SPEAKERS CONTENTS INSERTS
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28–424PDF
2006
MAKING SAFE BLOOD AVAILABLE IN AFRICA
HEARING AND BRIEFING
BEFORE THE
SUBCOMMITTEE ON AFRICA, GLOBAL HUMAN RIGHTS AND INTERNATIONAL OPERATIONS
OF THE
COMMITTEE ON
INTERNATIONAL RELATIONS
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
JUNE 27, 2006
Serial No. 109–200
Printed for the use of the Committee on International Relations
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Available via the World Wide Web: http://www.house.gov/international—relations
COMMITTEE ON INTERNATIONAL RELATIONS
HENRY J. HYDE, Illinois, Chairman
JAMES A. LEACH, Iowa
CHRISTOPHER H. SMITH, New Jersey,
Vice Chairman
DAN BURTON, Indiana
ELTON GALLEGLY, California
ILEANA ROS-LEHTINEN, Florida
DANA ROHRABACHER, California
EDWARD R. ROYCE, California
PETER T. KING, New York
STEVE CHABOT, Ohio
THOMAS G. TANCREDO, Colorado
RON PAUL, Texas
DARRELL ISSA, California
JEFF FLAKE, Arizona
JO ANN DAVIS, Virginia
MARK GREEN, Wisconsin
JERRY WELLER, Illinois
MIKE PENCE, Indiana
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THADDEUS G. McCOTTER, Michigan
KATHERINE HARRIS, Florida
JOE WILSON, South Carolina
JOHN BOOZMAN, Arkansas
J. GRESHAM BARRETT, South Carolina
CONNIE MACK, Florida
JEFF FORTENBERRY, Nebraska
MICHAEL McCAUL, Texas
TED POE, Texas
TOM LANTOS, California
HOWARD L. BERMAN, California
GARY L. ACKERMAN, New York
ENI F.H. FALEOMAVAEGA, American Samoa
DONALD M. PAYNE, New Jersey
SHERROD BROWN, Ohio
BRAD SHERMAN, California
ROBERT WEXLER, Florida
ELIOT L. ENGEL, New York
WILLIAM D. DELAHUNT, Massachusetts
GREGORY W. MEEKS, New York
BARBARA LEE, California
JOSEPH CROWLEY, New York
EARL BLUMENAUER, Oregon
SHELLEY BERKLEY, Nevada
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GRACE F. NAPOLITANO, California
ADAM B. SCHIFF, California
DIANE E. WATSON, California
ADAM SMITH, Washington
BETTY McCOLLUM, Minnesota
BEN CHANDLER, Kentucky
DENNIS A. CARDOZA, California
RUSS CARNAHAN, Missouri
THOMAS E. MOONEY, SR., Staff Director/General Counsel
ROBERT R. KING, Democratic Staff Director
Subcommittee on Africa, Global Human Rights and International Operations
CHRISTOPHER H. SMITH, New Jersey, Chairman
THOMAS G. TANCREDO, Colorado
JEFF FLAKE, Arizona
MARK GREEN, Wisconsin
JOHN BOOZMAN, Arkansas
JEFF FORTENBERRY, Nebraska
EDWARD R. ROYCE, California,
Vice Chairman
DONALD M. PAYNE, New Jersey
GREGORY W. MEEKS, New York
BARBARA LEE, California
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DIANE E. WATSON, California
BETTY McCOLLUM, Minnesota
EARL BLUMENAUER, Oregon
MARY M. NOONAN, Subcommittee Staff Director
GREG SIMPKINS, Subcommittee Professional Staff Member
NOELLE LUSANE, Democratic Professional Staff Member
SHERI A. RICKERT, Subcommittee Professional Staff Member and Counsel
LINDSEY M. PLUMLEY, Staff Associate
C O N T E N T S
WITNESSES
The Honorable Chakah Fattah, a Representative in Congress from the State of Pennsylvania
Caroline Ryan, M.D., Sr. Technical Advisor, Deputy Directory for Program Services, Office of the Global AIDS Coordinator, U.S. Department of State
Robert E. Ferris, M.D., Medical Officer, Bureau for Global Health, U.S. Agency for International Development
Jerry A. Holmberg, Ph.D., Senior Advisor for Blood Policy, Office of Public Health and Science, U.S. Department of Health and Human Services
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Ms. Karen Shoos Lipton, Chief Executive Officer, AABB (formerly the American Association of Blood Banks)
Edward C. Green, Ph.D., Member of the Presidential Advisory Council on HIV/AIDS
BRIEFING BY
Neelam Dhingra, M.D., Coordinator, Blood Transfusion Safety, Essential Health Technologies, World Health Organization
LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING
The Honorable Christopher H. Smith, a Representative in Congress from the State of New Jersey, and Chairman, Subcommittee on Africa, Global Human Rights and International Operations: Prepared statement
The Honorable Chakah Fattah: Prepared statement
Caroline Ryan, M.D.: Prepared statement
Robert E. Ferris, M.D.: Prepared statement
Jerry A. Holmberg, Ph.D.: Prepared statement
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Ms. Karen Shoos Lipton: Prepared statement
Edward C. Green, Ph.D.: Prepared statement
Neelam Dhingra, M.D.: Prepared statement
APPENDIX
Material Submitted for the Hearing Record
MAKING SAFE BLOOD AVAILABLE IN AFRICA
TUESDAY, JUNE 27, 2006
House of Representatives,
Subcommittee on Africa, Global Human Rights
and International Operations,
Committee on International Relations,
Washington, DC.
The Subcommittee met, pursuant to notice, at 3 o'clock p.m. in room 2172, Rayburn House Office Building, Hon. Christopher Smith (Chairman of the Subcommittee) presiding.
Mr. SMITH. The Subcommittee will come to order. Good afternoon everyone, and welcome to the Subcommittee on Africa, Global Human Rights and International Operations, and I do apologize to our witnesses for the hour delay. We did, as you know, have a markup on an important resolution dealing with India, which, because of several amendments that were considered, carried into the early afternoon. Again, I apologize for that delay.
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It is my pleasure to convene this hearing of the Subcommittee. Today the Subcommittee is examining the important issue of the availability of safe blood within the medical systems of sub-Saharan Africa. I want to thank Chakah Fattah for originally suggesting that the Subcommittee convene this hearing. He brought to the Subcommittee a great deal, a wealth of information that all of us on the Committee found to be very, very useful, informative, provocative and more importantly demanding of our action. So I want to thank him for his leadership both on the Appropriations Committee in the Congress and for helping this Subcommittee as well.
From my extensive travels to Africa, which have included visits to HIV/AIDS clinics and other healthcare facilities, I too have long been concerned about global health issues including HIV/AIDS, malaria and maternal health. It is disturbing, to say the least, to visit a district hospital in remote areas of Africa that only have one or two pints of blood in their refrigerators and to see rooms filled with expectant mothers and emaciated children experiencing an emergency.
One also has to experience a long drive on the narrow, sub-Saharan two-lane highways to appreciate the significant danger of serious road accidents and resulting need for blood to save the injured. One dodges past overloaded trucks broken down in the middle of the road and passes within feet of adults and children walking on the road's edge intermingled with goats and other livestock.
The increased dangers and health crises in Africa call for increased means to address them, including adequate and safe supplies of blood. A medical benefit related to safe blood that I have long promoted is the use of umbilical cord blood stem cells. On December 20, 2005, the Stem Cell Therapeutic and Research Act of 2005—which I sponsored and my good friend and colleague was one of the principle cosponsors—that legislation provides $265 million for life-saving stem cell therapy, cord blood and bone marrow transplant, and it was signed into law by the President.
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Today in America, umbilical cord blood stem cells and adult stem cells are curing people of a myriad of terrible conditions and diseases. One of my greatest hopes is that these current day miracles will become common medical practice and available to tens of thousands of patients, including, one day, to the peoples of sub-Saharan Africa.
This hope is inspired by people who have overcome incredible odds, thanks to cord blood stem cell transplants, like Keone Penn. He was born with severe sickle cell anemia, which afflicts more than 70,000 Americans, about one out of every 500 in America, and a disproportionate number of others. It is also a serious problem in Africa. According to a WHO report on sickle cell anemia, in 2005 over 200,000 infants are born each year with sickle cell disease on the subcontinent of Africa.
After years of suffering when no other treatments worked, Keone Penn's doctors decided as a measure of last resort to perform a transplant with cord blood from an unrelated donor. This was the first time such a transplant had been tried for sickle cell disease, and it proved successful. One year after the transplant, Keone's doctors pronounced him cured.
Cord blood stem cells hold enormous promise, and have already been used to treat thousands of patients of more than 67 diseases. This potential should not be limited to the developing world but also for those in Africa and in other parts of the world where it has great utility.
Again, I want to thank my good friend and colleague, Congressman Chakah Fattah, who knows of my interest and the interest of other Members of this Committee in Africa and health issues. I know that he shares my related interest in cord blood, and he helped to move the legislation, particularly when it was bottlenecked over on the Senate side.
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Therefore, again, I am happy to take his suggestion of having this hearing to propel the Subcommittee into this debate. We have not done all that much in the past on the availability of blood in Africa. I can assure you, my friend and colleague, that we will now really focus on this.
In its recent report for 2007, it bears noting, the House Appropriations Committee expressed its concern about the existence of unsafe blood as a source of HIV infection in the developing world. The report notes that contaminated blood is of particular concern for women who require a blood transfusion to address complications from pregnancy and childbirth and for children whose lives are threatened by anemia.
Based on these concerns, the Committee requested that the Office of the U.S. Global AIDS Coordinator together with the Agency for International Development, the Department of Health and Human Services and other relevant parties develop a comprehensive multi-year strategy for the PEPFAR focus countries. The strategy should aim to achieve a sufficient supply of blood for each country's needs, the recruitment of voluntary non-remunerated blood donors, universal testing of donated blood for infectious diseases and the reduction of unnecessary transfusions.
A separate strategy is requested for non-focus countries that would provide for the standardized operation and control of blood collection, adequate training, documentation and assessment measures.
This hearing provides the opportunity to examine the extent of the current need in sub-Saharan Africa for an adequate supply of safe blood. We look forward to hearing from our distinguished witnesses about the challenges as well as the opportunities that this region faces in providing this essential medical service.
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We also hope to learn about what we need to do to overcome the difficulties and the best means to accomplish our common goal: A safe and adequate supply of blood to meet the needs of the people of Africa.
I would like to yield to my friend and colleague, Mr. Payne, for his opening comments.
[The prepared statement of Mr. Smith follows:]
PREPARED STATEMENT OF THE HONORABLE CHRISTOPHER H. SMITH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY AND CHAIRMAN, SUBCOMMITTEE ON AFRICA, GLOBAL HUMAN RIGHTS AND INTERNATIONAL OPERATIONS
It is my pleasure to convene this hearing of the Subcommittee on Africa, Global Human Rights and International Operations. Today, the Subcommittee is examining the important issue of the availability of safe blood within the medical systems of sub-Saharan Africa.
