• Open Access

‘Someone should oversee it’: patient perspectives on the ethical issues arising with the regulation of probiotics

Authors

  • Krista L. Harrison BA,

    Research Assistant, Doctoral Candidate
    1. Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA
    2. Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
    Search for more papers by this author
  • Ruth M. Farrell MD MA FACOG,

    Staff, Corresponding author
    1. Departments of Obstetrics/Gynecology and Bioethics, Cleveland Clinic, Cleveland, OH, USA
    • Correspondence

      Ruth M. Farrell MD MA FACOG

      Assistant Professor of Surgery

      Department of Bioethics and OB/GYN

      9500 Euclid Avenue, JJ-60

      Cleveland, OH 44195, USA

      E-mail: farrelr@ccf.org

    Search for more papers by this author
  • Margaret A. Brinich BA,

    Research Assistant
    1. Department of Bioethics, Cleveland Clinic, Cleveland, OH, USA
    Search for more papers by this author
  • Janelle Highland BA MA,

    Research Assistant
    1. Department of Bioethics, Cleveland Clinic, Cleveland, OH, USA
    Search for more papers by this author
  • MaryBeth Mercer BA MPH,

    Research Coordinator
    1. Department of Bioethics, Cleveland Clinic, Cleveland, OH, USA
    Search for more papers by this author
  • Jennifer B. McCormick PhD MPP,

    Assistant Professor of Biomedical Ethics
    1. Department of General Internal Medicine, Mayo Clinic, Rochester, MN, USA
    Search for more papers by this author
  • Jon Tilburt MD MPH,

    Assistant Professor of Biomedical Ethics, Associate Professor of Medicine
    1. Department of General Internal Medicine, Mayo Clinic, Rochester, MN, USA
    Search for more papers by this author
  • Gail Geller ScD MHS,

    Professor
    1. Department of Medicine and Berman Bioethics Institute, Johns Hopkins University, Baltimore, MD, USA
    Search for more papers by this author
  • Patricia Marshall PhD,

    Professor, Co-Director
    1. Department of Bioethics, School of Medicine, Case Western Reserve University, Cleveland, OH, USA
    2. Center for Genetic Research Ethics and Law, Case Western Reserve University, Cleveland, OH, USA
    Search for more papers by this author
  • Richard R. Sharp PhD

    Staff, Co-Director
    1. Department of Bioethics, Cleveland Clinic, Cleveland, OH, USA
    2. Center for Genetic Research Ethics and Law, Case Western Reserve University, Cleveland, OH, USA
    Search for more papers by this author

Abstract

Background

Although many probiotic products are currently available in yogurt or pill form in the United States (US), there is uncertainty surrounding the structure of regulation of these products. As more therapeutic probiotics are developed, changes to existing regulatory process in the United States may be required to meet the needs of patients and users in the population.

Objective

This study examined how patients with chronic gastrointestinal (GI) diseases view the regulation of probiotics.

Design

We conducted a multi-site qualitative study consisting of focus groups of patients with chronic gastrointestinal diseases at three tertiary hospitals: at [institutions removed for blinded review].

Results

We conducted 22 focus groups with 136 patients with major gastrointestinal (GI) diseases between March and August 2009. Participants were not familiar with the existing regulation of probiotic products but wanted assurances of accurate labelling of strain as well as safety. Participants raised concerns that regulation of probiotics might be accompanied by greater costs, reduced access and increased involvement of pharmaceutical companies. Although participants voiced significant doubt of government regulators, they felt that products containing genetically modified probiotic strains should have oversight comparable to that of pharmaceutical drugs.

Discussion and conclusion

If GI patient perspectives are indicative of public perceptions of therapeutic probiotics in the United States, consumers may expect more rigorous regulation in the future while simultaneously wanting low costs, easy access and low involvement of pharmaceutical companies. Manufacturers, translational scientists, clinicians and regulators should be sensitive to consumer attitudes when designing, testing and regulating new therapeutic probiotics.

Ancillary