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AIDS ISSUES (Part 1) HEARINGS

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AIDS ISSUES (Part 1) HEARINGS AIDS ISSUES (Part 1) HEARINGS BEFORE THE SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDREDTH CONGRESS FIRST SESSION MARCH 10, 1987-COST AND AVAILABILITY OF AZT APRIL 27, 1987-AIDS AND MINORITIES SEPTEMBER 22, 1987-AIDS RESEARCH AND EDUCATION Serial No. 100-68 Printed for the use of the Committee on Energy and Commerce 0 U.S. GOVERNMENT PRINTING OFFICE 72635". WASHINGTON : 1987 For sale by the Superintendent of Documents, Congressional Sales Office US. Government Printing Office, Wshington, DC 20402 COMMITTEE ON ENERGY AND COMMERCE JOHN D. DINGELL, Michigan, Chairman JAMES H. SCHEUER, New York NORMAN F. LENT, New York HENRY A. WAXMAN, Califbrnia EDWARD R. MADIGAN, Illinois PHILIP R. SHARP, Indiana CARLOS J. MOORHEAD, California JAMES J. FLORIO, New Jersey MATTHEW J. RINALDO, New Jersey EDWARD J. MARKEY, Massachusetts WILLIAM E. DANNEMEYER, California THOMAS A. LUKEN, Ohio BOB WHITTAKER, Kansas DOUG WALGREN, Pennsylvania THOMAS J. TAUKE, Iowa AL SWIFT, Washington DON RITTER, Pennsylvania MICKEY LELAND, Texas DAN COATS, Indiana CARDISS COLLINS, Illinois THOMAS J. BLILEY, JR., Virginia MIKE SYNAR, Oklahoma JACK FIELDS, Texas W.J. "BILLY" TAUZIN, Louisiana MICHAEL G. OXLEY, Ohio RON WYDEN, Oregon HOWARD C. NIELSON, Utah RALPH M. HALL, Texas MICHAEL BILIRAKIS, Florida DENNIS E. ECKART, Ohio DAN SCHAEFER, Colorado WAYNE DOWDY, Mississippi JOE BARTON, Texas BILL RICHARDSON, New Mexico SONNY CALLAHAN, Alabama JIM SLATTERY, Kansas GERRY SIKORSKI, Minnesota JOHN BRYANT, Texas JIM BATES, California RICK BOUCHER, Virginia JIM COOPER, Tennessee TERRY L. BRUCE, Illinois WM. MICHAEL KITZMILLER, Staff Director PAUL C. SMITH, Minority Chief Counsel/Staff Director SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT HENRY A. WAXMAN, California, Chairman JAMES H. SCHEUER, New York EDWARD R. MADIGAN, Illinois DOUG WALGREN, Pennsylvania WILLIAM E. DANNEMEYER, California RON WYDEN, Oregon BOB WHITTAKER, Kansas GERRY SIKORSKI, Minnesota THOMAS J. TAUKE, Iowa JIM BATES, California DAN COATS, Indiana TERRY L. BRUCE, Illinois THOMAS J. BLILEY, JR., Virginia MICKEY LELAND, Texas JACK FIELDS, Texas CARDISS COLLINS, Illinois NORMAN F. LENT, New York RALPH M. HALL, Texas (Ex Officio) WAYNE DOWDY, Mississippi JOHN D. DINGELL, Michigan (Ex Officio) KAREN NELSON, Staff Director TIMOTHY M. WESTMORELAND, Counsel ANDREAS G. SCHNEIDER, Counsel EDWIN H. ALLEN, Minority Counsel (11) CONTENTS Page Hearings held on: M a rch 10, 19 87 ......................................................................................................... 1 A pril 27, 1987 (H ouston, T X ) ................................................................................. 53 Septem ber 22, 1987 ................................................................................................... 155 Testimony of: Awe, Robert J., chief, Pulmonary Medicine, Jefferson Davis Hospital ......... 145 Barry, David, vice president, research, Burroughs Wellcome Co ................... 4 Bascetta, Cynthia, Human Resources Division, General Accounting Office 176 Callen, Michael, Community Research Initiative, People With AIDS Coa- litio n , In c ................................................................................................................ 2 73 Corey, Lawrence, director, AIDS Treatment Evaluation Program and pro- fessor of medicine, University of Washington ................................................ 270 Haigler, T.E., Jr., president and chief executive officer, Burroughs Well- co m e Co .................................................................................................................. 4 Haughton, James, director, city of Houston Department of Health and H u m an Services .................................................................................................... 78 Kihnel, Chris, president, People With AIDS Coalition ..................................... 133 Krim, Mathilde, associate research scientist, St. Luke's-Roosevelt Hospi- tal Center and Columbia University, and founding chairwoman, Ameri- can Foundation for A IDS Research .................................................................. 77 Lane, J. Michael, Director, Center for Prevention Services, Centers for Disease Control, Public Health Service, Department of Health and H u m an Services ................................................................................................... 60 Lawson, Rev. William, Wheeler Avenue Baptist Church ................................. 128 Lovell, Sue, board of directors, AIDS Foundation ............................................. 132 McFarren, Ann E., executive director, AIDS Action Council, and presi- dent, AIDS Action Foundation ................................................................. 