Uneasy alliance—clinical investigators and the pharmaceutical industry

Bodenheimer, Thomas

doi:10.1056/nejm200005183422024

Cited by 765Pharmaceutical industry and healthcareHealth and Medical Research ImpactsPharmaceutical Economics and Policy

Uneasy alliance—clinical investigators and the pharmaceutical industry

Bodenheimer, Thomas·2000·New England Journal of Medicine

DOI 10.1056/nejm200005183422024

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Abstract

Clinical practice is changing rapidly. New cardiovascular drugs, antiinflammatory drugs, cancer chemotherapy, and other pharmacologic weapons are being added to physicians' therapeutic armamentarium virtually daily. Most clinical studies that bring new drugs from bench to bedside are financed by pharmaceutical companies. Many of these drug trials are rigorously designed, employing the skills of outstanding clinical researchers at leading academic institutions.But academic medical centers are no longer the sole citadels of clinical research. The past 10 years have seen the spectacular growth of a new research model. Commercially oriented networks of contract-research organizations (CROs) and site-management organizations (SMOs) have altered . . .

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Source of funding and outcome of clinical trials
Davidson, R. A. (1986) · Journal of General Internal Medicine · doi:10.1007/bf02602327 · Cited by 397 · see citing works
Problems in the Design and Reporting of Trials of Antifungal Agents Encountered During Meta-analysis
Johansen, H. K. (1999) · JAMA · doi:10.1001/jama.282.18.1752 · Cited by 128 · see citing works

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A postmodern moral tale: the ethics of research relationships
Somerville, M. (2002) · Nature reviews. Drug discovery · doi:10.1038/nrd773 · Cited by 2,175 · see citing works
Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review
Bekelman, J. E., Li, Y., & Gross, C. P. (2003) · JAMA · doi:10.1001/jama.289.4.454 · Cited by 1,816 · see citing works
“For-profit contract research organizations now consume more than 60% of clinical research funding from industry, leveraging their ability to complete trials more rapidly and less expensively than academic institutions.(8) In addition, management of financial interests at the institutional level is particularly challen…”
Assessing the Gold Standard — Lessons from the History of RCTs
Bothwell, L. E., Greene, J. A., Podolsky, S. H., & Jones, D. S. (2016) · New England Journal of Medicine · doi:10.1056/nejmms1604593 · Cited by 664 · see citing works
Conflict of Interest in Medical Research, Education, and Practice
Institute of Medicine (2009) · National Academies Press eBooks · doi:10.17226/12598 · Cited by 824 · see citing works
“Funding arrangements with contract research organizations have also raised concerns about inappropriate control by industry sponsors (Bodenheimer, 2000; Mirowski and Van Horn, 2005; Shuchman, 2007; Lenzer, 2008).”
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Why Olanzapine Beats Risperidone, Risperidone Beats Quetiapine, and Quetiapine Beats Olanzapine: An Exploratory Analysis of Head-to-Head Comparison Studies of Second-Generation Antipsychotics
Heres, S., Davis, J. M., Maino, K., Jetzinger, E., Kissling, W., & Leucht, S. (2006) · American Journal of Psychiatry · doi:10.1176/appi.ajp.163.2.185 · Cited by 447 · see citing works
“We focused on several factors that have been discussed as potential sources of bias, including features of study design, dose ranges, titration schedules, statistics, reporting ofresults, and wording of findings (4,7,8).”
Background
Neurobehavioral Performance of Residents After Heavy Night Call Versus After Alcohol Ingestion
Sierles, F., Brodkey, A. C., Cleary, L., McCurdy, F. A., Mintz, M., Frank, J., Lynn, D. J., Chao, J., Morgenstern, B., Shore, W., et al. (2005) · Journal of the American Medical Association (JAMA) · doi:10.1097/01.aog.0000186260.82840.6b · Cited by 405 · see citing works
“One public school’s student handbook contains a paragraph about support from commercial entities, permitting support if: (1) an academic administrator approves; (2) the representative gives no presentations; (3) the support does not interfere with the educational process; (4) the support is available to groups but not…”
Background
Is academic medicine for sale?
Angell, M. (2000) · New England Journal of Medicine · doi:10.1056/nejm200005183422009 · Cited by 377 · see citing works
Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005.
