Awareness is in: DTC disease campaigns surge in the U.S.

Disease awareness advertising is soaring in the U.S. Over the past 20 years, the number of direct-to-consumer awareness ad campaigns annually has grown from 44 to 401, according to a recent study published in the Journal of the American Medical Association.

And spending has increased along with it, climbing from $177 million in 1997 to $430 million in 2016.

Study co-author Steven Woloshin, a physician and Dartmouth professor, said the ads are part of an effective formula used by some companies to market prescription drugs. The company primes the market—sometimes beginning before a drug has even been approved by the FDA—with disease awareness ads that lay out the condition or symptoms to get consumers and physicians thinking about it.

Then, usually six months to a year after FDA approval, the brand-name drug is introduced, usually also with an ad campaign, offering a solution to that same problem or condition.

While disease awareness advertising has ramped up over 20 years, it's turned sharply upward over the past few, Woloshin noted. There has been a "hockey stick" increase since 2012, from 223 campaigns that year to 401 in 2016.

“These campaigns are very effective. They’re more socially acceptable than drug ads because they don’t feel like advertising. ... They teach people how to diagnose themselves by taking a quiz—quizzes which are very nonspecific and cast a very broad net. They even typically provide a script of what you should say to the doctor to make sure you're taken seriously,” he said, adding “To be fair, sometimes there is an educational function, but a lot of times it's marketing dressed up as education.”

RELATED: Big Pharma finds a hit with disease awareness social media posts in 2016

Adding to the issue is little oversight. Neither the FTC nor the FDA claim specific governance over disease awareness advertising. The FDA only covers ads that mention a drug by name, Woloshin said, and the FTC has yet to take up any of the cases. He has lobbied the FTC in the past and said while it agrees that there should be more oversight, the FTC and the FDA are stretched thin with small staffs and many products and industries to oversee. The boom in digital advertising has only added to their caseloads.

The problem doesn't lie only with consumer advertising campaigns. Pharma companies spent $59 million on disease awareness education in 2016 to physicians and teaching hospitals through speaker fees, honoraria and education, according to the research.

Woloshin sees potential harm in unchecked disease awareness ad campaigns. The ads can encourage people to look for medical solutions when none is needed and time and money may be wasted on unnecessary tests, he said. Additionally, some consumers may convince their doctors to prescribe drugs that end up not working and causing harmful side effects.

“There is an interest in educating people and letting them know about their treatment options, but the problem is that’s so easily subverted by companies that have a strong financial interest to get people to think they need to be treated with a particular drug,” Woloshin said. “No one is looking over these companies’ shoulders. No one is calling them on it.”

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Woloshin and study co-author and physician Lisa Schwartz have been studying medical communications and advertising and ways to improve them at Dartmouth Institute for years across a range of topics, including disease awareness, prescription drug advertising, and marketing to professionals. The two won the John P. McGovern Award from the American Medical Writers Association in 2017, which recognized their research "working to improve the communication of medical evidence to physicians, journalists, policymakers and the public so they can make wiser decisions.”

Schwartz, who was also Woloshin’s wife, died in November. Dartmouth quoted her description of their research in its tribute to her.

“A lot of what you read about medicine sounds too good to be true, or sometimes even too bad to be true. Our goal has been to give people a realistic sense of what is known and what is not known—how hopeful or worried they should be,” she said.