I went to a meeting last week and became focused on the progress underway signaling more options for broad implementation of PR in blood centers. After decades of reading papers and listening to abstracts at conferences, real movement toward reducing known emerging and future infectious risks from transfused blood may be measurable in months to years, not years and years and years. At the risk of being a jinx, it’s a good time to celebrate that.
For years I have (tonguenotin cheek) toyed with the idea of creating an ABC award called theDon Quixote Award for Tilting at Windmills. The consensus (among me, myself, and I) inaugural winners, representing teams at their companies, would surely be Larry Corash, MD, at Cerus and Ray Goodrich, PhD, formerly at TerumoBCT, now of Colorado State University. They persisted in developing and evaluating the INTERCEPT and Mirasol platforms with doggedness that gives the lie to any purported exclusive focus of our commercial partners on short-term return on investment.
INTERCEPT for platelets and plasma is already licensed in the U.S. Hundreds of thousands of Mirasol platelet doses have been transfused outside the U.S. and clinical trials are starting here as we speak. Mirasol whole blood-the first PR process to demonstrate a reduction in the risk of a transmission by transfusion diseases (TTD) in a randomized controlled trial (transfusion-transmitted malaria in Ghana)-will enter trial in the U.S. “imminently” as will an INTERCEPT process for red blood cells. The acronyms (for which I bear no responsibility) you need to watch for, include MiPLATE, PRAISE, RedeS (enrolling now), ReCePi and SCient.
The risk from bugs falls to historical lows. Bar side conversations at AABB meetings about suspending testing for bacteria in platelets, syphilis, Trypanosoma cruzi and HTLV (et al?) become realistic. The donor interrogation is simplified. We get to decommission our irradiators. Agents emerge and reemerge, or even just when we get nervous about a theoretical pathogen, the processes are validated on them (or in appropriate models) proactively and we avoid complex interventions (read “Zika”). Nirvana.
Assume for a second the trials succeed. What will remain are the hard decision-making processes about how much safety and quality we are willing to pay for-in the broadest sense of the term. We will measure the cost not just in dollars per unit, but also product lost to the processes, rare adverse events, and against competing priorities for what will likely be scarce healthcare resources extending into the foreseeable future. May you live in interesting times.
Louis Katz, MD; Chief Medical Officer; firstname.lastname@example.org