Managing physician financial conflicts of interest in clinical trials conducted in the private practice setting

Food and Drug Law Journal

Volumn 59, Issue 1, 2004, Pages 45-77

  Williams, Kevin W ^a  

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DIDANOSINE; DRUG; NEW DRUG; ZIDOVUDINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; CLINICAL RESEARCH; CLINICAL TRIAL; DOCTOR PATIENT RELATION; DRUG LEGISLATION; DRUG MARKETING; DRUG RESEARCH; FINANCIAL MANAGEMENT; HEALTH CARE NEED; HISTORY OF MEDICINE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFORMED CONSENT; MALPRACTICE; MANAGED CARE; MEDICAL ETHICS; MEDICAL PRACTICE; PATIENT RIGHT; PHYSICIAN; PRIMARY MEDICAL CARE; PRIVATE PRACTICE; PUBLIC HEALTH SERVICE; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CONFLICT OF INTEREST; DRUG INDUSTRY; ECONOMICS; ETHICS; INSTITUTIONAL ETHICS; INTERPERSONAL COMMUNICATION; LEGAL APPROACH; LEGAL ASPECT; MEDICAL RESEARCH; MOORE V. REGENTS OF THE UNIVERSITY OF CALIFORNIA; ORGANIZATION; PUBLIC RELATIONS; RESEARCH ETHICS; STANDARD; UNITED STATES;

HUMAN IMMUNODEFICIENCY VIRUS;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH; MOORE V. REGENTS OF THE UNIVERSITY OF CALIFORNIA;

ACADEMIES AND INSTITUTES; BIOMEDICAL RESEARCH; CLINICAL TRIALS; CONFLICT OF INTEREST; DRUG INDUSTRY; DRUGS, INVESTIGATIONAL; ETHICS, INSTITUTIONAL; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; INTERINSTITUTIONAL RELATIONS; PHYSICIAN-PATIENT RELATIONS; PHYSICIANS; PRIVATE PRACTICE; TRUTH DISCLOSURE; UNITED STATES;

EID: 2942696166     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (198)

1. Jay Katz, Human Experimentation and Human Rights, 38 ST. LOUIS U. L.J. 7, 13 (1993).
2. Much of medical practice amounts to experimentation and research in the sense that physicians often treat patients with off-label uses of Food and Drug Administration (FDA)-approved medications. Federal courts repeatedly have asserted, however, that FDA does not have the authority to regulate the "practice of medicine," which each state regulates under its general police power to protect the health and welfare of its citizens. See e.g., Linder v. U.S., 268 U.S. 5 (1925).
3. Katz, supra note 1, at 13.
4. Pilar Ossorio, Pills, Bills and Shills: Physician-Researcher's Conflict of Interest, 8 WIDENER L. SYMP. J. 75, 94 (2001).
5. KAISER FAMILY FOUNDATION/HARVARD SCHOOL OF PUBLIC HEALTH SURVEY OF PHYSICIANS AND NURSES: SUMMARY OF FINDINGS AND CHART PACK (July 1999), available at http://www.kff.org/kaiserpolls/loader.cfm?url=/commonspot/security/getfile. cfm&PageID=13233 (last accessed Mar. 10, 2004).
6. See T.E. Miller & W.M. Sage, Disclosing Physician Financial Incentives, 281 JAMA 1424-30 (1999); D.A. Conrad, C. Maynard, A. Cheadle et al., Primary Care Physician Compensation Method in Medical Groups, 279 JAMA 853-58 (1998); K. Grumbach, D. Osmond, K. Vranizan et al., Primary Care Physicians' Experience of Financial Incentives in Managed-Care Systems, 339 NEW ENG. J. MED. 1516-21 (1998); D.M. Berwick, Payment of Capitation and the Quality of Care, 335 NEW ENG. J. MED. 1227-30 (1996); A.L. Hillman, M.V. Pauly & J.J. Kerstein, How Do Financial Incentives Affect Physicians' Clinical Decisions and the Financial Performance of Health Maintenance Organizations?, 321 NEW ENG. J. MED. 86-92 (1989); A.L. Hillman, Financial Incentives for Physicians in HMOs. Is There a Conflict of Interest?, 317 NEW ENG. J. MED. 1743-48 (1987).
7. See T.E. Miller & W.M. Sage, Disclosing Physician Financial Incentives, 281 JAMA 1424-30 (1999); D.A. Conrad, C. Maynard, A. Cheadle et al., Primary Care Physician Compensation Method in Medical Groups, 279 JAMA 853-58 (1998); K. Grumbach, D. Osmond, K. Vranizan et al., Primary Care Physicians' Experience of Financial Incentives in Managed-Care Systems, 339 NEW ENG. J. MED. 1516-21 (1998); D.M. Berwick, Payment of Capitation and the Quality of Care, 335 NEW ENG. J. MED. 1227-30 (1996); A.L. Hillman, M.V. Pauly & J.J. Kerstein, How Do Financial Incentives Affect Physicians' Clinical Decisions and the Financial Performance of Health Maintenance Organizations?, 321 NEW ENG. J. MED. 86-92 (1989); A.L. Hillman, Financial Incentives for Physicians in HMOs. Is There a Conflict of Interest?, 317 NEW ENG. J. MED. 1743-48 (1987).
