Source: NPR Health News

This isn’t the first time we’ve heard about the crisis of drug shortages in U.S. Hospitals.  However, it isn’t just patented drugs anymore -it’s the generics.  One particular generic drug, methotraxate, has been the deciding factor in the lives or deaths of children with acute lymphoblastic leukemia and osteogenic sarcoma.  High doses of methotrexate are given to children with these cancers.  “There’s really no known curative therapy without methotrexate,” according to Dr. Howard Weinstein of Massachusetts General Hospital. “Based on our current outlook, if we don’t get any supply, we’re going to be out of methotrexate in the next couple of weeks.”  Weeks, not months, at a major hospital.  And they aren’t alone, the situation is just as critical at the Children’s Hospital and Clinics of Minnesota.

Why is it so difficult to obtain methotrexate for children with these cancers?   Medical Oncologists (cancer doctors) inject methotrexate directly into the spines of patients with ALL.  The treatment requires high doses of the drug.  Because it is going directly into the spine, it must be free of alcohol-based preservatives which could cause paralysis.  A major manufacturer of injectable methotrexate, Ben Venue Laboratories of Bedford, Ohio, was shut down by the FDA in November of 2011.  Why?  A host of reasons including mold on the walls of the factory and rust from manufacturing equipment literally falling into open vials.  For those of you picturing white sterile laboratories free of contamination, you’d be incorrect.

In corrective action, Ben Venue Laboratories claims to have invested over $250 million and three years of time upgrading facilities to restore safe production.  Unfortunately Ben Venue Laboratories is also the sole world-wide manufacturer of Doxil, a drug previously used to treat women with ovarian and breast cancers, which is now unobtainable.

Again, manufacturers of off-patent generic drugs claim that the costs are high to produce the drugs and that the rewards (profits) are low.  Various forms of subsidies have been suggested to encourage drug manufacturers to continue to produce much-needed medications, such as methotrexate.  The costs of not producing these drugs is fairly high as well.

Posted by: David M. Schwadron, Esquire