Life-saving children's drug reaches critical shortage, with exhaustion seen in as little as two weeks

Michael Santo's picture

A medicine critical to the treatment of childhood leukemia has seen its supply dwindle to the point that hospitals across America could exhaust their reserves within the next two weeks, a sign of the largest nationwide shortage of crucial and lifesaving hospital medications in nearly a decade.

The drug is named methotrexate. It is used to treat the cancer acute lymphoblastic leukemia, or A.L.L., by slowing the growth of cancer cells. A.L.L. most commonly affects children between the ages of 2 to 5.

A.L.L is a very virulent form of leukemia. It often spreads to the lining of the spine and brain, and oncologists can prevent this by injecting large quantities of preservative-free methotrexate directly into the spinal fluid. It must be preservative-free methotrexate, because the preservative can cause paralysis when injected into the spinal column, which complicates matters.

All five pharmaceutical companies that make the injection drug have either slowed and stopped manufacturing of the drug, according to the U.S. Food and Drug Administration (FDA). The companies have cited high demand or manufacturing delays as reasons for the shortage.

According to Dr. Michael Link, pediatric oncologist and president of the American Society of Clinical Oncology, "There are couple other drugs that can be injected into the spinal fluid, but none that are as effective. As for the high dose version of the drug, there's no workaround for it.

“This is a crisis that I hope the F.D.A.’s hard work can help to avert. 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.”

The FDA is reportedly attempting to find foreign supplier of the drug to provide an emergency import supply until the approved domestic ones can meet demand.

Late last year, when the shortages of not just methotrexate (Trexall, Rheumatrex), but other drugs such as paclitaxel (Taxol), doxorubicin (Doxil), vincristine (Oncovin), methotrexate(Trexall, Rheumatrex), leucovorin and bleomycin (Blenoxane) became known, the Obama administration directed the FDA to take steps to help resolve the shortages, including speeding up reviews of new drug-manufacturing facilities and making companies report shortages earlier, giving regulators increased time to manage limited supplies of a particular drug.

Although companies have given their own particular reasons for such shortages, a Perspective report in the New England Journal of Medicine pointed to a simpler reason: economics and greed. Oncologists rely on drug sales for about half of their revenue. In 2003, Medicare changed the way it paid for these drugs, saying it would only pay a 6 percent premium over the wholesale drug price.

ood for the taxpayers, but bad for oncologists, who used pocket $1.6 billion a year on the sales of drugs, according to a report in the Journal of the National Cancer Institute.

The problem is that doctors now have an incentive to prescribe the most expensive drugs. It's simple math. Why prescribe a drug that costs $100 when you can prescribe one that costs $5,000 ... and make 6 percent of $5,000 instead of $100?


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