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Addressing the Neglected Diseases Treatment Gap

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Addressing the Neglected Diseases Treatment Gap ADDRESSING THE NEGLECTED DISEASES TREATMENT GAP HEARING BEFORE THE SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS OF THE COMMITTEE ON FOREIGN AFFAIRS HOUSE OF REPRESENTATIVES ONE HUNDRED THIRTEENTH CONGRESS FIRST SESSION JUNE 27, 2013 Serial No. 113–76 Printed for the use of the Committee on Foreign Affairs ( Available via the World Wide Web: http://www.foreignaffairs.house.gov/ or http://www.gpo.gov/fdsys/ U.S. GOVERNMENT PRINTING OFFICE 81–698PDF WASHINGTON : 2013 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001 VerDate 0ct 09 2002 14:15 Nov 07, 2013 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 F:\WORK\_AGH\062713\81698 HFA PsN: SHIRL COMMITTEE ON FOREIGN AFFAIRS EDWARD R. ROYCE, California, Chairman CHRISTOPHER H. SMITH, New Jersey ELIOT L. ENGEL, New York ILEANA ROS-LEHTINEN, Florida ENI F.H. FALEOMAVAEGA, American DANA ROHRABACHER, California Samoa STEVE CHABOT, Ohio BRAD SHERMAN, California JOE WILSON, South Carolina GREGORY W. MEEKS, New York MICHAEL T. MCCAUL, Texas ALBIO SIRES, New Jersey TED POE, Texas GERALD E. CONNOLLY, Virginia MATT SALMON, Arizona THEODORE E. DEUTCH, Florida TOM MARINO, Pennsylvania BRIAN HIGGINS, New York JEFF DUNCAN, South Carolina KAREN BASS, California ADAM KINZINGER, Illinois WILLIAM KEATING, Massachusetts MO BROOKS, Alabama DAVID CICILLINE, Rhode Island TOM COTTON, Arkansas ALAN GRAYSON, Florida PAUL COOK, California JUAN VARGAS, California GEORGE HOLDING, North Carolina BRADLEY S. SCHNEIDER, Illinois RANDY K. WEBER SR., Texas JOSEPH P. KENNEDY III, Massachusetts SCOTT PERRY, Pennsylvania AMI BERA, California STEVE STOCKMAN, Texas ALAN S. LOWENTHAL, California RON DESANTIS, Florida GRACE MENG, New York TREY RADEL, Florida LOIS FRANKEL, Florida DOUG COLLINS, Georgia TULSI GABBARD, Hawaii MARK MEADOWS, North Carolina JOAQUIN CASTRO, Texas TED S. YOHO, Florida LUKE MESSER, Indiana AMY PORTER, Chief of Staff THOMAS SHEEHY, Staff Director JASON STEINBAUM, Democratic Staff Director SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS CHRISTOPHER H. SMITH, New Jersey, Chairman TOM MARINO, Pennsylvania KAREN BASS, California RANDY K. WEBER SR., Texas DAVID CICILLINE, Rhode Island STEVE STOCKMAN, Texas AMI BERA, California MARK MEADOWS, North Carolina (II) VerDate 0ct 09 2002 14:15 Nov 07, 2013 Jkt 000000 PO 00000 Frm 00002 Fmt 5904 Sfmt 5904 F:\WORK\_AGH\062713\81698 HFA PsN: SHIRL C O N T E N T S Page WITNESSES Lee Hall, M.D., Ph.D., chief, Parasitology and International Programs Branch, Division of Microbiology and Infectious Diseases, National Institute of Al- lergy and Infectious Diseases, National Institutes of Health, U.S. Depart- ment of Health and Human Services ................................................................. 5 Jesse Goodman, M.D., chief scientist, Food and Drug Administration, U.S. Department of Health and Human Services ...................................................... 21 Peter J. Hotez, M.D., Ph.D., president, Sabin Vaccine Institute ......................... 52 Jay Siegel, M.D., chief biotechnology officer and head of scientific strategy and policy, Johnson & Johnson ........................................................................... 69 Alix Zwane, Ph.D., executive director, Evidence Action ....................................... 84 LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING Lee Hall, M.D., Ph.D.: Prepared statement ........................................................... 8 Jesse Goodman, M.D.: Prepared statement ........................................................... 24 Peter J. Hotez, M.D., Ph.D.: Prepared statement ................................................. 58 Jay Siegel, M.D.: Prepared statement ................................................................... 72 Alix Zwane, Ph.D.: Prepared statement ................................................................ 87 APPENDIX Hearing notice .......................................................................................................... 100 Hearing minutes ...................................................................................................... 101 Written response from NIAID to question submitted for the record by the Honorable Christopher H. Smith, a Representative in Congress from the State of New Jersey, and chairman, Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations ................................. 