United states private-sector physicians and pharmaceutical contract research: A qualitative study

PLoS Medicine

Volumn 9, Issue 7, 2012, Pages

  Fisher, Jill A ^a   Kalbaugh, Corey A ^b  

^a VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^b IL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COMMERCIAL PHENOMENA; DATA BASE; DRUG DESIGN; EXPERIMENTAL DESIGN; FINANCIAL MANAGEMENT; HUMAN; MOTIVATION; ORGANIZATION AND MANAGEMENT; PHYSICIAN; QUALITATIVE RESEARCH; RESEARCH ETHICS; SCIENCE; SCIENTIST; SEMI STRUCTURED INTERVIEW; UNITED STATES;

CONTRACTS; DRUG INDUSTRY; HUMANS; MOTIVATION; PHYSICIANS; PRIVATE SECTOR; QUALITATIVE RESEARCH; UNITED STATES;

EID: 84864478351     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1001271     Document Type: Article

References (48)

1. Fisher JA (2009) Medical research for hire: the political economy of pharmaceutical clinical trials. New Brunswick: Rutgers University Press.
2. Petryna A (2009) When experiments travel: clinical trials and the global search for human subjects. Princeton: Princeton University Press.
3. Shuchman M, ((2007)) Commercializing clinical trials: risks and benefits of the CRO boom. N Engl J Med 357:: 1365--1368.
4. Steinbrook R, ((2005)) Gag clauses in clinical-trial agreements. N Engl J Med 352:: 2160--2162.
5. Bodenheimer T, ((2000)) Uneasy alliance: clinical investigators and the pharmaceutical industry. N Engl J Med 342:: 1539--1544.
6. Angell M (2004) The truth about the drug companies: how they deceive us and what to do about it. New York: Random House.
7. Biddle J, ((2007)) Lessons from the Vioxx debacle: what the privatization of science can teach us about social epistemology. Soc Epistemol 21:: 21--39.
8. Lemmens T, Freedman B, ((2000)) Ethics review for sale? Conflict of interest and commercial research ethics review. Milbank Q 78:: 547--584.
9. Lexchin J, Bero L, Djulbegovic B, Clark O, ((2003)) Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 326:: 1167--1170.
10. Sismondo S, ((2007)) Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med 4:: e286 doi:10.1371/journal.pmed.0040286.
11. Ashar BH, Miller RG, Getz KJ, Powe NR, ((2004)) Prevalence and determinants of physician participation in conducting pharmaceutical-sponsored clinical trials and lectures. J Gen Intern Med 19:: 1140--1145.
12. Bero LA, Rennie D, ((1996)) Influences on the quality of published drug studies. Int J Technol Assess Health Care 12:: 209--237.
13. Matheson A, ((2008)) Corporate science and the husbandry of scientific and medical knowledge by the pharmaceutical industry. BioSocieties 3:: 355--382.
14. Dorsey ER, Thompson JP, Carrasco M, de Roulet J, Vitticore P, et al. ((2009)) Financing of U.S. biomedical research and new drug approvals across therapeutic areas. PLoS ONE 4:: e7015 doi:10.1371/journal.pone.0007015.
15. Lakoff A, ((2007)) The right patients for the drug: managing the placebo effect in antidepressant trials. BioSocieties 2:: 57--71.
16. Logdberg L, ((2011)) Being the ghost in the machine: a medical ghostwriter's personal view. PLoS Med 8:: e1001071 doi:10.1371/journal.pmed.1001071.
17. Starr P (1982) The social transformation of American medicine: the rise of a sovereign profession and the making of a vast industry. New York: Basic Books.
18. Cray E (1970) In failing health: the medical crisis and the AMA. New York: Bobbs-Merrill.
19. Kennedy EM (1972) In critical condition: the crisis in America's health care. New York: Simon & Schuster.
20. Tu HT, Ginsburg PB (2006) Losing ground: physician income, 1995-2003. Washington (District of Columbia): Center for Studying Health System Change.
21. Kassirer JP (2005) On the take: how America's complicity with big business can endanger your health. New York: Oxford University Press. 251 p.
22. Pham HH, Devers KJ, May JH, Berenson R, ((2004)) Financial pressures spur physician entrepreneurialism. Health Aff (Millwood) 23:: 70--81.
