FLICKR, DEREK K MILLER
Drug shortages in the United States have been growing since 2007, with several common chemotherapy drugs like doxorubicin and paclitaxel falling well below demand, Nature reported. A plethora of factors are behind the declining stocks, including the consolidation of generic drug makers, a tendency by hospitals and wholesalers to order medicines on demand rather than stockpile supplies, and manufacturing problems such as contamination from mold or glass particles. As a result, hospitals have started rationing dwindling supplies, and some clinical trials have been postponed indefinitely.
As of late August, 198 drug shortages have already been reported in the United States, according to the University of Utah’s drug information service, and of these 15 are cancer drugs required for clinical research. More than 150 trials sponsored by the National Cancer Institute (NCI) involve drugs that are in short supply. “If there was ever a national cancer-research emergency, this is it,” Robert Comis, president of the Coalition of Cancer Cooperative Groups, told Nature.
Most shortages affect old, generic drugs, but clinical trials often use these products as staples for control groups or in combination with experimental medicines. Unless patients can be ensured of completing a full dose of medication, NCI will not enroll new patients in clinical trials. A trial testing a combination of chemotherapy and antiretroviral drugs for treating advanced AIDS-related Kaposi sarcoma is on hold for at least a year because of this problem, for example. Some clinicians skirt around the issue by substituting alternative drugs when supplies of others wane, but this presents new problems with interpreting data and submitting applications to the US Food and Drug Administration for drug approval.