FDA vs. Drug Ads: Cut the Kids and Dogs, Spell Out Side Effects

Xconomy National — 

If you’ve turned on your TV anytime in the last, oh, decade or so, you’ve no doubt been bombarded by ads imploring you to “ask your doctor” about Drug X. And you’re well familiar with the routine: You get treated to happy images of folks dancing, perhaps, or walking their dogs in pretty green meadows, while a soothing voice in the background tells you that Drug X may cause you to lose your ability to drive safely, lose your vision, or lose your mind.

Forgive the exaggeration but you get the picture.

Well, the FDA isn’t pleased with the pharmaceutical industry’s advertising practices. So it’s proposing a new set of rules that would not only limit the ability of drug advertisers to use so many cheerful images, but may indeed force them to place more emphasis on their products’ potential side effects.

The FDA actually proposed the new rules back in 2010. But it re-opened the matter to public comment on January 27, after it published the results from an experiment it sponsored to measure the impact of distraction on consumers’ ability to understand the risks and benefits of drugs being advertised. The rules would pertain to direct-to-consumer (DTC) ads for prescription drugs on television or radio.

The original proposal is rather bulky. But here are the basics of what the FDA is suggesting: The agency wants to amend the rules for DTC advertising to more clearly define the standards for determining whether side effects are presented in a “clear, conspicuous, and neutral manner.” For example, the new guidelines would dictate that the adds cannot include “distracting representations,” such as statements, images, or sounds that might draw the audience’s attention away from those laundry lists of potentially adverse events.

So what exactly makes an ad distracting? The FDA’s proposal doesn’t really spell it out clearly, but you can get a hint of what the agency was thinking in the newly released report on its study, which it titled, “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements.” The FDA planned the study to answer a number of questions. Among them: Do visual images that are positive in tone affect viewers’ ability to comprehend the risks inherent in a product? Do positive images influence how people feel about the product? And if the advertiser super-imposes text onto the images—spelling out the side effects—does that change how viewers perceive the product?

All good questions, to be sure. To answer them, the FDA asked 2,000 consumers to go online and watch an ad for a fake blood-pressure drug called Zintria. But the participants didn’t all see the same ad. Some heard the side effects cited while watching “mildly” positive images (rocks, chairs, metal arches), while others saw “strongly” positive images (babies, puppies, girls jumping with beach balls). Some viewers saw the side effects spelled out in superimposed text, while others didn’t.

Not surprisingly, those who watched cute babies and puppies while hearing about the side effects felt better overall about the product than those who watched the more boring images. Both groups, however, understood Zintria’s risks just fine—and they really got it when the side effects were displayed on the screen in clear text, too.

The FDA has published the study on the Web and re-opened the proposed rules to comments, which the public can submit up until February 27 (instructions below).

We here at Xconomy are plenty distracted by the plethora of peppiness in drug advertising. Here are our votes forthe five most distracting images ever to appear in drug ads, in no particular order. And just for fun, we’re throwing in a bonus video pick, courtesy of the folks at Saturday Night Live, who are not shy about picking on the drug industry. (Our apologies to Pfizer, but we couldn’t resist.)

Do you agree with our selections? What ads do you find most distracting? We’d love to hear from you, so feel free to weigh in with your comments below.

Dogs frolicking on the beach: Celebrex
Speaking of puppies, this commercial for Pfizer’s arthritis pill Celebrex is full of them. The ad depicts a relaxed-looking older gentleman being goaded into a game of catch with his spaniel on the beach. The festival of cuteness only intensifies when they meet up with their neighbors and all their dogs. If you’re a dog lover (guilty!), you may be so busy thinking “Oh, what a cute Corgi” to bother paying attention to the warnings about how Celebrex can increase the chance of heart attack and stroke.

“Pfizer is committed to ensuring that all of our advertising communicates both the benefits and the risks of our medicines,” says a spokesman for Pfizer in an e-mail. He adds that the company does not want to comment on the potential impact of the proposed rule changes, but it contributed to and supports statements made by The Pharmaceutical Research and Manufacturers of America (PhRMA), the main industry trade group, on the issue.

