The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Conflict of Interest in Medical Research, Education, and Practice
Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole. Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 401
Conflict of Interest in Medical Research, Education, and Practice
Index
A
Academic detailing programs, 139–140, 183
Accountability
of conflict of interest policies, 7, 59
culture of, 2, 5, 29, 229, 230
extent of, as factor in conflict of interest evaluation, 56
of institutions, 15
in professional writing and speaking, 153–157
public engagement in conflict of interest policies and, 59
quality improvement initiatives, 232–233
role of sanctions, 235
Accounting profession, 317–328
Accreditation Council for Continuing Medical Education, 125, 150, 156, 161
Accreditation Council for Graduate Medical Education, 125
Accreditation organizations
conflict of interest policy requirements, 128
for continuing medical education, 20
for medical schools, 125
purpose, 125
recommendations for, 14, 15–16, 19, 21, 22, 213, 236–238
requirements, 128
in support of systemic change, 230, 231
Advanced Medical Technology Association, 41, 173, 231
Agency for Healthcare Policy and Research, 191
Agency for Healthcare Quality and Research, 191, 238–239
AGREE, 203
American Academy of Dermatology, 138–139
American Academy of Family Physicians, 125, 220
American Academy of Pediatrics, 176
American Association of University Professors, 39
American Board of Medical Specialties, 125
American College of Cardiology, 189, 190, 197
American College of Chest Physicians, 205–206
American College of Obstetricians and Gynecologists, 176
American College of Physicians, 67, 166, 176, 177–178, 192, 223
American College of Rheumatology, 176
American Council in Education, 39
American Heart Association, 189, 197
American Hospital Association, 125
American Medical Association
on access to physician prescribing information, 186
in accreditation process, 125
OCR for page 402
Conflict of Interest in Medical Research, Education, and Practice
conflict of interest policies, 40, 138, 139, 176
on funding of continuing medical education, 151
industry relations, 34
American Medical Student Association, 63, 76, 131, 234
American Psychiatric Association, 220
American Society of Clinical Oncology, 72
Architecture profession, 328–336
Association of American Medical Colleges
on authorship and speaking fees, 155
conflict of interest policies, 40, 62, 92
on continuing medical education, 151
on industry gifts, 137–138
on industry-sponsored scholarships and training positions, 139
on institutional conflicts of interest, 221–223, 229
research rules, 8, 29–30, 62, 76, 80, 82, 92, 110–112, 116
restrictions on industry access, 133
role in strengthening and implementing policies, 230, 231, 233
on uses of drug samples, 136
Association of American Universities, 8, 29–30, 39, 62, 110–111, 221–223, 229, 233
B
Basic research. See Research, medical
Bayh-Dole Act, 97–98
Biomedical research. See Research, medical
Biotechnology companies
benefits of collaborative relationships, 23–24, 44, 98, 99
concerns about relationships, 2, 5, 24, 35, 166–167, 189–190
historical evolution of professional relationships with, 34, 101
recommendations regarding financial relationships, 18, 20, 90, 94, 95, 187
research and development process, 23, 99
See also Collaborative relationships in medicine;
Medical product companies;
Pharmaceutical companies;
Research, medical
Blue Cross Blue Shield Association, 190–191
Brandeis, Louis, 67
C
Centers for Disease Control and Prevention, 191
Centers for Medicare and Medicaid Services, 170, 191
Charitable giving to institutions, 158
Clinical practice guidelines
challenges in development of, 189
conflict of interest concerns, 1, 13, 25, 189–190, 193–196, 203–204, 210–211
current shortcomings, 192
current strategies and policies to prevent bias in development of, 204–210
definition and purpose, 189, 190
development costs, 194
disclosure of funding for, 201, 203
dissemination, 196, 199
evolution of, 190–192
financial relationships in development of, 198–204
groups in development of, 194, 196–198
identification of bias, 25