8. See T.E. Miller & W.M. Sage, Disclosing Physician Financial Incentives, 281 JAMA 1424-30 (1999); D.A. Conrad, C. Maynard, A. Cheadle et al., Primary Care Physician Compensation Method in Medical Groups, 279 JAMA 853-58 (1998); K. Grumbach, D. Osmond, K. Vranizan et al., Primary Care Physicians' Experience of Financial Incentives in Managed-Care Systems, 339 NEW ENG. J. MED. 1516-21 (1998); D.M. Berwick, Payment of Capitation and the Quality of Care, 335 NEW ENG. J. MED. 1227-30 (1996); A.L. Hillman, M.V. Pauly & J.J. Kerstein, How Do Financial Incentives Affect Physicians' Clinical Decisions and the Financial Performance of Health Maintenance Organizations?, 321 NEW ENG. J. MED. 86-92 (1989); A.L. Hillman, Financial Incentives for Physicians in HMOs. Is There a Conflict of Interest?, 317 NEW ENG. J. MED. 1743-48 (1987).
9. See T.E. Miller & W.M. Sage, Disclosing Physician Financial Incentives, 281 JAMA 1424-30 (1999); D.A. Conrad, C. Maynard, A. Cheadle et al., Primary Care Physician Compensation Method in Medical Groups, 279 JAMA 853-58 (1998); K. Grumbach, D. Osmond, K. Vranizan et al., Primary Care Physicians' Experience of Financial Incentives in Managed-Care Systems, 339 NEW ENG. J. MED. 1516-21 (1998); D.M. Berwick, Payment of Capitation and the Quality of Care, 335 NEW ENG. J. MED. 1227-30 (1996); A.L. Hillman, M.V. Pauly & J.J. Kerstein, How Do Financial Incentives Affect Physicians' Clinical Decisions and the Financial Performance of Health Maintenance Organizations?, 321 NEW ENG. J. MED. 86-92 (1989); A.L. Hillman, Financial Incentives for Physicians in HMOs. Is There a Conflict of Interest?, 317 NEW ENG. J. MED. 1743-48 (1987).
10. See T.E. Miller & W.M. Sage, Disclosing Physician Financial Incentives, 281 JAMA 1424-30 (1999); D.A. Conrad, C. Maynard, A. Cheadle et al., Primary Care Physician Compensation Method in Medical Groups, 279 JAMA 853-58 (1998); K. Grumbach, D. Osmond, K. Vranizan et al., Primary Care Physicians' Experience of Financial Incentives in Managed-Care Systems, 339 NEW ENG. J. MED. 1516-21 (1998); D.M. Berwick, Payment of Capitation and the Quality of Care, 335 NEW ENG. J. MED. 1227-30 (1996); A.L. Hillman, M.V. Pauly & J.J. Kerstein, How Do Financial Incentives Affect Physicians' Clinical Decisions and the Financial Performance of Health Maintenance Organizations?, 321 NEW ENG. J. MED. 86-92 (1989); A.L. Hillman, Financial Incentives for Physicians in HMOs. Is There a Conflict of Interest?, 317 NEW ENG. J. MED. 1743-48 (1987).
11. See T.E. Miller & W.M. Sage, Disclosing Physician Financial Incentives, 281 JAMA 1424-30 (1999); D.A. Conrad, C. Maynard, A. Cheadle et al., Primary Care Physician Compensation Method in Medical Groups, 279 JAMA 853-58 (1998); K. Grumbach, D. Osmond, K. Vranizan et al., Primary Care Physicians' Experience of Financial Incentives in Managed-Care Systems, 339 NEW ENG. J. MED. 1516-21 (1998); D.M. Berwick, Payment of Capitation and the Quality of Care, 335 NEW ENG. J. MED. 1227-30 (1996); A.L. Hillman, M.V. Pauly & J.J. Kerstein, How Do Financial Incentives Affect Physicians' Clinical Decisions and the Financial Performance of Health Maintenance Organizations?, 321 NEW ENG. J. MED. 86-92 (1989); A.L. Hillman, Financial Incentives for Physicians in HMOs. Is There a Conflict of Interest?, 317 NEW ENG. J. MED. 1743-48 (1987).
12. Katz stated that [t]he physician-patient encounter continues to be shaped by the belief, shared by doctors and patients, that in therapeutic settings doctors at least try to do their level best for the individual patient who seeks their help .... In clinical research, on the other hand, patient-subjects are also being used for the ends of science .... Individual patient-centered therapy gives way to a collective patient-centered endeavor in which the abstraction of the research question tends to objectify the person-patient. Katz, supra note 1, at 15-16.
13. One could argue that there are benefits the normal, healthy research subject gains in this situation. First, there might be some monetary benefits, as healthy volunteers frequently are paid for their participation in Phase I studies. These payments are minimal and are intended to compensate subjects for their participation. Institutional review boards (IRBs) and medical professional organizations discourage, and frequently ban, the use of large monetary payments as incentives to participate in research. Second, there are intangible benefits that might accrue to the healthy volunteer, such as the personal fulfillment attained through advancing scientific knowledge and contributing to the development of new therapies to treat sick patients. For the individual healthy volunteer, these monetary and personal benefits likely do exceed the potential risks involved in the procedure. My point merely is that these types of benefits are for the most part less tangible than the benefits involved in the risk-benefit calculation that occurs in the doctor-patient relationship and, as such, have the potential to subject the research subject to more physical risks without any offsetting physical benefits than the patient in clinical practice.
14. Many Phase I studies, particularly in cancer research, also are conducted on patients with terminal illnesses for whom there is a lack of encouraging standard treatment options. In these situations, the danger of confusing the researcher and clinician roles is at least as great, if not greater than in Phase II or III studies, because the patient suffering from end-stage cancer is particularly vulnerable to a belief in the therapeutic benefit of an unproven medication given his or her poor short-term prognosis and lack of response to standard therapies.
