While occasional shortages can be a common occurrence, this appears to be the first time oncology drugs have been involved. “I’ve been a medical oncologist for 25 years and have never come across this before,” said Dr. Melody Cobleigh, professor and director of the Comprehensive Breast Cancer Center at Rush University. Despite this, both doctors say they haven’t had to refuse or restructure treatment for any patients yet.
But when such important drugs are in short supply, physicians are forced to make decisions about who-gets-what treatment. According to Schilsky, in these cases doctors use a priority tree to determine the appropriate course of action. The priority tree takes into account factors like the patient’s diagnosis and treatment goals. Are they attempting a cure or merely prolonging life? “The bottom line is that we are all very concerned,” said Cobleigh. At Rush, a committee of cancer doctors have been meeting regularly to discuss how to deal with the shortage when it arrives.
Beyond threatening patient treatment, the shortage also could potentially interfere with clinical trials, threatening the viability of their results. Currently it’s recommended that another cancer drug be substituted for doxorubicin. However, that drug hasn’t been studied in conjunction with the cocktail of drugs used in the trials. Cobleigh describes the process as an “educated guess” in terms of dosages and outcomes.
Many of the drugs involved in the shortage are generic, which usually means they are older. Bedford Laboratories is one of the companies that manufactures several of these cancer drugs in short supply. “Bedford is currently facing manufacturing capacity constraints that are resulting in back orders of some products,” Jason Kurtz, spokesperson for Bedford Laboratories, said in an email. “We are working diligently to prioritize and expedite manufacturing for all current orders.”
But the fact that all these drugs are generic has raised the question of whether profitability may have played a role in the shortage. The Food and Drug Administration claims the shortages are a result of quality issues and manufacturing delays. Cancer drugs can also be more complicated to manufacture, so when one firm has production issues, the others are generally unable to make up the difference. “Fewer firms are making these older products” said Christopher Kelly, spokesperson for the FDA. “These older drugs in general are usually not economically attractive to firms and firms discontinue them in favor of newer more profitable products.”
In terms of dealing with shortages, Kelly points out the FDA can only encourage drug companies to report their such instances. “The FDA cannot require firms to continue to make a product,” he said. “There is not any requirement for firms to report shortages or discontinuations except for sole manufacturers in certain circumstances.”
In the meantime, several area hospitals are working on a plan to address the shortage. Kevin Colgan, corporate director of pharmacy at Rush University, along with pharmacy directors at the University of Chicago Medical Center, Northwestern Memorial Hospital and North Shore Hospital are collaborating on a regional co-op to ensure that no patient goes without needed drug therapy. The aim of the co-op would allow hospitals to develop ways to deal with shortages by meeting regularly, sharing drug supplies and agreeing not to hoard medication.
Updated: 11/30/2010 4:20 p.m.