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^^ CHOLESTEROL MEASUREMENT: \*^ ERROR AND VARIABILITY Y 4, SCI 2: 104/4 AxviJN Cholesterol Heasurenent: Error and... (jT BEFORE THE SUBCOMMITTEE OX TECHNOLOGY OF THE COMMITTEE ON SCIENCE HOUSE OF REPRESENTATIVES U.S. ONE HUNDRED FOURTH CONGRESS FIRST SESSION FEBRUARY 14, 1995 [No. 4] Printed for the use of the Committee on Science r^r^f^f MAY 2 9 U.S. GOVERNMENT PRINTING OFFICE 89-535CC WASHINGTON 1995 : ForsalebytheU.S.GovernmentPrintingOffice SuperintendentofDocuments.CongressionalSalesOffice.Washington,DC 20402 ISBN 0-16-047054-4 ^H CHOLESTEROL MEASUREMENT: ^ ERROR AND VARIABILITY 4, SCI 2:104/4 olesterol Heasurenent: Error and... AxviJNljr BEFORE THE SUBCOMMITTEE ON TECHNOLOGY OF THE COMMITTEE ON SCIENCE HOUSE OF REPRESENTATIVES U.S. ONE HUNDRED FOURTH CONGRESS FIRST SESSION FEBRUARY 14, 1995 [No. 4] Printed for the use of the Committee on Science MAY2g U.S. GOVERNMENT PRINTING OFFICE 89-535CC WASHINGTON 1995 : ForsalebytheU.S.GovernmentPrintingOffice SuperintendentofDocuments,CongressionalSalesOffice,Washington.DC 20402 ISBN 0-16-047054-4 COMMITTEE ON SCIENCE ROBERT S. WALKER, Pennsylvania, Chairman F. JAMES SENSENBRENNER, Jr., GEORGE E. BROWN, Jr., California RMM* Wisconsin RALPH M. HALL, Texas SHERWOOD L. BOEHLERT, New York JAMES A. TRAFICANT, Jr., Ohio HARRIS W. FAWELL, Illinois JAMES A. HAYES, Louisiana CONSTANCE A. MORELLA, Maryland JOHN S. TANNER, Tennessee CURT WELDON, Pennsylvania PETE GEREN, Texas DANA ROHRABACHER, California TIM ROEMER, Indiana STEVEN H. SCHIFF, New Mexico ROBERT E. (Bud) CRAMER, Jr., Alabama JOE BARTON, Texas JAMES A. BARCIA, Michigan KEN CALVERT, California PAUL McHALE, Pennsylvania BILL BAKER, California JANE HARMAN, California ROSCOE G. BARTLETT, Maryland EDDIE BERNICE JOHNSON, Texas VERNON J. EHLERS, Michigan** DAVID MINGE, Minnesota ZACH WAMP, Tennessee JOHN W. OLVER, Massachusetts DAVE WELDON, Florida ALCEE L. HASTINGS, Florida LINDSEY O. GRAHAM, South Carolina LYNN N. RIVERS, Michigan MATT SALMON, Arizona KAREN McCarthy, Missouri THOMAS M. DAVIS, Virginia MIKE WARD, Kentucky STEVE STOCKMAN, Texas ZOE LOFGREN, California GIL GUTKNECHT, Minnesota LLOYD DOGGETT, Texas ANDREA H. SEASTRAND, California MICHAEL F. DOYLE, Pennsylvania TODD TIAHRT, Kansas SHEILA JACKSON LEE, Texas STEVE LARGENT, Oklahoma WILLIAM P. LUTHER, Minnesota VAN HILLEARY, Tennessee BARBARA CUBIN, Wyoming MARK ADAM FOLEY, Florida SUE MYRICK, North Carolina David D. Clement, ChiefofStaffand ChiefCounsel Barry Beringer, General Counsel TiSH Schwartz, ChiefClerk andAdministrator Robert E. Palmer, Democratic StaffDirector Subcommittee on Technology CONSTANCE A. MORELLA, Maryland, Chairman SUE MYRICK, North Carolina JOHN S. TANNER, Tennessee KEN CALVERT, Cahfomia PAUL McHALE, Pennsylvania GIL GUTKNECHT, Minnesota EDDIE BERNICE JOHNSON, Texas ANDREA H. SEASTRAND, California KAREN McCarthy, Missouri TODD TIAHRT, Kansas ZOE LOFGREN, California BARBARA CUBIN, Wyoming *RankingMinorityMember **ViceChairman (II) CONTENTS WITNESSES Page February 14, 1995: Kwai-Cheung Chan, Director ofProgram Evaluation in Physical Systems Areas, GAO, Washington, DC; accompanied byJohn E. Oppenheim 17 Claude Lenfant, M.D. Director, National Heart, Lung, and Blood Insti- tute, NIH, Bethesda, Maryland 105 (III) CHOLESTEROL MEASUREMENT: ERROR AND VARL^ILITY TUESDAY, FEBRUARY 14, 1995 U.S. House of Representatives, Committee on Science, Subcommittee on Technology, Washington, D. C. The subcommittee met, pursuant to call, at 1:05 p.m. in Room 2318 of the Rayburn House Office Building, the Honorable Con- stance A. Morella, chairwoman ofthe subcommittee, presiding. Mrs. Morella. I think we will start now. It is a great pleasure to convene our first meeting of the Sub- committee on Technology ofthe House Science Committee. It isn't official yet, but we have some reason to believe that this is the first Congressional committee or subcommittee in the history of the House of Representatives comprised of a majority of women. I am excited about that, given the context especially of 48 out of 435 Members in the House, but I am also very excited about the issues that will be coming before our subcommittee during this Congress. Technology lies close to the heart of everything that we do and offers all of us a more prosperous and bountiful future. Technology offers us much promise. The promise of a safer and cleaner environment; the promise ofmore profitable and competitive industries; the promise of a more informed, better educated, and healthier citizenry. Realizing these promises is the important work to which we will all be dedicating ourselves. This