implications of recommendations for individuals and organizations, 214–215
importance of, 25
industry involvement, 194–196
objective procedures for development of, 43
panel membership, 13–14, 20–21, 211, 212–213
political sensitivity, 191
public participation, 14
publication requirements, 21
quality of evidence base for, 193–194, 210
recommendations, 13–14, 20–21, 210–214
role of professional organizations in promoting transparency of, 21
standardization of presentation and assessment of, 208–210
systematic reviews in development of, 190, 193–194, 207–208
OCR for page 403
Conflict of Interest in Medical Research, Education, and Practice
topic selection, 195
transparency in development of, 13, 14, 21, 211, 212
See also National Guideline Clearinghouse
Clinical research. See Research, medical
Collaborative relationships in medicine
benefits of, 1, 2, 23, 44, 158–159
concerns, 1, 2, 3, 23
development of clinical practice guidelines, 13–14, 194–198, 211–214
historical evolution, 33
instruction for medical professionals on conduct in, 132, 160–161
new product development, 98, 99
recommendations for physicians and industry, 12–13, 20, 184–188
scope of, 2
See also Disclosure of financial relationship;
Financial relationships with industry;
Research, medical;
Role of supporting organizations
in strengthening and implementing conflict of interest policies
Computer technology
compliance monitoring, 87
database of payments to medical professionals, 94, 95
public reporting of financial relationship disclosures, 9
supporting standardization of disclosure requirements, 8–9, 92–93
Confidentiality, disclosure rules and, 58
Conflict of commitment, 48
Conflict of interest policies, generally
accountability provisions, 7, 59
in accounting profession, 317–328
accreditation requirements, 128
in architecture profession, 328–336
common features, 64
for community physicians, 175–183
complementary strategies to limit bias, 41–43
conflict of commitment provisions, 48
consistency across institutions and settings, 60
cost-benefit analysis, 27
criteria for evaluation, 6–7, 56–60
criticisms of, 26–27, 39, 62–63
current literature, 66–67
current variations and deficiencies, 4, 7–8, 87–88, 117
dissemination, 86, 89
distinction between perceived versus actual conflicts, 52
effectiveness evaluation, 57, 63
in engineering profession, 336–350
fairness of, 7, 60
goals, 1, 5, 6, 26, 28, 48–50, 61, 97, 117, 121, 229
government role in development of, 33, 38–39
historical and conceptual evolution, 7, 33–41, 62
incentives to adopt and implement, 233–234, 235–238
in legal profession, 305–317
monitoring and enforcement. See Monitoring and enforcement
multiple obligations of individuals, 65–66
ongoing performance evaluation of, 59
oversight committees, 8, 14–15, 18, 21–22, 81, 88–90, 120, 225, 226–228
participants in development and implementation, 2, 5
principles for formulation and implementation, 45, 60
proportionality in, 6, 57–58
public involvement in implementation, 59
research needs, 15–16, 22, 30, 84–85, 238–239
role of supporting organizations in strengthening and implementing, 2, 5, 22, 29–30, 120, 230–239
scope of individuals subject to, 60, 90
sources of, 38–41, 110–116, 175–183
transparency of, 6–7, 47, 58–59
See also Disclosure of financial relationship
Conflict of obligation, 48
Conflicts of interest, generally
challenges in avoiding, 25
definition, 6, 26, 45–46, 61, 303–304
elements of, 46–48
ethics violations and, 6, 49
identifying. See Identifying and assessing conflicts of interest
institutional. See Institutional conflicts of interest
OCR for page 404
Conflict of Interest in Medical Research, Education, and Practice
knowledge base, 30, 32–33, 238–239
magnitude of problem, 4, 26
managing. See Managing conflicts of interest
in nonmedical professions, 31, 50, 302–355
perceived versus actual, 52
policies. See Conflict of interest policies, generally
prevention. See Prevention of conflicts of interest
primary interests, 46
research on. See Research on conflict of
interest issues
secondary interests, 46–47
sources of, 5, 14, 32, 45–48, 166–167
threats to medical profession in, 44–45
Congress, U.S.
