“One of the most perplexing aspects of the ubiquitous direct-to-consumer (DTC) prescription drug advertisements is the seemingly endless recitation of side effects in drug ads,” cardiology expert Larry Husten
stated in an opinion piece
on MedPage Today.
“The list is, alternatively, horrifying, boring, concerning, and silly. It is reasonable to wonder how these ads, with their interminable lists of side effects, lead to greater sales of the drugs they promote.”
Some clues might be found in research
published in the journal Nature Human Behavior in 2017. The study, “The unintended consequences of argument dilution in direct-to-consumer drug advertisements,” was conducted by Niro Sivanathan and Hemant Kakkars of the London Business School.
After six experiments embracing 3,059 U.S. participants, the authors concluded that “when commercials list severe side effects along with those that are most frequent (which include both serious and minor side effects), as required by the Food and Drug Administration, it dilutes consumers’ judgments of the overall severity of the side effects, compared with when only the serious side effects are listed.”
The presence of “minor side effects significantly diluted participants' severity judgments," about more serious side effects and helped sell the drug, the researchers wrote.
Specifically, subjects who listened to or read versions of drug ads in which information about minor side effects was mixed in with information about more serious ones exhibited “greater attraction” to those drugs, according to the researchers. The minor side effects somehow take the sting out of the more severe risks and, perversely, boost the drug, they hypothesize.
that the side effect list has the effect of “hypnotizing” viewers in a process sometimes called autonomous sensory meridian response (ASMR)—an experience, often found on the internet, that people seek out and enjoy.
ASMR has been defined as a pleasurable feeling that originates in a person's head and spreads to their spine and sometimes their limbs, according to Husten. An ASMR can “lull or practically hypnotize viewers into a state of benign, uncritical acceptance.”
'Ask-Your-Doctor' Drug Ads Are 2nd Largest U.S. Ad Revenue Source
However it is that the ads work (something that maybe only the marketing psychologists working for those companies really understand), the one thing we know for sure is that they're effective.
Since “Ask-Your-Doctor” DTC drug ads began in 1997, when they were authorized
by the U.S. Food and Drug Administration (FDA), they've become the second largest U.S. ad revenue source, after life and entertainment ads, according to Statistica. And they “move product.”
In 1992, five years before DTC ads began, Americans took an average of seven
prescription drugs per year—by 2007 that number had leaped to 12
per year and is likely much higher now. DTC drug advertising is only legal in the United States and New Zealand
, and drug makers are some of the top national television advertisers
, according to Media Radar.
The COVID-19 pandemic didn't seem to dampen drug makers' zeal. While most advertisers cut their spending during the pandemic, drug makers didn't, according to the pharmaceutical industry website FiercePharma—they spent $5 billion on advertising in 2021
alone. Nor did drug makers “go digital” with online ads like so many advertisers have but, rather, stayed TV centered possibly because of their older demographic—almost half of drug ad spending was for arthritis, diabetes, and depression drugs, according to the U.S. Government Accountability Office
, and Medicare beneficiaries spent more than $280 billion on advertised drugs between 2016 and 2018.
A Short DTC Drug Advertising History
Before 1997, drug maker marketing tended to be image building and institutional, such as “Pfizer’s ‘Partners in Healthcare,’" rather than promoting one drug,” Frank J. Ascione
, a doctor of pharmacy, wrote in a chapter in “O'Donnell's Drug Injury,” an informational guidebook for health care practitioners or attorneys.
And prior to 1962 and the 1961 Thalidomide
tragedy, drug marketing wasn't even overseen by the FDA (which has regulatory origins dating back to the 1906 Pure Food and Drug Act) but by the Federal Trade Commission (FTC). However, it soon became apparent that the FTC lacked both the scientific expertise with which to regulate drugs and the power to hold manufacturers responsible, according to Ascione
Passage of the 1962 Kefauver–Harris Amendment
, which required drug makers to prove their products were safe and effective, “enhanced the FDA’s role in ensuring accurate information about drug products,” he wrote. At the same time, consumer groups began demanding more information about prescription drugs.
