Ethical Issues Pertaining to Conflicts of Interest Between Neurologists and the Pharmaceutical and Medical Device Industries

Abstract

A conflict of interest (COI) exists when a physician's professional responsibilities are compromised by personal or financial relationships. COIs between physicians and the pharmaceutical or medical device industry (Industry) are common. Collaborations with Industry have many potential benefits, but also raise potential ethical pitfalls. Industry-related COIs have widespread influence on medical education, research, and clinical practice, and therefore have profound implications for the integrity of the field of medicine. Full disclosure is an important step toward mitigating COI but does not redress subconscious accompanying biases. I review the spectrum of potential COI faced by physicians, with a focus on the ethics surrounding the relationship between neurologists and Industry. Other financial and nonfinancial COIs that influence neurologists and nonindividual entities, such as academic institutions, medical journals, and professional societies, are also discussed. Solutions ranging from disclosure to avoidance and recusal are briefly considered.

Keywords

conflict of interest - ethics - neurology - industry - pharmaceutical

• References

• 1 Merriam-Webster Online. Available at: https://www.merriam-webster.com/dictionary/conflict%20of%20interest . Accessed February 25, 2018
• 2 Rubin EB, Bernat JL. Resident and fellow section. Conflicts of interest between physicians and the pharmaceutical industry: focus on headache medicine. Headache 2008; 48 (10) 1545-1549
• 3 Stead WW. The complex and multifaceted aspects of conflicts of interest. JAMA 2017; 317 (17) 1765-1767
• 4 Green MJ, Masters R, James B, Simmons B, Lehman E. Do gifts from the pharmaceutical industry affect trust in physicians?. Fam Med 2012; 44 (05) 325-331
• 5 Grande D, Shea JA, Armstrong K. Pharmaceutical industry gifts to physicians: patient beliefs and trust in physicians and the health care system. J Gen Intern Med 2012; 27 (03) 274-279
• 6 Ethics and Humanities Subcommittee. American Academy of Neurology policy on conflicts of interest. Neurology 1998; 50 (02) 332-334
• 7 Holloway RG, Mooney CJ, Getchius TSD, Edlund WS, Miyasaki JO. Invited article: conflicts of interest for authors of American Academy of Neurology clinical practice guidelines. Neurology 2008; 71 (01) 57-63
• 8 Hutchins JC, Rydell CM, Griggs RC, Sagsveen M, Bernat JL. ; American Academy of Neurology Pharmaceutical and Device Industry Conflict of Interest Task Force. American Academy of Neurology policy on pharmaceutical and device industry support. Neurology 2012; 78 (10) 750-754
• 9 American Academy of Neurology. Principles Governing Academy Relationships with External Sources of Support. 2014. Available at: https://www.aan.com/siteassets/home-page/footer/membership-and-support/member-resources/professionalism–disciplinary-program/13academyprinciples_ft.pdf . Accessed February 28, 2018
• 10 Boyd EA, Bero LA. Assessing faculty financial relationships with industry: a case study. JAMA 2000; 284 (17) 2209-2214
• 11 DeJong C, Aguilar T, Tseng CW, Lin GA, Boscardin WJ, Dudley RA. Pharmaceutical industry-sponsored meals and physician prescribing patterns for Medicare beneficiaries. JAMA Intern Med 2016; 176 (08) 1114-1122
• 12 Fleischman W, Agrawal S, King M. , et al. Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study. BMJ 2016; 354: i4189
• 13 Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift?. JAMA 2000; 283 (03) 373-380
• 14 Bero LA, Grundy Q. Why having a (nonfinancial) interest is not a conflict of interest. PLoS Biol 2016; 14 (12) e2001221
