Index

A

Academic detailing programs, 139140, 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, 153157

public engagement in conflict of interest policies and, 59

quality improvement initiatives, 232233

role of sanctions, 235

Accounting profession, 317328

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, 1516, 19, 21, 22, 213, 236238

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, 238239

AGREE, 203

American Academy of Dermatology, 138139

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, 205206

American College of Obstetricians and Gynecologists, 176

American College of Physicians, 67, 166, 176, 177178, 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



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Index A Advanced Medical Technology Association, 41, 173, 231 Academic detailing programs, 139–140, 183 Agency for Healthcare Policy and Research, Accountability 191 of conflict of interest policies, 7, 59 Agency for Healthcare Quality and culture of, 2, 5, 29, 229, 230 Research, 191, 238–239 extent of, as factor in conflict of interest AGREE, 203 evaluation, 56 American Academy of Dermatology, of institutions, 15 138–139 in professional writing and speaking, American Academy of Family Physicians, 153–157 125, 220 public engagement in conflict of interest American Academy of Pediatrics, 176 policies and, 59 American Association of University quality improvement initiatives, 232–233 Professors, 39 role of sanctions, 235 American Board of Medical Specialties, 125 Accounting profession, 317–328 American College of Cardiology, 189, 190, Accreditation Council for Continuing 197 Medical Education, 125, 150, 156, American College of Chest Physicians, 161 205–206 Accreditation Council for Graduate Medical American College of Obstetricians and Education, 125 Gynecologists, 176 Accreditation organizations American College of Physicians, 67, 166, conflict of interest policy requirements, 176, 177–178, 192, 223 128 American College of Rheumatology, 176 for continuing medical education, 20 American Council in Education, 39 for medical schools, 125 American Heart Association, 189, 197 purpose, 125 American Hospital Association, 125 recommendations for, 14, 15–16, 19, 21, American Medical Association 22, 213, 236–238 on access to physician prescribing requirements, 128 information, 186 in support of systemic change, 230, 231 in accreditation process, 125 0

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0 INDEX conflict of interest policies, 40, 138, 139, Blue Cross Blue Shield Association, 176 190–191 on funding of continuing medical Brandeis, Louis, 67 education, 151 industry relations, 34 C American Medical Student Association, 63, 76, 131, 234 Centers for Disease Control and Prevention, American Psychiatric Association, 220 191 American Society of Clinical Oncology, 72 Centers for Medicare and Medicaid Architecture profession, 328–336 Services, 170, 191 Association of American Medical Colleges Charitable giving to institutions, 158 on authorship and speaking fees, 155 Clinical practice guidelines conflict of interest policies, 40, 62, 92 challenges in development of, 189 on continuing medical education, 151 conflict of interest concerns, 1, 13, on industry gifts, 137–138 25, 189–190, 193–196, 203–204, on industry-sponsored scholarships and 210–211 training positions, 139 current shortcomings, 192 on institutional conflicts of interest, current strategies and policies to prevent 221–223, 229 bias in development of, 204–210 research rules, 8, 29–30, 62, 76, 80, 82, definition and purpose, 189, 190 92, 110–112, 116 development costs, 194 restrictions on industry access, 133 disclosure of funding for, 201, 203 role in strengthening and implementing dissemination, 196, 199 policies, 230, 231, 233 evolution of, 190–192 on uses of drug samples, 136 financial relationships in development of, Association of American Universities, 8, 198–204 29–30, 39, 62, 110–111, 221–223, groups in development of, 194, 196–198 229, 233 identification of bias, 25 implications of recommendations for individuals and organizations, B 214–215 Basic research. See Research, medical importance of, 25 Bayh-Dole Act, 97–98 industry involvement, 194–196 Biomedical research. See Research, medical objective procedures for development of, Biotechnology companies 43 benefits of collaborative relationships, panel membership, 13–14, 20–21, 211, 23–24, 44, 98, 99 212–213 concerns about relationships, 2, 5, 24, political sensitivity, 191 35, 166–167, 189–190 public participation, 14 historical evolution of professional publication requirements, 21 relationships with, 34, 101 quality of evidence base for, 193–194, recommendations regarding financial 210 relationships, 18, 20, 90, 94, 95, 187 recommendations, 13–14, 20–21, research and development process, 23, 210–214 99 role of professional organizations in See also Collaborative relationships promoting transparency of, 21 in medicine; Medical product standardization of presentation and companies; Pharmaceutical assessment of, 208–210 companies; Research, medical systematic reviews in development of, 190, 193–194, 207–208

