February 15, 2012
Childhood Leukemia Drug In Seriously Short Supply
Methotrexate, a lifesaving drug used to treat childhood leukemia and rheumatoid arthritis, is in such short supply that hospitals across the country fear supplies could be exhausted in just a few weeks, leaving thousands of children at risk, health officials say.
Despite looming fears, the US Food and Drug Administration (FDA) said this week that the shortage should ease before hospitals run out. But drug makers are giving few details about how they will find a long-term solution.The FDA´s drug shortage program associate director, Valerie Jensen, said officials are working with the three makers of Methotrexate to come up with a solution to the problem.
The drug, which cures up to 90 percent of children with acute lymphoblastic leukemia (ALL), has been in short supply for the past year-and-a-half, and in far shorter supply in recent weeks because a leading maker of the drug shut down some of its factories last year.
“This is dire,” said Jensen. “Supplies are just not meeting demand.”
Ben Venue Laboratories was one of the nation´s largest suppliers of injectable preservative-free Methotrexate, but the company suspended operations at its Bedford, Ohio plant because of “significant manufacturing and quality concerns,” the company announced.
Since then, drug supplies have gradually dwindled.
“This is a crisis that I hope the FDA´s hard work can help to avert,” Dr. Michael P. Link, president of the American Society of Clinical Oncology, told the New York Times. “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.”
Ben Venue said in a statement that it is working closely with the FDA to bring Methotrexate back to market as soon as possible, and understands “the urgent need” for the medication.
“Since we suspended the production of all products in November 2011, our team has been working around the clock to implement changes needed to ensure a more sustained supply of the medicines we produce, and to address the manufacturing related issues at our facility noted in recent inspections by the FDA and other global regulatory agencies,” the company said.
“Over the past three years, we have invested more than $250 million to upgrade our facilities, and continue to invest millions more in order to restore production as quickly as possible. “¦ We are committed to doing all that we can to help seek a solution to this urgent need, and are hopeful that some of the other companies licensed to manufacture Methotrexate will be able to increase production while we work to restore manufacturing at our facilities,” it added.
“In the meantime, our inability to produce Methotrexate and other medicines critical to patient care weighs heavily on us all,” the statement concluded.
Jensen told The Associated Press (AP) that the three drug companies should be starting to ship doses of Methotrexate by the end of the month. She noted that federal regulations bar the FDA from discussing plans of specific companies, as it is considered proprietary information.
Elizabeth Raetz, a pediatric oncologist at the NYU Langone Medical Center, Liz Szabo of USA TODAY that the Methotrexate shortage is a matter of life and death for the 3,500 kids diagnosed with ALL each year. They endure two to three years of exhausting therapies but are nearly always cured of their disease, and there is no replacement therapy for Methotrexate; going without it, or even delaying it, could leave children vulnerable to a fatal relapse, she said.
FDA officials “have been reassuring in discussions that this is not going to be a prolonged shortage,” Dr. Peter Adamson, chairman of the Children´s Oncology Group, a network of 200-plus North American hospitals treating children with cancer, told the AP. But until the drug is delivered, we can´t be sure, he noted.
According to the AP's Linda A. Johnson, multiple hospitals and cancer specialists say they still have enough of the drug to treat its current patients. But a survey of 204 oncologists in January found at least 40 percent believed that one or more patients in the past year either died prematurely or suffered a tumor recurrence because of the shortage of Methotrexate.
Though Link praised the FDA for working so fast, he said the US still needs to find a long-term solution to the problem. Methotrexate shortages is only one of a long list of 286 other drugs that are facing supply exhaustion.
“People are panicking,” Erin Fox, manager of the drug information service at the University of Utah, told Gardiner Harris of the New York Times. “There isn´t a lot of hope that supplies will improve drastically over the next few weeks, which is why people are so worried.”
President Obama signed an executive order in October 2011 giving the FDA greater authority to manage drug shortages as well as counter price-gouging. The FDA has reversed 114 shortages in this manner since October 31, said FDA spokeswoman Shelly Burgess.
Sen. Amy Klobuchar, D-Minnesota, has introduced legislation to require manufacturers to report shortfalls of all medications to the FDA. “In the Senate, it´s so hard to get an individual bill to pass.” She said she will keep fighting until this strategy works.
Today, drugmakers are required to notify the FDA of shortages only in scarce drugs for which they´re the only supplier.
Currently there are five manufacturers of Methotrexate in the US, and they are trying to increase their production. The FDA is also seeking a foreign supplier to provide emergency imports until suppliers can meet demand in the US, said Jensen.
“We´re working on many fronts, and will keep this a priority,” she added.
On the Net:
- US Food and Drug Administration (FDA)
- Ben Venue Laboratories
- American Society of Clinical Oncology
- NYU Langone Medical Center
- Children´s Oncology Group
- University of Utah