subcommittee has a distinguished history of exercising jurisdiction whenever technology or technological research has had an impact on the lives, the health, or the prosperity of the Amer- ican people. And I can't think of a more interesting or important topic than the one before us today: the accuracy of cholesterol measurement. This is especially true today, on Valentine's Day, when I am sure that most i^ericans are paying attention to the hearts they have, and the hearts that they want to keep. Today's hearing grows out of the work conducted by the former Investigations and Oversight Subcommittee on which I served as the Ranking Member in the past Congress. We owe a debt of gratitude to the two former chairmen who helped to make this hearing possible today. I am speaking of my former colleague, Howard Wolpe, who as Chairman of the Inves- tigations and Oversight Subcommittee ofthe House Science, Space, and Technology Committee, initiated the General Accounting Office (1) studies on cholesterol, and also our former Chairman Jimmy Hayes, who sustained and guided these studies over the course of the past Congress when I served as Ranking Minority on that subcommittee. My thanks go out to both ofthem. The subject ofcholesterol and health is not a simple one. We will certainly not hear the last word on it today. The GAO study that is being released today is the first ofthree that are planned. A second study, due out in a few months, will look at the sci- entific basis of the National Cholesterol Education Program, or NCEP as it is called in abbreviated form. A third study will examine the effects of cholesterol programs on the medical, pharmaceutical, and food industries. But today's hearing will be the first in a series of hearings that we do plan on this subject. Its purpose is not to force conclusions on cholesterol testing, the procedures for its testing, or its testing methodology. This subcommittee intends to further pursue this matter when the GAO releases its follow-up report in May. At that time, we can make appropriate recommendations and suggestions based on addi- tional findings to the American people. I have reviewed this first study of the GAO on cholesterol measurement accuracy and variability with great interest, as have many others. Heart disease is one of the leading killers in America today. Heart disease claims more than half a million lives every year and it costs society in excess of$50 billion annually. High levels of serum cholesterol are correlated with an increased risk of coronary heart disease, and some two-thirds of American adults have had their cholesterol tested at some time over the past five years. About 15 percent of people are modifying their diets in an effort to combat cholesterol, and some 4 to 5 million people are receiving cholesterol- lowering medications. The total cost of cholesterol tests, treatments, diets, and programs may exceed, it is estimated, $10 billion annually. The American public indeed has every right to inquire whether this is money that is well spent, and the public has the right to know whether it is being provided with health information that is accurate, useful, and reliable. I look forward to having some of these questions answered here today. I want to thank our very able and learned panelists for testi- fying today. I want now to recognize the distinguished Ranking Member of this subcommittee, Mr. Tanner, for any opening remarks that he may have. [The prepared statement ofMrs. Morella follows:] Chairv/omanConnieManila TechnologySubcommittee CholesterolMeasurementHearing OpeningStatement February14, 1995 It is a great pleasure to convene our first meeting of the Subcommittee on Technology of the House Science Committee. It's not official yet but we have some reason to believe that this is the first Congressional committee or subcommittee in the history of our Union comprised of a majority of women. am excited about that, and am also I I very excited about the issues that will be coming before our subcommittee during this Congress. 2 Technology lies close to the heart of we everything do and offers all of us a more prosperous and bountiful future. Technology offers us much promise: the promise of a safer and cleaner environment; the promise of more profitable and competitive industries; the promise of a more informed, better educated, and healthier citizenry. Realizing these promises is the important work to which we will all be dedicating ourselves. This subcommittee has a distinguished history of exercising jurisdiction whenever technalogy-or technological research has had an impact on the lives, the health, or