My extensive travels to Africa have included visits to HIV/AIDS clinics and other health care facilities, and I have long been concerned about global health issues including HIV/AIDS, malaria, and maternal health. It is disturbing, to say the least, to visit district hospitals in remote areas of Africa that have only one or two pints of blood in their refrigerators and to see rooms filled with expectant mothers and emaciated children experiencing an emergency. One also has to experience a long drive on the narrow, sub-Saharan two-lane highways to appreciate the significant danger of serious road accidents and the resulting need for blood to save the injured. One dodges past overloaded trucks broken down in the middle of the road and passes within feet of adults and children walking on the road's edge, intermingled with goats and other livestock. The increased dangers and health crises in Africa call for increased means to address them, including adequate and safe supplies of blood.
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A medical benefit related to safe blood that I have long promoted is umbilical cord-blood stem cells. On December 20, 2005, the Stem Cell Therapeutic and Research Act of 2005, which I sponsored, was signed into law. This law provides $265 million for life saving stem cell therapy, cord blood and bone marrow transplant. Today, in America, umbilical cord-blood stem cells and adult stem cells are curing people of a myriad of terrible conditions and diseases.
One of my greatest hopes is that these current-day miracles will become common medical practice and available to tens of thousands of patients, including one day to the peoples of sub-Saharan Africa. This hope is inspired by people who have overcome incredible odds thanks to cord-blood stem cells transplants, like Keone Penn who was born with severe sickle cell anemia. Sickle cell anemia afflicts more than 70,000 Americans and a disproportionate number of African-Americans. It is also a serious problem in Africa. According to a WHO report on sickle cell anemia, in 2005 over 200,000 infants are born each year with sickle cell disease in Africa.
After years of suffering, when no other treatments worked, Keone's doctors decided as a measure of last resort to perform a transplant with cord blood from an unrelated donor. This was the first time such a transplant had been tried for sickle cell disease, and it proved successful. One year after the transplant, Keone's doctors pronounced him cured.
Cord blood stem cells hold enormous promise, and have already been used to treat thousands of patients of more than 67 diseases. This potential should not be limited to the developed world, but should also be explored for the benefit of the peoples in Africa and around the world.
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My good friend and colleague Congressman Chakah Fattah knows of my interest in health issues in Africa, and shares my related interest in cord blood stem cell research and medical treatments. Therefore, I was happy to take up his suggestion that the sub-committee conduct this hearing on the availability of safe blood transfusions in Africa.
In its recent report for FY 2007, the House Appropriations Committee expressed its continued concern about the existence of unsafe blood as a source of HIV infection in the developing world. The report notes that contaminated blood is of particular concern for women who require a blood transfusion to address complications from pregnancy and childbirth and for children whose lives are threatened by anemia.
Based on these concerns, the Committee requested that the Office of the Global AIDS Coordinator, together with the Agency for International Development, the Department of Health and Human Services and other relevant parties, develop a comprehensive multi-year strategy for the PEPFAR focus countries. The strategy should aim at achieving a sufficient supply of blood for each country's needs, the recruitment of voluntary, non-remunerated blood donors, universal testing of donated blood for infectious diseases, and the reduction of unnecessary transfusions. A separate strategy is requested for non-focus countries that would provide for the standardized operation and control of blood collection, adequate training, documentation and assessment measures.
This hearing is providing the opportunity to examine the extent of the current need in sub-Saharan Africa for an adequate and safe supply of blood. We look forward to hearing from our distinguished witnesses about the challenges as well as the opportunities that this region faces in providing this essential medical service. We also hope to learn about what we need to do to overcome the difficulties and the best means to accomplish our common goal: a safe and adequate supply of blood to meet the needs of the people of Africa.
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Mr. PAYNE. Thank you very much, Mr. Chairman. I do not think there is anything more important than what our hearing is on today, making safe blood available in Africa. I commend you for calling this important hearing and of course to acknowledge my good friend and colleague, the Honorable Chakah Fattah, who early on a year or 2 ago talked about his idea of making safe blood available in Africa. I commend him for steadfastness.
There are many, many programs that are important and necessary and needed. However, the appropriators have a very difficult time venturing into new programs. It is with a great deal of persistence that we could see a new program come in that we are talking about. I would like to actually commend you for your persistence and concern.
As we will be hearing from our witnesses, there is a need for our immediate assistance concerning the urgent problem of blood storage and unsafe blood particularly in Africa. Unsafe blood only contributes to the enormous burden of HIV and AIDS. The risks of HIV infections through unsafe blood and blood products is exceptionally high, 95 to 100 percent compared to other routes of HIV exposure such as mother to child which is 11 to 32 percent and for other sexual contacts.
In an era where HIV and AIDS has and still is devastating and killing millions, the importance of making safe blood available in Africa is very, very crucial. The problem of blood storage is another issue especially because the primary people affected are women and children. We must not ignore that we face many challenges such as limited resources and inadequate infrastructures that will greatly slow efforts.
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However, we must still take immediate steps to prevent further crises, and strive for improved health conditions. For example, organizations such as the World Health Organization along with others have advocated a strategy to achieve effective, cost efficient and safe national blood supply systems with the aim of increasing voluntary blood donations, screening blood for infections and prioritizing blood transfusions.
I would like to hear about U.S. support for these efforts and innovative strategies that the international community can collaborate on. I hope that we can work together to strengthen the system for blood safety and availability. I was very pleased at the announcement yesterday where the Buffet and the Gates group would be coming together, and this may be that, an area where we could even make an inquiry into that new expanded foundation to even assist in some of the Federal dollars that we are looking at putting into this.
I certainly would like to thank all of our witnesses for their efforts and progress in ensuring universal access to safe blood, and look forward to hearing the testimony of our witnesses. Thank you.
Mr. SMITH. Thank you very much, Mr. Payne. Mr. Tancredo? If not, then I would like to welcome the Honorable Chakah Fattah, an experienced lawmaker serving in his sixth term in the U.S. House. He represents the Second Congressional District of Pennsylvania, which includes parts of Philadelphia and Cheltenham Township. Congressman Fattah has been a leader and a strong and powerful advocate on the issue of safe blood for Africa for a number of years in his position on the House Appropriations Committee. Congressman, the floor is yours.
STATEMENT OF THE HONORABLE CHAKAH FATTAH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF PENNSYLVANIA
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Mr. FATTAH. Thank you, Mr. Chairman. Let me first of all commend you in your leadership on this Subcommittee and the Ranking Member for your interest in this matter, and for convening this hearing today on a subject that I think has gotten far too little attention, and also it is exceptionally unique in our chamber that you would have a collaboration between appropriators and authorizers on a matter.
I want to indicate my appreciation for your willingness to hear from an appropriator on a policy matter but this is something of extreme importance. I have had long conversations with you and the Ranking Member, and I want to thank you.
Before I get into the substance of my abbreviated remarks I want to also add into the record letters from the Secretary General of the UN in support of this initiative, and also the Ambassador for the European Union, and also from Prime Minister Tony Blair, all indicating in sum and substance the same points that you made which is that this issue has gotten far too little attention.
There have been billions assembled to combat the problem of AIDS, particularly in sub-Saharan Africa. We have had a long debate between abstinence and condoms and the whole focus on the ABC approach but too little attention has been focused on this particular problem.
We have in these 45 countries something less than 10 percent of the world's population but 60 percent of the cases of people living with HIV and some 15,000 people dying everyday. It is clear that a significant number of people have gotten through blood transfusions diseases that are transmitted through the blood supply including HIV, and the World Health Organization in an executive summary of a report that I will also provide for the Committee's records, says that, 'Unsafe blood transfusions have significantly contributed to the burden of new HIV infections in Africa. The risk of transfusion associated transmissions of HIV infection is exceptionally high, 95 to 100 percent, compared to other routes of HIV exposure.'
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Now, in our own country we recall not too long ago when we had problems in our blood supply, and we had to create new routines for testing blood and making sure that the blood supply was safe in terms of for transfusion purposes from HIV, and we accomplished that in the early 1980s. We actually know how to do this. It is not something that we have not accomplished. We know how to do it. We know how to train others to do it, and it is something that we could accomplish and save many, many lives in sub-Saharan Africa.
This is a problem in other parts of the world also, in developing countries, and it is critically important I think that we focus some of our efforts in areas where we can demonstrate a result, and we know for certain that just because a child has malaria does not mean they have to have a death sentence through a blood transfusion that gives them a disease that will be fatal like HIV. There would also be the benefits of being able to screen for other diseases that would be transmitted through the blood supply.
I come today first of all to say that we have asked for a study and a review of this matter. You are going to hear from officials with a variety of agencies, the Global AIDS Coordinating Office, the CDC, the World Health Organization and others about their review of this matter but clearly it is an area where we can have an impact. We are today having an impact in terms of some of the pediatric cases through efforts through USAID and through entities here in America and around the world working on this problem.
I believe that we can have a major impact on this if we would make it a major part of our policy focus in terms of the HIV epidemic in Africa, that we can save many, many lives and the cost benefit ratio compared to other dollars spent I think would bear out well. I also think that there are plenty of others who want to be helpful, and I met with the Ambassador from the European Union, and they provide substantial aid sub-Saharan Africa.
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They indicate in the communications that I am putting in the record that they would like to see this as a major part of their thrust. I think there are partnerships that can be developed.
I have also met with officials from the Gates Foundation because you do point out correctly that there are a number of entities, including some Mr. Chairman that you have mentioned associated with the Catholic Charities Organization that is doing work there and others that we could involve in a way to substantially respond to this problem.
I appreciate the fact that you are holding this hearing, and resting on our decisionmaking we could impact perhaps millions of lives that otherwise would be lost to a disease that we do not have a cure for, we do not have a vaccine for but we could make certain that when people have a blood transfusion that they in fact do not have to be infected with this disease. That is one route that we can cut off. We know how to do it, and the resources are available to do it.
It is just a matter of us coming together, and we have found a bipartisan support for this on the Appropriations Committee, Chairman Jerry Lewis, and the Chairman of my Subcommittee on Foreign Operations, Chairman Kolbe, and others are quite supportive of this effort, and we would like to find a way after this hearing for us to go down this road together and make a dynamic difference in terms of the chances of people, particularly women and children—19 of the 20 countries in this world in which women die through post pregnancy hemorrhages and in need of safe transfusions are in sub-Saharan Africa.
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We can make a difference. This is I think a signal that we can work together and find concrete routes to solve some of the more intractable problems that we face in this world. It is not just Warren Buffet and Bill Gates who have gotten together but if appropriators and authorizers can find a way to join hands on this I think we can make a significant difference. I thank you, Mr. Chairman, and I thank the Committee. I also thank the Ranking Member.
[The prepared statement of Mr. Fattah follows:]
PREPARED STATEMENT OF THE HONORABLE CHAKAH FATTAH, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF PENNSYLVANIA
Thank you, Chairman Smith, Ranking Member Payne, and distinguished members of this committee. I appreciate the opportunity to appear before you today, and would like to thank this committee, particularly the Chairman and the Ranking Member, for your continued interest in matters of social justice and human rights.
