Universal Leukoreduction - Responses to the Opposition

In response to recent letters from national organizations opposing universal leukoreduction, two national recognized proponents of universal leukoreduction (ULR) - Dr. Neil Blumberg of the University of Rochester, and Dr Bernadine Healy, President of the American National Red Cross - have gone on record reinforcing their support for ULR. In keeping with the the CBBS web site's commitment to balanced reporting we are reproducing letters they recently sent to the leadership at HHS and the American Hospital Association.

(From Dr. Blumberg)

Aug. 3, 2001

The Honorable Tommy G. Thompson
Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Secretary Thompson:

Recently eight organizations wrote to you urging that you not mandate universal leukoreduction of transfused blood at this time. As a member of two of these organizations (the American Society of Hematology and the College of American Pathologists) I must respectfully, but strongly disagree with that advice. I write as one who has participated in multiple peer-reviewed, published investigations performed in the USA studying the effects of leukoreduced transfusions on clinical outcomes. My opinions and those of a substantial number of other expert physician members of ASH and CAP are not reflected in the recommendation you received from these organizations.

Some of the research supporting the benefits of leukoreduction is controversial. Nonetheless, there is a voluminous body of epidemiologic, animal model and randomized clinical trial data demonstrating that transfusions have profound and largely unfavorable immunologic effects on many patients, and that transfused leukocytes are responsible for some of these effects.

Patients who require repetitive transfusions for anemia, leukemia, lymphoma and other diseases where there are risks of febrile reactions, cytomegalovirus transmission and platelet transfusion refractoriness should receive leukoreduced transfusions. For these 20-30% of all transfusion recipients there is consensus that leukoreduced transfusions are indicated.

In addition there are also five (of six total) randomized trials in surgical patients demonstrating reductions in morbidity (primarily post-operative infection), mortality and length of stay in patients receiving leukoreduced transfusions. In one study, mortality was reduced 60% in cardiac surgery by use of leukoreduced transfusions. Our own studies support these findings. The lack of consensus about these studies, while undeniable, conflicts with the fact that the vast majority of scientific and clinical data do support the clinical efficacy and cost benefits of leukoreduction of transfusions to surgical patients. Because surgical patients use about 50% of the blood transfused in this country, the scientific literature now supports leukoreduction in close to 70-80% of all patients. This leads to the conclusion that universal leukoreduction makes logistic sense as a public health measure.

Our group's peer reviewed, published estimates, based upon randomized trials and epidemiologic data, are that universal leukoreduction will save thousands, perhaps tens of thousands of lives per year in the United States, while reducing total national health expenditures by as much as 1% overall. Thus, leukoreduction, the most important public health measure in transfusion medicine since the invention of infectious disease testing, will almost certainly save both lives and money.

I would be pleased to provide further data and reprints of papers from the medical literature in support of my recommendation that you proceed with previous advice of the FDA's Blood Products Advisory Committee and HHS's Advisory Committee on Blood Safety and Availability to mandate universal leukoreduction as soon as practically feasible.

Sincerely,

Neil Blumberg MD
Professor of Pathology and Laboratory Medicine

The letter from Dr. Healy of the American Red Cross (July 27) may be read by visiting the ARC web site. (As of June 10, 2002, this page is no longer available.) 

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator