Spending on medical marketing has increased by nearly 70% during the past 20 years, driven largely by aggressive marketing to medical professionals and a rapid rise in direct-to-consumer (DTC) advertising of drugs and health services, new data show.
The dramatic jump, which reflects an increasingly consumer-focused landscape, has not been accompanied by a comparable increase in regulatory oversight, according to researchers from the Center for Medicine in the Media in the Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire.
In an article by the late Lisa M. Schwartz, MD, and Steven Woloshin, MD, published online January 8 in JAMA, the marketing of prescription drugs, disease awareness campaigns, health services, and laboratory tests to consumers and professionals from 1997 to 2016 are reviewed. The consequences and regulation of medical marketing in the United States are also examined.
The topic "affects every physician and patient, and virtually every for-profit entity (and many not-for-profit organizations) involved with the US health care system," JAMA Editor-in-Chief Howard Bauchner, MD, and JAMA Executive Editor Phil B. Fontanarosa, MD, write in an accompanying editorial.
"This report should serve to raise awareness about the extent of, investment in, and potential influence of medical marketing and will serve as a valuable benchmark for years to come," they continue.
For their review of marketing practices and expenditures, the researchers analyzed data from a media monitoring service, the IQVIA Institute for Human Data Science, the Centers for Medicare & Medicaid Services' Open Payments database, and studies identified through a literature search. To evaluate regulatory oversight, they relied on information from local, state, and federal resources, including the US Food and Drug Administration (FDA), the Federal Trade Commission (FTC), all state attorneys general websites, the FDA Office of Prescription Drug Promotion (OPDP), the Center for Devices and Radiologic Health, the FTC Bureau of Consumer Protection, and Public Citizen.
Through their analysis, the researchers determined that from 1997 to 2016, spending on marketing of drugs, disease awareness, health services, and laboratory testing increased from $17.7 billion to $29.9 billion. The following are some of the key contributors to the growth during this period.
Spending on marketing to physicians and other healthcare professionals by pharmaceutical companies increased from $15.6 billion to $20.3 billion. Spending including $5.6 billion for prescriber detailing, $13.5 billion for free samples, $979 million for direct physician payments related to specific drugs (speaking fees, meals), and $59 million for disease education.
Overall DTC advertising expenditures increased from $2.1 billion (11.9% of total spending) to $9.6 billion (32.0% of total spending).
Spending on DTC prescription drug advertising increased from $1.3 billion (including 79,000 television commercials) to $6 billion (including 4.6 million television commercials).
Spending on DTC advertising for health services increased from $542 million to $2.9 billion.
There was a concomitant drop in spending (from $744 million to $119 million) on medical journal advertisements, a tool for reaching the professional audience, the researchers write.
On the DTC front, television became the media of choice over print advertising in the late 1990s, the authors report. Spending on TV ads, which are more costly than print advertising, increased through the early 2000s, after which there was a period of decline until 2012. There has been an increase in such spending in the years since.
During the study period, advertising expenditures rose across all therapeutic categories expect for allergy, cholesterol, and osteoporosis medications. "In each case for these 3 categories of drugs, the larger advertising campaigns in 1997 ended as top-selling products lost patent protection (statins and bisphosphonates) or became available over-the-counter (antihistamines), without replacement by equally large advertising campaigns for new drugs in the category," the authors explain.
The therapeutic categories that saw the greatest increase in advertising spending were diabetes/endocrinology (from $22 million to $725 million), dermatology (from $67 million to $605 million), pain/central nervous system (from $56 million to $542 million), arthritis (from $27 million to $484 million), cardiac diseases (from $0 to $379 million), and cancer (from $3 million to $274 million). These increases largely reflect "competition among expensive new biologics and cancer therapies," the authors write.
Marketing Changes Affect Care
The clinical implications of the marketing shift are notable, according to the authors. "DTC advertising has been associated with increased patient requests and prescriptions (despite cost-effective alternatives) and higher costs through more patient visits," they write. For example, Schwartz and Woloshin point to one trial in which primary care patients were randomly assigned to request a brand-name antidepressant or not. Compared with patients in the control group, those in the brand-name request group "received more prescriptions whether indicated or not."
Similar associations were observed regarding disease awareness campaigns aimed at consumers and drug requests. Yet, the authors note that regulation has not kept up with the trend. "Despite the growth in disease awareness campaigns, no official FDA rules governing this type of marketing exist," they write.
