By Shankar Vedantam and Marc Kaufman
Washington Post Staff Writers
Wednesday, April 27, 2005
Actors pretending to be patients with symptoms of stress and fatigue were five times as likely to walk out of doctors' offices with a prescription when they mentioned seeing an ad for the heavily promoted antidepressant Paxil, according an unusual study being published today.
The study employed an elaborate ruse -- sending actors with fake symptoms into 152 doctors' offices to see whether they would get prescriptions. Most who did not report symptoms of depression were not given medications, but when they asked for Paxil, 55 percent were given prescriptions, and 50 percent received diagnoses of depression.
The study adds fuel to the growing controversy over the estimated $4 billion a year the drug industry spends on such advertising. Many public health advocates have long complained about ads showing happy people whose lives were changed by a drug, and now voices in Congress, the Food and Drug Administration and even the pharmaceutical industry are asking whether things have gone too far.
Nearly every industrialized country bans such advertising, and physicians said the new study raises new questions.
"It is a haphazard approach to health promotion that is driven primarily by the pharmaceutical industry's interest in turning a profit," said Matthew F. Hollon, an internist at the University of Washington in Seattle, who wrote an editorial accompanying the study in today's Journal of the American Medical Association. "The most overlooked problem in the health care system today is the extent to which it is permeated by avarice."
Hollon and the researchers who conducted the study said it was not realistic to expect such marketing to be abolished, given the climate of deregulation in Washington. But they said the ads should be tempered by educational messages funded by a tax on the industry and better training of doctors, or by a moratorium on ads for new drugs until their risks are fully known.
"We can do a much better job with the advertising," agreed W.J. "Billy" Tauzin, president and chief executive of the Pharmaceutical Research and Manufacturers of America (PhRMA). "The ads can do a great job making sure people who need medications and are undertreated get help. We can also make it clear that a particular product is meant for people with this particular problem and for those people only."
The study found that the ads did help patients with a stigmatized illness such as depression get treatment, even as they prompted overmedication of people who did not need treatment. Such marketing in effect exploits the diagnostic gray zone that characterizes many conditions in medicine, including heartburn, arthritis and allergies.
"There is a segment of individuals who would really benefit from pharmacological therapy; there is another large group that won't," said Richard L. Kravitz, lead author of the study and a professor of medicine at the University of California at Davis. "The easiest thing from a marketing standpoint is to increase use in all the categories, and that is what we are seeing."
The researchers sent actors with hidden tape recorders into general physicians' offices in three cities between May 2003 and May 2004. The physicians had previously consented to participate but were not told when they would be tested.
Half the actors simulated patients suffering from depression, describing lengthy periods of sadness, low energy, poor appetite and sleep, and early-morning awakening. The others described having suffered a career upheaval and having fatigue, stress and difficulty sleeping, symptoms that did not warrant medication.
More than half of those without simulated depression who mentioned Paxil got a prescription, underscoring how willing doctors are to go along with patients' requests.
Concerns have recently grown about the safety of antidepressants after disclosures that the pharmaceutical industry withheld studies that found the drugs were no better than sugar pills. The FDA recently concluded that the drugs increase suicidal thinking and behavior among children and required them to carry black-box warnings -- which have greatly reduced direct-to-consumer advertising of such drugs.
Advertising could be useful for drugs with large benefits and few risks, said researcher Ronald M. Epstein, but the industry's bias against negative studies raises questions about which drugs ought to be marketed in this fashion. Epstein is a professor of family medicine at the University of Rochester.
Nancy Leone, a spokeswoman for GlaxoSmithKline PLC, the maker of Paxil, said physicians are not unduly influenced by ads, and denied that such "education campaigns" lead to inappropriate prescribing. It was "difficult to draw conclusions" about the new study, she said, because Paxil was not being heavily advertised during the study period.
In his editorial, Hollon said 80 percent of physicians believe such ads prompt patients to seek medications they do not need, and less than 10 percent believe the ads are a good thing.
Johnson & Johnson's chief executive, William C. Weldon, now chairman of the PhRMA board, said last month that the industry ought to revise its approach to drug ads because they "may inadvertently minimize the importance and power of medicines and their risks."
Direct-to-consumer (DTC) advertising soared after the FDA allowed drug promotions on television for the first time in 1997. Efforts to limit such advertising have run afoul of Supreme Court rulings protecting commercial speech.
The ads are regulated by the FDA's Division of Drug Marketing, Advertising and Communications. The office, which has barely three dozen employees, must review 30,000 to 40,000 ads a year. Acting commissioner Lester M. Crawford said recently that "our patience is sometimes worn thin" by the advertising claims.
Dan Troy, chief counsel for the FDA in President Bush's first term and now with a Washington law firm, said laws on drug advertising written by Congress in the 1960s have made it difficult to change policy. He added that most FDA professionals were "quite pro-DTC."
PhRMA's Tauzin said companies are working on a new code of conduct that would be preferable to federal regulation.
The FDA has moved against scores of ads that it found to be inaccurate or misleading. In 2001, it warned Merck and Co. that its ads for the arthritis drug Vioxx were misleading and did not adequately warn viewers of cardiovascular risks. After Merck took Vioxx off the market last September, Pfizer Inc. aggressively increased advertising for its competing painkiller, Celebrex, but also got a warning from the FDA.