Herbert, V. Bureaucrats Create Our Blood Shortages, Letter to NEJM.

CV# 816Let. Herbert V. Bureaucrats create our blood shortages. N Engl J Med, submitted 2/10/99.

Letters to the Editor
New England Journal of Medicine
10 Shattuck Street
Boston, MA 02115

Bureaucrats Create Our Blood Shortages.

To the Editor: One of the variables in the equation of when to give blood transfusions is the availability of safe donor blood in blood banks.^1-3 This should not be a variable because there would be no shortages of safe donor blood if the FDA would adopt the petition⁴to stop stigmatizing the safe donor blood of the about 1% of the American population who have homozygous hemochromatosis and need therapeutic phlebotomy every week or two⁵. The American Association of Blood Banks (AABB), in a meeting with the FDA, agreed that the throwing away of hemochromatosis blood was not a safety issue, because the blood is safe, but a money issue⁶ (approximately $200 million/year profit from charging for therapeutic phlebotomies)⁵. Annually in the United States, over 11 million units of red cells are transfused in more than 3 million patients³. One percent of about 260 million Americans is about 2.6 million, which, multiplied by about 26 units per year per such person, adds up to 67.6 million units per year, 6 times the annual usage.

Victor Herbert, M.D., J.D., M.A.C.P

REFERENCES

1. Hebert PC, Wells G, Blajchman MA, Marshall J, et. al. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. N Engl J Med 1999; 340: 409-417.

2. Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Medical progress: Transfusion medicine (first of two parts)-blood transfusion. N Engl J Med 1999; 340: 438-447.

3. Ely EW, Bernard GR. Transfusions in critically ill patients. N Engl J Med 1999; 340: 467-468.

4. Herbert V: Petition to the Food & Drug Administration (FDA Docket Number 96-0328CP 1. filed September 5, 1996) : A. Action requested: That the FDA insert in 21 CFR Ch. 1 (4-1-93) ß640n.3(d) after the title. ìTherapeutic bleedings,î the words: ìExcept for blood withdrawn from persons with iron overload disease, whose blood should not be stigmatized, but should be labeled solely ëvolunteer donorí in accordance with 21 CFR Ch 1 (4-1-93) Edition, ß606 121(5)....î.

5. Herbert V. A triple hematologic nightmare: grossly underdiagnosing and not treating the most common US genetic disorder (hemochromatosis) and garbaging each year so many tons of good hemochromatosis donor blood as to create donor blood shortages in each of the past 30 years. Am J Hemat 1998;59:261-263.

6. ABC (American Blood Centers) Newsletter, November 8, 1996, p. 10.