legislative action on conflict of interest issues, 40
proposed requirements for reporting of payments to physicians, 71
recommendations for, 9, 18, 94
CONSORT checklist, 113
Consulting arrangements
academic department chairs in, 101, 219
assessing likelihood of undue influence in, 54, 100
current conflict of interest policies, 138, 176, 177–178, 179
disclosure, 40, 182–183, 221
recommendations, 13, 19, 20, 157, 158, 184, 185, 187
standardization of disclosure requirements, 92
Continuing medical education
accreditation, 125
comparison with other professions, 142–143
conflict of interest concerns, 11, 145–149, 161
current conflict of interest policies, 150–153
curriculum, 141–142
funding, 2, 11–12, 19–20, 26–27, 34, 127, 142, 143–145, 161–163, 221
legal requirements, 141
monitoring, 150–151
nonaccredited programs, 142, 151, 152, 164
profitability, 143
purpose, 140
recommendations, 11–12, 19–20, 161–164
scope of programs and activities, 140–141
solicitations of industry support, 145
speaking fees, 145, 154
Contracts
industry conflict of interest policies, 179–181
research, 108–109, 111–112
Cost of care
challenges for academic medical centers, 126
and drug samples, 11, 186
Council of Medical Specialty Services, 178
Council on Government Relations, 62, 76
Culture of accountability, 2, 5, 29, 229, 230
incentives to adopt and implement conflict of interest policies, 235–236
D
Department of Defense, U.S., 120
Department of Health and Human Services, U.S., 15, 152–153, 221, 231
recommendations for, 22, 238–239
Department of Justice, U.S., 3, 15, 71, 148, 152, 154, 179, 182, 231
Diagnostic and Statistical Manual of Mental Disorders, 202–203
Disclosure of financial relationship
adequacy of, in maintaining integrity and public trust, 8
administrative burden, 7, 18, 29, 72–73, 91–92
adverse consequences, 67–68, 77
assistance to employees for compliance, 73
categories of relationships, 93
in clinical practice guideline development, 201, 203, 205, 211–212
confidentiality concerns, 58
current requirements for companies, 71–72
current requirements for medical professionals, 68–71
deterrent function, 67
effectiveness of policies, 77–79
OCR for page 405
Conflict of Interest in Medical Research, Education, and Practice
extent of noncompliance, 74–75
follow-up actions, 29
historical evolution of medical profession policies, 39–40
importance of, 1–2, 5, 8, 28, 67, 90
to individuals potentially affected by, 68–69
journal publication requirements, 69–70, 115
legislative requirements, 9, 63–64, 71–72, 94, 181–183
monitoring and enforcement, 75–76
objections to, 62–63
to patients of community physicians, 187
physician ownership of medical facilities, 170, 187
public access to reports, 9, 71, 94, 95, 180, 187
quantity of disclosed information, 77
recommendations for companies, 18, 94–96
recommendations for policy design and implementation, 8–9, 18, 89–93
reporting thresholds, 18, 68, 72, 90, 91, 118
requirements for marketing activities, 174
to research participants, 78, 109, 115–116
review responsibility, 64, 81, 82
risk assessment, 82–83
specificity of requirements, 91, 93
standardization, 8–9, 18, 29, 91–93, 164
strategies for managing conflicts of interest, 83–84
time frame for, 72, 90–91, 95
variations among conflict of interest policy requirements, 7–8, 87–88, 91–92
voluntary reporting from companies, 180–181
Discretion, 54–55
Drug research and development
approval rate, 23
costs, 23
process, 98–99
pro-industry research findings, 104–105, 106
withholding of research findings, 24, 106, 108
Drug samples
current restrictions, 135–136
documentation of distribution, 136
ethical concerns, 3–4, 11, 25, 135, 174–175, 186
industry spending, 171
intended purpose, 11, 134, 186
prevalence, 172
recommendations, 10–11, 13, 19, 20, 157, 159–160, 184, 186–187
E
ECRI Institute, 133, 191
Education and training of medical professionals
academic detailing programs, 139–140, 183
access of industry representatives to students and faculty, 131–133, 157, 158–159
accreditation, 15, 125
appropriate industry presence in, 10
authority and discretion of administrators, 55
burden of compliance with disclosure requirements, 73
charitable donations for, 158
conflict of interest concerns, 1, 2, 24, 123, 133, 157
conflict of interest instruction in, 11, 19
