WEDNESDAY, Aug. 15 (HealthDay News) -- Drug company spending on direct-to-consumer advertising continues to skyrocket, even as criticisms against it have soared.
Calling for a moratorium, rather than just restrictions, on such advertising might be in order, say the authors of a study in the Aug. 16 issue of the New England Journal of Medicine.
"Direct-to-consumer advertising spending is increasing in terms of its share of total marketing budget, but it's still a smaller share relative to promotion aimed at influencing prescribers," said study author Julie M. Donohue, an assistant professor of health policy and management at the University of Pittsburgh Graduate School of Public Health.
The U.S. Food and Drug Administration started allowing direct-to-consumer advertising of prescription drugs on television 10 years ago.
Since that time, spots of Dorothy Hamill and Sally Field peddling Vioxx and Boniva, respectively, cartoon characters illustrating the effects of the antidepressant Zoloft, and a wide range of similar promotions have become commonplace on American TV screens and in other media.
But so, too, has criticism of the practice. Skeptics say that direct-to-consumer advertising encourages overuse of medications and drives up drug spending.
The controversy reached critical proportions when the arthritis drug Vioxx, one of the most heavily promoted medications ever, was withdrawn from the market in 2004 because of serious cardiovascular risks.
"It's been 10 years since the FDA clarified its policy with respect to broadcast advertising and unleashed direct-to-consumer advertising on television, which was new," Donohue said. "We wanted to see, in the wake of the Vioxx withdrawal and an increased focus on the safety of drugs and a focus on drug costs in light of the implementation of the new Medicare drug benefit, what industry and the FDA were doing with respect to advertising."
For this analysis, Donohue and her colleagues looked at pharmaceutical company spending on direct-to-consumer advertising and promotion to physicians over the past decade.
Total pharmaceutical industry spending on promotion soared from $11.4 billion in 1996 to almost $30 billion in 2005. During that time, spending on direct-to-consumer advertising increased by 330 percent, yet this type of advertising only made up 14 percent of total promotional expenditures.
These mass-media advertising blitzes generally start before a drug's safety track record has been established in the marketplace, the researchers said.
"For the majority of heavily advertised drugs, direct-to-consumer advertising starts within about a year of FDA approval and typically well before the safety profile has been established," Donohue said.
The most heavily marketed drug in 2005 was that "little purple pill," Nexium, a proton pump inhibitor heartburn drug, on which AstraZeneca spent $224 million. Next came the sleeping pill Lunesta ($214 million), followed by the cholesterol-lowering statins Vytorin ($155 million) and Crestor ($144 million), then Advair, a corticosteroid ($137 million). Viagra was 17th on the list, with $80 million spent in 2005.
Eight of the top 10 drug classes in terms of sales had at least one product that was promoted through DTC advertising. Manufacturers of proton pump inhibitors, statins and erythropoietin medications (drugs such as Procrit, which increase red blood cell counts) spent 34 percent, 34 percent and 31 percent of their total marketing budget on direct-to-consumer advertising in 2005, respectively.
"In the majority of top-selling classes, at least one drug is advertised to consumers and in more than half of the classes multiple drugs are advertising to consumers, so it really does play a major role," Donohue said. "DTC advertising is used for a small subset of drugs, whereas other forms of promotion like 'detailing' [person-to-person meetings] and free samples are used by manufacturers for virtually all branded products."
The antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which include Celexa, Paxil, Prozac and Zoloft, led the field in promotional spending with more than $1 billion spent in 2005. Next were statins ($859 million), then proton pump inhibitors ($884 million).
At the same time, Donohue stated, "The FDA's monitoring of drug advertising has not kept pace with the volume of advertising of prescription drugs. The number of warning letters going out to drug companies has decreased markedly [from 142 in 1997 to 21 in 2006], and the number of FDA staff responsible for ads was relatively flat in recent years, in spite of spending increases."
It may be that the rules themselves are sufficient, but that enforcement powers are not.
"My view is that the advertising regulations that are on the book now are adequate. Prescription drug ads are among the most heavily regulated advertisements if you look at all other consumer products," Donohue said. "But the enforcement of the regulations needs to be there as well, and resources necessary for reviewing advertisements need to be adequate."
"And drug manufacturers do not have to have FDA approval of advertisements before airing them, so an ad campaign can run its course before the FDA is able to review the ads," she added.
In response to the study, Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA), said in a statement: "DTC advertising has been shown to play a key role in educating and empowering patients, improving patient understanding of disease and available treatments, and fostering strong relationships between patients and their health-care providers. Unfortunately, the study published today in the New England Journal of Medicine all but overlooks these important contributions to patient health."
"Surveys show that DTC advertising brings patients into their doctors' offices and helps start important doctor-patient conversations about conditions that might otherwise go undiagnosed or untreated. In fact, a national survey by Prevention Magazine found that 29 million patients talked to their doctor for the first time about a health condition after seeing a DTC ad. The survey also found that of these patients, most discuss behavioral and lifestyle changes and more than half receive a recommendation for nonprescription or generic alternatives," the statement said.
Dr. A. Mark Fendrick, a professor of health management policy at the University of Michigan School of Public Health in Ann Arbor, said: "As the health-care consumerism movement encourages more data on cost and quality, it is increasingly important to consider the source of information."
"This study confirms that direct-to-consumer advertising of drugs is here to stay and will contribute to the information overload confronted by the typical consumer. Patients, clinicians and payers should work together to implement measures to maximize the positive aspect of DTC advertising -- increased use of drugs in those most likely to benefit -- while minimizing the safety concerns and unnecessary expense of inappropriate use," he said.
There's more on the impact of direct-to-consumer advertising at the Kaiser Family Foundation.
SOURCE: Julie M. Donohue, Ph.D., assistant professor, health policy and management, University of Pittsburgh Graduate School of Public Health; A. Mark Fendrick, M.D., professor, internal medicine, University of Michigan School of Medicine, and professor, health management and policy, University of Michigan School of Public Health, Ann Arbor; Aug. 15, 2007, prepared statement, Ken Johnson, vice president, PhRMA, Washington, D.C.; Aug. 16, 2007, New England Journal of Medicine