5/31/2016
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`Supply of Methotrexate, a Cancer Drug, May Run Out Soon - The New York Times
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`MONEY & POLICY
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`Supply of a Cancer Drug May Run Out
`Within Weeks
`
`By GARDINER HARRIS FEB. 10, 2012
`A crucial medicine to treat childhood leukemia is in such short supply that
`hospitals across the country may exhaust their stores within the next two
`weeks, leaving hundreds and perhaps thousands of children at risk of dying
`from a largely curable disease, federal officials and cancer doctors say.
`
`“This is dire,” said Valerie Jensen, associate director of the Food and Drug
`Administration’s drug shortages program. “Supplies are just not meeting
`demand.”
`
`The drug is methotrexate, and the cancer it treats is known as acute
`lymphoblastic leukemia, or A.L.L., which most often strikes children ages 2 to
`5. It is an unusually virulent cancer of white blood cells that are overproduced
`in bone marrow and invade other parts of the body.
`
`The cancer commonly spreads to the lining of the spine and brain, and
`oncologists prevent this by injecting large quantities of preservative-free
`methotrexate directly into the spinal fluid. The preservative can cause
`paralysis when injected into the spinal column, so cannot be used for this
`disease. Methotrexate is also used to treat rheumatoid arthritis.
`
`Ben Venue Laboratories was one of the nation’s largest suppliers of
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`5/31/2016
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`Supply of Methotrexate, a Cancer Drug, May Run Out Soon - The New York Times
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`injectable preservative-free methotrexate, but the company voluntarily
`suspended operations at its plant in Bedford, Ohio, in November because of
`“significant manufacturing and quality concerns,” the company announced.
`
`Since then, supplies of methotrexate have gradually dwindled to the point
`where oncologists now say they are fearful that shortfalls may occur at many
`hospitals within two weeks.
`
`“This is a crisis that I hope the F.D.A.’s hard work can help to avert,” said
`Dr. Michael P. Link, president of the American Society of Clinical Oncology.
`“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.”
`
`Jackson Schwartz, 6, of Langhorne, Pa., received a diagnosis of A.L.L. in
`August after he complained of terrible stomach pains and spent much of his
`family’s vacation sleeping on the beach, said his father, Jon Schwartz. A doctor
`initially gave Jackson a diagnosis of constipation, but when the constipation
`medicine did not ease his symptoms, Jackson’s parents took him to Children’s
`Hospital of Philadelphia.
`
`Within a day, doctors started Jackson on methotrexate, and the drug has
`been an essential part of his treatment ever since. Jackson is scheduled to have
`methotrexate injected into his spine weekly for the next eight weeks to ensure
`that his cancer does not return. If the hospital is unable to get more supplies,
`however, Jackson’s treatment and life may be in serious jeopardy, Mr.
`Schwartz said.
`
`“It would be devastating if we can’t get this drug,” he said.
`
`There are four other manufacturers of methotrexate in the United States,
`and they are trying to increase production, Ms. Jensen said. The F.D.A. is also
`seeking a foreign supplier to provide emergency imports until the approved
`domestic ones can meet demand, she said.
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`Supply of Methotrexate, a Cancer Drug, May Run Out Soon - The New York Times
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`“We’re working on many fronts, and will keep this a priority,” Ms. Jensen
`said.
`
`So far this year, at least 180 drugs that are crucial for treating childhood
`leukemia, breast and colon cancer, infections and other diseases have been
`declared in short supply — a record number. Prices for some have risen as
`much as eightyfold. President Obama issued an executive order in October to
`help ease the problems.
`
`“People are panicking” about the methotrexate shortage, said Erin Fox,
`manager of the drug information service at the University of Utah. “There isn’t
`a lot of hope that supplies will improve drastically over the next few weeks,
`which is why people are so worried.”
`
`A version of this article appears in print on February 11, 2012, on page A15 of the New York edition
`with the headline: Supply of a Cancer Drug May Run Out in Weeks.
`
`© 2016 The New York Times Company
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