15. P.S. APPELBAUM, L.H. ROTH, C.W. LIDZ ET AL., FALSE HOPES AND BEST DATA: CONSENT TO RESEARCH AND THE THERAPEUTIC MISCONCEPTION 20-24 (Apr. 1987) (Hastings Center Report).
16. B.R. Cassileth, E.J. Lusk, D.S. Miller & S. Hurwitz, Attitudes Toward Clinical Trials Among Patients and Public, 248 JAMA 968-70 (1982).
17. Ibid. Id.
18. F.G. Miller & D.L. Rosenstein, The Therapeutic Orientation to Clinical Trials, 348 NEW ENG. J. MED. 1383-86 (2003).
19. See S.M. Grunberg & W.T. Cefalu, The Integral Role of Clinical Research in Clinical Care, 348 NEW ENG. J. MED. 1386-88 (2003); C. Daugherty, M.J. Ratain, E. Grochowski et al., Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials, 13 J. CLIN. ONCOL. 1062-72 (1995); C.K. Daugherty, Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective, 17 J. CLIN. ONCOL. 1601-17 (1999).
20. See S.M. Grunberg & W.T. Cefalu, The Integral Role of Clinical Research in Clinical Care, 348 NEW ENG. J. MED. 1386-88 (2003); C. Daugherty, M.J. Ratain, E. Grochowski et al., Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials, 13 J. CLIN. ONCOL. 1062-72 (1995); C.K. Daugherty, Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective, 17 J. CLIN. ONCOL. 1601-17 (1999).
21. See S.M. Grunberg & W.T. Cefalu, The Integral Role of Clinical Research in Clinical Care, 348 NEW ENG. J. MED. 1386-88 (2003); C. Daugherty, M.J. Ratain, E. Grochowski et al., Perceptions of Cancer Patients and Their Physicians Involved in Phase I Trials, 13 J. CLIN. ONCOL. 1062-72 (1995); C.K. Daugherty, Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective, 17 J. CLIN. ONCOL. 1601-17 (1999).
22. R.J. Levine, Informed Consent in Research and Practice: Similarities and Differences, 143 ARCH. INTERN. MED. 1229-31 (1983).
23. See Mohr v. Williams, 104 N.W. 12 (Minn. 1905) (defendant physician was found to be liable in battery for operating on the patient's other ear in addition to the ear operation consented to by the patient); Schloendorff v. Soc'y of N.Y. Hospital, 105 N.E. 92 (N.Y. 1914) (defendant hospital was found not to be liable for the actions of a staff surgeon who performed an operation on the patient without her consent).
24. See Mohr v. Williams, 104 N.W. 12 (Minn. 1905) (defendant physician was found to be liable in battery for operating on the patient's other ear in addition to the ear operation consented to by the patient); Schloendorff v. Soc'y of N.Y. Hospital, 105 N.E. 92 (N.Y. 1914) (defendant hospital was found not to be liable for the actions of a staff surgeon who performed an operation on the patient without her consent).
25. Ken Marcus Gatter, Protecting Patient-Doctor Discourse: Informed Consent and Deliberative Autonomy, 78 OR. L. REV. 941, 950 (1999).
26. Schloendorff, 105 N.E. at 93.
27. 317 P.2d 170 (Cal. 1957).
28. Id. at 181.
29. 464 F.2d 772 (1972).
30. Id. at 780.
31. Id. at 786-87.
32. 350 P.2d 1093 (Kan. 1960).
33. While many states utilize the "reasonable patient" standard, the majority rule by a small margin is still the "professional disclosure" standard. See, e.g., 88 A.L.R.3d 1008 (1978).
34. T.L. BEAUCHAMP & J.F. CHILDRESS, PRINCIPLES OF BIOMEDICAL ETHICS 63 (5th ed. 2001).
35. 502 P.2d 1 (Cal. 1972) (defendant physician was found liable for failing to inform the plaintiff, who underwent two subsequent surgeries as a result of complications suffered from duodenal ulcer surgery, of the potential complications of the initial surgery).
36. Id. at 10.
37. 545 N.W.2d 495 (Wis. 1996) (defendant surgeon was found to be liable for not disclosing to the plaintiff that the morbidity and mortality associated with a particular surgical procedure rose from 10-15% to 20-30% when performed by an inexperienced surgeon such as himself).
38. The Nuremberg Code, reprinted in HAROLD Y. VANDERPOOL, THE ETHICS OF RESEARCH INVOLVING HUMAN SUBJECTS: FACING THE 21ST CENTURY 431-32 (1996).
39. Id. The Nuremberg Code explained the principle of informed consent as follows: This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
40. George Annas, The Changing Landscape of Human Experimentation: Nuremberg, Helsinki, and Beyond, 2 HEALTH MATRIX 119, 122 (1992) [hereinafter Annas, Changing Landscape].
41. The Declaration of Helsinki, adopted by the 18th World Medical Assembly Helsinki, Finland, June 1964 and amended by the 29th World Medical Assembly Tokyo, Japan, October 1975, 35th World Medical Assembly, Venice, Italy, Oct. 1983, and the 41st World Medical Assembly, Hong Kong, Sept. 1989, reprinted in VANDERPOOL supra note 30, at 433-36.
