Accepting the risks

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It's not by coincidence that TV viewers are becoming well acquainted with the negative side effects associated with popular prescription medications.

The recent onslaught in direct-to-consumer advertising is a result of clarification of rules regarding such advertising by the U.S. Food & Drug Administration's Division of Drug Marketing, Advertising and Communications.

In August, DDMAC issued what it calls a "final guidance" for consumer-directed TV advertising, giving drug marketers better direction on what can and should be included in those commercials.

The ads must present balance, with equal time given to both benefits and side effects of prescription drugs advertised by brand name. For example, Xenical, an anti-obesity drug from Hoffmann-La Roche, is forthright about stating what the side effects are, including the "inability to control bowel movements" and "oily spotting." But until the August guidelines, there was considerable confusion about what the FDA would find acceptable for a prescription drug commercial.


"There is a compelling need for manufacturers to use television advertising for prescription medications -- we recognize that -- but they wanted to know how they could be in compliance with our rules for presenting the risk factors," says Nancy Ostrove, DDMAC branch chief. "Companies thought they had to present a more detailed summary than what we actually felt is necessary.

"In 1997, a couple of manufacturers started to ask us how to comply with the rules in broadcast advertising," Ms. Ostrove says. "We said that as long as there is a way to provide adequate provision for the dissemination of product information, broadcast of brand-name prescription drug advertising could proceed."

That 1997 clarification led to an explosion of spending on consumer advertising. Competitive Media Reporting estimated that immediately following the FDA's loosening of restrictions, consumer advertising for prescription drugs hit $100 million per month in 1998 alone.


While CMR data show $1.9 billion was spent on DTC advertising in 1999, Sander Flaum, chairman-CEO at Robert A. Becker Inc., New York, predicts spending in 2000 will leap to about $2.5 billion. That level places DTC pharmaceutical advertising in the top 10 categories of ad spending, and it's only going to continue to grow.

"Two years from right now, I expect that there will be even more prescription drug advertising," says Matt Giegerich, president of Quantum Group, a division of CommonHealth, Parsippany, N.J. The division handles ad accounts for pharmaceutical giants SmithKline Beecham and Schering-Plough Corp., among others.

"What's on the air now is only a tiny portion of what's still to come," he adds.

While consumers are directed to healthcare providers for more information about prescription drugs, they also get an earful, and eyeful, from ads on the pros and cons.

These prescription drug spots reel off seemingly endless lists of possible side effects: BuSpar, the general anxiety disorder remedy from Bristol-Meyers Squibb Co., lists excitement, dizziness, nausea, lightheadedness, headache and nervousness, while Vioxx, an arthritis pain reliever from Merck & Co., is upfront about the risk of serious, but rare complication of sudden bleeding that can lead to hospitalization or death.

"At times, it can seem like we're giving consumers more information than might be necessary, but yes, consumers do want to be fully informed, and that includes both the benefits and the risks," says Tom Lom, managing director, Saatchi & Saatchi Healthcare Connection, New York, which handles Glaxo Wellcome's Relenza flu remedy, among other brands.

"Sure, the transition between the benefits of the drug and the risks can be jarring. It can push the envelope of good taste, but consumers demand that kind of upfront information," says Steve Kaplan, CEO, Bounty SCA Worldwide, Glenview, Ill., a marketing services agency that specializes in healthcare.


A 1999 Prevention "DTC Monitor" survey indicated more respondents than in 1998 said that TV commercials now are doing a good or excellent job of communicating risks associated with prescription drugs. Prevention's study also found that 56% of consumers believe TV ads provide adequate information concerning risks and side effects, compared with 49% in 1998.

"Side effects vary from drug to drug, and it's to the consumer's benefit that we share with them what are the most common side effects," a Glaxo Wellcome spokesman says.

Those side effects cannot be glossed over, nor can advertisers try to mask the rundown of the side effects by speeding up background music, adding distracting visuals or increasing the rate of the voice-over copy. Roche was reprimanded by the FDA when ads for fat-blocker Xenical, created by Lowe & Partners, New York, used distracting music to drown its list of gastrointestinal and other side effects, says the FDA. The music was toned down in later ads.

"The scrutiny is just so intense from the FDA as well as internal company reviewers that the chance of something like that slipping through is, well, minimal," says Mr. Giegerich. "All of the broadcast advertising is reviewed very intensely, with attention paid, frame by frame, to the balance of the benefits and the side effects."

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