Studies Related to Our Core Question "Should Prescription Drugs Be Advertised Directly to Consumers?"
The articles listed below represent a random sampling of studies that investigate the effects of direct to consumer advertising (DTCA) of prescription drugs.
We have listed the studies in chronological order and have bolded the sections of the summary/abstract that we felt best related to our core question "Should prescription drugs be advertised directly to consumers?"
Summary / Abstract of Study
1. Adam Atherly and Paul H. Rubin, "The Cost-Effectiveness of Direct-To-Consumer Advertising for Prescription Drugs," Medical Care Research and Review, May 7, 2009
"In this paper we use published information to analyze the economic value of Direct to Consumer Advertising (DTCA). The reviewed research finds that DTCA leads to increased demand for the advertised drug and that the effect of the drug tends to be class-wide rather than product specific. There is weak evidence that DTCA may increase compliance and improve clinical outcomes. However, there is little research on the effect of DTCA on inappropriate prescribing or on the characteristics of patients who respond to treatment. On net, if the advertised drugs are cost effective on average and the patients using the drugs in response to the advertisement are similar to other users, DTCA is likely cost effective. Overall, the literature to date is consistent with the idea that DTCA is beneficial, but further research is needed before definitive conclusions can be drawn."
2. Benett Parnes and Peter C. Smith, et al., "Lack of Impact of Direct-To-Consumer Advertising on the Physician-Patient Encounter in Primary Care," Annals of Family Medicine, Jan. - Feb. 2009
"Direct-to-consumer advertising (DTCA) has increased tremendously during the past decade. Recent changes in the DTCA environment may have affected its impact on clinical encounters. Our objective was to determine the rate of patient medication inquiries and their influence on clinical encounters in primary care...
One hundred sixty-eight clinicians in 22 practices completed forms after 1,647 patient encounters. In 58 encounters (3.5%), the patient inquired about a specific new prescription medication... Most clinicians reported the requested medication was not their first choice for treatment (62%), but it was prescribed in 53% of the cases. Physicians interpreted the overall impact on the visit as positive in 24% of visits, neutral in 66%, and negative in 10%.
Patient requests for prescription medication were uncommon overall, and even more so among patients in lower income groups. These requests were rarely perceived by clinicians as having a negative impact on the encounter. Future mixed methods studies should explore specific socioeconomic groups and reasons for clinicians’ willingness to prescribe these medications."
3. Lourdes S. Martinez and Nehama Lewis, "The Role of Direct-To-Consumer Advertising in Shaping Public Opinion Surrounding Prescription Drug Use to Treat Depression or Anxiety in Youth," Journal of Health Communication," Vol. 14, 2009
"This study investigated the impact of exposure to prescription drug advertisements for antidepressants and antianxiety medications on public opinion regarding preferred treatment options for youth suffering from depression or anxiety. The study randomly recruited a nationally representative adult sample (N¼402) through the 2007 Annenberg National Health Communication Survey. The study examined the distribution of public support for the use of antidepressant drugs to treat depression and anxiety disorders in youth. The analysis adjusted for the effects of demographic characteristics, prior knowledge about prescription drugs, and personal and familial drug history. Attitude toward direct-to-consumer advertising (DTCA, for all products) moderated the effect of exposure to ads for these drug treatments on support for their use among youth as a preferred treatment. Among respondents with negative attitude toward direct-to-consumer advertising (for all products), with increased exposure to ads for antidepressants and antianxiety medications, support for the use of these drugs to treat youth decreased. Among this group, with high levels of exposure to advertisements, the predicted probability of support decreased from 0.68 (95% CI: 0.61 to 0.76) to 0.46 (95% CI: 0.38 to 0.56)."
4. Marc-André Gagnon and Joel Lexchin, "The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States," Public Library of Science Medicine, Jan. 2008
"It appears that pharmaceutical companies spend almost twice as much on promotion as they do on R&D. These numbers clearly show how promotion predominates over R&D in the pharmaceutical industry, contrary to the industry’s claim. While the amount spent on promotion is not in itself a confirmation of Kefauver’s depiction of the pharmaceutical industry, it confirms the public image of a marketing-driven industry and provides an important argument to petition in favor of transforming the workings of the industry in the direction of more research and less promotion."
5. Wendy Macias and Kartik Pashupati, et al., "A Wonderful Life or Diarrhea and Dry Mouth? Policy Issues of Direct-To-Consumer Drug Advertising on Television," Health Communication, 2007
"Over $4 billion is being spent on direct-to-consumer advertising (DTCA) of prescription drugs. Although the greatest proportion of this media budget is spent on television, relatively few studies have investigated the key issues of DTCA on television (DTCA-TV), including fair balance, FDA regulations and if information or appeals is focused on more. This study found that emotional and rational appeals were used to a similar degree in DTCA-TV. Print tends to be more informative than TV. After developing a four-tiered classification scheme (lawbreakers, bare minimums, DTC main pack/peloton and proactives), this study found that DTCA-TV ads are not doing a good job of meeting the FDA’s fair balance requirement, particularly in presenting risk information in a comprehensible manner. Today’s new active healthcare consumers often want to learn what issues are important to consider when investigating drugs and how to evaluate alternative courses of treatment. Given the proportion of money spent on television, the medical industry is correct to be concerned that education does not appear more important to DTCA advertisers."
