期刊论文详细信息
BMC Medical Ethics
“Snake-oil,” “quack medicine,” and “industrially cultured organisms:” biovalue and the commercialization of human microbiome research
Amy L McGuire1  Simon N Whitney2  Laura S Achenbaum1  Sheryl A McCurdy3  Melody J Slashinski1 
[1] Center for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030, USA;Department of Family and Community Medicine, Baylor College of Medicine, 3701 Kirby Drive, Suite 600, Houston, TX, 77098, USA;University of Texas School of Public Health, Center for Health Promotion and Prevention Research, 7000 Fannin Street, Houston, TX, 77030, USA
关键词: Qualitative research;    Dietary supplements;    Ethical legal and social implications (ELSI);    Human microbiome;    Commercialization;   
Others  :  800016
DOI  :  10.1186/1472-6939-13-28
 received in 2012-05-02, accepted in 2012-10-15,  发布年份 2012
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【 摘 要 】

Background

Continued advances in human microbiome research and technologies raise a number of ethical, legal, and social challenges. These challenges are associated not only with the conduct of the research, but also with broader implications, such as the production and distribution of commercial products promising maintenance or restoration of good physical health and disease prevention. In this article, we document several ethical, legal, and social challenges associated with the commercialization of human microbiome research, focusing particularly on how this research is mobilized within economic markets for new public health uses.

Methods

We conducted in-depth, semi-structured interviews (2009–2010) with 63 scientists, researchers, and National Institutes of Health project leaders (“investigators”) involved with human microbiome research. Interviews explored a range of ethical, legal, and social dimensions of human microbiome research, including investigators’ perspectives on commercialization. Using thematic content analysis, we identified and analyzed emergent themes and patterns.

Results

Investigators discussed the commercialization of human microbiome research in terms of (1) commercialization, probiotics, and issues of safety, (2) public awareness of the benefits and risks of dietary supplements, and (3) regulation.

Conclusion

The prevailing theme of ethical, legal, social concern focused on the need to find a balance between the marketplace, scientific research, and the public’s health. The themes we identified are intended to serve as points for discussions about the relationship between scientific research and the manufacture and distribution of over-the-counter dietary supplements in the United States.

