Conflicts of interest in medical research: How much conflict should exceed legal boundaries?

Journal of BioLaw and Business

Volumn 8, Issue 3, 2005, Pages 37-

  Klanica, Kaley ^a  

^a BOSTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BAYH-DOLE ACT 1980; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL TRIAL; CONFLICT OF INTEREST; DRUG INDUSTRY; ECONOMICS; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE ORGANIZATION; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; LEGAL APPROACH; LEGAL ASPECT; MEDICAL RESEARCH; PERSONNEL; RESEARCH SUBJECT; STANDARD; UNITED STATES; UNIVERSITY;

BAYH-DOLE ACT 1980; BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH;

BIOMEDICAL RESEARCH; CLINICAL TRIALS; CONFLICT OF INTEREST; DISCLOSURE; DRUG INDUSTRY; GOVERNMENT REGULATION; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; NATIONAL INSTITUTES OF HEALTH (U.S.); RESEARCH PERSONNEL; RESEARCH SUBJECTS; RESEARCH SUPPORT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; UNIVERSITIES;

EID: 33645061030     PISSN: 10955127     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (32)

1. For an example of this entanglement see Gina Kolata, New Conclusions on Cholesterol, N.Y. Times, Mat 9, 2004, at A1.
2. See Karine Morin et al., Managing Conflicts of Interest in the Conduct of Clinical Trials, 287 JAMA 78 (2002).
3. See generally Kenneth J. Rothman, Conflict of Interest: The New McCarthyism in Science, 269 JAMA 2782 (1993) (noting that sexual orientation of the researcher may affect results of research on homosexuality and that research on lifestyle choices touted by the researcher's religion may be influenced by such researcher's religious beliefs).
4. Patricia C. Kuszler, Conflicts of Interest in Clinical Research: Legal and Ethical Issues: Curing Conflicts of Interest in Clinical Research: Impossible Dreams and Harsh Realities, 8 Wid. L. Symp. J. 115, 139 (2001) (noting that the conflicted researcher in Gelsinger case was offended when he was publicly accused of bias due to a conflict of interest; however, he did admit that he was driven by academic recognition, honors, and a potential Nobel prize).
5. Ann Neuer, Academic Technology Transfer Offices Evolve Into Marketing Units, 9 The Scientist 1 (Apr. 17, 1995) (quoting Duke Leahey, past president of Association of University Technology Managers (AUTM))
6. Joseph B. Martin & Dennis L. Kasper, In Whose Best Interest? Breaching the Academic-Industrial Wall, 343 New Eng. J. of Med. 1646 (2000).
7. Two major forms of private sector research organizations have emerged in recent years. Contract research organizations (CROs) and site-management organizations (SMOs) purportedly complete trials quicker and cheaper than academic medical centers do. Mark Barnes & Patrik Florencio, Investigator, IRB and Institutional Financial Conflicts of Interest in Human-Subjects Research: Past, Present and Future, 32 Seton Hall L. Rev. 525, 526-527 (2002). See also Morin et al., supra note 2.
8. The restrictions on stem cell research are only one example. See President George W. Bush, Remarks on Stem Cell Research (Aug. 9, 2001), at http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html.
9. David Willman, Stealth Merger: Drug Companies and Government Medical Research; Some of the National Institutes of Health's Top Scientists are Also Collecting Paychecks and Stock Options From Biomedical Firms, L.A. Times, Dec. 7, 2003, at A1.
10. Henry T. Stelfox, et al., Conflict of Interest in the Debate over Calcium-Channel Antagonists, 338 New Eng. J. of Med. 101 (1998).
11. Is it important to note that these skewed results may not be due to bias, but perhaps due to select publication of only positive results or drug companies seeking to sponsor the research of investigators who are already finding success with their treatments. Marcia Angell, Is Academic Medicine for Sale? 342 New Eng. J. of Med. 1516(2000).
