" DOCUMENT RESUME ED 245 148 CG 017 518 TITLE Safety and Efficacy of Over-the-Counter Drug Use by the Elderly. Hearing before the Subcommittee on Health and Long-Term Care of the Select Committee on Aging. House of Representatives, Ninety-Eighth Congress, First Session. INSTITUTION Congress of the U.S., Washington, D.C. House Select Committee on Aging. REPORT NO House-Comm-Pub-98-409 PUB DATE 21 Jul 83 NOTE 507p.; Some pages are marginally legible due to small print. PUB TYPE Legal/Legislative/Regulatory Materials (090) EDRS PRICE MF02 Plus Postage. PC Not Available from EDRS. DESCRIPTORS *Consumer Protection; Dietetics; Drug Legislation; *Drug Use; Gerontology; Hearings; *Older Adults; Physical Health; *Safety IDENTIFIERS Congress 98th; Long Term Care; *Nonprescription Drugs; *PPA ABSTRACT This document contains the prepared statements and panel testimony from the Congressional hearing on over-the-counter (OTC) drug use by the elderly. Opening statements are given by Representatives Claude Pepper (chairman), Ralph Regula, Mary Rose Oakar, Michael Bilirakis, Tom Lantos, and Hal Daub. Topics which are covered include the incidence and quantity of drug use by the elderly, health risks, adverse reactions, phenylpropanolamine (PPA), consumer protection, and the Federal Drug Administration's (FDA) role in the OTC drug safety and reguIatiem. Testimony of the first panel on OTC drugs, particularly weight reduction medications containing PPA, is given by representatives of the Health Research Group, the National Broadcasting Company, and consumers. Testimony of the second panel on mail fraud schemes perpetrated against senior citizens is given by consumer advocates representing the United States Postal Service, Criminal Investigations and Consumer Protection Divisions, and the Center for Science in the Public Interest. Testimony of the third panel on evaluating the safety and efficacy of various drugs including PPA is given by medical experts from Georgetown, Indiana, Johns Hopkins, and George Washington Universities. Testimony of the fourth and final panel on the safety and efficacy of PPA is given by industry officials from the Thompson Medical Company, Inc., representing the fields of pharmacy, cardiology, sociology, psychology, and medicine. The three appendices contain additional material on medication use/abuse among the Pinellas County, Florida elderly, the FDA list of adverse drug reactions to PPA, the Washington State Board of Pharmacy review of OTC drugs, and prepared statements of panel representatives (BL) *********************************************************************** * Reproductions supplied by EDRS are the best that can be made * * from the original document. * *********************************************************************** SAFETY AND EFFICACY OF OVER-THE-COUNTER co DRUG USE BY THE ELDERLY 4" (NJ HEARING BEFORE THE SUBCOMMITTEE ON HEALTH AND LONG-TERM CARE OF THE SELECT COMMITTEE ON AGING HOUSE OF REPRESENTATIVES NINETY-EIGHTH CONGRESS FIRST SESSION JULY 21, 1983 Printed for the use of the Select Committee on Aging Comm. Pub. No 98-409 _U,$DEPA_STMENT OF EDUCATION NATIONAL INSTITUTE_Of EDUCATION EDUCATIONAL_RESOURCES