Fair Price Working Group Consensus Statement on the Pricing of EC ddI and ABT-378

March 10, 2000 We, the undersigned, have serious concerns regarding the growing costs of therapy for HIV disease. While we are heartened by the progress made in moving toward simpler, easier to use regimens, we are dismayed by the possibility that prices of new drugs and price increases of approved drugs are escalating ever higher, and with each new price increase setting new benchmarks. As drugs become available which might facilitate better adherence and possibly more durable long-term treatment, manufacturers should be planning to lower or at least contain the daily cost of their regimens, not increase them. The long-term survival afforded by the present generation of therapies makes it possible for manufacturers to set lower, or at least stable prices, and still have adequate incentive to reinvest in continued development of HIV/AIDS drugs. Recently cited reductions in the overall cost of health care for HIV infected people will almost certainly be reversed in coming years if manufacturers continue to increase or maintain current pricing levels. We are in a new era in the treatment of HIV disease and rethinking drug pricing which reflects this changing reality is long overdue. To the best of our knowledge, the development costs of Bristol Myers Squibb new enteric-coated formulation of ddI and Abbott Labs' new protease inhibitor, Kaletra™ (lopinavir), do not justify a leap in prices. There has been nothing extraordinary about the cost of clinical trials required to bring these new formulations and drugs to market, while the duration of their use by patients may be greatly extended. Enteric coated ddl is likely to be used by both treatment- naïve and treatment-experienced patient populations, making its potential market very large. The tolerability profile of the earlier versions of this drug has long suppressed its sales, resulting in pent-up demand for an effective nucleoside analogue drug. If the price is as high as current indications suggest, and the drug is used in naïve populations in place of existing drugs, the overall cost of therapy will go up substantially. Similarly, if the price of lopinavir reaches new heights for a protease inhibitor and it is used by both treatment-naïve and treatment-experienced people, the overall cost of therapy will escalate dramatically. We cannot stand idly by while the price of living with HIV disease rises so rapidly. ADAP programs and other forms of government funding support have limited amounts of money allocated to them each year. Moreover, the long-term use of extremely expensive drugs is threatening the lifetime limits of many private insurance policies. Some state ADAP and Medicaid programs have removed vital medications to prevent and treat opportunistic infections from their formularies. State ADAP and Medicaid programs are under close scrutiny by governmental panels in order to cut costs. The price of one drug can affect the availability of other medications. Increasingly, this same sad scenario is beginning to affect the availability of drugs within HMO settings. The price of these drugs will have a pervasive impact on the overall quality of care people with HIV/AIDS receive in this country. Bristol Myers Squibb and Abbott Labs have expressed a strong desire to create goodwill and cooperative working relationships with the community. No one wants to see those relationships jeopardized over this issue, but that surely occur if pricing is inappropriate. Exploitative pricing will trigger widespread mistrust, contentious debate, and closer scrutiny of industry practices in general and give comfort to those who think that AIDS is simply a scam designed to line the coffers of the pharmaceutical industry. This will have far reaching consequences. Though we call for a major reduction in the price of HIV therapies in general, these drugs must at least be priced fairly and in accordance with other drugs of their respective classes. Neither represents a major advance in therapy that might otherwise reduce the overall cost of care. We urge manufacturers to rethink their plans for pricing and to act as responsible citizens playing a key role in the fight against a worldwide epidemic. Without responsible pricing, there can be no constructive dialogue between industry and the HIV affected populations worldwide.