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0 INDEX topic selection, 195 current variations and deficiencies, 4, transparency in development of, 13, 14, 7–8, 87–88, 117 21, 211, 212 dissemination, 86, 89 See also National Guideline distinction between perceived versus Clearinghouse actual conflicts, 52 Clinical research. See Research, medical effectiveness evaluation, 57, 63 Collaborative relationships in medicine in engineering profession, 336–350 benefits of, 1, 2, 23, 44, 158–159 fairness of, 7, 60 concerns, 1, 2, 3, 23 goals, 1, 5, 6, 26, 28, 48–50, 61, 97, development of clinical practice 117, 121, 229 guidelines, 13–14, 194–198, 211–214 government role in development of, 33, historical evolution, 33 38–39 instruction for medical professionals on historical and conceptual evolution, 7, conduct in, 132, 160–161 33–41, 62 new product development, 98, 99 incentives to adopt and implement, recommendations for physicians and 233–234, 235–238 industry, 12–13, 20, 184–188 in legal profession, 305–317 scope of, 2 monitoring and enforcement. See See also Disclosure of financial Monitoring and enforcement relationship; Financial relationships multiple obligations of individuals, with industry; Research, medical; 65–66 Role of supporting organizations ongoing performance evaluation of, 59 in strengthening and implementing oversight committees, 8, 14–15, 18, 21– conflict of interest policies 22, 81, 88–90, 120, 225, 226–228 Computer technology participants in development and compliance monitoring, 87 implementation, 2, 5 database of payments to medical principles for formulation and professionals, 94, 95 implementation, 45, 60 public reporting of financial relationship proportionality in, 6, 57–58 disclosures, 9 public involvement in implementation, supporting standardization of disclosure 59 requirements, 8–9, 92–93 research needs, 15–16, 22, 30, 84–85, Confidentiality, disclosure rules and, 58 238–239 Conflict of commitment, 48 role of supporting organizations in Conflict of interest policies, generally strengthening and implementing, 2, accountability provisions, 7, 59 5, 22, 29–30, 120, 230–239 in accounting profession, 317–328 scope of individuals subject to, 60, 90 accreditation requirements, 128 sources of, 38–41, 110–116, 175–183 in architecture profession, 328–336 transparency of, 6–7, 47, 58–59 common features, 64 See also Disclosure of financial for community physicians, 175–183 relationship complementary strategies to limit bias, Conflict of obligation, 48 41–43 Conflicts of interest, generally conflict of commitment provisions, 48 challenges in avoiding, 25 consistency across institutions and definition, 6, 26, 45–46, 61, 303–304 settings, 60 elements of, 46–48 cost-benefit analysis, 27 ethics violations and, 6, 49 criteria for evaluation, 6–7, 56–60 identifying. See Identifying and assessing criticisms of, 26–27, 39, 62–63 conflicts of interest current literature, 66–67 institutional. See Institutional conflicts of interest