Ridker, P., & Torres, J. L. (2006) · Journal of the American Medical Association (JAMA) · doi:10.1001/jama.295.19.2270 · Cited by 308 · see citing works
“If confirmed in other areas of investigation, this observation could have implications for the design and conduct of jointly funded projects for which the primary intent is to share costs of pivotal trials with industry partners.(9,16,17) Finally, we believe our observations of differential rates of positive trial rep…”
Background
Psychology should list empirically supported principles of change (ESPs) and not credential trademarked therapies or other treatment packages
Rosen, G. M., & Davison, G. C. (2003) · Behavior Modification · doi:10.1177/0145445503027003003 · Cited by 305 · see citing works
“…has set aside concepts central to the study, practice, and teaching of our field (Borkovec, 1997; Borkovec & Castonguay, 1998; G. C. Davison, 1998) while exposing psychology to entrepreneurial influences not unlike those currently afflicting academic medicine (see Angell, 2000; Bodenheimer, 2000).”
Background
A national survey of physician-industry relationships.
Campbell, E., Gruen, R., Mountford, J., Miller, L. G., Cleary, P., & Blumenthal, D. (2007) · New England Journal of Medicine · doi:10.1056/nejmsa064508 · Cited by 303 · see citing works
Ghost Authorship in Industry-Initiated Randomised Trials
Gøtzsche, P. C., Hróbjartsson, A., Johansen, H. K., Haahr, M. T., Altman, D. G., & Chan, A.-W. (2007) · PLoS Medicine · doi:10.1371/journal.pmed.0040019 · Cited by 289 · see citing works
“We conclude that ghost authorship in industry-initiated randomised trials is very common, and we believe that this practice serves commercial purposes [13,17,21,22].”
The therapeutic orientation to clinical trials.
Miller, F., & Rosenstein, D. (2003) · New England Journal of Medicine · doi:10.1056/nejmsb030228 · Cited by 254 · see citing works
Ghost Management: How Much of the Medical Literature Is Shaped Behind the Scenes by the Pharmaceutical Industry?
Sismondo, S. (2007) · PLoS Medicine · doi:10.1371/journal.pmed.0040286 · Cited by 252 · see citing works
“The industry provides twice as much funding for clinical trials and related research as do not-for-profit agencies [27].”
European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions
Mentzelopoulos, S. D., Couper, K., Voorde, P. V. D., Druwé, P., Blom, M., Perkins, G. D., Lulic, I., Djakow, J., Raffay, V., Lilja, G., et al. (2021) · Resuscitation · doi:10.1016/j.resuscitation.2021.02.017 · Cited by 246 · see citing works
Financial Ties between DSM-IV Panel Members and the Pharmaceutical Industry
Cosgrove, L., Krimsky, S., Vijayaraghavan, M., & Schneider, L. (2006) · Psychotherapy and Psychosomatics · doi:10.1159/000091772 · Cited by 241 · see citing works
Infections and Inequalities
Farmer, P., Walton, D. S., & Tarter, L. (1999) · doi:10.1023/a:1010088804348 · Cited by 227
The Contract Research Organization and the Commercialization of Scientific Research
Mirowski, P., & van Horn, R. V. (2005) · Social Studies of Science · doi:10.1177/0306312705052103 · Cited by 223 · see citing works
Ethics Manual: Fifth Edition
Snyder, L., Leffler, C., & for the Ethics and Human Rights Committee, A. C. O. P. (2005) · Annals of Internal Medicine · doi:10.7326/0003-4819-142-7-200504050-00014 · Cited by 219 · see citing works
Clinical Inertia and Outpatient Medical Errors
O’Connor, P. J., Sperl‐Hillen, J. M., Johnson, P. E., Rush, W. A., & Biltz, G. R. (2008) · Journal of Medical Regulation · doi:10.30770/2572-1852-94.2.19 · Cited by 135 · see citing works
Types and Distribution of Payments From Industry to Physicians in 2015
Tringale, K., Marshall, D., Mackey, T., Connor, M., Murphy, J., & Hattangadi-Gluth, J. (2017) · Journal of the American Medical Association (JAMA) · doi:10.1001/jama.2017.3091 · Cited by 212 · see citing works
“of payments 6 (2-22) 6 (2-16) 6 (2-27) 4 (1-17) 9 (2-39) <.”
Changing Use of Antibiotics in Community-Based Outpatient Practice, 19911999
Steinman, M., Gonzales, R., Linder, J., & Landefeld, C. (2003) · Annals of Internal Medicine · doi:10.7326/0003-4819-138-7-200304010-00001 · Cited by 212
Policies on faculty conflicts of interest at US universities.
