TRENTON, N.J. (AP) —
Four pharmaceutical companies that make a crucial cancer drug for
children that's suddenly in short supply are being urged to try to
quickly step up production to prevent unnecessary deaths.
A
senator and three doctor groups late Monday sent the pleas to the
companies, saying that hospitals will run out of the drug in days to
weeks, increasing chances that young patients who might otherwise
survive will die.
The critical shortage of methotrexate has
doctors and hospitals around the country panicking because it's the key
treatment for a common childhood cancer called acute lymphoblastic
leukemia, or ALL.
With the drug, doctors say they can cure nearly
90 percent of the roughly 3,500 American children and teens diagnosed
with this cancer each year.
Last year, there were a record 267 new
drug shortages reported, and most remain unresolved. The inability to
get crucial medicines has disrupted chemotherapy, surgery and are for patients with infections and pain. At least 15 deaths since 2010 have been blamed on the shortages.
Specialty groups representing researchers and doctors who care for children with cancer say the methotrexate shortage began in
December when production declined. That drop resulted primarily from Ben
Venue Laboratories Inc. temporarily closing its factory in Bedford,
Ohio, in November after federal inspectors said the company had not been
properly maintaining equipment or promptly addressing defective product
batches and sterility problems.
Besides making methotrexate, the
factory was the sole source for Johnson & Johnson's Doxil, a drug
widely used for breast and ovarian cancer that's not been available for
new patients for months.
Each of the remaining four manufacturers
of methotrexate has had some type of production problem, and it's been
unclear when the next batches of the drug will be sent to wholesalers
and hospitals, according to Erin R. Fox, manager of the University of
Utah Drug Information Service, which tracks national drug shortages.
Late
Monday, the heads of the American Society of Clinical Oncology,
American Cancer Society of Pediatric Hematology/Oncology and Children's
Oncology Group, a nationwide network of researchers, wrote to top
executives at four U.S. makers of the drug pleading for help.
The
cancer groups urged the drugmakers to "take all necessary steps to
rapidly increase access" to the preservative-free version of
methotrexate, which is needed for children because the preservatives can
be dangerous for them.
"Doctors and pharmacists 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 letters state.
Sen. Amy Klobuchar, D-Minn., sent a similar plea to the companies Monday evening.
"Families
fighting childhood cancer should not have to worry about where they're
going to get the next dose of the drug they need to save their child's
life," Klobuchar wrote.
The letters went to APP Pharmaceuticals
LLC, Hospira Inc., Sandoz Inc. and Mylan Inc. An APP spokeswoman wrote
that the company doesn't have FDA approval for a preservative-free
product, but "over the next two weeks we will be shipping additional
methotrexate" with preservative to customers across the U.S.
Spokespeople at the other three companies did not have responses Monday evening.
Klobuchar
is the sponsor of a bill that would require manufacturers to notify the
Food and Drug Administration immediately of impending shortages of key
drugs — to give the FDA enough advance notice that it can take steps to
prevent a shortage by working with other manufacturers. The agency
increasingly has been doing that and already is working to increase the
supply of methotrexate, also used to treat rheumatoid arthritis.
Most
of the medicines that have become scarce are sterile injected drugs
that are the workhorses of hospitals and are normally inexpensive
because they've long been available as generics.
The FDA says the
main reason for the shortages is manufacturing deficiencies leading to
production shutdowns. Shortages also are resulting from companies
halting production of drugs with low profit margins, companies
consolidating in the generic drug industry and supplies of some
ingredients shrinking.
___
Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma
Copyright 2012 The Associated Press.