What is a doctor to do when there is a proven treatment for a disease but the principal drug in that treatment is in short supply?
That is the dilemma for doctors charged with treating children with acute lymphoblastic leukemia. According to a report by National Public Radio, the drug of choice is un-preservative treated methotrexate - a generic drug made by only a few companies.
A principal supplier, Ben Venue Laboratories of Bedford, Ohio, flunked an inspection by the Food and Drug Administration in November and shut down. The company says it is investing millions to fix the problems and restore the supply.
In the meantime, though, some hospitals have only a few weeks worth of the drug on hand.
The problem is that many large drug companies concentrate on brand-name drugs that have a much higher profit margin than generics. When a brand-name drug's patent protection expires, the larger companies often concentrate on developing new drugs with patent protections - and leave the manufacturing of generic versions of the older drug to smaller companies.
For six decades, methotrexate has been the drug of choice for treating acute lymphoblastic leukemia and a bone cancer called osteogenic sarcoma. No newer, better drugs have been created for treatment of these diseases.
The patent protection for methotrexate expired long ago - so its production has been left to smaller, less profitable firms like Ben Venue. And, when they have troubles, so do the patients relying on their drugs.
"There's really no known curative therapy without methotrexate," Dr. Howard Weinstein of Massachusetts General Hospital told NPR.
With all of the talk about health care reform, one would have hoped the protection of the supply of effective, inexpensive drugs might have been a lynchpin.
But, it wasn't. Now doctors and a small company are in a race against time to restore a lifesaving supply line before children start dying.
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