42. Annas, Changing Landscape, supra note 32, at 122.
43. J. KATZ, A.M. CAPRON & E.S. GLASS, EXPERIMENTATION WITH HUMAN BEINGS: THE AUTHORITY OF THE INVESTIGATOR, SUBJECT, PROFESSIONS, AND STATE IN THE HUMAN EXPERIMENTATION PROCESS 9-65 (1972). In this study, physicians injected liver cancer cells into unsuspecting patients with chronic, debilitating diseases to study the nature of the human transplant rejection process.
44. D.J. ROTHMAN & S.M. ROTHMAN, THE WILLOWBROOK WARS: A DECADE LONG STRUGGLE FOR SOCIAL JUSTICE (1984). In this research experiment, physicians deliberately infected mentally-retarded children with hepatitis to better understand the natural history of the infectious hepatitis virus.
45. Henry K. Beecher, Ethics and Clinical Research, 274 NEW ENG. J. MED. 1354-60 (1966).
46. Id. at 1356-59.
47. PUBLIC HEALTH SERV., U.S. DEP'T OF HEALTH, EDUCATION, AND WELFARE, FINAL REPORT OF THE TUSKEGEE SYPHILIS STUDY AD HOC ADVISORY PANEL (Apr. 1973).
48. Jesse Goldner, An Overview of Legal Controls on Human Experimentation and the Regulatory Implications of Taking Professor Katz Seriously, 38 ST. LOUIS U. L.J. 63, 96 (1993).
49. The Belmont Report, reprinted in VANDERPOOL, supra note 30, at 437-48.
50. Id. at 438. The Belmont Report stated: For the most part, the term "practice" refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals. By contrast, the term "research" designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective. Id.
51. Id. at 442-48.
52. In 1991, the Common Rule was enacted. It is the federal policy regarding the protection of human subjects, and covers research supported by seventeen different federal agencies. Its provisions are identical to the Department of Health and Human Services regulations regarding the protection of human subjects, codified in 45 C.F.R. § 46, subpt. A.
53. 21 C.F.R. § 50.20.
54. Id. § 50.25 (stating that typical elements of an informed consent include the type of research to be performed, the potential risks and benefits associated with the proposed treatment, the experimental nature of the research, the alternatives to participation in the clinical trial, and the subject's freedom to withdraw from or not participate in the research study without any detrimental effect on the patient's access to continued appropriate medical services).
55. 53 D.L.R.2d 436 (1963).
56. It should be noted that while a duty has been well established for the physician-researcher, this is not the case for the nonphysician-researcher. This article is concerned throughout with the duty owed by the physician-researcher.
57. Halushka, 53 D.L.R.2d at 443-44.
58. 793 P.2d 479 (Cal. 1990).
59. Id. at 481.
60. Ibid. Id.
61. Ibid. Id.
62. Id. at 481-82
63. Ibid. Id.
64. Ibid. Id.
65. Id. at 484.
66. See Canterbury v. Spence, 464 F.2d 772, 790 (D.C. Cir. 1972) ("[A]s in malpractice actions generally, there must be a causal relationship between the physician's failure to adequately divulge and damage to the patient. A causal connection exists when, but only when, disclosure of significant risks incidental to treatment would have resulted in a decision against it.").
67. Claire Turcotte Maatz, University Physician-Researcher Conflicts of Interest: The Inadequacy of Current Controls and Proposed Reform, 7 HIGH TECH. L.J. 137, 173 (1993).
68. Canterbury v. Spence, 464 F.2d at 790 ("An unrevealed risk that should have been made known must materialize, for otherwise the omission, however unpardonable, is legally without consequence. Occurrence of the risk must be harmful to the patient, for negligence unrelated to injury is nonactionable.").
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73. J.L. Fox, Gene-Therapy Death Prompts Broad Civil Lawsuit, 18 NAT. BIOTECHNOL. 1136 (2000). Eighteen-year-old Jesse Gelsinger, who suffered from a mild form of the rare metabolic disease ornithine transcarbamylase deficiency syndrome, died while participating in a Phase I clinical trial at the University of Pennsylvania in 1999. This trial tested an engineered adenovirus vector carrying a gene intended to correct the deficiency. A wrongful death lawsuit filed by Gelsinger's father claimed that because the physician-researchers stood to gain financially from the successful completion of the study, they understated the experiment's risks and misrepresented the efficacy of the procedure.
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94. Id. at 90.
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98. See AAMC, supra note 88.
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100. ASS'N OF AM. UNIVERSITIES (AAU) TASK FORCE ON RESEARCH AND ACCOUNTABILITY, REPORT ON INDIVIDUAL AND INSTITUTIONAL FINANCIAL CONFLICT OF INTEREST (2001), available at http://www.aau.edu/research/ COI.01.pdf (last accessed Mar. 10, 2004); AM. SOC'Y OF GENE THERAPY (ASGT), POLICY OF THE AMERICAN SOCIETY OF GENE THERAPY ON FINANCIAL CONFLICT OF INTEREST IN CLINICAL RESEARCH (2000), available at http: //www.asgt.org/position_statements/ conflict_of_interest.html (last accessed Mar. 9, 2004); NAT'L BIOETHICS ADVISORY COMM'N (NBAC), ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS (2001), available at http://www.georgetown.edu/research/nrcbl/nbac/ human/overvol1.pdf (last accessed Mar. 10, 2004); NAT'L HUMAN RESEARCH PROTECTIONS ADVISORY COMM. (NHRPAC), NHRPAC RECOMMENDATIONS ON HIHS's DRAFT INTERIM GUIDANCE ON FINANCIAL RELATIONSHIPS IN CLINICAL RESEARCH (2001), available at http://ohrp.osophs.dhhs.gov/nhrpac/documents/aug01a.pdf (last accessed Mar. 9, 2004).
