Stories of critical drug shortages--including cancer drugs--have been making news for months. Now the Food and Drug Administration is announcing that replacement supplies of two of those drugs, Doxil and methotrexate, should be available within weeks.
Both drugs are used to treat cancer. Methotrexate is used for many conditions, but of particular concern is its use for a type of childhood leukemia. If a child does not get the drug, the cancer can easily recur.
As the New York Times reports, some experts say the new supplies are only a temporary solution:
Dr. Peter C. Adamson, chairman of the Children’s Oncology Group, which is financed by the National Cancer Institute, said he was pleased that the immediate threat of a methotrexate shortage had passed. “But this is at best a Band-Aid approach to the problem,” he said.
Shortages of both drugs developed when Ben Venue Laboratories temporarily closed its manufacturing facility in Bedford, Ohio, because it could not guarantee product safety.
In the case of Doxil, which is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma, the F.D.A. has decided to allow temporary shipments from India of Lipodox, which is similar to Doxil and is made by Sun Pharma Global.
The FDA says it is also permitting the pharmaceutical company Hospira to ship 31,000 vials of methotrexate from its overseas facilities to hospitals and treatment centers across the U.S. This quantity of vials is enough to meet U.S. demand for one month.
At UC San Francisco, oncologist Alan Venook, said drug shortages have affected his practice as well. But he expressed concern about drugs coming from overseas. "You do worry about quality assurance, this is a real issue," he told me. "is it a good solution? I don't think so, but it probably will be fine."
Venook treats patients with gastrointestinal cancers. Last summer, his group experienced a shortage of a chemotherapy drug. "We didn't have enough drug for all 40 patients we would have treated," he said. "Each week we would have a conference call on Thursday where we would decide who we were going to treat next week."
One of those 40 patients was Jay Cuetara who was being treated for stage 4 rectal cancer. One day last August he came to the clinic, only to discover there was no drug for him. "I was shocked," he said. "I wasn't angry. I was shocked. How can we not have the drug I need in the United States? How does that work?"
Ultimately, that one session was the only one he missed. But that was all it took. He has become an activist on the issue and has testified before Congress. There are bills before both the House and the Senate to give the FDA more legal authority to prevent drug shortages.