番茄社区

Prominently featuring severe adverse effects of a fictitious Alzheimer's disease drug in print advertising was associated with consumers perceiving the drug as riskier, survey data showed.

The study included 1,007 American adults who were shown one of four print ads with information ranging from qualitatively described benefits and common adverse effects to quantitatively described benefits and severe adverse effects of an imaginary anti-amyloid monoclonal antibody for Alzheimer's.

As quantitative data replaced qualitative descriptions in the ads, and as information about severe adverse effects was included, survey respondents perceived the drug to have greater risks, be less effective, or have more risks than benefits, reported Michael DiStefano, PhD, of the University of Colorado in Aurora, and co-authors.

Respondents also were less likely to ask their physician about the drug, consider using the drug, or recommend it to a family member, the researchers reported in a research letter.

"The findings add to the evidence base that consumer perceptions of a drug can be significantly influenced by the content and layout of ads," DiStefano told 番茄社区.

FDA guidance says direct-to-consumer promotional communications, including print advertisements, should describe a drug's benefits and risks in a balanced way and for presenting quantitative efficacy and risk data.

Print product-claim ads must include a brief summary of all risks, but there's no requirement that every risk be prominently presented or that severe risks be highlighted, DiStefano and colleagues noted.

"This is one of those gee-whiz studies that have to be done over and over, lest we forget: Talking about side effects is a real turn-off and hurts sales, even when the advertisement features efficacy and benefits," noted Lon Schneider, MD, MS, of the University of Southern California in Los Angeles, who wasn't involved with the study.

"It's a slippery slope," Schneider told 番茄社区. "Emphasizing side effects could inhibit some people from accepting necessary medicines, vaccines, insulin, or analgesics, as examples," he said.

"Much of the controversy with Alzheimer's treatments are their small, questionably important, clinical effects and expense in terms of both money and time," Schneider continued. "With that in mind, risks become of even greater concern than they otherwise would. People who participated in this study are telling us that."

Prescribing information for the two anti-amyloid Alzheimer's drugs currently available in the U.S. -- (Leqembi) and (Kisunla) -- carry boxed warnings for amyloid-related imaging abnormalities (ARIA), which include ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H).

The American Academy of Neurology has emphasizing judicious patient selection to minimize risks of serious adverse events like ARIA with these drugs. include monitoring guidelines for ARIA, noting that while most cases have been asymptomatic, a few have been serious or fatal.

DiStefano and colleagues collected data using the NORC survey from November 30 to December 4, 2023. Among 1,007 survey respondents, 23% were ages 65 and older, and about half (51.3%) were women. The survey had a 16% completion rate.

Respondents saw one of four print ads for a fictitious Alzheimer's drug called Altana (altenemab injection for intravenous use). Ads were based on for lecanemab.

The first ad included qualitatively described benefits and common adverse effects; the second added qualitatively described severe adverse effects. The third ad had quantitatively described benefits and common adverse effects, and the fourth one added quantitatively described severe adverse effects.

The quantitative language in the third and fourth ads stated that in "an 18-month clinical trial, people taking Altana declined in cognitive function on average by 1.21 points on an 18-point scale (7%), while people not taking the drug declined in cognitive function on average by 1.68 points on an 18-point scale (9%)."

The fourth ad also stated that in a clinical trial, "31 out of 898 people (3%) had life threatening symptoms of swelling or bleeding in the brain compared to 2 out of 897 (0.2%) in people not taking the drug."

After viewing an ad, participants used 5-point scales to report their perceptions of Altana's benefits and risks, its risk-benefit balance, their likelihood of asking a doctor about the drug, and their likelihood of using it or recommending that a family member use it.

Results were not significant between respondents who viewed the two ads with quantitative information (the third and the fourth ads), DiStefano and colleagues reported. "However, in the sensitivity analysis, those who viewed an advertisement with quantitative description and severe adverse effects were significantly more likely to perceive the drug as riskier," they wrote.

The FDA should consider requiring severe adverse events for Alzheimer's drugs be prominently displayed in print advertising, the researchers suggested. "We do not think that the brief summary requirement for print ads is adequate," DiStefano said. "These summaries may be written in technical language or may not be displayed prominently in the print ad."

The study had several limitations including the low completion rate of the survey.

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