INFORMATION CENTER (ERIC) 7t, This document has been reproduced as received ;ram the person or organization originating it. Minor changes have been made to improve reproduction quality. Points of view or opinions stated in this doou: ment do not necessarily represent official NIE position or policy. U.S. GOVERNMENT PRINTING OFFICE 21-436 0 WASHINGTON : 1983 SELECT COMMITTEE ON AGING EDWARD R. ROYBAL, California,Chairman CLWIDE PEPPER, Flo, ,da MATTHEW J. RINALDO, New Jersey, If ACO BIAGGI, New York Ranking Minority lifern&er it ANDREWS, North Carolina JOHN PAUL HAMMERSCHMIDT, Arkansas .rstiNKER, Washington RALPH REGULA, Ohio 'T,I(')".'iAS J. DOWNEY, New York NORMAN D. SHUMWAY, California IA T. FLOR40, New Jersey OLYMPIA J. SNOWE, Maine TY.' )LL! E. FORD; Tennessee JAMES M. JEFFORDSVermont WILLiAM_J. HUGHES; New Jersey THOMAS J, TAUKE, Iowa MARILYN_ LLOYD ; Tennessee _ JUDD GREGG; New Hampshire srio; K . _LIINDINE_New York GEORGE C. WORTLEY, New York MARY ROSE OAKAR, Ohio HAL_DAUB,_Nebiliskti THOVA3 A. LUKEN, Ohio LARRY E. CRAIG, Idaho C'',..ALLYNP A. FERRARO, New York COOPER EVANS, Iowa nyv Et11, B. BYRON, Maryland JIM COURTER, New Jersey WILLI.? 1IR RATCHFORD, Connecticut LYLE WILLIAMS, Ohio DAN 1v1 A 'Florida C_ LAUDINE SCHNEIDER, Rhode Island HENTh A WAXMAN; California THOMAS J. RIDGE) Pennsylvania . "MAE Olerthorria JOHN McCAIN, Arizona KLITI L'R_1)L2KICK_:outh Carolina MICHAEL _BILIRAKIS, Florida BRUI.;F.-VEN-T0,-Miiinesota GEORGE WGEKAS, Pennsylvania BARNEY FRANK, Maana.r4-isetts MARK-D.-SILJANDER,_Michigan TOM LANTOS, Californin CHRISTOPHER H. SMITH, New Jersey RON WYDEN, Oregon MICHAEL DEWINE, Ohio DONA. Li JOSEPH ALB(Y7TA. Michigan GEC 'v. CROCAZETT, JR., MInhig_an WILLI d "ILL BONER; Tennessee IKE_S4IEr.:TON, Missouri DENN S_ N!, IICRT_EL, _Michigan ROBERT A BORSKL_Pennaylvaatia FREDERrii C. (RICK! BOUCHER, Virginia BEN ERDRE7CH, Alabama BUDDY MAr.KAY, Florida HARRY M. PEW., Nevada NORMAN SISISKY, Virginia TOM VANDERGRIFF, Tzxas ROBERT E-WISE _JR., West virgin:a BILL RICHARWON. N- Mr0 JOPC1' LAMBRINOS,Staff Director PAUL SCHLEGEIMinority Staff Director SUBCOMMITTEE ON HEALT:i AND LONG-TERM CARE CLAUDE PEPPER. Florida,Chairman IKE ANDREWS, North Carolina RALPH REGULA, Ohio, JAMES J. FLORIO, New Jersey Ranking Minority Member HAROLD E. FORD, Tennessee THOMAS J. TAUKE, Iowa MARILYN LLOYD-Tennessee GEORGE C. WORTLEY, New York MARY ROSE OAKAR; Ohio HAL DAUB; Nebraska THOMAS A; LUKEN; Ohio LARRY E. CRAIG, Idaho WILLIAN_R;_RATCHFORD,_Connecticut JIM COURTER; New Jersey BUTLER DERRICK; Sbuth Carolina THOMAS J, RIDGE; Pennsylvania RON WYDEN, Oregon JOHN MUCAIN,_ Arizona_ GERALDINE A. FERRARO, New York MICHAEL BILIRAKIS, Florida HENRY A. WAXMAN, California MICHAEL DEWINE, Ohio BRUCE F. VENTO, Minnesota MATTHEW J. RINALDO, New Jersey IKE SKELTON, Missouri (Ex Officio) DENNIS M. HERTEL, Michigan ROBERT A. BORSKI; Pennsylvania EDWARD R, ROYBAL; California (Eic Officio) BILL HALAMANDARIS,Staff Director KATHLEEN GARDNER CFtAVEDI,Assistant Staff Director JAMES P. OBERLE; Ph. D.;Minority Staff Director CONTENTS MEMBERS' OPENING STATEMENT Page Chairman Cla,.'',.'pler 1 Ralph Regula . 5 Mary Rose Oak, , ... 