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Rise of celebrity testimonials spurs FDA scrutiny

WASHINGTON -- Crowds lined roadways here this month to watch seven-time Tour de France winner and cancer survivor Lance Armstrong lead cyclists on the final leg of the Tour of Hope ride. The 3,300-mile trek, sponsored by drug manufacturer Bristol-Myers Squibb, promoted clinical trials for new cancer drugs. Armstrong is a fixture in the company's print advertising campaigns to raise awareness of the disease.

For now.

The Food and Drug Administration will hold meetings Tuesday and Wednesday that could produce the first significant changes to drug advertising after months of criticism from Congress and other groups. Some say Vioxx advertisements featuring Olympian Dorothy Hamill, who has arthritis, fueled an excessive number of prescriptions before the painkiller's heart risks became known, potentially imperiling millions.

Among the FDA's questions: Do testimonials by celebrities mislead the public about prescription drug safety?

''It's hard to imagine a setting in which a celebrity endorsement of a drug conveys any meaningful information to patients in terms of either efficacy or side effects," said Dr. Alastair J.J. Wood, associate dean of Vanderbilt Medical Center.

''I don't think the messenger is what potentially presents a 'good' or 'misleading' message. It's the message. That's what you've got to focus on," said Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, known as PhRMA, the drug industry's Washington, D.C., lobbying group. Tauzin is also a cancer survivor who says drug companies saved his life. ''Frankly, I think patients delivering the message are the best ones. They tell real stories. They can talk from some experience," he said.

Celebrity drug pitches previously generated enmity when stars appeared on television talk shows and told about how various treatments helped them, without mentioning they had been paid by drug companies to make the glowing endorsements.

''That was a practice that got the drug industry a lot of bad press. And rightly so," said Bob Ehrlich, former Parke-Davis vice president of consumer marketing.

Bristol-Myers Squibb hopes the FDA distinguishes between questionable past practices and current advertisements that harness celebrity star power to raise awareness of health conditions affecting millions.

''Lance has been used in corporate advertising relative to the BMS brand, not in product advertising," said Tony Plohoros, a company spokesman. ''We believe there is a significant difference in advertising that focuses on corporate brand building, or disease awareness, versus individual product advertising."

The New York company in June volunteered to delay consumer advertising for at least a year after the FDA approves its drugs. Some in Congress are pushing for tougher advertising curbs, including a bill that calls for a three-year moratorium on advertising for most new drugs. A voluntary code crafted by the industry does not set a specific time frame but suggests, for many drugs, that companies educate doctors before they advertise to patients.

PhRMA's Tauzin says the three-year ad ban backed by US Representative Rosa DeLauro, Democrat of Connecticut, would be excessive for such remedies as an experimental drug that has shown great promise in preventing cervical cancer.

''Do you think anybody ought to wait three years before telling people? I want my daughter to know about that right away," Tauzin said. ''If it's a medicine for the sniffles," he said, a delay might not be unreasonable.

''If it's a medicine that makes a difference in whether you're going to get cancer or not, you probably ought to get it out a little quicker," Tauzin said.

Andrew McDonald, a ThinkEquity Partners analyst, estimates the industry would lose $7 billion to $9 billion if a two-year ban on drug ads floated by US Senate majority leader Bill Frist is endorsed by Congress.

Because drug companies have a First Amendment right to commercial speech, many say modest tinkering by the FDA is more probable.

For every $1 a pharmaceutical company invests in advertising to consumers, it rings up $4.20 in prescription drug sales, according to a recent Kaiser Family Foundation study.

A firm that matches stars with drug companies said celebrities make advertising returns more lucrative. Drug companies that pay $200,000 to $1 million to include a celebrity in a product campaign receive $10 for every dollar spent, said Mick Kleber, who runs Spotlight Health's celebrity division.

The Los Angeles company was behind the 1999 live web broadcast of singer Carnie Wilson's gastric bypass surgery. The previous year, 19,000 opted for the surgery. A year after Wilson's surgery, the number was 100,000, Kleber said.

Ehrlich, who marketed Lipitor when Parke-Davis launched what would become the nation's best-selling drug, said there is little evidence that celebrity pitches are more effective than other advertising. In fact, one company replaced a star with a patient who proved to be more popular with consumers.

Allergan dropped actress Janine Turner as its spokeswoman for Restasis, a remedy for chronic dry eye. Now, Ashley Campbell, a previously anonymous Restasis user, is the smiling face patients see when they visit the drug's website. Market research indicated consumers reacted more positively to ''someone they could relate to," said Heather Katt, an Allergan spokeswoman.

But Ehrlich, Kleber, and the FDA all agree that no one raises disease awareness better than a bigger-than-life star.

Ortho Biotech Products, a Johnson & Johnson subsidiary that makes Procrit, an anemia drug used by kidney disease patients, tapped NBA star Alonzo Mourning to spread the word about the health condition that almost ended his career. Lorraine Bracco, who plays a psychiatrist on HBO's ''The Sopranos," discussed her depression in advertising sponsored by Pfizer Inc. Actress Cheryl Ladd addressed menopause in a campaign funded by Wyeth. And former New York mayor Rudy Giuliani suggested men of a certain age get checked for prostate cancer, following in the footsteps of former US senator Bob Dole, whose appearances in Viagra ads are credited with persuading more men to discuss erectile dysfunction with their doctors.

Drug manufacturers have increased spending on such disease-awareness campaigns this year, according to Nielsen Monitor-Plus.

In the first eight months of 2005, companies spent $273.6 million advertising their corporate brands and building disease awareness, with $43.4 million spent in August compared with $24.5 million spent in January. They devoted another $3.4 million to campaigns, like the ads featuring Bracco, that pointed consumers to brand or disease awareness websites, with $2.2 million spent in August compared with $354,252 spent in January.

That is still dwarfed by the $2.8 billion the industry devoted to traditional product-specific drug advertising from January to August.

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


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