6. Julie M. Donohue, et al., "A Decade of Direct-To-Consumer Advertising of Prescription Drugs," New England Journal of Medicine," Aug. 16, 2007
"Evidence suggests that direct-to-consumer advertising of prescription drugs increases pharmaceutical sales and both helps to avert underuse of medicines and leads to potential overuse...
Total spending on pharmaceutical promotion grew from $11.4 billion in 1996 to $29.9 billion in 2005. Although during that time spending on direct-to-consumer advertising increased by 330%, it made up only 14% of total promotional expenditures in 2005. Direct-to-consumer campaigns generally begin within a year after the approval of a product by the FDA. In the context of regulatory changes requiring legal review before issuing letters, the number of letters sent by the FDA to pharmaceutical manufacturers regarding violations of drug-advertising regulations fell from 142 in 1997 to only 21 in 2006.
Spending on direct-to-consumer advertising has continued to increase in recent years in spite of the criticisms leveled against it."
7. Ziad F. Gellad and Keneth W. Lyles, "Direct-To-Consumer Advertising of Pharmaceuticals," American Journal
of Medicine, June 2007
"Pharmaceutical companies continue to increase funding for direct-to-consumer advertising. Evidence discussed above suggests that direct-to-consumer advertising stimulates patient demand for pharmaceuticals, may influence physician prescribing habits, and likely increases drug spending... Providers need to understand that patients may not have adequate information about a particular particular drug from advertisements, especially risks, and that specific reinforcement of the risks of a drug is key to assuring that the patient makes an informed decision. Additionally, providers may want to prepare printed material for patients ahead of time for some of the most heavily advertised drugs."
8. JE Calfee, "An Assessment of Direct-To-Consumer Advertising of Prescription Drugs," Clinical Pharmacology & Therapeutics, Oct. 2007
"The effects of DTCA are subtle, often indirect, and yet to be measured with confidence. Overt effects are narrowly focused on a few therapeutic drug classes, with small, almost negligible direct impact in the overall health-care market. Growing evidence shows DTCA brings important spillover benefits: new patient–physician discussions about undiagnosed, untreated, or undertreated conditions; physician recommendations for nonpharmaceutical therapies; greater patient receptivity to necessary drug therapy; and improved adherence to prescribed therapies. Physician complaints notwithstanding, the dominant role of physicians in drug prescribing is essentially unimpaired when genuine risk–benefit trade-offs are involved."
9. Dominick L. Frosch and Patrick M. Krueger, et al., "Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-To-Consumer Advertising," Annals of Family Medicine, Jan. - Feb. 2007
"Most ads (82%) made some factual claims and made rational arguments (86%) for product use, but few described condition causes (26%), risk factors (26%), or prevalence (25%). Emotional appeals were almost universal (95%). No ads mentioned lifestyle change as an alternative to products, though some (19%) portrayed it as an adjunct to medication. Some ads (18%) portrayed lifestyle changes as insuffi cient for controlling a condition. The ads often framed medication use in terms of losing (58%) and regaining control (85%) over some aspect of life and as engendering social approval (78%). Products were frequently (58%) portrayed as a medical breakthrough.
Despite claims that ads serve an educational purpose, they provide limited information about the causes of a disease or who may be at risk; they show characters that have lost control over their social, emotional, or physical lives without the medication; and they minimize the value of health promotion through lifestyle changes. The ads have limited educational value and may oversell the benefits of drugs in ways that might conflict with promoting population health."
10. Nile Khanfar, David Loudon and Feroza Sircar-Ramsewak, "FDA Direct-To-Conusmer Advertising for Prescription Drugs: What Are Consumer Prefrences and Response Tendencies?," Health Marketing Quarterly, Vol. 24, 2007
"The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers’ perceived preferences of DTC television advertisement in relation to 'reminder,' 'help-seeking,' and 'product-claim' FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers’ tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources."
11. Teresa Mastin et al., "Health Disparities and Direct-To-Consumer Prescription Drug Advertising: A Content Analysis of Targeted Magazine Generes, 1992-2002," Health Communication, Vol. 22, 2007
"In this study, we sought to determine whether DTCA for prescription drugs targets Blacks and women specifically by advertising in magazines designed for these audiences and differentially employing models of color or female models. We found significantly different patterns of drugs and portrayals between Black magazines and genres aimed at other target audiences...
Although the primary purpose of DTCA from a business perspective is to drive pharmaceutical sales, it is important to acknowledge the educational value of DTCA, especially for minority populations.
According to Black physicians, whose patients are primarily minorities, DTCA is a valuable tool in the arsenal of patient health care (Allison-Ottey et al., 2002, 2003). More specifically, DTCA generally encourages individuals to be more proactive in their health care, ranging from providing awareness of new drugs to encouraging patients to be more involved in their treatment plans. Simply, the results of our study support that DTCA is a valuable health information resource."