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0 INDEX knowledge base, 30, 32–33, 238–239 purpose, 140 magnitude of problem, 4, 26 recommendations, 11–12, 19–20, managing. See Managing conflicts of 161–164 interest scope of programs and activities, in nonmedical professions, 31, 50, 140–141 302–355 solicitations of industry support, 145 perceived versus actual, 52 speaking fees, 145, 154 policies. See Conflict of interest policies, Contracts generally industry conflict of interest policies, prevention. See Prevention of conflicts of 179–181 interest research, 108–109, 111–112 primary interests, 46 Cost of care research on. See Research on conflict of challenges for academic medical centers, interest issues 126 secondary interests, 46–47 and drug samples, 11, 186 sources of, 5, 14, 32, 45–48, 166–167 Council of Medical Specialty Services, 178 threats to medical profession in, 44–45 Council on Government Relations, 62, 76 Congress, U.S. Culture of accountability, 2, 5, 29, 229, 230 legislative action on conflict of interest incentives to adopt and implement issues, 40 conflict of interest policies, 235–236 proposed requirements for reporting of payments to physicians, 71 D recommendations for, 9, 18, 94 CONSORT checklist, 113 Department of Defense, U.S., 120 Consulting arrangements Department of Health and Human Services, academic department chairs in, 101, 219 U.S., 15, 152–153, 221, 231 assessing likelihood of undue influence recommendations for, 22, 238–239 in, 54, 100 Department of Justice, U.S., 3, 15, 71, 148, current conflict of interest policies, 138, 152, 154, 179, 182, 231 176, 177–178, 179 Diagnostic and Statistical Manual of Mental disclosure, 40, 182–183, 221 Disorders, 202–203 recommendations, 13, 19, 20, 157, 158, Disclosure of financial relationship 184, 185, 187 adequacy of, in maintaining integrity standardization of disclosure and public trust, 8 requirements, 92 administrative burden, 7, 18, 29, 72–73, Continuing medical education 91–92 accreditation, 125 adverse consequences, 67–68, 77 comparison with other professions, assistance to employees for compliance, 142–143 73 conflict of interest concerns, 11, categories of relationships, 93 145–149, 161 in clinical practice guideline current conflict of interest policies, development, 201, 203, 205, 150–153 211–212 curriculum, 141–142 confidentiality concerns, 58 funding, 2, 11–12, 19–20, 26–27, 34, current requirements for companies, 127, 142, 143–145, 161–163, 221 71–72 legal requirements, 141 current requirements for medical monitoring, 150–151 professionals, 68–71 nonaccredited programs, 142, 151, 152, deterrent function, 67 164 effectiveness of policies, 77–79 profitability, 143

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0 INDEX extent of noncompliance, 74–75 Drug samples follow-up actions, 29 current restrictions, 135–136 historical evolution of medical documentation of distribution, 136 profession policies, 39–40 ethical concerns, 3–4, 11, 25, 135, importance of, 1–2, 5, 8, 28, 67, 90 174–175, 186 to individuals potentially affected by, industry spending, 171 68–69 intended purpose, 11, 134, 186 journal publication requirements, 69–70, prevalence, 172 115 recommendations, 10–11, 13, 19, 20, legislative requirements, 9, 63–64, 157, 159–160, 184, 186–187 71–72, 94, 181–183 monitoring and enforcement, 75–76 E objections to, 62–63 to patients of community physicians, ECRI Institute, 133, 191 187 Education and training of medical physician ownership of medical facilities, professionals 170, 187 academic detailing programs, 139–140, public access to reports, 9, 71, 94, 95, 183 180, 187 access of industry representatives to quantity of disclosed information, 77 students and faculty, 131–133, 157, recommendations for companies, 18, 158–159 94–96 accreditation, 15, 125 recommendations for policy design and appropriate industry presence in, 10 implementation, 8–9, 18, 89–93 authority and discretion of reporting thresholds, 18, 68, 72, 90, 91, administrators, 55 118 burden of compliance with disclosure requirements for marketing activities, requirements, 73 174 charitable donations for, 158 to research participants, 78, 109, conflict of interest concerns, 1, 2, 24, 115–116 123, 133, 157 review responsibility, 64, 81, 82 conflict of interest instruction in, 11, 19 risk assessment, 82–83 conflict of interest management specificity of requirements, 91, 93 variations within, 81–82 standardization, 8–9, 18, 29, 91–93, 164 current conflict of interest policies, strategies for managing conflicts of 68–69, 110, 133, 135–136, 137–138, interest, 83–84 139 time frame for, 72, 90–91, 95 current scale, 124 variations among conflict of interest debt burden of physicians, 126 policy requirements, 7–8, 87–88, department chairs or deans, conflict of 91–92 interest risks for, 101, 218, 219 voluntary reporting from companies, dissemination of conflict of interest 180–181 policies, 86 Discretion, 54–55 distribution of industry spending, 127 Drug research and development elements of learning environment, approval rate, 23 122–123 costs, 23 emergence of concerns about industry process, 98–99 relationships, 35, 39 pro-industry research findings, 104–105, faculty member relationships with 106 industry, 2, 10, 24 withholding of research findings, 24, financial challenges, 126 106, 108

