An ad for the prescription drug Zoloft asks: "Feeling sad? Anxious? Tired?" Zoloft is sold by Pfizer as a treatment for depression and other disorders. It is but one of many print and broadcast advertisements that pitch prescription drugs directly to consumers - a category of ads scrutinized last week at a hearing held by the Food and Drug Administration.
The two-day hearing, in Washington, was part of the agency's review of the rules governing prescription-drug advertising. Because many of the 29 studies presented at the hearing reported positive public results - like increased communication between patients and doctors - the prevailing prediction among supporters of the ads was that the drug agency would allow the ads to continue in much the same form as today.
"It's rare that you get such validation from a meeting like this," said Dick O'Brien, executive vice president and director for government affairs at the American Association of Advertising Agencies, a longtime advocate for the ads. "This is one where you feel all of a sudden like you're on the side of angels."
"My hope is that these two days were so positive that they may help to put this controversy to bed once and for all."
Even critics were not optimistic that the agency would make significant changes. They said the event, at which research was presented by attendees from Pfizer to Time Inc. to the Mayo Clinic, told just part of the story. Calls for change continued from critics like Senator John Edwards of North Carolina, a candidate for the Democratic presidential nomination.
"Senator Edwards thinks it's misleading for an ad to show a woman running through a field while the fine print says 'may cause serious side effects,' " said Michael Briggs, the senator's press secretary. "The F.D.A. should require drug manufacturers to provide fair and balanced information about a drug's risks as well as the potential benefits."
Meanwhile, though, the ads are the darlings of broadcasting and publishing executives. Even in an uncertain economic climate, spending in the prescription-drug category totaled more than $2.5 billion last year, up from nearly $1.6 billion in 1999, according to TNS Media Intelligence/CMR, part of Taylor Nelson Sofres.
More than just revenue, magazine executives said, the ads even give readers another reason to buy their publications.
"Both the advertising and the editorial product provide information, and that presents a benefit to the reader," said Ellen Oppenheim, executive vice president and chief marketing officer at the Magazine Publishers of America. Even some F.D.A. officials said the meeting showed that the ads can also have public health benefits.
"It's been an incredible sea change, from 'Is it a good thing?' to 'This is a good thing, and how can we make it better?' " said Peter J. Pitts, the drug agency's associate commissioner for external relations.
Making it better might mean communicating risks more effectively, he said: "That's exactly what we're studying now. We're going to try to reach our own judgment on what would be the best path forward." The agency expects to propose any rule changes by the end of the year.
At Pfizer, executives said few if any changes were necessary. "We feel that the regulations are working the way they are," said Dorothy Wetzel, the company's vice president for United States consumer marketing of pharmaceuticals.
"My hope is that whatever comes out of the meeting really advances our ability as an industry to effectively communicate with consumers," she said. "It would be a shame if what comes out makes it more complicated and confusing."
But some critics showed no sign of backing off.
"This is a really unlevel playing field for consumers," said Larry D. Sasich, a research analyst at the health research group of Public Citizen, a consumer advocacy group. "You have an industry that maintains that a 30-second or 60-second television spot empowers consumers to make an informed decision about their drug therapy."
Instead, Mr. Sasich said, the spots play up the promise of the products, leaving consumers on their own to ferret out potential side effects or adverse reactions.
The Washington meeting did not adequately address such issues, said Barbara Mintzes, a post-doctoral fellow at the Center for Health Services and Policy Research at the University of British Columbia in Vancouver.
"The question is: Who was talking?" Ms. Mintzes said. "There were a few people presenting who were independent, but the large majority were either people from the industry or financed by them."
Anyone was welcome to present original research at the meeting, but an open door does nothing to ensure that all the relevent research is included, Ms. Mintzes said.
Linda Golodner, president at the National Consumers League, another nonprofit advocacy group, said that the meeting generally showed that consumers were using the information from ads as a springboard to seek more information. "They are not necessarily demanding the drug, but they want to see if that drug is right for them."
The problem with the ads, Ms. Golodner said, is that in many cases information on effectiveness and potential side effects is too hard to find, in contrast with the marketing claims being made about benefits.
"When risk information is given, an upset stomach is sort of given the same equality of liver damage," she said.
The Consumers League is pushing for rules requiring print ads to include a box summarizing all that information, similar to the nutrition box on packaged food.
But the Consumers League agreed with Ms. Mintzes and Public Citizen that the biggest improvement would be additional money for monitoring of the ads and greater power to punish violators.
Mr. Pitts, the drug agency commissioner, said that the agency constantly reviewed ads and was getting better at it.
Posted on October 2, 2003
Nat Ives, The New York Times. September 29, 2003
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