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Index A Advanced Medical Technology Association, 41, 173, 231 Academic detailing programs, 139â140, 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, 238â239 extent of, as factor in conflict of interest AGREE, 203 evaluation, 56 American Academy of Dermatology, of institutions, 15 138â139 in professional writing and speaking, American Academy of Family Physicians, 153â157 125, 220 public engagement in conflict of interest American Academy of Pediatrics, 176 policies and, 59 American Association of University quality improvement initiatives, 232â233 Professors, 39 role of sanctions, 235 American Board of Medical Specialties, 125 Accounting profession, 317â328 American College of Cardiology, 189, 190, Accreditation Council for Continuing 197 Medical Education, 125, 150, 156, American College of Chest Physicians, 161 205â206 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, 177â178, 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, 15â16, 19, 21, American Medical Association 22, 213, 236â238 on access to physician prescribing requirements, 128 information, 186 in support of systemic change, 230, 231 in accreditation process, 125 401
402 INDEX conflict of interest policies, 40, 138, 139, Blue Cross Blue Shield Association, 176 190â191 on funding of continuing medical Brandeis, Louis, 67 education, 151 industry relations, 34 American Medical Student Association, 63, C 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, 328â336 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, 137â138 25, 189â190, 193â196, 203â204, on industry-sponsored scholarships and 210â211 training positions, 139 current shortcomings, 192 on institutional conflicts of interest, current strategies and policies to prevent 221â223, 229 bias in development of, 204â210 research rules, 8, 29â30, 62, 76, 80, 82, definition and purpose, 189, 190 92, 110â112, 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, 190â192 on uses of drug samples, 136 financial relationships in development of, Association of American Universities, 8, 198â204 29â30, 39, 62, 110â111, 221â223, groups in development of, 194, 196â198 229, 233 identification of bias, 25 implications of recommendations for individuals and organizations, B 214â215 Basic research. See Research, medical importance of, 25 Bayh-Dole Act, 97â98 industry involvement, 194â196 Biomedical research. See Research, medical objective procedures for development of, Biotechnology companies 43 benefits of collaborative relationships, panel membership, 13â14, 20â21, 211, 23â24, 44, 98, 99 212â213 concerns about relationships, 2, 5, 24, political sensitivity, 191 35, 166â167, 189â190 public participation, 14 historical evolution of professional publication requirements, 21 relationships with, 34, 101 quality of evidence base for, 193â194, recommendations regarding financial 210 relationships, 18, 20, 90, 94, 95, 187 recommendations, 13â14, 20â21, research and development process, 23, 210â214 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, 208â210 companies; Research, medical systematic reviews in development of, 190, 193â194, 207â208
INDEX 403 topic selection, 195 current variations and deficiencies, 4, transparency in development of, 13, 14, 7â8, 87â88, 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, 336â350 benefits of, 1, 2, 23, 44, 158â159 fairness of, 7, 60 concerns, 1, 2, 3, 23 goals, 1, 5, 6, 26, 28, 48â50, 61, 97, development of clinical practice 117, 121, 229 guidelines, 13â14, 194â198, 211â214 government role in development of, 33, historical evolution, 33 38â39 instruction for medical professionals on historical and conceptual evolution, 7, conduct in, 132, 160â161 33â41, 62 new product development, 98, 99 incentives to adopt and implement, recommendations for physicians and 233â234, 235â238 industry, 12â13, 20, 184â188 in legal profession, 305â317 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; 65â66 Role of supporting organizations ongoing performance evaluation of, 59 in strengthening and implementing oversight committees, 8, 14â15, 18, 21â conflict of interest policies 22, 81, 88â90, 120, 225, 226â228 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, 57â58 disclosures, 9 public involvement in implementation, supporting standardization of disclosure 59 requirements, 8â9, 92â93 research needs, 15â16, 22, 30, 84â85, Confidentiality, disclosure rules and, 58 238â239 Conflict of commitment, 48 role of supporting organizations in Conflict of interest policies, generally strengthening and implementing, 2, accountability provisions, 7, 59 5, 22, 29â30, 120, 230â239 in accounting profession, 317â328 scope of individuals subject to, 60, 90 accreditation requirements, 128 sources of, 38â41, 110â116, 