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Global Challenges in Diagnosing and Managing Lyme Disease—Closing Knowledge Gaps Hearing Committee on Foreign Affairs House Of GLOBAL CHALLENGES IN DIAGNOSING AND MANAGING LYME DISEASE—CLOSING KNOWLEDGE GAPS HEARING BEFORE THE SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, AND HUMAN RIGHTS OF THE COMMITTEE ON FOREIGN AFFAIRS HOUSE OF REPRESENTATIVES ONE HUNDRED TWELFTH CONGRESS SECOND SESSION JULY 17, 2012 Serial No. 112–169 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 75–161PDF WASHINGTON : 2012 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 09:45 Oct 01, 2012 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 Y:\WORK\AGH\071712\75161 HFA PsN: SHIRL COMMITTEE ON FOREIGN AFFAIRS ILEANA ROS-LEHTINEN, Florida, Chairman CHRISTOPHER H. SMITH, New Jersey HOWARD L. BERMAN, California DAN BURTON, Indiana GARY L. ACKERMAN, New York ELTON GALLEGLY, California ENI F.H. FALEOMAVAEGA, American DANA ROHRABACHER, California Samoa DONALD A. MANZULLO, Illinois BRAD SHERMAN, California EDWARD R. ROYCE, California ELIOT L. ENGEL, New York STEVE CHABOT, Ohio GREGORY W. MEEKS, New York RON PAUL, Texas RUSS CARNAHAN, Missouri MIKE PENCE, Indiana ALBIO SIRES, New Jersey JOE WILSON, South Carolina GERALD E. CONNOLLY, Virginia CONNIE MACK, Florida THEODORE E. DEUTCH, Florida JEFF FORTENBERRY, Nebraska DENNIS CARDOZA, California MICHAEL T. MCCAUL, Texas BEN CHANDLER, Kentucky TED POE, Texas BRIAN HIGGINS, New York GUS M. BILIRAKIS, Florida ALLYSON SCHWARTZ, Pennsylvania JEAN SCHMIDT, Ohio CHRISTOPHER S. MURPHY, Connecticut BILL JOHNSON, Ohio FREDERICA WILSON, Florida DAVID RIVERA, Florida KAREN BASS, California MIKE KELLY, Pennsylvania WILLIAM KEATING, Massachusetts TIM GRIFFIN, Arkansas DAVID CICILLINE, Rhode Island TOM MARINO, Pennsylvania JEFF DUNCAN, South Carolina ANN MARIE BUERKLE, New York RENEE ELLMERS, North Carolina ROBERT TURNER, New York YLEEM D.S. POBLETE, Staff Director RICHARD J. KESSLER, Democratic Staff Director SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, AND HUMAN RIGHTS CHRISTOPHER H. SMITH, New Jersey, Chairman JEFF FORTENBERRY, Nebraska KAREN BASS, California TOM MARINO, Pennsylvania RUSS CARNAHAN, Missouri ANN MARIE BUERKLE, New York THEODORE E. DEUTCH, Florida ROBERT TURNER, New York (II) VerDate 0ct 09 2002 09:45 Oct 01, 2012 Jkt 000000 PO 00000 Frm 00002 Fmt 5904 Sfmt 5904 Y:\WORK\AGH\071712\75161 HFA PsN: SHIRL C O N T E N T S Page WITNESSES Stephen W. Barthold, Ph.D., distinguished professor, Department of Pathol- ogy, Microbiology and Immunology, Center of Comparative Medicine, School of Veterinary Medicine, University of California, Davis ................................... 8 Raphael Stricker, M.D., vice president, International Lyme and Associated Diseases Society ................................................................................................... 24 Mark Eshoo, Ph.D., director, New Technology Development, Abbott ................. 46 Ms. Patricia Smith, president, Lyme Disease Association ................................... 54 Mr. Evan White, Lyme disease patient ................................................................. 76 Ms. Stella Huyshe-Shires, chair, Lyme Disease Action ........................................ 83 LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING Stephen W. Barthold, Ph.D.: Prepared statement ................................................ 10 Raphael Stricker, M.D.: Prepared statement ........................................................ 26 Mark Eshoo, Ph.D.: Prepared statement ............................................................... 49 Ms. Patricia Smith: Prepared statement ............................................................... 57 Mr. Evan White: Prepared statement .................................................................... 79 Ms. Stella Huyshe-Shires, chair, Lyme Disease Action ........................................ 86 APPENDIX Hearing notice .......................................................................................................... 104 Hearing minutes ...................................................................................................... 105 The Honorable Christopher H. Smith, a Representative in Congress from the State of New Jersey, and chairman, Subcommittee on Africa, Global Health, and Human Rights: Statement from the Infectious Diseases Soceity of America ............................................................................................................. 