Mr. Chairman, much of the current discussion pertaining to the fight against global HIV/AIDS involves advocating for the implementation of one of three possible options. One possible option is to demand increased funding to the United States' contribution to the Global Fund, which was established to provide funding to mostly developing countries to combat HIV/AIDS, tuberculosis, malaria, and other infectious diseases. Another frequently advocated option is to place continued pressure on pharmaceutical manufactures to provide low cost antiretroviral drugs to developing countries. Antiretroviral medicines prevent HIV from replicating and causing further damage to a compromised immune system, but many of these drugs require funds that are far beyond the means of most people residing in developing countries. The third option involves either the aggressive promotion of abstinence from all sexual activity, or encouraging the use of condoms to drastically reduce the possibility of transmission of HIV/AIDS due to unprotected sex.
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Mr. Chairman, I suggest to you a different focus that does not involve battling over the relative size of the U.S. contribution to internationally funded programs as compared to other donor nations, evoking the invariably passionate debate on the merits of whether abstinence is an effective strategy, or weighing the morality of potentially promoting sexual promiscuity of providing condoms to adults and sexually active children. Rather, more must be done to ensure the availability of a safe, clean, blood supply in Sub-Saharan Africa and other parts of the developing world, where preventable contamination from numerous infectious diseases such as HIV, hepatitis B, and hepatitis C occurs at unacceptable levels.
The transmission of infectious diseases such as HIV due to an unsafe blood supply is completely preventable. Ensuring a clean blood supply is the only HIV/AIDS preventative measure that is virtually 100 percent effective. In the United States, for example, the blood supply has never been safer than it is today. Techniques for screening and testing blood donors have dramatically reduced the risk of transfusion transmitted viral infection. The risk of infection from HIV or AIDS from contaminated blood has decreased from as high as 1 in 100 units in some U.S. cities in the early 1980s to currently 1 in 1 billion units. The safety and integrity of the blood supply is maintained in the U.S. by mandating all collected and donated blood must comply with the Food and Drug Administration's (FDA) blood safety regulations, which consist of five layers of overlapping safeguards. The regulations address:
Donor Screening: Potential donors are screened by questioning them about their health, medical history, and risk factors for infectious diseases. Individuals whose blood may pose a health hazard are deferred
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Deferral Registries: Independent blood centers maintain a list, or registry, of all deferred donors and check all potential donors against that list. The American Red Cross has established a national registry that covers all its regional blood centers. Donors who are deferred on a temporary basis may resume donating once the deferral period has ended and provided the reason for the deferral no longer exists.
Blood Testing: Donated blood is tested for infectious disease, including HIV, HBV, and HCV. Positive tests are discarded and the donors are deferred.
Blood Quarantining: Blood donations are quarantined until they have been tested and the donation records verified.
Correcting System Deficiencies: Blood centers must investigate any breaches of these safeguards and correct deficiencies that are identified by themselves or during FDA inspections.
With HIV-positive rates approaching or exceeding 20 percent in Sub-Saharan Africa, blood transfusions account for an ever-growing percentage of new HIV/AIDS cases. Of the estimated 6 million blood transfusions performed each year in sub-Saharan Africa, as many as half are improperly or untested for infectious diseases. Less than half of all African countries have adopted standard national blood transfusion policies that would limit HIV infections. More disturbingly, less than one-third of all African countries have some type of policy that attempts to limit HIV infection through blood transfusion.
The global AIDS pandemic is well documented. Sub-Saharan Africa has just over 10 percent of the world's population, but is home to more than 60 percent of all people living with HIV, which is approximately 25.8 million. In 2005, an estimated 3.2 million people in the region became newly infected, while 2.4 million adults and children died of AIDS. Worldwide, there will be an estimated 45 million new cases of infections due to HIV/AIDS by 2010 if efforts to fight the pandemic are not aggressively increased.
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The World Health Organization (WHO) estimates that approximately 120 countries lack proper blood supplies and offer inadequate screening. Out of the total population of HIV/AIDS infected persons, the WHO estimates that up to 10 percent of infections are from corrupted blood supplies and tainted blood transfusions. As I previously noted, these infections are 100 percent preventable. Understand, over 300,000 people in Sub-Saharan Africa alone would be saved from enduring unbearable hardship and pain due to HIV/AIDS each year.
There are many moving examples of personal tragedy throughout the world due to blood transfusions from unsafe blood supplies. Five years ago, a gentleman by the name of Raj Shekhar received a blood transfusion after an accident at a time when blood harvesting programs in India had few safeguards. Nearly a year later, he tested positive for HIV after being hospitalized for severe chest pain. Instead of being admitted to the operating room, his doctor refused to perform the necessary surgery due to fears of infection. Soon after learning Raj was infected with HIV, his wife left him.
In a similar instance, the wife of a couple living in the Philippines in a squatter camp near Manila's financial district required a blood transfusion due to a serious illness. Hospital officials gave the wife six units of blood, some of which were infected by HIV. Before her own contraction of the disease, she believed the virus to be a disease that afflicted homosexual men. Fearing her husband's reaction, she chose not to tell him of her infection. The wife and her husband continued to engage in unprotected sex despite the wife's knowledge she would probably infect her husband with HIV. The wife later became pregnant and gave birth to a baby girl. Though the couple's daughter did not contract the disease, both parents developed the AIDS virus to their exposure to HIV.
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Assuring the existence of a safe and clean blood supply is the most cost effective and commonsensical approach to reducing the number of newly reported HIV cases each year. Recognizing more needs to be done to ensure the safety of the blood supply in Africa, last year I successfully appealed to my colleagues on the Foreign Operations Subcommittee on Appropriations to direct the Centers for Disease Control, the Office of the Global AIDS Coordinator, USAID, and the World Health Organization (WHO) to jointly issue a report detailing the severity of the impact contaminated blood has on the global fight against HIV/AIDS, as well as providing specific policy recommendations for immediate implementation. To ensure the safety of each blood unit, the following key activities were identified: (1) establishment of systems for the supply of test kits and reagents for blood screening and good laboratory practice; (2) recruitment of safe blood donors; (3) implementation of quality systems in blood transfusion services, and; (4) safe and appropriate use of blood to reduce unnecessary transfusions.
Acknowledging the importance of the need to provide safe blood, the Foreign Operations Subcommittee on Appropriations has recently indicated in the Foreign Operations Committee Report for Fiscal Year 2007 that:
The Committee remains concerned about the problem of unsafe or contaminated blood as a source of HIV infection in the developing world. According to the March 2006 Report on Blood Safety, submitted by the Office of the Global AIDS Coordinator, ''substantial problems have been documented'' across all components of safe blood programs in developing countries. Many hospitals in the developing world do not have effective or complete screening of blood, and as a result, there can be a risk of transfusion-transmitted infectious diseases. The prevalence of contaminated blood acutely impacts women requiring blood transfusions due to complications from pregnancy and childbirth, as well as children with life-threatening illnesses such as anemia.
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Worldwide the major risk is hepatitis followed by HIV, malaria and syphilis. The Committee recognizes that there are a wide array of challenges in order to achieve adequate capacity and sustainability to support blood transfusion services in developing countries, including adequate infrastructure (such as reliable electricity for refrigeration), staff recruitment and training, laboratory equipment, effective legislation/policy, and financial/management systems to support blood services.
The Committee understands that the Emergency Plan currently supports the Ministries of Health or the government's National Blood Transfusion Service (NBTS) in fourteen of the fifteen focus countries for the purpose of developing nationally directed regionalized blood systems. The Committee strongly supports these activities and the Emergency Plan's goal of establishing high-quality, sustainable blood transfusion-safety programs in each country. The Committee notes that the bill includes an over 40 percent increase in bilateral funding for focus countries and urges the Coordinator to increase significantly funding for safe blood programs over fiscal year 2006 levels.
The Committee also recognizes that capacity building and infrastructure development are processes that require a period of years which realistically must be approached incrementally. In the Committee's view, to achieve success in advancing blood safety requires a comprehensive and coordinated strategy among Ministries of Health, local communities, donors, and experts in blood transfusion.
Therefore, the Committee requests that the Office of the United States Global AIDS Coordinator, working in coordination with other health sectors in USAID and HHS, and in consultation with WHO, other blood safety experts, and private foundations active in global health, develop and submit to the Committee a comprehensive, integrated multi-year strategic plan for PEPFAR focus countries to achieve the following:
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(1) A sufficient supply of safe blood to meet the needs of the country;
(2) A continuous and adequate supply of voluntary non-remunerated blood donation from the safest possible donors from low risk populations;
(3) The universal testing of donated blood, including quality assured screening of all donated blood for infectious diseases; and
(4) The reduction of unnecessary transfusions; safe and rational blood utilization, and the use of alternatives to transfusions whenever possible.
The pace and resource requirements of the plan should consider the other medical (e.g. mother-to-child transmission and safe medical injections) and non-medical prevention activities in PEPFAR countries and the impact of the strategic plan on maintaining a diversified prevention portfolio. The Committee further requests the Office of the Global AIDS Coordinator, working in coordination with the aforementioned agencies and non-governmental organizations, develop and submit to the Committee a comprehensive implementation strategy for non-focus countries that achieves standardized operation and controls of blood collection, adequate training, documentation, and assessment measures. The strategic plans for both focus and non-focus countries shall be submitted to the Committee no later than 180 days of enactment. Finally, the plan also should examine expenditure rates and factor them into the recommendations in order to ensure the timely obligation and expenditure of funds.
Through the relentless efforts of myself and my staff, I continue to garner enthusiastic support for my call to ensure the availability of a safe and clean blood supply in Africa from numerous countries, international governmental organizations, and non-governmental organizations. Many of these NGOs provide the tactical support necessary for carrying out aid programs and will be an integral part of ensuring Africa's safe blood supply. Africare, U.S. Doctors for Africa, the Global AIDS Interfaith Alliance and the Global Impact Foundation have all enthusiastically endorsed my program. Julius Coles, the President of Africare, has acknowledged that this program is a ''necessary component of HIV/AIDS prevention that has gotten too little attention up to now.'' The support I have received from various NGOs reinforces my conviction that the problem of contaminated blood in Africa is one that we must rectify as quickly as possible.
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I am also heartened by the enthusiastic international support for my call for a clean blood supply. English Prime Minister Tony Blair indicates safe blood is an integral part of the development of a health care infrastructure within African nations. Similarly, the Head of the European Union Delegation in Washington, DC, Mr. John Bruton, believes that my fight to secure a safe blood supply will have a lasting effect on the impact of infectious disease in Africa, indicated that, ''Blood safety should be an integral part of any national strategy for HIV/AIDS prevention, as well as a standard component of national health policies.'' Lastly, Secretary General Kofi Annan has also endorsed my efforts, stating that my Safe Blood Initiative ''will play an invaluable role in benefiting the lives of millions of Africans.'' I am humbled by the international support of my initiative, and I look forward to working with these countries and agencies as we work to help improve the lives of Africans now and in the future.
