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512 Understanding Expanded Access: Who are the Patients?
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- Misty Gravelin, Joan E Adamo, Sharon Ellison, Erika Segear, Amanda Parrish, Christine Deeter, Jennifer Hamill, Erik Soliz, Ahamed Idris, George A Mashour, Kevin J Weatherwax, Laurie Rigan
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- Journal:
- Journal of Clinical and Translational Science / Volume 8 / Issue s1 / April 2024
- Published online by Cambridge University Press:
- 03 April 2024, p. 152
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OBJECTIVES/GOALS: The FDA allows physicians to request clinical use of investigational drugs, biologics, and devices for patients with no satisfactory treatment options through a pathway called Expanded Access (EA). TEAMSS (Transforming Expanded Access to Maximize Support and Study) sought to examine single-patient cases to better characterize these patients. METHODS/STUDY POPULATION: We prospectively collected data on requests for single-patient EA at any one of the four collaborating TEAMSS institutions (Duke University, University of Rochester, University of Michigan, and University of Texas Southwestern) between September 1, 2021 and February 28, 2023. Regulatory and health records were reviewed for past cases that occurred between June 1, 2018 and August 31, 2021. Descriptive statistics were performed on data from the submission process, the patient demographics, the indication for treatment, and patient health status over time. RESULTS/ANTICIPATED RESULTS: The patient population was representative with respect to the largest racial groups (69.3% White / 13.0% Black or African American) and legal sex (51.3% male / 48.7% female). All ages were represented, with overrepresentation of those 60-70 years old (16.8%) and under 10 (14.8%). Patients were most often treated for infectious diseases (44.2%) or oncologic conditions (39.0%). Those who received more than one dose stayed on treatment for 76 days (median) and up to 1427 days (maximum). At the end of study, 53.9% had completed treatment as planned, moved to commercial product, or continued treatment. Death, disease progression, or failure to respond occurred for 31.9% of patients. DISCUSSION/SIGNIFICANCE: The population that receives Expanded access treatments is heterogeneous in both demographics and medical conditions. Some successful treatments are continued for years. Many patients complete their treatment, and a minority experience death or disease progression during treatment.
508 A Multi-Institutional Look at Single-Patient Expanded Access Submissions
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- Misty Gravelin, Laurie Rigan, Joan E Adamo, Sharon Ellison, Erika Segear, Amanda Parrish, Christine Deeter, Jennifer Hamill, Erik Soliz, Ahamed Idris, George A Mashour, Kevin J Weatherwax
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- Journal:
- Journal of Clinical and Translational Science / Volume 8 / Issue s1 / April 2024
- Published online by Cambridge University Press:
- 03 April 2024, pp. 150-151
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OBJECTIVES/GOALS: Physicians can request the clinical use of investigational products for their patients through an FDA pathway called Expanded Access (EA). Most evaluations of EA focus on the FDA submission only. We sought to evaluate these requests through the full academic medical center process. METHODS/STUDY POPULATION: Through the Transforming Expanded Access to Maximize Support and Study grant, we reviewed regulatory records for single-patient EA requests at four institutions (Duke University, University of Rochester, University of Michigan, and University of Texas Southwestern) which occurred between June 1, 2021 and February 28, 2023. Key data was collected, including the investigational product requested, submission and approval dates, urgency of request, and indication for treatment. Descriptive statistics were performed with Microsoft Excel. RESULTS/ANTICIPATED RESULTS: A total of 405 EA requests were identified, of which 319 (78.8%) were for drugs, 59 (14.6%) for biologics, and 27 (6.7%) for medical devices. The majority were characterized as non-emergency (60.7%), but the proportion of emergency to non-emergency cases varied considerably when stratified by year, with a peak in emergency cases in 2020. The most common products included therapies for COVID-19 and Mpox. Median time to obtain all approvals for treatment was 7 days for emergency cases and 28 days for non-emergency. The FDA review took the least time, with a median of 1 day in non-emergency cases. Full board approval from an institutional review board in non-emergency cases was 7 days. DISCUSSION/SIGNIFICANCE: These results generally align with previous reports on EA submissions received by the FDA. The timelines for the EA process represent an important benchmark both for treatment planning and institutional improvement.
National landscape assessment of academic medical center support for expanded access to investigational products
- Misty Gravelin, Joan E. Adamo, Sharon Ellison, Erika Segear, Amanda B. Parrish, Christine Deeter, Jennifer Hamill, Laurie Rigan, George A. Mashour, Kevin J. Weatherwax
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- Journal:
- Journal of Clinical and Translational Science / Volume 7 / Issue 1 / 2023
- Published online by Cambridge University Press:
- 16 November 2022, e4
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Expanded access (EA) provides a pathway for the clinical use of investigational products (drugs, biologics, and medical devices) for patients who are without satisfactory therapeutic options and for whom a clinical trial is not available. Academic medical centers (AMCs) are likely to encounter EA requests, but it is unknown what support is available at these institutions for physicians seeking EA for patients. Methods: A landscape assessment was conducted at AMCs, focused on those within the Clinical and Translational Science Awards (CTSA) consortium. Results: Forty-seven responses were evaluated including 42 CTSA hubs. The large majority (43 of 47 respondents) reported using single-patient EA, while 37 reported multi-patient industry sponsored EA and 37 reported multi-patient investigator-initiated EA. Only half reported central tracking of EA requests. Support was available at 89% of sites for single-patient EA but less often for multi-patient EA. Types of support varied and were focused largely on the initial submission to the FDA. Conclusion: Use of and support for EA is widespread at AMCs, with support focused on single-patient requests. Gaps in support are common for activities after initial submission, such as FDA reporting and data collection.