Cartoon pipes shopping, visiting jazz clubs, and walking the dog: Vesicare
Yep, it’s another dog, though this one is made of metal and therefore, one could argue, not as cute as the real thing. Nevertheless, the pipe pup is a recurring character in this ad campaign for Vesicare, co-marketed by Astellas US and GlaxoSmithKline. The ads depict the problem of overactive bladder with animated pipe people, who delicately ask viewers, “Are you worried your pipes might leak?” The campaign continues online, where three pipe women named Bree, Jackie, and Nell host a talk show about overactive bladder. And yes, the dog is there, too. Anyone remember the potential side effects? They include severe abdominal pain, constipation, and swelling of the face, lips, throat, or tongue.

A spokeswoman for Astellas US says in an e-mail that the company did not comment to the FDA on the proposed new rules, but, “We take our responsibility to inform consumers about potential drug side effects very seriously and are committed to complying with all relevant regulations.”

Amorous couples in outdoor bathtubs: Cialis
Can someone explain this to us? Please? In this ad for Eli Lilly’s blockbuster to treat erectile dysfunction, we see a man and a woman, in separate bathtubs, holding hands, outside. Is this what happens when your love life improves? Perhaps, but it’s enough to make one overlook the potential side effects, which include back pain, muscle aches, and a sudden decrease in hearing or vision. Distraction aside, this ad clearly works for Lilly, so much so that those two happy people in their bathtubs are featured (in silhouette) on Lilly’s website.

A spokeswoman for Lilly says in an e-mail that the Cialis ads are designed to educate men about erectile dysfunction in a straightforward and honest way that’s in line with the corporate brand. “Also, the ads provide men with important benefit and risk information, consistent with current FDA guidelines, allowing men to make a decision about whether to consult with their physician about Cialis. We have and will continue to work closely with the FDA to make sure our advertising is in line with their guidelines,” she writes.

Fluttering green butterfly: Lunesta
This ubiquitous, glowing creature is the main image associated with Lunesta, the heavily advertised insomnia drug from Sunovion Pharmaceuticals. The butterfly is so famous now that Sunovion has been confident enough lately to run some ads that are only 15 seconds long and feature nothing but the insect, a reference to the drug’s website, and a soft female voice saying, “Follow the wings.” This is a brilliant marketing tactic because it saves the company from having to recite the side effects that patients taking insomnia drugs have reported, such as walking, eating, or driving while asleep, without remembering it the next day. That’s because according to the FDA’s rules, if you don’t cite the benefits of a drug in an ad, you don’t have to cite the risks either. (The long version of the ad does have to include the risks, and you can see both versions on Lunesta’s site.)

A company spokeswoman says in an e-mail, “Sunovion Pharmaceuticals is aware of the FDA’s proposed new rule regarding direct-to-consumer advertising. We will continue to adhere to all FDA guidelines and regulations related to DTC advertising, as we do today.”

Celebrity golfer with children: Enbrel
The use of famous people in drug ads has sparked so much debate in the pharmaceutical world the FDA could probably do a whole separate study just on that topic. Are celebrities inherently distracting? One could argue that they are, especially when you pair them with children. In this ad for Amgen’s blockbuster biotech drug Enbrel, pro golfer Phil Mickelson describes his battle with the painful condition psoriatic arthritis, one of the diseases Enbrel is used to treat. We see Mickelson golfing on a beautiful, rolling green course, and then playing soccer with a group of adorable children. Meanwhile, a voice in the background is telling viewers that because Enbrel suppresses the immune system, it might “lower your ability to fight infections,” and that “sometimes fatal events” such as cancer and nervous-system disorders have occurred.

A spokeswoman for Amgen tells Xconomy in an e-mail that Mickelson is the “ideal” person to call attention to psoriatic arthritis, and that early diagnosis of the condition is crucial to preventing joint damage. “This campaign was developed in accordance with the Food and Drug Administration’s guidance for industry regarding consumer-directed advertisements,” she says.

Real smokers kicking the habit: Chantix
This campaign features actual people who stopped smoking with the help of Pfizer’s Chantix. There’s nothing distracting about these compelling, real-life tales—except maybe the side effects themselves, which can include hostility, agitation, depressed mood, and suicidal thoughts or actions. Saturday Night Live certainly found the ads spoof-worthy, as you see here.