158 McKinney, Charles, director of education, Gay Mens' Health Crisis ............ 208 Mansell, Peter, Institute for Immunological Disorders .................................... 143 Miike, Lawrence, Senior Associate-Health Programs, Office of Technology A ssessm e n t ............................................................................................................. 18 1 Perez, Jose, Gay and Lesbian Hispanics Unidas ................................................ 130 Roper, William L., Administrator, Health Care Financing Administra- tion, Department of Health and Human Services ......................................... 33 Sweeney, Tim, deputy director for government relations, Gay Mens' H ea lth C risis ......................................................................................................... 208 Taylor, Elizabeth, national chairman, American Foundation for AIDS R esea rch ................................................................................................................. 167 Terry, Robert J., president, Texas Southern University .................................. 58 Weissman, Irving L., professor of pathology, Stanford University, member of Steering Committee on AIDS, National Academy of Sciences ................ 264 Windom, Robert E., Assistant Secretary for Health, Public Health Serv- ice, Department of Health and Human Services ........................................... 27 Zimmerman, Michael, Senior Associate Director, Human Resources Divi- sion, General Accounting O ffi ce ........................................................................ 176 (Ill) IV Page Material submitted for the record by: AIDS Foundation Houston, statement ................................................................. 152 American Pharmaceutical Association, statement .................... 51 Bruce, H on. Terry, statem ent ............................................................................... 3 Health and the Environment Subcommittee, materials supplied by Amer- ican Social Health Association AIDS Hotline outlining their various p rogram s ............................................................................................................... 214 Office of Technology Assessment, statement "How Accurate is AIDS Anti- body Testing?" was submitted in response to questions of Mr. Danne- meyer at the hearing ........................................................................................... 189 i AIDS ISSUES Cost and Availability of AZT TUESDAY, MARCH 10, 1987 HOUSE OF REPRESENTATIVES, COMMITTEE ON ENERGY AND COMMERCE, SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT, Washington, DC. The subcommittee met, pursuant to notice, at 9:55 a.m., in room 2322, Rayburn House Office Building, Hon. Henry A. Waxman (chairman) presiding. Mr. WAXMAN. The meeting of the subcommittee will come to order. Last September the Department of Health and Human Services and the Burroughs Wellcome Company made a dramatic joint an- nouncement. There was an AIDS drug. The drug AZT had been in clinical trials in humans for 7 months. The trials were double- blinded and placebo-controlled. That is, by secret random selection half of the patients received AZT and half received a placebo. A few months later researchers began to report that some AIDS patients were clearly getting better. Others were dying. The re- searchers insisted that a scientific safety board break the secret code to see if the drug was producing these results. In September the safety board revealed that about 1 out of 8 pa- tients in the control group had died compared to one out of 145 of the patients receiving AZT. Given this information, both HHS and Burroughs Wellcome decided that it would be unethical to continue the study, that keeping some patients off the drug endangered their lives. While formal approval procedures began, all control group pa- tients were given AZT. In addition, Burroughs Wellcome and HHS began to supply AZT free of charge to any AIDS patient in Amer- ica who had symptoms similar to those of the study. To date, over 4,500 patients have been given the drug. In January the FDA's scientific advisory panel recommended that the drug be approved for sale in the U.S., England and France have already approved its sale. Last month Burroughs Wellcome announced that the drug will wholesale for about $7,000 per pa- tient per year. The retail price is expected to be between $8,000 and $10,000. There are a number of major questions that mus' be answered in today's hearing. Is this a fair price? Who will pay for the people who are now being treated for free? Who will pay for the people (1) 2 who become ill after the drug is approved? Who is responsible for people who cannot pay? But the guiding principle in
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