The Neutral Hydrogen Cosmological Mass Density at z = 5
- Neil H. M. Crighton, Michael T. Murphy, J. Xavier Prochaska, Gábor Worseck, Marc Rafelski, George D. Becker, Sara L. Ellison, Michele Fumagalli, Sebastian Lopez, Avery Meiksin, John M. O’Meara
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- Journal:
- Proceedings of the International Astronomical Union / Volume 11 / Issue S321 / March 2016
- Published online by Cambridge University Press:
- 21 March 2017, pp. 309-314
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- March 2016
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We present the largest homogeneous survey of redshift > 4.4 damped Lyα systems (DLAs) using the spectra of 163 quasars that comprise the Giant Gemini GMOS (GGG) survey. With this survey we make the most precise high-redshift measurement of the cosmological mass density of neutral hydrogen, ΩHI. After correcting for systematic effects using a combination of mock and higher-resolution spectra, we find ΩHI= 0.98+0.20-0.18 × 10−3 at 〈z〉 = 4.9, assuming a 20% contribution from lower column density systems below the DLA threshold. By comparing to literature measurements at lower redshifts, we show that ΩHI can be described by the functional form ΩHI(z) ∝ (1 + z)0.4. This gradual decrease from z = 5 to 0 suggests that in the galaxies which dominate the cosmic star formation rate, Hi is a transitory gas phase fuelling star formation which must be continually replenished by more highly-ionized gas from the intergalactic medium, and from recycled galactic winds.
Contributors
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- By Rose Teteki Abbey, K. C. Abraham, David Tuesday Adamo, LeRoy H. Aden, Efrain Agosto, Victor Aguilan, Gillian T. W. Ahlgren, Charanjit Kaur AjitSingh, Dorothy B E A Akoto, Giuseppe Alberigo, Daniel E. Albrecht, Ruth Albrecht, Daniel O. Aleshire, Urs Altermatt, Anand Amaladass, Michael Amaladoss, James N. Amanze, Lesley G. Anderson, Thomas C. Anderson, Victor Anderson, Hope S. Antone, María Pilar Aquino, Paula Arai, Victorio Araya Guillén, S. Wesley Ariarajah, Ellen T. Armour, Brett Gregory Armstrong, Atsuhiro Asano, Naim Stifan Ateek, Mahmoud Ayoub, John Alembillah Azumah, Mercedes L. García Bachmann, Irena Backus, J. Wayne Baker, Mieke Bal, Lewis V. Baldwin, William Barbieri, António Barbosa da Silva, David Basinger, Bolaji Olukemi Bateye, Oswald Bayer, Daniel H. Bays, Rosalie Beck, Nancy Elizabeth Bedford, Guy-Thomas Bedouelle, Chorbishop Seely Beggiani, Wolfgang Behringer, Christopher M. Bellitto, Byard Bennett, Harold V. Bennett, Teresa Berger, Miguel A. Bernad, Henley Bernard, Alan E. Bernstein, Jon L. Berquist, Johannes Beutler, Ana María Bidegain, Matthew P. Binkewicz, Jennifer Bird, Joseph Blenkinsopp, Dmytro Bondarenko, Paulo Bonfatti, Riet en Pim Bons-Storm, Jessica A. Boon, Marcus J. Borg, Mark Bosco, Peter C. Bouteneff, François Bovon, William D. Bowman, Paul S. Boyer, David Brakke, Richard E. Brantley, Marcus Braybrooke, Ian Breward, Ênio José da Costa Brito, Jewel Spears Brooker, Johannes Brosseder, Nicholas Canfield Read Brown, Robert F. Brown, Pamela K. Brubaker, Walter Brueggemann, Bishop Colin O. Buchanan, Stanley M. Burgess, Amy Nelson Burnett, J. Patout Burns, David B. Burrell, David Buttrick, James P. Byrd, Lavinia Byrne, Gerado Caetano, Marcos Caldas, Alkiviadis Calivas, William J. Callahan, Salvatore Calomino, Euan K. Cameron, William S. Campbell, Marcelo Ayres Camurça, Daniel F. Caner, Paul E. Capetz, Carlos F. Cardoza-Orlandi, Patrick W. Carey, Barbara Carvill, Hal Cauthron, Subhadra Mitra Channa, Mark D. Chapman, James H. Charlesworth, Kenneth R. Chase, Chen Zemin, Luciano Chianeque, Philip Chia Phin Yin, Francisca H. Chimhanda, Daniel Chiquete, John T. Chirban, Soobin Choi, Robert Choquette, Mita Choudhury, Gerald Christianson, John Chryssavgis, Sejong Chun, Esther Chung-Kim, Charles M. A. Clark, Elizabeth A. Clark, Sathianathan Clarke, Fred Cloud, John B. Cobb, W. Owen Cole, John A Coleman, John