Cho, M., Shohara, R., Schissel, A., & Rennie, D. (2000) · Journal of the American Medical Association (JAMA) · doi:10.1016/s0002-9394(01)00841-8 · Cited by 204
The need for research in primary care.
Maeseneer, J. D., van Driel, M., Green, L., & van Weel, C. (2003) · The Lancet · doi:10.1016/s0140-6736(03)14576-x · Cited by 199 · see citing works
A national survey of policies on disclosure of conflicts of interest in biomedical research.
van McCrary, S., Anderson, C. B., Jakovljević, J., Khan, T., McCullough, L., Wray, N., & Brody, B. (2000) · New England Journal of Medicine · doi:10.1056/nejm200011303432207 · Cited by 194 · see citing works
A new view of women's sexual problems: Why new? Why now?
Tiefer, L. (2001) · The Journal of Sex Research · doi:10.1080/00224490109552075 · Cited by 192 · see citing works
“Our critique of the pharmaceutical industry's undue influence dovetails with others emerging in journalism and medicine, and we call upon our sexological colleagues to assert their independence and vision strongly in the coming years (Angelí, 2000; Bodenheimer, 2000; Relman, 2001; Tiefer, 2000a).”
Background
Conflict-of-interest policies for investigators in clinical trials.
Lo, B., Wolf, L. E., & Berkeley, A. (2000) · New England Journal of Medicine · doi:10.1056/nejm200011303432206 · Cited by 181 · see citing works
Neuromarketing and consumer neuroscience: contributions to neurology
Javor, A., Koller, M., Lee, N. J., Chamberlain, L., & Ransmayr, G. N. (2013) · BMC Neurology · doi:10.1186/1471-2377-13-13 · Cited by 195 · see citing works
“Reports suggesting that industry may alter, obstruct, or stop publication of negative results have been published [144,145].”
Background
DESIGN AND REPORTING MODIFICATIONS IN INDUSTRY-SPONSORED COMPARATIVE PSYCHOPHARMACOLOGY TRIALS
SAFER, D. J. (2002) · The Journal of Nervous and Mental Disease · doi:10.1097/00005053-200209000-00002 · Cited by 180 · see citing works
“Although legal restraints have curtailed some excessive industry financial incentives to physicians, the financial power of the big pharmaceutical companies continues to make them far and away the dominant vendors of clinical research (Bodenheimer, 2000; Silversides, 1998).”
Background
The pharmaceutical industry as a medicines provider.
Henry, D., & Lexchin, J. (2002) · The Lancet · doi:10.1016/s0140-6736(02)11527-3 · Cited by 179 · see citing works
A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors.
Schulman, K., Seils, D. M., Timbie, J. W., Sugarman, J., Dame, L., Weinfurt, K., Mark, D., & Califf, R. (2002) · New England Journal of Medicine · doi:10.1056/nejmsa020349 · Cited by 176 · see citing works
Changing Use of Antibiotics in Community-Based Outpatient Practice, 19911999
Steinman, M., Gonzales, R., Linder, J., & Landefeld, C. (2003) · Annals of Internal Medicine · doi:10.7326/0003-4819-138-7-200304010-00008 · Cited by 173 · see citing works
Institutional academic industry relationships.
Campbell, E., Weissman, J., Ehringhaus, S., Rao, S. R., Moy, B., Feibelmann, S., & Goold, S. (2007) · Journal of the American Medical Association (JAMA) · doi:10.1001/jama.298.15.1779 · Cited by 169 · see citing works
“Founder of a company 38 (9) 21 (7) 17 (11) .”
Background
Corporate practices and health: a framework and mechanisms
Lima, J. M., & Galea, S. (2018) · Globalization and Health · doi:10.1186/s12992-018-0336-y · Cited by 163 · see citing works
Evolution of the Randomized Controlled Trial in Oncology Over Three Decades
Booth, C. M., Cescon, D. W., Wang, L. E., Tannock, I. F., & Krzyzanowska, M. K. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2008.16.5456 · Cited by 165 · see citing works
Biomedical conflicts of interest: a defence of the sequestration thesis—learning from the cases of Nancy Olivieri and David Healy
Schafer, A. (2004) · Journal of Medical Ethics · doi:10.1136/jme.2003.005702 · Cited by 161 · see citing works
Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study
Ahn, R., Woodbridge, A., Abraham, A., Saba, S., Korenstein, D., Madden, E., Boscardin, W., & Keyhani, S. (2017) · British medical journal · doi:10.1136/bmj.i6770 · Cited by 156 · see citing works
Manufacturing Desire: The Commodification of Female Sexual Dysfunction
Fishman, J. R. (2004) · Social Studies of Science · doi:10.1177/0306312704043028 · Cited by 152 · see citing works
Good publication practice for pharmaceutical companies
Wager, E., Field, E. A., & Grossman, L. (2003) · Current Medical Research and Opinion · doi:10.1185/030079903125001767 · Cited by 148 · see citing works
Conflict of interest in orthopaedic research. An association between findings and funding in scientific presentations.
