Methotrexate is a crucial medication needed to help treat childhood leukemia. Each year, nearly 3,000 kids and adolescents under the age of 20 are diagnosed with acute lymphoblastic leukemia (ALL) in the United States. Unfortunately, as with many other much needed medications, Methotrexate is in short supply and cancer centers or hospitals may not have enough Methotrexate to help treat their pediatric leukemia patients. Without this medication, thousands of children are at risk of dying from their leukemia, which according to the National Cancer Institute is a very curable cancer where approximately eighty percent of the children are successfully treated.
Childhood leukemia, which often strikes children ages 2 to 5, is a cancer of the germ fighting white blood cells and the most common cause of childhood cancer. If a child has leukemia, it causes the bone marrow to produce abnormal white blood cells. The abnormal cells crowd out the healthy blood cells and make it very difficult for a child to fight off any infection. If not diagnosed and treated early enough, the leukemia cancer can spread to the lining of the brain and spine.
In order to prevent the spread of the cancer to the spine and brain, pediatric oncologists often order or inject large dosages of preservative-free Methotrexate directly into the spinal fluid. Within the next week or so, pediatric oncology patients who have leukemia may not be so lucky due to a critical shortage and production of Methotrexate.
Ben Venue Laboratories was one of the nation's largest suppliers of preservative free Methotrexate, but it suspended operations in November due to, "significant manufacturing and quality concerns." In theUnited States, the production costs for some of these medications can outweigh the money the pharmaceutical companies can make off of them and the lack of profits along with a limit on manufacturing can contribute to the drug shortages. To date, there are four other manufacturers of Methotrexate in the Unites States, but they have not been able to keep up with the supply and demand of this childhood leukemia treatment medication.
While the Food and Drug Administration (FDA) can oversee imports of medications, they cannot regulate how much of a drug a company can make. The amount of a drug delivered to a hospital or cancer center is dictated by an agreement between the healthcare organization and the drug manufacturer. Manufacturers are not required to report drug shortages to the FDA and unfortunately many patients aren't even aware that they will not receive their medication until it is time for it to be administered.
To compensate for the Methotrexate shortage, some physicians and oncologists have no other choice and are being forced to either split the vials among patients or worse yet, delay treatment for some because another cancer patient may need it.
Valerie Jensen, associate director of the Food and Drug Administration's drug shortage program, said, "This is dire and we are working on many fronts, and will keep this a priority." The FDA is also exploring foreign markets to see if they can provide emergency imports of Methotrexate until the domestic markets can meet the demand.
Dr. Michael P. Link, president of the American Society of Clinical Oncology, hit the nail on the head by saying, "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 (Methotrexate) anymore, that sets us back decades."
In most cases, childhood leukemia is curable if the proper medication is available. Unfortunately the supplies of Methotrexate used to treat childhood leukemia may run out in the next week or so. What once was a curable childhood cancer is no longer curable due to an error in supply and demand of a much needed chemotherapy medication.
If you have high blood pressure, you do not want to be told there is no blood pressure pill for you. If you have diabetes, you do not want to be told there is no more insulin. If you have atrial fibrillation you do not want to hear there is no more coumadin. Why? It is because if you do not receive the medication you are supposed to be taking for your medical condition, it could lead to permanent injuries or even death. The sad reality is that some children with leukemia may not get the medication they need to treat their cancer.
In just the past year alone, there have been at least 180 medications that are needed to treat childhood leukemia, breast cancer, colon cancer, infections, sepsis, and other diseases that have been in short supply. It is so bad that a price for some of these medications has risen eighty times over their base price and President Obama issued an executive order in October to help ease these prescription medication problems.
If you or your child did not receive a much needed medication because of a drug shortage or some other reason, please feel free to contact one of our experienced lawyers, doctors or nurses at 1.800.588.1030 for a strictly confidential and free consultation. The Beasley Law Firm has been around since 1958, with a solid documented history of going after and winning against large pharmaceutical companies, big businesses, and corporations. To date, we have been awarded over $2 billion on behalf of our injured clients.