NEW YORK — A crucial item is missing from America’s health care debate: our blood supply. It is easily contaminated, in chronic shortage and it goes bad more quickly than milk.
The good news is that there is new technology that addresses those problems. The bad news is that it isn't available in the United States.
America is behind on many international races these days, including the one to purify the blood supply. Other countries have already begun to use a blood purification technology, called Intercept, that brings to life the concept of pathogen inactivation — bacteria in the blood is “inactivated” so that the risk of diseases transmitted by blood transfusions is greatly reduced.
The Intercept blood platelet system is the first of its kind approved for use in Europe, Russia and parts of the Middle East and Asia. Some countries have even been using it for six years.
So far, the results have been promising. Half a million successful blood transfusions have been performed across Europe using the system. Data taken from more than 40,000 transfusions done in the Alsace region show there have been zero bacterial infections from transfusions since the use of Intercept.
The ingenious part of this concept is that it inactivates not only known diseases, but also unknown, or undetected, ones. This component of the technology is critical. Blood donations are always screened — the donor is screened and the donor’s blood is screened for known bacteria and diseases. But with an increasingly international community, thanks to cheap and easy travel, more and more unknown bacteria are entering our blood system. And not just from human contact, but from animal contact as well.
Had this technology been developed for the right blood components when HIV broke into the human blood stream, it would have mitigated the spread of the disease, at least through blood transfusions. Tens of thousands of unsuspecting hemophiliacs worldwide contracted the AIDS virus because the blood they received was unknowingly contaminated with it.
With concerns that AIDS might become a full-blown epidemic again and with the constant rise of emerging diseases that spread much more quickly — think swine flu — and natural disasters — Haiti, Katrina, Thailand’s tsunami — where many blood transfusions are needed, there is an urgency to approve such life-saving products in the U.S.
“If [Intercept] were available tomorrow, I’d use it,” said a hematological oncologist, Dr. Michael Bar, who was an internist when AIDS broke out. “It is a really great thing.”
This technology, if developed and used for all four different components of whole blood, could help prevent another epidemic like AIDS.
Whole blood gets separated into platelets, plasma, red blood cells and cryoprecipitate. Cerus Corp., the company that owns and makes the Intercept products, has developed systems for the former three components.
There are also two great additional benefits from the Intercept platelet and plasma systems. One is that it increases the amount of blood that can be used because less “bad” blood has to be thrown out.
Two, the platelet system increases the shelf life of blood platelets, which typically last up to five days, by about 30 to 40 percent. In turn, this also increases the amount of blood that can be used, which is extremely helpful for those, typically cancer patients, who await blood platelet transfusions.
America has yet to approve the use of the Intercept platelet product, the one system that Cerus has tried for approval in the U.S. It passed Phase I and II of the FDA trials, but failed the phase III trial, the largest clinical trial for blood safety performed at that date, in 2003.
Between then and now, Cerus has been working with the FDA to redesign a new phase III trial to address the FDA’s concerns. In November 2009, with the FDA’s support, Cerus put a proposal in front of the FDA’s independent Blood Products Advisory Committee.
“The best case scenario for the U.S. to get this platelet technology is four years,” CEO of Cerus Claes Glassell said.
In February, France’s national blood transfusion service announced that it entered into an agreement with Cerus to help develop Cerus’ Intercept red blood cell system. France, whose health care system was ranked No. 1 by the World Health Organization when it did its last and final rankings in 2000, has been using the platelet system since 2003 and the plasma system since 2006. In that same ranking, America’s health care system came in a pathetic 37th place.
You would think that with all the blood spilled in Iraq and Afghanistan that having enough clean blood for our wounded soldiers and the rest of our population would be a priority. A good sign is that the U.S. Department of Defense is interested in Intercept — especially after the recent incident when Americans accidentally gave some bad blood to British soldiers in Iraq.
President Barack Obama should get behind this technology as well. Having a blood purification system is one sure way to make the health care bill much more effective. It is also a step in the right direction to implementing preventative care, an extremely important concept that is finally catching on here in America. Instead of responding to crises, we should prevent them from happening.
Katharine Herrup is a journalist who lives in New York, where she works for Newsweek. From 2006 to 2008, she was the op-ed editor and a contributing writer of The New York Sun.
Editor's note: This story was updated to correct the spelling of a name.