Clipboard: Researchers document more cancer relapse following drug shortage

A national group of researchers, including some from Boston, were tracking the toxicity and long-term effects of a specific chemotherapy regimen in children and adolescents treated for Hodgkin’s lymphoma when one of the drugs, marketed as Mustargen, became unavailable. The researchers swapped it for what they thought was a comparable drug, but when they looked at their data later they found that those who were treated with the substitute had a significantly higher chance of relapsing.

Drug shortages have surged in recent years. The researchers’ results, published Wednesday by the New England Journal of Medicine, provide a small window into the potential effects on patient care:

[Dr. Michael Link, professor of pediatrics at Stanford University School of Medicine and an author on the paper,] said the results of the Mustargen substitution were eye-opening. Doctors thought they had a good alternative, but the data showed otherwise. When other critical drugs became unavailable for months — for example, cisplatin or doxorubicin, which are important in treating testicular and breast cancers affecting many more people — there were no clear substitutes and there has been little documentation of the consequence for patients.

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Many of the major cancer drug shortages have eased or been resolved in recent months, Link said. Lundbeck was producing Mustargen again in October and the drug was readily available by November, according to tracking by Fox’s group. (Lundbeck recently announced plans to sell its Mustargen product and other drugs to another manufacturer.)

The FDA has taken steps to mitigate the effects of shortages, including pushing manufacturers to notify the government when they expect a supply interruption. But, Link said, the changes don’t go far enough to prevent future shortages.

“We have no confidence that we have a durable solution,” he said. “The worry is, when’s the next one going to happen?”

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