Fair Price Working Group Bill Arnold, Title II Community AIDS National Network, Inc. Ben Cheng, Assoc. Dir. Information & Advocacy, Project Inform Lynda Dee, President, AIDS Action Baltimore Martin Delaney, Founding Director, Project Inform Yvette Delph, Antiviral Policy Director, Treatment Action Group Ken Fornataro, Exec. Dir., AIDS Treatment Data Network Dave Gilden, Director of Treatment Information, AmFAR Linda Grinberg, President, FAIR/Foundation for AIDS & Immune Research Mark Harrington, Senior Policy Director, Treatment Action Group Carlton Hogan, University of Minnesota Richard Jeffreys, Access Project Director, AIDS Treatment & Data Network Michael Marco, Director, Infections and Oncology, Treatment Action Group Organizational and Invididual Endorsements Organizations: ABIA (Associação Brasileira Iterdisciplinar de AIDS) São Paulo, BRAZIL ACT UP/Cleveland, Cleveland, OH ACT UP/East Bay, Oakland, CA ACT UP/Los Angeles, Los Angeles, CA ACT UP/Philadelphia, Philadelphia, PA ACT/UP New York, New York, NY AGIHAS, Riga, LATVIA Agua Buena Human Rights Association, Costa Rica Aid for AIDS, New York, NY AIDS Action Baltimore, Baltimore, MD AIDS Committee of Toronto (ACT), Toronto, ON CANADA AIDS Survival Project, Atlanta, GA AIDS Treatment & Data Network, New York, NY AIDS Treatment News, San Francisco, CA Asian & Pacific Islander Wellness Center: Community HIV Services, San Francisco, CA Asociación Gente Positiva, Guatemala City, GUATEMALA Atlanta Hispanic PLWA Group, Atlanta, GA Aunt Bee's Project Return Australian Federation of AIDS Organisations (AFAO), AU British Columbia Persons with AIDS, Vancouver, BC C-WOW, The Center With Out Walls, Trauma Integration Advantage Program, Columbus, OH Canadian Treatment Advocates Council, Toronto, ON CANADA Center for AIDS, Houston, TX Chicago ACTG, Northwestern Medical Center, Chicago, IL Colombian Lesbian and Gay Association (COLEGA), New York, NY Community Prescription Service, New York, NY DAAIR, New York, NY Deutsche AIDS-Hilfe, Berlin, GERMANY FLAAC/Florida AIDS Action Council, Miami, Florida Foundation for AIDS and Immune Research, Los Angeles, CA Gay Men's Health Crisis, New York, NY German Activists Network, GERMANY GIV (Grupo de Incentivo à Vida) Rio de Janeiro, BRAZIL Haitian Centers Council, Brooklyn, NY 11201 Hawaii Adult Aids Clinical Trials Unit - University of Hawaii, Hawaii Hawaii Drug Assistance Program, Hawaii Hawaii Sero-Positive&Medical Management Program, Hawaii Hawaii C.A.R.E.S - Ryan White Title II Planning Group, Hawaii Health Initiatives for Youth, San Francisco, CA Hepatitis C Action & Advocacy Coalition (HAAC) New York, NY Hepatitis C Action & Advocacy Coalition (HAAC) San Francisco, CA HIV in Prison Committee of California Prison Focus, San Francisco, CA HIVCare at St. Francis Memorial Hospital, San Francisco, CA Holistic Health Center, Ft. Lauderdale, FL Latino Commission on AIDS, New York, NY Lighthouse Group, Asheville, NC Loving Food Resources, Inc, Asheville, NC Mano a Mano, New York, NY Nashville CARES, Nashville TN NATAP (National AIDS Treatment Advocacy Project) New York, NY New York City AIDS Housing Network, New York, NY New York Peer AIDS Education Coalition, New York, NY North Carolina AIDS Policy Center, Asheville, NC North Coast HIV/AIDS Coalition, Cleveland, OH OASIS (Organización de Apoyo a una Sexualidad Integral frente al SIDA) Guatemala City, GUATEMALA Other Options, Inc., Oklahoma City, OK Pioneer Valley Hepatitis C Action Project (PVHepCAP) of Western Massachusetts, MA Positive Peaches, Inc., Conyers, GA Positives For Positives, Cheyenne, WY POZ Magazine, New York, NY Prisoners With AIDS - Rights Advocacy Group, Los Angeles, CA Project Inform, San Francisco, CA PWA Health Group, New York, NY PWACMI/PWA Committee of Maryland, Inc. Frederick, Maryland San Francisco AIDS Foundation, San Francisco, CA Search for a Cure, Boston, MA Sisters of St. Elizabeth of Hungary, San Juan Capistrano, CA Survive AIDS (formerly ACT UP Golden Gate), Francisco, CA Treatment Action Group, New York, NY Washington Dept. of Health HIV Early Intervention Program, Steering Committee, WA Washington State ADAP Program, WA Individuals: Judith A. Aberg, M.D., Director of HIV Services, Washington University, AIDS Clinical Trials Unit, St Louis, MO Carol Adamovicz, North Royalton, OH Moises Agosto, New York, NY Doug Allen, writer for POZ and other publications, New York City, NY Averil D.