Drug Shortage Linked To Cancer Recurrence In Certain Patients

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Drug Shortage Linked To Cancer Recurrence In Certain Patients.

A study linking drug shortages to worse outcomes in certain cancer patients received a moderate amount of coverage in print and online, as well as on one of last night's network news broadcasts. Many sources pointed to the study as an example of the serious threat to public health that drug shortages pose. The CBS Evening News (12/26, story 9, 3:10, Axelrod) reported, "For more than a year now, we've been reporting on the nationwide shortage of medicine used to treat some types of cancer. Today a study in the New England Journal of Medicine shows evidence of a link between the drug shortage and reduced effectiveness of treating some of the youngest cancer victims."

        The San Francisco Chronicle (12/27, Colliver) reports, "Wednesday's report, led by researchers at St. Jude Children's Research Hospital in Memphis...looked at more than 200 children, teenagers and young adults who had been enrolled in an ongoing national clinical trial to treat intermediate or high-risk Hodgkin's lymphoma." That "trial focused on tailoring radiation therapy for patients, but had to be modified when one of the drugs used in the trial -- an injectable drug called mechlorethamine, also known as Mustargen or nitrogen mustard -- became unavailable in 2009." Thus, the researchers had to offer cyclophosphamide rather than mechlorethamine. Being that "cyclophosphamide is used almost interchangeably with mechlorethamine, researchers were not expecting much of a difference in outcomes for the patients, but while none of the patients died, the percentage of patients who remained cancer free two years after treatment fell from 88 to 75 percent."

        USA Today (12/26, Vergano) reports, "The finding suggests that substitutes for drugs in short supply can pose unsuspected health risks for patients with cancer." USA Today notes that the American Society for Health-System Pharmacists "lists 231 drugs as undergoing shortages, many of them vaccines and generic cancer drugs." Food and Drug Administration spokesperson Stephanie Yao said, "While the quality of drugs is a key focus, we remain extremely concerned about the current and potential shortages."

        The AP (12/26) reports that physicians "sometimes substitute different drugs for ones in short supply." However, "proving that the swaps led to poorer results has been tough, especially for cancer patients whose disease and response to treatment vary so much." Dr. Michael Link, a cancer specialist at Stanford University and past president of the American Society of Clinical Oncology, said, "We really couldn't put our finger on, did anybody really suffer?"

        In a front-page story, the Boston Globe (12/27, A1, Conaboy) reports, "Of all the substitutions made during recent shortages, this one looked as if it would have the least consequence," said Dr. Link, who was "an author on the paper." The Globe points out that the FDA has "taken steps to mitigate the effects of shortages, including pushing manufacturers to notify the government when they expect a supply interruption." However, Link "said, the changes don't go far enough to prevent future shortages."

        The NPR (12/26, Stein) "Shots" blog adds that Dr. Link said this is "only the tip of the iceberg because this is only dealing with the anti-cancer drugs. We have heard plenty of horror stories because of shortages of antibiotics and anesthetic drugs as well."

        According to the Memphis (TN) Commercial Appeal (12/26, Charlier), "The study provides the most tangible evidence yet of the havoc that can be wreaked on cancer therapy and patients by the growing problem of drug shortages. Between 2006 and the end of last year, the number of drugs added to the Food and Drug Administration's shortage list nearly quadrupled, rising from 70 to 267, with oncology medicines accounting for the largest share."

        Medscape (12/27, Nelson) reports, "Drug shortages are expected to persist for the foreseeable future, despite action being taken" by the FDA, "drug manufacturers, and other stakeholders, explained Richard Schilsky, MD, professor of medicine at the University of Chicago, Illinois, during a session held at this year's annual meeting of the American Society of Clinical Oncology (ASCO)." He noted that the "crisis has been particularly bad in cancer care." Moreover, Dr. Schilsky pointed out that because "many of the mainstays of treatment are drugs that are decades old -- generic, injectable, and irreplaceable -- in many cases, there are no acceptable medical substitutes."

        MedPage Today (12/27, Phend) reports that the researchers wrote, "Our results suggest that even promising substitute regimens should be examined carefully before adoption; what might appear to be a suitable alternative regimen may result in an inferior outcome -- an intolerable situation for young people with curable diseases."

        HealthDay (12/27, Gordon) reports, "Dr. Arlene Redner, associate chief of oncology at Cohen Children's Medical Center in New Hyde Park, N.Y., suggested, 'The FDA should ensure that the orphan drugs that are vital in pediatric oncology are manufactured and [that there are] companies known to have excellent manufacturing facilities without production problems to produce them.'" According to Dr. Redner, the "decision to manufacture these orphan drugs or to stop the manufacture of them should not be a decision of the drug company alone."