Methotrexate is a drug used to treat acute lymphoblastic leukemia (ALL), which is most common in children ages 2-5 years old. A shortage of this drug in the United States means that hospitals across the country may soon run out of this medicine within the next two weeks, and children nationwide may be in serious trouble.
If this happens, oncologists and federal officials say that hundreds, perhaps thousands, of children will be at risk of dying from a largely curable disease, as reported by The New York Times.
One of the nation’s largest suppliers of injectable, preservative-free methotrexate was Ben Venue Laboratories. But in November 2011, the company suspended operations at its plant in Bedford, Ohio, due to what it called “significant manufacturing and quality concerns.” There are three other pharmaceutical companies that make this crucial cancer drug, as well.
Dr. Michael P. Link, president of the American Society of Clinical Oncology, said, “This is a crisis that I hope the FDA’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.”
A senator and three doctor groups sent pleas to the companies late Monday, explaining that hospitals will run out of the drug in days to weeks, increasing the chances that young patients who might otherwise survive, will die. Approximately 3,500 American children and teens are diagnosed with this cancer each year.
Last year, there were a record 267 new drug shortages reported, most of which remain unresolved today. The inability to get crucial medicine has disrupted chemotherapy, surgery, and many other serious problems in many patients. So far, at least 15 deaths have been blamed on the shortages since 2010.
Specialty groups representing researchers and doctors who care for children with cancer say the methotrexate shortage began in December, when production declined. That drop was primarily caused when Ben Venue Laboratories, Inc. temporarily closed its factory based on findings by the federal inspectors. Besides making methotrexate, the factory was the sole source for Johnson & Johnson’s Doxil, a drug widely used for breast and ovarian cancer that has not been available for new patients for months.
Late Monday, several cancer groups urged drug makers to “take all necessary steps to rapidly increase access” to the preservative-free version of methotrexate,needed for children, since preservatives can be dangerous for them. “Doctors and pharmacist are scrounging for supply with very little luck and are beginning to ration the remaining supply. It is not an understatement to say that this is creating a panic in the childhood cancer community,” the cancer group’s letter states.
The FDA says that the main reason for the shortages is manufacturing deficiencies leading to production shutdowns. Shortages also can be blamed as the result of companies halting production of drugs with low profit margins and supplies of some ingredients becoming less available.
It is really so sad that families suffering with childhood cancer, trying to fight this awful disease, should not have to have the added burden of worrying where to get their child’s next dose of medicine to save their child’s life. Is this justice?