101. ASS'N OF AM. UNIVERSITIES (AAU) TASK FORCE ON RESEARCH AND ACCOUNTABILITY, REPORT ON INDIVIDUAL AND INSTITUTIONAL FINANCIAL CONFLICT OF INTEREST (2001), available at http://www.aau.edu/research/ COI.01.pdf (last accessed Mar. 10, 2004); AM. SOC'Y OF GENE THERAPY (ASGT), POLICY OF THE AMERICAN SOCIETY OF GENE THERAPY ON FINANCIAL CONFLICT OF INTEREST IN CLINICAL RESEARCH (2000), available at http: //www.asgt.org/position_statements/ conflict_of_interest.html (last accessed Mar. 9, 2004); NAT'L BIOETHICS ADVISORY COMM'N (NBAC), ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS (2001), available at http://www.georgetown.edu/research/nrcbl/nbac/ human/overvol1.pdf (last accessed Mar. 10, 2004); NAT'L HUMAN RESEARCH PROTECTIONS ADVISORY COMM. (NHRPAC), NHRPAC RECOMMENDATIONS ON HIHS's DRAFT INTERIM GUIDANCE ON FINANCIAL RELATIONSHIPS IN CLINICAL RESEARCH (2001), available at http://ohrp.osophs.dhhs.gov/nhrpac/documents/aug01a.pdf (last accessed Mar. 9, 2004).
102. ASS'N OF AM. UNIVERSITIES (AAU) TASK FORCE ON RESEARCH AND ACCOUNTABILITY, REPORT ON INDIVIDUAL AND INSTITUTIONAL FINANCIAL CONFLICT OF INTEREST (2001), available at http://www.aau.edu/research/ COI.01.pdf (last accessed Mar. 10, 2004); AM. SOC'Y OF GENE THERAPY (ASGT), POLICY OF THE AMERICAN SOCIETY OF GENE THERAPY ON FINANCIAL CONFLICT OF INTEREST IN CLINICAL RESEARCH (2000), available at http: //www.asgt.org/position_statements/ conflict_of_interest.html (last accessed Mar. 9, 2004); NAT'L BIOETHICS ADVISORY COMM'N (NBAC), ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS (2001), available at http://www.georgetown.edu/research/nrcbl/nbac/ human/overvol1.pdf (last accessed Mar. 10, 2004); NAT'L HUMAN RESEARCH PROTECTIONS ADVISORY COMM. (NHRPAC), NHRPAC RECOMMENDATIONS ON HIHS's DRAFT INTERIM GUIDANCE ON FINANCIAL RELATIONSHIPS IN CLINICAL RESEARCH (2001), available at http://ohrp.osophs.dhhs.gov/nhrpac/documents/aug01a.pdf (last accessed Mar. 9, 2004).
103. RESPONSIBLE RESEARCH: A SYSTEMS APPROACH TO PROTECTING RESEARCH PARTICIPANTS (D.D. Friedman, K.E. Hanna, L.L. Rodriguez, eds., Committee on Assessing the System for Protecting Human Research Participants, Institute of Medicine (IOM) of the National Academies 2003).
104. Dep't of Health and Human Services (DHHS), Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection, 68 Fed. Reg. 15,456 (Mar. 31, 2003).
105. 42 C.F.R. § 50.601.
106. Id. § 50.604.
107. Id. § 50.603.
108. Ibid. Id.
109. 21 C.F.R. § 54.
110. S.V. McCrary, C.B. Anderson, J. Jakovljevic et al., A National Survey of Policies on Disclosure of Conflicts of Interest in Biomedical Research, 343 NEW ENG. J. MED. 1621-26 (2000).
111. 21 C.F.R. § 54.2(e).
112. B. Lo, L.E. Wolf & A. Berkeley, Conflict-of-Interest Policies for Investigators in Clinical Trials, 343 NEW ENG. J. MED. 1616-20 (2000).
113. Id. at 1618.
114. Id. at 1619.
115. M.K. Cho, R. Shohara, A. Schissel & D. Rennie, Policies on Faculty Conflicts of Interest at U.S. Universities, 284 JAMA 2203-08 (2000).
116. Thompson, supra note 61, at 575-76.
117. E.A. Boyd & L.A. Bero, Assessing Faculty Financial Relationships With Industry: A Case Study, 284 JAMA 2209-14 (2000).
118. D. Shalala, Protecting Research Subjects - What Must Be Done, 343 NEW ENG. J. MED. 808-10 (2000).
119. Witt & Gostin, supra note 68, at 550-51.
120. K. Morin, H. Rakatansky, F.A. Riddick et al., Managing Conflicts of Interest in the Conduct of Clinical Trials, 287 JAMA 78-84 (2002).
121. Id. at 78-79.
122. M. Hovde & R. Seskin, Selecting U.S. Clinical Investigators, APPLIED CLIN. TRIALS, Feb. 1997, at 34-42.
123. Morin et al., supra note 108, at 79.
124. Mark Bames & Patrick Florencio, Investigator, IRB, and Institutional Conflicts of Interest in Human Subjects Research: Past, Present, and Future, 32 SETON HALL L.R. 525, 527 (2002).
125. R.G. Beran & M.E. Beran, Conduct of Trials in Private Clinical Practice, 41 EPILEPSIA 475-79 (2000).
126. H. Helmchen, M. Linden & G. Schüssler, The Private Practice Study Group as Phase IV Research Tool, 17 PHARAMCOPSYCHIAT. 157-61 (1984).