23. Chin T (2005 November 21) Doctors' costs going up faster than revenues. American Medical News. Available: http://www.ama-assn.org/amednews/2005/11/21/bisb1121.htm. Accessed.
24. Robinson JC (1999) The corporate practice of medicine: competition and innovation in health care. Berkeley: University of California Press.
25. Gray BH (1993) The profit motive and patient care: the changing accountability of doctors and hospitals. Cambridge: Harvard University Press.
26. Relman AS, ((2007)) Medical professionalism in a commercialized health care market. JAMA 298:: 2668--2670.
27. Fisher JA, ((2008)) Practicing research ethics: private-sector physicians & pharmaceutical clinical trials. Soc Sci Med 66:: 2495--2505.
28. Lader EW, Cannon CP, Ohman EM, Newby LK, Sulmasy DP, et al. ((2004)) The clinician as investigator: participating in clinical trials in the practice setting. Circulation 109:: 2672--2679.
29. Korieth K (2011) Liability demands putting sites at risk. CenterWatch Monthly 18: 1,13-15.
30. Getz KA, ((2010)) Sizing up the clinical research market. Appl Clin Trials 19:: 32--34.
31. Parexel (2005) Pharmaceutical R& statistical sourcebook 2005/2006. Waltham (Massachusetts): Parexel International Corporation.
32. Hall MA, Friedman JY, King NMP, Weinfurt KP, Schulman KA, et al. ((2010)) Commentary: per capita payments in clinical trials: reasonable costs versus bounty hunting. Acad Med 85:: 1554--1556.
33. Gray T (2004) Getting the most out of community-based research. ACP Internist. Available: http://www.acpinternist.org/archives/2004/04/cbr.htm. Accessed 17 June 2012.
34. Weinfurt KP, Hall MA, Chantelle Hardy N, Friedman JY, Schulman KA, et al. ((2010)) Oversight of financial conflicts of interest in commercially sponsored research in academic and nonacademic settings. J Gen Intern Med 25:: 460--464.
35. Rainville B, ((2002)) Strategic outsourcing with contract research organizations: targeting corporate goals. Drug Inf J 36:: 77--81.
36. CenterWatch (2006) State of the clinical trials industry: a sourcebook of charts and statistics. Boston: Thomson CenterWatch.
37. DiCicco-Bloom B, Crabtree BF, ((2006)) The qualitative research interview. Med Educ 40:: 314--321.
38. Fisher JA, ((2010)) Re-inscribing gender in new modes of medical expertise: the investigator-coordinator relationship in the clinical trials industry. Gend Work Organ 17:: 150--173.
39. Emerson RM, Fretz RI, Shaw LL ((1995)) Writing ethnographic fieldnotes. Chicago: University of Chicago Press.
40. Charmaz K (2006) Constructing grounded theory. London: Sage.
41. Klein JE, Fleischman AR, ((2002)) The private practicing physician-investigator: ethical implications of clinical research in the office setting. Hastings Cent Rep 32:: 22--26.
42. Bourgeois FT, Murthy S, Mandl KD, ((2010)) Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 153:: 158--166.
43. Jones WB, Taylor SM, Kalbaugh CA, Joels CS, Blackhurst DW, et al. ((2007)) Lost to follow-up: a potential under-appreciated limitation of endovascular aneurysm repair. J Vasc Surg 46:: 434--441.
44. Sleight P, ((2004)) Where are clinical trials going? society and clinical trials. J Intern Med 255:: 151--158.
45. Applbaum K, ((2009)) Getting to yes: corporate power and the creation of a psychopharmaceutical blockbuster. Cult Med Psychiatry 33:: 185--215.
46. Mirowski P, Van Horn R, ((2005)) The contract research organization and the commercialization of scientific research. Soc Stud Sci 35:: 503--548.
47. Blumenthal D, Causino N, Campbell E, Louis KS, ((1996)) Relationships between academic institutions and industry in the life sciences: an industry survey. N Engl J Med 334:: 368--374.
48. Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, et al. ((2009)) Ethical and scientific implications of the globalization of clinical research. N Engl J Med 360:: 816--823.