Medical Marketing in the United States, 1997-2016
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Clinical Review & Education JAMA | Special Communication Medical Marketing in the United States, 1997-2016 Lisa M. Schwartz, MD, MS; Steven Woloshin, MD, MS Editorial pages 40 and 42 and IMPORTANCE Manufacturers, companies, and health care professionals and organizations use Editor's Note page 96 an array of promotional activities to sell and increase market share of their products and Supplemental content services. These activities seek to shape public and clinician beliefs about laboratory testing, CME Quiz at the benefits and harms of prescription drugs, and some disease definitions. jamanetwork.com/learning OBJECTIVE To review the marketing of prescription drugs, disease awareness campaigns, health services, and laboratory tests and the related consequences and regulation in the United States over a 20-year period (1997-2016). EVIDENCE Analysis (1997-2016) of consumer advertising (Kantar Media data for spending and number of ads); professional marketing (IQVIA Institute for Human Data Science, Open Payments Data [Centers for Medicare & Medicaid Services]); regulations and legal actions of the US Food and Drug Administration (FDA), Federal Trade Commission (FTC), state attorneys general, and US Department of Justice; and searches (1975-2018) of peer-reviewed medical literature (PubMed), business journals (Business Source Ultimate), and news media (Lexis Nexis) for articles about expenditures, content, and consequences and regulation of consumer and professional medical marketing. Spending is reported in 2016 dollars. FINDINGS From 1997 through 2016, spending on medical marketing of drugs, disease awareness campaigns, health services, and laboratory testing increased from $17.7 to $29.9 billion. The most rapid increase was in direct-to-consumer (DTC) advertising, which increased from $2.1 billion (11.9%) of total spending in 1997 to $9.6 billion (32.0%) of total spending in 2016. DTC prescription drug advertising increased from $1.3 billion (79 000 ads) to $6 billion (4.6 million ads [including 663 000 TV commercials]), with a shift toward advertising high-cost biologics and cancer immunotherapies. Pharmaceutical companies increased DTC marketing about diseases treated by their drugs with increases in disease awareness campaigns from 44 to 401 and in spending from $177 million to $430 million. DTC advertising for health services increased from $542 million to $2.9 billion, with the largest spending increases by hospitals, dental centers, cancer centers, mental health and addiction clinics, and medical services (eg, home health). DTC spending on advertising for laboratory tests (such as genetic testing) increased from $75.4 million to $82.6 million, although the number of ads increased more substantially (from 14 100 to 255 300), reflecting an increase in less expensive electronic media advertising. Marketing to health care professionals by pharmaceutical companies accounted for most promotional spending and increased from $15.6 billion to $20.3 billion, including $5.6 billion for prescriber detailing, $13.5 billion for free samples, $979 million for direct physician payments (eg, speaking fees, meals) related to specific drugs, and $59 million for disease education. Manufacturers of FDA-approved laboratory tests paid $12.9 million to professionals in 2016. From 1997 through 2016, the number of consumer and professional drug promotional materials that companies submitted for FDA review increased from 34 182 to 97 252, while FDA violation letters for misleading drug marketing decreased from 156 to 11. Since 1997, 103 financial settlements between drug companies and federal and state governments resulted in more than $11 billion in fines for off-label or deceptive marketing practices. The FTC has acted against misleading marketing by a single for-profit cancer center. Author Affiliations: The Center for Medicine in the Media, Dartmouth Institute for Health Policy and Clinical CONCLUSIONS AND RELEVANCE Medical marketing increased substantially from 1997 through Practice, Lebanon, New Hampshire. 2016, especially DTC advertising for prescription drugs and health services. Pharmaceutical Corresponding Author: Steven marketing to health professionals accounted for most spending and remains high even with Woloshin, MD, MS, Dartmouth new policies to limit industry influence. Despite the increase in marketing over 20 years, Institute for Health Policy and Clinical regulatory oversight remains limited. Practice, Geisel School of Medicine at Dartmouth, 1 Medical Center Dr, WRTB, Level 5, Lebanon, NH 03756 JAMA. 2019;321(1):80-96. doi:10.1001/jama.2018.19320 ([email protected]). 