Piercing the veil of corporate secrecy about clinical trials

Hastings Center Report

Volumn 34, Issue 5, 2004, Pages 14-18

  Lemmens, Trudo ^a,b  

^a UNIVERSITY OF TORONTO   (Canada)

^b INSTITUTE FOR ADVANCED STUDY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

SEROTONIN UPTAKE INHIBITOR;

BIOTECHNOLOGY; CLINICAL TRIAL; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERPERSONAL COMMUNICATION; MEDICAL RESEARCH; PUBLICATION; REVIEW; SIDE EFFECT; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CONFIDENTIALITY; ECONOMICS; LEGAL ASPECT; ORGANIZATION AND MANAGEMENT; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

CLINICAL TRIALS; CONFIDENTIALITY; DRUG APPROVAL; DRUG INDUSTRY; HUMANS; UNITED STATES;

EID: 14644437641     PISSN: 00930334     EISSN: None     Source Type: Journal    
DOI: 10.2307/3527585     Document Type: Review

References (24)

1. See S. Krimsky, Science in the Private Interest: Has the Lure of Profit Corrupted Biomedical Research? (Lanham, Md.: Rowman & Littlefield, 2003), at 79-81.
2. D. Willman, "Stealth Merger: Drug Companies and Government Medical Research," Los Angeles Times, December 7, 2003.
3. C.P. Cannon et al., "Intensive versus Moderate Lipid Lowering with Statins after Acute Coronary Syndromes," NEJM 350 (2004): 1495-1504.
4. R. Winslow, "For Brystol-Myers, Challenging Pfizer Was A Big Mistake," Wall Street Journal, March 9, 2004.
5. D. Healy, The Anti-Depressant Era (Cambridge, Mass.: Harvard University Press, 1997) . See also C. Elliott, Better Than Well: American Medicine Meets the American Dream (New York: W.W. Norton, 2003); J.R. Brown, "Funding, Objectivity, and the Socialization of Medical Research," Science and Engineering Ethics 8, no. 3 (2002): 295.
6. D. Healy, The Anti-Depressant Era (Cambridge, Mass.: Harvard University Press, 1997) . See also C. Elliott, Better Than Well: American Medicine Meets the American Dream (New York: W.W. Norton, 2003); J.R. Brown, "Funding, Objectivity, and the Socialization of Medical Research," Science and Engineering Ethics 8, no. 3 (2002): 295.
7. D. Healy, The Anti-Depressant Era (Cambridge, Mass.: Harvard University Press, 1997) . See also C. Elliott, Better Than Well: American Medicine Meets the American Dream (New York: W.W. Norton, 2003); J.R. Brown, "Funding, Objectivity, and the Socialization of Medical Research," Science and Engineering Ethics 8, no. 3 (2002): 295.
8. See the discussion in S. Brownlee, "Doctors without Borders," Washington Monthly, April 2004.
9. See J.M. Drazen and G.D. Curfman, "Financial Associations of Authors," NEJM 346 (2002): 1901-1902.
10. D. Healy and D. Cattell, "Interface between Authorship, Industry and Science in the Domain of Therapeutics," British Journal of Psychiatry 183 (2003): 22-27; T. Bodenheimer, "Uneasy Alliance: Clinician Investigators and the Pharmaceutical Industry," NEJM 342, no.20 (2000): 1539-44, at 1539; and W.T. Carpenter, "From Clinical Trial to Prescription," Archives of General Psychiatry 59 (2002): 282-85.
11. D. Healy and D. Cattell, "Interface between Authorship, Industry and Science in the Domain of Therapeutics," British Journal of Psychiatry 183 (2003): 22-27; T. Bodenheimer, "Uneasy Alliance: Clinician Investigators and the Pharmaceutical Industry," NEJM 342, no.20 (2000): 1539-44, at 1539; and W.T. Carpenter, "From Clinical Trial to Prescription," Archives of General Psychiatry 59 (2002): 282-85.
12. D. Healy and D. Cattell, "Interface between Authorship, Industry and Science in the Domain of Therapeutics," British Journal of Psychiatry 183 (2003): 22-27; T. Bodenheimer, "Uneasy Alliance: Clinician Investigators and the Pharmaceutical Industry," NEJM 342, no.20 (2000): 1539-44, at 1539; and W.T. Carpenter, "From Clinical Trial to Prescription," Archives of General Psychiatry 59 (2002): 282-85.
13. M. Baram, "Making Clinical Trials Safer for Human Subjects," American Journal of Law and Medicine 27 (2001): 253-282, at 262.
14. E.J. Garland, "Facing the Evidence: Anti-Depressant Treatment in Children and Adolescents," Canadian Medical Association Journal 170, no. 4 (2004): 489-92.
15. C.J. Whittington et al., "Selective Serotonin Reuptake Inhibitors in Childhood Depression: Systematic Review of Published versus Unpublished Data," Lancet 363 (2004): 1341-45.
16. "Seroxat/Paxil - Adolescent Depression: Position Piece on the Phase III Clinical Studies," October 1998. Document obtained from David Healy.
17. D. Healy, letter to Peter J. Pitts, Associate Commissioner for External Relations at the Food and Drug Administration, February 19, 2004.
18. "Depressing Research," Lancet 363 (2004): 1335.
19. Krimsky, Science in the Private Interest, at 229.
20. Institute of Medicine, Responsible Research: A Systems Approach to Protecting Research Participants (Washington, D.C.: National Academy of Sciences, 2003), at 200-204; R. Steinbrook, "Public Registry of Clinical Trials," NEJM 351 (2004): 315-17.
21. Institute of Medicine, Responsible Research: A Systems Approach to Protecting Research Participants (Washington, D.C.: National Academy of Sciences, 2003), at 200-204; R. Steinbrook, "Public Registry of Clinical Trials," NEJM 351 (2004): 315-17.
22. F. Fleck, "WHO and Science Publishers Team Up on Online Register of Trials," British Medical Journal 328 (2004): 854.
23. Council on Scientific Affairs, American Medical Association, "Featured CSA Report: Influence of Funding Source on Outcome, Validity, and Reliability of Pharmaceutical Research (A-04)," June 2004, at http://www.ama-assn.org/ama/publ/article/print/2036-8608.html.
24. C. De Angelis et al., "Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors," NEJM 351 (2004): 1250-51.