Okike, K., Kocher, M., Mehlman, C., & Bhandari, M. (2007) · Journal of Bone and Joint Surgery. American volume · doi:10.2106/jbjs.f.00994 · Cited by 141 · see citing works
Regulating academic-industrial research relationships--solving problems or stifling progress?
Stossel, T. (2005) · New England Journal of Medicine · doi:10.1056/nejmsb051758 · Cited by 141 · see citing works
Reporting financial conflicts of interest and relationships between investigators and research sponsors.
Deangelis, C., Fontanarosa, P., & Flanagin, A. (2001) · Journal of the American Medical Association (JAMA) · doi:10.1001/jama.286.1.89 · Cited by 140 · see citing works
Assessing faculty financial relationships with industry: A case study.
Boyd, E. A., & Bero, L. (2000) · Journal of the American Medical Association (JAMA) · doi:10.1001/jama.284.17.2209 · Cited by 139 · see citing works
“In addition to the effects that corporate sponsorship might have on design, outcome, or publication of results, concern exists that a growing number of faculty researchers also have personal financial relationships with the companies sponsoring their research.(16,17) In 1996, Krimsky et al(18) Author Affiliations: Cen…”
Background
The impact of disclosing financial ties in research and clinical care: a systematic review.
Licurse, A. M., Barber, E., Joffe, S., & Gross, C. (2010) · Archives of Internal Medicine · doi:10.1001/archinternmed.2010.39 · Cited by 136 · see citing works
Academic Medical Centers' Standards for Clinical-Trial Agreements with Industry
Mello, M. M., Clarridge, B. R., & Studdert, D. M. (2005) · New England Journal of Medicine · doi:10.1056/nejmsa044115 · Cited by 132 · see citing works
Another view of therapy for cognition in schizophrenia.
Carpenter, W., & Gold, J. (2002) · Biological Psychiatry · doi:10.1016/s0006-3223(02)01399-9 · Cited by 131 · see citing works
Alteplase for stroke: money and optimistic claims buttress the “brain attack” campaignCommentary: Who pays the guideline writers?Commentary: Thrombolysis in stroke: it works!
Lenzer, J., Warlow, C., Saver, J. L., Kidwell, C. S., & Starkman, S. (2002) · BMJ · doi:10.1136/bmj.324.7339.723 · Cited by 111 · see citing works
Public values and public failure in US science policy
Bozeman, B., & Sarewitz, D. (2005) · Science and Public Policy · doi:10.3152/147154305781779588 · Cited by 127 · see citing works
“Bodenheimer (2000) catalogued a variety of ways in which a drug test can be carried out to favor one result or another without rendering the data itself invalid.”
Background
Industry-sponsored clinical research: a double-edged sword.
Montaner, J., O'Shaughnessy, M., & Schechter, M. (2001) · The Lancet · doi:10.1016/s0140-6736(01)06891-x · Cited by 125 · see citing works
European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications
Jacobs, A., & Wager, E. (2005) · Current Medical Research and Opinion · doi:10.1185/030079905x25578 · Cited by 124 · see citing works
Association between pharmaceutical involvement and outcomes in breast cancer clinical trials.
Peppercorn, J., Blood, E., Winer, E., & Partridge, A. (2007) · Cancer · doi:10.1002/cncr.22528 · Cited by 123 · see citing works
“Journal J Clin Oncol 48 (34) 14 (31) 13 (33) 21 (38) Ann Oncol 23 (16) 8 (18) 5 (13) 10 (18) Breast Cancer Res Treat 18 (13) 4 (9) 6 (15) 8 (14) Cancer 16 (11) 3 (7) 7 (18) 6 (11) Eur J Cancer 16 (11) 8 (18) 2 (5) 6 (11) Br J Cancer 10 (7) 4 (9) 3 (8) 3 (5) J Natl Cancer Inst 3 (2) 1 (2) 1 (3) 1 (2) Lancet, JAMA, N En…”
Protecting the Navajo people through tribal regulation of research
Brugge, D., & Missaghian, M. (2006) · Science and Engineering Ethics · doi:10.1007/s11948-006-0047-2 · Cited by 122 · see citing works
PhysicianIndustry Relations. Part 1: Individual Physicians
Coyle, S. (2002) · Annals of Internal Medicine · doi:10.7326/0003-4819-136-5-200203050-00014 · Cited by 122 · see citing works
“In particular, physicians invited to join “postmarketing studies” that require the prescribing of a company’s product need to consider the scientific validity of the research and its potential to enhance medical progress (44, 50, 51).”
