DIRECT-TO-CONSUMER GENETIC TESTING AND THE CONSEQUENCES TO THE PUBLIC HEALTH HEARING BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED ELEVENTH CONGRESS SECOND SESSION JULY 22, 2010 Serial No. 111–148 ( Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov U.S. GOVERNMENT PRINTING OFFICE 78–125 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 Mar 15 2010 04:56 Mar 28, 2013 Jkt 078125 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 E:\HR\OC\A125.XXX A125 tjames on DSK6SPTVN1PROD with HEARING COMMITTEE ON ENERGY AND COMMERCE HENRY A. WAXMAN, California, Chairman JOHN D. DINGELL, Michigan JOE BARTON, Texas Chairman Emeritus Ranking Member EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas RICK BOUCHER, Virginia FRED UPTON, Michigan FRANK PALLONE, JR., New Jersey CLIFF STEARNS, Florida BART GORDON, Tennessee NATHAN DEAL, Georgia BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky ANNA G. ESHOO, California JOHN SHIMKUS, Illinois BART STUPAK, Michigan JOHN B. SHADEGG, Arizona ELIOT L. ENGEL, New York ROY BLUNT, Missouri GENE GREEN, Texas STEVE BUYER, Indiana DIANA DEGETTE, Colorado GEORGE RADANOVICH, California Vice Chairman JOSEPH R. PITTS, Pennsylvania LOIS CAPPS, California MARY BONO MACK, California MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon JANE HARMAN, California LEE TERRY, Nebraska TOM ALLEN, Maine MIKE ROGERS, Michigan JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma JAY INSLEE, Washington TIM MURPHY, Pennsylvania TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee ANTHONY D. WEINER, New York PHIL GINGREY, Georgia JIM MATHESON, Utah STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina CHARLIE MELANCON, Louisiana JOHN BARROW, Georgia BARON P. HILL, Indiana DORIS O. MATSUI, California DONNA M. CHRISTENSEN, Virgin Islands KATHY CASTOR, Florida JOHN P. SARBANES, Maryland CHRISTOPHER S. MURPHY, Connecticut ZACHARY T. SPACE, Ohio JERRY MCNERNEY, California BETTY SUTTON, Ohio BRUCE L. BRALEY, Iowa PETER WELCH, Vermont (II) VerDate Mar 15 2010 04:56 Mar 28, 2013 Jkt 078125 PO 00000 Frm 00002 Fmt 5904 Sfmt 5904 E:\HR\OC\A125.XXX A125 tjames on DSK6SPTVN1PROD with HEARING SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS BART STUPAK, Michigan, Chairman BRUCE L. BRALEY, Iowa GREG WALDEN, Oregon Vice Chairman Ranking Member EDWARD J. MARKEY, Massachusetts ED WHITFIELD, Kentucky DIANA DEGETTE, Colorado MIKE FERGUSON, New Jersey MIKE DOYLE, Pennsylvania TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois MICHAEL C. BURGESS, Texas MIKE ROSS, Arkansas DONNA M. CHRISTENSEN, Virgin Islands PETER WELCH, Vermont GENE GREEN, Texas BETTY SUTTON, Ohio JOHN D. DINGELL, Michigan (ex officio) (III) VerDate Mar 15 2010 04:56 Mar 28, 2013 Jkt 078125 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 E:\HR\OC\A125.XXX A125 tjames on DSK6SPTVN1PROD with HEARING VerDate Mar 15 2010 04:56 Mar 28, 2013 Jkt 078125 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 E:\HR\OC\A125.XXX A125 tjames on DSK6SPTVN1PROD with HEARING C O N T E N T S Page Hon. Bart Stupak, a Representative in Congress from the State of Michigan, opening statement ................................................................................................ 1 Prepared statement .......................................................................................... 4 Hon. Michael C. Burgess, a Representative in Congress from the State of Texas, opening statement .................................................................................... 10 Prepared statement .......................................................................................... 12 Hon. Henry A. Waxman, a Representative in Congress from the State of California, opening statement ............................................................................. 19 Prepared statement .......................................................................................... 21 Hon. Parker Griffith, a Representative in Congress from the State of Ala- bama, opening statement .................................................................................... 24 Hon. Diana DeGette, a Representative in Congress from the State of Colo- rado, opening statement ...................................................................................... 25 Hon. Robert E. Latta, a Representative in Congress from the State of Ohio, opening statement ................................................................................................ 26 Prepared statement .......................................................................................... 