conflict of interest management variations within, 81–82
current conflict of interest policies, 68–69, 110, 133, 135–136, 137–138, 139
current scale, 124
debt burden of physicians, 126
department chairs or deans, conflict of interest risks for, 101, 218, 219
dissemination of conflict of interest policies, 86
distribution of industry spending, 127
elements of learning environment, 122–123
emergence of concerns about industry relationships, 35, 39
faculty member relationships with industry, 2, 10, 24
financial challenges, 126
OCR for page 406
Conflict of Interest in Medical Research, Education, and Practice
gifts to students and faculty, 136–138
goals, 10, 122, 127
historical development, 124
individuals subject to conflict of interest policies, 60
industry funding, 126–127
industry-sponsored scholarships and training positions, 138–139
influence on physician beliefs and attitudes, 127–128, 139
instruction on how to interact with industry representatives, 132, 160–161
management of conflicts of interest, 81, 83–84
off-site facilities, 131, 160
policy ratings, 131
prohibitions on financial relationships, 79
recommendations, 10–12, 17t, 19, 89, 157–161
restrictions on access of industry representatives, 133
scope of industry relationships in, 10, 32, 101–102, 129, 131
settings for, 122, 125
sources of data on industry support, 127
strategies for reducing conflict of interest risk, 139–140
value of industry relationships in, 129–131, 133
See also Continuing medical education;
Institutional conflicts of interest;
Students, medical
Eliminating conflicts of interest, 80
Enforcement. See Monitoring and enforcement;
Sanctions
Engineering profession, 336–350
Evidence-based medicine, 13, 191
F
Fairness of conflict of interest policies, 7, 60
Federal Demonstration Partnership, 73
Federation of American Societies for Experimental Biology, 62
Federation of State Medical Boards, 125
Financial relationships with industry
academic department chairs, 101, 218, 219
acceptable forms, 158
assessing likelihood of undue influence in, 53–55
continuing medical education financing, 2, 11–12, 34, 142, 143–145, 161–163
in development of clinical practice guidelines, 13–14, 198–204, 211–213
duration, 54
historical development of conflict of interest concerns, 35–41
historical evolution, 33–35
illegal payments to medical professionals, 25, 40, 148, 152–153, 154, 181–183
indirect, 145
industry-sponsored scholarships and training positions, 138–139
medical education institutions, 126–127
in medical publishing, 24
motivation of medical professionals to enter into, 126
negative effects of conflict of interest policies, 26–27, 62–63
in nonclinical research, 10, 101
percentage of organizational funds given by industry, 220–221, 223
physician–industry, 25, 172–173
physician perceptions of, 172–173
prohibition effects, 79–80
project benefits exceeding risk of bias, 57–58
recommendations for medical practice relationships with industry, 12–13, 184–188
regulatory and legislative actions, 181–183, 188
research-related gifts, 101–102
restrictions on human participants research, 9, 19, 110, 117–118
restrictions on researchers with financial interest in research outcome, 9–10, 117–119
scope of, 54, 101, 118, 129, 131
as secondary interest in conflicts of interest, 46–47
See also Disclosure of financial relationship;
Gifts to physicians;
Institutional conflicts of interest
Food and Drug Administration, 99
advisory committee membership, 82–83
clinical trials regulation, 113
OCR for page 407
Conflict of Interest in Medical Research, Education, and Practice
new device approval and company training, 132
recommendations for, 92, 238–239
research rules, 83
Foundations, 9, 18, 20, 49, 94, 145, 163, 187, 211
G
Ghostwriting, 10, 13, 19, 20, 24, 108, 153, 154–155, 156, 157, 158, 184, 185, 187
Gifts to institutions, 218
Gifts to physicians
acceptable forms, 158
assessing likelihood of undue influence of, 53–54
current conflict of interest policies, 137–138, 176
ethical concerns, 2, 4, 136–137, 185
extent, 136
in medical education settings, 10, 19, 129–131, 136–137
patient perception, 78–79
physician perspective, 126, 172
prevalence, 12, 172
prohibitions on, 79
public awareness, 78
purpose of disclosure policies, 67
recommendations, 13, 19, 20, 157, 158, 184, 187, 188
