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MDMA Is Not Ecstasy: The Production of Pharmaceutical Safety through Documents in Clinical Trials
dc.contributor.authorHendy, Katherine
dc.date.accessioned2021-04-06T02:15:44Z
dc.date.available2022-04-05 22:15:43en
dc.date.available2021-04-06T02:15:44Z
dc.date.issued2021-03
dc.identifier.citationHendy, Katherine (2021). "MDMA Is Not Ecstasy: The Production of Pharmaceutical Safety through Documents in Clinical Trials." Medical Anthropology Quarterly 35(1): 5-24.
dc.identifier.issn0745-5194
dc.identifier.issn1548-1387
dc.identifier.urihttps://hdl.handle.net/2027.42/167133
dc.description.abstractNonprofit efforts to develop ±3,4‐methylenedioxymethamphetamine (MDMA)—better known as the street drug Ecstasy—as a prescription pharmaceutical provide the opportunity to examine recent theorizations of pharmaceuticals as fluid objects transformed in new informational and material environments. Drawing from ethnographic research, this article interrogates MDMA researchers’ own distinction between MDMA and the street drug Ecstasy. While researchers maintain that pure MDMA is distinct from Ecstasy, this article argues that the difference between the two hangs not on a distinction in substance, but on a distinction in safety that must be produced through the trial. This article tracks the production of safety through the inter‐connected work of clinical documents, which manage both which bodies are allowed to absorb the drug and which bodily events count as effects. MDMA’s safety emerges from the careful management of relations through these documentary practices.
dc.publisherWiley Periodicals, Inc.
dc.publisherDuke University Press
dc.subject.otherclinical trials
dc.subject.otherknowledge production
dc.subject.otherpharmaceuticals
dc.subject.otherpsychedelics
dc.subject.otherscience studies
dc.titleMDMA Is Not Ecstasy: The Production of Pharmaceutical Safety through Documents in Clinical Trials
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelMedicine (General)
dc.subject.hlbsecondlevelAnthropology
dc.subject.hlbtoplevelHealth Sciences
dc.subject.hlbtoplevelSocial Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/167133/1/maq12548_am.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/167133/2/maq12548.pdf
dc.identifier.doi10.1111/maq.12548
dc.identifier.sourceMedical Anthropology Quarterly
dc.identifier.citedreferencePersson, A., C. E. Newman, L. Mao, and J. de Wit. 2016. On the Margins of Pharmaceutical Citizenship: Not Taking HIV Medication in the:“Treatment Revolution” Era. Medical Anthropology Quarterly 30: 359 – 77.
dc.identifier.citedreferenceParrott, A., R. Milani, R. Parmar, and J. Turner. 2001. Recreational Ecstasy/MDMA and Other Drug Users from the UK and Italy: Psychiatric Symptoms and Psychobiological Problems. Psychopharmacology 159: 77 – 82.
dc.identifier.citedreferencePeterson, K. 2014. Speculative Markets: Drug Circuits and Derivative Life in Nigeria. Durham: Duke University Press.
dc.identifier.citedreferencePetryna, A. 2009. When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. Princeton, NJ: Princeton University Press.
dc.identifier.citedreferenceRajan, K. Sunder. 2017. Pharmocracy: Value, Politics and Knowledge in Global Biomedicine. Durham: Duke University Press.
dc.identifier.citedreferenceRicaurte, G., L. Forno, M. Wilson, L. Delanney, I. Irwin, M. Molliver, and J. Langston. 1988. (±)3,4‐Methylenedioxymethamphetamine Selectively Damages Central Serotonergic Neurons in Nonhuman Primates. Journal of the American Medical Association 260: 51 – 55.
dc.identifier.citedreferenceRicaurte, G., J. Yuan, G. Hatzidimitriou, J. Branden, and U. McCann. 2002. Severe Dopaminergic Neurotoxicity in Primates after a Common Recreational Dose Regimen of MDMA (“Ecstasy”). Science 297: 2260 – 63.
dc.identifier.citedreferenceRicaurte, G., J. Yuan, G. Hatzidimitriou, J. Branden, and U. McCann. 2003. Retraction. Science 301: 1479.
dc.identifier.citedreferenceRicaurte, G., J. Yuan, and U. McCann. 2000. (±3),4‐Methylenedioxymethamphetamine (“Ecstasy”)‐Induced Serotonin Neurotoxicity: Studies in Animals. Neuropsychobiology 42: 5 – 10.
dc.identifier.citedreferenceRosenbaum, M. 2002. Ecstasy: America’s New “Reefer Madness.” Journal of Psychoactive Drugs 34: 137 – 42.