J. Collins, Sylvia Collins-Mayo, Paul K. Conkin, Beth A. Conklin, Sean Connolly, Demetrios J. Constantelos, Michael A. Conway, Paula M. Cooey, Austin Cooper, Michael L. Cooper-White, Pamela Cooper-White, L. William Countryman, Sérgio Coutinho, Pamela Couture, Shannon Craigo-Snell, James L. Crenshaw, David Crowner, Humberto Horacio Cucchetti, Lawrence S. Cunningham, Elizabeth Mason Currier, Emmanuel Cutrone, Mary L. Daniel, David D. Daniels, Robert Darden, Rolf Darge, Isaiah Dau, Jeffry C. Davis, Jane Dawson, Valentin Dedji, John W. de Gruchy, Paul DeHart, Wendy J. Deichmann Edwards, Miguel A. De La Torre, George E. Demacopoulos, Thomas de Mayo, Leah DeVun, Beatriz de Vasconcellos Dias, Dennis C. Dickerson, John M. Dillon, Luis Miguel Donatello, Igor Dorfmann-Lazarev, Susanna Drake, Jonathan A. Draper, N. Dreher Martin, Otto Dreydoppel, Angelyn Dries, A. J. Droge, Francis X. D'Sa, Marilyn Dunn, Nicole Wilkinson Duran, Rifaat Ebied, Mark J. Edwards, William H. Edwards, Leonard H. Ehrlich, Nancy L. Eiesland, Martin Elbel, J. Harold Ellens, Stephen Ellingson, Marvin M. Ellison, Robert Ellsberg, Jean Bethke Elshtain, Eldon Jay Epp, Peter C. Erb, Tassilo Erhardt, Maria Erling, Noel Leo Erskine, Gillian R. Evans, Virginia Fabella, Michael A. Fahey, Edward Farley, Margaret A. Farley, Wendy Farley, Robert Fastiggi, Seena Fazel, Duncan S. Ferguson, Helwar Figueroa, Paul Corby Finney, Kyriaki Karidoyanes FitzGerald, Thomas E. FitzGerald, John R. Fitzmier, Marie Therese Flanagan, Sabina Flanagan, Claude Flipo, Ronald B. Flowers, Carole Fontaine, David Ford, Mary Ford, Stephanie A. Ford, Jim Forest, William Franke, Robert M. Franklin, Ruth Franzén, Edward H. Friedman, Samuel Frouisou, Lorelei F. Fuchs, Jojo M. Fung, Inger Furseth, Richard R. Gaillardetz, Brandon Gallaher, China Galland, Mark Galli, Ismael García, Tharscisse Gatwa, Jean-Marie Gaudeul, Luis María Gavilanes del Castillo, Pavel L. Gavrilyuk, Volney P. Gay, Metropolitan Athanasios Geevargis, Kondothra M. George, Mary Gerhart, Simon Gikandi, Maurice Gilbert, Michael J. Gillgannon, Verónica Giménez Beliveau, Terryl Givens, Beth Glazier-McDonald, Philip Gleason, Menghun Goh, Brian Golding, Bishop Hilario M. Gomez, Michelle A. Gonzalez, Donald K. Gorrell, Roy Gottfried, Tamara Grdzelidze, Joel B. Green, Niels Henrik Gregersen, Cristina Grenholm, Herbert Griffiths, Eric W. Gritsch, Erich S. Gruen, Christoffer H. Grundmann, Paul H. Gundani, Jon P. Gunnemann, Petre Guran, Vidar L. Haanes, Jeremiah M. Hackett, Getatchew Haile, Douglas John Hall, Nicholas Hammond, Daphne Hampson, Jehu J. Hanciles, Barry Hankins, Jennifer Haraguchi, Stanley S. Harakas, Anthony John Harding, Conrad L. Harkins, J. William Harmless, Marjory Harper, Amir Harrak, Joel F. Harrington, Mark W. Harris, Susan Ashbrook Harvey, Van A. Harvey, R. Chris Hassel, Jione Havea, Daniel Hawk, Diana L. Hayes, Leslie Hayes, Priscilla Hayner, S. Mark Heim, Simo Heininen, Richard P. Heitzenrater, Eila Helander, David Hempton, Scott H. Hendrix, Jan-Olav Henriksen, Gina Hens-Piazza, Carter Heyward, Nicholas J. Higham, David Hilliard, Norman A. Hjelm, Peter C. Hodgson, Arthur Holder, M. Jan Holton, Dwight N. Hopkins, Ronnie Po-chia Hsia, Po-Ho Huang, James Hudnut-Beumler, Jennifer S. Hughes, Leonard M. Hummel, Mary E. Hunt, Laennec Hurbon, Mark Hutchinson, Susan E. Hylen, Mary Beth Ingham, H. Larry Ingle, Dale T. Irvin, Jon Isaak, Paul John Isaak, Ada María Isasi-Díaz, Hans Raun Iversen, Margaret C. Jacob, Arthur James, Maria Jansdotter-Samuelsson, David Jasper, Werner G. Jeanrond, Renée Jeffery, David Lyle Jeffrey, Theodore W. Jennings, David H. Jensen, Robin Margaret Jensen, David Jobling, Dale A. Johnson, Elizabeth A. Johnson, Maxwell E. Johnson, Sarah Johnson, Mark D. Johnston, F. Stanley Jones, James William Jones, John R. Jones, Alissa Jones Nelson, Inge Jonsson, Jan Joosten, Elizabeth Judd, Mulambya Peggy Kabonde, Robert Kaggwa, Sylvester Kahakwa, Isaac Kalimi, Ogbu U. Kalu, Eunice Kamaara, Wayne C. Kannaday, Musimbi