research-related gifts, 101–102
size of gift, 47, 53–54, 136–137
Government role
continuing medical education conflict of interest policies, 152–153
in development of clinical practice guidelines, 190–191, 197, 199, 214
evolution of conflict of interest policies, 33
historical development of biomedical research, 97–98
institutional conflict of interest regulation, 221
in promoting adoption and implementation of conflict of interest policies, 22, 231, 236–238
regulation of physician–industry financial relationships, 181–183
See also specific department or agency
H
Health care facilities
financial challenges for teaching hospitals, 126
ownership by physicians, 5, 32, 40, 95–96, 167, 169–170, 187
recommendations for teaching hospitals, 11, 19, 133, 157, 158, 160
See also Education and training of medical professionals;
Institutional conflicts of interest
Health insurance plans. See supporting organizations
I
Identifying and assessing conflicts of interest
accountability considerations, 56
assessing risks of disclosed relationships, 82–83
in clinical practice guideline development, 25
conceptual basis, 46–48, 49
conceptual model, 64–65
criteria for evaluating conflict of interest policies, 6–7
criterion of proportionality in, 52–53
current variations and deficiencies, 88
definition, 6, 26, 45–46, 61
evaluation of motives, 50–51
financial relationships in nonclinical research, 10
identifying primary and secondary interests, 46–47
in institutional settings, 14–15, 22, 218, 224, 225, 226–228
likelihood of undue influence, 53–55, 61
for management of conflicts of interest, 80–81
principles, 45, 61
proportionality considerations, 57–58
recommendations for policy design and implementation, 8–9, 89–90
in research, 9–10, 110–116
seriousness of possible harm, 55–56, 61
severity, 6, 52–53, 82
See also Disclosure of financial relationship
Illegal payments to medical professionals, 25, 40, 148, 152–153, 154, 181–183
OCR for page 408
Conflict of Interest in Medical Research, Education, and Practice
Informed consent for research participants, 115–116
Institutional conflicts of interest
accountability procedures, 59
conflicts of commitment, 48
current policies and strategies, 221–224
current shortcomings in policy development, 231
definition, 218
disclosure, 28–29
identifying and assessing, 218, 224, 226–228
implications for reputations of associated individuals, 55–56, 111, 216–217
individual behavior as source of, 218, 225
managing, 222–223, 224–226
oversight committee, 14–15, 21–22, 120, 225, 226–228
public acceptance of, 225–226
range of institutions, 31–32, 216
recommendations, 14–15, 17t, 21–22, 226–229
risk, 178, 216–217
role of supporting organizations in policy development, 231–239
rules for research institutions, 22
sharing of conflict of interest policies and procedures, 58–59
significance of, 14, 216–217
sources and concerns, 14, 218, 219–221
Institutional review boards, 221
Insurance industry, 15, 21, 22, 32, 89, 230, 231, 234, 236–238
Integrity in Scientific Research, 32
International Committee of Medical Journal Editors, 29–30, 69, 112, 113
J
Journal of the American Medical Association, 113
Journalists, 74
K
Kickbacks. See Illegal payments to medical professionals
L
Legal profession, 142–143, 305–317
Liaison Commission on Medical Education, 125
Licensing and certification, 15, 22, 231, 236
M
Managing conflicts of interest
assessing risks of disclosed relationships, 82–83
in clinical practice guideline development, 14, 21, 211, 213
continuation of financial relationships, 80
current policies and practices, 81–82
current variations and deficiencies, 88
eliminating or prohibiting, 79–80
indications, 80–81
institutional conflicts in research, 222–223, 224–226
in nonclinical research, 119
options, 81
research needs, 84–85
strategies, 83–84
See also Monitoring and enforcement
Medicaid, 170
Medical device companies
access to medical students and faculty, 131–133, 159
illegal payments to physicians, 182–183
new product development, 99, 100
physician training from, 131–132, 133, 159, 176
recommendations for disclosure of financial relationships, 18, 94, 95
reporting of payments to physicians, 71
See also Medical product companies
Medical education and communication companies, 140, 141, 143, 145.