102 (III) VerDate 0ct 09 2002 14:15 Nov 07, 2013 Jkt 000000 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 F:\WORK\_AGH\062713\81698 HFA PsN: SHIRL VerDate 0ct 09 2002 14:15 Nov 07, 2013 Jkt 000000 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 F:\WORK\_AGH\062713\81698 HFA PsN: SHIRL ADDRESSING THE NEGLECTED DISEASES TREATMENT GAP THURSDAY, JUNE 27, 2013 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS, COMMITTEE ON FOREIGN AFFAIRS, Washington, DC. The subcommittee met, pursuant to notice, at 2:06 p.m., in room 2200, Rayburn House Office Building, Hon. Christopher H. Smith (chairman of the subcommittee) presiding. Mr. SMITH. Good afternoon. Today’s hearing will examine the neglected diseases that affect a relatively small but a significant number of children around the world. These diseases are not only debilitating for their victims but far too often fatal when untreated. Such diseases largely impact poor people in poor countries. They are not only small in numbers but those folks who are un- able to pay market prices for treatments and are unlikely to lead the social movements to force action on their respective diseases. That means that research on detection, vaccines, and drug treat- ment for their ailments do not receive the priority that diseases such as HIV/AIDS, often seen in pandemic levels, are given. The World Health Organization has identified 17 neglected trop- ical diseases, or NTDs. The list ranges from Chagas to rabies to leprosy to dengue fever. However, there are others not on the list of 17 diseases that also receive less attention. These include such diseases as polio and smallpox, which have largely been eliminated from the planet, and fatal, fortunately rare NTDs such as kuru and Ebola. I would note parenthetically, back in the early 1980s, when I au- thored what was known as the Child Survival Reauthorization Amendment for some $50 million, I traveled to El Salvador, and the polio vaccine was given to upwards of 200,000 children, along with other immunizations to guard against pertussis, diphtheria, and other leading killers of children. Thankfully, some of those dis- eases are largely gone, but some, sadly, are making a comeback. I would also point out that we have had hearings in this sub- committee and I have introduced legislation to focus on another problem, particularly in Africa, of the infection-based hydrocephalic condition that is hurting so many children in places like Uganda. I actually went to CURE International’s clinic in Uganda and saw children who got the treatment. Dr. Benjamin Warf has devel- (1) VerDate 0ct 09 2002 14:15 Nov 07, 2013 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 F:\WORK\_AGH\062713\81698 HFA PsN: SHIRL 2 oped it out of Harvard. There are no shunts involved, and these kids went from very large painful conditions in their head, water on the brain, to very healthy children. And at least 5,000 kids have been saved there. We have been asking, urging, begging practically, that USAID do something administratively to try to address that issue. This hearing will consider the current U.S. Government’s han- dling of these and other neglected diseases to determine what more can be done or should be done to address this situation. Current U.S. law favors research on those diseases threatening the Amer- ican homeland, but in today’s world diseases can cross borders as easily as those affected by them or the products imported from the United States. For example, Chagas is most prevalent in Latin America, but it has been identified in patients in Texas. And cases of dengue fever have recently been reported in Florida. We cannot afford to assume that what may have seemed to be an exotic disease only happens to people in other countries. Ten years ago, West Nile virus, another NTD, was not seen in the United States or anywhere else outside of the East African na- tion of Uganda, but in less than a decade it has spread across the country and much of the rest of the world. Last year, 286 people died from West Nile virus in the United States alone. As recently as the mid-1990s, this disease was seen only sporadically and was considered a minor risk for human beings. Generally, NTDs affect the health of the poor in developing coun- tries where access to clean water, sanitation, and health care is limited. Roughly 2 billion people are being treated for at least one NTD, although most individuals are infected with several NTDs at once. Several NTDs are difficult to control by drug treatment alone be- cause of their complicated transition cycles that involve nonhuman carriers, such as insects. Furthermore, some of the drugs have sig- nificant side effects, including death, and cannot be used by young children or pregnant women. A study done in 2001 found that research and development of drugs to treat infectious diseases had ground to a near standstill. From
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