The Perfect Sunny Day?
There's the proverbial expression of what happens when many bad variables converge to bring us a "perfect storm." I wondered recently what we might call it if industry, regulatory, and economic factors all became aligned after decades of discussion to finally bring us pathogen reduction (PR) for US blood products. Were that to happen, might we call this a "perfect sunny day?"
My optimism regarding PR began when I attended the February GSABC Technology Summit in Palm Springs, Calif., and heard some very encouraging presentations by Terumo BCT, Macopharma, and others about their latest PR innovations and interactions with the Food and Drug Administration.
In the last few months, Cerus received the FDA go-ahead for its premarket approval applications for PR in plasma and platelets. The submissions were based on clinical data obtained in the late 1990s and early 2000s, as well as from customer experience and hemovigilance findings in Europe; the company's platelet product was approved in Europe in 2002. Cerus also has a study currently underway in Europe for a PR system for acute and chronic red cell transfusions. Then there is the promising Mirasol system, developed by Terumo BCT, utilizing vitamin B2 and UV light. It too offers the potential to protect the plasma and cellular blood supply from bacteria, viruses, and other replicating cells. The Mirasol system began clinical trials in the Netherlands in 2010 and later crossed the pond to Canada, with clinical trials started there just this past January. In addition to demonstrating that Mirasol platelets were as effective as regular platelets in the European clinical trials, researchers also showed a reduced risk of human leukocyte antigen (HLA)-alloimmunization in recipients. Centers in Europe were able to employ the amotosalen method of PR in lieu of blood irradiation to reduce the risk of graft-versus-host disease (GVHD).
Aside from the obvious advantage of being able to proactively protect against emerging infectious diseases transmitted through our blood supply, I see pathogen reduction as a more consolidated, cost-sustainable approach to blood safety. All divisive politics aside, one objective of the Affordable Care Act (ACA) was to arrest unsustainable cost trends. For some future iteration of the ACA to succeed, every healthcare sector, including blood, will have to find technical and regulatory alignments that will get us where we need to be in terms of cost sustainability, while also achieving the highest safety standards. There is a lot that pathogen reduction could do to "future-ize" our nation's blood supply. Diligent scientists and regulators, successful clinical trials, and blood industry demand could all converge to bring us that "perfect sunny day."
Chris Staub, MT(ASCP) SBB, Board Member; [email protected]
Posted: 06/28/2013 | By: Chris Staub | Permalink
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