FDA is pressuring drug companies to get serious.
The News Journal (Wilmington, Delaware)
May 9, 2005 Monday
LENGTH: 1340 words
By RICHARD SINE
The News Journal
For its previous TV ad for cholesterol dampener Crestor, AstraZeneca PLC tapped actor Patrick Stewart, who once enchanted audiences with his one-man performance of "A Christmas Carol."
The ad evoked the fairy tale feeling of the show. Stewart intoned Crestor's virtues in rhyming prose as one patient's story was accompanied by gauzy special effects and whimsical music.
Since then, it appears, the Ghost of Christmas Future has taken AstraZeneca on a little tour.
The new Crestor ad features Mandy Patinkin, who played a doctor on the television series "Chicago Hope." Debuting last month, it is rhyme-free, whimsy-free, and somewhat less special in its special effects.
While AstraZeneca is one of the first drug companies to sober up its advertising, it likely won't be the last, drug marketing experts say.
Controversies over marketing and safety have damaged the industry's reputation. Meanwhile, the U.S. Food and Drug Administration is clamping down on companies that underplay the risks of their drugs in ads.
So the pressure is rising on drug companies to stop selling drugs the way other firms sell toothpaste.
"I fervently hope that companies will see the writing on the wall and get serious about their ads," said Jack Angel, owner of health marketing firm Greenwich Communications in Greenwich, Conn. "Companies that continue on their merry way and wait for the FDA or Congress to act are going to be very disappointed."
The original Crestor TV ad was devised as AstraZeneca - which has its U.S. headquarters in Fairfax - sought a way to distinguish its new cholesterol drug that was entering an already crowded field.
"When Crestor performed in a head-to-head test, its lowering effect was clearly the best," Stewart rhymed.
Sales slowed, however, after health advocacy group Public Citizen called for Crestor's withdrawal, claiming high rates of serious side effects.
The company pulled the TV ad in December as the public was reeling from the withdrawal of the popular arthritis drug Vioxx and suspicions emerged about other drugs such as Celebrex and Bextra.
The spectacle of heavily advertised drugs suddenly coming under scrutiny has led some people to conclude that drug companies had become little more than amoral drug pushers.
"The ads make it seem like you can go and just pick up the drug," said Jane Sanna, a receptionist shopping at Newark's University Plaza last week. "Like you don't even need an exam."
Federal pressure
Since the Vioxx debacle, some in Congress have criticized the U.S. Food and Drug Administration for lax oversight of drug marketing. The FDA responded by sending out more letters demanding withdrawal of drug ads it dubs misleading.
In March, the Crestor ads were targeted. An FDA regulator said the "head-to-head test" that Stewart cited did not in fact prove that Crestor was "clearly the best." In fact, a higher dose of competitor Lipitor could beat out lower doses of Crestor, the regulator said.
AstraZeneca also pulled its print ads for Crestor, which cited the study and used a rhyming style.
Though the FDA didn't criticize the tone of the Crestor ads, it clearly signaled that tone matters, especially when it comes to how risks are presented.
In March, an FDA official speaking at a national conference of drug marketing executives replayed an ad in which a voice-over described risks as a woman played with a cute dog. That approach was unacceptable, she said.
"Rufus is adorable," said the official, Kathryn Aikin, as reported in The Boston Globe. "But Rufus is adorable during the risk information."
Crestor's new ads follow the FDA's lead both in tone and content. They don't cite the head-to-head study attacked by the FDA. And the risk information - previously murmured by an anonymous voice actor - is now enumerated by Patinkin himself.
David Brennan, AstraZeneca's chief executive in the United States, said the new ads emerged after the company decided to "re-evaluate our principles" during the safety controversy over Crestor.
Drug ads changing
Johnson & Johnson, the New Brunswick, N.J., maker of Tylenol, has led the way in changing the style of drug ads, industry observers say.
In a sort of anti-ad that aired last fall, a Johnson & Johnson executive declared that if patients weren't going to read the label on Tylenol, she'd prefer they didn't take the drug. More recent ads for the company's drugs feature real doctors, not actors, speaking frankly about risks.
Johnson & Johnson Chief Executive William Weldon in March became chairman of the Pharmaceutical Research and Manufacturers of America, the drug industry's principal trade group. As he accepted the job, he told drug executives that advertising would have to start emphasizing education to forestall regulation that might put an end to consumer advertising.
"It was a challenge to the rest of the industry," John Mack, editor of industry newsletter Pharma Marketing News, said of Weldon's testimony. "So far, the jury's out on whether they will follow his lead."
But with multimillion-dollar ad campaigns being launched to drive billions in sales, the question remains whether drug firms can afford to soften their pitches.
In a survey, Mack found that most drug marketers felt that advertising should be steered back toward education.
But only a chief executive can set that direction, Mack said. Among marketers, "nobody wants to put their career on the line and get poor results."
Effective advertising
AstraZeneca is certainly hoping to boost sales for Crestor. It is still aiming to capture a fifth of the $20 billion market for so-called statin drugs.
In March, the FDA reaffirmed Crestor's safety. As a result, some analysts have suggested the time is right for a big advertising push for Crestor.
But by releasing a more conservative ad, AstraZeneca could blunt the effect of its new campaign, said Harry Sweeney, chief executive of Dorland Global Health Communications in Philadelphia.
"With the previous ad, that little bit of poetry made it stand out from the pack. I don't know if this new one will be as effective."
Cornered into producing ads that are little more than bland and highly cautionary presentations, some companies may decide to stop advertising drugs on television altogether.
TAP Pharmaceuticals disclosed last month that it had pulled its $100 million TV advertising campaign for heartburn drug Prevacid. The company will instead focus on print media because it gives more space to explain the drug's risks, a spokeswoman said.
It's too early to tell whether this decision forebodes a trend. Drug advertising expenditures for early 2005 show a small decrease in advertising on network television but a large increase in cable TV spending, according to TNS Media Intelligence, a market research firm.
A big advertising decrease would be a blow to cable and network TV, which attracts about two-thirds of drug advertising dollars. Worst hit would be network TV news, which receives about a third of its ad revenues from drug ads, Advertising Age magazine reports.
Dawn Smithson, a Newark mortgage broker, said she couldn't recall the risk information in most TV ads and would favor a clearer presentation of risks. But she once switched drugs after seeing an ad.
"It showed me there was another option in addition to what the doctor told me," she said.
Jayne Riley, a Newark office manager, would be happy to see all the ads disappear.
"They give people the idea they can medicate themselves," Riley said. "That should be between the doctor and the patient."
Contact Richard Sine at 324-2878 or [email protected].
AT A GLANCE
Arthritis drug Vioxx is pulled from the market in September.
The FDA demands withdrawal of misleading drug ads.
In March, Crestor ads are targeted. FDA said the ads did not prove Crestor was "clearly the best."
AstraZeneca pulls print ads (TV ads already had been pulled).
New Crestor ads meet FDA's new guidelines for tone and content.
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