A problem of such magnitude demands an unequivocal commitment from Congress to combat all aspects of the HIV/AIDS scourge. I believe with the leadership of the distinguished Chairman and the Ranking Member, substantive measures can be implemented to ensure significant improvements to blood and transfusion services that will result in a clean and reliable blood supply in Africa. I thank the distinguished members of this committee, and I will gladly answer any questions.
Mr. SMITH. Thank you very much, my friend. First of all, I have read the report that was submitted pursuant to your request, and I think it is a very good report in many ways. It does point out that the integrated strategy for blood safety adopted by the Emergency Plan and endorsed by focus countries includes a sufficient supply of blood, voluntary non-remunerated blood donation, universal testing and I think we all will agree, especially in light of the number you pointed out from the report by the WHO. If some contamination is in the blood, the recipient is going to get it. With 95 to 100 percent probability, if it is in the blood you are going to get infected, and I think that point—as opposed to sexual transfer or some other means, while a baby is being born or whatever—no other means of transmission comes close.
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The WHO report did say that 5 to 10 percent of new HIV infections are transmitted through unsafe blood amounting to between 160,000 and 320,000 new infections per year as a result of unsafe blood in sub-Saharan Africa. I will be asking our other witnesses if they agree with that number but that is a staggering number of, again, preventable diseases.
I think you make another good point that other diseases, as well, are transmitted through the blood or contaminated blood: Hepatitis B and C, syphilis, malaria, and West Nile virus to name a few. As the blood is cleaned, certainly there are other positive outcomes from other diseases not contracted, as well.
Your testimony was very comprehensive, so I thank you for that. I basically have one question. Do you think we are spending enough? The Administration, I believe, went from $25 million to $50 million to $32 million. Their argument, I think, is that there is money in the pipeline, an enormous amount of it, and it is building up an infrastructure and trying to encourage countries to develop that infrastructure. Are we spending that money fast enough in your view? Is there sufficient funding available?
Mr. FATTAH. I would say a couple of things, Mr. Chairman. One is I think there is a tremendous amount of effort being extended but I think that there is too much passivity in terms of the urgency. That is that if you have 15,000 people dying each day in sub-Saharan Africa, and we have billions sitting in a global AIDS fund, if we have billions in the Millennium Challenge Account. There are reasons why we have not spent down large amounts of these dollars but this particular issue has not really been at the forefront.
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I question and there is a record of Ambassador Tobias before he took his new position in his old position as focus in terms of the Global AIDS Coordinator, and this really was not at the front and center of their work. I just want to see us move this further.
I was in Nigeria and spoke to the health minister there. It was indicated to me that over 22 percent at that time of the new HIV cases were related to blood transfusions, and some of what is being said once you pull back the envelope is not as accurate as we might want it to be. That is that countries report that they have been 100 percent testing but there is no one that is actually knowledgeable about this that believes that there is actually 100 percent testing of the blood before it is being made available for transfusions. I would invite you to question other witnesses on that.
Secondly, they have a waiver for testing in most of these countries when they say that it is a family contribution, and they produce someone in which many experts believe are remunerated individuals and who then say that they are a family member and provide the blood, and therefore they move around the testing requirement. When I began this effort a year and a half ago, I called up into my office experts from CRS, who know as much as we can know about Africa. I asked them one simple question. These are our own experts here in the Congress. I asked, if I were traveling in Africa and I needed to get a blood transfusion, what country would I want to be in at the time that I needed that transfusion? The CRS experts that work for the Congress said that there would be no place that they would think that I would want to get a blood transfusion. In fact, there would be other circumstances that would be provided for me because there really was not a safe system to control and make sure that the blood supply is free of diseases in much of the continent.
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We spend about $357 per unit of blood in the United States to make sure that if we get a transfusion it is safe. Less than a dollar and a half is being spent in sub-Saharan Africa in any system at all to deal with the availability of safe blood.
Mr. SMITH. You make a good point about whether or not we are getting accurate information. I noted again in the UA Working Group documents they claim, based on their statistics, that 10 percent of the total are from paid donors, 32 percent from family replacement donors, and voluntary unpaid donors make up 57 percent, which sounds pretty positive unless it is inaccurate. I think your point was well taken. Mr. Payne.
Mr. PAYNE. Once again as I have indicated, Congressman Fattah, I commend you for spearheading this initiative in the Appropriations Committee. We certainly, as an authorizing Committee, here will attempt certainly to work closely with you to move this forward. I wonder if in your research has the question about needles come up? The fact that healthcare providers in many instances are themselves being infected by their work around the blood, and in particular needles and sometimes being pricked themselves by mistake? In your talk about clean blood, has there been any conversation regarding needles in general?
Mr. FATTAH. One of the things that I think you are going to hear from future witnesses today is that there is a tremendous need for training and for a laboratory environment in which we can avoid some of that. One of your colleagues, Steve Rothman, there is an expert in New Jersey, a doctor who specializes in helping train doctors in what are called bloodless surgeries but really is a way to limit the need for large amounts of transfusions.
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There are a range of ways that we can go about this issue but clearly—and I said this to the Chairman—that if we are going to clean up the blood supply it will require some effort. It will require the ability to store blood, to recruit voluntary healthy donors, to test blood, to train African doctors and healthcare professionals.
The African Union has now set up an entity to focus in on—and you and I have discussed that—the healthcare infrastructure. Clearly some part of the challenges on the continent relate to the whole issue of health and the infrastructure not just on this question but on many questions related to the healthcare infrastructure is weak up to an including creating electricity to rural villages and other places so that you can have an ability to store blood and blood products safely.
Mr. PAYNE. I certainly appreciate and there is no question that the healthcare system is weak in many of the developing countries. As a matter of fact, that was one of the questions that President Tobleman Becky in South Africa was talking about when he was sort of misunderstood to some degree on his question about HIV and AIDS being just equal to other diseases. I think he was really trying to make the point that unless you get a healthcare system that can provide safe health in general that you are bound to fail. I think you certainly reiterate the fact that we really have to work on a system to assist developing countries to have a sustainable energy, have various equipment, refrigeration, things that they need in order to try to get the job done.
Once again, let me commend you for this. With that, Mr. Chairman, I will yield back the balance of my time.
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Mr. SMITH. Ms. Lee.
Ms. LEE. Thank you, Mr. Chairman. Let me also thank you for this hearing, and thank you for your leadership. I also visited Nigeria several years ago and met with the ministry of health, the President and others—I believe it was Mr. Gadenson when he was our Ranking Member—and learned of this very critical need and aspect of the whole HIV/AIDS pandemic.
For the life of me, I still cannot figure out why understanding that a large percentage of HIV and AIDS transmission are related to unsafe blood transfusions, here in America we have been able to solve that crisis, that problem. Why in the world—and this is one thing that I tried to figure out when we were there—on a country-by-country basis as we look at PEPFAR and the Global Fund and all of these initiatives that this is not a specific requirement, and that we do not find?
Certainly here in the United States we have the Red Cross. We have other partners who could take a country, go over to that country, set up shop and help them within a year's time develop the infrastructure and develop what is needed to be able to begin to turn this around.
You know I cannot figure out why that has not happened or why it is not happening now. I wondered if you had any insights since you have been working so hard on this, Mr. Fattah, and your leadership has been so vital in bringing this to this point? No one has been able to answer that question.
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Mr. FATTAH. I think that there is a tendency when you look at the question of the HIV epidemic on the continent and in sub-Saharan Africa to think that it is just so enormous that almost nothing can be done. Then we have through President Bush's leadership created a multibillion dollars initiative that will be scaled up to $15 billion over a few short years in the global AIDS fund are focused at HIV, malaria and TB.
Now, we have children—it is estimated by one of the State Department vendors that provide safe blood for Americans if they are in need of a transfusion anywhere in Africa—that there are at least 2 million of these 25 million victims of HIV are children who have gotten malaria through mosquito bites and which could have been prevented or could have been treated in other ways but at some point absent that treatment those children are in need of blood transfusions. So you solve one problem by giving almost a death sentence to a young person through an unsafe contaminated blood transfusion.
I think the point that I would make is I think there is obvious benefits in the ABC approach, and I think there are good hearted people working on this. This is an area in which this is an absolute way to prevent transmission through this method, and that is through investing in a safe blood supply and all of the elements that would be needed to do that. That is that you would need laboratories and training and electricity and so on to get this done.
If you think about what we can do when we are compelled to do it, I mean we can transport anything almost anywhere in the world. We just funded a new blood bank in Nigeria through USAID but we could literally put hundreds of new blood banks in sub-Saharan Africa if we decided that we wanted to do it, and we could do it not in 5 year's time. We could literally do it in less than 1 year because we as a nation and especially if we unite with other partners, if we decided that the lives that could be saved were worth saving then we could kind of have a different sense of urgency about this challenge.
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Ms. LEE. Mr. Chairman, I think that is the point. This is so clear, and I guess I am asking you from your perspective why have we not made this a priority, understanding that the Global Fund is there to fund initiatives to prevent and treat HIV and AIDS. We have PEPFAR. We have USAID. We have several initiatives, and we should be going to the world community to say we can reduce the incidence of transmission if in fact we have safe blood supply. It just seems like a no-brainer to me. We have done it here in America. Other countries have done it. Why can we not do it on the continent of Africa?
Mr. FATTAH. I think where we are now is that we have arrived at a consensus that we are going to do it. I have talked to officials in the Bush Administration. We got this study that you are going to hear about, and we have new language in the Foreign Ops bill this year to move this matter forward. I think that the attention that the International Affairs Committee has now brought to this matter and the dialogue that will follow me, will be immensely helpful in having all of the various entities that are involved understand that the Congress in a bipartisan way wants to see some progress made on this matter, and wants to see it as a very high priority.
Ms. LEE. Thank you, Mr. Chairman. This is very important this development in this hearing today because many of us have tried to figure out how to move this forward, and thank you again for your leadership.
Mr. SMITH. Thank you. Let me just conclude with a question and something to take back—something I will be asking of our other witnesses, as well. In the report, Mr. Fattah, which you asked to be produced, there was a discussion on incremental versus nonincremental approaches, and the conclusion is that only the incremental approach is realistic for establishing blood services in developing countries, including in sub-Saharan Africa, and then they give their reasons for that conclusion.
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I wonder if there can be accelerated incremental approach, given the fact that so many people are dead or dying. One of our witnesses later on, Dr. Jerry Holmberg, will point out that an estimated 14 million blood units are needed. He cites in 2004 that only 3.6 million units were collected.
The issue, I think, is two-fold. It is one of safe blood, so you do not get infected when you get a transfusion, and the other issue is having capacity, because all these others folks who will get sick and are in need of a transfer of blood who will not get it. You and I have both talked about how we have been to hospitals, particularly in the rural setting, where you open up a refrigerator and there is one pint of blood just sitting there, and you wonder how long it has been sitting there. That is a very discouraging thing to see.