Kanyoro, Veli-Matti Kärkkäinen, Frank Kaufmann, Léon Nguapitshi Kayongo, Richard Kearney, Alice A. Keefe, Ralph Keen, Catherine Keller, Anthony J. Kelly, Karen Kennelly, Kathi Lynn Kern, Fergus Kerr, Edward Kessler, George Kilcourse, Heup Young Kim, Kim Sung-Hae, Kim Yong-Bock, Kim Yung Suk, Richard King, Thomas M. King, Robert M. Kingdon, Ross Kinsler, Hans G. Kippenberg, Cheryl A. Kirk-Duggan, Clifton Kirkpatrick, Leonid Kishkovsky, Nadieszda Kizenko, Jeffrey Klaiber, Hans-Josef Klauck, Sidney Knight, Samuel Kobia, Robert Kolb, Karla Ann Koll, Heikki Kotila, Donald Kraybill, Philip D. W. Krey, Yves Krumenacker, Jeffrey Kah-Jin Kuan, Simanga R. Kumalo, Peter Kuzmic, Simon Shui-Man Kwan, Kwok Pui-lan, André LaCocque, Stephen E. Lahey, John Tsz Pang Lai, Emiel Lamberts, Armando Lampe, Craig Lampe, Beverly J. Lanzetta, Eve LaPlante, Lizette Larson-Miller, Ariel Bybee Laughton, Leonard Lawlor, Bentley Layton, Robin A. Leaver, Karen Lebacqz, Archie Chi Chung Lee, Marilyn J. Legge, Hervé LeGrand, D. L. LeMahieu, Raymond Lemieux, Bill J. Leonard, Ellen M. Leonard, Outi Leppä, Jean Lesaulnier, Nantawan Boonprasat Lewis, Henrietta Leyser, Alexei Lidov, Bernard Lightman, Paul Chang-Ha Lim, Carter Lindberg, Mark R. Lindsay, James R. Linville, James C. Livingston, Ann Loades, David Loades, Jean-Claude Loba-Mkole, Lo Lung Kwong, Wati Longchar, Eleazar López, David W. Lotz, Andrew Louth, Robin W. Lovin, William Luis, Frank D. Macchia, Diarmaid N. J. MacCulloch, Kirk R. MacGregor, Marjory A. MacLean, Donald MacLeod, Tomas S. Maddela, Inge Mager, Laurenti Magesa, David G. Maillu, Fortunato Mallimaci, Philip Mamalakis, Kä Mana, Ukachukwu Chris Manus, Herbert Robinson Marbury, Reuel Norman Marigza, Jacqueline Mariña, Antti Marjanen, Luiz C. L. Marques, Madipoane Masenya (ngwan'a Mphahlele), Caleb J. D. Maskell, Steve Mason, Thomas Massaro, Fernando Matamoros Ponce, András Máté-Tóth, Odair Pedroso Mateus, Dinis Matsolo, Fumitaka Matsuoka, John D'Arcy May, Yelena Mazour-Matusevich, Theodore Mbazumutima, John S. McClure, Christian McConnell, Lee Martin McDonald, Gary B. McGee, Thomas McGowan, Alister E. McGrath, Richard J. McGregor, John A. McGuckin, Maud Burnett McInerney, Elsie Anne McKee, Mary B. McKinley, James F. McMillan, Ernan McMullin, Kathleen E. McVey, M. Douglas Meeks, Monica Jyotsna Melanchthon, Ilie Melniciuc-Puica, Everett Mendoza, Raymond A. Mentzer, William W. Menzies, Ina Merdjanova, Franziska Metzger, Constant J. Mews, Marvin Meyer, Carol Meyers, Vasile Mihoc, Gunner Bjerg Mikkelsen, Maria Inêz de Castro Millen, Clyde Lee Miller, Bonnie J. Miller-McLemore, Alexander Mirkovic, Paul Misner, Nozomu Miyahira, R. W. L. Moberly, Gerald Moede, Aloo Osotsi Mojola, Sunanda Mongia, Rebeca Montemayor, James Moore, Roger E. Moore, Craig E. Morrison O.Carm, Jeffry H. Morrison, Keith Morrison, Wilson J. Moses, Tefetso Henry Mothibe, Mokgethi Motlhabi, Fulata Moyo, Henry Mugabe, Jesse Ndwiga Kanyua Mugambi, Peggy Mulambya-Kabonde, Robert Bruce Mullin, Pamela Mullins Reaves, Saskia Murk Jansen, Heleen L. Murre-Van den Berg, Augustine Musopole, Isaac M. T. Mwase, Philomena Mwaura, Cecilia Nahnfeldt, Anne Nasimiyu Wasike, Carmiña Navia Velasco, Thulani Ndlazi, Alexander Negrov, James B. Nelson, David G. Newcombe, Carol Newsom, Helen J. Nicholson, George W. E. Nickelsburg, Tatyana Nikolskaya, Damayanthi M. A. Niles, Bertil Nilsson, Nyambura Njoroge, Fidelis Nkomazana, Mary Beth Norton, Christian Nottmeier, Sonene Nyawo, Anthère Nzabatsinda, Edward T. Oakes, Gerald O'Collins, Daniel O'Connell, David W. Odell-Scott, Mercy Amba Oduyoye, Kathleen O'Grady, Oyeronke Olajubu, Thomas O'Loughlin, Dennis T. Olson, J. Steven O'Malley, Cephas N. Omenyo, Muriel Orevillo-Montenegro, César Augusto Ornellas Ramos, Agbonkhianmeghe E. Orobator, Kenan B. Osborne, Carolyn Osiek, Javier Otaola Montagne, Douglas F. Ottati, Anna May Say Pa, Irina Paert, Jerry G. Pankhurst, Aristotle Papanikolaou, Samuele F. Pardini, Stefano Parenti, Peter Paris, Sung Bae Park, Cristián