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Cue the puppies: How drug ads downplay health risks

 

Critics say drug ads mislead consumers by showing happy images as they recite health risks.

Are TV drug ads designed to distract viewers from possible side-effects?

Humira, a plaque psoriasis drug from Abbott Laboratories: Its TV ad shows a woman at a cabin on a beautiful lake in the mountains, walking onto a dock and painting names on the stern of a sailboat while a man puts an affectionate arm around her shoulder. A group of friends sit on the dock, then sail the boat. At the same time, a male voice says: “Humira can lower your ability to fight infections including tuberculosis. Serious, sometimes fatal events can occur such as infections, lymphoma or other types of cancer, blood, liver and nervous system problems, serious allergic reactions and new or worsening heart failure.”

Asked whether the ad would meet a proposed new FDA rule that might limit such unrelated images during the listing of potential side effects, Abbott spokeswoman Tracy Sorrentino said: “All of our pharmaceutical TV ads are in compliance with current regulations and promotional guidelines. As to any future guidelines, it’s premature to speculate.”

Abilify, an add-on antidepressant by Bristol-Myers Squibb: A cartoon family walks through a pretty park, lays a tablecloth on the ground and picnics while a male voice warns of possible side effects such as suicidal thoughts, risk of death or stroke for elderly dementia patients, trouble standing and high blood sugar that could lead to coma or death.

Bristol-Myers spokeswoman Sonia Choi said her company’s ads are “appropriate and provide an important service, alerting the adults diagnosed with major depressive disorder who do not experience adequate relief from antidepressant treatment that another treatment option for use with their antidepressant is available.”

Lunesta, a sleep aid from Sunovion Pharmaceuticals: A glowing, green butterfly glides serenely through a darkened city while a female voice warns of possible side effects such as walking, eating or driving while asleep, aggression, agitation, hallucinations, confusion, worsening depression including risk of suicide, and rare allergic reactions such as tongue and throat swelling that might be fatal.

Sunovion spokeswoman Patricia Moriarty says her firm is aware new rules are proposed and will follow them if they are finalized.


ftasker@MiamiHerald.com

You’ve seen the drug ads on TV. A voice intones a chilling list of side effects — liver damage, tuberculosis, suicidal thoughts, cancer, heart failure, even death — while the video shows a smiling group of friends swinging their feet from the dock at a mountain lake, a cartoon family picnicking in a verdant park, a glowing green butterfly gliding serenely through a darkened city.

The contrast between audio and video is stunning. What’s going on?

“It’s just advertising,” says Ken Goodman, director of the Bioethics Program at University of Miami. “And the point of the ads is not to educate, it’s to sell a product.”

Adds Allyse Lancaster, director of the advertising program at UM’s School of Communications: “They use the tranquil scenes to lessen the impact. If you just listened to the words, it would scare the heck out of you.”

Are we so easily manipulated? Consider that pharmaceutical company media spending increased by 54 percent in the decade leading up to 2010, to $4.3 billion, and U.S. consumer spending on medicines increased by 78 percent, to $307 billion, according to the Kaiser Family Foundation and the IMS Institute for Healthcare Informatics.The Consumer Price Index went up only 23 percent in that time.

“They wouldn’t do it if they didn’t have very good data that it’s effective,” says Laurence Gardner, professor of medicine and executive dean for clinical affairs at the UM Miller School of Medicine. “It’s clear that nobody listens to the negative litany.”

The U.S. Food and Drug Administration suspects that’s true. It has issued a proposed new rule that direct-to-consumer TV drug ads should not include “distracting representations” that detract from the statement of side effects.

“Critics of TV ads speculate that visual images of emotionally pleasant scenes during the presentation of risk information detract from the comprehension of that risk information,” the FDA says.

The new rule was proposed in March 2010. Public comments are being heard. Studies by the FDA are under way. A final rule is pending. The pharmaceutical industry says it will follow any new rules that are finalized, but hopes they won’t be too stringent.

In its written reply to the FDA, the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry’s lobbying group, agreed that TV drug ads should be “accurate and not misleading.” But it asked that not all such visual images be banned, only those that “significantly” detract from the statement of side effects, and that the “net effect” of the entire ad be taken into account.

One current TV pharmaceutical ad, for the plaque psoriasis drug Humira, shows visuals of a group of friends at a cabin on a pretty mountain lake while a voiceover warns of such possible side effects as cancer, liver damage and heart failure. Asked whether it is the type of ad the FDA is trying to change, Tracy Sorrentino, spokeswoman for its maker, Abbott Laboratories, said: “All of our pharmaceutical TV ads are in compliance with current regulations and promotional guidelines. As to any future guidelines, it’s premature to speculate.”

To better understand the issue, the FDA last year convened a panel of TV ad experts to study how much people are influenced during direct-to-consumer prescription drug ads by such factors as “images, scene changes, words on the screen and music that occur at the same time as an audio presentation of risk information.”

The panel created two mockup TV ads for a fictitious blood pressure drug it called “Zintria,” and showed them to 2,000 consumers. In both ads, a voiceover listed seriously negative side effects of the drug. In one ad, the voiceover was accompanied by mildly positive visuals of people in an art gallery looking at pictures. A second ad used the same voiceover but showed a fetching video of children playing with puppies.

In a June 2011 report, the panel found evidence that ads with the most-positive visuals gave viewers positive feelings about the drugs.

But because of a flaw in the experiment, the group said it could draw no conclusions on a key question: whether the tone of visuals affected comprehension of risks.

“We cannot definitively state that specific images will or will not result in distraction,” said FDA spokeswoman Shelly Burgess.

“It’s a difficult question,” says Jack Swasy, a member of the FDA panel who is an associate professor of marketing at American University and a TV drug ad specialist. “It may get down to how dynamic the scene is, how provocative the characters are.”

Other studies on the subject, he said, “suggest there’s good reason to believe this could be detrimental to comprehension. I think it can interfere.”

Connors, the PhRMA spokeswoman, argues that direct-to-consumer TV ads are helpful in informing consumers about medicines that might benefit them. She pointed to a 2008 FDA survey of 500 physicians that said 73 percent felt direct-to-consumer ads “helped patients ask thoughtful questions,” and 91 percent said the ads did not motivate patients to try to influence their treatment “in a way that would have been harmful.”

Lancaster, the UM advertising professor, says TV drug ads are very sophisticated: “I’m sure it’s deliberate in terms of the images they’re showing when they’re talking about the side effects. They bank on the fact that people are more stimulated visually than orally.”

Goodman, the UM bioethics expert, calls the ads “promotion, not science. The reason a doctor should prescribe a drug is that she believes it will work; the reason a patient should ask for a drug is not that he was beguiled by some TV ad.”

TV ads sometimes prompt patients to demand prescriptions for inappropriate drugs from doctors, says Gardner, the UM medical professor. “I have the occasional patient who asks,” he said, adding that he isn’t swayed by such requests.

With the continuing disagreements about the purpose and use of the ads, it’s difficult to predict how, and how soon, the issue will be resolved and a final rule enacted, says Burgess, the FDA spokeswoman.

“Since we’re in the process of evaluating all the factors and input involved with the proposed rule, it would be premature to speculate on the exact outcome” or timeframe, she says.

Meanwhile, as the ads continue, expect to see lots more pretty sunsets and idyllic mountain scenes accompanied by voices warning of everything from suicidal thoughts to heart attacks.

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