• 15 Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA 2003; 290 (02) 252-255
• 16 Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: attitudes and practices of medicine house staff toward pharmaceutical industry promotions. Am J Med 2001; 110 (07) 551-557
• 17 Rosenbaum L. Understanding bias--the case for careful study. N Engl J Med 2015; 372 (20) 1959-1963
• 18 Shaywitz DA, Stossel TP. It's Time to Fight the ‘PharmaScolds’. The Wall Street Journal; 2009. Available at: https://www.wsj.com/articles/SB123914780537299005 . Accessed February 25, 2018
• 19 Johnston SC, Hauser SL, Desmond-Hellmann S. Enhancing ties between academia and industry to improve health. Nat Med 2011; 17 (04) 434-436
• 20 Rothman KJ. Conflict of interest. The new McCarthyism in science. JAMA 1993; 269 (21) 2782-2784
• 21 Schwid SR, Gross RA. Bias, not conflict of interest, is the enemy. Neurology 2005; 64: 1830-1831
• 22 Wilson M. The Sunshine Act: commercial conflicts of interest and the limits of transparency. Open Med 2014; 8 (01) e10-e13
• 23 Grundy Q, Tierney L, Mayes C, Lipworth W. Health professionals “make their choice”: pharmaceutical industry leaders' understandings of conflict of interest. J Bioeth Inq 2017; 14 (04) 541-553
• 24 Larkin I, Loewenstein G. Business model–related conflict of interests in medicine: problems and potential solutions. JAMA 2017; 317 (17) 1745-1746
• 25 Bero L. Addressing bias and conflict of interest among biomedical researchers. JAMA 2017; 317 (17) 1723-1724
• 26 Levinsky NG. Nonfinancial conflicts of interest in research. N Engl J Med 2002; 347 (10) 759-761
• 27 Yeh JS, Franklin JM, Avorn J, Landon J, Kesselheim AS. Association of industry payments to physicians with the prescribing of brand-name statins in Massachusetts. JAMA Intern Med 2016; 176 (06) 763-768
• 28 De Lott LB, Burke JF, Kerber KA, Skolarus LE, Callaghan BC. Medicare Part D payments for neurologist-prescribed drugs. Neurology 2016; 86 (16) 1491-1498
• 29 Flegel KM. Physicians, finder's fees and free, informed consent. CMAJ 1997; 157 (10) 1373-1374
• 30 Solomon AJ, Klein EP, Corboy JR, Bernat JL. Patient perspectives on physician conflict of interest in industry-sponsored clinical trials for multiple sclerosis therapeutics. Mult Scler 2015; 21 (12) 1593-1599
• 31 The Ethics and Humanities Subcommittee of the American Academy of Neurology. Ethical issues in clinical research in neurology: advancing knowledge and protecting human research subjects. Neurology 1998; 50 (03) 592-595
• 32 Bernat JL. Ethical Issues in Neurology. Philadelphia, PA: Lippincott Williams & Wilkins; 2008
• 33 Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003; 289 (04) 454-465
• 34 Vogeli C, Koski G, Campbell EG. Policies and management of conflicts of interest within medical research institutional review boards: results of a national study. Acad Med 2009; 84 (04) 488-494
• 35 Campbell EG, Weissman JS, Vogeli C. , et al. Financial relationships between institutional review board members and industry. N Engl J Med 2006; 355 (22) 2321-2329
• 36 Klein E, Solomon AJ, Corboy J, Bernat J. Physician compensation for industry-sponsored clinical trials in multiple sclerosis influences patient trust. Mult Scler Relat Disord 2016; 8: 4-8
• 37 Relman AS. Industry support of medical education. JAMA 2008; 300 (09) 1071-1073
• 38 Lexchin J. Interactions between physicians and the pharmaceutical industry: what does the literature say?. CMAJ 1993; 149 (10) 1401-1407
• 39 Schofferman J. The medical-industrial complex, professional medical associations, and continuing medical education. Pain Med 2011; 12 (12) 1713-1719
• 40 Bowman MA, Pearle DL. Changes in drug prescribing patterns related to commercial company funding of continuing medical education. J Contin Educ Health Prof 1988; 8 (01) 13-20