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06 INDEX gifts to students and faculty, 136–138 assessing likelihood of undue influence goals, 10, 122, 127 in, 53–55 historical development, 124 continuing medical education financing, individuals subject to conflict of interest 2, 11–12, 34, 142, 143–145, policies, 60 161–163 industry funding, 126–127 in development of clinical practice industry-sponsored scholarships and guidelines, 13–14, 198–204, 211–213 training positions, 138–139 duration, 54 influence on physician beliefs and historical development of conflict of attitudes, 127–128, 139 interest concerns, 35–41 instruction on how to interact with historical evolution, 33–35 industry representatives, 132, illegal payments to medical 160–161 professionals, 25, 40, 148, 152–153, management of conflicts of interest, 81, 154, 181–183 83–84 indirect, 145 off-site facilities, 131, 160 industry-sponsored scholarships and policy ratings, 131 training positions, 138–139 prohibitions on financial relationships, medical education institutions, 126–127 79 in medical publishing, 24 recommendations, 10–12, 17t, 19, 89, motivation of medical professionals to 157–161 enter into, 126 restrictions on access of industry negative effects of conflict of interest representatives, 133 policies, 26–27, 62–63 scope of industry relationships in, 10, in nonclinical research, 10, 101 32, 101–102, 129, 131 percentage of organizational funds given settings for, 122, 125 by industry, 220–221, 223 sources of data on industry support, 127 physician–industry, 25, 172–173 strategies for reducing conflict of interest physician perceptions of, 172–173 risk, 139–140 prohibition effects, 79–80 value of industry relationships in, project benefits exceeding risk of bias, 129–131, 133 57–58 See also Continuing medical education; recommendations for medical practice Institutional conflicts of interest; relationships with industry, 12–13, Students, medical 184–188 Eliminating conflicts of interest, 80 regulatory and legislative actions, Enforcement. See Monitoring and 181–183, 188 enforcement; Sanctions research-related gifts, 101–102 Engineering profession, 336–350 restrictions on human participants Evidence-based medicine, 13, 191 research, 9, 19, 110, 117–118 restrictions on researchers with financial interest in research outcome, 9–10, F 117–119 scope of, 54, 101, 118, 129, 131 Fairness of conflict of interest policies, 7, 60 as secondary interest in conflicts of Federal Demonstration Partnership, 73 interest, 46–47 Federation of American Societies for See also Disclosure of financial Experimental Biology, 62 relationship; Gifts to physicians; Federation of State Medical Boards, 125 Institutional conflicts of interest Financial relationships with industry Food and Drug Administration, 99 academic department chairs, 101, 218, advisory committee membership, 82–83 219 clinical trials regulation, 113 acceptable forms, 158

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0 INDEX H new device approval and company training, 132 Health care facilities recommendations for, 92, 238–239 financial challenges for teaching research rules, 83 hospitals, 126 Foundations, 9, 18, 20, 49, 94, 145, 163, ownership by physicians, 5, 32, 40, 187, 211 95–96, 167, 169–170, 187 recommendations for teaching hospitals, 11, 19, 133, 157, 158, 160 G See also Education and training of Ghostwriting, 10, 13, 19, 20, 24, 108, 153, medical professionals; Institutional 154–155, 156, 157, 158, 184, 185, conflicts of interest 187 Health insurance plans. See supporting Gifts to institutions, 218 organizations Gifts to physicians acceptable forms, 158 I assessing likelihood of undue influence of, 53–54 Identifying and assessing conflicts of interest current conflict of interest policies, accountability considerations, 56 137–138, 176 assessing risks of disclosed relationships, ethical concerns, 2, 4, 136–137, 185 82–83 extent, 136 in clinical practice guideline in medical education settings, 10, 19, development, 25 129–131, 136–137 conceptual basis, 46–48, 49 patient perception, 78–79 conceptual model, 64–65 physician perspective, 126, 172 criteria for evaluating conflict of interest prevalence, 12, 172 policies, 6–7 prohibitions on, 79 criterion of proportionality in, 52–53 public awareness, 78 current variations and deficiencies, 88 purpose of disclosure policies, 67 definition, 6, 26, 45–46, 61 recommendations, 13, 19, 20, 157, 158, evaluation of motives, 50–51 184, 187, 188 financial relationships in nonclinical research-related gifts, 101–102 research, 10 size of gift, 47, 53–54, 136–137 identifying primary and secondary Government role interests, 46–47 continuing medical education conflict of in institutional settings, 14–15, 22, 218, interest policies, 152–153 224, 225, 226–228 in development of clinical practice likelihood of undue influence, 53–55, 61 guidelines, 190–191, 197, 199, 214 for management of conflicts of interest, evolution of conflict of interest policies, 80–81 33 principles, 45, 61 historical development of biomedical proportionality considerations, 57–58 research, 97–98 recommendations for policy design and institutional conflict of interest implementation, 8–9, 89–90 regulation, 221 in research, 9–10, 110–116 in promoting adoption and seriousness of possible harm, 55–56, 61 implementation of conflict of interest severity, 6, 52–53, 82 policies, 22, 231, 236–238 See also Disclosure of financial regulation of physician–industry relationship financial relationships, 181–183 Illegal payments to medical professionals, See also specific department or agency 25, 40, 148, 152–153, 154, 181–183