Any member of the public is welcome to submit comments to the FDA about its proposed new rules on drug advertising. Just go to the site regulations.gov, follow the instructions for submitting comments on docket number FDA-2009-N-0582, and label your comments with the heading ”ATTN: Distraction Study.” You can also download a copy of the FDA’s distraction study there.

To repeat an over-used but in this case appropriate cliché, stay tuned: It will be interesting to see if the FDA’s latest shot against the pharma industry changes the way we all experience drug advertising.

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8 responses to “FDA vs. Drug Ads: Cut the Kids and Dogs, Spell Out Side Effects”

  1. Bob says:

    Anybody hear of Freedom of Speech? FDA is stepping over the line but nobody will challenge them since future drug approvals are at risk. This stuff would not hold up in a Constitutional debate.

  2. Nicole says:

    I don’t mind the happy pictures while saying this may kill you, because at the end of the day a professional doctor has to prescribe the medicine and the consumer must be made aware of the potential side effects. I DO have a problem with all of the sexual dysfunction advertisements that come on during “family” oriented television (shows and times). I do not want to explain to my 5 year old what it means to have an erection for more than four hours!!! Please include time appropriate advertising for things that are targeted towards a more mature audience!

  3. Rogan says:

    @Bob: Commercial speech isn’t the same as political speech.

    I’m actually not sure why Direct to Consumer advertisement is legal for prescription drugs. Consumers have no idea how to choose between drugs, and the very way that they are marketed speaks volumes to this.

  4. Betsy says:

    Right, Rogan — we’re asking the wrong questions. Why do we as consumers allow the pharmaceuticals to advertise at all, as well as make huge profits, instead of reducing the cost of medications?

  5. Dreama says:

    Betsy and Rogan: I completely agree with both of you. My mother (a nurse) and I had this discussion a few years back. Because we, as the actual consumer of the medication, do not know the harmful side effects that could be caused to yourself and they don’t mention side effects and adverse interactions with different medications, we (mom and I) thought it was completely unethical of the drug companies to be marketing their ‘products’ to the consumer.
    There are drug representatives who spend countless dollars wining and dining the staff of doctors’ offices who are trained in presenting these drugs to the doctors. This is what they should stick with in our opinion. The drug companies still make millions upon millions of dollars, but we as the consumer, are given the risks and benefits by a trained professional instead of happy puppies and ocean-side views.

  6. Thanks, all, for your comments. A bit of trivia: Only the U.S. and New Zealand allow direct-to-consumer drug ads on television! The practice is banned in all other countries.

  7. Elina says:

    I think that ads have to match the message that they portray. The image of the Lunesta commercial comes to mind. The beautiful butterfly..and the peaceful sleep… No one ever mentions the HUGE side effect profile…it’s gone through very quickly at the end…Freedom of speech has nothing to do with this. As a drug company, you have to market EVERYTHING and not just focus on the positive aspects of the drug. At the end of the day, people are very influenced by advertisements, and yes, someone who is VERY sleep deprived might look at the images and say, “Wow, I can have that!” and not once think about the side effects. Yes, it’s the doctor’s responsibility to counsel patients, but seriously, how many doctors tell patients EVERYTHING there is to know about a prescription? No offense to doctors, but they see you for 5 minutes, and that’s it. Most of the counseling is done by the pharmacists. In the pharmacy, we always hear, “Well, the doctor didn’t tell me that!” or “I take this medication and my doctor didn’t warn me about taking the two together.” So, yes, commercials have to also EMPHASIZE the side effects. I’m all for the FDA doing this….

  8. Judy says:

    Direct-to-consumer marketing of drugs is not only dangerous but also hugely expensive. Drug companies demand extremely high prices for their drugs and justify it with the cost of R&D – but when you look at their financial statements you see what is really costing the big bucks: adverting. Case in point, Pfizer’s PnL for 2010 shows approx. $9.5B in R&D (admittedly a nice chunk of money) but the real whopper are the “Selling General and Administrative” with almost $24B – that’s where advertising is – and of course, other cost associated with selling the drugs.