G. Parker, Raquel Pastor, Joseph Pathrapankal, Daniel Patte, W. Brown Patterson, Clive Pearson, Keith F. Pecklers, Nancy Cardoso Pereira, David Horace Perkins, Pheme Perkins, Edward N. Peters, Rebecca Todd Peters, Bishop Yeznik Petrossian, Raymond Pfister, Peter C. Phan, Isabel Apawo Phiri, William S. F. Pickering, Derrick G. Pitard, William Elvis Plata, Zlatko Plese, John Plummer, James Newton Poling, Ronald Popivchak, Andrew Porter, Ute Possekel, James M. Powell, Enos Das Pradhan, Devadasan Premnath, Jaime Adrían Prieto Valladares, Anne Primavesi, Randall Prior, María Alicia Puente Lutteroth, Eduardo Guzmão Quadros, Albert Rabil, Laurent William Ramambason, Apolonio M. Ranche, Vololona Randriamanantena Andriamitandrina, Lawrence R. Rast, Paul L. Redditt, Adele Reinhartz, Rolf Rendtorff, Pål Repstad, James N. Rhodes, John K. Riches, Joerg Rieger, Sharon H. Ringe, Sandra Rios, Tyler Roberts, David M. Robinson, James M. Robinson, Joanne Maguire Robinson, Richard A. H. Robinson, Roy R. Robson, Jack B. Rogers, Maria Roginska, Sidney Rooy, Rev. Garnett Roper, Maria José Fontelas Rosado-Nunes, Andrew C. Ross, Stefan Rossbach, François Rossier, John D. Roth, John K. Roth, Phillip Rothwell, Richard E. Rubenstein, Rosemary Radford Ruether, Markku Ruotsila, John E. Rybolt, Risto Saarinen, John Saillant, Juan Sanchez, Wagner Lopes Sanchez, Hugo N. Santos, Gerhard Sauter, Gloria L. Schaab, Sandra M. Schneiders, Quentin J. Schultze, Fernando F. Segovia, Turid Karlsen Seim, Carsten Selch Jensen, Alan P. F. Sell, Frank C. Senn, Kent Davis Sensenig, Damían Setton, Bal Krishna Sharma, Carolyn J. Sharp, Thomas Sheehan, N. Gerald Shenk, Christian Sheppard, Charles Sherlock, Tabona Shoko, Walter B. Shurden, Marguerite Shuster, B. Mark Sietsema, Batara Sihombing, Neil Silberman, Clodomiro Siller, Samuel Silva-Gotay, Heikki Silvet, John K. Simmons, Hagith Sivan, James C. Skedros, Abraham Smith, Ashley A. Smith, Ted A. Smith, Daud Soesilo, Pia Søltoft, Choan-Seng (C. S.) Song, Kathryn Spink, Bryan Spinks, Eric O. Springsted, Nicolas Standaert, Brian Stanley, Glen H. Stassen, Karel Steenbrink, Stephen J. Stein, Andrea Sterk, Gregory E. Sterling, Columba Stewart, Jacques Stewart, Robert B. Stewart, Cynthia Stokes Brown, Ken Stone, Anne Stott, Elizabeth Stuart, Monya Stubbs, Marjorie Hewitt Suchocki, David Kwang-sun Suh, Scott W. Sunquist, Keith Suter, Douglas Sweeney, Charles H. Talbert, Shawqi N. Talia, Elsa Tamez, Joseph B. Tamney, Jonathan Y. Tan, Yak-Hwee Tan, Kathryn Tanner, Feiya Tao, Elizabeth S. Tapia, Aquiline Tarimo, Claire Taylor, Mark Lewis Taylor, Bishop Abba Samuel Wolde Tekestebirhan, Eugene TeSelle, M. Thomas Thangaraj, David R. Thomas, Andrew Thornley, Scott Thumma, Marcelo Timotheo da Costa, George E. “Tink” Tinker, Ola Tjørhom, Karen Jo Torjesen, Iain R. Torrance, Fernando Torres-Londoño, Archbishop Demetrios [Trakatellis], Marit Trelstad, Christine Trevett, Phyllis Trible, Johannes Tromp, Paul Turner, Robert G. Tuttle, Archbishop Desmond Tutu, Peter Tyler, Anders Tyrberg, Justin Ukpong, Javier Ulloa, Camillus Umoh, Kristi Upson-Saia, Martina Urban, Monica Uribe, Elochukwu Eugene Uzukwu, Richard Vaggione, Gabriel Vahanian, Paul Valliere, T. J. Van Bavel, Steven Vanderputten, Peter Van der Veer, Huub Van de Sandt, Louis Van Tongeren, Luke A. Veronis, Noel Villalba, Ramón Vinke, Tim Vivian, David Voas, Elena Volkova, Katharina von Kellenbach, Elina Vuola, Timothy Wadkins, Elaine M. Wainwright, Randi Jones Walker, Dewey D. Wallace, Jerry Walls, Michael J. Walsh, Philip Walters, Janet Walton, Jonathan L. Walton, Wang Xiaochao, Patricia A. Ward, David Harrington Watt, Herold D. Weiss, Laurence L. Welborn, Sharon D. Welch, Timothy Wengert, Traci C. West, Merold Westphal, David Wetherell, Barbara Wheeler, Carolinne White, Jean-Paul Wiest, Frans Wijsen, Terry L. Wilder, Felix Wilfred, Rebecca Wilkin, Daniel H. Williams, D. Newell Williams, Michael A. Williams, Vincent L. Wimbush, Gabriele Winkler, Anders Winroth, Lauri Emílio Wirth, James A. Wiseman, Ebba Witt-Brattström, Teofil Wojciechowski, John Wolffe, Kenman L. Wong, Wong Wai Ching, Linda Woodhead, Wendy M. Wright, Rose Wu, Keith E. Yandell, Gale A. Yee, Viktor Yelensky, Yeo Khiok-Khng, Gustav K. K. Yeung, Angela Yiu, Amos Yong, Yong Ting Jin, You Bin, Youhanna Nessim Youssef, Eliana Yunes, Robert Michael Zaller, Valarie H. Ziegler, Barbara Brown Zikmund, Joyce Ann Zimmerman, Aurora Zlotnik, Zhuo Xinping