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0 INDEX L Informed consent for research participants, 115–116 Legal profession, 142–143, 305–317 Institutional conflicts of interest Liaison Commission on Medical Education, accountability procedures, 59 125 conflicts of commitment, 48 Licensing and certification, 15, 22, 231, 236 current policies and strategies, 221–224 current shortcomings in policy development, 231 M definition, 218 disclosure, 28–29 Managing conflicts of interest identifying and assessing, 218, 224, assessing risks of disclosed relationships, 226–228 82–83 implications for reputations of in clinical practice guideline associated individuals, 55–56, 111, development, 14, 21, 211, 213 216–217 continuation of financial relationships, individual behavior as source of, 218, 80 225 current policies and practices, 81–82 managing, 222–223, 224–226 current variations and deficiencies, 88 oversight committee, 14–15, 21–22, 120, eliminating or prohibiting, 79–80 225, 226–228 indications, 80–81 public acceptance of, 225–226 institutional conflicts in research, range of institutions, 31–32, 216 222–223, 224–226 recommendations, 14–15, 17t, 21–22, in nonclinical research, 119 226–229 options, 81 risk, 178, 216–217 research needs, 84–85 role of supporting organizations in strategies, 83–84 policy development, 231–239 See also Monitoring and enforcement rules for research institutions, 22 Medicaid, 170 sharing of conflict of interest policies Medical device companies and procedures, 58–59 access to medical students and faculty, significance of, 14, 216–217 131–133, 159 sources and concerns, 14, 218, 219–221 illegal payments to physicians, 182–183 Institutional review boards, 221 new product development, 99, 100 Insurance industry, 15, 21, 22, 32, 89, 230, physician training from, 131–132, 133, 231, 234, 236–238 159, 176 Integrity in Scientific Research, 32 recommendations for disclosure of International Committee of Medical Journal financial relationships, 18, 94, 95 Editors, 29–30, 69, 112, 113 reporting of payments to physicians, 71 See also Medical product companies Medical education and communication J companies, 140, 141, 143, 145. See also Medical publications Journal of the American Medical Medical journals. See Medical publications Association, 113 Medical product companies Journalists, 74 appropriate role in medical education, 10 current requirements for disclosure of K payments, 71–72 Kickbacks. See Illegal payments to medical in development of clinical practice professionals guidelines, 13–14, 211–214