175â183 in architecture profession, 328â336 transparency of, 6â7, 47, 58â59 common features, 64 See also Disclosure of financial for community physicians, 175â183 relationship complementary strategies to limit bias, Conflict of obligation, 48 41â43 Conflicts of interest, generally conflict of commitment provisions, 48 challenges in avoiding, 25 consistency across institutions and definition, 6, 26, 45â46, 61, 303â304 settings, 60 elements of, 46â48 cost-benefit analysis, 27 ethics violations and, 6, 49 criteria for evaluation, 6â7, 56â60 identifying. See Identifying and assessing criticisms of, 26â27, 39, 62â63 conflicts of interest current literature, 66â67 institutional. See Institutional conflicts of interest
404 INDEX knowledge base, 30, 32â33, 238â239 purpose, 140 magnitude of problem, 4, 26 recommendations, 11â12, 19â20, managing. See Managing conflicts of 161â164 interest scope of programs and activities, in nonmedical professions, 31, 50, 140â141 302â355 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 179â181 interest research, 108â109, 111â112 primary interests, 46 Cost of care research on. See Research on conflict of challenges for academic medical centers, interest issues 126 secondary interests, 46â47 and drug samples, 11, 186 sources of, 5, 14, 32, 45â48, 166â167 Council of Medical Specialty Services, 178 threats to medical profession in, 44â45 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, 235â236 proposed requirements for reporting of payments to physicians, 71 recommendations for, 9, 18, 94 D 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, 152â153, 221, 231 assessing likelihood of undue influence recommendations for, 22, 238â239 in, 54, 100 Department of Justice, U.S., 3, 15, 71, 148, current conflict of interest policies, 138, 152, 154, 179, 182, 231 176, 177â178, 179 Diagnostic and Statistical Manual of Mental disclosure, 40, 182â183, 221 Disorders, 202â203 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, 72â73, Continuing medical education 91â92 accreditation, 125 adverse consequences, 67â68, 77 comparison with other professions, assistance to employees for compliance, 142â143 73 conflict of interest concerns, 11, categories of relationships, 93 145â149, 161 in clinical practice guideline current conflict of interest policies, development, 201, 203, 205, 150â153 211â212 curriculum, 141â142 confidentiality concerns, 58 funding, 2, 11â12, 19â20, 26â27, 34, current requirements for companies, 127, 142, 143â145, 161â163, 221 71â72 legal requirements, 141 current requirements for medical monitoring, 150â151 professionals, 68â71 nonaccredited programs, 142, 151, 152, deterrent function, 67 164 effectiveness of policies, 77â79 profitability, 143
INDEX 405 extent of noncompliance, 74â75 Drug samples follow-up actions, 29 current restrictions, 135â136 historical evolution of medical documentation of distribution, 136 profession policies, 39â40 ethical concerns, 3â4, 11, 25, 135, importance of, 1â2, 5, 8, 28, 67, 90 174â175, 186 to individuals potentially affected by, industry spending, 171 68â69 intended purpose, 11, 134, 186 journal publication requirements, 69â70, prevalence, 172 115 recommendations, 10â11, 13, 19, 20, legislative requirements, 9, 63â64, 157, 159â160, 184, 186â187 71â72, 94, 181â183 monitoring and enforcement, 75â76 objections to, 62â63 E 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, 139â140, public access to reports, 9, 71, 94, 95, 183 180, 187 access of industry representatives to quantity of disclosed information, 77 students and faculty, 131â133, 157, recommendations for companies, 18, 158â159 94â96 accreditation, 15, 125 recommendations for policy design and appropriate industry presence in, 10 implementation, 8â9, 18, 89â93 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, 115â116 123, 133, 157 review responsibility, 64, 81, 82 conflict of interest instruction in, 11, 19 risk assessment, 82â83 conflict of interest management specificity of requirements, 91, 93 variations within, 81â82 standardization, 8â9, 18, 29, 91â93, 164 current conflict of interest policies, strategies for managing conflicts of 68â69, 110, 133, 135â136, 137â138, interest, 83â84 139 time frame for, 72, 90â91, 95 current scale, 124 variations among conflict of interest debt burden of physicians, 126 policy requirements, 7â8, 87â88, department chairs or deans, conflict of 91â92 interest risks for, 101, 218, 219 voluntary reporting from companies, dissemination of conflict of interest 180â181 policies, 86 Discretion, 54â55 distribution of industry spending, 127 Drug research and development elements of learning environment, approval rate, 23 122â123 costs, 23 emergence of concerns about industry process, 98â99 relationships, 35, 39 pro-industry research findings, 104â105, faculty member relationships with 106 industry, 2, 10, 24 withholding of research findings, 24, financial challenges, 126 106, 108