- Edited by Daniel Patte, Vanderbilt University, Tennessee
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- The Cambridge Dictionary of Christianity
- Published online:
- 05 August 2012
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- 20 September 2010, pp xi-xliv
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Genotyping the Future: Scientists' Expectations about Race/Ethnicity after BiDil
- Richard Tutton, Andrew Smart, Paul A. Martin, Richard Ashcroft, George T. H. Ellison
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- Journal:
- Journal of Law, Medicine & Ethics / Volume 36 / Issue 3 / Fall 2008
- Published online by Cambridge University Press:
- 01 January 2021, pp. 464-470
- Print publication:
- Fall 2008
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In a recent discussion about how scientific knowledge might potentially change our understanding of the nature and extent of human genetic, cultural, or biological variation, the sociologist David Skinner identified two competing visions of the future: one that was decidedly dystopian, which conjured up a “re-racialized” future, and an opposing utopian future in which the potential for racialized thinking might be finally overcome. We can situate the ongoing debates about the congestive heart failure drug BiDil, approved by the Food and Drug Administration (FDA) for use only by African Americans, in relation to these differing future prospects.
When the FDA announced its approval of BiDil in June 2005, it located the drug, and perhaps the future of pharmaceutical development, within a particular vision of the future, heralding BiDil as “representing a step toward the promise of personalized medicine.” The discourse of “personalized medicine” can be characterized as part of a utopian future, one in which clinicians will be able to make increasingly individualized decisions based on each patient’s genetic makeup so that the drugs they take will be those that work best for them.
Flaws in the U.S. Food and Drug Administration's Rationale for Supporting the Development and Approval of BiDil as a Treatment for Heart Failure Only in Black Patients
- George T. H. Ellison, Jay S. Kaufman, Rosemary F. Head, Paul A. Martin, Jonathan D. Kahn
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- Journal:
- Journal of Law, Medicine & Ethics / Volume 36 / Issue 3 / Fall 2008
- Published online by Cambridge University Press:
- 01 January 2021, pp. 449-457
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- Fall 2008
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There is likely to be widespread agreement with much of the FDA’s rationale for approving BiDil (a combination of hydralazine hydrochloride and isosorbide dinitrate; H-I) as a treatment for heart failure. In particular, most would agree that the evidence of effectiveness provided by the African American Heart Failure Trial (A-HeFT) is compelling. Likewise, few health scientists would believe that it is either necessary or responsible to withhold therapies such as BiDil from those who might benefit until there is a full understanding of how they work. And although there is substantial concern that biomedical differences between racial groups are routinely misinterpreted as evidence of innate genetic differences (hence Jonathan Kahn’s call for all such claims to be supported by genetic evidence), most would concede that using race as a “descriptive” variable can help identify differences in health and access/response to treatment that might warrant further investigation or intervention.