Industry Sponsorship and Authorship of Clinical Trials Over 20 Years
Buchkowsky, S., & Jewesson, P. (2004) · The Annals of Pharmacotherapy · doi:10.1345/aph.1d267 · Cited by 121 · see citing works
Industry Funding of Clinical Trials: Benefit or Bias?
Chopra, S. S. (2003) · JAMA · doi:10.1001/jama.290.1.113 · Cited by 127 · see citing works
Ethical perspectives on pharmacogenomic profiling in the drug development process
Issa, A. (2002) · Nature reviews. Drug discovery · doi:10.1038/nrd771 · Cited by 119 · see citing works
The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review
Sun, X., Briel, M., Busse, J. W., You, J. J., Akl, E. A., Mejza, F., Bała, M. M., Bassler, D., Mertz, D., Diaz-Granados, N., et al. (2011) · BMJ · doi:10.1136/bmj.d1569 · Cited by 98 · see citing works
Potential research participants’ views regarding researcher and institutional financial conflicts of interest
Kim, S. Y. H., Millard, R., Nisbet, P. A., Cox, C., & Caine, E. (2004) · Journal of Medical Ethics · doi:10.1136/jme.2002.001461 · Cited by 109 · see citing works
Ten‐Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs
Khan, M., Shahid, I., Siddiqi, T., Khan, S. U., Warraich, H. J., Greene, S., Butler, J., & Michos, E. (2020) · Journal of the American Heart Association : Cardiovascular and Cerebrovascular Disease · doi:10.1161/jaha.119.015594 · Cited by 108 · see citing works
Funding source, trial outcome and reporting quality: are they related? Results of a pilot study
Clifford, T., Barrowman, N., & Moher, D. (2002) · BMC Health Services Research · doi:10.1186/1472-6963-2-18 · Cited by 108 · see citing works
“For example, in the United States, approximately 70% of clinical drug trials are now funded by industry [2].”
Background
Is the concept of informed consent applicable to clinical research involving critically ill patients?
Luce, J. (2003) · Critical Care Medicine · doi:10.1097/01.ccm.0000054901.80339.01 · Cited by 99 · see citing works
“In addition to these nonfinancial conflicts of interest, investigators have been shown increasingly in recent years to have financial conflicts of interest (36).”
Background
Financial Conflicts of Interest in Physicians' Relationships with the Pharmaceutical Industry — Self-Regulation in the Shadow of Federal Prosecution
Studdert, D., Mello, M. M., & Brennan, T. (2004) · New England Journal of Medicine · doi:10.1056/nejmlim042229 · Cited by 97 · see citing works
Alternative Medicine: A Mirror Image for Scientific Reasoning in Conventional Medicine
Vandenbroucke, J., & de Craen, A. D. (2001) · Annals of Internal Medicine · doi:10.7326/0003-4819-135-7-200110020-00010 · Cited by 97 · see citing works
Forbidden Knowledge: Public Controversy and the Production of Nonknowledge1
Kempner, J., Merz, J., & Bosk, C. (2011) · Sociological Forum · doi:10.1111/j.1573-7861.2011.01259.x · Cited by 93 · see citing works
The social and cultural shaping of medical evidence: case studies from pharmaceutical research and obstetric science.
de Vries, R., & Lemmens, T. (2006) · Social Science & Medicine (1967) · doi:10.1016/j.socscimed.2005.11.026 · Cited by 92 · see citing works
“Various authors have detailed the strengthening of industry’s grip on medical research (Angell, 2004; Bodenheimer, 2000; Krimsky, 2003; Rettig, 2000).”
BackgroundResultInfluential
Pills, Power, People: Sociological Understandings of the Pharmaceutical Industry
Busfield, J. (2006) · Sociology · doi:10.1177/0038038506062034 · Cited by 92 · see citing works
Total and cause specific mortality among Swedish women with cosmetic breast implants: prospective study
Koot, V. C., Peeters, P., Granath, F., Grobbee, D., & Nyren, O. (2003) · British medical journal · doi:10.1136/bmj.326.7388.527 · Cited by 92
In whose best interest? Breaching the academic-industrial wall.