• 41 Orlowski JP, Wateska L. The effects of pharmaceutical firm enticements on physician prescribing patterns. There's no such thing as a free lunch. Chest 1992; 102 (01) 270-273
• 42 Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003; 326 (7400): 1167-1170
• 43 Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev 2017; 2: MR000033
• 44 Cataldo JK, Prochaska JJ, Glantz SA. Cigarette smoking is a risk factor for Alzheimer's disease: an analysis controlling for tobacco industry affiliation. J Alzheimers Dis 2010; 19 (02) 465-480
• 45 McCambridge J, Hartwell G. Has industry funding biased studies of the protective effects of alcohol on cardiovascular disease? A preliminary investigation of prospective cohort studies. Drug Alcohol Rev 2015; 34 (01) 58-66
• 46 Gilstad JR, Finucane TE. Results, rhetoric, and randomized trials: the case of donepezil. J Am Geriatr Soc 2008; 56 (08) 1556-1562
• 47 Koepp R, Miles SH. Meta-analysis of tacrine for Alzheimer disease: the influence of industry sponsors. JAMA 1999; 281 (24) 2287-2288
• 48 Barden J, Derry S, McQuay HJ, Moore RA. Bias from industry trial funding? A framework, a suggested approach, and a negative result. Pain 2006; 121 (03) 207-218
• 49 Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med 2009; 361 (20) 1963-1971
• 50 Vedula SS, Goldman PS, Rona IJ, Greene TM, Dickersin K. Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin litigation. Trials 2012; 13: 136-136
• 51 Liu JJ, Bell CM, Matelski JJ. , et al. Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study. BMJ 2017; 359: j4619
• 52 Dorsey ER, de Roulet J, Thompson JP. , et al. Funding of US biomedical research, 2003-2008. JAMA 2010; 303 (02) 137-143
• 53 Rosenblatt M. How academia and the pharmaceutical industry can work together: the president's lecture, annual meeting of the American Thoracic Society, San Francisco, California. Ann Am Thorac Soc 2013; 10 (01) 31-38
• 54 Kesselheim AS, Robertson CT, Myers JA. , et al. A randomized study of how physicians interpret research funding disclosures. N Engl J Med 2012; 367 (12) 1119-1127
• 55 Radecki RP. Pharmaceutical sponsorship bias influences thrombolytic literature in acute ischemic stroke. West J Emerg Med 2011; 12 (04) 435-441
• 56 Lenzer J. Alteplase for stroke: money and optimistic claims buttress the “brain attack” campaign. BMJ 2002; 324 (7339): 723-729
• 57 Relman AS. The new medical-industrial complex. N Engl J Med 1980; 303 (17) 963-970
• 58 Doucet M, Sismondo S. Evaluating solutions to sponsorship bias. J Med Ethics 2008; 34 (08) 627-630
• 59 Steinbrook R. Controlling conflict of interest--proposals from the Institute of Medicine. N Engl J Med 2009; 360 (21) 2160-2163
• 60 Cho MK, Shohara R, Schissel A, Rennie D. Policies on faculty conflicts of interest at US universities. JAMA 2000; 284 (17) 2203-2208
• 61 McCrary SV, Anderson CB, Jakovljevic J. , et al. A national survey of policies on disclosure of conflicts of interest in biomedical research. N Engl J Med 2000; 343 (22) 1621-1626
• 62 Resnik DB, Ariansen JL, Jamal J, Kissling GE. Institutional conflict of interest policies at U.S. Academic Research Institutions. Acad Med 2016; 91 (02) 242-246
• 63 Lo B, Wolf LE, Berkeley A. Conflict-of-interest policies for investigators in clinical trials. N Engl J Med 2000; 343 (22) 1616-1620
• 64 Ethics and Humanities Subcommittee. American Academy of Neurology policy on conflicts of interest. Neurology 1998; 50 (02) 332-334
• 65 Patient Protection and Affordable Care Act. U.S. Congress. 2010. 42: 18001 et seq
• 66 Center for Medicare and Medicaid Services. Open Payments. Available at: https://www.cms.gov/openpayments/ . Accessed February 25, 2018
