While drug shortages are nothing new, shortages of certain key generic cancer drugs seem to be getting worse. The risk of running out of drugs long-used against many types of cancer is quite real and disturbing. Even worse is the danger these drug shortages present for children and teenagers undergoing chemotherapy treatment for Hodgkin s lymphoma.
According to a hospital analysis, shortages of the generic chemotherapy drug mechlorethamine necessitating use of a substitute drug, may have led to cancer relapses in children and young adults in 2010. Mechlorethamine is one of hundreds of drugs that have been in short supply in the last three years, according to the Food and Drug Administration.
Researchers used the hospital records of 181 patients who had been treated with Mechlorethamine and 40 patients treated with the substitute. They found that 25 percent of patients undergoing treatment with the substitute drug suffered cancer relapses while only 12 percent of those patients on the original drug had a relapse. Monika Metzger of St. Jude Children s Research Hospital in Memphis and lead author of the report appearing in the New England Journal of Medicine says that the difference is just shocking. This had a real impact on patients. We thought the alternative was just as safe, of course, so it was a real surprise when we reviewed the data.
And although cancer expert Bruce Chabner of Massachusetts General Hospital in Boston warns that this is not the most tightly controlled study ever conducted, he points out that it raises real questions about safety with all these shortages. What it really comes down to, he says, is the fact that generic drugs are a low-profit industry, making it less attractive to drugmakers.
ACSH s Dr. Gilbert Ross added, While the main factor behind the seemingly-endless shortages is the lack of profit motive for drug companies to rectify production lapses in these low-profit-margin generics, FDA delays in approving new plants and new sources is also playing a role. It s easy to say this is an unacceptable situation, but much harder to come up with effective remedies. Flexibility from all the major players is required to deal with this dire situation.