Martin, J. B., & Kasper, D. L. (2000) · New England Journal of Medicine · doi:10.1056/nejm200011303432213 · Cited by 92
Bias in Psychiatric Diagnosis
Caplan, P., & Cosgrove, L. (2004) · doi:10.5040/9798216437000 · Cited by 92
“Researchers and, indeed, at least one editor of a major medical journal are concerned about the association between funding source and study outcome (e.g., Angell 2000; Bodenheimer 2000; Davidson 1986; Friedberg, Saffran, Stinson, Nelson, and Bennett 1999; Korn 2000).”
Background
Comparative efficacy of antipsychotics in the treatment of schizophrenia: a critical assessment.
Tandon, R., & Fleischhacker, W. (2005) · Schizophrenia Research · doi:10.1016/j.schres.2005.07.025 · Cited by 91 · see citing works
“With over 70% of the funding for clinical trials in the United States now being provided by the pharmaceutical industry and the likelihood of biased presentation of data by industry (Davidson, 1986; Bodenheimer, 2000; Angell, 2000; Davidoff et al., 2001), this issue takes on added significance.”
Background
Ethics review for sale? Conflict of interest and commercial research review boards.
Lemmens, T., & Freedman, B. (2000) · Milbank Quarterly · doi:10.1111/1468-0009.00185 · Cited by 89 · see citing works
“Academic research centers are increasingly entering into institutional relationships with some major pharmaceutical companies and may become partly dependent on them (Bodenheimer 2000).”
Background
Publication Practices and Responsible Authorship: A Review Article
Tarkang, E., Kweku, M., & Zotor, F. (2017) · Journal of Public Health in Africa · doi:10.4081/jphia.2017.723 · Cited by 85
Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health
Merrill, S. A., & Mazza, A. (2006) · doi:10.17226/11487 · Cited by 85
“For example, companies have preferred not to publish the results of studies resulting in less-than-optimal data, although academics asserted that the insights to be gained by publication would advance scientific understanding (Bodenheimer, 2000).”
Background
Ethical issues concerning the relationships between medical practitioners and the pharmaceutical industry
Komesaroff, P. A., & Kerridge, I. (2002) · Medical Journal of Australia · doi:10.5694/j.1326-5377.2002.tb04318.x · Cited by 84 · see citing works
Extent and impact of industry sponsorship conflicts of interest in dermatology research.
Perlis, C., Harwood, M., & Perlis, R. (2005) · Journal of American Academy of Dermatology · doi:10.1016/j.jaad.2005.01.020 · Cited by 83 · see citing works
Financial Conflict-of-Interest Policies in Clinical Research
Boyd, E. A., Cho, M. K., & Bero, L. A. (2003) · Academic Medicine · doi:10.1097/00001888-200308000-00002 · Cited by 81 · see citing works
“However, growing evidence suggests that close financial ties between industry sponsors and clinical investigators may influence the quality and outcome of clinical studies.(3,4) Furthermore, these relationships may undermine the public’s trust of clinical research.”
Background
Risk perception, risk communication, and stakeholder involvement for biosolids management and research.
Beecher, N., Harrison, E., Goldstein, N., Mcdaniel, M., Field, P., & Susskind, L. (2005) · Journal of Environmental Quality · doi:10.2134/jeq2005.0122a · Cited by 82 · see citing works
“The interest in improved dialogue and collaboration significant predictor of research outcome (Bodenheimer, 2000; Cho and Bero, 1996; Friedberg et al., 1999; with the public is also extending into research on contentious aspects of biosolids management. The Water Envi- van Kolfschooten, 2002).”
Background
Health-related quality of life in non-small-cell lung cancer: methodologic issues in randomized controlled trials.
Bottomley, A., Efficace, F., Thomas, R., Vanvoorden, V., & Ahmedzai, S. (2003) · Journal of Clinical Oncology · doi:10.1200/jco.2003.01.203 · Cited by 82 · see citing works
Association of funding and findings of pharmaceutical research at a meeting of a medical professional society.
Finucane, T., & Boult, C. (2004) · American Journal of Medicine · doi:10.1016/j.amjmed.2004.05.029 · Cited by 76 · see citing works
Beyond the medical model of women's sexual problems: A campaign to resist the promotion of 'female sexual dysfunction'
Tiefer, L. (2002) · Sexual & Relationship Therapy · doi:10.1080/14681990220121248 · Cited by 75 · see citing works
“The pharmaceutical industry has ‘partnered’ with many in academia and academic medicine during this period, to the point where partnership is slipping into dependency and resulting in increasing concern about ethics and con icts of interest (Bodenheimer, 2000; Korn, 2000; Relman, 2001).”