dc.identifier.citedreferenceSaethre, E., and J. Stadler. 2013. Malicious Whites, Greedy Women, and Virtuous Volunteers: Negotiating Social Relations through Clinical Trial Narratives in South Africa Clinical Trial Narratives in South Africa. Medical Anthropology Quarterly 27: 103 – 20.
dc.identifier.citedreferenceSanabria, E. 2016. Plastic Bodies: Sex Hormones and Menstrual Supression in Brazil. Durham: Duke University Press.
dc.identifier.citedreferenceSanabria, E., and A. Hardon. 2017. Fluid Drugs: Revisiting the Anthropology of Pharmaceuticals. Annual Review of Anthropology 46: 117 – 32.
dc.identifier.citedreferenceSchroder, T. 2014. Acid Test: LSD, Ecstasy, and the Power to Heal. New York: Blue Rider Press.
dc.identifier.citedreferenceStolaroff, M. J. 2004. The Secret Chief: Conversations with a Pioneer of the Underground Psychedelic Therapy Movement. Santa Cruz, CA: Multidisciplinary Association for Psychedelic Studies.
dc.identifier.citedreferenceTseng, S., G. Pak, K. Washenik, M. Keltz Pomeranz, and J. L Shupack. 1996. Clinical Review: Rediscovering Thalidomide: A Review of Its Mechanism of Action, Side Effects, and Potential Uses. Journal of American Academy of Dermatology 35: 969 – 79.
dc.identifier.citedreferencevan der Geest, S., and S. R. Whyte. 1991. The Context of Medicines in Developing Countries: Studies in Pharmaceutical Anthropology. Amsterdam: Het Spinhuis.
dc.identifier.citedreferencevan der Geest, S., S. R. Whyte, and A. Hardon. 1996. The Anthropology of Pharmaceuticals: A Biographical Approach. Annual Review of Anthropology 25: 153 – 78.
dc.identifier.citedreferenceVollenweider, F., A. Gamma, M. Liechti, and T. Huber. 1999. Is a Single Dose of MDMA Harmless? Neuropsychopharmacology 21: 598 – 600.
dc.identifier.citedreferenceVollenweider, F., R. Jones, and M. Baggott. 2001. Caveat Emptor: Editors Beware. Neuropsychopharmacology 24: 461 – 63.
dc.identifier.citedreferenceWhitmarsh, I. A. N. 2008. Biomedical Ambivalence: Asthma Diagnosis, the Pharmaceutical, and Other Contradictions in Barbados. American Ethnologist 35: 49 – 63.
dc.identifier.citedreferenceWolfson, P. E. 1986. Meetings at the Edge with Adam: A Man for All Seasons? Journal of Psychoactive Drugs 18: 329 – 23.
dc.identifier.citedreferenceYear‐end 2000 Emergency Department Data from the Drug Abuse Warning Network. 2001. DAWN Series D‐18, 1–115. Rockville, MD: DHHS Publications.
dc.identifier.citedreferenceHunt, G., M. Moloney, and K. Evans. 2010. Youth, Drugs and Nightlife. New York: Routledge.
dc.identifier.citedreferenceHolland, J., ed. 2001. Ecstasy: The Complete Guide. Rochester, VT: Park Street Press.
dc.identifier.citedreferenceHull, M. S. 2012. Documents and Bureaucracy. Annual Review of Anthropology 41: 251 – 67.
dc.identifier.citedreferenceAbadie, R. 2010. The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects. Durham: Duke University Press.
dc.identifier.citedreferenceBargaje, C. 2011. Good Documentation in Clinical Research. Perspectives in Clinical Research 2: 59 – 63.
dc.identifier.citedreferenceBarry, A. 2005. Pharmaceutical Matters: The Invention of Informed Materials. Theory, Culture & Society 22: 51 – 69.
dc.identifier.citedreferenceBiehl, J. 2004. The Activist State: Global Pharmaceuticals, AIDS, and Citizenship in Brazil. Social Text: 105 – 32.
dc.identifier.citedreferenceBiehl, J. 2013. The Judicialization of Biopolitics: Claiming the Right to Pharmaceuticals in Brazilian Courts. American Ethnologist 40: 419 – 36.
dc.identifier.citedreferenceBrady, K, T. Pearlstein, G. M. Asnis, B. Rothbaum, C. R. Sikes, and G. M. Farfel. 2000. Efficacy and Safety of Sertraline Treatment of Posttraumatic Stress Disorder. Journal of American Medical Association 283: 1837 – 44.
dc.identifier.citedreferenceCraddock, S. 2004. AIDS and Ethics: Clinical Trials Pharmaceuticals and Global Scientific Practice. In HIV and AIDS in Africa: Beyond Epidemiology edited by E. Kalipeni, S. Craddock, J. Oppong, and J. Ghosh, 240 – 51. Oxford: Blackwell Publishing.
