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

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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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“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
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Influence of drug company authorship and sponsorship on drug trial outcomes.
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“Third, we believe that readers should be skeptical about unpublished data if the data are provided directly by the manufacturer of the device without the opportunity for peer review (22).”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
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“…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
Bias from industry trial funding? A framework, a suggested approach, and a negative result
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“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.
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“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
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Implications of Pharmaceutical Industry Funding on Clinical Research
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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: Health Sciences › Nursing › Issues, ethics and legal aspects › 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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