Background
Collaboration between academics and industry in clinical trials: cross sectional study of publications and survey of lead academic authors
Rasmussen, K., Bero, L., Redberg, R., Gøtzsche, P. C., & Lundh, A. (2018) · BMJ · doi:10.1136/bmj.k3654 · Cited by 74 · see citing works
Effectiveness of oseltamivir in adults: a meta-analysis of published and unpublished clinical trials.
Ebell, M., Call, M., & Shinholser, J. (2013) · Family Practice · doi:10.1093/fampra/cms059 · Cited by 74 · see citing works
Influence of drug company authorship and sponsorship on drug trial outcomes.
Tungaraza, T. E., & Poole, R. (2007) · The British journal of psychiatry : the journal of mental science · doi:10.1192/bjp.bp.106.024547 · Cited by 73 · see citing works
Challenges in Systematic Reviews of Therapeutic Devices and Procedures
Hartling, L., McAlister, F. A., Rowe, B. H., Ezekowitz, J., Friesen, C., & Klassen, T. P. (2005) · Annals of Internal Medicine · doi:10.7326/0003-4819-142-12_part_2-200506211-00010 · Cited by 69 · see citing works
“Third, we believe that readers should be skeptical about unpublished data if the data are provided directly by the manufacturer of the device without the opportunity for peer review (22).”
Background
Authors' reports about research integrity problems in clinical trials
Gardner, W., Lidz, C. W., & Hartwig, K. C. (2005) · Contemporary Clinical Trials · doi:10.1016/j.cct.2004.11.013 · Cited by 69 · see citing works
BiDil: Assessing a Race-Based Pharmaceutical
Brody, H., & Hunt, L. M. (2006) · The Annals of Family Medicine · doi:10.1370/afm.582 · Cited by 75 · see citing works
Psychology in the prescription era: building a firewall between marketing and science.
Antonuccio, D., Danton, W., & McClanahan, T. M. (2003) · American Psychologist · doi:10.1037/0003-066x.58.12.1028 · Cited by 69 · see citing works
“…effects, (f) funding only those research projects that have a high likelihood of producing favorable results for a particular drug company’s product (see Bodenheimer, 2000), (g) terminating negative studies before they are ready for publication, (h) involving large numbers of physicians in…”
BackgroundInfluential
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Barden, J., Derry, S., McQuay, H., & Moore, A. (2006) · Pain · doi:10.1016/j.pain.2005.12.011 · Cited by 68 · see citing works
“In recent years, an additional potential bias has been suggested, that of bias associated with trial funding (Bodenheimer, 2000; Bekelman et al., 2003; Lexchin et al., 2003).”
Background
Evidence-based practices in geriatric mental health care: an overview of systematic reviews and meta-analyses.
Bartels, S., Dums, A. R., Oxman, T., Schneider, L., Areán, P., Alexopoulos, G., & Jeste, D. (2003) · Psychiatric Clinics of North America · doi:10.1016/s0193-953x(03)00072-8 · Cited by 62 · see citing works
“Seventy percent of the funding for clinical drug trials conducted in the United States is procured from industry [96], presenting the possibility of bias in study design and in reporting of findings.”
Background
Financial Conflicts of Interest
Lopez, J., Lopez, S., Means, J. J., Mohan, R., Soni, A., Milton, J. N., Tufaro, A. P., May, J. W., & Dorafshar, A. H. (2015) · Plastic & Reconstructive Surgery · doi:10.1097/prs.0000000000001718 · Cited by 65 · see citing works
Evidence-based medicine and women: do the principles and practice of EBM further women's health?
Rogers, W. (2004) · Bioethics · doi:10.1111/j.1467-8519.2004.00378.x · Cited by 60
Antidepressants: A triumph of marketing over science?
Antonuccio, D., Burns, D. D., & Danton, W. (2002) · Prevention & Treatment · doi:10.1037/1522-3736.5.1.525c · Cited by 60 · see citing works
Neodymium‐doped yttrium aluminium garnet (Nd:YAG) 1064‐nm picosecond laser vs. Nd:YAG 1064‐nm nanosecond laser in tattoo removal: a randomized controlled single‐blind clinical trial
Pinto, F., Große-Büning, S., Karsai, S., Weiss, C., Bäumler, W., Hammes, S., Felcht, M., & Raulin, C. (2017) · British Journal of Dermatology · doi:10.1111/bjd.14962 · Cited by 59
Research ethics III: Publication practices and authorship, conflicts of interest, and research misconduct.
