{"id":35051,"date":"2016-03-04T17:12:13","date_gmt":"2016-03-04T23:12:13","guid":{"rendered":"http:\/\/news.medill.northwestern.edu\/chicago\/?p=35051"},"modified":"2016-03-04T17:12:13","modified_gmt":"2016-03-04T23:12:13","slug":"fda-gives-top-priority-to-protecting-the-blood-supply-from-zika-virus","status":"publish","type":"post","link":"https:\/\/news.medill.northwestern.edu\/chicago\/fda-gives-top-priority-to-protecting-the-blood-supply-from-zika-virus\/","title":{"rendered":"FDA gives top priority to protecting the blood supply from Zika virus"},"content":{"rendered":"

By Neil Murthy<\/strong><\/p>\n

The Food and Drug Administration is turning to technology to protect the nation\u2019s blood supply from Zika, as the virus continues to sweep across the Americas and Chicago reported the first case here last week.<\/p>\n

Currently there have been no confirmed cases of Zika virus transmission through blood transfusions in the United States, according to the Centers for Disease Control and Prevention. However, multiple cases of Zika virus transmission associated with blood transfusions have occurred in Brazil\u2014ground zero of the current Zika epidemic. As a result, the FDA considers finding a way to protect the nation\u2019s blood supply a \u201ctop priority,” according to FDA public affairs specialist Tara Goodin.<\/p>\n

<\/p>\n

\n

What You Need to Know About Zika Virus: <\/strong>
\n[vimeo 157747509 w=474]<\/p>\n

\n

The FDA is looking into\u00a0 Pathogen Reduction Technology\u2014a process that involves ultraviolet light and other chemicals to alter the genetic material of disease-causing bacteria and viruses so that they are not able to replicate in blood. Although the technology is not specifically approved for Zika, the FDA did approve this technology in December 2014 for a \u201cpanel of viruses, including flaviviruses such as dengue and West Nile.\u201d And since Zika virus is a type of flavivirus,\u00a0 scientists are investigating if this technology can be used in the battle to fight Zika. A study<\/a> published in January in the journal Transfusion <\/em>shows that pathogen reduction is effective at removing Zika virus from blood products.<\/p>\n

In its latest guidance<\/a> regarding blood transfusions, the FDA already\u00a0 recommended using this technology to clean donated blood products in Puerto Rico\u2014an area where there is active Zika transmission.<\/p>\n

\u201cPathogen reduction technology has been widely used in over 100 blood centers in over 20 countries,\u201d said Stacey Lea\u00f1os, associate director of Investor and Public Relations at CERUS Corporation, the manufacturer that makes the FDA-approved technology.<\/p>\n

Furthermore, this technology is not new and its safety profile has been well established.<\/p>\n

According to CERUS, pathogen reduction was first introduced in Europe in 2002. Switzerland made it mandatory to use the technology in 2013. In December 2015, in the midst of the current Zika virus outbreak, Brazil got on board and is now using this technology to clean their blood products.<\/p>\n

But startup time means that protecting blood supplies through pathogen reduction requires moving forward now.<\/p>\n

\u201cWe just can\u2019t start this up tomorrow,\u201d said Dr. Julie Cruz, medical director of the Heartland Blood Centers, a major blood bank that serves the greater Chicago area. \u201cYou have to make some physical adjustments in terms of space, train the staff and perform quality steps. All of this requires FDA approval.\u201d<\/p>\n

Cruz said that the technology is something they that are \u201cconsidering and would want to employ\u201d in the future.<\/p>\n

Other blood banks have already made plans to start using the technology. The American Red Cross, which supplies 40 percent of the nation\u2019s blood supply, just signed a contract with CERUS last month to start implementing pathogen reduction technology starting this summer.<\/p>\n

However, there are some drawbacks to the technology.<\/p>\n

Currently, the process is only approved for plasma and platelet donations, and not for whole blood, since a protein found in red blood cells called hemoglobin interferes with ultraviolet light. As a result, the technology as it stands now can only be used to clean a portion of the blood supply. CERUS has acknowledged that research is in the pipeline to see if pathogen reduction technology can be expanded in the future to clean all blood products.<\/p>\n

And lastly, there is the issue of cost associated with this technology.<\/p>\n

Dr. Robert Allison, who is the Deputy Section Chief of the Infectious Diseases Section of the National Institutes of Health, believes that the reason why more blood banks are not using pathogen reduction technology is because of issues surrounding cost and reimbursement.<\/p>\n

\u201cA unit of blood in the United States costs about $400 on average for all of the testing and processing,\u201d said Allison at the American College of Preventive Medicine<\/a> annual conference in Washington, D.C.\u00a0 last week. \u201cWhen you add pathogen reduction, it\u2019s about $25 more. The problem is that there is no mechanism for reimbursing it. If you are a blood center, you are just losing that $25 for every single unit of blood,\u201d said Allison.<\/p>\n

Currently, the Centers for Medicare and Medicaid Services provide a single bundle payment for blood transfusions and the compensation is the same whether a blood product is pathogen reduced or not. Allison said that the lack of reimbursement for pathogen reduction is the reason why more blood centers are not utilizing this technology.<\/p>\n

That may change as the Zika virus outbreak continues to spread.<\/p>\n

\u201cSafety always trumps cost,\u201d Cruz acknowledged. \u201cFirst and foremost, we want to make sure that our product is safe and that we are doing the right thing for donors and recipients.\u201d<\/p>\n

Photo at top: Graphic illustrating mosquito bite (From the Zika virus animation scripted by Neil Murthy\/Medill; produced by Next Media Animation)<\/p>\n","protected":false},"excerpt":{"rendered":"

By Neil Murthy The Food and Drug Administration is turning to technology to protect the nation\u2019s blood supply from Zika, as the virus continues to sweep across the Americas and Chicago reported the first case here last week. Currently there have been no confirmed cases of Zika virus transmission through blood transfusions in the United […]<\/p>\n","protected":false},"author":269,"featured_media":35062,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28,29,585],"tags":[2045,1077,1080,1131,301,2046,192,171,1107,1075],"class_list":["post-35051","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-general-interest","category-health-and-science","category-winter-2016","tag-blood","tag-cdc","tag-epidemic","tag-fda","tag-medical-technology","tag-mosquito","tag-promo","tag-technology","tag-virus","tag-zika"],"yoast_head":"\nFDA gives top priority to protecting the blood supply from Zika virus - Medill Reports Chicago<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/news.medill.northwestern.edu\/chicago\/fda-gives-top-priority-to-protecting-the-blood-supply-from-zika-virus\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA gives top priority to protecting the blood supply from Zika virus - Medill Reports Chicago\" \/>\n<meta property=\"og:description\" content=\"By Neil Murthy The Food and Drug Administration is turning to technology to protect the nation\u2019s blood supply from Zika, as the virus continues to sweep across the Americas and Chicago reported the first case here last week. 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