Widely reported shortages of cancer drugs around the U.S. are triggering a bad case of anxiety among drug developers in the field. Reporting for the San Francisco Business Times, Ron Leuty found that developers are taking a variety of steps--including stockpiling--to ensure that they have the marketed drugs they need in order to carry out a randomized study of an experimental treatment.
"Before we start the study, we need to be sure that patients will get through all the cycles" of treatment, Threshold CEO Barry Selick tells Leuty. Sunesis, for example, says it placed its orders for cytarabine early to make sure researchers were covered.
Reports of shortages have been circulating for months now. Back in April the University of Chicago told ABC News: "[The] cytarabine shortage has critically affected our leukemia clinical trials being run by the CALGB at member institutions across the country. We have been actively trying to negotiate borrowing and sharing of cytarabine between institutions so that patients can stay on schedule with their protocol-directed treatments."
Soon after the ABC News report, the American Society of Hematology reported a number of incidents involving drug shortages. "For example," ASH noted, "one cancer clinic has halted all clinical trials using ARA-C (cytarabine) because of the drug shortage, preventing hematologist/oncologists from treating patients with necessary and timely drug therapy."
Cancer studies involving large numbers of patients can be notoriously expensive and time consuming, making any do-over for a drug developer almost unthinkable. USA Today reports that 180 drugs have been in short supply this year, with injectables on the critical list. Manufacturing problems as well as the fact that many of these therapies are older treatments with smaller margins helped contribute to the problem.