dc.identifier.citedreferenceDoblin, R. 2002. A Clinical Plan for MDMA (Ecstasy) in the Treatment of Post‐traumatic Stress Disorder (PTSD): Partnering with the FDA. Journal of Psychoactive Drugs 342: 185 – 94.
dc.identifier.citedreferenceDrug and Chemical Evaluation Section. 2013. 3,4‐METHYLENEDIOXYMETHAMPHETAMINE. https://www.deadiversion.usdoj.gov/drug_chem_info/ (accessed July 19, 2019).
dc.identifier.citedreferenceDumit, J. 2012. Drugs for Life: How Pharmaceutical Companies Define Our Health. Durham: Duke University Press.
dc.identifier.citedreferenceDyck, E. 2008. Psychedelic Psychiatry: LSD from Clinic to Campus. Baltimore: Johns Hopkins Univeristy Press.
dc.identifier.citedreferenceEcks, S. 2005. Pharmaceutical Citizenship: Antidepressant Marketing and the Promise of Demarginalization in India Pharmaceutical Citizenship. Anthropology and Medicine 12: 239 – 54.
dc.identifier.citedreferenceFisher, J. 2009. Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. New Brunswick, NJ: Rutgers University Press.
dc.identifier.citedreferenceFreudenmann, R. W., F. Oxler, and S. Bernschneider‐Reif. 2006. The Origin of MDMA (Ecstasy) Revisited: The True Story Reconstructed from the Original Documents. Addiction 101: 1241 – 45.
dc.identifier.citedreferenceGouzoulis‐Mayfrank, E., and J. Daumann. 2006. The Confounding Problem of Polydrug Use in Recreational Ecstasy/MDMA Users: A Brief Overview. Journal of Psychopharmacology 20: 188 – 93.
dc.identifier.citedreferenceGreene, J. 2014. Generic: The Unbranding of American Medicine. Baltimore: Johns Hopkins Univeristy Press.
dc.identifier.citedreferenceGreenslit, N. 2005. Depression and Consumption: Psychopharmaceuticals, Branding, and New Identity Practices. Culture, Medicine Psychiatry 29: 477 – 501.
dc.identifier.citedreferenceGreer, G., and R. Tolbert. 1986. Subjective Reports of the Effects of MDMA in a Clinical Setting. Journal of Psychoactive Drugs 18: 319 – 27.
dc.identifier.citedreferenceGrob, C. 2000. Deconstructing Ecstasy: The Politics of MDMA Research. Addiction Research & Theory 8: 549 – 88.
dc.identifier.citedreferenceGrob, C., G. Bravo, R. Walsh, and M. Liester. 1992. The MDMA‐Neurotoxicity Controversy: Implications for Clinical Research with Novel Psychoative Drugs. The Journal of Nervous and Mental Disease 180: 355 – 56.
dc.identifier.citedreferenceHalpern, J. H., H. G. Pope, Jr., A. R. Sherwood, S. Barry, J. I. Hudson, and D. Yurgelun‐Todd. 2004. Residual Neuropsychological Effects of Illicit 3,4‐methylenedioxymethamphetamine (MDMA) in Individuals with Minimal Exposure to Other Drugs. Drug and Alcohol Dependence 75: 135 – 47.
dc.identifier.citedreferenceHayden, C. 2007. A Generic Solution? Pharmaceuticals and the Politics of the Similar in Mexico. Current Anthropology 48: 475 – 95.
dc.identifier.citedreferenceHayden, C. 2012. Rethinking Reductionism, or, the Transformative Work of Making the Same. Anthropological Forum 22: 271 – 83.
dc.identifier.citedreferenceHoffman, R. 1995. The Same and Not the Same. New York: Columbia University Press.
dc.identifier.citedreferenceHolland, J. 1999. Positron Emission Tomography Findings in Heavy Users of MDMA. The Lancet 353: 592.
dc.identifier.citedreferenceInternational Conference on Harmonization. 1995. ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports (E3). https://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html (accessed September 18, 2019).
dc.identifier.citedreferenceJain, S. L. 2010. The Mortality Effect: Counting the Dead in the Cancer Trial. Public Culture 22: 89 – 117.
dc.identifier.citedreferenceJansen, K. L. R., and A. R. W. Rorrest. 1999. Toxic Effect of MDMA on Brain Serotonin Neurons. The Lancet 353: 1270.
dc.identifier.citedreferenceJenkins, J., ed. 2011. Pharmaceutical Self: The Global Shaping of Experience in an Age of Psychopharmacology. Santa Fe: School for Advanced Research Press.