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0 INDEX historical development of conflict of ownership of medical facilities, 32, 40, interest concerns, 35–41, 62 95–96, 167, 169–170 historical development of relationships participation in industry promotional with medical profession, 33–35 activities, 171 illegal payments to physicians, 25, 40, payment issues, 5, 32, 167, 168–169 148, 152–153, 154, 181–183 privileges and responsibilities, 166 medical education funding, 126–127 public disclosure of payments to, 94, 95 officers and board members, medical public trust, 49–50 professionals as, 219 receptivity to industry gifts, 126 recommendations for disclosure of recommendations for medical practice financial relationships, 18, 94–96 relationships with industry, 12–13, recommendations for medical practice 17t, 20, 184–188 relationships, 12–13, 20, 187–188 role in strengthening and implementing research spending trends, 101 policies, 2, 5, 22, 29 role in strengthening and implementing scope of industry presence in medical policies, 231 practice, 12, 25, 172–173 scope of relationships in medical See also Clinical practice guidelines; education, 10, 32, 101–102, 129, Collaborative relationships in 131 medicine; Gifts to physicians; scope of relationships in medical Professional societies and practice, 12 organizations; Research, medical sponsorship of nonaccredited continuing Medical publications, 15 education programs, 142 clinical practice guidelines in, 21, 201, voluntary conflict of interest regulation, 213 180–181, 188, 238 conflict of interest policies, 69–70 See also Biotechnology companies; contract restrictions on release of Collaborative relationships in research, 108–109, 111–112 medicine; Financial relationships with current disclosure requirements, 69–70, industry; Gifts to physicians; Medical 115 device companies; Pharmaceutical delayed publication of research findings, companies; Sales and marketing 103, 106 activities effectiveness of disclosure requirements, Medical professionals 77 academic department chairs, 101, 218, ghostwriting issues, 10, 13, 19, 24, 108, 219 153, 154–155, 156, 157, 158, 184 community physicians’ participation in industry advertising, 34 clinical trials, 173–174, 175 industry influence, 24 conflict of interest concerns, 166–167, industry-sponsored supplements, 69 183–184 journalists’ compliance with disclosure in continuing medical education, requirements, 74 industry payments to, 145 medical education and communication as corporate officers or board members, companies, 140, 141, 143 219 monitoring and enforcement of current conflict of interest policies for disclosure rules, 75–76 community physicians, 175–183 peer review, 115 education debt, 126 pro-industry research findings, 104–108 implications of recommendations for publication of clinical practice institutions and industry, 188 guidelines, 21 income trends, 167–168 review and editorial articles, 69–70 industry marketing to, 170–172 withholding of research findings, 24, information sources, 175 106, 108, 112, 193–194

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0 INDEX P Medicare, 126, 170 Medicare Payment Advisory Commission Patent rights and income (MedPAC), 72, 136, 160, 167 historical development of law, 97–98 disclosure proposals, 94–96, 170 institutional conflict of interest risk, Merck Manual of Diagnosis and Therapy, 219–220 34 royalty income disclosure, 68 Meta-analysis, 190 Patient advocacy groups, 71, 94 Monitoring and enforcement Pharmaceutical companies assessment of clinical practice guidelines, access to medical students and faculty, 208–210 131–133 clinical trial registration and reporting access to physician prescribing requirements, 112 information, 186 in continuing medical education, benefits of collaborative relationships, 150–151 23–24, 129–131 current state, 75–76 conflict of interest concerns, 12, 24 current variations and deficiencies, 88 continuing medical education funding, electronic tracking tool, 87 148–149 public disclosure of payments to medical government guidelines for payment to professionals, 94, 95 physicians, 181 recommendations, 88–90 historical evolution of professional in research institutions, 86–87 relationships, 34 research oversight, 54–55, 84–85, illegal payments to physicians, 25, 148, 118–119, 120, 228–229 152–153, 181–182 See also Sanctions influence on prescribing practice, 12, 25, 132, 136, 174–175 as information sources for physicians, N 175 National Academy of Sciences, 39 marketing activities, 170–172, 173–174 National Fibromyalgia Association, 220 policies on relationships with physicians, National Guideline Clearinghouse, 14, 15, 179–180 21, 191–192, 205, 213, 231 recommendations for disclosure of National Institutes of Health, 231 financial relationships, 18, 94, 95 assistance to employees for disclosure reporting of payments to physicians, compliance, 73 71–72 compliance monitoring activities, 15, 87, research and development process, 23, 231 374–383 financial relationship policies, 79–80 restrictions on access to students, 133 institutional conflict of interest, scope of relationships with medical 238–239 professionals, 2 noncompliance with disclosure rules, 74 support for medical organizations, recommendations for, 15, 22, 92, 120, 220–221 228–229, 238–239 withholding of unfavorable research research support and regulation, 7–8, findings, 24 34, 100, 120 See also Biotechnology companies; Drug National Library of Medicine, 69, research and development; Drug 233–234 samples; Medical product companies National Research Council, 33 Pharmaceutical Research and Manufacturers of New England Journal of Medicine, 39–40, America, 41, 79, 138, 139, 173, 231 70 on physician relationships, 179 Nonclinical research. See Research, medical recommendations for, 187–188