See also Medical publications
Medical journals. See Medical publications
Medical product companies
appropriate role in medical education, 10
current requirements for disclosure of payments, 71–72
in development of clinical practice guidelines, 13–14, 211–214
OCR for page 409
Conflict of Interest in Medical Research, Education, and Practice
historical development of conflict of interest concerns, 35–41, 62
historical development of relationships with medical profession, 33–35
illegal payments to physicians, 25, 40, 148, 152–153, 154, 181–183
medical education funding, 126–127
officers and board members, medical professionals as, 219
recommendations for disclosure of financial relationships, 18, 94–96
recommendations for medical practice relationships, 12–13, 20, 187–188
research spending trends, 101
role in strengthening and implementing policies, 231
scope of relationships in medical education, 10, 32, 101–102, 129, 131
scope of relationships in medical practice, 12
sponsorship of nonaccredited continuing education programs, 142
voluntary conflict of interest regulation, 180–181, 188, 238
See also Biotechnology companies;
Collaborative relationships in medicine;
Financial relationships with industry;
Gifts to physicians;
Medical device companies;
Pharmaceutical companies;
Sales and marketing activities
Medical professionals
academic department chairs, 101, 218, 219
community physicians’ participation in clinical trials, 173–174, 175
conflict of interest concerns, 166–167, 183–184
in continuing medical education, industry payments to, 145
as corporate officers or board members, 219
current conflict of interest policies for community physicians, 175–183
education debt, 126
implications of recommendations for institutions and industry, 188
income trends, 167–168
industry marketing to, 170–172
information sources, 175
ownership of medical facilities, 32, 40, 95–96, 167, 169–170
participation in industry promotional activities, 171
payment issues, 5, 32, 167, 168–169
privileges and responsibilities, 166
public disclosure of payments to, 94, 95
public trust, 49–50
receptivity to industry gifts, 126
recommendations for medical practice relationships with industry, 12–13, 17t, 20, 184–188
role in strengthening and implementing policies, 2, 5, 22, 29
scope of industry presence in medical practice, 12, 25, 172–173
See also Clinical practice guidelines;
Collaborative relationships in medicine;
Gifts to physicians;
Professional societies and organizations;
Research, medical
Medical publications, 15
clinical practice guidelines in, 21, 201, 213
conflict of interest policies, 69–70
contract restrictions on release of research, 108–109, 111–112
current disclosure requirements, 69–70, 115
delayed publication of research findings, 103, 106
effectiveness of disclosure requirements, 77
ghostwriting issues, 10, 13, 19, 24, 108, 153, 154–155, 156, 157, 158, 184
industry advertising, 34
industry influence, 24
industry-sponsored supplements, 69
journalists’ compliance with disclosure requirements, 74
medical education and communication companies, 140, 141, 143
monitoring and enforcement of disclosure rules, 75–76
peer review, 115
pro-industry research findings, 104–108
publication of clinical practice guidelines, 21
review and editorial articles, 69–70
withholding of research findings, 24, 106, 108, 112, 193–194
OCR for page 410
Conflict of Interest in Medical Research, Education, and Practice
Medicare, 126, 170
Medicare Payment Advisory Commission (MedPAC), 72, 136, 160, 167
disclosure proposals, 94–96, 170
Merck Manual of Diagnosis and Therapy, 34
Meta-analysis, 190
Monitoring and enforcement
assessment of clinical practice guidelines, 208–210
clinical trial registration and reporting requirements, 112
in continuing medical education, 150–151
current state, 75–76
current variations and deficiencies, 88
electronic tracking tool, 87
public disclosure of payments to medical professionals, 94, 95
recommendations, 88–90
in research institutions, 86–87
research oversight, 54–55, 84–85, 118–119, 120, 228–229
See also Sanctions
N
National Academy of Sciences, 39
National Fibromyalgia Association, 220
National Guideline Clearinghouse, 14, 15, 21, 191–192, 205, 213, 231
National Institutes of Health, 231
assistance to employees for disclosure compliance, 73
compliance monitoring activities, 15, 87, 231
financial relationship policies, 79–80
institutional conflict of interest, 238–239
noncompliance with disclosure rules, 74
recommendations for, 15, 22, 92, 120, 228–229, 238–239
research support and regulation, 7–8, 34, 100, 120
National Library of Medicine, 69, 233–234
National Research Council, 33
New England Journal of Medicine, 39–40, 70
Nonclinical research. See Research, medical
P
Patent rights and income
historical development of law, 97–98
institutional conflict of interest risk, 219–220
royalty income disclosure, 68