127. I.D. Fleming, Clinical Trials for Cancer Patients: The Community Practicing Physician Perspective, 65 CANCER 2388-90 (1990).
128. J. Cohen, Clinical Trial Monitoring: Hit or Miss?, 264 Sci. 1534-37 (1994).
129. W.J. Burman, R.R. Reves, D.L. Cohn & R.T. Schooley, Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards, 134 ANN. INTERN. MED. 152-57 (2001).
130. David Forster, Independent Institutional Review Boards, 32 SETON HALL L.R. 513, 518 (2002).
131. The information regarding the development and conduct of clinical trials in private practices devoted to the treatment of HIV-infected patients is gathered from two sources: 1) the author's personal experiences and insights after working in three Los Angeles-based HIV-specialty private practice groups during an eight-year period and 2) personal communications with Dr. Jim Thommes, former Director of Research at Pacific Oaks Medical Group (a Los Angeles-based multispecialty private practice group) and current U.S. Medical Director of Roche Laboratories, Inc.
132. Annas, Changing Landscape, supra note 32, at 132.
133. George Annas, Faith (Healing), Hope and Charity at the FDA: The Politics of AIDS Drugs Trials, 34 VILL. L. REV. 771, 795 (1989).
134. D. Abrams, T. Mitchell, C. Child et al., Factors Influencing Physicians' Participation in Community-based Clinical Trials, 6 INT. CONF. AIDS 290 (1990) (abstract no. S.D.801).
135. APPELBAUM ET AL., supra note 10, at 23 (emphasis in original).
136. The opposite risk that the physician will perform his role as patient advocate to the detriment of the research study also exists in this situation. For example, a physician might believe that an experimental agent offers the best hope for his patient's survival. The patient, however, does not meet the study criteria. Confronted with this situation, the physician might decide to "fudge" the patient's laboratory data to meet the enrollment criteria. Here, the physician chooses his role as patient advocate over his role as researcher. Unfortunately, he has determined to resolve the conflict between the two roles of clinician and researcher in a manner that inappropriately advances the patient's interest over those of the research protocol.
137. Morin et al., supra note 108, at 80.
138. See J.H. Wong, J.F. Max & M.E. Suarez-Almozar, Regional Performance of Carotid Endarterectomy: Appropriateness, Outcomes, and Risk Factors for Complications, 28 STROKE 891-98 (1997); L. Kleinman, J. Kosecoff, R.W. Dubois & R.H. Brook, The Medical Appropriateness of Tympanostomy Tubes Proposed for Children Younger Than 16 Years in the United States, 271 JAMA 1250-55 (1994); C.M. Winslow, J.B. Kosecoff, M.R. Chassin et al., The Appropriateness of Performing Coronary Artery Bypass Graft Surgery, 260 JAMA 505-09 (1988).
139. See J.H. Wong, J.F. Max & M.E. Suarez-Almozar, Regional Performance of Carotid Endarterectomy: Appropriateness, Outcomes, and Risk Factors for Complications, 28 STROKE 891-98 (1997); L. Kleinman, J. Kosecoff, R.W. Dubois & R.H. Brook, The Medical Appropriateness of Tympanostomy Tubes Proposed for Children Younger Than 16 Years in the United States, 271 JAMA 1250-55 (1994); C.M. Winslow, J.B. Kosecoff, M.R. Chassin et al., The Appropriateness of Performing Coronary Artery Bypass Graft Surgery, 260 JAMA 505-09 (1988).
140. See J.H. Wong, J.F. Max & M.E. Suarez-Almozar, Regional Performance of Carotid Endarterectomy: Appropriateness, Outcomes, and Risk Factors for Complications, 28 STROKE 891-98 (1997); L. Kleinman, J. Kosecoff, R.W. Dubois & R.H. Brook, The Medical Appropriateness of Tympanostomy Tubes Proposed for Children Younger Than 16 Years in the United States, 271 JAMA 1250-55 (1994); C.M. Winslow, J.B. Kosecoff, M.R. Chassin et al., The Appropriateness of Performing Coronary Artery Bypass Graft Surgery, 260 JAMA 505-09 (1988).
141. B.J. Hillman, C.A. Joseph, M.R. Mabry et al., Frequency and Costs of Diagnostic Imaging in Office Practice - A Comparison of Self-Referring and Radiologist-Referring Physicians, 323 NEW ENG. J. MED. 1604-08 (1990).
142. J.M. Mitchell & E. Scott, New Evidence of the Prevalence and Scope of Physician Joint Ventures, 268 JAMA 80-84 (1992).
143. Id. at 82.
144. Ibid. Id.
145. The Medicare and Medicaid Patient Protection Act of 1987, Pub. L. No. 100-93, 101 Stat. 680 (1987) (codified at 42 U.S.C. § 1320a-7b), provides for criminal penalties for the offer or receipt of remuneration (broadly defined) in return for referrals for or recommending purchase of supplies and services reimbursable under government healthcare programs.
146. The Omnibus Budget Reconciliation Act (OBRA) of 1989 (Stark I) disallows physician referral of Medicare patients to any clinical laboratory in which the physician or members of his family have a financial interest while the OBRA of 1993 (Stark II) extends that prohibition to include a number of "designated health services" and Medicaid services.
147. 42 C.F.R. § 1001.952.