27 Hon. Donna M. Christensen, a Representative in Congress from the Virgin Islands, opening statement ................................................................................. 30 Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, opening statement ................................................................................................ 30 Hon. Joe Barton, a Representative in Congress from the State of Texas, prepared statement .............................................................................................. 180 WITNESSES Gregory Kutz, Managing Director, Forensic Audits and Special Investigations, Government Accountability Office ...................................................................... 32 Prepared statement .......................................................................................... 35 Answers to submitted questions ...................................................................... 183 Jeffrey Shuren, M.D., Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration ................................................................... 68 Prepared statement .......................................................................................... 70 James Evans, Editor-in-Chief, Genetics in Medicine, Bryson Professor of Ge- netics and Medicine, University of North Carolina at Chapel Hill ................. 100 Prepared statement .......................................................................................... 103 Answers to submitted questions ...................................................................... 187 Ashley Gould, General Counsel, 23andMe ............................................................ 107 Prepared statement .......................................................................................... 109 Answers to submitted questions ...................................................................... 191 Vance Vanier, President and CEO, Navigenics, Inc. ............................................ 142 Prepared statement .......................................................................................... 144 Answers to submitted questions ...................................................................... 211 David Becker, Chief Scientific Officer, Pathway Genomics Corporation ............ 150 Prepared statement .......................................................................................... 152 Answers to submitted questions ...................................................................... 217 (V) VerDate Mar 15 2010 04:56 Mar 28, 2013 Jkt 078125 PO 00000 Frm 00005 Fmt 5904 Sfmt 5904 E:\HR\OC\A125.XXX A125 tjames on DSK6SPTVN1PROD with HEARING VerDate Mar 15 2010 04:56 Mar 28, 2013 Jkt 078125 PO 00000 Frm 00006 Fmt 5904 Sfmt 5904 E:\HR\OC\A125.XXX A125 tjames on DSK6SPTVN1PROD with HEARING DIRECT-TO-CONSUMER GENETIC TESTING AND THE CONSEQUENCES TO THE PUBLIC HEALTH THURSDAY, JUNE 22, 2010 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. The subcommittee met, pursuant to call, at 9:34 a.m., in Room 2123, Rayburn House Office Building, Hon. Bart Stupak [chairman of the subcommittee] presiding. Present: Representatives Stupak, DeGette, Christensen, Waxman (ex officio), Burgess, Gingrey, Griffith, and Latta. Staff Present: Phil Barnett, Staff Director; Bruce Wolpe, Senior Advisor; Stephen Cha, Professional Staff Member; Eric Flamm, FDA Detailee; Dave Leviss, Chief Oversight Counsel; Meredith Fuchs, Chief Investigative Counsel; Tiffany Benjamin, Counsel; Erika Smith, Professional Staff Member; Ali Neubauer, Special As- sistant; Derrick Franklin, HHS Detailee; Karen Lightfoot, Commu- nications Director, Senior Policy Advisor; Elizabeth Letter, Special Assistant; Alan Slobodin, Minority Counsel; Melissa Bartlet, Minor- ity Counsel; Robert Frisbee, Minority Detailee; and Garrett Golding, Minority Legislative Analyst. OPENING STATEMENT OF HON. BART STUPAK, A REPRESENT- ATIVE IN CONGRESS FROM THE STATE OF MICHIGAN Mr. STUPAK. This meeting will come to order. Today we have a hearing entitled, ‘‘Direct-to-Consumer Genetic Testing and the Consequences to the Public Health.’’ The chairman, ranking member, and chairman emeritus will be recognized for a 5-minute opening statement. Other members of the subcommittee will be recognized for a 3-minute opening state- ment. I will begin. ‘‘Genetic testing can effect how well some drugs work for you or whether they work at all.’’ ‘‘Learn if you have a propensity for obe- sity, cancers, diabetes, and more.’’