To: The BayWatcher who wrote (227 ) 4/29/1998 3:07:00 PM From: Xpiderman Read Replies (1) | Respond to of 354
IVIG shortage: does this shortage present opportunity for Nabi? Sunday, April 26 While thousands of patients, many of them children, are wondering why a drug their lives depend on mysteriously became so scarce and expensive, officials are questioning whether the shortage is real or a cruel ploy by someone in the supply chain to increase profits. 60 Minutes investigated the shortage in a report which aired last Sunday. The shortage of immune globulin (IG), a drug made from blood plasma that fights off potentially fatal illnesses in people whose immune systems cannot fight them on their own, has Dr. Arthur Caplan incensed. "I think there are vultures out there in the blood supply....people who are making money off the lives of American kids," said Caplan, who heads the government's Advisory Committee on Blood Safety and Availability. "It is beyond my understanding that we haven't had Congressional outrage, and indeed, international outrage," he told co-editor Mike Wallace. Dr. Caplan's advisory committee will meet April 27-28 in Washington to discuss the shortage and its causes. The U.S. Congress will also be examining the shortage next month in hearings conducted by Representative Christopher Shays (R-Conn.) who heads its Subcommittee on Human Resources and Intragovernmental Relations. "The shortage is critical, but we're not convinced that it is not being manufactured by the companies themselves," Shays tells Wallace. He is concerned that the manufacturers might be able to produce more IG, but are instead blaming aggressive FDA regulation of the industry for the shortage. "One of the things we are very concerned about is that you don't have shortage blackmail," continues Shays. "The FDA is coming to [the IG makers] and saying 'we need you to produce more.' They in turn say, 'You just aren't allowing us the ability to produce the amount that we need to.'" The shortage has already prompted the FDA to approve the emergency release of IG that had been originally withdrawn for fear that it may be infected with Creutzfeldt Jakob Disease (CJD). CJD is a fatal brain disease similar to "mad cow" disease. Although there have been no documented cases of CJD transmission from blood or plasma products, scientists still have no clear understanding of how the disease is spread. According to an internal FDA memo found by 60 Minutes, "very large inventories of intravenous immune globulin" have been identified but are "not reaching U.S. consumers." 60 Minutes' investigation also discovered that 20 percent of IG is exported overseas where, in some cases, it fetches a much higher price. In another memo, the FDA says that "supply disruptions also may have occurred due to stockpiling or other market phenomena." Jan Bult, who runs the blood plasma industry's trade group, was the only industry figure who would speak to Wallace. Bult said he couldn't comment on the FDA memo but denies that the industry is stockpiling the drug. He tells Wallace that the shortage is due to IG's increasing popularity -- too many doctors prescribing it for too many illnesses -- and because it is a difficult drug to produce in sufficient quantity. The FDA told Wallace it has no authority over the export or pricing of a drug like immune globulin. Meanwhile, some drug brokers are selling IG at exorbitant prices. A hospital in Greenville, North Carolina, was used to paying $15 per gram but was recently offered IG at $125 per gram by Taylor Pharmaceuticals of San Clemente, California. People who need IG but cannot buy it have resorted to asking the relatives of deceased patients for their leftover IG. Hospitals must cope with the shortage the best they can and life-and-death decisions are apt to present themselves as the shortage continues. "At any given time in the United States, in a children's hospital, someone is trying to make a decision about which child is going to get immune globulin in that hospital....They're going to be making triage decisions about this vital substance," Caplan tells Wallace.marketing.cbs.com