Some doctors may soon be forced to give parents of leukemia patients some devastating news that a critical, life-saving leukemia drug is not available. The nation s supply of injectable methotrexate, which is standard treatment for acute lymphoblastic leukemia patients, is dwindling. And all five pharmaceutical companies that produce this drug have slowed or stopped production; the companies blame high demand and delays in manufacturing for the drug shortage.
Almost 3,000 people under the age of 20 are diagnosed with acute lymphoblastic leukemia in the U.S. each year, making this the most common form of childhood leukemia. The use of methotrexate, which, in its preservative-free form can be injected directly into the spinal fluid, has contributed to the impressive 80 percent treatment success rate. As ACSH's Dr. Gilbert Ross explains, Mortality rates for childhood leukemia used to be far more devastating, closer to 85 or 90 percent. But with advances in treatment, including total body radiotherapy and intra-thecal (into the cerebrospinal fluid) methotrexate, mortality rates have plummeted. It s been a true miracle. Yet now this life-saving drug may not be available to many who need it.
Drug shortages in the U.S. have been worsening, and treatments for heart and cancer patients, intravenous medications, and certain antibiotics have been hit especially hard. In response to these shortages, an executive order in October 2011 attempted to address the problem of drug shortages by encouraging pharmaceutical companies to report potential drug shortages to the FDA. The order also called on the FDA to conduct expedited regulatory reviews and investigate problems of price gouging. But while the agency has some power over regulating drug imports when there are supply shortages, they cannot force drug makers to manufacture more of any given drug. And many are concerned that the executive order will not do much to help the situation, especially given the urgency of the shortages.
As the crisis has progressed, ACSH's Dr. Elizabeth Whelan wonders why there is so little outrage in the country. ACSH s Dr. Josh Bloom replies that people just don t realize yet what s happening. Now that children are affected, the problem of drug shortages will probably start to get some notice. People will be shocked. However, he adds, it s a very complicated problem with multiple causes. Price controls, for one, have prevented many generic companies from making a profit on certain drugs so they ve just stopped making them. These ongoing drug shortages are real, and they re getting worse.
To read more about the drug shortage crisis in the U.S. and what can be done to address it, take a look at Dr. Bloom s most recent blog post at Medical Progress Today.