Blood Banks' Contamination Concerns Less than FDA, CDC

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blood transfusionIn a lengthy column this week in the Wall Street Journal, Laura Landro discusses "The Rising Risk of a Contaminated Blood Supply." Since Ms. Landro is an established health and science writer and author of the "Informed Patient" column, I was sufficiently alarmed at the prospect referred to in her headline.

Imagine, then, my surprise to find the dearth of actual data supporting the bold type. Here's one example, from a chart included in her article: "Since 1980, when the first U.S. case of [the tick-borne parasitic malaria-like disease] babesiosis was reported, more than 200 cases of transfusion-associated infection have been documented ... although the actual number is thought to be much higher."

Wow. Documented transfusion-associated babesiosis at the rate of ... 200 (or maybe more) cases over the course of 35 years!? According to my calculator, that's roughly six cases per year. Rising risk?

The thrust of the article concerns itself with the rather hypothetical or exaggerated fears expressed by the FDA and the CDC about the possibility of new, as yet unrecognized infectious agents, likely emanating from the then-impending disastrous transmission of the AIDS agent, HIV, between 1981 and the development and approval of the test for HIV in blood, in April of 1985.

The best estimate for actual transmission of HIV during those fraught times was 14,000 cases, but recent data suggest that such transfusion-associated HIV is rare. (Recently, the FDA even modified their longstanding ban on blood donations from gay men and men who have had sex with men, requiring "only" a one-year abstinence interval for accepting donations.)

Of course, there are still transfusion-related infections via contaminated blood products: red blood cells, plasma, and platelets. The estimated number of blood product units transfused this year is currently 17 million. That's a huge number to be sure, but way down from the well over 20 million in 2011, thanks to lower demand for blood.

This, in turn, is due to more reliance on minimally-invasive surgeries and more conservative parameters for transfusions. Nevertheless, surgeries, trauma, bleeding disorders and cancer treatments all require blood for transfusion or merely on standby just in case.

The viral agents of recent concern, including Dengue and Chikungunya, as well as the aforementioned Babesiosis, have no available test to detect them in blood.

Yet, according to Ms. Landro, "[d]uring recent epidemics of the mosquito-borne illnesses dengue fever and Chikungunya in the Caribbean, high rates of the viruses were found in donated blood." But neither she, nor any of the agencies or blood centers that she cites, supply any hard data to support a widespread alarm about the ostensible "rising risk."

The CDC's position is reported by Matthew Kuehnert, director of the Office of Blood, Organ and Other Tissue Safety. Blood saves lives. But transfusions have risks, and they can transmit infectious disease and cause reactions," he said. "And that requires careful screening and monitoring.

Well, every medical procedure has risks, including transfusion. The question is, what is the balance between risk and benefit of blood (product) transfusion? The FDA is also "erring" on the side of an excess of caution.

The agency "recently approved some technologies, called pathogen reduction, that can reduce or eliminate many disease-causing organisms in blood. But they don t work on every type of organism and the FDA is not mandating their use. Blood centers, which collect and test blood, say they can t afford to add new technologies that aren t mandated, as they struggle with a sharp drop in hospital demand for blood. Some have merged to stay afloat, trimming staff."

At the same time, the FDA asserts that "the U.S. has one of the largest and safest blood supplies, but in response to mounting pressures on the system, the federal Department of Health and Human Services is planning a study on how to ensure the sustainability of a safe and adequate supply."

We here at the American Council on Science and Health have nothing against maintaining a reasonable level of safety when it comes to transfused blood and blood products. But given the facts that our blood supply is quite safe, and the demand for blood is declining, why is now a good time to expend scarce and precious healthcare dollars on a study to find out how to get from very safe ... to very, very safe?

We already test for HIV, hepatitis C and syphilis. Recently, tests for Chagas' disease and West Nile Virus have been added. Ms. Landro adds that "the costs to test, screen, process and transfuse blood products have steadily risen."

Sure, but what hasn't risen lately. And then she plunges on ahead with this doozy: "But blood can t be screened for emerging infections for which there are no tests or for diseases that haven t yet been recognized."

Let's spend a load of money on developing tests for ... what? ... diseases that have not yet been recognized?

I'd say that we're doing quite well with the tests we have now, and if we're not, I'd appreciate seeing a more incisive discussion of the actual risk and the trends in transfusion-related infections, rather than this evidence-free alarmist piece which seems to be aiming merely to scare the reader.