80 (Reprinted) jama.com © 2019 American Medical Association. All rights reserved. Downloaded From: on 01/09/2019 Medical Marketing in the United States, 1997-2016 Special Communication Clinical Review & Education ealth care spending in the United States is the highest in the world, totaling $3.3 trillion—17.8% of the gross Key Points domestic product in 2016.1 To capture market share H Question How has the marketing of prescription drugs, disease and to expand the potential market, drug manufacturers, compa- awareness, health services, and laboratory tests in the United nies that manufacture clinical and home-based laboratory tests, States changed from 1997 through 2016? and health care organizations use an array of promotional activi- Findings From 1997 through 2016, medical marketing expanded ties to sell their products and services. These activities seek to substantially, and spending increased from $17.7 to $29.9 billion, shape public and clinician perceptions about the benefits and with direct-to-consumer advertising for prescription drugs and harms of health care, prescription drugs, laboratory tests, and health services accounting for the most rapid growth, and specific diseases and their definitions. Medical marketing influ- pharmaceutical marketing to health professionals accounting for ences behaviors and choices that can have important health con- most promotional spending. sequences and also may adversely influence efforts to control Meaning There has been marked growth in expenditures on and unsustainable health care spending. extent of medical marketing in the United States from 1997 The marketing of medicine involves a complex interaction in- through 2016. volving industry, organizations, and individuals involved in health care. Pharmaceutical and device manufacturers target health care professionals and health care organizations, and these companies, Marketing to Professionals along with those that manufacture other clinical products and con- Annual professional drug promotion data (medical journal adver- sumer-based products, target various health care organizations and tising, detailing, and free samples) from 1997 through 2016 were ob- audiences to generate sales directly (such as with marketing to- tained from IQVIA Institute for Human Data Science. Because dis- ward consumers, clinicians, pharmacy benefit managers, insurers, ease and drug promotion cannot be distinguished, all spending was and employers) and indirectly (by funding patient advocacy orga- counted toward drug promotion because these products likely rep- nizations and opinion leaders who in turn generate interest in drugs, resent the majority of spending. devices, testing, and other services). Physician and teaching hospital nonresearch payments were This Special Communication reviews marketing of prescrip- determined using the Open Payments 2016 general payment data tion drugs, disease awareness campaigns, health services, and labo- set, excluding nonmarketing payments (royalties, and licenses). ratory tests to consumers and professionals, and examines the con- These data were not available for 1997. Company websites sequences and regulation of medical marketing in the United States and products associated with payments (when available) were over a 20-year period, from 1997 through 2016. used to identify pharmaceutical and laboratory test manufactur- ers. Consistent with company explanations,3 only payments for speaker fees, honoraria, and education not related to a specific drug Methods (ie, unbranded disease education) were counted toward disease awareness marketing. Direct-to-consumer (DTC) and professional medical marketing for prescription drugs, disease awareness campaigns, health ser- Regulatory Oversight of Medical Marketing vices, and laboratory tests in the United States from 1997 through Todetermine regulatory and legal actions, the US Food and Drug Ad- 2016 were analyzed. Prescription drug marketing included DTC ministration (FDA), the Federal Trade Commission (FTC), and all state and professional branded advertising, detailing visits, free drug attorneys general websites were searched, and staff were con- samples, direct physician and hospital payments (eg, speaker tacted by phone and email at the FDA Office of Prescription Drug fees, food, travel); disease awareness marketing included Promotion (OPDP) and Center for Devices and Radiologic Health unbranded DTC advertising and direct physician and hospital pay- [which regulates laboratory testing]), the FTC Bureau of Consumer ments for disease education; health services included DTC adver- Protection, and Public Citizen (which provided data from its analy- tising for hospitals, clinics, practices and services such as home ses of major financial settlements between drug companies and fed- health care; and laboratory testing included DTC advertising for eral and state governments). commercial tests