12. Claire T. Driscoll, Evolving NIH Patent & Licensing Policies and Practices for Genomic Inventions in the Post-Human Genome Project Era, Presentation at Boston University School of Law, March 16, 2004, notes on file with the author.
13. See generally Michael Baram, Making Clinical Trials Safer for Humans, 27 Am. J. L. & Med. 253, 268 (2001).
14. Dana Ziker, Reviving Informed Consent: Using Risk Perception in Clinical Trials, 2003 Duke L. & Tech. Rev. 15 (2003).
15. See generally Lars Noah, Informed Consent and the Elusive Dichotomy between Standard and Experimental Therapy, 28 Am. J. L. Med. 361 (2002).
16. Scott Y. Kim et al., Potential Research Participants' Views Regarding Researcher and Institutional Financial Conflicts of Interest, 30 J. Med. Ethics 73, 77 (2004) (reporting that 64-87% of respondents felt any conflict of interest should be part of the informed consent requirement while only 2-20% respondents would not consider participating if there was a financial conflict of interest).
17. Thomas Bodenheimer, Uneasy Alliance-Clinical Investigators and the Pharmaceutical Industry, 342 New Eng. J. of Med. 1539.
18. See also Mildred K. Cho et al., Policies on Faculty Conflicts of Interest at U.S. Universities, 284 JAMA 2203, 2203 (2000) ("Conflicts of interest are of concern because of their potential effect on the quality, outcome, and dissemination of research, as well as their effects on the public's perception of and trust in researchers and universities.")
19. Donna Shalala, Protecting Research Subjects - What Must Be Done, 343 New Eng. J. of Med. 808 (2000).
20. See also Tom Abate, Maybe Conflicts of Interests are Scaring Clinical Trial Patients: Report that Blames Negative Media also Cites Complaint Surge, S.F. Chron., Apr. 30, 2001, at D1.
21. Sheryl Gay Stolberg, The Biotech Death of Jesse Gelsingen N.Y. Times Mag., Nov. 28, 1999, at 137.
22. Phase one clinical trials test for safety, not efficacy. See Frances H. Miller, Trusting Doctors: Tricky Business When It Comes to Clinical Research, 81 B.U. L. Rev. 423 (2001).
23. Kuszler, supra note 4, at 132. See also Scott Hensley, Targeted Genetics Genovo Deal Leads to Windfall for Researcher, Wall St. J., Aug. 10, 2000, at B12.
24. S. Van McCrary et al., A National Survey of Policies on Disclosure of Conflicts of Interest in Biomedical Research, 343 New Eng. J. of Med. 1621 (2000)
25. (citing The Alcohol, Drug Abuse, and Mental Health Administration. Request for comment on proposed guidelines for policies on conflicts of interest. NIH guide to grants and contracts. Vol. 18. No. 32. Bethesda, Md.: National Institutes of Health, 1989:3-4.)
26. Letter from Elias A. Zerhouni, M.D., Director, NIH, to IC Directors and OD Senior Staff (Nov. 20, 2003), available at http://www.nih.gov/news/pr/ dec2003/11202003drzerhounimemo.doc.
27. Guidelines for Conflicts of Interest, Harvard Medical School, available at http://www.hms.harvard.edu/integrity/guide.html.
28. Bernard Lo et al., Conflict-of-interest Policies for Investigators in Clinical Trials, 343 New Eng, J. of Med. 1616 (2000); McCrary et al., supra note 65.
29. Ray Moynihan, Who Pays for the Pizza? Redefining the Relationships between Doctors and Drug Companies, 326 Brit. Med. J. 1193 (2003).
30. Barnes & Florencio, supra note 12, at 528 (citing Marcia Angell, Remarks at the NIH Conference on Human Subject Protection and Financial Conflicts-of-Interest (Aug. 15-16, 2000)).
31. See also Jerome P. Kassirer & Marcia Angell, Financial Conflicts of Interest in Biomedical Research, 329 New Eng. J. Med. 570 (1993).
32. Moynihan, supra note 89. For an example of such censorship, see Drummond Rennie, Thyroid Storm, 277 JAMA 1238 (1997).