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Asymmetry in Scientific Method and Limits to Cross-Disciplinary Dialogue
  1. Vural Ozdemir,
  2. Bryn Williams-Jones,
  3. Janice E. Graham,
  4. Sheldon H. Preskorn,
  5. Dimitrios Gripeos,
  6. Stephen J. Glatt,
  7. Robert H. Friis,
  8. Christopher Reist,
  9. Sandor Szabo,
  10. James B. Lohr,
  11. Toshiyuki Someya
  1. From the VA Long Beach Medical Center (V.O., D.G., C.R., S.S.), School of Medicine, University of California, Irvine, Long Beach, CA; Department of Psychiatry (V.O., T.S.), Clinical Pharmacology Program, Niigata University Graduate School of Medical and Dental Sciences, Niigata City, Niigata, Japan; Groupe de recherche en bioéthique et Département de médicine sociale et préventive (B.W.-J.), Université de Montréal, Montréal, QC; Department of Bioethics (J.E.G.), Faculty of Medicine, Dalhousie University, Halifax, NS; University of Kansas School of Medicine and the Clinical Research Institute (S.H.P.), Wichita, KS; Department of Psychiatry and Behavioral Sciences and Medical Genetics Research Center (S.J.G.), SUNY Upstate Medical University, Syracuse, NY; Center for Behavioral Genomics and Psychopharmacology Research Initiatives Center of Excellence (S.J.G., J.B.L.), Department of Psychiatry, University of California, San Diego, San Diego, CA; Department of Health Science and the California State University-VA Long Beach Medical Center Joint Studies Institute (R.H.F.), Long Beach, CA.
  1. Supported in part by the VISN 22 Mental Illness Research, Education, and Clinical Center (to V.O.), grants from the Canadian Institutes of Health Research and the Faculty of Medicine, Université de Montréal (to B.W.-J.), the University of California-San Diego Center for Behavioral Genomics and the National Alliance for Research on Schizophrenia and Depression (to S.J.G.), the California State University-VA Long Beach Healthcare System Joint Studies Institute (to R.H.F.), and the Pacific Rim Association for Clinical Pharmacogenetics (to T.S.). Janice E. Graham, a medical anthropologist, holds the Canada Research Chair in Bioethics at Dalhousie University and is funded by the Canadian Institutes of Health Research.
  2. Address correspondence to: Dr. Vural Ozdemir, Senior Scientist, Bioethics Programs, Department of Preventitive and Social Medicine, Faculty of Medicine, University of Montreal. C.P. 6128, 6th floor, Succ. Centre-ville, Montreal, Quebec, Canada. H3C 3J7; e-mail: m.vural.ozdemir{at}gmail.com.

Toward a Shared Language and Science Policy in Pharmacogenomics and Human Disease Genetics

Abstract

Pharmacogenomics is a hybrid field of experimental science at the intersection of human disease genetics and clinical pharmacology sharing applications of the new genomic technologies. But this hybrid field is not yet stable or fully integrated, nor is science policy in pharmacogenomics fully equipped to resolve the challenges of this emerging hybrid field. The disciplines of human disease genetics and clinical pharmacology contain significant differences in their scientific practices. Whereas clinical pharmacology originates as an experimental science, human disease genetics is primarily observational in nature. The result is a significant asymmetry in scientific method that can differentially impact the degree to which gene-environment interactions are discerned and, by extension, the study sample size required in each discipline. Because the number of subjects enrolled in observational genetic studies of diseases is characteristically viewed as an important criterion of scientific validity and reliability, failure to recognize discipline-specific requirements for sample size may lead to inappropriate dismissal or silencing of meritorious, although smaller-scale, craft-based pharmacogenomic investigations using an experimental study design. Importantly, the recognition that pharmacogenomics is an experimental science creates an avenue for systematic policy response to the ethical imperative to prospectively pursue genetically customized therapies before regulatory approval of pharmaceuticals. To this end, we discuss the critical role of interdisciplinary engagement between medical sciences, policy, and social science. We emphasize the need for development of shared standards across scientific, methodologic, and socioethical epistemologic divides in the hybrid field of pharmacogenomics to best serve the interests of public health.

Key words
  • pharmacogenomics
  • human genetics
  • clinical pharmacology
  • hybrid science
  • comparative critique
  • science policy
  • bioethics
  • gene-environment interaction
  • science and technology studies
  • medical sociology
  • interdisciplinary analysis
  • sociology of innovation
  • social pharmacology

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