Does DTC Advertising Benefit Patients?

On April 18 in Boston, awards were given to a group of individuals whom some credited with raising the national consciousness of the risks of elevated cholesterol, persuading thousands of patients to discuss medical concerns with their physicians and contributing to improving the health of the nation overall.

But not everyone agrees. Their critics say these people helped raise the costs of health care, led to confusion among patients about their treatment and added to the burdens of physicians.

Among those nominated were the marketers who created advertising for products such as Claritin (loratadine), Zyrtec (cetirizine), Nexium (esomeprazole), Lipitor (atorvastatin) and Paxil (paroxetine). Their accomplishments are seen by millions of television viewers, magazine readers and newspaper subscribers. They are the leaders of a relatively new category of prescription drug sales: direct-to-consumer (DTC) advertising.

"There is a major difference of opinion," according to Gary Stein, Ph.D., director of federal regulatory affairs for the American Society of Health-System Pharmacists. He explained to Psychiatric Times, "There are those who believe that increased DTC advertising leads to increased patient demand for those drugs and to increased prescribing. On the other side, some people believe that increased DTC advertising causes more patients to go to their health care providers and talk about whatever conditions they may have. If the prescriber happens to write a prescription, that's fine. They also believe that in many cases the physician will prescribe something else."

Direct-to-consumer advertising has become the focal point of a major national debate over pharmaceutical marketing practices. Critics say it is a major factor in the 17.1% increase in prescription drug spending last year, and at least one member of the U.S. Congress has called for its ban.

But supporters of DTC advertising argue that consumers have benefited from the ads. For example, a spokesperson for the Pharmaceutical Research and Manufacturers of America told a Congressional hearing, "In the two years that ads for a medicine for erectile dysfunction [Viagra] have appeared, millions of men have visited their doctors to ask for a prescription. For every million who asked for the medicine, it was discovered that some 30,000 had untreated diabetes, 140,000 had untreated high blood pressure, and 50,000 had untreated heart disease."

Marketers spent $2.8 billion on DTC advertising in 2001, a 12% increase over the year before, according to NDCHealth, an Atlanta-based health care information services company. NDCHealth said the rate of growth in drug promotional cost slowed to 6% from 6.7% in 2000.

The 20 best-selling prescription medications in 2001 included three antidepressants -- Zoloft (sertraline), Paxil and Prozac (fluoxetine) -- and two antipsychotics -- Zyprexa (olanzapine) and Risperdal (risperidone). Paxil ranked third in DTC advertising expenditures at $95.8 million, according to NDCHealth. Another study, published in the Wall Street Journal, put spending on Paxil ads at $65.12 million, and DTC advertising for Zoloft at $55.93 million.

Earlier this year, the Henry J. Kaiser Family Foundation published a study titled "Trends in Direct-to-Consumer Advertising of Prescription Drugs." Among the findings:

• Spending on direct-to-consumer advertising increased from $266 million in 1994 to nearly $2.5 billion in 2000. Much of the growth can be attributed to a greater use of television commercials to promote drugs: "In 1994, television advertising accounted for roughly 13 percent of the DTC advertising spending, while in 2000 over 60 percent of the DTC advertising spending was on television advertising."

• Physician promotion -- detailing, sampling conferences and journal advertising -- still accounts for nearly 85% of the total spending on prescription drug promotion. Spending on physician-oriented promotion increased by roughly 58% between 1996 and 2000, the report noted, but DTC's share of the promotional budget rose from 9% to 15% during that period.

• Promotional expenditures as a percentage of total sales has remained relatively constant at around 14% a year. "Marketing budgets are not claiming a larger share of the sales dollar today than they did in the early 1990s," the report stated. Still, promotion represents a larger percentage of the sales dollar in the pharmaceutical field than it does in most other industries, and DTC's share of the pharmaceutical sales dollar has grown from 1.2% to 2.2%.

• Direct-to-consumer advertising is concentrated on a relatively small number of products, but its impact is substantial. The 20 products with the highest levels of DTC spending in 2000 accounted for about 59% of the total industry spending on consumer-oriented promotion. But those 20 drugs are among the 50 best-selling prescription medications. "In addition, high DTC advertising spending appears to be associated with relatively new products that have no generic competitors," the report states. "In some cases, products at the end of their patent protection advertise directly to consumers to promote their product for a new indication or because they are switching to over-the-counter status and need to build brand equity."

According to NDCHealth, DTC advertising in 2001 accounted for 23% of the total promotional budget for all prescription medications, while journal advertising fell to only 3% of the total.

Robert Erlich, chief executive officer of Rx Insight Inc. and publisher of DTC Perspectives Magazine, told PT that it is not surprising that consumer-oriented advertising requires a larger budget than journal advertising. "Just look at the cost of the media. You pay $60,000 for some pages in People. A minute on ER can cost $500,000 to $600,000. You pay $2 million a minute for the Super Bowl. That's more than your whole journal budget for a year."