148. T.S. Crane, The Problem of Physician Self-Referral Under the Medicare and Medicaid Antikickback Statute: The Hanlester Network Case and the Safe Harbor Regulation, 268 JAMA 85-91 (1992).
149. M. Chren, S. Landefeld, T.H. Murray, Doctors, Drug Companies, and Gifts, 262 JAMA 3448-51 (1989).
150. PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PHRMA), PHRMA CODE ON INTERACTIONS WITH HEALTHCARE PROFESSIONALS (July 2002), available at http://www.phrma.org/publications/policy//2004-01-19.391.pdf (last accessed Mar. 10, 2004).
151. Council on Ethical and Judicial Affairs, American Medical Ass'n (AMA), Current Opinions of the Council on Ethical and Judicial Affairs, E-8.061: Gifts to Physicians From Industry and E-11.02: Clarification of Opinion 8.061 in AMA CODE OF MEDICAL ETHICS: CURRENT OPINIONS WITH ANNOTATIONS 2002-2003 (2002).
152. Off. of the Inspector General (OIG), Dep't of Health and Human Services (DHHS), OIG Compliance Program Guidance for Pharmaceutical Manufacturers, 68 Fed. Reg. 23,731 (May 5, 2003).
153. D. Hemenway, A. Killen, S.B. Cashman et al., Physicians' Responses to Financial Incentives: Evidence from a For-Profit Ambulatory Care Center, 322 NEW ENG. J. MED. 1059-63 (1990).
154. See Hillman et al., supra note 6.
155. A.S. Relman, Shattuck Lecture-The Health Care Industry: Where is It Taking Us?, 325 NEW ENG. J. MED. 854-59 (1991).
156. See Ossorio, supra note 4, at 96.
157. S.E. Lind, Finder's Fees for Research Subjects, 323 NEW ENG. J. MED. 192-94 (1990).
158. D.S. Shimm & R.G. Spece, Industry Reimbursement for Entering Patients Into Clinical Trials: Legal and Ethical Issues, 115 ANN. INTERN. MED. 148-51 (1991).
159. Personal communication from Dr. Jim Thommes (Apr. 2002).
160. A. Miller, Trial Run: Small Practices Can Participate in Clinical Trials. Here's How, AM. MED. NEWS, Sept. 27, 1999, available at amednews.com http://www.ama-assn.org/amednews/1999/pick_99/biza0927.htm (last accessed Mar. 10, 2004).
161. K. Eichenwald & G. Kolata, Drug Trials Hide Conflicts for Doctors, N.Y. TIMES, May 16, 1999, at 1.
162. OFF. OF INSPECTOR GENERAL (OIG), DEP'T OF HEALTH AND HUMAN SERVICES (DHHS), RECRUITING HUMAN SUBJECTS: PRESSURES IN INDUSTRY-SPONSORED CLINICAL RESEARCH (June 2000), available at http://oig.hhs.gov/oei/reports/oei-01-97- 00195.pdf (last accessed Mar. 10, 2004).
163. R. Steinbrook, Improving Protection for Research Subjects, 346 NEW ENG. J. MED. 1425-29 (2002).
164. Ibid. Id.
165. Shalala, supra 106, at 810.
166. Shimm & Spece, supra note 144, at 149.
167. See NBAC, supra note 90, at 12; Friedman et al., supra note 91, at 187.
168. See 68 Fed. Reg. 15,456. In its draft guidance, the guidelines state that the Department recommends that investigators consider the potential effect that a financial relationship of any kind might have on a clinical trial, including interactions with research subjects, and whether to take any of the following actions: 1) Including information in the consent document, such as a) the source of funding and funding arrangements for the conduct and review of research, or b) information about a financial arrangement of an institution or an investigator and how it is being managed; 2) Using special measures to modify the consent process when a potential or actual financial conflict exists, such as a) having a non-biased third party obtain consent, especially when a potential or actual conflict of interest could influence the tone, presentation, or type of information presented during the consent process, or b) considering independent monitoring of the research, e.g. using a data and safety monitoring committee. Id. at 15,459 (emphasis added.)
169. Nancy Moore, What Doctors Can Learn From Lawyers About Conflicts of Interest, 81 B.U. L. REV. 445, 455-56 (2001).
170. Shimm & Spece, supra note 144, at 149.
171. See AAMC, supra note 88.
172. See AFCR, supra note 88.
173. See AAU, supra note 90.
174. See ASGT, supra note 90.
175. The Association for the Accreditation of Human Research Protection Programs (AAHRPP), incorporated in 2001, states in its mission that it "works to protect the rights and welfare of research participants by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants ... by using an accreditation process based on self-assessment, peer review, and education." See AAHRPP website at http://www.aahrpp.org.
176. Shimm & Spece, supra note 144, at 150.
177. Personal communication from Dr. Jim Thommes (Apr. 2002).
178. OFF. OF INSPECTOR GENERAL (OIG), DEP'T OF HEALTH AND HUMAN SERVICES (DHHS), INSTITUTIONAL REVIEW BOARDS (JUNE 1988). PART I: THEIR ROLE IN REVIEWING APPROVED RESEARCH, available at http://oig.hhs.gov/oei/reports/oei-01-97-00190. pdf (last accessed Mar. 10, 2004); PART II: PROMISING APPROACHES, available at http://oig.hhs.gov/oei/reports/oei-01-97-00191.pdf (last accessed Mar. 10, 2004); PART III: THE EMERGENCE OF INDEPENDENT BOARDS, available at http://oig.hhs.gov/oei/reports/oei-01-97-00192.pdf (last accessed Mar. 10, 2004); and PART IV: A TIME FOR REFORM, available at http://oig.hhs.gov/oei/ reports/oei-01-97-00193.pdf (last accessed Mar. 10, 2004).