Can Science Alone Improve the Measurement and Communication of Race and Ethnicity in Genetic Research? Exploring the Strategies Proposed by Nature Genetics
- Andrew Smart, Richard Tutton, Richard Ashcroft, Paul A. Martin, George T.H. Ellison
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- Journal:
- BioSocieties / Volume 1 / Issue 3 / September 2006
- Published online by Cambridge University Press:
- 25 October 2006, pp. 313-324
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- September 2006
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The long-standing concerns about the measurement and communication of race and ethnicity in genetic research have spilled over into the editorial columns of a growing number of biomedical journals. Nature Genetics has played a prominent role in this debate with a series of editorials published between 2000–2004, culminating in the publication of an open-access Special Issue (Genetics for the human race) in November 2004. The Special Issue brought together contemporary research on the relationship between race, ethnicity and genetic variation, and a range of views on the social and ethical implications of this research. In this article we analyse interviews with each of three the editors in charge of Nature Genetics during this period to show that scientific concerns related to the measurement and communication of race and ethnicity in genetic research had been responsible for making this a ‘special issue’ for the journal. Two broad strategies for tackling these concerns were identified from an analysis of contributions to the Special Issue: continuing to use racial and ethnic categories until such time as these become obsolete; or replacing racial and ethnic categories with alternatives based on socio-cultural and geographical ancestry. We also identified additional suggestions for improving the communication of genetic findings disaggregated by race or ethnicity, which were: developing guidelines for measurement and interpretation; and greater ‘community engagement’. We argue that neither of the broad strategies and neither of the suggestions for improving communication can be wholly effective. We suggest that this is because these proposals do not adequately confront the notion that race and ethnicity are difficult concepts to operationalize or examine in scientific research precisely because they have meanings and uses which exist beyond the domain of scientific practice or control.
ANTHROPOLOGICAL INSIGHTS INTO THE USE OF RACE/ETHNICITY TO EXPLORE GENETIC CONTRIBUTIONS TO DISPARITIES IN HEALTH
- SIMON M. OUTRAM, GEORGE T. H. ELLISON
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- Journal:
- Journal of Biosocial Science / Volume 38 / Issue 1 / January 2006
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- 03 November 2005, pp. 83-102
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Anthropological insights into the use of race/ethnicity to explore genetic contributions to disparities in health were developed using in-depth qualitative interviews with editorial staff from nineteen genetics journals, focusing on the methodological and conceptual mechanisms required to make race/ethnicity a genetic variable. As such, these analyses explore how and why race/ethnicity comes to be used in the context of genetic research, set against the background of continuing critiques from anthropology and related human sciences that focus on the social construction, structural correlates and limited genetic validity of racial/ethnic categories. The analyses demonstrate how these critiques have failed to engage geneticists, and how geneticists use a range of essentially cultural devices to protect and separate their use of race/ethnicity as a genetic construct from its use as a societal and social science resource. Given its multidisciplinary, biosocial nature and the cultural gaze of its ethnographic methodologies, anthropology is well placed to explore the cultural separation of science and society, and of natural and social science disciplines. Anthropological insights into the use of race/ethnicity to explore disparities in health suggest that moving beyond genetic explanations of innate difference might benefit from a more even-handed critique of how both the natural and social sciences tend to essentialize selective elements of race/ethnicity. Drawing on the example of HIV/AIDS, this paper demonstrates how public health has been undermined by the use of race/ethnicity as an analytical variable, both as a cipher for innate genetic differences in susceptibility and response to treatment, and in its use to identify ‘core groups’ at greater risk of becoming infected and infecting others. Clearly, a tendency for biological reductionism can place many biomedical issues beyond the scope of public health interventions, while socio-cultural essentialization has tended to stigmatize ‘unhealthy behaviours’ and the communities where these are more prevalent.
List of contributors
- Edited by George Ellison, South Bank University, London, Melissa Parker, Brunel University, Catherine Campbell, London School of Economics and Political Science
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- Learning from HIV and AIDS
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- 14 January 2010
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- 30 October 2003, pp ix-x
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10 - Postscript: reflections on HIV/AIDS and history
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- By Shula Marks, Professor, School of Oriental and African Studies, University of London, London, WC1H 0XG, George T. H. Ellison, Professor of Public Health and Director of the Institute of Primary Care and Public Health, South Bank University, London
- Edited by George Ellison, South Bank University, London, Melissa Parker, Brunel University, Catherine Campbell, London School of Economics and Political Science
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- Learning from HIV and AIDS
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- 14 January 2010
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- 30 October 2003, pp 268-292
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Summary
Some 10 years ago, the British medical historian Virginia Berridge (1992a: 326), strikingly declared: ‘History and historians have had a significant role in interpreting the AIDS epidemic … History, in some national responses to AIDS, became a direct policy-relevant science.’ At the outset, she argued, history was used in two ways: as a form of background knowledge; and as ‘“historical partisanship”, the use of historical example to advance particular policy positions’ (Berridge, 1992a: 326). It entered the policy debate directly and, at least in the UK, ensured a liberal non-punitive approach to people with HIV/AIDS. Analysing the chapters in the pioneering volume edited by Elizabeth Fee and Daniel Fox (1989) she showed how, in the early days of the disease, the presence of historians at international conferences was assiduously courted in the United States and the UK. They were called on to deal with earlier public health and popular responses to the spread of infectious (especially sexually transmitted) disease – quarantine and compulsory vaccination – all of which had relevance to the contemporary debate. Even more surprisingly, she maintained, leading medical authorities (notably Sir Donald Acheson, Chief Medical Officer at the Department of Health, and Michael Adler at the Middlesex Hospital) had themselves drawn direct analogies with the past and addressed historical precedents in their advocacy of a liberal public health policy (Berridge, 1992b; see also: Berridge, 1992a; Berridge and Strong, 1993; Berridge, 1996).