406 INDEX gifts to students and faculty, 136â138 assessing likelihood of undue influence goals, 10, 122, 127 in, 53â55 historical development, 124 continuing medical education financing, individuals subject to conflict of interest 2, 11â12, 34, 142, 143â145, policies, 60 161â163 industry funding, 126â127 in development of clinical practice industry-sponsored scholarships and guidelines, 13â14, 198â204, 211â213 training positions, 138â139 duration, 54 influence on physician beliefs and historical development of conflict of attitudes, 127â128, 139 interest concerns, 35â41 instruction on how to interact with historical evolution, 33â35 industry representatives, 132, illegal payments to medical 160â161 professionals, 25, 40, 148, 152â153, management of conflicts of interest, 81, 154, 181â183 83â84 indirect, 145 off-site facilities, 131, 160 industry-sponsored scholarships and policy ratings, 131 training positions, 138â139 prohibitions on financial relationships, medical education institutions, 126â127 79 in medical publishing, 24 recommendations, 10â12, 17t, 19, 89, motivation of medical professionals to 157â161 enter into, 126 restrictions on access of industry negative effects of conflict of interest representatives, 133 policies, 26â27, 62â63 scope of industry relationships in, 10, in nonclinical research, 10, 101 32, 101â102, 129, 131 percentage of organizational funds given settings for, 122, 125 by industry, 220â221, 223 sources of data on industry support, 127 physicianâindustry, 25, 172â173 strategies for reducing conflict of interest physician perceptions of, 172â173 risk, 139â140 prohibition effects, 79â80 value of industry relationships in, project benefits exceeding risk of bias, 129â131, 133 57â58 See also Continuing medical education; recommendations for medical practice Institutional conflicts of interest; relationships with industry, 12â13, Students, medical 184â188 Eliminating conflicts of interest, 80 regulatory and legislative actions, Enforcement. See Monitoring and 181â183, 188 enforcement; Sanctions research-related gifts, 101â102 Engineering profession, 336â350 restrictions on human participants Evidence-based medicine, 13, 191 research, 9, 19, 110, 117â118 restrictions on researchers with financial interest in research outcome, 9â10, F 117â119 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, 46â47 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, 82â83 219 clinical trials regulation, 113 acceptable forms, 158
INDEX 407 new device approval and company H training, 132 recommendations for, 92, 238â239 Health care facilities research rules, 83 financial challenges for teaching Foundations, 9, 18, 20, 49, 94, 145, 163, hospitals, 126 187, 211 ownership by physicians, 5, 32, 40, 95â96, 167, 169â170, 187 recommendations for teaching hospitals, G 11, 19, 133, 157, 158, 160 See also Education and training of Ghostwriting, 10, 13, 19, 20, 24, 108, 153, medical professionals; Institutional 154â155, 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 assessing likelihood of undue influence I of, 53â54 current conflict of interest policies, Identifying and assessing conflicts of interest 137â138, 176 accountability considerations, 56 ethical concerns, 2, 4, 136â137, 185 assessing risks of disclosed relationships, extent, 136 82â83 in medical education settings, 10, 19, in clinical practice guideline 129â131, 136â137 development, 25 patient perception, 78â79 conceptual basis, 46â48, 49 physician perspective, 126, 172 conceptual model, 64â65 prevalence, 12, 172 criteria for evaluating conflict of interest prohibitions on, 79 policies, 6â7 public awareness, 78 criterion of proportionality in, 52â53 purpose of disclosure policies, 67 current variations and deficiencies, 88 recommendations, 13, 19, 20, 157, 158, definition, 6, 26, 45â46, 61 184, 187, 188 evaluation of motives, 50â51 research-related gifts, 101â102 financial relationships in nonclinical size of gift, 47, 53â54, 136â137 research, 10 Government role identifying primary and secondary continuing medical education conflict of interests, 46â47 interest policies, 152â153 in institutional settings, 14â15, 22, 218, in development of clinical practice 224, 225, 226â228 guidelines, 190â191, 197, 199, 214 likelihood of undue influence, 53â55, 61 evolution of conflict of interest policies, for management of conflicts of interest, 33 80â81 historical development of biomedical principles, 45, 61 research, 97â98 proportionality considerations, 57â58 institutional conflict of interest recommendations for policy design and regulation, 221 implementation, 8â9, 89â90 in promoting adoption and in research, 9â10, 110â116 implementation of conflict of interest seriousness of possible harm, 55â56, 61 policies, 22, 231, 236â238 severity, 6, 52â53, 82 regulation of physicianâindustry See also Disclosure of financial financial relationships, 181â183 relationship See also specific department or agency Illegal payments to medical professionals, 25, 40, 148, 152â153, 154, 181â183
