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Ephedra: Who Is Protecting the American Consumers?

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Ephedra: Who Is Protecting the American Consumers? S. Hrg. 107–870 EPHEDRA: WHO IS PROTECTING THE AMERICAN CONSUMERS? HEARING BEFORE THE OVERSIGHT OF GOVERNMENT MANAGEMENT, RESTRUCTURING, AND THE DISTRICT OF COLUMBIA SUBCOMMITTEE OF THE COMMITTEE ON GOVERNMENTAL AFFAIRS UNITED STATES SENATE ONE HUNDRED SEVENTH CONGRESS SECOND SESSION OCTOBER 8, 2002 Printed for the use of the Committee on Governmental Affairs ( U.S. GOVERNMENT PRINTING OFFICE 83–482 PDF WASHINGTON : 2003 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) 512–2250 Mail: Stop SSOP, Washington, DC 20402–0001 VerDate 11-MAY-2000 15:05 Apr 14, 2003 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 83482.TXT SAFFAIRS PsN: SAFFAIRS COMMITTEE ON GOVERNMENTAL AFFAIRS JOSEPH I. LIEBERMAN, Connecticut, Chairman CARL LEVIN, Michigan FRED THOMPSON, Tennessee DANIEL K. AKAKA, Hawaii TED STEVENS, Alaska RICHARD J. DURBIN, Illinois SUSAN M. COLLINS, Maine ROBERT G. TORRICELLI, New Jersey GEORGE V. VOINOVICH, Ohio MAX CLELAND, Georgia THAD COCHRAN, Mississippi THOMAS R. CARPER, Delaware ROBERT F. BENNETT, Utah JEAN CARNAHAN, Missouri JIM BUNNING, Kentucky MARK DAYTON, Minnesota PETER G. FITZGERALD, Illinois JOYCE A. RECHTSCHAFFEN, Staff Director and Counsel RICHARD A. HERTLING, Minority Staff Director DARLA D. CASSELL, Chief Clerk OVERSIGHT OF GOVERNMENT MANAGEMENT, RESTRUCTURING, AND THE DISTRICT OF COLUMBIA SUBCOMMITTEE RICHARD J. DURBIN, Illinois, Chairman DANIEL K. AKAKA, Hawaii GEORGE V. VOINOVICH, Ohio ROBERT G. TORRICELLI, New Jersey TED STEVENS, Alaska THOMAS R. CARPER, Delaware SUSAN M. COLLINS, Maine JEAN CARNAHAN, Missouri THAD COCHRAN, Mississippi MARK DAYTON, Minnesota PETER G. FITZGERALD, Illinois MARIANNE CLIFFORD UPTON, Staff Director and Chief Counsel ANDREW RICHARDSON, Minority Staff Director ANNE MARIE MURPHY, PH.D., Senator Durbin’s Staff BRIAN MCLAUGHLIN, Staff Assistant (II) VerDate 11-MAY-2000 15:05 Apr 14, 2003 Jkt 000000 PO 00000 Frm 00002 Fmt 5904 Sfmt 5904 83482.TXT SAFFAIRS PsN: SAFFAIRS C O N T E N T S Opening statement: Page Senator Durbin ................................................................................................. 1 WITNESSES TUESDAY, OCTOBER 8, 2002 Kevin Riggins, Lincoln, Illinois .............................................................................. 4 Debbie Riggins, Lincoln, Illinois ............................................................................. 6 Charles Fricke, Logan County Coroner, Lincoln, Illinois ..................................... 7 Lanny J. Davis, Esq., Counsel on behalf of David W. Brown, President and Chief Executive Officer, Metabolife International, Inc., San Diego, Cali- fornia ..................................................................................................................... 15 J. Howard Beales, III, Ph.D., Director, Bureau of Consumer Protection, Fed- eral Trade Commission ........................................................................................ 18 Bill Jeffery, L.LB., National Coordinator, Centre for Science in the Public Interest (CSPI), Carleton University, Ottawa, Ontario, Canada ..................... 19 Ronald M. Davis, M.D., Board of Trustees, American Medical Association, Chicago, Illinois .................................................................................................... 21 Sidney M. Wolfe, M.D., Director, Public Health Citizen Health Research Group, Washington, DC ....................................................................................... 23 Frank D. Uryasz, President, National Center for Drug Free Sport, Kansas City, Missouri on behalf of the National Collegiate Athletic Association ....... 26 Lester M. Crawford, D.V.M., Ph.D., Acting Commissioner, Food and Drug Administration, U.S. Department of Health and Human Services ................. 39 ALPHABETICAL LIST OF WITNESSES Beales, J. Howard, III, Ph.D.: Testimony .......................................................................................................... 18 Prepared statement .......................................................................................... 79 Crawford, Lester M., D.V.M., Ph.D.: Testimony .......................................................................................................... 39 Prepared statement .......................................................................................... 116 Davis, Lanny J., Esq.: Testimony .......................................................................................................... 15 Prepared statement of David W. Brown with attachments submitted by Mr. Lanny Davis ........................................................................................... 