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 INDEX on speaking fees, 156–157 Public perception and understanding on support for continuing medical conflict of interest concerns, 1, 51 education, 151–152 in development of clinical practice Prevention of conflicts of interest guidelines, 14 prohibition policies, 79–80 disclosure effects on research participant restrictions on access of industry enrollment, 78 representatives to medical schools, disclosure rules and, 8 133 dissemination of conflict of interest Primary interests, 46 policies, 89 Professional societies and organizations financial relationships in research, 109 community physicians, current conflict goals of conflict of interest policies, 5, of interest policies for, 176–179 28, 49–50, 51 compliance monitoring in research influence of industry gifts to physicians, institutions, 86–87 78–79 conflict of interest concerns, 15 institutional conflicts of interest, consistency of conflict of interest policies 225–226 among, 60 of institutions, 49–50 continuing medical education, 140–141, participation in conflict of interest policy 142, 143 implementation, 59 continuing medical education conflict of patient awareness of industry gifts to interest policies, 151–152 physicians, 78 current disclosure requirements, 71 rating of conflict of interest policies, 234 in development of clinical practice reporting of financial relationship guidelines, 196, 197–198 disclosures, 9, 71, 94, 95, 187 dissemination of conflict of interest research participants’ perceptions of policies, 86 research collaborations, 109 evolution of conflict of interest policies, transparency of conflict of interest 35–40, 62 policies and procedures, 58 funding sources, 34–35 trust and confidence in medical historical development of medical profession, 1, 2, 3, 23, 24–25, 28, industry relationships, 34 117 primary interests, 46 in promoting transparency of clinical Q practice guidelines, 21, 213–214 public trust in, 50 Quality improvement initiatives, 232–233 recommendations for, 13, 15–16, 18, 21, Quality of care 22, 88–89, 92, 94, 95 conflict of interest concerns, 1, 2 in reform of continuing medical patient trust in, 24–25 education financing, 19–20, 1 See also Clinical practice guidelines 61–162 role of supporting organizations in strengthening and implementing R conflict of interest policies, 2, 5, 22, 29–30, 120, 230–239 RAND Corporation, 191 scope of, 31–32 Rebuttable presumption, 80, 81, 110, 111 significance of industry funding, Referrals to facilities owned by referring 220–221 physician, 5, 40, 169–170 See also Institutional conflicts of interest; Reimbursement, 5, 32, 167–169, 219 specific organizations Research, medical Proportionality aspects of conflict of interest assessing conflict of interest risk, 82, 83 policies, 6, 57–58 basic research. See Nonclinical research