408 INDEX Informed consent for research participants, L 115â116 Institutional conflicts of interest Legal profession, 142â143, 305â317 accountability procedures, 59 Liaison Commission on Medical Education, conflicts of commitment, 48 125 current policies and strategies, 221â224 Licensing and certification, 15, 22, 231, 236 current shortcomings in policy development, 231 definition, 218 M disclosure, 28â29 Managing conflicts of interest identifying and assessing, 218, 224, assessing risks of disclosed relationships, 226â228 82â83 implications for reputations of in clinical practice guideline associated individuals, 55â56, 111, development, 14, 21, 211, 213 216â217 continuation of financial relationships, individual behavior as source of, 218, 80 225 current policies and practices, 81â82 managing, 222â223, 224â226 current variations and deficiencies, 88 oversight committee, 14â15, 21â22, 120, eliminating or prohibiting, 79â80 225, 226â228 indications, 80â81 public acceptance of, 225â226 institutional conflicts in research, range of institutions, 31â32, 216 222â223, 224â226 recommendations, 14â15, 17t, 21â22, in nonclinical research, 119 226â229 options, 81 risk, 178, 216â217 research needs, 84â85 role of supporting organizations in strategies, 83â84 policy development, 231â239 See also Monitoring and enforcement rules for research institutions, 22 Medicaid, 170 sharing of conflict of interest policies Medical device companies and procedures, 58â59 access to medical students and faculty, significance of, 14, 216â217 131â133, 159 sources and concerns, 14, 218, 219â221 illegal payments to physicians, 182â183 Institutional review boards, 221 new product development, 99, 100 Insurance industry, 15, 21, 22, 32, 89, 230, physician training from, 131â132, 133, 231, 234, 236â238 159, 176 Integrity in Scientific Research, 32 recommendations for disclosure of International Committee of Medical Journal financial relationships, 18, 94, 95 Editors, 29â30, 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 Journal of the American Medical also Medical publications Association, 113 Medical journals. See Medical publications Journalists, 74 Medical product companies appropriate role in medical education, 10 K current requirements for disclosure of payments, 71â72 Kickbacks. See Illegal payments to medical in development of clinical practice professionals guidelines, 13â14, 211â214
INDEX 409 historical development of conflict of ownership of medical facilities, 32, 40, interest concerns, 35â41, 62 95â96, 167, 169â170 historical development of relationships participation in industry promotional with medical profession, 33â35 activities, 171 illegal payments to physicians, 25, 40, payment issues, 5, 32, 167, 168â169 148, 152â153, 154, 181â183 privileges and responsibilities, 166 medical education funding, 126â127 public disclosure of payments to, 94, 95 officers and board members, medical public trust, 49â50 professionals as, 219 receptivity to industry gifts, 126 recommendations for disclosure of recommendations for medical practice financial relationships, 18, 94â96 relationships with industry, 12â13, recommendations for medical practice 17t, 20, 184â188 relationships, 12â13, 20, 187â188 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, 172â173 scope of relationships in medical See also Clinical practice guidelines; education, 10, 32, 101â102, 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 180â181, 188, 238 conflict of interest policies, 69â70 See also Biotechnology companies; contract restrictions on release of Collaborative relationships in research, 108â109, 111â112 medicine; Financial relationships with current disclosure requirements, 69â70, 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, 154â155, 156, 157, 158, 184 community physiciansâ participation in industry advertising, 34 clinical trials, 173â174, 175 industry influence, 24 conflict of interest concerns, 166â167, industry-sponsored supplements, 69 183â184 journalistsâ 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, 75â76 community physicians, 175â183 peer review, 115 education debt, 126 pro-industry research findings, 104â108 implications of recommendations for publication of clinical practice institutions and industry, 188 guidelines, 21 income trends, 167â168 review and editorial articles, 69â70 industry marketing to, 170â172 withholding of research findings, 24, information sources, 175 106, 108, 112, 193â194
