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With advertising under siege, drug makers rethink their marketing message

Push is on to explain risks better and spur doctor discussions

WASHINGTON -- Lunesta, a new insomnia treatment, blazed into the marketplace this spring.

An army of sales representatives working for Marlborough-based Sepracor Inc. gave 50,000 doctors free samples of the drug, while educational programs introduced it to another 23,000 physicians. Reaching patients through television and print advertising could cost Sepracor as much as $100 million.

The spirited campaign, however, comes as such drug advertising targeted at consumers faces scrutiny from Congress, consumers, and physicians.

Aggressive advertising of questionable drugs, such as the painkiller Vioxx, generated huge profits but exposed thousands of Americans to heart risks, critics say. As Congress mulls changing advertising laws, drug companies already are reconsidering how they market drugs and explain their risks. Some have rolled out new campaigns that sell the company brand, push for more conversations with doctors, and better explain drug risks. The industry's newfound caution has also translated into a dip in drug ad spending in the first quarter of 2005, compared with a 28 percent increase in annual spending for all of 2004.

Earlier this month, the Pharmaceutical Research and Manufacturers of America, the drug industry's lobbying arm, unveiled voluntary guiding principles for advertising. PhRMA's working document includes a request that companies discuss new drugs with doctors before launching advertising targeting consumers.

The guidelines closely followed a US Senate floor speech by Majority Leader Bill Frist, Republican of Tennessee, who derided such advertising, saying it drives a wedge between doctors and patients and increases prescription drug costs. Frist called on the industry to voluntarily ban advertising in the first two years new drugs are sold.

If the voluntary restrictions don't work, Congress should step in, Frist told Senate colleagues.

''There is no question that prescription drug advertising is under a very hot spotlight," said Dan Jaffe, executive vice president of government relations for the Association of National Advertisers. The group's top 100 spenders pay $100 billion on advertising per year.

Jaffe said Frist fired a warning shot, ''rather than shoot at us directly."

While it's unclear whether there are enough votes for Congress to impose limits on direct-to-consumer advertising this session, cracking down on drug advertising places young companies with new products such as Sepracor in a quandary, observers say.

Advertising can educate patients about new drugs, inform them about silent health conditions, and trigger conversations between doctors and patients, proponents say.

But it also increases the number of prescriptions that doctors write. Every dollar spent on drug advertising creates an extra $4.20 in drug sales, a recent Kaiser Family Foundation study found. Doctors also tend to write eight times more prescriptions in a single year for heavily advertised drugs, according to the Government Accountability Office.

The Food and Drug Administration relaxed its rules on drug marketing, which permitted consumer advertising to appear on television beginning in 1997. Claritin, Nexium, and Vioxx were among the drug blockbusters born from that FDA policy shift, said Dr. John Abramson, a clinical instructor at Harvard Medical School and author of ''Overdosed America."

Schering-Plough has pitched its allergy drug Claritin aggressively -- with spending reaching as high as $185 million in one year. At the height of its marketing of the arthritis drug Vioxx, Merck & Co. spent $160.8 million, and AstraZeneca spent $257 million in a single year selling Nexium, its ulcer treatment, to consumers, Abramson said.

''If you look at each of the three, it's unlikely that reasonable people knowing all the facts would conclude that these drugs were worth the amount we were spending on them," Abramson said.

The backlash against such advertising includes doctors themselves. Six resolutions to curb drug ads were forwarded during the American Medical Association's recent annual meeting.

Advertising consultant Frank Ginsberg expects drug companies will generally take a more conservative approach with future ads, but expects little change for Sepracor's advertising blitz.

''Advertising works. Heavy spending works," said Ginsberg, chairman of advertising firm Avrett Free Ginsberg, which has worked on Enterprise Rent-a-Car and Bacardi Rum campaigns.

A former FDA associate commissioner, however, said companies that tread the tried-and-true drug advertising path now do so at their own peril.

''It calls on young companies to be more creative," said Peter Pitts. ''They can't do it the old way. The decks are stacked against them."

In addition to ubiquitous product ads that sell a specific drug, an emerging trend is brand advertising that educates the public about a drug company or a disease while using a recognizable face -- for example, cancer messages from Bristol-Myers Squibb Co. featuring cyclist Lance Armstrong.

''I hope it is a continuing trend. But it will not be a measurable or important trend until significant dollars are put against it," Pitts said.

According to Nielsen Monitor-Plus, such ''house" ads accounted for $68.3 million in spending in the first quarter of 2005. That compares with $986 million spent by companies to advertise specific prescription drugs in the same period.

With or without changes to the law, some drug companies already have shifted advertising messages away from products and toward brands.

Merck is spending roughly $20 million to tell consumers about the role its research played in ending childhood scourges from past generations, including measles, mumps, and rubella. The company says the corporate branding campaign was in the works long before Vioxx became the rallying point for class-action lawsuits and congressional angst about drug advertising.

Forty percent of Merck's new ads also inform patients of programs offering discounted drugs. Patient assistance requests increased 63 percent in June, said Merck spokesman Len Tacconi.

AstraZeneca, whose statin drug was under fire in medical journal articles and congressional testimony, unveiled television ads this spring that use actor Mandy Patinkin to clearly and slowly explain Crestor's risks. In print, a new Crestor ad devotes nearly half the text to the drug's risks.

''They chose to address the risk issue straight on," said Pitts, an AstraZeneca consultant on other issues but not for the Crestor campaign. ''AstraZeneca could have very easily said, 'We're not going to advertise these drugs.' "

Bristol-Myers Squibb has received plaudits for voluntarily banning advertising in at least the first year new drugs are on the market, said spokesman Brian Henry. Two experimental drugs awaiting FDA approval will be affected by the firm's pledge to educate doctors about new drugs before advertising them to patients.

While such advertising has benefits, critics have reservations, said Henry: ''Whatever you do in the future is going to have to marry up those two things."

Diedtra Henderson can be reached at dhenderson@globe.com.

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