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While shortage of generics has eased, more must be done to preventfuture shortfalls, experts say. By E.J. Mundell HealthDay Reporter MONDAY, June 4 (HealthDay News) -- John Mahan, a 58-year-oldNashville firefighter battling a gastrointestinal cancer, couldn'tbelieve what he was hearing last July. His doctor had just told him that his clinic had run out ofinjectable fluorouracil (5-FU), the generic chemotherapy Mahanneeded to keep his tumor at bay. "My initial reaction was, 'you've got to be kidding, right?'" hesaid. Unfortunately, the news was all too real. Mahan was switched toanother drug, capecitabine. Taken in pill form, it had the sameanti-cancer effectiveness as 5-FU but with more onerous sideeffects. "It made me feel bad, weak," Mahan said, "just run down, feelingtired all of the time, loss of appetite." At a Monday news briefing at the annual meeting of the AmericanSociety of Clinical Oncology (ASCO) in Chicago, Mahan spoke onbehalf of the thousands of cancer patients who have been hit hardby the recent nationwide shortages of generic, injectable cancerdrugs. The crisis peaked earlier this year when children with a leadingform of childhood cancer, acute lymphoblastic leukemia (ALL), werefaced with a looming shortage of a lifesaving drug, methotrexate.Quick action on the part of the U.S. Food and Drug Administration,the pharmaceutical industry and others averted that shortage, butdeficits in this and other cancer medicines are still possible,experts warn. "The good news has been that the frequency of the drug shortageshas begun to decline for a variety of reasons," Dr. RichardSchilsky, chair of ASCO's government relations committee, toldreporters. "But there is still an unpredictable availability ofmany drugs and we are never sure exactly when a generic drug issuddenly going to go out of supply. That creates a tremendousamount of uncertainty -- anxiety for our patients and greatdifficulty in planning if you're a physician." Overall, 22 crucial oncology therapies have recently been in shortsupply, noted ASCO President Dr. Michael Link. Of most concernright now, he said, are shortages of a handful of medicines: Methotrexate -- while there is currently an adequate supply ofmethotrexate for ALL and other cancers, there is now a shortage ofa compound needed for patients who require high-dose infusions ofthe drug, Link said. 5-FU -- gaps in supply remain for this mainstay generic medicine,used to fight cancers of the colon, pancreas, head-and-neck andother sites. Nitrogen mustard -- one of the earliest anti-cancer therapiesdeveloped, it remains essential to care of lymphomas and Hodgkin'sdisease. "It has been unavailable for some time," Link said, andthere are no really good substitutes. Paclitaxel (Taxol) -- periods of short supply continue for this keytreatment for breast cancer and other malignancies. "Hearing from our members, we are learning that the shortages aremost acute among community practices where the majority of adultpatients are cared for," Link added. Smaller centers may not havethe buying clout that larger, academic medical centers might have,leaving them more vulnerable to shortages, he explained. These drug shortages typically occur among sterile injectablecancer medications that have gone to cheaper, generic status. Theexperts gathered at the meeting noted that the world's supply ofgeneric medications is now concentrated in only about six companiesthat may produce dozens or hundreds of drugs. "So, for example if one company makes 30 products and they have aproblem, suddenly 30 products are at risk of a shortage," explainedDr. Sandra Kweder, deputy director of the Office of New Drugs atthe FDA. Producing highly sophisticated, sterile injectables is aparticularly complicated process, she said, and quality issues canarise that cause plants to be temporarily shut down while the issueis resolved. In many cases, these safety issues are not minor ones, Kwedernoted, and can include "particles of glass or metal shavings" foundin vials that, of course, pose safety issues for patients. But, why the shortages now? According to Kweder, it's not that new,tougher quality-control rules have come into place recently.Instead, a host of popular drugs have recently gone off-patent and"what we've seen is great growth in the generic world," she said.As more generics get produced at more production facilities, "weare just seeing more in terms of problems in that manufacturing,"Kweder said. Many companies are now modernizing their productionfacilities, she said, but that will take time. According to Kweder, the FDA, in close consultation with drugcompanies, has already prevented about 150 drug shortages sinceOctober of last year, when President Barack Obama signed a specialExecutive Order demanding action on the issue. As companies gaveFDA early warning of looming problems, the agency and thepharmaceutical industry worked together to find alternate sourcesof supply, including imports from abroad, Kweder said. Methotrexate, the drug needed by children with leukemia, "continuesto be very carefully monitored," Kweder said. "We expect the[shortage of] the injectable that has been difficult for somepractices to obtain to be resolved within the next monthcompletely." Progress is taking place at the Congressional level as well, theexperts said, as a bill makes its way through the House and Senatethat would mandate that generic drug makers give the FDA six monthsadvance notice of any possible production problems. The bill, which has the full support of ASCO, also includes aprovision that generics makers would pay the FDA a user fee, aimedat speeding oversight and approval for new generics. All of this gives some comfort to Mahan, whose cancer hasprogressed but is being held in check by a new course of therapy.Still, he worries about other patients who may be facing the samedilemmas he did. "Until this impacts you personally," he said, "most people aren'teven aware that there's even a shortage going on." More information Find out more about the shortage of cancer medications at the U.S. Food and Drug Administration . SOURCES: June 4, 2012, press briefing, annual meeting of theAmerican Society of Clinical Oncology (ASCO), Chicago, with: JohnMahan, Nashville; Richard Schilsky, M.D., chair, governmentrelations committee, ASCO, and chief, hematology/oncology,University of Chicago School of Medicine; Michael Link, M.D.,president, ASCO, Stanford University School of Medicine and LucilePackard Children's Hospital, Stanford, Calif.; Rear Admiral SandraKweder, M.D., deputy director, Office of New Drugs, U.S. Food andDrug Administration Copyright © 2012 HealthDay . All rights reserved. The e-commerce company in China offers quality products such as Casting Slabs , CCM Continuous Casting Machine Manufacturer, and more. For more , please visit Billet Casting Machine today!
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