June 8, 2001 NHLBI Workshop on ìMaintaining Iron Balance in Women Blood Donors of Child-Bearing Age,î Lister Hill Auditorium, NIH

April 19, 2001

Barbara Alving, M.D.

Director, Division of Blood Diseases and Resources, NHLBI, NIH

Rockledge II, Room 10160

6701 Rockledge Drive, MSC 7950

Bethesda, MD 20892-7950

RE: June 8, 2001 NHLBI Workshop on ìMaintaining Iron Balance in Women Blood Donors of Child-Bearing Age,î Lister Hill Auditorium, NIH.

Dear Dr. Alving:

The proposed program for the above Workshop does not include among the presentation titles the most practical one, namely a presentation entitled:

ìTaking the Guesswork Out of Determining Who Needs Iron Replacement (and to Who it Could be Harmful) Among Women Blood Donors of Childbearing Age by Measuring Serum Transferrin Saturation (Tf_sat) ± Ferritin of Each Donated Unit.î

All of the other proposed program titles deal with what it means and what to do when one suspects Tf_sat ± ferritin are low, normal, or high (and what cut-off points one should use to designate low, normal, and high). In the absence of having a program presentation whose title states that measuring serum Tf_sat ± serum ferritin in all donors must be done, the program appears to be an academic exercise in probabilities, devoid of any real value for the individual donors (or of any take-home message for the thousands of blood bankers who read the presentation titles in the program mailed to them but do not attend the actual June 8, 2001 Workshop).

Further to this matter, Enclosure A is our relevant abstract of our poster presentation on ìFDA Now Approves Hemochromatosis BloodÖ.etcî (FASEB J, 2001 [March 8]: 15 (5, PART II): A793) at EB2001 in Orlando, FL, on April 4, 2001, and Enclosure B is our data presented on our April 4 posterboard in Orlando on low, normal, and high Tf_sat and ferritin results on 122 sequential Mount Sinai male and female employee blood donors, identifying the lows in both sexes who need iron replacement (6 of the 56 females and 6 of the 66 males) and the highs who definitely should not get iron replacement (3 of the 56 females and 6 of the 66 males). The bottom half of Enclosure B names the 15 blood banks (including the Magnuson Clinical Center of the NIH) who have joined us so far in getting variances from the FDA to use healthy hemochromatosis blood as normal donor blood.

In her April 2001 paper entitled, ìPhlebotomy, Blood Donation, and Hereditary Hemochromatosisî, in Transfusion Medicine Reviews, 15 (2) (April), pp. 136-143, Cathy Conry-Cantilena of the Department of Transfusion Medicine of the Magnuson Clinical Center of the NIH raises the possibility that changes in red cell MCV (mean corpuscular volume) may be a good way to follow status of repeatedly phlebotomized persons with hemochromatosis. That is an interesting possibility, but it is irrelevant to the necessity for assessing iron status of each fertile female donor.

On the issue of assessing iron status from a blood sample, I believe the best single test is the one we created, namely measurement of ferritin-iron (i.e. the number of atoms of iron per molecule of ferritin protein (Enclosure C: V Herbert et al. Serum ferritin iron, a new test, measures human body iron stores unconfounded by inflammation. Stem Cells 1997; 15: 291-296). First published in 1997, it is still in process of gradually being learned about and used and confirmed for its value by other labs. Relevant to fertile females, Christian Breymann, M.D., and his associates at the Clinic of Obstetrics at the University Hospital of Zurich in Switzerland reported that measuring serum ferritin-iron is the only way of accurately assessing a womanís iron status as her pregnancy progresses (see the published-in-1998 ìProceedings of the FIGO Committee on Perinatal Health (CPH) Symposium on Prevention and Management of Anaemia In Pregnancy and Postpartum Haemorrhage,î (edited by A. Huch, R. Huch, and C. Breymann), obtainable from Prof. A. Huch, Chair of Obstetrics, University of Zurich, Frauenklinikstr. 10, 8091 Zurich, Switzerland.

Cordially,

Victor Herbert, M.D., J.D., M.A.C.P., F.R.S.M. (London)

P.S. Incidentally, Enclosure A and B are on my web site, victorherbert.com.

cc: Mount Sinaiís Drs. Morton Spivack (Blood Bank Director Emeritus) and Carolyn Whitsett (Blood Bank Director).