Drug shortage slows clinical trials

[n2doc]

By Heidi Ledford of Nature magazine

Potential cancer treatments are loitering in the wings as clinical trials are delayed by widespread shortages of common chemotherapy drugs.

The I-SPY 2 Breast Cancer Clinical Trial, for example, a high-profile experiment aiming to test the use of certain molecular markers to guide cancer treatment, was designed to allow researchers to adapt the study's protocol in response to early results. But principal investigator Laura Esserman, an oncologist at the University of California, San Francisco, is finding it harder to adapt to the shortages.

Faced with a dearth of the decades-old chemotherapy drug doxorubicin--a result of manufacturing delays and increased demand--Esserman's team substituted the drug epirubicin. However, finding an alternative when supplies of paclitaxel dried up proved more challenging. The logical substitution was a medication called abraxane, but there were insufficient safety data on combining that with other drugs used in the trial. Instead, Esserman's team encouraged hospitals involved in the trial to use abraxane for patients not enrolled in I-SPY 2, freeing up more of the limited supplies of paclitaxel for trial participants.

According to the University of Utah's drug information service, 198 drug shortages had been reported in the United States by late August this year, 15 of which are cancer drugs required for clinical research. More than 150 trials sponsored by the US National Cancer Institute (NCI) involve drugs that are in short supply. "If there was ever a national cancer-research emergency, this is it," says Robert Comis, president of the Coalition of Cancer Cooperative Groups, based in Philadelphia, Pennsylvania.


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http://www.scientificamerican.com/article.cfm?id=drug-shortage-slows-clinical-trials