FDA to begin talks today on safety questions, calls for changing ads

Taking the word of celebrities on drugs you'll take

November 01, 2005|By THE BOSTON GLOBE

WASHINGTON -- Not long after winning the Tour de France for the seventh time, cancer survivor Lance Armstrong led cyclists on a 3,300-mile trek, sponsored by drug manufacturer Bristol-Myers Squibb Co., to promote 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 today and tomorrow that could produce the first significant changes to drug advertising after months of criticism from Congress and other groups.

Some contend Vioxx advertisements featuring Baltimore resident Dorothy Hamill, the Olympic figure-skating gold medalist who has arthritis, helped lead to 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 in Nashville, Tenn.

"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 lobbying group.

Tauzin, the former Louisiana Republican congressman, 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," Tauzin said.

Celebrity drug pitches previously generated enmity when stars appeared on television talk shows and told how various treatments helped them without mentioning that 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 vice president of consumer marketing for Parke-Davis.

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 volunteered in June to delay consumer advertising for at least a year after the FDA approves its drugs. Some in Congress are pushing for tougher restrictions, 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 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 Rep. Rosa DeLauro, a Connecticut Democrat, 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 Tennessee Republican and 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.

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