If you wanted to comment on that issue.
Mr. FATTAH. Fortunately, I was a student at one point in my life at the Kennedy School, and they had a whole theory on this whole question of nonincremental versus incremental policy initiatives, and we have seen them and various renditions of them in which the urgency and which we want to accomplish something dictates what we do and how fast we try to do it.
There are several pieces to this obviously. If we want to create a system of voluntary donations in a cultural environment in which donating blood has not been yet seen as something that people generally do, then that is a matter of public education but we do not have to wait 3 years to design a public education campaign and encourage healthy people in Africa to give blood. We could even have people in other parts of the world donate blood.
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You could have African-Americans encouraged here to give blood that can go. I mean we can deal with this in a much more urgent way than I think that the study lays out. Again, I think that even though there are some very good and helpful points that are made, I think that part of the discussion is about how many lives can be saved? If it is just 10 percent of 25 million, and what does that mean yearly and how many lives, and therefore how much resources?
I think that the point that you will see in both Kofi Annan's comment here where he says that the HIV/AIDS pandemic poses an unprecedented threat to human security and development in the continent. The epidemic demands an exceptional response, and that this initiative on safe blood will play an invaluable role in benefitting lives of millions of Africans.
You see the European Union which says that they provide a substantial share of the worldwide package of aid that goes to sub-Saharan Africa. Their Ambassador said they are willing to make this their number one priority. If we would I think find ways to partner with others and if we could have help, since we are politicians, designing a program that actually could work I think we could get at this a little bit sooner but I do think we have to give weight to their viewpoints but I do think that they should be questioned on it because we should have a sense of urgency when we have a chance to save lives.
Mr. SMITH. Chakah, thank you so much for your tremendous leadership and for helping us today to better understand this issue.
Mr. FATTAH. Thank you, Mr. Chairman. Let me thank your staff for all of their assistance and thank my staff for their work on this matter. Thank you.
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Mr. SMITH. Thank you. I would like to now invite to the witness table our second panel, beginning with Dr. Caroline Ryan who since October 2004 has been detailed to the Office of the U.S. Global AIDS Coordinator where she serves as senior technical advisor for the prevention and technical team lead. Previously, Dr. Ryan served as the Associate Director for International Activities in the Division of STD Prevention, and subsequently served as chief of the Prevention Branch in CDC's Global AIDS Program.
We will then hear from Dr. Robert E. Ferris. Dr. Ferris has served since 2005 as medical transmission manager at the Office of HIV/AIDS at USAID, Division of Technical Leadership and Research. Dr. Ferris completed his residency in 2003 at Internal Medicine/Pediatrics Program at Saint Vincent's Hospital in New York, New York.
We will then hear from Dr. Jerry Holmberg, who has served since 2003 as Senior Advisor for Blood Policy in the Office of Public Health and Science at the U.S. Department of Health and Human Services. Between 1980 and 2000, Dr. Holmberg served in the U.S. Navy, achieving the rank of Commander. During that period, he held various positions directing blood banks, blood donor centers and frozen blood bank deposits.
Dr. Ryan, if you could begin with your testimony.
STATEMENT OF CAROLINE RYAN, M.D., SR. TECHNICAL ADVISOR, DEPUTY DIRECTORY FOR PROGRAM SERVICES, OFFICE OF THE GLOBAL AIDS COORDINATOR, U.S. DEPARTMENT OF STATE
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Dr. RYAN. Mr. Chairman and Members of the Subcommittee, thank you for this opportunity to discuss President Bush's Emergency Plan for AIDS Relief and the successes and challenges of providing safe blood in the developing world, primarily sub-Saharan Africa. This testimony will be a summary of my written remarks.
We greatly appreciate the partnership between PEPFAR and the International Relations Committee, especially the Subcommittee on Africa, and we would like to thank all the Members of the Subcommittee for your commitment to the U.S. leadership in the fight against this tragic pandemic.
The President and the Congress made a strategic decision to direct the activities of the Emergency Plan to focus on the prevention, care and treatment of HIV and AIDS. A focus of the Emergency Plan is to build local capacity, to provide long-term, sustainable programs in the countries with which we partner. Ensuring the availability of safe blood is one component of a multi prong HIV prevention strategy that includes prevention of sexual transmission, prevention of mother to child transmission and prevention of medical transmission.
For the developing countries in which the Emergency Plan works, there are significant challenges to developing and maintaining an adequate, sustainable supply of safe blood. These include a lack of strong healthcare systems, a lack of or inadequate policy around blood safety and clinical use of blood, a lack of basic infrastructure such as consistent electricity for refrigeration and a lack of available and sufficiently trained health personnel.
These conditions are pervasive in sub-Saharan Africa and are part of a larger and more complex development challenge. The Emergency Plan with its clear mandate to prevention, treatment and care for those infected with and affected by HIV/AIDS cannot alone address the infrastructure, policy and capacity challenges faced by developing countries.
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At the request of Representative Fattah and the House Appropriations Subcommittee for Foreign Operations, the Office of the Global AIDS Coordinator has prepared a report on blood safety as a component of the HIV/AIDS prevention strategy. Together with our colleagues from the Department of Health and Human Services, the U.S. Agency for International Development and the World Health Organization, we invited a group of technical consultants with expertise in blood safety to discuss the magnitude of the problem posed by unsafe blood products, the level of resources required to address the problem, the feasibility of a nonincremental approach to expanding transfusion services and the cost effectiveness of implementing a safe blood program in reducing rates of infection.
The group's consensus was presented in the report findings provided to this Committee. Let me first discuss the HIV transmission risk from unsafe blood and program components needed to assure its safety. Actual data from PEPFAR focus countries blood programs show an average of 3.2 percent of donors are HIV positive. Several studies have documented that blood transfusions are not the major cause of HIV transmission in most countries, especially those with generalized epidemics where most new infections are a result of heterosexual contact.
There are challenges to providing safe blood at a national level, and these include assuring that a sufficient amount of blood is collected in the country, assuring the implementation of a system to recruit low risk donors, assuring that quality screening of donated blood is occurring and assuring that national policies and oversights to reduce unnecessary transfusions are in place. Without these components in place, there is a higher risk of transfusion transmitted diseases, and these include viral hepatitis, malaria in addition to HIV and AIDS.
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To reduce HIV and AIDS transmission risks prevented by blood transfusions, the Emergency Plan supports national programs to improve the quality of blood supplies through improved policies, the establishment of laboratory facilities and commodity procurement and healthcare worker training and management. The Emergency Plan in the focus countries supports national blood transfusion services, and provides technical assistance to them by partnering them with international blood safety organizations.
The goal of the technical assistance is to increase blood supply through donor recruitment, to ensure blood safety through proper screening of donors and donated blood and to support the development of an improved national blood service in each country.
I would like to discuss the issues on focus countries. In 2004, PEPFAR partners obligated a total of $24.4 million in funds to blood safety activities in the focus countries. In 2005, that amount was increased to $50 million. For fiscal year 2006, the current planned amount for blood safety activities is $32.3 million.
During the first 2 years of the program, countries only spent one-third of the Emergency Plan funds allocated to ministries of health and national blood transfusion services. At the end of fiscal year 2005, approximately $50 million was still in the pipeline and available in addition to the $32 million in funding plan for fiscal year 2006.
This is largely due to the infrastructure, human capacity and policy constraints. These countries cannot effectively spend funding until another layer of infrastructure is in place to allow for sustainable expansion of services. Additionally, most blood safety related activities supported by the Emergency Plan are implemented through partnerships with focus country government organizations such as ministries of health. These structures are traditionally slower to act in applying interventions at the national level.
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Assuming that those funds currently in the pipeline are appropriately out laid, the planned funding for blood activities in fiscal year 2007 will increase. The current funding level for blood safety activities does strike a reasonable balance between the absorptive capacity of the host country to develop national blood services and the continuation of a comprehensive and effective prevention program that focuses prevention efforts where new infections are occurring.
The Emergency Plan must continue to be strategic in choosing where each prevention dollar is spent in support of this full portfolio of prevention interventions. Blood safety activities continue to be supported as a necessary element of this portfolio. At current levels we feel this both meets the capacity needs of the focus countries and fits a comprehensive and cost effective prevention strategy consistent with the epidemiology of where new infections are occurring.
Mr. Chairman, the Emergency Plan is experiencing success in supporting HIV strategies in our host nations. Providing safe blood in Africa is a broad issue addressing the risks from all transfusion transmissible diseases including HIV/AIDS, hepatitis and malaria. We at the Office of the Global AIDS Coordinator will continue to work with our colleagues at the Department of Health and Human Services and USAID to support the ongoing blood safety programs as part of the Emergency Plans efforts to focus on HIV and AIDS.
As countries continue to develop their basic infrastructure and strengthen their systems that they can maintain over the long-term, safe blood will begin to expand for national coverage. The large scale programs implemented as part of the Emergency Plan have begun to address this need through a thorough and comprehensive approach that will produce immediate results, long-term improvement and the likelihood of sustainability.
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The results of this strategy are already visible. The Emergency Plan supports approximately 600 blood safety service outlets or programs in the focus countries, and South Africa and Botswana now have safe blood supplies at the national level. In Kenya, there are 150,000 more units of safe blood up from 40,000 in 2004.
This Subcommittee can be proud that through the President's Emergency Plan the American people are partners with families, communities and nations that are reclaiming their future. Thank you for the opportunity to speak with you today, and I would be happy to address your questions.
[The prepared statement of Dr. Ryan follows:]
PREPARED STATEMENT OF CAROLINE RYAN, M.D., SR. TECHNICAL ADVISOR, DEPUTY DIRECTORY FOR PROGRAM SERVICES, OFFICE OF THE GLOBAL AIDS COORDINATOR, U.S. DEPARTMENT OF STATE
Mr. Chairman and Members of the Subcommittee:
Thank you for this opportunity to discuss President Bush's Emergency Plan for AIDS Relief (PEPFAR/Emergency Plan) and the successes and challenges of providing safe blood in the developing world, primarily Sub-Saharan Africa.
We have greatly appreciated the partnership between PEPFAR and the International Relations Committee, especially the Subcommittee on Africa. We would like to thank all the members of the Subcommittee, and your commitment to the U.S. leadership in the fight against this tragic pandemic.
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The President and the Congress made a strategic decision to direct the activities of the Emergency Plan for global HIV/AIDS, and particularly on interventions designed for its prevention, care, and treatment. Of course, HIV/AIDS in the developing world is closely related to numerous other issues: economic development, food security, conflict, gender issues, and many more.
A focus of the Emergency Plan is to build local capacity to provide long-term, sustainable HIV/AIDS prevention, care and treatment programs in the countries with which we partner. Ensuring the availability of safe blood is one component of a multi-prong strategy to prevent HIV transmission. And the results of this strategy are already visible: South Africa and Botswana now have safe or nearly safe blood supplies available at the national levels. In Kenya, there are 150,000 more units of safe blood, up from 40,000 in 2004.
