The Food and Drug Administration has approved a pathogen reduction (PR) process for platelets. For much of my career, this would have been as big a deal as finding the grail. But, in the weeks since, I have heard (a not unexpected chorus) telling me that “we” cannot afford it. There are two “we’s” in this opera. The first is the blood community, living with the realities of DRG (diagnosis related group) reimbursement and horrid pressures to cut our prices to hospitals. It will cost more than $50 per platelet dose, and we do not think we can pass it through. The second “we” is the hospitals. They may have higher safety priorities (consider healthcare-associated infections, medication errors, falls), and don’t think the main driver for platelet PR – bacterial contamination of platelets – merits the use of limited resources. I would have more sympathy for the latter argument if I believed dollars not spent to fix platelet sepsis would be diverted to the “larger” issues.
Here is what we know. Our approach to bacterial contamination is (charitably) around 50 percent effective. So, as many as 1 in 1,000 platelets contain bacteria. Diagnosis of platelet sepsis in recipients is terrible – so we do not know the real clinical burden. This is a patient group dominated by critically ill patients with multiple reasons to be septic, and clinicians may not recognize the association with transfusion. In addition, we may not appreciate late complications of contamination at all, which remain unstudied. The FDA draft guidance reads, to me, like a Rube Goldberg device. Also, it represents only a partial solution, mainly because its most effective elements would be voluntary and require resources (money).
Some ABC members think PR should be the standard of care to address platelet-associated sepsis – I am one. It would essentially eliminate the problem, and PR has the added advantage of being a proactive approach to emerging bugs. It can be funded, partly, by stopping some extant safety measures and avoiding some new ones – if FDA and “we” seize the opportunity. Finally, there are liability issues if we use partial solutions to this problem in the face of a “definitive” fix.
We have the opportunity to make an important problem go away and may actually be able to make it work if we understand the way “big pharma” launches new products in uncertain markets. May you live in interesting times.
Louis Katz, MD, Chief Medical Officer, firstname.lastname@example.org