410 INDEX Medicare, 126, 170 P Medicare Payment Advisory Commission (MedPAC), 72, 136, 160, 167 Patent rights and income disclosure proposals, 94â96, 170 historical development of law, 97â98 Merck Manual of Diagnosis and Therapy, institutional conflict of interest risk, 34 219â220 Meta-analysis, 190 royalty income disclosure, 68 Monitoring and enforcement Patient advocacy groups, 71, 94 assessment of clinical practice guidelines, Pharmaceutical companies 208â210 access to medical students and faculty, clinical trial registration and reporting 131â133 requirements, 112 access to physician prescribing in continuing medical education, information, 186 150â151 benefits of collaborative relationships, current state, 75â76 23â24, 129â131 current variations and deficiencies, 88 conflict of interest concerns, 12, 24 electronic tracking tool, 87 continuing medical education funding, public disclosure of payments to medical 148â149 professionals, 94, 95 government guidelines for payment to recommendations, 88â90 physicians, 181 in research institutions, 86â87 historical evolution of professional research oversight, 54â55, 84â85, relationships, 34 118â119, 120, 228â229 illegal payments to physicians, 25, 148, See also Sanctions 152â153, 181â182 influence on prescribing practice, 12, 25, 132, 136, 174â175 N as information sources for physicians, 175 National Academy of Sciences, 39 marketing activities, 170â172, 173â174 National Fibromyalgia Association, 220 policies on relationships with physicians, National Guideline Clearinghouse, 14, 15, 179â180 21, 191â192, 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 71â72 compliance monitoring activities, 15, 87, research and development process, 23, 231 374â383 financial relationship policies, 79â80 restrictions on access to students, 133 institutional conflict of interest, scope of relationships with medical 238â239 professionals, 2 noncompliance with disclosure rules, 74 support for medical organizations, recommendations for, 15, 22, 92, 120, 220â221 228â229, 238â239 withholding of unfavorable research research support and regulation, 7â8, findings, 24 34, 100, 120 See also Biotechnology companies; Drug National Library of Medicine, 69, research and development; Drug 233â234 samples; Medical product companies National Research Council, 33 Pharmaceutical Research and Manufacturers of New England Journal of Medicine, 39â40, America, 41, 79, 138, 139, 173, 231 70 on physician relationships, 179 Nonclinical research. See Research, medical recommendations for, 187â188
INDEX 411 on speaking fees, 156â157 Public perception and understanding on support for continuing medical conflict of interest concerns, 1, 51 education, 151â152 in development of clinical practice Prevention of conflicts of interest guidelines, 14 prohibition policies, 79â80 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, 176â179 28, 49â50, 51 compliance monitoring in research influence of industry gifts to physicians, institutions, 86â87 78â79 conflict of interest concerns, 15 institutional conflicts of interest, consistency of conflict of interest policies 225â226 among, 60 of institutions, 49â50 continuing medical education, 140â141, participation in conflict of interest policy 142, 143 implementation, 59 continuing medical education conflict of patient awareness of industry gifts to interest policies, 151â152 physicians, 78 current disclosure requirements, 71 rating of conflict of interest policies, 234 in development of clinical practice reporting of financial relationship guidelines, 196, 197â198 disclosures, 9, 71, 94, 95, 187 dissemination of conflict of interest research participantsâ perceptions of policies, 86 research collaborations, 109 evolution of conflict of interest policies, transparency of conflict of interest 35â40, 62 policies and procedures, 58 funding sources, 34â35 trust and confidence in medical historical development of medical profession, 1, 2, 3, 23, 24â25, 28, industry relationships, 34 117 primary interests, 46 in promoting transparency of clinical practice guidelines, 21, 213â214 Q public trust in, 50 Quality improvement initiatives, 232â233 recommendations for, 13, 15â16, 18, 21, Quality of care 22, 88â89, 92, 94, 95 conflict of interest concerns, 1, 2 in reform of continuing medical patient trust in, 24â25 education financing, 19â20, 1 See also Clinical practice guidelines 61â162 role of supporting organizations in strengthening and implementing conflict of interest policies, 2, 5, 22, R 29â30, 120, 230â239 RAND Corporation, 191 scope of, 31â32 Rebuttable presumption, 80, 81, 110, 111 significance of industry funding, Referrals to facilities owned by referring 220â221 physician, 5, 40, 169â170 See also Institutional conflicts of interest; Reimbursement, 5, 32, 167â169, 219 specific organizations Research, medical Proportionality aspects of conflict of interest assessing conflict of interest risk, 82, 83 policies, 6, 57â58 basic research. See Nonclinical research
