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JUNE 5, 2003
By Amy Tsao Toward a Safer Blood Supply John Barr, president and CEO of Vitex, says his new "wash" treatment can help remove contaminants such as viruses from blood cells Giving blood hasn't changed much over the years. It still involves a needle prick, 20 minutes, and maybe some light-headedness. What has changed: Standards for making sure the donated blood is safe. From asking potential donors about their sexual practices to submitting samples for expensive tests, agencies such as the Red Cross are taking steps to prevent a host of diseases from contaminating the blood supply. The issue came to the fore in the 1980s after it was found that HIV-infected blood had been transfused into patients. In recent years, a range of newer, hard-to-detect diseases has kept blood-donation agencies on their toes. The latest threat is the deadly virus that causes severe acute respiratory syndrome (SARS). While it's still not clear that the disease can be passed on through blood, agencies are already turning away people with possible SARS symptoms. Meanwhile, mad cow disease has resurfaced in Canada and West Nile virus is expected to flourish on the West Coast this summer. The American Red Cross, which collects about 50% of the blood in the U.S., says on its Web site: "Increased demand coupled with more stringent eligibility guidelines make it more difficult than ever to ensure that blood is available for every patient." "PEEL BACK THE ONION." Watertown (Mass.)-based Vitex (VITX ) is developing a product that could help improve that situation. Called Inactine, it can inactivate known -- and even unknown -- pathogens in donated blood. By acting as a broad swipe at potential threats that can taint the supply, Inactine could help lower the cost of testing blood. Donations would still be screened and tested, but this additional measure could help increase confidence in the overall safety of the supply. The costs and difficulty of screening blood have soared. One unit of red blood cells (the part used to increase oxygen-carrying capacity in patients who are bleeding or anemic) costs hospitals $200, up from $60 just 10 years ago, figures John Barr, president and CEO of Vitex. "When you peel back the onion, virtually all of those costs are new safety steps," he says. "We keep adding more complexity and more opportunities for error." If Inactine passes its safety hurdles, it could simplify blood screening and remove those opportunities for error, Barr believes. He hopes Vitex can file for Food & Drug Administration approval for Inactine, which is in Phase 3 testing, in the second half of 2004. On May 30, Barr discussed the blood supply and his hopes for Inactine with BusinessWeek Online Reporter Amy Tsao. Edited excerpts of their conversation follow: Q: What problems do blood-donation agencies face today? A: We keep deferring more and more donors because for many of the safety threats we face, there's no diagnostic or screening solution. Part of it is inefficiency of the systems that we use. Every time we have a new threat, it requires a unique solution. For example, with increasing concerns over the human form of mad cow disease, we now exclude anyone who has spent meaningful time in the U.K. West Nile and SARS are classic emerging threats. They're showing up places they've never shown up before. West Nile wasn't detected before 1999 in the U.S., and it's now in every state. People are really nervous about that this year. Mobility [of diseases] is probably the largest pathogenic trend. All of this compresses the potential supply of donors. The other big factor facing blood is supply. It used to be that you would hear an appeal to come in once or twice a year. Now, it's a year-round phenomenon. A lot of that is due to excluding more and more donors. Q: What's happening to demand for blood? A: Blood use continues to increase at about 5% a year, due primarily to demographics. The average person who receives blood is 69 years old and receives about three units. This is one of the fastest-growing populations. Also, there are more aggressive chemotherapy regimens that require chronic transfusion regimens. Use is going up while its harder to keep the supply up because of safety concerns. Q: What are some lesser known diseases that could hurt the blood supply? A: There are emerging parasites people are worried about, like T. cruzi, which is endemic in Central and South America. Something like 18 million to 19 million people are thought to be carriers of this parasite, which causes Chagas disease. [Chagas can produce lesions on internal organs including the heart, esophagus, colon and the peripheral nervous system. After several years of showing no symptoms, 27% of those infected develop cardiac symptoms that may lead to sudden death.] With global warming, we're seeing things we haven't seen in a long time. There were two ponds in Maryland last year where they found malaria. Temperatures are going up everywhere. That gives pathogens a larger potential environment in which to thrive. Q: What kinds of pathogens can Inactine kill? A: Inactine has been demonstrated to have the broadest-spectrum technology that can be added to red cells. It inactivates pathogens while preserving the therapeutic properties of red cells. We can inactivate both envelope viruses [like HIV and hepatitis B and C, which are coated with an extra membrane around them] and nonenvelope ones, which are harder to kill. We can kill particularly potent parasites, like the one that causes malaria and the one that causes a malaria-like disease called Babesia. Q: How does Inactine work? A: We add the Inactine chemical to a single unit of red cells. It inactivates the red cells while in the red-cell bag for 18 to 24 hours. At the end of that process, we wash cells to remove Inactine. At the same time, the cell washing removes [the inactivated pathogens]. Q: What would be the financial impact of such a treatment? A: What it will do is simplify testing. Currently, there are three separate tests for HIV. By adding this kind of pathogen-reduction system, you could go to faster, less costly, less sensitive tests for existing threats like HIV. And with new threats, you wouldn't have to run out and do a new test and layer yet another test on top. We haven't set a price, but we think with Inactine, the cost per unit of red-blood cells would be $100 to $130, down from the $200 it costs now. Q: Can Inactine inactivate SARS in blood? A: It's very hard to get SARS samples right now. We'll probably test another member of the corona virus family. Typically if you can kill one, you can kill them all. There's a very high probability we can kill SARS, since it's an envelope virus, and we've killed every envelope virus we've ever tested.  Tsao covers biotechnology issues for BusinessWeek Online. Follow The Biotech Beat every week, only on BusinessWeek Online Edited by Patricia O'Connell Get BusinessWeek directly on your desktop with our RSS feeds.  Add BusinessWeek news to your Web site with our headline feed. Click to buy an e-print or reprint of a BusinessWeek or BusinessWeek Online story or video. To subscribe online to BusinessWeek magazine, please click here. Learn more, go to the BusinessWeekOnline home page  | | |
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