Horner, J., & Minifie, F. (2011) · Journal of Speech, Language and Hearing Research · doi:10.1044/1092-4388(2010/09-0263 · Cited by 59 · see citing works
The effect of conflict of interest on biomedical research and clinical practice guidelines: can we trust the evidence in evidence-based medicine?
Abramson, J., & Starfield, B. (2005) · The Journal of the American Board of Family Practice · doi:10.3122/jabfm.18.5.414 · Cited by 57 · see citing works
“However, the drug companies typically retain control over the data from their sponsored trials so the majority of the researchers don’t have open access to the results from their own studies.(8,10) The editors, peer reviewers, and editorial writers who are trusted to evaluate the accuracy of the analyses are thus ofte…”
Background
Implications of Pharmaceutical Industry Funding on Clinical Research
Lexchin, J. (2005) · The Annals of Pharmacotherapy · doi:10.1345/aph.1e224 · Cited by 56 · see citing works
CHARACTERISTICS OF DRUG COMBINATION THERAPY IN ONCOLOGY BY ANALYZING CLINICAL TRIAL DATA ON CLINICALTRIALS.GOV
Wu, M., Sirota, M., Butte, A., & Chen, B. (2014) · Pacific Symposium on Biocomputing · doi:10.1142/9789814644730_0008 · Cited by 55 · see citing works
“Another possible explanation is that industry and academia are increasingly linked, and conflicts of interest may exist [19-21].”
Background
Enrollment of Patients With Lung and Colorectal Cancers Onto Clinical Trials
Fouad, M. N., Lee, J. Y., Catalano, P. J., VOGT, T. M., Zafar, S. Y., West, D. W., Simon, C., Klabunde, C. N., Kahn, K. L., Weeks, J. C., et al. (2013) · Journal of Oncology Practice · doi:10.1200/jop.2012.000598 · Cited by 66 · see citing works
Conflict of interest policies and disclosure requirements among European Society of Cardiology national cardiovascular journals
Alfonso, F., Timmis, A., Pinto, F., Ambrosio, G., Ector, H., Kulakowski, P., Vardas, P., Antoniades, L., Ahmad, M., Apetrei, E., et al. (2011) · Heart · doi:10.1007/s12471-012-0277-7 · Cited by 54 · see citing works
Medical specialists and pharmaceutical industry‐sponsored research: a survey of the Australian experience
Henry, D., Kerridge, I., Hill, S., McNeill, P., Doran, E., Newby, D. A., Henderson, K., Maguire, J., Stokes, B., Macdonald, G., et al. (2005) · Medical Journal of Australia · doi:10.5694/j.1326-5377.2005.tb06813.x · Cited by 54 · see citing works
Seeking evidence from medical research consumers as part of the medical research process could improve the uptake of research evidence.
Whitstock, M. T. (2003) · Journal of Evaluation In Clinical Practice · doi:10.1046/j.1365-2753.2003.00376.x · Cited by 54 · see citing works

Authors: Bodenheimer, T.
Corresponding author: Bodenheimer, Thomas
ORCID: Bodenheimer, Thomas
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2000-05-18
Volume: 342
Issue: 20
Pages: 1539-1544
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejm200005183422024
OpenAlex: W2337821671
Cited by: 765
References: 0
Citations by year: 2026: 2 · 2025: 2 · 2024: 4 · 2023: 8 · 2022: 10 · 2021: 10 · 2020: 17 · 2019: 11 · 2018: 14 · 2017: 18 · 2016: 11 · 2015: 14 · 2014: 20 · 2013: 31 · 2012: 34
FWCI: 51.34
Type: journal article
Language: en
Open access: closed
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
DigitalGeorgetown (Georgetown University Library) (submittedVersion)
Topics: Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
Keywords: clinical investigators, pharmaceutical industry, contract research organizations, academic medical centers, clinical trials, conflicts of interest, drug development
MeSH terms: Academic Medical Centers, Authorship, Clinical Trials as Topic, Drug Evaluation, Drug Industry, Interinstitutional Relations, Publishing, Research Support as Topic, Social Change, United States, United States Food and Drug Administration, Conflict of Interest, Drug Approval, Disclosure, Contracts, Biomedical Research

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Uneasy alliance—clinical investigators and the pharmaceutical industry

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