(Cookie) Arbuckle, Director, Other Options, Inc. (ASO) OK Bill Arnold, Title II Community AIDS National Network, Inc., Washington, DC Götz Bähr, Berliner AIDS-Hilfe e.V, Berlin, GERMANY David Balsam, Agua Buena Human Rights Association, Costa Rica Irl Barefield, Director, HIVCare at St. Francis Memorial Hospital, San Francisco, CA Charles R. Belt, MD, HIV Clinic Board Staff Physician, Univ. of Arkansas, Fayetteville Student Health Services, Fayetteville, AK Jorge Beloqui GIV, São Paulo and ABIA, Rio de Janeiro, Brazil Jeanne Bergman, Ph.D., New York, NY Thomas Blount, Miami Beach, FL Sally Brookins, Southern Colorado AIDS Project, Colorado Springs, CO James M. Carr, Director, HIV Consumer Association of Indiana, IN George Carter, San Francisco, CA George M. Carter, Director, Treatment Info. Development, DAAIR, New York, NY Peter Cashman, ACT UP/LA, Los Angeles, CA Matthew Chappell, MSW, Survive AIDS, San Francisco, CA Ben Cheng, Assoc. Director Information & Advocacy, Project Inform, San Francisco, CA Nicholas Cheonis, San Francisco AIDS Foundation, San Francisco, CA Erickson Chiclayo, Executive Director, Asociación Gente Positiva, Guatemala City, GUATEMALA Danny Cohen, San Francisco CA Evan Collins, MD, FRCPC, Chair, Advocacy Committee, AIDS Committee of Toronto and Assistant Professor, University of Toronto, Toronto, ON, CANADA LinDee Cook, Director of Programs on Aging, C-WOW, The Center Without Walls, Columbus, OH Jim Corti, Foundation for AIDS & Immune Research, Bangkok, THAILAND Daniel G. Craig, Staten Island, NY Myron C. Crider, Morrow, GA Anna J. Cushman, Kalamazoo, MI Dee Danna, San Jose, CA Paul Davis, ACT UP Philadelphia, Philadelphia, PA Anne S. De Groot MD, TB/HIV Research Lab, HIV Education/Prison Project at the Brown AIDS Program, http://www.Brown.edu/Research/TB-HIV-Lab, http://www.Brown.edu/Research/Vaccine-Center, Providence Rhode Island Anne S. De Groot, MD, Lynda Dee, President, AIDS Action Baltimore, MD Martin Delaney, Founding Director, Project Inform, San Francisco, CA Yvette Delph, Antiviral Policy Director, Treatment Action Group Sharon Dolan, Executive Director, Health Initiatives for Youth, San Francisco, CA Anne Donnelly, Director, Public Policy, Project Inform, San Francisco, CA Andres Duque, Director of the LGBT Initiative, Latino Commission on AIDS, Coordinator Mano a Mano, Co-chair, Colombian Lesbian and Gay Association (COLEGA) New York, NY Steve Dutky, Takoma Park, MD Paul Edmonds, Truckee, CA Bruce Edwards, MPH, Correctional HIV Consortium, San Francisco, CA Isabella Erlich, HIV-Coordinator, AIDS-Hilfe Stuttgart e.V. Stuttgart, GERMANY Jim Eigo, New York, NY Sister Mary Elizabeth, OSM, AEGIS, San Juan Capistrano, CA Richard Elliott, Director, Policy & Research, Canadian HIV/AIDS Legal Network Francisco M.P.Faria, xicofaria@hotmail.com, PORTUGAL Vanessa Filley, San Francisco, CA Leonard Fisher, North Vernon, Indiana Peter Fisher Co-chair, Pioneer Valley Hepatitis C Action Project (PVHepCAP) of Western Massachusetts, MA Jennifer Flynn, Executive Director, New York City AIDS Housing Network, New York, NY Robert Folan-Johnson, ACT UP Boston, Boston, MA Ken Fornataro, Executive Director, AIDS Treatment Data Network Kevin Fox, Volunteer/Project Inform/Positive Resource, San Francisco, CA Urszula Frydman, Oakland, CA Marilyn Ganns, RN, BSN, ACRN, OCN, St. Lukes Hospital, Kansas City, MO Roger Garza, Atlanta Hispanic PLWA Group, Atlanta, GA Stephen Gendin, CEO, Community Prescription Service Jeff Getty, Survive AIDS, San Francisco, CA Dave Gilden, Director of Treatment Information, AmFAR, New York, NY Gregg Gonsalves, Policy Director, Treatment Action Group, New York, NY Jeff