U.S. Drug Shortage Could Threaten U.S. Health System

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Shortages Force Medical Centers to Use Substitutes

Speyer, who has spoken openly about the shortages at NYU, said today that the cancer center has re-established short-term supplies of some key drugs through "legitimate supply sources" and "purposefully" chose not to deal with so-called gray market suppliers, who buy up quantities of drugs and re-sell them at higher prices. At the Beebe Medical Center in Lewes, Del., Sam Roberts, director of pharmacy, said the medical center views the gray market as a last resort. In 2010, "we purchased a drug for $600 that we normally would pay $25 for. We did not pass any of that additional cost on to patients."

In an interview on Aug. 25, Speyer said NYU was "cold out" of a key drug used frequently for gastrointestinal malignancies, 5-fluorouracil (5-FU). During the week of Aug. 22, "we had over 30 patients who had their treatment delayed or changed to capecitabine (Xeloda)." Some patients had trouble tolerating the oral drug while others faced unaffordable co-pays for the more expensive substitute.

Speyer said a month of 5FU costs the medical center about $30; a month of capecitabine costs about $3,000. During the shortage, he was put in the heartbreaking position of telling Medicare recipients who couldn't afford a $250 co-pay that he couldn't treat them. "Sometimes you just look across the bed and say 'this is what I have,'" Speyer said. A month later, with enough 5FU on hand to get through the next one to two months, there's no way to know how those who went untreated for a month may have suffered, he said.

In late August, paclitaxel, an important treatment for ovarian, breast and lung cancers, was in such short supply, "we were not able to enter any patients into clinical trials that required (paclitaxel) because we couldn't guarantee the drug for the course of treatment." Since then, Speyer said, "we have started to re-enter patients in trials" on the drug.

NYU is still grappling with a shortage of the drug Doxil, and no patients beginning chemotherapy are getting it. However, a program by the drug's manufacturer, "got off to a bit of a rocky start for us," he said. Janssen Products initially was going to supply enough Doxil for just four of the 48 NYU cancer patients who already were taking and benefiting from Doxil. Since then, he said, "about two-thirds of our people are now getting the drug."

Doxil is unusual because it's one of the few oncology drugs still protected by a patent. Most of the shortages have affected older, generic injectable or intravenous drugs that have been on the market for decades, and are only marginally profitable. That has left fewer companies to make them.

One particularly disturbing consequence of the industry consolidation and the concomitant aging of manufacturing plants has been quality control, Koh said. "We literally are tracking products that have particulate matter, even pieces of glass and pieces of metal in what should be sterile products that are injected into patients."

Kweder said the FDA is willing to work with companies "to help them develop solutions to fix the problem and avoid interruption in production. That is not always possible," she said. "It's simply not always possible."

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