid.

The preservative can cause paralysis when injected into the spinal column, so cannot be used for this disease. Methotrexate is also used to treat rheumatoid arthritis.

Quality concerns Ben Venue Laboratories was one of the nation’s largest suppliers of injectable preservative-free methotrexate, but the company voluntarily suspended operations at its plant in Bedford, Ohio, in November because of “significant manufacturing and quality concerns,” the company announced.

Since then, supplies of methotrexate have gradually dwindled to the point where oncologists now say they are fearful that shortfalls may occur at many hospitals within two weeks.

“This is a crisis that I hope the F.D.A.’s hard work can help to avert,” said Dr. Michael P. Link, president of the American Society of Clinical Oncology. “We have worked very hard to take what was an incurable disease and make it curable for 90 percent of the cases. But if we can’t get this drug anymore, that sets us back decades.” More >>