The U.S. Senate and medical groups have raised concerns about a national shortage of a scarce cancer drug for children. The scarcity relates to the volume of medicine being prepared by pharmaceutical companies.
The New York Times has reported that children who have a common childhood cancer called acute lymphoblastic leukemia are being put at risk due to low levels of the drug methotrexate. The limited stocks are due to problems with production on the part of the four pharmaceutical companies who manufacture the medicine.
Methotrexate is used for chemotherapy either alone or in combination with other agents. It is effective for the treatment of a number of cancers including: breast, head and neck, leukemia, lymphoma, lung, osteosarcoma and bladder.
The shortage across the country has led to concerns being raised in the Senate (by Sen. Amy Klobuchar, D-Minn) and by medical groups (including American Society of Clinical Oncology, American Cancer Society of Pediatric Hematology/Oncology and Children's Oncology Group). The activists fear that if production is not accelerated then unnecessary deaths will occur.
The Huffington Post notes that the medical groups have written to the pharmaceutical companies who make the drug. In their letter they wrote:
“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.”
At the moment federal law does not require pharmaceutical manufacturers to notify the Federal Drug Administration (FDA) if shortages are likely to occur.
One of the reasons for the shortage, as US News Reports, is the closure of a factory owned by Ben Venue Laboratories Inc. (in Bedford, Ohio), which was undertaken at the bequest of the FDA due to hygiene standards. The other manufacturers each have a production problem. These companies are APP Pharmaceuticals LLC, Hospira Inc., Sandoz Inc. and Mylan Inc.
The website PharmaPro reports that in 2011 there were 267 new drug shortages reported, and most of these remain unresolved into 2012. The report states that “the inability to get crucial medicines has disrupted chemotherapy, surgery and care for patients with infections and pain. At least 15 deaths since 2010 have been blamed on the shortages.”
The only company to respond so far is APP Pharmaceuticals LLC, who have stated that they hope to be able to supply more quantities of the drug over the next few weeks.
Many drugs shortages occur because valuable patents have been lost by ‘big pharma’ and generic drug manufacturers have been unable to supply or haver encountered process problems or have been blocked by regulatory authorities, or production has slowed due to low profit margins on certain drugs. Whichever way it is a worrying time for those who re reliant upon lifesaving medicines.