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Institutionalising the Medical Evaluation of CAM: Dietary and Herbal Supplements as a Peculiar Example of (Differential) Legitimisations of CAM in the USA

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Abstract

In this chapter, we present a specific aspect of our socio-anthropological research focusing on the federal institutionalisation of CAM in the USA: the case of ‘dietary and herbal supplements’ (D/HS). We show how the case provides a good example of different and specific configurations of medical research on CAM since the 1990s through the creation of three federal entities. Based on an analysis of controversies and challenges around specific ‘D/HS’, we interrogate the manners in which a plurality of federal and non-federal agents involved in this mixed social space collaborates and competes on the medical evaluation of CAM—particularly around ideas of efficacy, safety, authenticity, and integration—shaping and re-shaping the places they assign to CAM within the broader American health system.

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Fig. 12.1

Notes

  1. 1.

    We chose the term ‘dietary and herbal supplements’ from NCCIH to illustrate both the legal wording and use of most D/HS (sold as dietary supplements) and the focus on botanical-based dietary supplements in the following examples, thus questioning different distinctions between conventional and lab-synthesised drugs and plant-derived dietary supplements.

  2. 2.

    Congressional findings related to Dietary Supplements Health and Education Act of 1994, Pub. L. No. 103–417, § 2, 15 (A), 108 Stat. 4325; 4326, October 25 1994 (s).

  3. 3.

    For the most recent one, see: Clarke et al. 2015 (s).

  4. 4.

    As defined by the NCCIH: ‘a product that is intended to supplement the diet, contains one or more dietary ingredients (including vitamins, minerals, herbs, or other botanicals), a plant or part of a plant used for its flavor, scent, or potential therapeutic properties (includes flowers, leaves, bark, fruit, seeds, stems, and roots, amino acids, and certain other substances) or their constituents, is intended to be taken by mouth, in forms such as tablet, capsule, powder, softgel, gelcap, or liquid, and is labeled as being a dietary supplement’ (https://nccih.nih.gov/health/supplements). Federal institutions such as NCCIH and NCI mention different CAM categories related to botanicals: ‘natural products’, ‘complex natural products’, ‘dietary supplements’, ‘nutritional therapeutics’, ‘botanicals’, ‘herbs’, ‘special diets’.

  5. 5.

    An inductive socio-anthropological ‘networked ethnography’ (Atlani-Duault 2009; Olivier de Sardan 2008), or what we might call ‘starfish ethnography’, departing from the institutions and expanding back and forth from the investigation to their networks of interactions with other agents involved in this mixed social space of medical research on CAM and cancer CAM.

  6. 6.

    We compiled sources from the institutions we studied (‘institutional corpus’), archives from newspapers, scientific journals, legal texts, online sources, and so on. See the ‘Sources’ section in bibliography.

  7. 7.

    We conducted about 60 formal and informal ethnographic interviews, many informal discussions, and observations between November 2014 and June 2017.

  8. 8.

    See Bothwell and Podolsky 2016; Meldrum 2000.

  9. 9.

    Manufacturers only bear the responsibility of their safety before their release on the market, they do not need to report it to the FDA.

  10. 10.

    US Department of Health & Human Services Food and Drug Administration, Center for Drug Evaluation and Research (June 2004), ‘Botanical Drug Products’ (s).

  11. 11.

    For a long-term history of Ephedra , see: Lee 2011.

  12. 12.

    Haller and Benowitz 2000 (s).

  13. 13.

    US Department of Health and Human Services, Office of Inspector General 2001 (s).

  14. 14.

    New York Times 1993 (s).

  15. 15.

    Public Citizen 2001 (s).

  16. 16.

    Bodley 2003 (s); Connolly 2008 (s).

  17. 17.

    NCCIH, ‘Minutes’, March 2003 (s).

  18. 18.

    Fontanarosa et al. 2003 (s).

  19. 19.

    Wolfe 2003 (s ).

  20. 20.

    FDA, 6 February 2004 (s).

  21. 21.

    FDA, June 2004 (s).

  22. 22.

    Regulatory science is defined by the FDA as ‘the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products’ See: FDA, October 2010. (s).

  23. 23.

