(HealthScoutNews) -- Drug makers tripled their spending on ads pitched directly to consumers between 1996 and 2000, but the dramatic increase doesn't appear to be connected to a 1997 government policy that gave pharmaceutical firms more latitude to market their products to the masses.

Spending on consumer ads rose from roughly $800 million in 1996 to nearly $2.5 billion in 2000, according to a new study that appears in tomorrow's issue of the New England Journal of Medicine.

That direct-to-consumer ad spending should be increasing is no surprise. The trend has been clear for nearly a decade. However, the U.S. Food and Drug Administration (FDA) took heat for its 1997 marketing guidelines that critics said were too lenient to industry. That policy -- which the agency considered a "clarification" of its rules -- would lead to a flood of ads aimed at vulnerable consumers with little means of distinguishing fact from hype, skeptics claimed.

However, the result hasn't been quite as bad as some had feared.

"This really isn't as story about deregulation," says Meredith Rosenthal, a health economist at the Harvard School of Public Health and lead author of the study. Direct-to-consumer marketing "has been growing very rapidly" on its own for some time, she notes.

The 1997 policy does appear linked to one dramatic shift: Before the clarified rules, spending on print ads and other materials dwarfed that for television campaigns. However, drug makers spent more than $1.5 billion on TV pitches by 2000, compared with $893 million on the rest of their patient marketing efforts.

Still, those amounts make up only a small fraction of the total marketing budgets of drug firms, the bulk of which is aimed not at patients but at doctors. In 2000, for example, drug companies spent more than $13 billion on professional marketing materials, including nearly $8 billion in free samples and $4 billion in office-based promotions.

Consumer ads have increased as a percentage of sales, from 1.2 percent in 1996 to 2.2 percent in 2000, the study shows. However, even the higher number is well below the 11.8 percent figure in 2000 for professional marketing efforts. Total promotional spending by drug companies hovered around 14 percent of sales during the study period, while rising from $9.1 billion to $15.7 billion.

As other research has shown, drug companies devote the lion's share of their direct-to-consumer dollars to a relatively few products. The latest study confirms those reports, finding that in 2000, 20 drugs accounted for nearly 60 percent of the marketing budget for consumer ads.

Rosenthal says most of the drugs on the list have a few mild side effects, and can be taken by a wide range of patients.

"You don't really want to be advertising a drug that has a lot of potential hazards. It doesn't sound that good," she says. In addition, many drugs, such as antidepressants, treat conditions clouded by embarrassment and low diagnosis rates.

Rosenthal and her colleagues also looked at whether drug companies push members of select classes of medications. However, the answer seems to be no.

"Compared with professional promotion, where all drugs in a given class have relatively similar levels [of spending], it appears when you look at them that there's a lot of variation within class" for consumer advertising, she says.

Steven Findlay, of the National Institute for Health Care Management Foundation, says the trends reflect the drug industry's approach of jumping into the direct-to-consumer marketing waters -- with one foot.

"They're taking a few of their big and most salable products to a broad base of the public," says Findlay, who has studied the phenomenon. "They don't have endless ad budgets, and they can't afford to spend $150 million on every one" of their drugs.

In a separate article in the journal, two Harvard researchers express concern about the medical device industry's aggressive promotion to consumers of certain screening tests. They point to two technologies, both of which involve CT scans, for artery disease and various cancers, which people are encouraged to seek despite no data supporting their usefulness.

"We have serious reservations about the clinical, financial and ethical implications of offering these tests as screening interventions that are marketed directly to consumers," write the authors, Drs. Thomas Lee and Troyen Brennan.

The drug industry says the surge in direct-to-consumer marketing is a boon for both doctors and patients.

"The physician-patient relationship is strengthened, not weakened" when advertisements prompt patients to discuss a condition for the first time, writes Alan F. Holmer, of the Pharmaceutical Research and Manufacturers of America in Washington, D.C. Marketing materials promote patient education, he argues, and prescription drugs "are often the most effective and least expensive form of health care."

However, consumer advocates take a dimmer view.

"Although increased access by patients to accurate, objective information about tests to diagnose and drugs to treat illnesses is an important advance, confusion arises when commercially driven promotional information is presented as educational," writes Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, a Washington, D.C., nonprofit organization.

Spending on prescription drugs is the fastest-growing segment of the health-care economy. While spending on ads to consumers has soared, Wolfe writes, the FDA's ability to adequately police the claims has waned.

Wolfe calls the agency's marketing oversight division "grossly understaffed," and notes that since 1998 the number of enforcement actions it has taken has fallen sharply -- from 158 to 73 in 2001 -- even as drug ad budgets have ballooned.

Findlay says his group is "agnostic" on the debate over whether direct-to-consumer ads do harm.

"They could be playing a very beneficial educational and informational public health rose, or they could well be leading to an increase in inappropriate demand and inappropriate prescriptions," he says. "We simply just don't know."

What To Do

To find out more about medications and how they're regulated, visit the FDA.

You can also check out kaisernetwork.

For the industry's perspective, try the Pharmaceutical Research and Manufacturers of America.

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