412 INDEX benefits of industry collaboration, 9, 97, research needs on conflict of interest 99â100, 102, 116 issues, 119â120 clinical trial registration and reporting, research participant enrollment, 112 disclosure effects on, 78, 109, community physiciansâ participation in, 115â116 173â174, 175 researcher discretion, 54â55 compliance with conflict of interest seeding trials, 173â174 policies, 86â87 standardization of methodology, 113 conflict of interest concerns, 1, 2, 3, 9, study design, conflict of interest 14, 24, 100, 102â103, 108, 116â117 management and, 113 conflict of interest management, 81, supervision of, conflict of interest 84â85 concerns in, 109, 116 contractual restrictions on release of time frame for disclosure of financial data, 108â109, 111â112 relationships, 72 current conflict of interest policies, trade secrets as result of, 103 111â116, 222, 295â301 withholding or delay of publication, 24, drug development process, 374â383 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, 66â67, 87 40, 110â111 data collection and analysis, 4â5 exceptions to conflict of interest effectiveness of management strategies, prohibitions, 9â10, 57â58, 118â119, 84â85 223 goals, 2, 5, 30 extent of industry support, 101â102 knowledge base, 4, 30, 32â33, 238â239 government role, 97â98 methodological approach, 30â31, 43, historical evolution of industry 285â286 involvement, 33, 34, 97â98, 101 in nonclinical research, 119â120 industry contributions, 98â99 prominent reports, 41 informed consent for research psychology research, 358â372 participants, 115â116 recommendations, 15â16, 22, 228â229, institutional conflict of interest policies, 238â239 22, 120, 222 scope of, 27â28, 31â32 investigatorsâ perceptions of conflict of Residency programs interest requirements, 85 accreditation, 125 nonclinical research, 10, 101, 111, industry gifts to residents, 136â137 119â120 industry influence on physician behavior, openness of scientific process and, 136, 137 103â104 industry support, 127, 129 oversight, 54â55, 62, 84â85, 118â119, number of, 124 120, 228â229 use of drug samples, 135 process, 98â100 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, 104â108 29â30, 120, 230â239 quality of research designs, 105â106 Royalty income, 68 recommendations, 9â10, 16t, 19, 22, 117â121, 228â229
INDEX 413 S Standardization of clinical practice guidelines, 208â210 Sales and marketing activities of disclosure requirements, 8â9, 18, 29, academic detailing programs as 91â93, 164 alternative to drug detailing, of research designs, 113 139â140, 183 Stark laws, 170 continuing medical education funding to State government, 15 promote products, 148â149 academic detailing programs, 183 as hidden purpose of clinical trial, accreditation activities, 125 173â174 continuing medical education historical evolution in medical industry, requirements, 141 33â34 on disclosure of payments to physicians, industry spending, 170â171 181 interpersonal strategies, 171 in health care system, 231 mechanisms of influence, 40â41 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, 185â186 training positions, 138â139 as source of information for physicians, scope of industry contacts, 129, 131 175, 185â186 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, 181â183 for nondisclosure, 75, 76 T proper use, 234â235 See also Monitoring and enforcement Thresholds, reporting, 18, 68, 72, 90, 91, Secondary interests, 46â47 118 Seeding trials, 173â174 Transparency Selective serotonin reuptake inhibitors, 24 of conflict of interest policies, 6â7, 47, Society for General Internal Medicine, 58â59, 231â232 223â224 in development of clinical practice Speakers bureaus and speaking engagements guidelines, 13, 14, 21, 211, 212 academic department chairs, 219 reporting of financial relationship conflict of interest policies, 156â157, disclosures, 9 177â178 Trust, 28, 49â50, 51 in continuing medical education, 145, 154 ethical concerns, 153â154 U extent, 145, 154, 171 U.S. Preventive Services Task Force, in industry promotional campaigns, 190â191, 192 171â172 U.S. Public Health Service regulations prohibitions on, 79 compliance, 86â87 recommendations, 10, 89, 184, 185 on financial relationships in research, Specialty boards, 15 110
414 INDEX institutional applicability, 22, 60, 62, text, 295â301 221, 228 See also National Institutes of Health issued, 40 NIH support, 7â8, 231 purpose, 62 W recommendations for, 22, 228 World Association of Medical Journal reporting threshold and time frame, 72, Editors, 69, 230, 231 91