Shortages of pediatric cancer drugs are common

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Posted 7/19/2005 7:37 PM Updated 7/19/2005 9:15 PM

Shortages of pediatric cancer drugs are common

By Liz Szabo, USA TODAY

Doctors across the country are concerned about a shortage of some key drugs used to treat pediatric cancer.

Children's cancer drugs like methotrexate, above, are in short supply. This drug can also treat autoimmune diseases or induce abortion.

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In the past few years, pharmacists and physicians have scrambled to find at least five standard chemotherapy drugs at one time or other, says Relling, pharmaceutical department chair at St. Jude Children's Research Hospital in Memphis.

Most shortages have been temporary. But an experimental drug used to treat leukemia, called Erwinia asparaginase, has been unavailable for about a year and a half, Relling says. Doctors prescribed it for children who can't tolerate a similar chemotherapy drug. Although the drug has not been approved by the Food and Drug Administration, patients could appeal to the manufacturer for "compassionate use" of the medication. (Related story: Who takes care of kids with cancer?)

"It's very possible that children are dying because they are not getting this drug," Relling says.

SUPPORT GROUPS

Here is a list of groups supporting families of children with cancer.General information: American Cancer SocietyLeukemia and Lymphoma SocietyCandlelighters Childhood Cancer FoundationDrug development: Children's Cause for Cancer AdvocacyClinical trials:National Cancer InstituteFinancial issues: National Children's Cancer Society

Doctors periodically grapple with shortages of many kinds of drugs, from painkillers to antibiotics. The drug methotrexate, used in pediatric cancer as well as some adult autoimmune diseases, also has been in short supply. If forced to limit use of the drug, doctors give priority to patients whose lives most depend on them, says Arceci, director of pediatric oncology at the Kimmel Cancer Center at s Hopkins in Baltimore.

The shortage of cancer drugs has much in common with the shortage of flu vaccine that occurred last fall. Many older drugs are made by only one or two companies. If something goes wrong at a factory, drug supplies may dry up, says Mark Goldberger, coordinator of drug shortages at the FDA's Center for Drug Evaluation and Research.

American Pharmaceutical Partners, an Illinois company that makes methotrexate, shut down a newly acquired plant in Switzerland last year to address quality concerns, says company spokesman Jaffe. His company hopes to make methotrexate available by fall.

But the shutdown also disrupted methotrexate supplies from Mayne Pharma, an Australian company that got its supplies from the same Swiss factory, says spokesman Larry Hamson.

To help alleviate the shortage, the Food and Drug Administration allowed Mayne to ship drugs to the USA that had originally been intended for Canada. To save time, the FDA didn't require Mayne to replace Canadian product labels with American ones, Goldberger says. The agency also sped up the process of allowing Mayne to ship methotrexate directly to the USA. The FDA suggested that Mayne ship methotrexate directly to hospitals, rather than distributors, to prevent drugs from sitting in warehouses.

Some hospitals are looking into producing generic drugs themselves. St. Jude researchers are working to make asparaginase, a complex process that could take five years, Relling says. "We don't want to become a drug company," Relling says. "We just want drugs to give our children."