Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints
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{"title"=>"Strategies and practices in off-label marketing of pharmaceuticals: A retrospective analysis of whistleblower complaints", "type"=>"generic", "authors"=>[{"first_name"=>"Aaron S.", "last_name"=>"Kesselheim", "scopus_author_id"=>"6506525459"}, {"first_name"=>"Michelle M.", "last_name"=>"Mello", "scopus_author_id"=>"7102957738"}, {"first_name"=>"David M.", "last_name"=>"Studdert", "scopus_author_id"=>"7006304855"}], "year"=>2011, "source"=>"PLoS Medicine", "identifiers"=>{"issn"=>"15491277", "scopus"=>"2-s2.0-79955451265", "sgr"=>"79955451265", "pui"=>"361688659", "isbn"=>"1549-1676; 1549-1277", "pmid"=>"21483716", "doi"=>"10.1371/journal.pmed.1000431"}, "id"=>"0597e234-f407-390d-b5ff-fac36e052f6e", "abstract"=>"BACKGROUND: Despite 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.\\n\\nMETHODS AND FINDINGS: We 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%).\\n\\nCONCLUSIONS: Off-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.", "link"=>"http://www.mendeley.com/research/strategies-practices-offlabel-marketing-pharmaceuticals-retrospective-analysis-whistleblower-complai", "reader_count"=>69, "reader_count_by_academic_status"=>{"Unspecified"=>3, "Professor > Associate Professor"=>8, "Student > Doctoral Student"=>7, "Researcher"=>12, "Student > Ph. D. Student"=>7, "Student > Postgraduate"=>6, "Other"=>8, "Student > Master"=>9, "Student > Bachelor"=>6, "Lecturer"=>3}, "reader_count_by_user_role"=>{"Unspecified"=>3, "Professor > Associate Professor"=>8, "Student > Doctoral Student"=>7, "Researcher"=>12, "Student > Ph. D. Student"=>7, "Student > Postgraduate"=>6, "Other"=>8, "Student > Master"=>9, "Student > Bachelor"=>6, "Lecturer"=>3}, "reader_count_by_subject_area"=>{"Unspecified"=>4, "Biochemistry, Genetics and Molecular Biology"=>2, "Medicine and Dentistry"=>31, "Agricultural and Biological Sciences"=>5, "Arts and Humanities"=>1, "Business, Management and Accounting"=>4, "Pharmacology, Toxicology and Pharmaceutical Science"=>3, "Psychology"=>4, "Chemistry"=>3, "Social Sciences"=>9, "Computer Science"=>1, "Economics, Econometrics and Finance"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>31}, "Chemistry"=>{"Chemistry"=>3}, "Social Sciences"=>{"Social Sciences"=>9}, "Psychology"=>{"Psychology"=>4}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>5}, "Computer Science"=>{"Computer Science"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>4}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>2}, "Unspecified"=>{"Unspecified"=>4}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>3}, "Arts and Humanities"=>{"Arts and Humanities"=>1}}, "reader_count_by_country"=>{"Greece"=>1, "United States"=>3, "United Kingdom"=>2, "Malaysia"=>1, "France"=>1}, "group_count"=>3}

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  • {"unique-ip"=>"28", "full-text"=>"29", "pdf"=>"3", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"9"}
  • {"unique-ip"=>"40", "full-text"=>"42", "pdf"=>"8", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"10"}
  • {"unique-ip"=>"51", "full-text"=>"54", "pdf"=>"4", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"11"}
  • {"unique-ip"=>"35", "full-text"=>"37", "pdf"=>"2", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2018", "month"=>"12"}
  • {"unique-ip"=>"27", "full-text"=>"28", "pdf"=>"5", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"2"}
  • {"unique-ip"=>"28", "full-text"=>"33", "pdf"=>"8", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"3"}
  • {"unique-ip"=>"40", "full-text"=>"58", "pdf"=>"4", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"4"}

Relative Metric

{"start_date"=>"2011-01-01T00:00:00Z", "end_date"=>"2011-12-31T00:00:00Z", "subject_areas"=>[{"subject_area"=>"/Medicine and health sciences/Health care", "average_usage"=>[337, 676, 827, 964, 1066, 1171, 1267, 1396, 1503, 1580, 1663, 1758, 1822, 1887, 1968, 2037, 2107, 2173, 2246, 2357, 2419, 2488, 2576, 2637, 2724, 2815, 2887, 2956, 3034, 3111, 3174, 3245, 3294, 3357, 3404, 3464, 3529]}, {"subject_area"=>"/People and places/Population groupings", "average_usage"=>[344, 630, 756, 876, 981, 1083, 1179, 1272, 1346, 1421, 1508, 1583, 1659, 1744, 1809, 1891, 1954, 2030, 2105, 2174, 2247, 2324, 2386, 2441, 2502, 2557, 2621, 2685, 2753, 2825, 2882, 2935, 2989, 3052, 3117, 3181, 3242]}]}
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