Patient advocacy groups, 71, 94
Pharmaceutical companies
access to medical students and faculty, 131–133
access to physician prescribing information, 186
benefits of collaborative relationships, 23–24, 129–131
conflict of interest concerns, 12, 24
continuing medical education funding, 148–149
government guidelines for payment to physicians, 181
historical evolution of professional relationships, 34
illegal payments to physicians, 25, 148, 152–153, 181–182
influence on prescribing practice, 12, 25, 132, 136, 174–175
as information sources for physicians, 175
marketing activities, 170–172, 173–174
policies on relationships with physicians, 179–180
recommendations for disclosure of financial relationships, 18, 94, 95
reporting of payments to physicians, 71–72
research and development process, 23, 374–383
restrictions on access to students, 133
scope of relationships with medical professionals, 2
support for medical organizations, 220–221
withholding of unfavorable research findings, 24
See also Biotechnology companies;
Drug research and development;
Drug samples;
Medical product companies
Pharmaceutical Research and Manufacturers of America, 41, 79, 138, 139, 173, 231
on physician relationships, 179
recommendations for, 187–188
OCR for page 411
Conflict of Interest in Medical Research, Education, and Practice
on speaking fees, 156–157
on support for continuing medical education, 151–152
Prevention of conflicts of interest
prohibition policies, 79–80
restrictions on access of industry representatives to medical schools, 133
Primary interests, 46
Professional societies and organizations
community physicians, current conflict of interest policies for, 176–179
compliance monitoring in research institutions, 86–87
conflict of interest concerns, 15
consistency of conflict of interest policies among, 60
continuing medical education, 140–141, 142, 143
continuing medical education conflict of interest policies, 151–152
current disclosure requirements, 71
in development of clinical practice guidelines, 196, 197–198
dissemination of conflict of interest policies, 86
evolution of conflict of interest policies, 35–40, 62
funding sources, 34–35
historical development of medical industry relationships, 34
primary interests, 46
in promoting transparency of clinical practice guidelines, 21, 213–214
public trust in, 50
recommendations for, 13, 15–16, 18, 21, 22, 88–89, 92, 94, 95
in reform of continuing medical education financing, 19–20, 161–162
role of supporting organizations in strengthening and implementing conflict of interest policies, 2, 5, 22, 29–30, 120, 230–239
scope of, 31–32
significance of industry funding, 220–221
See also Institutional conflicts of interest;
specific organizations
Proportionality aspects of conflict of interest policies, 6, 57–58
Public perception and understanding
conflict of interest concerns, 1, 51
in development of clinical practice guidelines, 14
disclosure effects on research participant enrollment, 78
disclosure rules and, 8
dissemination of conflict of interest policies, 89
financial relationships in research, 109
goals of conflict of interest policies, 5, 28, 49–50, 51
influence of industry gifts to physicians, 78–79
institutional conflicts of interest, 225–226
of institutions, 49–50
participation in conflict of interest policy implementation, 59
patient awareness of industry gifts to physicians, 78
rating of conflict of interest policies, 234
reporting of financial relationship disclosures, 9, 71, 94, 95, 187
research participants’ perceptions of research collaborations, 109
transparency of conflict of interest policies and procedures, 58
trust and confidence in medical profession, 1, 2, 3, 23, 24–25, 28, 117
Q
Quality improvement initiatives, 232–233
Quality of care
conflict of interest concerns, 1, 2
patient trust in, 24–25
See also Clinical practice guidelines
R
RAND Corporation, 191
Rebuttable presumption, 80, 81, 110, 111
Referrals to facilities owned by referring physician, 5, 40, 169–170
Reimbursement, 5, 32, 167–169, 219
Research, medical
assessing conflict of interest risk, 82, 83
basic research. See Nonclinical research
OCR for page 412
Conflict of Interest in Medical Research, Education, and Practice
benefits of industry collaboration, 9, 97, 99–100, 102, 116
clinical trial registration and reporting, 112
community physicians’ participation in, 173–174, 175
compliance with conflict of interest policies, 86–87
conflict of interest concerns, 1, 2, 3, 9, 14, 24, 100, 102–103, 108, 116–117
conflict of interest management, 81, 84–85
contractual restrictions on release of data, 108–109, 111–112
current conflict of interest policies, 111–116, 222, 295–301
drug development process, 374–383
effectiveness of disclosure requirements, 77, 78
equipment purchases by industry, 127
evolution of conflict of interest policies, 40, 110–111
exceptions to conflict of interest prohibitions, 9–10, 57–58, 118–119, 223