【 授权许可】

   
2012 Slashinski et al.; licensee BioMed Central Ltd.

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【 参考文献 】
  • [1]McGuire AL, Colgrove J, Whitney SN, Diaz CM, Bustillos D, Versalovic J: Ethical, legal, and social considerations in conducting the human microbiome project. Genome Res 2008, 18:1861-1864.
  • [2]Bailey RL, Gahche JJ, Lentino CV, Dwyer JT, Engel JS, Thomas PR, Betz JM, Sempos CT, Picciano MF: Dietary supplement use in the United States, 2003–2006. J Nutr 2011, 141:261-266.
  • [3]Institute of Medicine of the National Academies: Dietary supplements: a framework for evaluating safety. 2004. Accessed November 10, 2011 at http://www.iom.edu/Reports/2004/Dietary-Supplements-A-Framework-for-Evaluating-Safety.aspx webcite
  • [4]Sanders ME, Levy DD: The science and regulation of probiotic food and supplement product labeling. Ann NY Acad Sci 2011, 1219(Suppl 1):E1-E23.
  • [5]American Dietetic Association: Position of the American dietetic association: functional foods. J Am Diet Assoc 2009, 109:735-746.
  • [6]Mercer MB, Brinich MA, Gellar G, Harrison K, Highland J, James K, Marshall P, McCormick JB, Tilburt J, Achkar JP, Farrell RM, Sharp RR: How patients view probiotics: findings from a multicenter study of patients with inflammatory bowel disease and irritable bowel syndrome. J Clin Gastroenterol 2012, 46:138-144.
  • [7]Sharp RR, Achkar JP, Brinich MA, Farrell RM: Helping patients make informed choices about probiotics: a need for research. Am J Gastroenterol 2009, 104:809-813.
  • [8]Waldby C: The visible human project: informatic bodies and posthuman medicine. Routledge, New York; 2000.
  • [9]National Institutes of Health Common Fund: Human microbiome project overview. Accessed February 1, 2012 at http://commonfund.nih.gov/Hmp/overview.aspx webcite
  • [10]Turnabugh PJ, Ley RE, Hamady M, Fraser-Liggett CM, Knight R, Gordon JI: The human microbiome project: a strategy to understand the microbial components of the human genetic and metabolic landscape and how they contribute to normal physiology and predisposition to disease. Nature 2007, 449:804-810.
  • [11]Rizkallah MR, Saad R, Aziz RK: The human microbiome project, personalized medicine and the birth of pharmacomicrobiomics. Curr Pharmacogenomics Person Med 2010, 8:182-193.
  • [12]Turnbaugh PJ, Hamady M, Yatsuneko T, Cantarel BL, Duncan A, Ley RE, Sogin ML, Jones WJ, Roe BA, Affourtit JP, Egholm M, Henrissat B, Heath AC, Knight R, Gordon JI: A core gut microbiome in obese and lean twins. Nature 2008, 457:480-484.
  • [13]Proctor L: The human microbiome project in 2011 and beyond. Cell Host Microbe 2011, 10:287-291.
  • [14]Koren O, Spor A, Felin J, Fåk F, Stombaugh J, Tremaroli V, Behre CJ, Knight R, Fagerberg B, Ley RE, Bäckhed F: Human oral, gut, and plaque microbiota in patients with atherosclerosis. PNAS 2011, 108:4592-4598.
  • [15]Young VB, Kahn SA, Schmidt TM, Chang EB: Studying the enteric microbiome in inflammatory bowel diseases: getting through the growing pains and moving forward. Front Microbio 2011., 2[ http://www.frontiersin.org/Cellular_and_Infection_Microbiology__closed_section/10.3389/fmicb.2011.00144/full webcite]
  • [16]Wang T, Zhang X, Zhang M, Wang L, Zhao L: Development of a fluorophore-ribosomal DNA restriction typing method for monitoring structural microbial communities. Arch Microbiol 2011, 193:341-350.
  • [17]Kassinen A, Krogius-Kurikka L, Mäkivuokko H, Rinttilä T, Paulin L, Corander J, Malinen E, Apajalahti J, Palva A: The fecal microbiota of irritable bowel syndrome patients differs significantly from that of healthy subjects. Gastroenterology 2007, 133:24-33.
  • [18]Spencer MD, Hamp TJ, Reid RW, Fischer LM, Zeisel SH, Fodor AA: Association between composition of the human gastrointestinal microbiome and development of fatty liver with choline deficiency. Gastroenterology 2011, 140:976-986.
  • [19]Gregory KE: Microbiome aspects of perinatal and neonatal health. J Perinat Neonatal Nurs 2011, 25:158-162.
  • [20]Wu Y, Ye Y: A novel abundance-based algorithm for binning metagenomic sequences using ʅ-tuples. J Comput Biol 2011, 18:523-534.
  • [21]Niu B, Zhu Z, Fu L, Wu S, Li W: FR-HIT, a very fast program to recruit metagenomic reads to homologous reference genomes. Bioinformatics 2011, 27:1704-1705.
  • [22]Stombaugh J, Widmann J, McDonald D, Knight R, Boulder: ALignment editor (ALE) a web-based RNA alignment tool. Bioinformatics 2011, 27:1706-1707.
  • [23]Creswell JW: Qualitative inquiry and research design: choosing among five approaches. Sage, Thousand Oaks; 2007.
  • [24]Guest G, MacQueen KM: Handbook for team-based qualitative research. AltaMira Press, Lanham; 2008.
  • [25]McGuire AL, Achenbaum LS, Whitney SN, Slashinski MJ, Versalovic J, Keitel WA, McCurdy S: Perspectives on human microbiome research ethics. J Empirical Res Human Res Ethics 2012, 7:1-14.
  • [26]Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R: Bacterial community variation in human body habitats across space and time. Science 2009, 326:1694-1697.
  • [27]Tannock GW: Probiotics: a critical review. Horizon Scientific Press, Wymondham; 1999.
  • [28]Senok AC, Ismaeel AY, Botta GA: Probiotics: facts and myths. Clin Microbiol Infect 2005, 11:958-966.
  • [29]Nettleton S: The sociology of health and illness. Polity, Malden; 2006.
  • [30]Dietary supplement health and education Act. Pub L. No. 103–417 (October 25, 1994)
  • [31]Spielmans GI, Parry PI: From evidence-based medicine to marketing-based medicine: evidence from internal industry documents. J Bioeth Inq 2010, 7:13-29.
  • [32]Watson DB, Moreira T, Murtagh M: Little bottles and the promise of probiotics. Health (London) 2009, 13:219-234.
  • [33]Federal Trade Commission: Enforcement policy statement on food advertising. 1994. Accessed November 10, 2011 at http://www.ftc.gov/bcp/policystmt/ad-food.shtm webcite
  • [34]Hawkins AK, O’Doherty C: “Who owns your poop?”: insights regarding the intersection of human microbiome research and the ELSI aspects of biobanking and related studies. BMC Med Genomics 2011, 4:72. [ http://www.biomedcentral.com/1755-8794/4/72 webcite] BioMed Central Full Text
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