CORRECTION APPENDED

The billions of dollars that power television drug advertisements may have been spent in vain, according to a study released by Harvard Medical School.

In the first controlled study of direct-to-consumer advertising by pharmaceutical companies, researchers at the Medical School found that such marketing has a modest effect, if any at all, on drug sales.

The U.S. and New Zealand are currently the only counties that do not ban drug companies from directly advertising their products to consumers. The Food and Drug Administration loosened pharmaceutical advertising restrictions in 1997, and pharmaceutical research companies now spend $4.8 billion per year on DTCA.

Proponents of such advertising point to studies that imply a correlation between ads and increased sales, but Medical School professor Stephen B. Soumerai, who is the principal investigator of the study, said that the conclusions were based on “scant data.” [CORRECTION BELOW]

Soumerai’s findings, published last Tuesday on the Web site of the British Medical Journal, show little or no effect of advertising on prescriptions and fuel the ever-controversial debate on DTCA.

THE SCIENTIFIC METHOD

In conducting their research, Soumerai and his colleagues were confronted with the problem of finding two comparable groups, one exposed to pharmaceutical advertising and the other free from such influence.

The answer lay some several hundred miles north of Boston.

While direct advertising is illegal in Canada, Michael R. Law, one of the paper’s authors and a research fellow at the school’s department of Ambulatory Care and Prevention, recalled that as a child growing up in Toronto, he would frequently see advertisements for prescription drugs while watching American television programs. [CORRECTION BELOW]

The researchers then compared prescribing behavior of French-speaking Quebec residents, who only tune in to American channels five percent of the time, with those living in English-speaking Canada, who are estimated to spend about 30 percent of their time in front of the television watching American shows.

Soumerai and Law focused on three drugs—Enbrel, Nasonex, and Zelnorm—all of which had been on the market for at least one year before the advertisements started popping up on television. The researchers then analyzed prescription statistics of these drugs from a five-year period using information from IMS Health Canada, a health information company that compiles data from about 2,700 Canadian pharmacies.

The research, which was funded by the Medical School and Harvard Pilgrim Health Care, among other sources, showed that for two of the drugs, direct advertising had no impact on prescription patterns for either group. Sales for Zelnorm did experience a short-lived spike at the start of the marketing campaign, but fell back to a similar prescription rate after a few years.

“The basic message from what we see from these three drugs,” Soumerai said, “is that the major campaigns that cost hundreds of millions of dollars had very unimpressive effects on physicians prescribing these products.”

JUST SAYING NO

Although the study may now undercut the arguments of DTCA opponents who have long claimed that direct advertising leads to drug misuse by impressionable patients—as prescriptions remain unaffected by the advertisements, both Soumerai and Law said that the costly practice should be banned in the U.S.

While proponents argue that direct advertising is purported to increase consumer awareness of potential health problems, Soumerai said that as it is a form of advertising, it is difficult to determine to what extent such advertisements are “appropriate.”

“It might not work so well,” Soumerai said, listing what he felt were the three main problems of direct advertising. “It potentially wastes billions of dollars, and—the biggest problem of all—it wastes physicians’ time.”

Soumerai said that many patients come into the doctor’s office asking about drugs they have seen advertised on television and that 15 minutes of a typical primary care visit are spent discussing a drug that the physicians do not end up prescribing.

“It’s remarkable that this study says that [physicians] are not just caving in to patient demand,” Soumerai said.

The Pharmaceutical Research and Manufacturers of America, a industry trade group representing pharmaceutical and biotechnology companies, issued statement yesterday lauding the positive effects of direct advertising.

“DTCA can be a valuable source of patient education,” senior vice president Ken Johnson said in the statement. “DTC ads increase awareness of disease and foster critical dialogues with physicians.”

Johnson alluded to surveys that show that direct advertising brings patients into their doctors’ offices about conditions that might otherwise go undiagnosed or untreated.

But Soumerai said that even if direct advertising raises patient awareness, there have been no behavior changes in the drugs physicians prescribe.

When asked if PhRMA member companies will continue to invest in direct advertising, spokesman Jennifer Page said that PhRMA has no knowledge of the companies’ business decisions due to federal anti-trust laws that prohibit collusion on business practices.

Several national drug companies did not return calls for comment.

But Soumerai added that several drug company executives have e-mailed him following the publication of his study admitting that they also think that the research supporting the effectiveness of DTCA is “extraordinarily weak or nonexistent.”

THE COSTS OF ADVERTISING

Because the research indicates that billions of dollars are wasted on crafting drug advertisements, Soumerai suggested that the cost of producing these advertisements translates into higher drug costs.

In a survey conducted jointly by USA Today and researchers at the Kaiser Family Foundation and the Harvard School of Public Health released in March, the majority of Americans also believe that prescription drugs cost too much money.

Only 18 percent of respondents said that they feel the cost of such drugs as “reasonable,” while 79 percent state otherwise.

The same poll found that 77 percent of respondents agree that “the cost of advertisements makes prescription drugs too expensive.”

Soumerai said that the FDA is looking into further regulation of direct advertising as a potential way to reduce the cost of prescription drugs.

—Staff writer June Q. Wu can be reached at junewu@fas.harvard.edu.

CORRECTION

The Sept. 11 story, "HMS Study Finds No Influence from Direct Drug Ads," misstated the roles of the two authors of the study in question. Harvard Medical School professor Stephen B. Soumerai was the co-author, not the principal investigator. The study was in fact the doctoral dissertation of Michael R. Law, who was the paper's primary author. The error was a result of erroneous information provided by the Medical School's communications office.