• 67 Marshall DC, Jackson ME, Hattangadi-Gluth JA. Disclosure of industry payments to physicians: an epidemiologic analysis of early data from the open payments program. Mayo Clin Proc 2016; 91 (01) 84-96
• 68 Ahlawat A, Narayanaswami P. Financial relationships between neurologists and industry: an analysis of the 2015 Open Payments Database. Neurology 2018; 90 (23) 1063-1070
• 69 Samuel AM, Webb ML, Lukasiewicz AM. , et al. Orthopaedic surgeons receive the most industry payments to physicians but large disparities are seen in Sunshine Act data. Clin Orthop Relat Res 2015; 473 (10) 3297-3306
• 70 Mehlman CT, Okike K, Bhandari M, Kocher MS. Potential financial conflict of interest among physician editorial board members of orthopaedic surgery journals. J Bone Joint Surg Am 2017; 99 (05) e19
• 71 Verma V. Financial relationships with industry of editorial board members of the three journals of the American Society for Radiation Oncology. Int J Radiat Oncol Biol Phys 2017; 99 (02) 286-291
• 72 Choudhry NK, Stelfox HT, Detsky AS. Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA 2002; 287 (05) 612-617
• 73 Campsall P, Colizza K, Straus S, Stelfox HT. Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry: a cross-sectional study. PLoS Med 2016; 13 (05) e1002029
• 74 Norris SL, Holmer HK, Ogden LA, Burda BU. Conflict of interest in clinical practice guideline development: a systematic review. PLoS One 2011; 6 (10) e25153
• 75 Cherla DV, Olavarria OA, Holihan JL. , et al. Discordance of conflict of interest self-disclosure and the Centers of Medicare and Medicaid Services. J Surg Res 2017; 218: 18-22
• 76 Olavarria OA, Holihan JL, Cherla D. , et al. Comparison of conflicts of interest among published hernia researchers self-reported with the Centers for Medicare and Medicaid Services Open Payments Database. J Am Coll Surg 2017; 224 (05) 800-804
• 77 Boddapati V, Fu MC, Nwachukwu BU, Ranawat AS, Zhen WY, Dines JS. Accuracy between AJSM author-reported disclosures and the Centers for Medicare and Medicaid Services Open Payments Database. Am J Sports Med 2018; 46 (04) 969-976
• 78 Luce EA, Jackman CA. Disclosure of financial conflicts of interest in plastic and reconstructive surgery. Plast Reconstr Surg 2017; 140 (03) 635-639
• 79 Forbes TL. Author disclosure of conflict of interest in vascular surgery journals. J Vasc Surg 2011; 54 (3, Suppl): 55S-58S
• 80 Thompson JC, Volpe KA, Bridgewater LK. , et al. Sunshine Act: shedding light on inaccurate disclosures at a gynecologic annual meeting. Am J Obstet Gynecol 2016; 215 (05) 661.e1-661.e7
• 81 Buerba RA, Fu MC, Grauer JN. Discrepancies in spine surgeon conflict of interest disclosures between a national meeting and physician payment listings on device manufacturer web sites. Spine J 2013; 13 (12) 1780-1788
• 82 Ju BL, Miller CP, Whang PG, Grauer JN. Quantifying the variability of financial disclosure information reported by authors presenting at annual spine conferences. Spine J 2011; 11 (01) 1-8
• 83 Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandari M. Accuracy of conflict-of-interest disclosures reported by physicians. N Engl J Med 2009; 361 (15) 1466-1474
• 84 Choo KJ, Yi PH, Burns R, Mohan R, Wong K. Variable reporting by authors presenting arthroplasty research at multiple annual conferences. J Arthroplasty 2017; 32 (01) 315-319
• 85 Wong K, Yi PH, Mohan R, Choo KJ. Variability in conflict of interest disclosures by physicians presenting trauma research. World J Orthop 2017; 8 (04) 329-335