7 Michael Husk's 27 Tom Lantos 28 Hal Daub 30 CHRONOLOGICAL LIST OF WITNESSES Panel 1.Over-the-counter consumers and consumer representatives: Sidney Wolfe; M.D., director; Health Research Group; and president; Public Citizen 31 Anthea Sachs, Westport, Conn 38 Gloria Jean Davis, Albany, Ga. 38 Janey Phipps, R.N., Gray, Ky 39 Kathleen O'Reilley, consumer expert, National Broadcasting Co 41 Frank Adam°. Johnson Creek, Wis 45 Panel 2.Consumer advocates: Charles P. Nelson; Assistant Chief Postal Inspector, Criminal Investiga- tions Division; U.S. Postal Service, Washington, D,C. accompanied by George Davis, Assistant General Counsel, Consumer Protection Divi- sion of the Law Department, U.S. Postal Service 71 Bambi-Batts Young, Center for Science in the Public Interest, Washing- ton, D.0 76 Panel 3.Medical experts: Dr. Sorell Schwartz, professor of pharmacology, Georgetown University School of Medicine, Washington, D.0 85 Dr. Shirley Mueller, director of neurology, Reganstreif Health Center, Indiana University School-of _Medicine, Indianapolis, Ind 88 Dr. Thaddeus Prout, associate professor of medicine, Johns _Hopkins Uni- versity School of Medicine; and chief of medicine; Greater Baltimore Medical Center, Baltimore, Md 96 Dr. James Ramey, associate clinical professor at George Washington Uni- versity r.r. 101 Panel 4. Industry officials, Thompson Medical Co., Irm: Dr. Harold I. Silverman, prof&sor of pharmacy, Massachusetts college of Pharmacy and Allied Health Services 114 Dr. Matthew H. Bradley, cardiologist, Miami Heart Institute, Miami, Fla 116 Dr. Charles Winick, professor of sociology,_City University of New York 119 Dr, Rudolf E. Nobel; 'director, Cathedral Hill Obesity Clinic, San Francis- co, Calif 126 Dr. Anthony Conte, beriatrician; Beaver, Pa ... ..... -- ............ ------ 129 Dr. Marianne Sebok; physician, affiliated with J. F. Kennedy Memorial Hospital, Frankford Hospital, and Albert Einstein Memorial Center; Philadelphia, Pa 139 Dr.- Frank Funderburk, the Behavioral Pharmaceutical Research Unit of the Johns Hopkins University School of Medicine.. 147 Dr. Edgar E. Coons, Ph. D., professor of psychology, New York University 196 James Schreiber, Jr 220 James Schreiber, Sr 220 Barbara Ritz 221 Bill Iv APPENDIX Appendix 1."Medication Use/Abuse Among the Pinellas County Elderly,7 by Operation PAit, Inc. Elder/Ed program, Pinellas Park; Fla.,submitted Page for the record by Representative Michael Bilirakis 223 Appendix 2.Material submitted for the record by Representative MaryRose Oakar: Food and Drug Administration computer printnut listing 1,040 reported adverse drug reactions to products containing PPA 259 Background material dealing with -the Washington State Board of Phar- macy review of over-the-counter drug preparations 317 Appendix 3.Additional material received for the recorit Food and Mug Administration, Public Health vice; Department of Health and Human Services, prepared statement.. 351 Medical Society of the State of New York, Edward Siegel, M.D.,executive vice-preeident, letter 366 The Propprietary Association, Washington, D.C., Allan R. Reicinger, direc- tor of legislative relations, prepared statement 367 Thompson Medical -Co., Inc New York, N.Y., Edward L. Steinberg;M