When it comes to television drug ads communicating adverse events and contraindications, the US Food and Drug Administration (FDA) wonders whether less is more.
Put another way, does a commercial’s seemingly endless litany of warnings leave viewers so dazed that they don’t take any of the warnings seriously or don’t remember the most important ones? Would a shorter, prioritized list better educate consumers?
The FDA is asking healthcare professionals and the public at large to comment on a proposal that would pare down the risks mentioned in direct-to-consumer (DTC) broadcast advertising. Drug makers would have to cite only risks that are life-threatening, serious enough to land people in the hospital or disable them, or actionable — for example, a patient should stop using the product if he or she experiences an adverse event. In addition, the ad must state that there are other risks and direct viewers to information about them, as in “talk to your healthcare provider.”
Critics of DTC drug advertising view the FDA proposal with skepticism. They suspect that the new format would give drug makers more air time to praise their products without really making patients any wiser.
Regulators have been mulling over how best to communicate risk in DTC drug ads for a long time. In 2004, the FDA stated in draft guidance on print drug ads that “exhaustive lists of minor risks distract from and make it difficult to comprehend and retain information on the more important risks.” Accordingly, the agency requires print ads to present the major risks in the main part of the ad but permits minor ones to appear in a summary on a separate page.
DTC broadcast ads for prescription drugs (ie, those on TV and radio) operate under a similar set of rules. They must present the most important risks in a “clear, conspicuous” manner. And risk statements must be spoken, although they also can appear in television video. Broadcast ads can dispense with all other risks by directing consumers to a website, a magazine print ad, a toll-free telephone number, or their healthcare provider.
Shorter Risk List, Better Recall, Study Says
To buttress its proposal for risk statements in DTC broadcast ads, the FDA points to a study conducted by some of its scientists and employees of the nonprofit research firm RTI International. The study, published in Research in Social and Administrative Pharmacy, found that a shorter, prioritized list improved the ability of viewers to recall and recognize drug risks as well as drug benefits.
The study involved 1500 adults who self-reported having depression, insomnia, or high cholesterol. Each group of 500 adults was randomly assigned to view four different versions of a television ad for a drug treating their condition. One version was the original ad airing on television. The other three versions were revised to include the following:
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An edited risk statement, confined to risks that were serious or actionable, and a disclosure that there were other risks, which someone could learn about by talking to a physician or reading the patient labelling;
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An edited risk statement without the disclosure statement; and
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An unedited risk statement, which contained serious or actionable risks as well as others, and a disclosure statement.
In each of the disease groups, people who saw the edited risk statement correctly recalled more of the serious and actionable risks immediately afterward from memory than their counterparts who saw the unedited statement, according to the study. (Testing long-term recall would have been more meaningful, noted Diana Zuckerman, PhD, president of the National Center for Health Research, in an interview with Medscape Medical News.)
People with depression and insomnia who were exposed to the edited risk statement also recognized more serious and actionable risks afterward on a list of choices, and more benefits as well. And the presence of the disclosure statement didn’t appear to hinder anyone from absorbing information on a drug’s upside and downside.
Should There Also Be Imagery of Adverse Events?
The question of a DTC drug ad’s content belongs to a larger discussion on whether these ads should be allowed in the first place.
PhRMA, the trade group for pharmaceutical companies, says on its website that the ads increase awareness about diseases and options to treat them, motivate patients to contact their physicians and talk about their health concerns, and increase the likelihood that patients are treated for frequently underdiagnosed and undertreated conditions. In contrast, the House of Delegates of the American Medical Association (AMA) voted in 2015 to have DTC drug ads banned.
“The goal of advertising is to drive choice and demand for a product, not educate,” the AMA said at the time, noting that New Zealand is the only other country that permits such advertising. One effect of DTC advertising, the AMA said, is to boost demand for costly treatments instead of less expensive but effective alternatives.
Medscape Medical News asked PhRMA where it stood on the FDA proposal for an abbreviated risk statement in DTC broadcast advertising. A spokesperson said the association wouldn’t grant an interview until after it had filed comments with the FDA.
Other figures in the debate over DTC advertising did share their thoughts. Sidney Wolfe, MD, the founder and senior advisor to the Health Research Group of the consumer watchdog group Public Citizen, said the FDA proposal fails to address a key issue — the difference between how risk and benefit information is conveyed. An oral recitation of adverse events and contraindication, he said, can get lost while the video portion of the ad depicts smiling patients restored to their family, friends, and favorite pastimes in a glow of sunshine. Tennis, anyone?
One solution, Dr Wolfe told Medscape Medical News, is to include imagery of adverse events, such as vomit, as well as happy events. “The pharmaceutical companies may not like that,” he said.
Dr Zuckerman at the National Center for Health Research also would like to see qualitative changes in risk information. “I’m not opposed to shortening the information about risks — it’s ridiculously long,” she said. “But why not make it more meaningful and useful?”
Statistics about risk would help, said Dr Zuckerman. “If one of the side effects is nausea, why don’t they say what percentage of patients are nauseous? They don’t.”
Likewise, adverse events could be characterized in more detail. “If the drug can cause a headache, are those blinding headaches?” said Dr Zuckerman. “Will I spend the rest of the day with a headache? There’s just not enough information about what the warnings mean.”
While an efficient presentation of risks has its merits, there’s something to be said for the traditional rollcall in ads, said Adriane Fugh-Berman, MD, director of PharmedOut, a project at the Georgetown University Medical Center in Washington, DC, to promote evidence-based prescribing.
“Consumers aren’t meant to memorize long lists of risks, but they may pick out the risks that apply to them,” Dr Fugh-Berman told Medscape Medical News. “Also, a long list is in itself a warning that a drug can cause many adverse events. The list itself is a message.”
Several studies, noted Dr Fugh-Berman, show that consumers want more risk information in drug advertising, not less. The article in Research in Social and Administrative Pharmacy acknowledges this finding but cites other studies indicating that consumer preferences may not necessarily relate to their ability to recall and understand risk information.
What exactly is the dividing line between adverse events that belong in a DTC drug ad and those that do not, asked Dr Wolfe at Public Citizen. That’s also one of the questions that the FDA poses in its formal request — posted on the Federal Register — for input on revamping risk statements. The agency will accept comments through November 20. The FDA solicitation on the Federal Register contains instructions on how to submit comments.
Follow Robert Lowes on Twitter @LowesRobert
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