dc.identifier.citedreferenceKish, S. 2002. How Strong Is the Evidence that Brain Serotonin Neurons Are Damaged in Human Users of Estasy? Pharmacology, Biochemistry and Behavior 71: 845 – 55.
dc.identifier.citedreferenceKleinman, A., and A. Petryna. 2006. Global Pharmaceuticals: Ethics, Markets, Practices. Durham: Duke University Press.
dc.identifier.citedreferenceLatour, B., and S. Woolgar. 1986. Laboratory Life: The Construction of Scientific Facts. Princeton, NJ: Princeton University Press.
dc.identifier.citedreferenceLisook, B. 1990. FDA Audits of Clinical Studies: Policy and Procedure. Journal of Clinical Pharmacology 30: 296 – 302.
dc.identifier.citedreferenceLy, C., A. C. Greb, L. P. Cameron, J. M. Wong, E. V. Barragan, P. C. Wilson, K. F. Burbach, S. Soltanzadeh Zarandi, A. Sood, M. R. Paddy, W. C. Duim, M. Y. Dennis, A. K. McAllister, K. M. Ori‐McKenney, J. A. Gray, and D. E. Olson. 2018. Psychedelics Promote Structural and Functional Neural Plasticity. Cell Reports 23: 3170 – 82.
dc.identifier.citedreferenceMalberg, J. E., and L. S. Seiden. 1998. Small Changes in Ambient Temperature Cause Large Changes in Neurotoxicity and Core Body Temperature in the Rat. Journal of Neuroscience 18: 5086 – 94.
dc.identifier.citedreferenceMarks, H. 2000. The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900–1990. New York: Cambridge University Press.
dc.identifier.citedreferenceMatthews, S. J., and C. McCoy. 2003. Thalidomide: A Review of Approved and Investigational Uses. Clinical Therapeutics 25: 342 – 95.
dc.identifier.citedreferenceMcCann, U., V. Eligulashvili, and G. Ricaurte. 2000. (±)3,4‐Methylenedioxymethamphetamine (‘Ecstasy’)‐Induced Serotonin Neurotoxicity: Clinical Studies. Neuropsychobiology 42: 11 – 16.
dc.identifier.citedreferenceMcCann, U., A. Ridenour, Y. Shaham, and G. Ricaurte. 1994. Serotonin Neurotoxicity after (±)3,4‐Methylenedioxymethamphetamine (MDMA; “Ecstasy”): A Controlled Study in Humans. Neuropsychopharmacology 10: 129 – 38.
dc.identifier.citedreferenceMcCann, U., Z. Szabo, U. Scheffel, R. F. Dannals, and G. A. Ricaurte. 1998. Positron Emission Tomographic Evidence of Toxic Effect of MDMA (“Ecstasy”) on Brain Serotonin Neurons in Human Beings. The Lancet 352: 1433 – 37.
dc.identifier.citedreferenceMcNeil, D., Jr. 2003. Research on Ecstasy Is Clouded by Errors. New York Times. December 2:F0001.
dc.identifier.citedreferenceMDMA‐assisted Psychotherapy. 2018. https://maps.org/research/mdma (accessed September 9, 2018).
dc.identifier.citedreferenceMDMA Investigator’s Brochure. 2018. https://maps.org/research/mdma/literature (accessed July 19, 2019).
dc.identifier.citedreferenceMithoefer, M., L. Jermone, and R. Doblin. 2003. MDMA (“Ecstasy”) and Neurotoxicity. Science 300: 1504.
dc.identifier.citedreferenceMoore, D., and M. Valverde. 2000. Maidens at Risk: “Date Rape Drugs” and the Formation of Hybrid Risk Knowledges. Economy and Society 29: 514 – 31.
dc.identifier.citedreferenceMorris, K. 1998. Ecstasy Users Face Consequences of Neurotoxicity. The Lancet 352: 1913.
dc.identifier.citedreferenceNardou, R., E. M. Lewis, R. Rothhaas, R. Xu, A. Yang, E. Boyden, and G. Dölen. 2019. Oxytocin‐dependent Reopening of a Social Reward Learning Critical Period with MDMA. Nature 569: 116 – 20.
dc.identifier.citedreferenceNguyen, V. K. 2005. Antiretroviral Globalism, Biopolitics, and Therapeutic Citizenship. In Global Assemblages: Technology, Politics, and Ethics as Anthropological Problems, edited by A. Ong and S. Collier, 124 – 44. Malden, MA: Blackwell Publishing.
dc.identifier.citedreferenceObenhouse, M. 2004. Primetime Thursday: Ecstasy Rising. ABC News, April 1.
dc.working.doiNOen
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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