Pages in People or spot ads during the Super Bowl have also raised the visibility of DTC advertising, leading some critics to call for its regulation or elimination. Rep. Henry Waxman (D-Calif.), the ranking minority member of the House Governmental Reform Committee, told a hearing, "Whatever your view of whether these ads should be allowed (and frankly I don't believe they should), most of us would agree that we should have a system that ensures that direct-to-consumer drug ads are accurate and fair. We do not have such a system."

Sidney M. Wolfe, M.D., director of the Public Citizen Health Research Group, in a letter to the New England Journal of Medicine, said, "The education of patients -- or physicians -- is too important to be left to the pharmaceutical industry." Wolfe called on the National Institutes of Health and the U.S. Food and Drug Administration to "replace tainted drug company 'education' with scientifically based, useful information that will stimulate better conversations between doctors and patients and lead to true empowerment."

The American Medical Association, while refusing to petition the government to ban DTC advertising, has called for a regulation requiring ads to feature the sentence, "Your physician may recommend other appropriate treatments." In addition, the AMA plans to collaborate with the National Council for Patient Information and Education to create and distribute materials that will educate consumers and physicians about the risks, benefits and potentially misleading information in drug ads.

Critics of consumer-oriented promotion of prescription drugs say that ads are changing the physician-patient relationship and that physicians will feel pressured to prescribe drugs that patients ask about based on advertising. One study in Health Affairs concluded, "Clinical quality of care is harmed by DTC advertising." However, while definitive studies of the effect of advertising are only beginning, the preliminary findings do not seem to support the critics' worst-case fears.

Researchers led by Meredith Rosenthal, Ph.D., of the Harvard School of Public Health wrote in the New England Journal of Medicine, "The relatively moderate emphasis on direct-to-consumer advertising by the pharmaceutical industry contrasts with the apparent degree of concern about it among physicians and policy makers."

One survey Rosenthal cited "found that 71 percent of family physicians believe that direct-to-consumer advertising pressures physicians into prescribing drugs that they would not ordinarily prescribe."

Rosenthal's team found "relatively few people surveyed (less than 6 percent), however, actually received a prescription for the advertised drug after being prompted by direct-to-consumer advertising to ask their doctor about the drug."

A study by Woodie M. Zachry III, Ph.D., and others in the American Journal of Health Systems Pharmacists raised further questions about the effectiveness of DTC advertising. It analyzed the relationship between advertising expenditures and sales of the drugs being promoted. While some medications showed a positive correlation, the effect was not consistent.

Using data from 1992 to 1997, Zachry and colleagues found, "Analyses related to the antihypertensives and BPH [benign prostate hypertrophy] medications produced no statistically significant associations between advertising expenditures and the number of prescriptions written or diagnoses.

"A significant relationship was found between the monthly number of diagnoses for hyperlipidemia and the amount of money spent advertising the NDCD [national drug code directory] class of antilipemics (p=0.008). A statistically significant relationship was found between the monthly number of antilipemic medications prescribed and the amount spent advertising all antilipemic drugs (p=0.003)...Every $1000 spent advertising antilipemics was associated with approximately 32 people diagnosed with hyperlipidemia and 41 antilipemic prescriptions written."

While "every $1000 spent advertising antihistamines was associated with 24 prescriptions written for Claritin, [there were also] approximately 20 fewer prescriptions for Seldane [terfenadine], and 7 fewer prescriptions for Hismanal [astemizole]." (Both Seldane and Hismanal were removed from the market -- Ed.)

In addition, "A significant negative association was found between the monthly number of prescriptions written for Zantac [ranitidine] and the amount of money spent advertising acid-peptic disorder medicationsEvery $1000 spent on advertising acid-peptic disorder medications was associated with approximately 59 fewer prescriptions written for Zantac."

The researchers said that DTC advertising "may not be a factor in the provision of care for every condition. When a statistically significant association was found, direct-to-consumer advertising expenditures accounted for a modest amount of the variance (approximately 10-30 percent) associated with diagnosing and prescribing."

While there are reasons to fear the impact of DTC advertising, so far the data do not tend to support those fears. A family practitioner, Robert D. Swift, M.D., said his main concern about DTC advertising was the impact of the warning messages mandated by the FDA in its 1967 guidelines. He told PT, "I have patients who are taking some of those drugs because they need them, and they are scared to death because they've heard all of the negatives in the advertising. And for some people, if you read about the side effects, you'll suddenly get them."

In March, the Wall Street Journal ran six articles in two days about the impact of DTC advertising. On its Web site, the newspaper provided a feedback box for readers to respond to the question, "Does advertising influence your use of prescription drugs?" While it hardly constitutes a scientific survey, the results may indicate that the public is more savvy than policy-makers give them credit for: 62% of the respondents checked the answer "I rely solely on my doctor's advice." (For more information on DTC Advertising, please see the PT Online Exclusive article "Patient Drug Information From Mass Media Sources" -- ED.)