• 86 Hannon CP, Chalmers PN, Carpiniello MF, Cvetanovich GL, Cole BJ, Bach Jr BR. Inconsistencies between physician-reported disclosures at the AAOS Annual Meeting and industry-reported financial disclosures in the Open Payments Database. J Bone Joint Surg Am 2016; 98 (20) e90
• 87 Alhamoud HA, Dudum R, Young HA, Choi BG. Author self-disclosure compared with pharmaceutical company reporting of physician payments. Am J Med 2016; 129 (01) 59-63
• 88 Checketts JX, Cook C, Vassar M. An evaluation of industry relationships among contributors to AAOS clinical practice guidelines and appropriate use criteria. J Bone Joint Surg Am 2018; 100 (02) e10
• 89 Horn J, Checketts JX, Jawhar O, Vassar M. Evaluation of industry relationships among authors of Otolaryngology Clinical Practice Guidelines. JAMA Otolaryngol Head Neck Surg 2018; 144 (03) 194-201
• 90 Checketts JX, Sims MT, Vassar M. Evaluating industry payments among dermatology clinical practice guidelines authors. JAMA Dermatol 2017; 153 (12) 1229-1235
• 91 Mendelson TB, Meltzer M, Campbell EG, Caplan AL, Kirkpatrick JN. Conflicts of interest in cardiovascular clinical practice guidelines. Arch Intern Med 2011; 171 (06) 577-584
• 92 Mitchell AP, Basch EM, Dusetzina SB. Financial relationships with industry among National Comprehensive Cancer Network Guideline authors. JAMA Oncol 2016; 2 (12) 1628-1631
• 93 Boyd EA, Akl EA, Baumann M. , et al; ATS/ERS Ad Hoc Committee on Integrating and Coordinating Efforts in COPD Guideline Development. Guideline funding and conflicts of interest: article 4 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report. Proc Am Thorac Soc 2012; 9 (05) 234-242
• 94 Feuerstein JD, Akbari M, Gifford AE. , et al. Systematic analysis underlying the quality of the scientific evidence and conflicts of interest in interventional medicine subspecialty guidelines. Mayo Clin Proc 2014; 89 (01) 16-24
• 95 Cosgrove L, Bursztajn HJ, Erlich DR, Wheeler EE, Shaughnessy AF. Conflicts of interest and the quality of recommendations in clinical guidelines. J Eval Clin Pract 2013; 19 (04) 674-681
• 96 Neuman J, Korenstein D, Ross JS, Keyhani S. Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. BMJ 2011; 343: d5621
• 97 Barnes M, Florencio PS. Financial conflicts of interest in human subjects research: the problem of institutional conflicts. J Law Med Ethics 2002; 30 (03) 390-402
• 98 Chimonas S, DeVito NJ, Rothman DJ. Bringing transparency to medicine: exploring physicians' views and experiences of the Sunshine Act. Am J Bioeth 2017; 17 (06) 4-18
• 99 Braillon A, Wilson M. The Sunshine Act: moving forward. Am J Med 2016; 129 (09) e201
• 100 Butcher L. IN PRACTICE: What the open payments program means for neurologists. Neurol Today 2015; 15 (02) 32-33
• 101 Pham-Kanter G, Mello MM, Lehmann LS, Campbell EG, Carpenter D. Public awareness of and contact with physicians who receive industry payments: a national survey. J Gen Intern Med 2017; 32 (07) 767-774
• 102 Kieburtz K. Avoiding conflicts of interest: responsibilities of authors, reviewers, and editors. Neurology 1998; 51 (06) 1527-1528
• 103 Whisnant JP. Report of the Ombudsman for Neurology. Neurology 2003; 60 (02) 352
• 104 American Academy of Neurology. Organizational Disclosures. Available at: https://www.aan.com/AAN-Resources/Details/about-the-aan/organizational-disclosures/ . Accessed February 26, 2018
• 105 Avanzini G, Engel Jr J. Dealing with drug dependency: a commentary on ILAE's partnership with the pharmaceutical industry. Epilepsia 2007; 48 (10) 1821-1824
• 106 Sun GH. Conflict of interest reporting in otolaryngology clinical practice guidelines. Otolaryngol Head Neck Surg 2013; 149 (02) 187-191
• 107 Guyatt G, Akl EA, Hirsh J. , et al. The vexing problem of guidelines and conflict of interest: a potential solution. Ann Intern Med 2010; 152 (11) 738-741