Graham, Executive Director, AIDS Survival Project, Atlanta, GA Judy Greenspan, Chairperson, California Prison Focus, HIV in Prison Committee/CPF, San Francisco, CA Linda Grinberg, President, FAIR/Foundation for AIDS & Immune Research Howard Grossman, M.D., Community Physician, New York, NY Tony Grove, Brisbane, AUSTRALIA Mark Grzebien, Laurel, MD Rich Grzesiak, Web Master, Being Alive Los Angeles, Axion Grafix, Silver Lake, CA Jeff Gustavson, Survive AIDS!, San Francisco, CA Greg Hacke, Consumer Representative, HIV/AIDS Nursing Certification Board Michael Haggerty, San Diego, CA Marie Hamilton, LCSW, Chicago, IL Alec Hardy, Prisoners With AIDS - Rights Advocacy Group, Los Angeles, CA Mark Harrington, Senior Policy Director, Treatment Action Group Tom Hemmingsen, Member, Chicago Adult ACTG CAB, Chicago, IL Steve Hendrix, ruedog@saturnnet.com Dr. Götz Hiller (BAH) Carlton Hogan, University of Minnesota, Minneapolis, MN Tim Horn, Physicians' Research Network, New York, NY Arnold House, Truckee, CA Valerie Huston, HIV Counseling & Testing Program, The Aliveness Project of Northwest Indiana, Gary, INDIANA T. Michael Hyde , Washington, D.C. Joseph Interrante, Executive Director, Nashville CARES, Nashville TN John Iversen, HIV Services Planning Council, Oakland, CA Richard Jackman, Member, RESIST THE LIST, Seattle, WA 72. Miki Jackson,Founding President, Aunt Bee's Project Return John S. James, AIDS Treatment News, San Francisco, CA Richard Jeffreys, Access Project Director, AIDS Treatment & Data Network, NY Lisa Jensen, Bar Association of S.F.,Oakland, CA Michael Jones, Community Consortium of San Francisco, San Francisco, CA Carol Katz, RN, CS-ANP, Channel 1 Michael Kinsley, San Francisco, CA Brian D. Klein, MA, LMSW, Hepatitis C Action & Advocacy Coalition (HAAC-SF), San Francisco, CA Stephen Kovacev, Board member Provincetown Positive People with Aids Coalition, Provincetown, MA Lark Lands, POZ Magazine Science Editor, Georgetown, CO Paul Langlotz, Los Angeles, CA Garrett Lanzy, Endicott, NY James Learned, CRIA, New York , NY Bob Lederer, ACT UP/New York, New York, NY Brenda Lein, Director, Information and Advocacy Depts., Project Inform, San Francisco, CA Steve Lems, Wyoming, MI Joel Nim Cho Leung, Secretary, British Columbia Persons with AIDS, Vancouver, BC, CANADA Jules Levin, Executive Director, NATAP (Nat'l. AIDS Treatment Advocacy Project) NY Michael E. Linhart, Prison Outreach Coordinator, BC Persons with AIDS Society, Member, Board of Directors, Canadian HIV/AIDS Legal Network Kathy Loucks, Inland Northwest AIDS Coalition, Spokane, WA Basil Lucas, NYC Lesbian and Gay Anti Violence Project, NYC, NY John Manzon-Santos, Executive Director, Asian & Pacific Islander Wellness Center Community HIV Services, San Francisco, CA Michael Marco, Director, Infections and Onocology Project, Treatment Action Group Oliver W. Martin III., Deputy Director, Conscious Contact of New York, Inc., NY Rubén Mayorga, MD. Executive Director, OASIS (Organización de Apoyo a un Sexualidad Integral frente al SIDA), Guatemala City, GUATEMALA Bob McCormick, Director, HIV Department, Lowell Community Health Center, Lowell, MA Bill McMahon, Volunteer, Northern Territory AIDS Council, Nightcliff, Australia Mark Milano, ACT UP New York, New York, NY Jacki Miller, MA, MS, Case Management/Consortium Coordinator, Lansing, MI Bob Mills, CTAC Alberta Repres., HIV Edmonton Bd. & Advocacy Committee Chair, Project Review Committee CWGHR, Canadian HIV/AIDS Legal Network, Alberta, BC Michael Mooney, Director of Research, Program For Wellness Restoration, Los Angeles, CA Robert J. Munk, PhD, Arroyo Seco, New Mexico James Musslewhite, Washington Dept. of Health HIV Early Intervention Program, Olympia, WA Meg D. Newman, M.D., UCSF Assistant Professor of Medicine, SFG Ward 84, Director, AIDS Education at the UCSF-Positive Health Program at SFGH, UCSF Internal Medicine Residency Site Director at SFGH, San Francisco, CA, Kevin P. Nuttall, Policy Analyst/Advisor, N. Carolina AIDS Policy Center, Asheville, NC Russel Ogelesby, Amethyst