On December 27th, the New England Journal of Medicine (NEJM) publicized a study indicating that drug shortages have resulted in relapses of Hodgkin’s Lymphoma in children. This appears to have been the first study to document negative impacts from a growing list of drug shortages for which the drug companies offer only vague explanations, if any.
According to the NEJM, a review of data from clinical trials of pediatric Hodgkin’s patients found that when the chemotherapy drug mechlorethamine became inexplicably unavailable in 2009, patients were forced to switch to a replacement regimen that turns out to have been less effective. It is too soon to say whether this drug shortage will result in earlier deaths among those patients forced to switch treatments. Treating the relapsed cancer, however, involved riskier medications that are associated with, among other things, infertility.
This begs the question, why should some of the wealthiest companies in the world have trouble manufacturing reliable drugs, some of which have been available for decades?
The Food and Drug Administration website offers general and unsatisfying supply- and cost-related answers: “…quality/manufacturing issues…production delays…(delays in) receiving raw materials and components from suppliers…”
Another problem is the voluntary decisions of companies to quit manufacturing established drugs. Drug companies are in business to make money, not cure diseases, so they sometimes discontinue drugs that don’t make as much money. “When one company discontinues production,” says the FDA, “it is difficult for the remaining firms to increase production quickly…”
In October 2011, president Obama issued an executive order that requires drug companies to report drug discontinuations (but doesn’t penalize failures to do so). The agency also works with the drug companies to prevent some of the drug shortages. For instance, the FDA has worked to make raw materials more available by exercising regulatory flexibility over imports. Similarly, they have “exercised flexibility” over manufacturing standards when necessary. As a result, mecholorethamine is one of the drugs for which manufacturing has begun again.
Only the drug companies know the real reasons any given drug shortage occurs, however. They report drug shortages on a voluntary basis, and there is no penalty for failing to give advance notice when they quit manufacturing a medically necessary drug.