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 INDEX benefits of industry collaboration, 9, 97, research needs on conflict of interest 99–100, 102, 116 issues, 119–120 clinical trial registration and reporting, research participant enrollment, 112 disclosure effects on, 78, 109, community physicians’ participation in, 115–116 173–174, 175 researcher discretion, 54–55 compliance with conflict of interest seeding trials, 173–174 policies, 86–87 standardization of methodology, 113 conflict of interest concerns, 1, 2, 3, 9, study design, conflict of interest 14, 24, 100, 102–103, 108, 116–117 management and, 113 conflict of interest management, 81, supervision of, conflict of interest 84–85 concerns in, 109, 116 contractual restrictions on release of time frame for disclosure of financial data, 108–109, 111–112 relationships, 72 current conflict of interest policies, trade secrets as result of, 103 111–116, 222, 295–301 withholding or delay of publication, 24, drug development process, 374–383 103, 106, 108, 112 effectiveness of disclosure requirements, See also Collaborative relationships in 77, 78 medicine equipment purchases by industry, 127 Research on conflict of interest issues evolution of conflict of interest policies, current shortcomings, 4, 66–67, 87 40, 110–111 data collection and analysis, 4–5 exceptions to conflict of interest effectiveness of management strategies, prohibitions, 9–10, 57–58, 118–119, 84–85 223 goals, 2, 5, 30 extent of industry support, 101–102 knowledge base, 4, 30, 32–33, 238–239 government role, 97–98 methodological approach, 30–31, 43, historical evolution of industry 285–286 involvement, 33, 34, 97–98, 101 in nonclinical research, 119–120 industry contributions, 98–99 prominent reports, 41 informed consent for research psychology research, 358–372 participants, 115–116 recommendations, 15–16, 22, 228–229, institutional conflict of interest policies, 238–239 22, 120, 222 scope of, 27–28, 31–32 investigators’ perceptions of conflict of Residency programs interest requirements, 85 accreditation, 125 nonclinical research, 10, 101, 111, industry gifts to residents, 136–137 119–120 industry influence on physician behavior, openness of scientific process and, 136, 137 103–104 industry support, 127, 129 oversight, 54–55, 62, 84–85, 118–119, number of, 124 120, 228–229 use of drug samples, 135 process, 98–100 Responsible Research, 32 productivity of researchers, 102 Role of supporting organizations in prohibitions on financial relationships in, strengthening and implementing 80 conflict of interest policies, 2, 5, 22, pro-industry findings, 104–108 29–30, 120, 230–239 quality of research designs, 105–106 Royalty income, 68 recommendations, 9–10, 16t, 19, 22, 117–121, 228–229

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 INDEX S Standardization of clinical practice guidelines, 208–210 Sales and marketing activities of disclosure requirements, 8–9, 18, 29, academic detailing programs as 91–93, 164 alternative to drug detailing, of research designs, 113 139–140, 183 Stark laws, 170 continuing medical education funding to State government, 15 promote products, 148–149 academic detailing programs, 183 as hidden purpose of clinical trial, accreditation activities, 125 173–174 continuing medical education historical evolution in medical industry, requirements, 141 33–34 on disclosure of payments to physicians, industry spending, 170–171 181 interpersonal strategies, 171 in health care system, 231 mechanisms of influence, 40–41 requirements for reporting of payments meetings with medical professionals, 12, to physicians, 71 13, 19, 20, 184 Students, medical physician participation in, 171 conflict of interest responsibilities, 60 physician perception of, 172 industry-sponsored scholarships and recommendations, 20, 184, 185–186 training positions, 138–139 as source of information for physicians, scope of industry contacts, 129, 131 175, 185–186 training on interactions with industry See also Drug samples representatives, 132, 160 Sanctions See also American Medical Student accountability requirements, 59 Association; Education and training current use, 234 of medical professionals goals of conflict of interest policies, 6 Systematic reviews, 190 illegal payments to medical professionals, 181–183 for nondisclosure, 75, 76 T proper use, 234–235 Thresholds, reporting, 18, 68, 72, 90, 91, See also Monitoring and enforcement 118 Secondary interests, 46–47 Transparency Seeding trials, 173–174 of conflict of interest policies, 6–7, 47, Selective serotonin reuptake inhibitors, 24 58–59, 231–232 Society for General Internal Medicine, in development of clinical practice 223–224 guidelines, 13, 14, 21, 211, 212 Speakers bureaus and speaking engagements reporting of financial relationship academic department chairs, 219 disclosures, 9 conflict of interest policies, 156–157, Trust, 28, 49–50, 51 177–178 in continuing medical education, 145, 154 U ethical concerns, 153–154 extent, 145, 154, 171 U.S. Preventive Services Task Force, in industry promotional campaigns, 190–191, 192 171–172 U.S. Public Health Service regulations prohibitions on, 79 compliance, 86–87 recommendations, 10, 89, 184, 185 on financial relationships in research, Specialty boards, 15 110

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 INDEX institutional applicability, 22, 60, 62, text, 295–301 221, 228 See also National Institutes of Health issued, 40 NIH support, 7–8, 231 W purpose, 62 recommendations for, 22, 228 World Association of Medical Journal reporting threshold and time frame, 72, Editors, 69, 230, 231 91