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Study: This Ain’t Your Father’s Medical Marketing

More and more money was pumped into medical marketing in the U.S. from 1997 to 2016, reflecting industry’s growing enthusiasm for targeting consumers.

Total spending to market drugs, disease awareness campaigns, health services, and laboratory testing increased from $17.7 billion in 1997 to $29.9 billion in 2016, according to Lisa Schwartz, MD, MS, and Steven Woloshin, MD, MS, both of Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, New Hampshire.

While marketing to health care professionals by pharmaceutical companies continued to dominate spending during this period ($15.6 billion in 1997 and $20.3 billion in 2016), direct-to-consumer advertising had the biggest growth, more than quadrupling to $9.6 billion in 2016, the researchers wrote in the January 1/8 issue of JAMA.

Direct-to-Consumer Marketing

Spending swelled over the years in all aspects of direct-to-consumer marketing captured by the Kantar Media database:

  • Prescription drug advertising: $1.3 billion to $6 billion
  • Pharmaceutical company spending on disease awareness campaigns (such as smoking cessation): $177 million to $430 million
  • Advertising for health services by hospitals, dental centers, clinics, and other medical services: $542 million to $2.9 billion
  • Advertising for lab tests (including genetic testing): $75.4 million to $82.6 million

Partly responsible for these trends may be sociodemographic changes that have “expanded the customer reservoir,” the authors suggested, including an aging population and broader insurance coverage.

There were only three areas where advertising spending for prescription drugs did not increase, but in fact declined: allergy, cholesterol, and osteoporosis drugs. These drugs had lost patent protection and/or had become available over-the-counter over the study period.

On the other hand, spending increases were greatest for drugs in diabetes, dermatology, pain, arthritis, cardiac disease, and cancer, “largely reflecting competition among expensive new biologics and cancer therapies,” according to Schwartz and Woloshin.

Lab tests such as 23andMe’s genetic scans benefited from an era of cheap digital ads that permitted ad volume to climb more than 18-fold without a sharp increase in marketing expenditure, the investigators noted.

When Professional Marketing Gets Out of Hand

Schwartz and Woloshin found that industry did not forget about healthcare professionals, although strategies evolved considerably. Spending on prescription detailing, once the mainstay of drug marketing, did not increase at all during the study period (about $5 billion in 1997 and in 2016) whereas costs of free samples rose from $8.9 billion to $13.5 billion, according to data from the IQVIA Institute for Human Data Science.

Direct payments to physicians (as recorded in the federal Open Payments database) approached $1 billion in 2016 but that was less than 5% of overall spending on healthcare professional marketing.

Spending on disease education for professionals paled in comparison, at $59 million in 2016, but Schwartz and Woloshin still found it problematic. The current opioid crisis “highlights the potential risks of entangling industry in disease education,” they wrote.

They recalled the 1996 consensus statement from the industry-funded American Academy of Pain Medicine and the American Pain Society endorsing opioids for chronic noncancer pain and describing addiction risk as low.

Another troubling phenomenon was the more than 20,000 pain education programs sponsored by Purdue Pharma (Oxycontin’s manufacturer) in 1996-2001, Schwartz and Woloshin said. “Opioid prescription sales and deaths quadrupled from 2000 to 2015.”

Even accredited CME disease education is not immune to inappropriate industry influence.

“For example, a Medscape-accredited CME program, ‘Unmasking ADHD in Adults,’ funded by Shire (the manufacturer of Adderall), taught primary care physicians that diagnosis can be made in 6 minutes. After questioning, the psychiatrist who created the program reconsidered and repudiated the claim,” according to the investigators.

Regulations Needed

They argued for better regulation of detailing and education.

“The OPDP [FDA Office of Prescription Drug Promotion] monitors promotional exhibits and activities at major medical meetings and conventions but not detailing visits, lunch or dinner presentations, or speaker trainings,” they pointed out.

If these promotional activities can’t be monitored, “a detailing ban might need to be considered,” Schwartz and Woloshin said.

From 1997 to 2016, the number of drug promotional materials submitted for FDA Office of Prescription Drug Promotion review increased from 34,182 to 97,252, whereas FDA violation letters for misleading drug marketing decreased from 156 to 11.

There were 103 financial settlements between drug companies and federal and state governments, totaling over $11 billion in fines for off-label or deceptive marketing practices.

During the same period, the Federal Trade Commission acted just once against misleading marketing by a for-profit medical center: Cancer Treatment Centers of America. (It did, however, sanction numerous drugmakers and other companies for false advertising of other products.)

In 2015, the FDA withdrew its 2004 standards on awareness advertising without instating new guidance, the researchers noted.

What’s Ahead

Schwartz and Woloshin said their study likely underestimated spending on medical marketing because certain payments were not counted in the study; their datasets didn’t account for money paid to advertising agencies or public relations firms, nor unmonitored promotion in the form of rebates and patient advocacy groups.

Nevertheless, “[t]his 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,” according to an accompanying editorial by JAMA editor-in-chief Howard Bauchner, MD, and executive editor Phil Fontanarosa MD, MBA.

Healthcare spending totaled $3.3 trillion in the U.S. in 2016 (or 17.8% of GDP), the investigators noted.

In such an environment, the legal doctrine and the profit motive both favor a continued thriving future of medical marketing, suggested Selena Ortiz, PhD, MPH, of Pennsylvania State University in University Park, and Meredith Rosenthal, PhD, of Harvard T.H. Chan School of Public Health in Boston, in a separate editorial.

“The fact that advertising also clearly produces harm, and the 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,” Ortiz and Rosenthal maintained.

They added that these constituents all have “a role to play in ensuring that medical marketing is not misleading, including not only the content of advertisements but also with respect to patient-physician relationships.”

Schwartz and Woloshin served as medical experts in testosterone litigation and cofounded Informulary, a now-defunct company that provided data about the benefits and harms of prescription drugs.

Rosenthal reported having served as a paid expert witness for plaintiffs in several lawsuits concerning alleged fraudulent promotion of pharmaceuticals and medical devices.

Bauchner, Fontanarosa, and Ortiz disclosed no conflicts of interest.