159 Davis, Ronald M., M.D.: Testimony .......................................................................................................... 21 Prepared statement .......................................................................................... 96 Fricke, Charles: Testimony .......................................................................................................... 7 Prepared statement .......................................................................................... 56 Jeffery, Bill, L.LB.: Testimony .......................................................................................................... 19 Prepared statement .......................................................................................... 91 Riggins, Debbie: Testimony .......................................................................................................... 6 Prepared statement .......................................................................................... 55 Riggins, Kevin: Testimony .......................................................................................................... 4 Prepared statement .......................................................................................... 53 Uryasz, Frank D.: Testimony .......................................................................................................... 26 Prepared statement .......................................................................................... 112 (III) VerDate 11-MAY-2000 15:05 Apr 14, 2003 Jkt 000000 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 83482.TXT SAFFAIRS PsN: SAFFAIRS IV Page Wolfe, Sidney M., M.D.: Testimony .......................................................................................................... 23 Prepared statement .......................................................................................... 104 APPENDIX Congresswoman Susan Davis, from the State of California, prepared state- ment ...................................................................................................................... 141 Letter dated October 1, 2002 from Robert G. Peterson, M.D., Ph.D., M.P.H., Director General, Health Canada, with attachments ....................................... 144 Questions and responses from Mr. Lanny Davis .................................................. 166 Questions and responses from Mr. Crawford ........................................................ 172 Questions and responses from Ullman, Shapiro & Ullman, LLP, New York, NY, for Robert Occhifinto of NVE Pharmaceuticals, the manufacturer of Yellow Jackets, with an attachment .................................................................. 177 VerDate 11-MAY-2000 15:05 Apr 14, 2003 Jkt 000000 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 83482.TXT SAFFAIRS PsN: SAFFAIRS EPHEDRA: WHO IS PROTECTING THE AMERICAN CONSUMERS? TUESDAY, OCTOBER 8, 2002 U.S. SENATE, OVERSIGHT OF GOVERNMENT MANAGEMENT, RESTRUCTURING, AND THE DISTRICT OF COLUMBIA SUBCOMMITTEE, OF THE COMMITTEE ON GOVERNMENTAL AFFAIRS, Washington, DC. The Subcommittee met, pursuant to notice, at 10 a.m., in room SD–342, Dirksen Senate Office Building, Hon. Richard Durbin, Chairman of the Subcommittee, presiding. Present: Senator Durbin. OPENING STATEMENT OF SENATOR DURBIN Senator DURBIN. Good morning. This hearing will come to order. I am pleased to welcome you to today’s hearing before the Senate Subcommittee on Oversight of Government Management, Restruc- turing, and the District of Columbia, focusing on ‘‘Ephedra: Who is Protecting the American Consumer?’’ Dietary supplements are safely consumed by millions of Ameri- cans every day. I, myself, take a variety of supplements, multi-vita- mins, folic acid, all the things that I think are going to make me live forever. I hope they do. For the vast majority of dietary supple- ments, there are few reports of harm. For some, there is strong sci- entific evidence that they provide a health benefit. However, that is not the case for the supplement ephedra, which is the focus of this hearing. The Food and Drug Administration re- ported that in the year 2001, 42 percent of the total number of ad- verse event reports, known as AERs, received for all dietary sup- plements by the agency were for one supplement, ephedra. In some years, such as 1996, the percentage was as high as 70 percent, as this chart indicates. Particularly alarming was the fact that many of these ephedra adverse events were suffered by young people. The HHS Inspector General noted that 60 percent of the alleged injured parties by ephedra were under the age of 40. Furthermore, if you look at some of the most serious adverse events reported to the FDA for dietary supplements, you find that ephedra is disproportionately rep- resented,
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