Marketing to professionals also appears to influence prescribing practices, the authors write. As evidence, they refer to observational studies that suggest detailing and samples influence prescribing and raise costs by promoting expensive newer brand-name drugs over equally effective, less-expensive alternative products or nondrug choices.
Regulatory Responses Decrease
With respect to regulatory oversight, the number of promotional materials submitted for review to the OPDP nearly tripled during the period of study, increasing from 34,182 in 1997 to 97,252 in 2016. During this period, violation letters issued for prescription drug advertising decreased from 156 per year to 11. "Companies might be producing better materials but it is also possible that FDA reviewers may be overwhelmed by the massive increase in promotional submissions," Schwartz and Woloshin write.
The nature of violation letters has changed as well. "Violation letters prior to 2007 mostly involved marketing unapproved doses and uses, but by 2014-2015, most letters involved inadequate risk information, including an increasing proportion addressing websites, sponsored links, or social media platforms," the authors explain.
Legal claims for unlawful promotion of drugs have led to 103 settlements and more than $10.5 billion in financial penalties. Nearly all of these settlements occurred in 2007 or later. By contrast, regulatory action related to the promotion of health services has been limited to a single action by the FTC in 1996 against the Cancer Treatment Centers of America for unsubstantiated survival claims, and FDA action against two stem cell clinics for marketing unapproved products in 2018.
Regarding the promotion of laboratory testing, the FDA Center for Devices and Radiological Health Division of Premarket and Labeling Compliance has issued multiple violation letters regarding DTC marketing of genetic testing, most commonly for promoting the tests without premarket review.
Better government oversight of promotional practices is warranted, the authors stress. They cite Oxycontin (Purdue Pharma) as an example of the potential harms associated with detailing. "[D]rug representatives, minimizing abuse potential and promoting off-label use for chronic pain, helped contribute to the current opioid crisis," they write (detailing of Oxycontin ceased in 2018). "If OPDP cannot monitor promotional activities for drugs with important public health risks, a detailing ban might need to be considered."
The shift in healthcare marketing, particularly the growth of DTC advertising, is based in the movement toward patient-centered healthcare, "which emphasizes patient agency in directing and managing health and health care decisions," according to the authors of an additional accompanying editorial.
Although patient engagement and shared decision making are a positive trend, "the expansion of DTC advertising remains controversial, with evidence of both benefits and harms," write Selena E. Ortiz, PhD, from the Department of Health Policy and Administration, College of Health and Human Development, the Pennsylvania State University, in University Park, and Meredith B. Rosenthal, PhD, C. Boyden Gray Professor of Health Economics and Policy, Department of Health Policy and Management, Harvard T. H. Chan School of Public Health in Boston, Massachussetts.
Among the potential harms is the erosion of the physician-patient relationship. "Even as the growth of DTC advertising increases the need for physicians to serve as their patients' information brokers, marketing by health care organizations (including a physician's employer, affiliate, or competitor) may at times create a conflict with this role," the editorialists suggest. "Physician endorsements of certain types of treatments, either explicit or implicit through affiliation with the marketing entity, may serve as cognitive shortcuts for patients that circumvent additional information seeking or deliberation and prompt incompletely informed decision making."
Although a legal ban that prevents clinicians and other healthcare entities from marketing is unlikely, "clinicians and health care entities may do well to consider the trust consequences of their marketing schemes," the editorialists emphasize. "[Patient] trust is established in part by expectations that physicians eschew blatant profit-maximizing behaviors such as advertising and base clinical decisions on the objective evaluation of patient needs."
All stakeholders should carefully consider the benefits of healthcare marketing, including educating patients and prompting them to seek care, and the potential harms, the editorialists write. "[T]he recognition that medical marketing is increasing its scope and scale, should be a call to action not only for regulators, but also for payers, physicians, and health care organizations."
Dr Schwartz and Dr Woloshin previously served as medical experts in testosterone litigation and were the cofounders of Informulary, a now-defunct company that provided data about the benefits and harms of prescription drugs. Dr Rosenthal has served as a paid expert witness for plaintiffs in several lawsuits concerning alleged fraudulent promotion of pharmaceuticals and medical devices. The other authors and editorialists have disclosed no relevant financial relationships.
Medscape Medical News © 2019
Cite this: Pharma Marketing: Spending Surges, Oversight Lags - Medscape - Jan 09, 2019.
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