Project, Inc., Statesboro, GA Jeff Palmer, Positives For Positives, Cheyenne, WY Roscoe E. Parker, WNC HIV/Aids Consortium, Asheville, NC June Pease, Co-chair, Pioneer Valley Hepatitis C Action Project (PVHepCAP) of Western Massachusetts, MA Stuart Peller, Managing Director, Holistic Health Center, Ft. Lauderdale, FL Billy Pick, San Francisco, CA Marie Pierre-Louis, Haitian Centers Council, Brooklyn, NY Curtis Ponzi, J.D., Project Inform/County Consortium Institutional Review Board, San Francisco, CA Andy Quan, Int'l. Policy Officer, Australian Federation of AIDS Organisations (AFAO), AU Myron Dean Quon, Esq., Lambda Legal Defense & Education Fund, San Francisco, CA Claire Rappoport, PWA, Brisbane, CA Tim Read, Melbourne, Australia Scott Riddle, Artistic Director, Center With Out Walls, Columbus, OH Esther Robison, Ph.D., Montefiore Medical Center, Bronx, NY Michelle Roland, MD, UCSF Positive Health Program, San Francisco General Hospital, San Francisco, CA Brad Roter, Co-Chairs, Washington ADAP Program, WA William W. Rydwels, National Association of HIV+s Over Fifty, Chicago, IL Kathy Ryerson, Democrat, San Francisco, CA Michael S. Saag, MD, Professor of Medicine, Director, AIDS Outpatient Clinic, University of Alabama at Birmingham, Birmingham, AL J.V. Schlichter, Orlando, FL Jeffrey T. Schouten, MD, Attorney at Law, Seattle Treatment Education Project (STEP) Seattle, WA David Scondras, former City Councilor, Search for a Cure, Boston, MA Stephanie Schwartzbeck- Founder/Executive Director, PWACMI/PWA Committee of Maryland, Inc. Frederick, Maryland Mardie Serenity, Programme Director, Canadian Treatment Advocates Council, Toronto, ONTARIO, CANADA Jack P. Shallow, Hayward, CA Iveta Skripste, Project Manager, Riga, LATVIA Theo Smart, Director of Treatment & Prevention Advocacy and Editor, Treatment Issues, GMHC/Gay Men's Health Crisis, New York, NY Matthew Sharp, Survive AIDS, San Francisco, CA J. Nathan Sherlock, M.D., Bloomington, IN Paul Simmons, RN, ACRN, Director of Treatment Information & Advocacy, Center for AIDS, Houston, TX Wendy Simmons, Asst. Director, Center With Out Walls, Columbus, OH Clint Spencer, Chair, CAB Hawaii Drug Assistance Program, Hawaii Sero-Positive & Medical Mgmt. Program, Hawaii Adult Aids Clinical Trials Unit, University of Hawaii, Hawaii C.A.R.E.S - Ryan White Title II Planning Group Bill Sprick, Board of Directors, Project Inform, San Francisco, CA Kenneth Stailey, Takoma Park, MD Richard Stern, Director, Agua Buena Human Rights Association, San José, COSTA RICA Victoria Stern, Columbia Science Honors Program and Spence School, New York, NY Suzanne Stoughton, RN, Ryan White Planning Council, Portland, OR Betsy Stubblefield, Assoc. Editor, Prison Project Newsletter, HEPP News, Brown University, Providence, RI Tracy Swan, Cambridge Health Alliance, Cambridge, MA Tim Teeter, RN, Assoc. Director, Treatment Support and Publications, San Francisco AIDS Foundation, San Francisco, CA Yolanda Teschner, Gloucester, VA Lilian Thiemann, CPS/PWA Health Group, New York, NY Dave Thomas, Chair, Chicago ACTG, Northwestern Medical Center, Chicago, IL Brenda Thorpe, Dallas, GA Jim Thorpe, Acworth, GA Michelle Thorpe, Acworth, GA Thomas Thorpe, Dallas, GA Enid Vasquez, Test Positive Aware, Chicago, IL Bernd Vielhaber, Editor, FaxReport (Germany), Editor HIV/AIDS Behandlung Aktiv, AUSTRIA, and German Activists Network, Berlin, GERMANY William E. Wade, DO, MPH - Family Medicine and Counseling, St. Louis, MO Steve Wakefield, Seattle, WA Tom Warne, University of Chicago, Pritzker School of Medicine, Chicago, IL Raleigh Watts, Co-Chair, Washington ADAP Program, WA 73. Gundo Weiler, Deutsche AIDS-Hilfe, Berlin, GERMANY Robert White, St. Louis, MO Brooke Willis, Special Events Chair, ACT UP Cleveland and North Coast HIV/AIDS Coalition, Cleveland, OH Hank Wilson, Survive AIDS, San Francisco, CA Ulrich Wuerdemann, Editor, HIV Nachrichten, Cologne, GERMANY Joey Wynn, FLAAC/Florida AIDS Action Council, Miami, Florida Engelbert Zankl, HIV-Therapie-Hotline, Munich, GERMANY Top of Page