The Department of Defense would like to thank you for allowing us to offer public comment.

I am Captain Bruce D. Rutherford, Medical Service Corps, United States Navy, the present Director of the Armed Services Blood Program.

On 5 February, 1999, Dr. Sue Bailey, the Assistant Secretary of Defense for Health Affairs, forwarded a letter to Vice Admiral David Satcher, Public Health Service, the Surgeon General of the United States.

In that letter, Dr. Bailey expressed her opposition and the opposition of the Surgeon Generals of the Army, Navy and Air Force on deferring individuals as blood donors based on "perception" of a "possible" risk of transfusion transmission of the agent for "new variant" CJD.

There has not been a single case, repeat, single case of transfusion transmitted new variant CJD or classical CJD reported in the world in more than 55 years since transfusion of blood products became widely accepted as a treatment regime.

In November of 1991, the Department of Defense issued an advisory recommending that individuals participating in Operation Desert Storm be deferred as blood donors after a number of Desert Storm troops were identified with cutaneous and visceral Leishmania tropica.

Knowing that Leishmania donavani was transfusion transmissible, and now knowing the extent of infection rate of the "at risk" population, the DOD decided to defer those individuals as blood donors who participated in country in the Persian Gulf.

It was not until December of 1993, or two years later, that the DOD stopped asking leishmaniasis related questions of its blood donors. The cessation was due to a concentrated effort by the military health system in identifying an extremely small number of infected individuals and the follow-on screening questions' ability in identifying an extremely small number of donors with symptoms where leishmaniasis could have been a possibility.

However, a study in the survivability and infectivity of viscerotropic Leishmania tropica in human blood donors from ODS participants was later shown to support our concern and was published in the American Journal of Tropical Medicine and Hygiene in 1993.

Transfusion transmission by Leishmania species was a known, not theoretical. We know the calculatable risk of being injured in a car accident, yet millions of individuals a day drive their cars with hundreds of thousands being injured per year and tends of thousands killed each year.

It is the same with airplanes, lightening and other activities.

In theory, anything is possible. I remember back a few years ago when the Institutes of Medicine came out with this HIV report. Yes, hindsight was better, but that has always been true.

I think in this case we have hindsight, 55 years of hindsight. We do not need to institute a UK deferral policy which will only lead to further crippling of our nation's blood supply and more product shortages.

However, what we do need is a concerted research effort by federal and civilian entities to develop human virus-free or non-human products to replace the majority of products that we presently use.

We need Hemoglobin-Based Oxygen Carriers presently in clinical trials moved through the regulatory process at a faster pace. We need better hemorrhage control products such as fibrin or non-fibrin based bandages.

We need more recombinant clotting factors produced in transgenic herds, yeast or bacteria. We need to move away from 80 years of collecting blood.

Thank you.

CHAIRMAN BROWN: Thank you, Captain Rutherford.

Are there any questions that any of the panel would wish to address to Captain Rutherford?

The next presentation will be by Kay R. Gregory of the American Association of Blood Banks.