ArticlePLoS medicine2011
Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints.
Article in PLoS medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 2 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
31 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Medical students' exposure to and attitudes about the pharmaceutical industry: a systematic review.PLoS medicine · 2011Pooled it
- Changing interactions between physician trainees and the pharmaceutical industry: a national survey.Journal of general internal medicine · 2013Trial
- Trends and off-label utilization of antipsychotics in children and adolescents from 2016 to 2021 in China: a real-world study.Child and adolescent psychiatry and mental health · 2024Article
- What did the scientific literature learn from internal company documents in the pharmaceutical industry? A scoping review.Cochrane evidence synthesis and methods · 2023Review
- Off-Label Use vs Off-Label Marketing: Part 2: Off-Label Marketing-Consequences for Patients, Clinicians, and Researchers.JACC. Basic to translational science · 2023Article
- Policing the promotion of prescription medicines - the new Medicines Australia Code of Conduct.Australian prescriber · 2021Article
- Policies and Practices Catalyzing the Use of Generic Medicines: A Systematic Search and Review.Ethiopian journal of health sciences · 2021Review
- Combatting Antibiotic Resistance Together: How Can We Enlist the Help of Industry?Antibiotics (Basel, Switzerland) · 2018Article
- Pharmaceutical lobbying and pandemic stockpiling of Tamiflu: a qualitative study of arguments and tactics.Journal of public health (Oxford, England) · 2018Article
- Cannabis regulatory science: risk-benefit considerations for mental disorders.International review of psychiatry (Abingdon, England) · 2018Review
- Unhealthy marketing of pharmaceutical products: An international public health concern.Journal of public health policy · 2016Article
- Physicians-Pharmaceutical Sales Representatives Interactions and Conflict of Interest: Challenges and Solutions.Inquiry : a journal of medical care organization, provision and financing · 2016Article
- Article
- Improving regulatory capacity to manage risks associated with trade agreements.Globalization and health · 2015Article
- Article
- Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities.Journal of pharmacology & pharmacotherapeutics · 2014Article
- [Medical students and drug marketing].Atencion primaria · 2014Article
- Antipsychotic prescription in children and adolescents: an analysis of data from a German statutory health insurance company from 2005 to 2012.Deutsches Arzteblatt international · 2014Article
- Content analysis of false and misleading claims in television advertising for prescription and nonprescription drugs.Journal of general internal medicine · 2014Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
backgroundDespite regulatory restrictions, off-label marketing of pharmaceutical products has been common in the US. However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing. METHODS AND
findingsWe obtained unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing (January 1996-October 2010) and conducted structured reviews of them. We coded and analyzed the strategic goals of each off-label marketing scheme and the practices used to achieve those goals, as reported by the whistleblowers. We identified 41 complaints arising from 18 unique cases for our analytic sample (leading to US$7.9 billion in recoveries). The off-label marketing schemes described in the complaints had three non-mutually exclusive goals: expansions to unapproved diseases (35/41, 85%), unapproved disease subtypes (22/41, 54%), and unapproved drug doses (14/41, 34%). Manufacturers were alleged to have pursued these goals using four non-mutually exclusive types of marketing practices: prescriber-related (41/41, 100%), business-related (37/41, 90%), payer-related (23/41, 56%), and consumer-related (18/41, 44%). Prescriber-related practices, the centerpiece of company strategies, included self-serving presentations of the literature (31/41, 76%), free samples (8/41, 20%), direct financial incentives to physicians (35/41, 85%), and teaching (22/41, 54%) and research activities (8/41, 20%).
conclusionsOff-label marketing practices appear to extend to many areas of the health care system. Unfortunately, the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches.
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