Some new drugs come with impressive safety and efficacy data. For others, well, there are TV commercials.
Just over 70% of prescription drugs advertised on TV have been classified as “low therapeutic value,” meaning they offer little benefit over drugs already on the market, according to a new study. The study, published in JAMA Open Network, aligns with longstanding skepticism that heavily promoted drugs have high therapeutic value.
“One explanation could be that drugs with substantial therapeutic value are likely to be recognized and prescribed without advertising, so manufacturers have more incentive to promote drugs of lesser value,” said the authors, who include researchers from Harvard, Yale and Dartmouth.
The United States is one of only two countries that allows direct-to-drug (DTC) advertisements, such as television commercials. (The other is New Zealand.) Doctors, medical associations and consumer advocates have long opposed this unusual practice. In 2006, consumer advocacy group Public Citizen summed up the DTC ad as “nothing less than an end to the doctor-patient relationship – an attempt to turn patients into agents of pharmaceutical companies as they pressure on doctors for drugs they may not need.”
In 2015, the American Medical Association called for a total ban on DTC ads for prescription drugs and medical devices. AMA members said the advertisements “spurred demand for expensive treatments despite the clinical effectiveness of less expensive alternatives”.
But the DTC drug ads continued, fueled by billions of dollars from the pharmaceutical industry.
Benefit not added
For the new study, researchers led by Aaron Kesselheim, who heads Harvard’s Program on Regulation, Therapeutics, and Law (PORTAL), looked at the monthly lists of the most advertised drugs on television in the United States between 2015 and 2021.
They also researched the therapeutic value ratings of these drugs from independent health rating agencies in Canada, France and Germany. Value ratings were based on the drugs’ therapeutic benefit, safety profile, and strength of evidence, compared to existing drugs. Any drug rated “moderate” or higher was categorized as a “high value” drug for the study. For drugs with multiple ratings, the study authors used the most favorable rating, which the authors believe may overestimate the proportion of more beneficial drugs.
Of the most advertised drugs, 73 had at least one value rating. Collectively, pharmaceutical companies spent $22.3 billion advertising these 73 drugs between 2015 and 2021. Even with generous ratings, 53 of the 73 drugs (about 73%) were classified as low-benefit. Collectively, these low-profit drugs accounted for $15.9 billion in ad spend. The top three low-benefit drugs by dollar amount were dulaglutide (type 2 diabetes), varenicline (smoking cessation), and tofacitinib (rheumatoid arthritis).
The outlook for change is bleak, the authors note. “Policymakers and regulators could consider limiting direct-to-consumer advertising to drugs of high therapeutic or public health value or requiring standardized disclosure of comparative efficacy and safety data,” Kesselheim and colleagues concluded. , “but policy changes would likely require industry cooperation or face a constitutional challenge.”
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