For the developing countries in which the Emergency Plan works, there are significant challenges to developing and maintaining an adequate sustainable supply of safe blood. These include:
A lack of basic infrastructure which includes such things as consistent electricity, refrigeration, physical structures, laboratory equipment;
Inadequate administrative procedures in place to allow for the purchase and management of blood-related commodities;
A lack of or inadequate policy around blood safety and the clinical use of blood;
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And, A lack of strong health care systems.
These issues are pervasive in Sub-Saharan Africa, and remain part of a larger and more complex development challenge. The Emergency Plan, with its clear mandate to the prevention, treatment, and care for those infected with and affected by HIV/AIDS, cannot alone address the infrastructure, policy and capacity challenges faced by developing countries.
At the request of Representative Fattah and the House Appropriations Sub-Committee for Foreign Operations, the Office of the Global AIDS Coordinator has prepared a report on blood safety as a component of the HIV/AIDS prevention strategy. Together with our colleagues from the Center for Disease Control (HHS/CDC), the U.S. Agency for International Development (USAID), and the World Health Organization (WHO), we invited a group of technical consultants with expertise in blood safety to discuss the magnitude of the problem posed by unsafe blood supplies, the level of resources required to address the problem, the feasibility of a non-incremental approach, and the cost effectiveness of implementing a safe blood program in reducing rates of infection. The group's consensus was presented in the report findings provided to this committee.
Let me first discuss the HIV transmission risk from unsafe blood in the Emergency Plan focus countries. Actual data collected from PEPFAR focus country blood safety programs show an average of 3.19% of donors were HIV positive. Several studies have documented that blood transfusions are not the major cause of HIV transmission in most countries. Among young women, for instance, the risk associated with transfusions appears low compared to the proportions infected by heterosexual transmission. This data reflects the prevalence of HIV/AIDS only.
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Even though transmission risk of HIV/AIDS through blood transfusions may be low, we have documented challenges in each of the following components of providing safe blood at the national level:
Assuring that a sufficient amount of blood is collected in the country;
Assuring the implementation of a system to recruit low risk donors;
Assuring that quality screening of donated blood is occurring;
And assuring that national policies and oversight to reduce unnecessary transfusions are in place.
These issues contribute to the higher risk of transfusion-transmitted diseases, including viral hepatitis and malaria, in addition to HIV/AIDS, in Africa.
To reduce the HIV/AIDS transmission risks presented by blood transfusions, the Emergency Plan supports
National programs to improve the quality of blood supplies through improved policies;
The establishment of laboratory facilities and commodity procurement;
Healthcare worker training and management.
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The Emergency Plan also provides technical assistance to aid countries in implementing the foundational components of effective national blood transfusion services.
PEPFAR promotes international blood safety organizations to partner with each of the focus countries to help in the development of a comprehensive system that includes low-risk blood donor selection, blood banking, and blood safety training. The goal of these programs is to increase blood supply through donor recruitment. The programs also work to ensure blood safety through proper screening of donors and donated blood. They support the development or improvement of a national blood service in each country.
In fiscal year 2005, the Emergency Plan supported approximately 600 blood safety service outlets or programs in the focus countries. In 2004, PEPFAR partners obligated a total of $24.4 million in funds to blood safety activities in the focus countries. In 2005, that amount increased to $50 million. For fiscal year 2006, the current planned amount for blood safety activities is $32.3 million.
During the first 20 months of funding, countries spent only one-third of the Emergency Plan funds allocated to Ministries of Health and National Blood Transfusion Services (MOH/NBTS) to establish safe blood systems. Two-thirds of funding remains in the pipeline. At the end of fiscal year 2005, approximately $50 million was still in the pipeline and available, in addition to the $32 million in funding planned for FY 2006. This is largely due to the infrastructure, human capacity, policy, and economic constraints experienced by the focus countries. These countries cannot effectively spend funding until another layer of infrastructure is in place to allow for sustainable expansion of services. Additionally, most blood safety-related activities supported by the Emergency Plan are implemented through partnerships with focus country government organizations such as the MOH. These structures are traditionally slower to act in applying interventions at the national level and often create an excess in available unused funding. Assuming that those funds currently in the pipeline are appropriately outlayed, the planned funding for blood safety activities will increase proportionately in FY 07.
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Now I would like to briefly discuss a baseline for assuming the cost effectiveness of safe blood as a means to avert HIV-transmission. Utilizing the simple WHO resource model of a cost of $45 to produce a unit of safe blood, the cost per HIV-infection averted can be extrapolated. Using a HIV prevalence rate of 3%, Testing 33 units of blood at $45 a unit equals $1500 per unit identified. As the potential for contracting HIV from tainted blood is 80%, the approximate cost per infection averted is $2000 per infection (assuming all units of blood are used). I would point out that the WHO resource model assumes that basic infrastructure components such as functioning roadways, consistent supply of electricity, and sufficiently trained and available healthcare workers are in place and accessible. As I have mentioned, we know this is not the case, and that these development issues still pose a significant challenge in the countries the Emergency Plan supports. In reality, the cost per infection averted would be much more than $2000 when including the infrastructure costs necessary.
The current levels of funding for blood safety activities strike a reasonable balance between the absorptive capacity of host countries to develop national blood services, and the continuation of a comprehensive and effective prevention program. The Emergency Plan must continue to be strategic in choosing where each prevention dollar is spent in support of this full portfolio of interventions. Blood safety activities continue to be supported as a necessary element of this portfolio. At current levels, we feel this both meets the capacity needs of the focus countries, and fits a comprehensive and cost effective prevention strategy.
Mr. Chairman, the Emergency Plan is experiencing success in supporting the HIV/AIDS strategies of our host nations. Providing safe blood in Africa is a broad issue, addressing the risk from all transfusion-transmissible diseases, including HIV/AIDS, hepatitis, and malaria. We at the Office of the Global AIDS Coordinator will continue to work with our colleagues at the Department of Health and Human Services to support the ongoing blood safety programs as part of the Emergency Plan efforts focusing on HIV/AIDS.
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As countries continue to develop basic infrastructure and strengthening systems that they can maintain over the long-term, safe blood services will begin to expand for national coverage. The large-scale programs implemented as part of the Emergency Plan have begun to address this need with a thorough and comprehensive approach that will produce immediate results, long-term improvement, and the likelihood of sustainability. This Subcommittee can be proud that through the President's Emergency Plan, the American people are partners with families, communities, and nations that are reclaiming their future.
Thank you for the opportunity to speak with you today, and I would be happy to now address your questions.
Mr. SMITH. Doctor, thank you very much. Dr. Ferris.
STATEMENT OF ROBERT E. FERRIS, M.D., MEDICAL OFFICER, BUREAU FOR GLOBAL HEALTH, U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT
Dr. FERRIS. Mr. Chairman, Members of the Subcommittee, good afternoon and thank you for the opportunity to testify on the important topic of safe blood in Africa. The U.S. Agency for International Development works with its partners to improve blood transfusion practices, obstetrical delivery practices and health systems to create a safer blood supply.
USAID and other U.S. Government partners recognize that safe blood saves lives. The medical knowledge and technical expertise exists. Implementing and sustaining safe blood supply systems in developing countries is the challenge today.
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Women and children are likely to be the greatest beneficiaries of safe blood supply in Africa. Women often require blood during a life threatening complication of childbirth. Children often require blood when their own blood levels are dangerously low from diseases such as malaria. During these not uncommon medical emergencies, access to safe blood is lifesaving.
Blood and blood products are not risk free. HIV, hepatitis B, hepatitis C and malaria are just a few of the harmful factors transmissible during blood transfusions. Up to 5 percent of HIV infections in the developing world are estimated to result from transfusion of contaminated blood.
USAID has directly worked to create a safer blood supply in several countries, including Nigeria and Egypt. Through the Safe Blood for Africa project, funded under the President's Emergency Plan for AIDS Relief, USAID, with other Safe Blood for Africa partners, is developing a blood collection and distribution center in Abuja, Nigeria, where blood services historically have been understaffed and underfunded. USAID efforts in this initiative have contributed to the long range goal of sustaining a national blood policy and establishing a Nigerian national blood transfusion service. Through the help of Safe Blood for Africa, 18 national blood transfusion services are now working to safeguard blood supply in developing countries.
In Egypt, USAID worked with public and private partners to enhance the blood banking enterprise. This project has developed a framework to increase voluntary blood donations. The project includes recordkeeping and data management systems to enable the retention of safe blood donors, a course in basic principles of safe blood collection and universal precaution guidelines, policies and procedures.
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USAID has had a long history of strengthening health systems and improving the quality and safety of healthcare in developing countries. USAID's health programs in Africa have improved the safety of medical practices through technological innovations in clinical training, through improved governance, policy guidance, strengthened management and logistic systems, better health financing and improvements in service quality.
USAID helps ensure proper blood safety procedures that can reduce the risk of HIV transmission from transfusions and contaminated needles. We do this by supporting education and behavior change among providers and patients, effective supply use by providers, improve distribution systems, improved supply forecasting ability and enhanced waste management practices.
USAID also helps to reduce the need for blood transfusions through better medical management and prevention of transfusion-causing conditions in our child survival, infectious disease and maternal health programs. While most of these programs are currently funded from our non-HIV/AIDS child survival budget, they make substantial contributions to preventing HIV in medical settings.
Two notable examples are the promotion of safe obstetrical delivery practices and combatting malaria. USAID promotes safe obstetrical delivery and care in its safe motherhood programs. For example, postpartum hemorrhage is a serious complication of childbirth that often requires blood transfusion. Our programs aim to reduce the need for transfusion by developing programs to prevent postpartum hemorrhage as well as protocols to manage hemorrhage appropriately when it occurs.
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Also, USAID funded the Program for Appropriate Technology and Health to test the feasibility of putting the drug oxytocin in Uniject prefilled, auto-disable injection devices. Oxytocin is a medication that effectively reduces bleeding following childbirth. The use of the Uniject device to deliver Oxytocin would make this lifesaving intervention even safer for patients and providers while decreasing the potential need for blood transfusion.
The USAID-funded maternal and neonatal health program works in 10 countries in Africa on infection prevention practices, for safe motherhood and newborn health. These programs work at the national level on policies and standards which are then reflected in the curricula for preservice and inservice training of healthcare workers, preparation of training sites, the development of job aids and supportive supervision systems.
We emphasize several key infection prevention behaviors: Injection safety, universal precautions, avoiding unnecessary medical procedures, proper sterilization of instruments, proper disposal of hazardous waste as well as newborn umbilical cord care.
USAID is also a partner with the White Ribbon Alliance, an international coalition that increases public awareness about the need to make pregnancy and childbirth safe for all women and newborns. Optimizing a pregnant woman's health is likely to prevent the need for some transfusions and reduce the strain on an already stretched supply of safe blood.
