The Center for Medicine in the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire.
JAMA. 2019 Jan 1;321(1):80-96. doi: 10.1001/jama.2018.19320.
Manufacturers, companies, and health care professionals and organizations use an array of promotional activities to sell and increase market share of their products and services. These activities seek to shape public and clinician beliefs about laboratory testing, the benefits and harms of prescription drugs, and some disease definitions.
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).
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.
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.
Medical marketing increased substantially from 1997 through 2016, especially DTC advertising for prescription drugs and health services. Pharmaceutical marketing to health professionals accounted for most spending and remains high even with new policies to limit industry influence. Despite the increase in marketing over 20 years, regulatory oversight remains limited.
制造商、公司和医疗保健专业人员和组织利用各种促销活动来销售和增加其产品和服务的市场份额。这些活动旨在影响公众和临床医生对实验室检测、处方药的益处和危害以及某些疾病定义的看法。
回顾美国 20 年来(1997-2016 年)处方药、疾病意识活动、卫生服务和实验室检测的营销以及相关后果和监管情况。
分析(1997-2016 年)消费广告(Kantar Media 的支出和广告数量数据);专业营销(IQVIA Institute for Human Data Science、Open Payments Data [Centers for Medicare & Medicaid Services]);美国食品和药物管理局(FDA)、联邦贸易委员会(FTC)、州检察长和美国司法部的监管和法律行动;以及对同行评议的医学文献(PubMed)、商业期刊(Business Source Ultimate)和新闻媒体(Lexis Nexis)进行的搜索(1975-2018 年),以获取有关消费和专业医疗营销的支出、内容和后果和监管的文章。支出以 2016 年美元计。
从 1997 年到 2016 年,药品、疾病意识活动、卫生服务和实验室检测的医疗营销支出从 17.7 亿美元增加到 299 亿美元。增长最快的是直接面向消费者(DTC)广告,从 1997 年的总支出的 11.9%(2.1 亿美元)增加到 2016 年的总支出的 32.0%(9.6 亿美元)。DTC 处方药广告从 1.3 亿美元(79000 则广告)增加到 60 亿美元(460 万则广告[包括 663000 则电视广告]),广告重点转向高成本生物制剂和癌症免疫疗法。制药公司增加了 DTC 对其药物治疗疾病的营销,疾病意识活动从 44 次增加到 401 次,支出从 1.77 亿美元增加到 4.3 亿美元。DTC 对健康服务的广告从 5.42 亿美元增加到 29 亿美元,其中最大的支出增长来自医院、牙科中心、癌症中心、精神健康和成瘾诊所以及医疗服务(如家庭健康)。DTC 对实验室检测(如基因检测)广告的支出从 7540 万美元增加到 8260 万美元,尽管广告数量增加更多(从 14100 则增加到 255300 则),反映出较便宜的电子媒体广告的增加。制药公司向医疗保健专业人员进行营销占促销支出的大部分,从 1560 亿美元增加到 2030 亿美元,其中包括 56 亿美元的处方细节,135 亿美元的免费样品,9.79 亿美元与特定药物相关的直接医生付款(如演讲费、餐费),以及 5900 万美元的疾病教育。经 FDA 批准的实验室检测制造商在 2016 年向专业人员支付了 1290 万美元。从 1997 年到 2016 年,公司提交给 FDA 审查的消费者和专业药物促销材料数量从 34182 份增加到 97252 份,而 FDA 因误导性药物营销而发出的违规信件从 156 封减少到 11 封。自 1997 年以来,制药公司与联邦和州政府之间达成了 103 项财务和解协议,罚款超过 110 亿美元,用于非标签或欺骗性营销行为。联邦贸易委员会已对一家营利性癌症中心的误导性营销采取了行动。
从 1997 年到 2016 年,医疗营销大幅增加,特别是处方药和健康服务的 DTC 广告。制药公司向医疗保健专业人员的营销支出占最大份额,即使有新政策限制行业影响力,支出仍然很高。尽管在 20 年的时间里增加了营销,但监管监督仍然有限。