    NCCAM, ‘Minutes’, November 2000 (s).

  24. 24.

    NCCAM, ‘Minutes’, October 2014 (s).

  25. 25.

    Berman and Larson 1995, x (s).

  26. 26.

    Ibid., ix. (s).

  27. 27.

    Burton 2002 (s).

  28. 28.

    NCCAM, ‘Press Release’, 5 October 2000 (s).

  29. 29.

    NCCAM, ‘Director Testimony’, November 2001 and ‘Congressional Justification’, 2002 (s).

  30. 30.

    Dipaola et al. 1998 (s).

  31. 31.

    NCCIH, ‘Minutes’, 2004 (s).

  32. 32.

    Burton 2000 (s).

  33. 33.

    Chan et al. 1993 (s); Cumberford 2012 (s).

  34. 34.

    NCCAM, ‘Congressional Justification’, 2003 (s).

  35. 35.

    NCCAM, ‘Congressional Justification’, 2004 (s).

  36. 36.

    NCCAM, ‘Strategic Plan’, 2004 (s).

  37. 37.

    NCCAM, ‘Strategic Plan’, 2004 (s).

  38. 38.

    Interview with a researcher working on D/HS, February 2017.

  39. 39.

    This term was employed by different researchers when the question of research protocols on CAM was raised.

  40. 40.

    FDA, June 2004 (s).

  41. 41.

    Miller et al. 2004 (s).

  42. 42.

    This first wave of CAM research initiated at NCCAM echoes the decision of extending RCT to every research domain in medicine. It also originates in the 1970s from a FDA recommendation to use such a regime of proof in new drug research and development (Bothwell and Podolsky 2016). Oncology has been the major field of expansion for RCTs, see: Bourret and Le Moigne 2014; Cambrosio and Keating 2008; and Cambrosio et al. 2014.

  43. 43.

    Hopp 2015 (s).

  44. 44.

    This term was mentioned during a conference on integrative medicine held at a renowned centre for integrative medicine in the USA, in March 2017.

  45. 45.

    Seifried et al. 2004 (s).

  46. 46.

    Cheng 2011 (s).

  47. 47.

    See, for example, the scholarly work of the former director of the Office of Alternative Medicine (previous name of NCCAM until 1998) who works on a reorganisation of proof production when CAM is concerned: Jonas 2005 (s).

  48. 48.

    Eisenberg et al. 1993 (s).

  49. 49.

    From a booklet given to us by a researcher in integrative medicine: Abrams et al. (2015) ‘PRIMIER, A National Integrative Medicine Database’, The Bravewell Collaborative (s).

  50. 50.

    Hopp 2015 (s); Barnes et al. 2008 (s).

  51. 51.

    Wang and Arnold 2002 (s); Ron et al. 2002 (s); Mansky and Strauss 2002 (s).

  52. 52.

    In 2009, the FDA released a warning letter with ethical concerns about ‘antineoplaston’ and the Burzinsky Research Institute investigating and providing this alternative therapy: FDA (5 October 2009), ‘Warning Letter, “Burzynski Research Institute/IRB”’, ref: 10-HFD-45-09-0 (s). This controversy is also present within the NCCAM unprocessed archives at the Office of NIH History (Cheung Series, Box 8, folder 3; Jonas Series, Box 24, folder 7; OAM series, Box 14, folder 8 & box 25, folder 8; etc.) (s).

  53. 53.

    We anonymised the disease to protect agents we met as they could be easily identified if we had mentioned the specific disease and herbs used in their research study.

  54. 54.

    Zia and White 2009 (s).

  55. 55.

    For an example, see: Banerji et al. 2008 (s).

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    Acknowledgements

    This research was funded by the French National Cancer Institute (INCa) from January 2015 to January 2018.

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    Carpier, G., Cohen, P. (2018). Institutionalising the Medical Evaluation of CAM: Dietary and Herbal Supplements as a Peculiar Example of (Differential) Legitimisations of CAM in the USA. In: Brosnan, C., Vuolanto, P., Danell, JA. (eds) Complementary and Alternative Medicine. Health, Technology and Society. Palgrave Macmillan, Cham. https://doi.org/10.1007/978-3-319-73939-7_12

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