179. OFF. OF INSPECTOR GENERAL (OIG), DEP'T OF HEALTH AND HUMAN SERVICES (DHHS), INSTITUTIONAL REVIEW BOARDS (JUNE 1988). PART I: THEIR ROLE IN REVIEWING APPROVED RESEARCH, available at http://oig.hhs.gov/oei/reports/oei-01-97-00190. pdf (last accessed Mar. 10, 2004); PART II: PROMISING APPROACHES, available at http://oig.hhs.gov/oei/reports/oei-01-97-00191.pdf (last accessed Mar. 10, 2004); PART III: THE EMERGENCE OF INDEPENDENT BOARDS, available at http://oig.hhs.gov/oei/reports/oei-01-97-00192.pdf (last accessed Mar. 10, 2004); and PART IV: A TIME FOR REFORM, available at http://oig.hhs.gov/oei/ reports/oei-01-97-00193.pdf (last accessed Mar. 10, 2004).
180. OFF. OF INSPECTOR GENERAL (OIG), DEP'T OF HEALTH AND HUMAN SERVICES (DHHS), INSTITUTIONAL REVIEW BOARDS (JUNE 1988). PART I: THEIR ROLE IN REVIEWING APPROVED RESEARCH, available at http://oig.hhs.gov/oei/reports/oei-01-97-00190. pdf (last accessed Mar. 10, 2004); PART II: PROMISING APPROACHES, available at http://oig.hhs.gov/oei/reports/oei-01-97-00191.pdf (last accessed Mar. 10, 2004); PART III: THE EMERGENCE OF INDEPENDENT BOARDS, available at http://oig.hhs.gov/oei/reports/oei-01-97-00192.pdf (last accessed Mar. 10, 2004); and PART IV: A TIME FOR REFORM, available at http://oig.hhs.gov/oei/ reports/oei-01-97-00193.pdf (last accessed Mar. 10, 2004).
181. OFF. OF INSPECTOR GENERAL (OIG), DEP'T OF HEALTH AND HUMAN SERVICES (DHHS), INSTITUTIONAL REVIEW BOARDS (JUNE 1988). PART I: THEIR ROLE IN REVIEWING APPROVED RESEARCH, available at http://oig.hhs.gov/oei/reports/oei-01-97-00190. pdf (last accessed Mar. 10, 2004); PART II: PROMISING APPROACHES, available at http://oig.hhs.gov/oei/reports/oei-01-97-00191.pdf (last accessed Mar. 10, 2004); PART III: THE EMERGENCE OF INDEPENDENT BOARDS, available at http://oig.hhs.gov/oei/reports/oei-01-97-00192.pdf (last accessed Mar. 10, 2004); and PART IV: A TIME FOR REFORM, available at http://oig.hhs.gov/oei/ reports/oei-01-97-00193.pdf (last accessed Mar. 10, 2004).
182. W.J. Burman, R.R. Reves, D.L. Cohn & R.T. Schooley, Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards, 134 ANN. INTERN. MED. 152-57 (2001); R.J. Levine, Institutional Review Boards: A Crisis in Confidence, 134 ANN. INTERN. MED. 161-63 (2001).
183. W.J. Burman, R.R. Reves, D.L. Cohn & R.T. Schooley, Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards, 134 ANN. INTERN. MED. 152-57 (2001); R.J. Levine, Institutional Review Boards: A Crisis in Confidence, 134 ANN. INTERN. MED. 161-63 (2001).
184. M.C. Christian, J.L. Goldberg, J. Killen et al., A Central Institutional Review Board for Multi-Institutional Trials, 346 NEW ENG. J. MED. 1405-08 (2002).
185. 21 C.F.R. § 56.107(a).
186. Kuszler, supra note 69, at 149.
187. Janet Fleetwood, Conflicts of Interest in Clinical Research: Advocating for Patient-Subjects, 8 WIDENER L. SYMP. J. 105, 113 (2001).
188. Id. at 113-14.
189. Daugherty, supra note 14, at 1611.
190. OIG, INSTITUTIONAL REVIEW BOARDS: PART II: PROMISING APPROACHES, supra note 164, at 12.
191. Ossorio, supra note 4, at 97.
192. The ensuing discussion of this model was derived from a personal communication with Dr. Jim Thommes (Apr. 2002).
193. Halushka, 53 D.L.R. 2d at 443-44.
194. M.M. Mello, D.M. Studdert & T.A. Brennan, The Rise of Litigation in Human Subjects Research, 139 ANN. INTERN. MED. 40-45 (2003).
195. Ibid. Id.
196. Id. at 41.
197. Brickenden v. London Loan and Sav. Co., 3 D.L.R. 465 (1934). When a party, holding a fiduciary relationship, commits a breach of his duty by non-disclosure of material facts, which his constituent is entitled to know in connection with the transaction, he cannot be heard to maintain that disclosure would not have altered the decision to proceed with the transaction, because the constituent's action would be solely determined by some other factor. Once the Court has determined that the non-disclosed facts were material, speculation as to what course the constituent, on disclosure, would have taken is not relevant. Id. at 469.
198. Peter Harrington, Faculty Conflicts of Interest in an Age of Academic Entrepreneurialism: An Analysis of the Problem, The Law and Selected University Policies, 27 J.C. & U.L. 775, 792 (2001).