extent of industry support, 101–102
government role, 97–98
historical evolution of industry involvement, 33, 34, 97–98, 101
industry contributions, 98–99
informed consent for research participants, 115–116
institutional conflict of interest policies, 22, 120, 222
investigators’ perceptions of conflict of interest requirements, 85
nonclinical research, 10, 101, 111, 119–120
openness of scientific process and, 103–104
oversight, 54–55, 62, 84–85, 118–119, 120, 228–229
process, 98–100
productivity of researchers, 102
prohibitions on financial relationships in, 80
pro-industry findings, 104–108
quality of research designs, 105–106
recommendations, 9–10, 16t, 19, 22, 117–121, 228–229
research needs on conflict of interest issues, 119–120
research participant enrollment, disclosure effects on, 78, 109, 115–116
researcher discretion, 54–55
seeding trials, 173–174
standardization of methodology, 113
study design, conflict of interest management and, 113
supervision of, conflict of interest concerns in, 109, 116
time frame for disclosure of financial relationships, 72
trade secrets as result of, 103
withholding or delay of publication, 24, 103, 106, 108, 112
See also Collaborative relationships in medicine
Research on conflict of interest issues
current shortcomings, 4, 66–67, 87
data collection and analysis, 4–5
effectiveness of management strategies, 84–85
goals, 2, 5, 30
knowledge base, 4, 30, 32–33, 238–239
methodological approach, 30–31, 43, 285–286
in nonclinical research, 119–120
prominent reports, 41
psychology research, 358–372
recommendations, 15–16, 22, 228–229, 238–239
scope of, 27–28, 31–32
Residency programs
accreditation, 125
industry gifts to residents, 136–137
industry influence on physician behavior, 136, 137
industry support, 127, 129
number of, 124
use of drug samples, 135
Responsible Research, 32
Role of supporting organizations in strengthening and implementing conflict of interest policies, 2, 5, 22, 29–30, 120, 230–239
Royalty income, 68
OCR for page 413
Conflict of Interest in Medical Research, Education, and Practice
S
Sales and marketing activities
academic detailing programs as alternative to drug detailing, 139–140, 183
continuing medical education funding to promote products, 148–149
as hidden purpose of clinical trial, 173–174
historical evolution in medical industry, 33–34
industry spending, 170–171
interpersonal strategies, 171
mechanisms of influence, 40–41
meetings with medical professionals, 12, 13, 19, 20, 184
physician participation in, 171
physician perception of, 172
recommendations, 20, 184, 185–186
as source of information for physicians, 175, 185–186
See also Drug samples
Sanctions
accountability requirements, 59
current use, 234
goals of conflict of interest policies, 6
illegal payments to medical professionals, 181–183
for nondisclosure, 75, 76
proper use, 234–235
See also Monitoring and enforcement
Secondary interests, 46–47
Seeding trials, 173–174
Selective serotonin reuptake inhibitors, 24
Society for General Internal Medicine, 223–224
Speakers bureaus and speaking engagements
academic department chairs, 219
conflict of interest policies, 156–157, 177–178
in continuing medical education, 145, 154
ethical concerns, 153–154
extent, 145, 154, 171
in industry promotional campaigns, 171–172
prohibitions on, 79
recommendations, 10, 89, 184, 185
Specialty boards, 15
Standardization
of clinical practice guidelines, 208–210
of disclosure requirements, 8–9, 18, 29, 91–93, 164
of research designs, 113
Stark laws, 170
State government, 15
academic detailing programs, 183
accreditation activities, 125
continuing medical education requirements, 141
on disclosure of payments to physicians, 181
in health care system, 231
requirements for reporting of payments to physicians, 71
Students, medical
conflict of interest responsibilities, 60
industry-sponsored scholarships and training positions, 138–139
scope of industry contacts, 129, 131
training on interactions with industry representatives, 132, 160
See also American Medical Student Association;
Education and training of medical professionals
Systematic reviews, 190
T
Thresholds, reporting, 18, 68, 72, 90, 91, 118
Transparency
of conflict of interest policies, 6–7, 47, 58–59, 231–232
in development of clinical practice guidelines, 13, 14, 21, 211, 212
reporting of financial relationship disclosures, 9
Trust, 28, 49–50, 51
U
U.S. Preventive Services Task Force, 190–191, 192
U.S. Public Health Service regulations
compliance, 86–87
on financial relationships in research, 110
OCR for page 414
Conflict of Interest in Medical Research, Education, and Practice
institutional applicability, 22, 60, 62, 221, 228
issued, 40
NIH support, 7–8, 231
purpose, 62
recommendations for, 22, 228
reporting threshold and time frame, 72, 91
text, 295–301
See also National Institutes of Health
W
World Association of Medical Journal Editors, 69, 230, 231