Learning from HIV and AIDS
- Edited by George Ellison, Melissa Parker, Catherine Campbell
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- Published online:
- 14 January 2010
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- 30 October 2003
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Different professional and academic disciplines have addressed the HIV/AIDS pandemic from a variety of perspectives, using different analytical approaches. By bringing these together in one volume, Learning from HIV/AIDS provides a more complete picture of this multi-faceted disease - from the biological and social factors which facilitate HIV transmission - to the powerful cultural and political forces which fuel the pandemic. Chapters from contributors working on the aetiology, treatment and prevention of HIV/AIDS identify how their work has helped predict the spread of HIV and has improved the survival of those infected. Yet interventions to reduce the spread of HIV have had limited success, and few HIV-infected individuals have access to combination drug therapies. Written for students and researchers, and taking an interdisciplinary perspective, this book demonstrates that progress in developing effective and acceptable interventions can only be achieved through collaboration between the biological, medical and social sciences.
Contents
- Edited by George Ellison, South Bank University, London, Melissa Parker, Brunel University, Catherine Campbell, London School of Economics and Political Science
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- Learning from HIV and AIDS
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- 14 January 2010
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- 30 October 2003, pp vii-viii
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Country index
- Edited by George Ellison, South Bank University, London, Melissa Parker, Brunel University, Catherine Campbell, London School of Economics and Political Science
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- Learning from HIV and AIDS
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- 14 January 2010
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- 30 October 2003, pp 293-294
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1 - Introduction. Learning from HIV and AIDS: from multidisciplinary to interdisciplinarity
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- By George T. H. Ellison, Professor of Public Health and Director of the Institute of Primary Care and Public Health, South Bank University, London, Melissa Parker, Director of the International Medical Anthropology Programme, Brunel University in London, Catherine Campbell, Reader in Social Psychology, London School of Economics and Political Science; Professor, University of Natal, Durban
- Edited by George Ellison, South Bank University, London, Melissa Parker, Brunel University, Catherine Campbell, London School of Economics and Political Science
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- Learning from HIV and AIDS
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- 14 January 2010
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- 30 October 2003, pp 1-31
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Summary
This disease is not like any other … in the 20 years since the disease was recognised, more than 20 million people have died from it. Another 40 million are infected. New infections are occurring at the rate of 15,000 a day, and the rate is still increasing. Unless there is a significant change for the better almost all these people will die.
The Economist, July 11th 2002[A]t current infection rates, AIDS, the deadliest epidemic in human history, will kill 68 million people in the 45 most affected countries over the next 20 years …”
Peter Piot, Executive Director of UNAIDS, writing in the New York Times in July 2002‘Learning from HIV and AIDS’ – a multidisciplinary symposium of the UK BioSocial Society
Mindful of the extraordinary contribution made by health professionals, academics, policy makers and the communities worst affected to understand and respond to HIV/AIDS, the UK BioSocial Society invited representatives from these groups to a multidisciplinary symposium held at the Institute of Education in May 2001. The sheer scale of the HIV/AIDS pandemic has resulted in unprecedented research activity, both theoretical and applied, and has led to a huge array of formal and informal publications (ranging from dedicated academic journals and professional texts, to local newsletters and global websites). For the most part, however, these cover responses to HIV/AIDS – at the individual-, familial-, communal-, institutional-, national-, regional- and global-level.
5 - What have clinicians learnt from working with HIV/AIDS? A medical perspective from London
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- By Chris G. A. Wood, HIV Unit, North Middlesex University Hospital, London N18 1QX, UK, George T. H. Ellison, Professor of Public Health and Director of the Institute of Primary Care and Public Health, South Bank University, London
- Edited by George Ellison, South Bank University, London, Melissa Parker, Brunel University, Catherine Campbell, London School of Economics and Political Science
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- Learning from HIV and AIDS
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- 30 October 2003, pp 111-147
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Summary
Introduction
This chapter sets out to provide a narrative account of learning from HIV and AIDS drawn from the perspective of a clinician (CW) who has been working with HIV/AIDS patients in London since 1990. It draws on CW's clinical experience gained during his initial specialist HIV training at the Chelsea and Westminster Hospital in Central London from 1990 to 1993, and on his experiences of working at the HIV Unit at the North Middlesex University Hospital (NMUH), a district general hospital in Edmonton), and in the Sexual Health Centre at St Ann's Hospital in Tottenham, both in North London. The community served by these two hospitals might best be described as ‘inner–outer London’ – a multicultural, multiethnic community with a large and diverse population comprising long-term residents and recent immigrants, including refugees and asylum seekers, living in an area with high levels of social deprivation, unemployment and welfare support. This local community happens to reflect the pattern of HIV infection globally and therefore provides an ideal setting from which to consider the impact of the disease on clinical perspectives and clinical practice, as well as some of the social and cultural dimensions of HIV/AIDS in the UK.
By reflecting on clinical practice this chapter aims to demonstrate how, despite the changing clinical context of HIV/AIDS in London, the barriers to treatment and therapy are common to many of the groups most at risk.
Subject index
- Edited by George Ellison, South Bank University, London, Melissa Parker, Brunel University, Catherine Campbell, London School of Economics and Political Science
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- Learning from HIV and AIDS
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- 14 January 2010
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- 30 October 2003, pp 295-299
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Frontmatter
- Edited by George Ellison, South Bank University, London, Melissa Parker, Brunel University, Catherine Campbell, London School of Economics and Political Science
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- Book:
- Learning from HIV and AIDS
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- 14 January 2010
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- 30 October 2003, pp i-vi
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