Severe anemia from malaria is also a frequent cause for blood transfusion in Africa especially for young children. USAID has been committed to saving lives from malaria since the 1950s. USAID works closely with national governments to build their capacity to prevent and treat this disease. USAID also advances the discovery and development of new anti-malarial drugs and malaria vaccines.
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In addition to its ongoing malaria programs, USAID also manages programs through the President's Malaria Initiative, a $1.2 billion, 5-year initiative to control malaria in Africa. PMI is a collaborative U.S. Government effort led by USAID in conjunction with the Department of Health and Human Services, the Department of State, the White House and others. The goal of the initiative is to reduce malaria deaths by half in 15 target countries by reaching 85 percent of the most vulnerable groups, children under 5 years of age and pregnant women with proven and effective malaria prevention and control measures.
Clearly in reducing malaria by improved treatment and prevention of malarial infections fewer transfusions will be required to save those severely infected.
Mr. Chairman and Committee Members, directly strengthening blood supply systems ultimately can make safe blood available throughout Africa. In the meantime, efforts that strengthen overall health systems and prevent medical emergencies like postpartum hemorrhage and severe anemia from malaria are critical to reduce the burden on currently fragile blood supply systems.
I would like to assure the Committee that USAID, in partnership with HHS and the President's Emergency Plan for AIDS Relief, will continue to work to strengthen systems to improve the delivery of safe blood in Africa. Thank you again for inviting me to speak on this important topic, and I am happy to take your questions.
[The prepared statement of Dr. Ferris follows:]
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PREPARED STATEMENT OF ROBERT E. FERRIS, M.D., MEDICAL OFFICER, BUREAU FOR GLOBAL HEALTH, U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT
Mr. Chairman and Members of the Subcommittee:
Good morning and thank you for the opportunity to testify on the important topic of safe blood in Africa. The U.S. Agency for International Development (USAID) works with its partners to improve blood transfusion practices, obstetrical delivery practices and health systems to create a safer blood supply.
USAID and other U.S. Government partners recognize that safe blood saves lives. The medical knowledge and technical expertise exists. Implementing and sustaining safe blood supply systems in developing countries is the challenge today.
Women and children are likely to be the greatest beneficiaries of a safe blood supply in Africa. Women often require blood during a life threatening complication of childbirth. Children often require blood when their own blood levels are dangerously low from diseases such as malaria. During these not uncommon medical emergencies, access to a safe blood supply can be life saving.
Blood and blood products are not risk-free. Human immunodeficiency virus (HIV), hepatitis B, hepatitis C, and malaria are some of the harmful factors transmissible during blood transfusions. Up to five percent of HIV infections in the developing world are estimated to result from transfusion of contaminated blood.
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USAID has directly worked to create a safer blood supply in several countries including Nigeria and Egypt. Through the Safe Blood for Africa project, USAID with the ExxonMobil Foundation, the Bill & Melinda Gates Foundation, Merck Pharmaceuticals, the Centers for Disease Control and Prevention (CDC) and Becton Dickson is developing a blood collection and distribution center in Abuja, Nigeria to prevent HIV transmission through blood transfusion. In Abuja, blood services historically had been understaffed and under funded. USAID's efforts in this initiative have contributed to the long range goal of sustaining a National Blood Policy and establishing a Nigerian National Blood Transfusion Service. Through Safe Blood for Africa, 18 national blood transfusion services are now safeguarding the blood supply.
In Egypt, USAID worked with public and private partners to enhance the blood banking enterprise. This project has developed a framework to increase voluntary blood donations. The project includes record-keeping and data-management systems to enable retention of safe donors; a course in basic principles of safe blood collection; and universal-precaution guidelines, policies, and procedures.
HEALTH SYSTEMS
USAID has a long history of strengthening health systems and improving the quality and safety of health care in developing countries. USAID's health programs in Africa have improved the safety of medical practices through technological innovations and clinical training and through improved governance, policy guidance, strengthened management, information and logistics systems; better health financing and improvements in service quality.
USAID helps ensure proper blood safety procedures that can reduce the risk of HIV transmission from transfusions and contaminated needles. We do this by supporting education and behavior change among providers and patients, effective supply chain management, effective supply use by providers, improved distribution systems, improved supply forecasting ability, and enhanced waste management practices.
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USAID also helps to reduce the need for blood transfusions through better medical management and prevention of transfusion-causing conditions in our child survival, infectious disease and maternal health programs. While most of these programs are currently funded from of our non-HIV/AIDS child survival budget, they make substantial contributions to preventing HIV in medical settings. Two notable examples are the promotion of safe obstetrical delivery practices and combating malaria.
SAFE OBSTETRICAL DELIVERY PRACTICES
USAID promotes safe obstetrical delivery and care in its safe motherhood programs. For example, postpartum hemorrhage is a serious complication of childbirth that often requires blood transfusions. Our programs aim to reduce the need for transfusions by developing programs to prevent postpartum hemorrhage as well as protocols to manage hemorrhage appropriately when it occurs.
Also,USAID funded the Program for Appropriate Technology in Health to test the feasibility of putting the drug oxytocin in Uniject pre-filled, auto-disable injection devices. Oxytocin is a medication that effectively reduces bleeding following birth, the biggest cause of maternal deaths. The use of the Uniject device to deliver oxytocin would make this life-saving intervention even safer for patients and providers while decreasing the potential need for blood transfusion.
The USAID-funded Maternal and Neonatal Health Program works in 10 countries in Africa on infection prevention practices for safe motherhood and newborn health. These programs work at the national level on policies and standards which are then reflected in curricula for pre-service and in-service training of health care workers, preparation of training sites, the development of job aids and supportive supervision systems. In addition, we emphasize several key infection prevention behaviors: injection safety, universal precautions, hand-washing, avoiding of unnecessary medical procedures, proper sterilization of instruments, proper disposal of hazardous waste, and newborn umbilical cord care.
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USAID is also a partner in the White Ribbon Alliance, an international coalition that increases public awareness about the need to make pregnancy and childbirth safe for all women and newborns. The Alliance disseminates technical information on safe delivery practices, mobilizes communities, and calls attention to the needs of HIV positive mothers.
MALARIA
USAID has been committed to saving lives from malaria since the 1950s. The Agency works closely with national governments to build their capacity to prevent and treat the disease. USAID also invests in the discovery and development of new antimalarial drugs and malaria vaccines.
In addition to its ongoing malaria programs, the Agency also manages programs through the President's Malaria Initiative (PMI), a $1.2 billion, five-year initiative to control malaria in Africa announced by President Bush in June 2005. PMI is a collaborative U.S. Government effort led by USAID, in conjunction with the Department of Health and Human Services (Centers for Disease Control and Prevention), the Department of State, the White House, and others.
The goal of the Initiative is to reduce malaria deaths by half in 15 target countries in Africa by reaching 85 percent of the most vulnerable groups—children under 5 years of age and pregnant women—with proven and effective malaria prevention and treatment control measures. PMI supports control measures including insecticide-treated bed nets, spraying with insecticides in communities, lifesaving antimalarial drugs, and treatment to prevent women from getting malaria. Clearly, in reducing the toll of malaria by improved treatment and prevention of malarial infections, fewer transfusions will be required to save those severely infected.
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CONCLUSION
Directly strengthening blood supply systems ultimately can make safe blood available throughout Africa. In the meantime, efforts that strengthen overall health systems and prevent medical emergencies like postpartum hemorrhage and severe anemia from malaria are critical to reduce the burden on currently fragile blood supply systems.
I would like to assure the Committee that USAID, in partnership with HHS and the President's Emergency Plan for AIDS Relief, will continue to work to strengthen systems to improve the delivery of safe blood in Africa. Thank you again for inviting me to speak on this important topic and I am happy to take your questions.
Mr. SMITH. Thank you so very much. And now, Dr. Holmberg.
STATEMENT OF JERRY A. HOLMBERG, PH.D., SENIOR ADVISOR FOR BLOOD POLICY, OFFICE OF PUBLIC HEALTH AND SCIENCE, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Mr. HOLMBERG. Good afternoon, Mr. Chairman. I am Dr. Jerry Holmberg, Senior Advisor for Blood Policy and the Executive Secretary to the Advisory Committee on Blood Safety and Availability for the Department of Health and Human Services. Sitting behind me today is my colleague from the Center for Disease Control and Prevention, Dr. Matthew Kuehnert. I have asked Dr. Kuehnert to be present at the hearing to collaborate with me on some of the questions you may ask.
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In the healthcare setting, HIV, the hepatitis viruses, hepatitis B and C and the parasites that cause malaria are easily transmitted through exposure to blood caused by unsafe injections, poor infection control practices and contaminated blood yet at present fewer than 30 percent of countries worldwide have fully functional national blood services.
The problem is especially acute in Africa where an estimated 14 million blood units are needed while only 3.6 million units were collected for distribution in 39 countries in 2004. Screening in general remains a challenge in many resource constrained countries. One-third of the 90 million units of blood transfused worldwide in 2000 were not screened for one of the three most serious transfusion transmitted viruses, that being HIV, hepatitis B virus and hepatitis C virus.
In 2005, AIDS killed 3 million people, with 80 percent of these deaths in sub-Saharan Africa. In addition, there were almost 5 million new HIV infections worldwide, more than 11,000 new infections each day. Around the world the vast majority of these infections are sexually transmitted. Intravenous drug use and perinatal transmission also accounts for significant numbers of infections.
Although blood transfusion accounts for a minority of new infections in countries with generalized epidemics where most infections are the result of heterosexual contact, contaminated blood remains the most efficient method for transmitting HIV from one person to another. Transfusions are estimated as the cause of 5 percent of HIV infections in developing countries.
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Much of the worldwide viral hepatitis burden, which includes acute infections, chronic hepatitis, cirrhosis and liver cancer, is due to hepatitis B virus. Hepatitis B virus kills about 620,000 persons worldwide annually. Approximately 350 million persons, 5 percent of the world population, live with chronic hepatitis B virus infection, with the highest rates of transmission and chronic infection primarily in parts of Africa and Asia.
Young children who become infected with hepatitis B virus are more likely to develop chronic infection. The risk of death from hepatitis B virus related liver cancer or cirrhosis is approximately 25 percent for persons who become chronically infected during childhood.
While less common than hepatitis B virus as the cause of acute hepatitis, hepatitis C is estimated to have infected about 170 million people, some 3 percent of the world's population, 130 million of whom are chronic carriers. Disease prevalence is high in many countries in Africa, Latin America, Central and Southeastern Asia. In these countries, prevalence rates range from 5 to 10 percent.
Malaria causes 300 to 500 million acute illnesses annually, and kills as many as 1 million people, mostly children under the age of five. Almost half the world's population lives in areas where malaria is endemic. In Africa alone, malaria is responsible for an estimated 25 to 35 percent of all outpatient visits and 20 to 45 percent of all hospital admissions.
Although malaria can be transmitted by blood, mosquitos are the primary vector of infection. However, blood transfusions play a critical role in sustaining the lives of children suffering from malaria induced anemia. In severe cases these children require blood transfusions to survive, the transfusions that are frequently unavailable due to a lack of blood.