106 (III) VerDate 0ct 09 2002 09:45 Oct 01, 2012 Jkt 000000 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 Y:\WORK\AGH\071712\75161 HFA PsN: SHIRL VerDate 0ct 09 2002 09:45 Oct 01, 2012 Jkt 000000 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 Y:\WORK\AGH\071712\75161 HFA PsN: SHIRL GLOBAL CHALLENGES IN DIAGNOSING AND MANAGING LYME DISEASE—CLOSING KNOWLEDGE GAPS TUESDAY, JULY 17, 2012 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, AND HUMAN RIGHTS, COMMITTEE ON FOREIGN AFFAIRS, Washington, DC. The subcommittee met, pursuant to notice, at 2:07 p.m., in room 2172, Rayburn House Office Building, Hon. Christopher H. Smith (chairman of the subcommittee) presiding. Mr. SMITH OF NEW JERSEY. The hearing will come to order. Good afternoon, and welcome to our witnesses and to everyone who is joining us for this first ever congressional hearing examining the global challenges in diagnosing, treating, and managing Lyme dis- ease. My personal commitment to combating Lyme disease is long- standing, going back 20 years, when one of our witnesses, Pat Smith, attended one of my town hall meetings in Wall Township, New Jersey, and asked me to get involved. I did. On September 28, 1993, I offered an amendment to establish a Lyme disease program through the Environmental Hygiene Agency of the U.S. Depart- ment of the Army. It passed and became law. On May 5, 1998, I introduced a comprehensive, bipartisan Lyme disease bill, H.R. 3795, the Lyme Disease Initiative Act of 1998, which had at its core the establishment of a task force, an advisory committee to comprehensively investigate Lyme with at least four major areas in mind: Protection, improved surveillance and report- ing, accurate diagnosis, and physician knowledge. I reintroduced the bill again in 1999, 2001, 2004, 2005, 2007, 2009, and have a pending bill that I introduced in 2011. I would note parenthetically that in 1998 I also introduced a comprehensive law to combat autism despite significant opposition in the Congress and at NIH and CDC that closely paralleled the Lyme bill’s struggle. That became law in 2000. Last year, I au- thored the Combating Autism Reauthorization Act of 2011, which was signed into law in the fall with the support of—not opposition, but the support of NIH and CDC. If only we had done the same with Lyme disease legislation in the late 1990s; there has been a missed decade on Lyme. As I have met scores of patients suffering the devastating effects of chronic Lyme who only got well after aggressive treatment by (1) VerDate 0ct 09 2002 09:45 Oct 01, 2012 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 Y:\WORK\AGH\071712\75161 HFA PsN: SHIRL 2 Lyme-literate physicians, I have been dismayed and, frankly, an- gered by the unwillingness of some to take a fresh, comprehensive look at this insidious disease. My current bill, H.R. 2557, simply es- tablishes a Tick-Borne Disease Advisory Committee, like we have been trying to do since 1998, with the requirement of ensuring di- versity of valid scientific opinion, a ‘‘broad spectrum of viewpoints’’ to pull language out of the legislation, serving on the committee. I would note to my colleagues that in Europe, Lyme disease syn- dromes were described as early as 1883, and by the mid-1930s, neurologic manifestations and the association with ticks were rec- ognized. In the United States, Lyme disease was not recognized until the early 1970s, when a statistically improbable cluster of pe- diatric arthritis occurred in the region around Lyme, Connecticut. This outbreak was investigated by Dr. Allen Steere and others from Yale and stimulated intense clinical and epidemiologic re- search. In 1981, Dr. Willy Burgdorfer, an NIH researcher at the Rocky Mountain Laboratories, identified the spiral-shaped bacteria, or spirochetes, causing Lyme disease and made the connection to the deer or black-legged tick. Lyme disease is the most common vector-borne illness in the United States and is also endemic in parts of Europe and Asia and recently has been confirmed to be endemic in the Amazon region of Brazil. In Europe, the highest rates are in Eastern and Central Europe. Recent surveillance studies have described growing prob- lems in Australia and Canada. In the United States, Lyme disease has been reported in 49 States—all except Hawaii—and is most common in the north- eastern and north-central States and in northern California into Oregon. Over 30,000 confirmed cases were reported to the CDC in 2010, making it the sixth most common reportable disease in the U.S. and the second most reportable in the Northeast. CDC has es- timated that actual new cases may be 10 times more than the re- ported number, indicating roughly 300,000 cases in 2010 alone. About 85,000 cases are reported annually in Europe as of 2006, ac- cording to the WHO, but that was recognized as a gross underesti- mate. In North America, the only Borrelia species to cause Lyme dis- ease is Borrelia
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