Congress responded to public pressure by proposing a system in which all prescription drugs came with FDA-approved information, an effort which “became known as the ‘Patient Package Insert (PPI)’ Initiative.”
“The main regulatory objective was to ensure that individual patients comprehended their illnesses and treatment regimens—especially an understanding of the proper and safe use of medications they used,” Ascione wrote.
Objections to Direct Drug Ads
Opposition from health care professionals and drug makers surfaced over the proposal to provide information directly to patients, according to Ascione. Would the information really increase drug safety, they asked. Would health professionals face increased liability over the new regulations? Would doctors resent consumer communication that bypassed them? And what about the cost of creating and printing the patient package inserts?
The prospect of DTC drug advertising brought up other concerns. Would such advertising “generate unneeded visits and inappropriate requests for medications ... [and] encourage drug products over healthier (and safer) lifestyle choices?” he wrote. Would it medicalize “nonmedical conditions, placing drug makers' needs over the public’s health? Such concerns
“Every time you turn on your television [or] open up a magazine ... there they are: glossy advertisements for countless prescription drugs that promise the possibility of relief from whatever ails you,” reads an editorial
in the American Medical Association's Journal of Ethics a few years ago. “These informational vehicles drive home a single, uniform message: ‘If you suffer from [insert any condition], talk to your doctor about whether [insert any drug name] is right for you.’”
DTC drug ads can “spur people to ask for medications they don’t need” and “create conflicts between patients asking for a drug and doctors who don’t recommend it,” Dr. Robert H. Shmerling wrote in a 2022 article
in Harvard Health Publishing, “How direct-to-consumer ads hook us.” Shmerling is a senior faculty editor at Harvard Health Publishing.
Do DTC Drug Ads ‘Sell’ Diseases?
An area of DTC drug advertising that especially generates controversy is what the ad industry calls “unbranded ads”—ads that raise awareness about a disease or condition without naming the actual drug that's being sold or even appearing to sell a drug. Instead, the ads are designed to create “awareness” and “demand.”
Disease awareness campaigns often establish a condition or disorder as a looming public health problem and can be made to sound like public service announcements that serve the general good, such as “smoke detectors save lives.” A hallmark of such unbranded advertising claiming that a disease is more widespread and serious than people think and that sufferers could have a condition and not know it.
The disease being given more awareness is often called “underdiagnosed,” “misdiagnosed,” and “underreported,” and TV viewers are told that “stigmas” and “barriers” prevent patients from getting the treatment they need. Examples of diseases and conditions boosted
by unbranded ads include exocrine pancreatic insufficiency, shift work sleep disorder, and non-24-hour, sleep-wake disorder. Few had heard of such conditions until drug maker advertising highlighted them.
Unbranded ads are often linked to online “symptom checkers” and “quizzes” to further self-diagnosis so that patients “ask their doctor” for a particular drug.
Health Professionals Weigh In
James O’Donnell, an associate professor of pharmacology at Rush Medical College in Chicago, told The Epoch Times that DTC drug ads “are not in fair balance” and have definitely not improved health care and patient education. In fact, the ads have reduced doctors to gatekeepers and order-takers while raising drug prices, he said.
Dr. Harry Haroutunian, the author of “Not As Prescribed: Recognizing and Facing Alcohol and Drug Misuse in Older Adults,” laments how drug-taking has become normalized. Salon asked him in an interview
about his opinion of DTC drug adverting.
“It is horrible," he responded. "It gives people magical thinking and the idea that any problem can be fixed with a drug and there are no consequences regardless of the list of dangerous side effects. The ads allow the patient to feel ‘smart’ by telling the doctor what he heard on TV, and then the doctor has to be smarter in what he chooses to prescribe.”
Writing in MedPage Today, Husten was even more blunt
“My own view is that drug ads are themselves like drugs,” he wrote.
And the long list of side effects that research suggests helps sell a drug?
“It would not surprise me at all to learn that the advertising agencies that produce the drug ads are consciously using ASMR videos as a model,” Husten said.