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HHS supports the development of a long-term, sustainable blood safety program in Africa and Asia through the Emergency Plan and other initiatives. The creation of a blood safety program requires that attention be paid to issues of sustainability. Strategies must ensure that each new service is supported by adequate infrastructure such as laboratories and reliable power, the staff is recruited, trained and retained, the laboratory equipment and reagents are appropriate and available, and that processing procedures are properly managed.
It is important to ensure that the blood safety strategies are not only comprehensive but integrated in or linked into other U.S. Government funded public health activities in a country. HHS works with its U.S. Government partners and with other international health organizations to ensure the programs funded through various mechanisms like the Emergency Plan, the Global Fund or private foundations do not duplicate efforts.
HHS and its agencies look forward to continuing its collaboration with U.S. and international partners to incrementally strengthen the current blood safety program as part of a diverse portfolio of global disease prevention strategies. Thank you for the opportunity to testify. I am happy to answer any questions.
[The prepared statement of Mr. Holmberg follows:]
PREPARED STATEMENT OF JERRY A. HOLMBERG, PH.D., SENIOR ADVISOR FOR BLOOD POLICY, OFFICE OF PUBLIC HEALTH AND SCIENCE, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Good morning, I am Dr. Jerry Holmberg, Senior Advisor for Blood Policy and Executive Secretary of the Advisory Committee on Blood Safety and Availability within the Office of Public Health and Science of the Department of Health and Human Services (HHS). I am pleased to be here today to discuss blood safety and transfusion-transmitted diseases, including HIV/AIDS, viral hepatitis, and malaria in Africa. I have over 35 years of experience, primarily in clinical laboratory science, and have been involved in the blood community since the early 1970s, and I take blood safety and the availability of blood products seriously.
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Sitting behind me today is my colleague from the Centers for Disease Control and Prevention (CDC), Dr. Matthew Kuehnert. Dr. Kuehnert is the Assistant Director for Blood Safety, Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention in Atlanta. I have asked Dr. Kuehnert to be present at this hearing to collaborate with me on questions you may ask.
Please permit me to state that in my official capacity, I participate internationally with the Global Collaboration for Blood Safety (GCBS). Recognition of the need for a GCBS was first endorsed by 41 countries represented during the Paris AIDS Summit in 1994 and adopted by the Forty-Eighth World Health Assembly (WHA) as WHA resolution 48.27 (1995), by all 191 World Health Organization (WHO) Member States in order to prioritize the need for global collaboration to improve blood safety. WHO is a participant of GCBS and also provides its secretariat.
The GCBS participants agree to collaborate in facilitating progress in the following areas:
international consensus on essential principles of global blood safety;
encouraging the recognition and establishment of national blood programs;
identifying priorities for the prevention of transfusion-related disease;
implementation of appropriate and recognized transfusion practices, which ensure donor and recipient safety and are free from discrimination;
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effective recruitment of safe donors through the use of appropriate selection criteria;
assuring quality and safety in the preparation of blood and blood products;
safe international practices for the collection, storage, and transport of plasma and the preparation and distribution of its derivatives;
the bi-directional traceability of blood products between donor and recipient whether in-country or across national borders; and
promote evidence-based use of blood and blood products
the exchange and use of information by encouraging data collection, management and dissemination.
The GCBS represents some of shared concerns that the Committee has in regards to improving blood safety and the medical infrastructure in Africa.
In my remarks today, I will be addressing the overall burden of disease of HIV/AIDS, viral hepatitis, and malaria in sub-Saharan Africa, and the role that unsafe blood transfusions play in the transmission of these diseases. I also will discuss the barriers and challenges related to implementing a long-term, sustainable blood safety program in the developing world, and will conclude by discussing some of the Department's efforts to improve blood safety and address the burden of disease in sub-Saharan Africa.
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HIV, VIRAL HEPATITIS, AND MALARIA IN SUB-SAHARAN AFRICA
In the health care setting, HIV, the hepatitis viruses (hepatitis B virus (HBV) and hepatitis C virus (HCV)), and the parasites that cause malaria are easily transmitted through exposures to blood caused by unsafe injections, poor infection control practices, and contaminated blood. Yet, at present fewer than 30% of countries worldwide have fully functioning national blood transfusion services. The problem is especially acute in Africa, where an estimated 14 million blood units are needed, while only 3.6 million units were collected for distribution in 39 countries in 2004.(see footnote 1) Improving access to safe blood in the developing world is a daunting challenge requiring development of sustainable infrastructure which is complex and resource- and time-intensive. I will address the barriers faced by many countries and the Department's response to them later in my testimony.
HIV/AIDS
Since 1981, AIDS has killed more than 25 million people, making it one of the most devastating epidemics in history. In 2005, AIDS killed three million people, with 80% of these deaths in sub-Saharan Africa. In addition, there were almost 5 million new HIV infections worldwide—more than 11,000 new infections every day—bringing the number of people living with HIV to more than 40 million (UNAIDS, 2005). Around the world, the vast majority of these infections are sexually transmitted. Intravenous drug use and perinatal transmission also account for significant numbers of infections. The cost in human lives lost is staggering. And there are important subsequent costs that accompany each new infection and each death. Persistent stigma and discrimination in much of the developing world mean infected people remain at risk of losing jobs, friends, and family support. AIDS has torn apart families, orphaned children, and put new stresses on developing economies. For example, countries with an HIV prevalence of 15%, as is the case in a number of sub-Saharan African countries, are estimated to lose 1% Gross Domestic Product (GDP) every year(see footnote 2)
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Although blood transfusions account for a minority of new infections in countries with generalized epidemics (where most new infections are the result of heterosexual contact), contaminated blood remains the most efficient method of transmitting HIV from one person to another. According to WHO, transfusions are estimated as the cause of 5% of HIV infections in developing countries.(see footnote 3) I must say that the prevalence may be higher since reporting, documentation, and investigation into causes of the HIV infection may be non-existent in these developing countries. Factors that contribute to transfusion-related transmission in sub-Saharan Africa and other parts of the developing world include: high rates of transfusion in some groups of patients (particularly women and children); a higher prevalence of HIV in the general and blood donor populations; inadequate HIV antibody screening in some countries; and a high residual risk of contamination in blood supplies despite antibody screenings.
Viral Hepatitis
Much of the worldwide viral hepatitis burden, which includes acute infections, chronic hepatitis, cirrhosis and liver cancer, is due to HBV. HBV kills about 620,000 persons worldwide annually. Approximately 350 million persons—5% of the world's population—live with chronic HBV infection, with the highest rates of transmission and chronic infection primarily in parts of Africa and Asia.
In sub-Saharan Africa, most of Asia, and the Pacific, most people become infected with HBV during childhood, and 8% to 10% of the general population is chronically infected. Young children who become infected with HBV are more likely to develop chronic infection. The risk of death from HBV-related liver cancer or cirrhosis is approximately 25% for persons who become chronically infected during childhood.
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While less common than HBV as a cause of acute hepatitis, HCV is estimated to have infected about 170 million people, some 3% of the world's population, 130 million of whom are chronic carriers, according to WHO. Disease prevalence is high in many countries in Africa, Latin America and Central and South-Eastern Asia. In these countries, prevalence rates range from 5% to 10% (WHO).
Screening in general remains a challenge in many resource constrained countries. According to WHO estimates based on country reports, one-third of the 90 million units of blood transfused worldwide in 2000 were not screened for one of the three most serious transfusion transmitted viruses, HIV, HBV and HCV.(see footnote 4) This gap in screening directly contributed to 78,000 HBV infections and more than half a million HCV infections.
In sub-Saharan Africa in 2000, more than 70% of blood donations were screened for HBV, but only about 10% were screened for HCV. The total number of infections attributed to unsafe blood donations was 30,000 for HBV and 52,000 for HCV, leading to 80 deaths from HBV infection and 440 deaths from HCV.
Although the overall proportion of new infections attributed to transfusion-transmitted HIV and viral hepatitis may be relatively low, because blood safety interventions are likely to be effective once they are implemented, they can be a potentially attractive preventive strategy. This, however, strongly depends on available resources and infrastructure for the interventions to be feasible.
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Malaria
Malaria causes 300–500 million acute illnesses annually and kills as many as 1 million people, mostly children under five years of age, according to WHO. Almost half of the world's population lives in areas where malaria is endemic. In Africa alone, malaria is responsible for an estimated 25% to 35% of all outpatient visits and 20% to 45% of all hospita1 admissions. The economic impact associated with lost work days due to malaria has been estimated to reduce the GDP of heavily burdened countries by between 1% and 4%. The cost of these losses may be as high as US$12 billion per year.
In the case of malaria, mosquitoes, not blood transfusions, are the primary vector of infection. However, blood transfusions play a critical role in sustaining the lives of children suffering from malaria-induced anemia. Anemic children lack sufficient red blood cells to carry oxygen to their organs. In severe cases, these children require blood transfusion to survive—transfusions that are frequently unavailable due to a lack of blood.
Screening donors for malaria has not been a priority activity in the African context because:
the overwhelming source of exposure to malaria in Africa is from infected mosquitoes rather than transfused blood;
screening tests are not sufficiently sensitive to effectively identify and defer donors to prevent them from transmitting infection; and
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many children receiving blood transfusions in this setting are already being treated for malaria as the underlying cause of their severe anemia.
in many countries where malaria has high prevalence, standard protocol is to treat all transfusion recipients for malaria.
Additionally, because of high rates of malaria among potential donors, screening would further diminish an already inadequate blood supply.
ISSUES RELATED TO BLOOD SAFETY IN DEVELOPING COUNTRIES
In the United States, the blood supply is considered very safe. The risks of infection with known blood-borne pathogens are low because of extensive donor exclusion guidelines, including laboratory screening. The medical transfusion community maintains continuously improved efforts to collect blood only from the safest donors and to screen all donated blood for blood-borne pathogens. The safety of the blood supply in the developing world, however, is markedly different than that in the United States.
Barriers to maintaining an adequate, safe blood supply in developing countries exist on many levels. In many sub-Saharan Africa countries, blood services are either non-existent or significantly under-resourced or lacking the infrastructure and capacity to ensure sustainable operations. Infrastructure challenges include problems with electricity to ensure the consistent refrigeration needed to store donated blood. Additionally, funding is frequently inadequate to purchase blood-banking equipment and test kits, especially in countries faced with extreme poverty, political instability, and armed conflict. Also, in these same countries, salaries and training for blood-banking and transfusion personnel may not be supported by the national budget.(see footnote 5) This is particularly true in countries lacking policies and legislation for blood safety. In addition, many hospitals do not have effective laboratories to ensure the complete screening of blood. In countries with a high prevalence of HIV, HBV, and HCV among blood donors, this risk is especially high. Consequently, an incremental and time-phased approach that establishes the political, medical, and logistical frameworks for transfusion services is recommended.
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