12. Kim Sheehan, "Consumer Friendly or Reader Hostile? An Evaluation of the Readability of DTC Print Ads," Health Marketing Quarterly, Vol. 23, 2006
"The Food and Drug Administration requires advertisements promoting prescription drugs to be written in 'consumer friendly' language. The purpose of this study is to examine the language of Direct- to-Consumer prescription drug advertisements to determine if such language is easy for consumers to read and understand. A series of advertisements for a variety of products, appearing in popular consumer magazines, were analyzed using the Flesch and Gunning-Fogg formulas to determine if DTC advertisements are more or less complex than other advertisements that consumers read today. Results indicate that DTC ads are among the most difficult print ads to read. Additionally, certain types of information contained in these print ads (such as information discussing a drug’s risks and contraindications) are significantly more difficult to read than information in any other type of ad copy in magazines today."
13. Wendy Macias and Liz S. Lewis, "How Well Do Direct-To-Consumer (DTC) Prescription Drug Web Sites Meet FDA Guidelines and Public Policy Concerns?," Health Marketing Quarterly, Vol. 22, 2005
"Direct-to-consumer drug advertising has increasingly become a focus of public policy concern and academic research. However, the Web has received very little of this attention. A content analysis of a sample of 90 complete DTC prescription drug Web sites examined whether the FDA’s fair balance criteria are being met, how they are rated according to industry evaluation criteria, what impact they may have upon the patient-physician relationship, and how the content of these Web sites compares to that of print DTC ads. The study identified that a majority [of DTC prescription drug Web sites] are meeting fair balance and adequate provision criteria, as well as several industry evaluative criteria. A comparison to print DTC reveals some strengths of the Web. Areas of continued concern include design elements and more information about supportive behaviors and competing/alternative treatments."
14. Henry J. Kaiser Family Foundation, "Impact of Direct-To-Consumer Advertising on Prescription Drug Spending," www.kff.org, June 2003
"After accounting for the fact that drugs with higher sales are more likely to be advertised to consumers and have higher levels of promotion to physicians, the study found that increases in DTC advertising were associated with significant growth in sales for the classes of drugs studied: for every 10% increase in DTC advertising, drug sales within the classes studied increased on average by 1%...
To simulate the overall impact of changes in DTC advertising on drug spending growth, these results were applied to changes in spending from 1999 to 2000 for the 25 drug classes with the highest retail sales. Drugs in these classes accounted for about 60% of the DTC advertising and about 75% of retail sales over that period. The study concludes that changes in DTC advertising during that period accounted for 12% ($2.6 billion) of the total growth in drug spending in 2000. This means that each additional dollar spent on DTC advertising in 2000 yielded $4.20 in additional pharmaceutical sales in that year."
15. US Government Accountability Office (GAO), "Prescription Drugs: FDA Oversight of Direct-To-Consumer Advertising Has Limitations," US Government Printing Office, Oct. 2002
"Pharmaceutical companies spend more on research and development initiatives than on all drug promotional activities, including DTC advertising. According to industry estimates, pharmaceutical companies spent $30.3 billion on research and development and $19.1 billion on all promotional activities, which includes $2.7 billion on DTC advertising, in 2001. Pharmaceutical companies have increased spending on DTC advertising more rapidly than they have increased spending on research and development. Between 1997 and 2001, DTC advertising spending increased 145 percent, while research and development spending increased 59 percent...
DTC advertising appears to increase prescription drug spending and utilization. Drugs that are promoted directly to consumers often are among the best-selling drugs, and sales for DTC-advertised drugs have increased faster than sales for drugs that are not heavily advertised to consumers...
We found that FDA’s oversight is generally effective at halting the dissemination of advertisements it reviews and identifies as misleading. The recent change directed by HHS in FDA’s procedures for reviewing draft regulatory letters has adversely affected FDA’s ability to enforce compliance with its regulations. Without more timely action, DTC advertisements that DDMAC has identified as misleading can remain on the air too long."
16. Meredith B. Rosenthal, et al., "Promotion of Prescription Drugs To Consumers," New England
Journal of Medicine, Feb. 14, 2002
"Annual spending on direct-to-consumer advertising for prescription drugs tripled between 1996 and 2000, when it reached nearly $2.5 billion. Despite this increase, such advertising accounts for only 15 percent of the money spent on drug promotion and is highly concentrated on a subgroup of products. Within a therapeutic class, there is marked variation in the intensity of direct-to-consumer advertising, and the amount of such advertising for specific products fluctuates over time. The initial surge in direct-to-consumer advertising preceded the 1997 FDA guidelines that clarified the rules for electronic direct-to-consumer advertising, and thus the 1997 guidelines may not have been the most important reason for the overall increase.
Although the use of direct-to-consumer advertising has grown disproportionately to other forms of promotion, it continues to account for a small proportion of total promotional efforts. Nevertheless, physicians must assist patients in evaluating health-related information obtained through direct advertising."