Needs Assessment: There has been an exponential rise in direct-to-consumer (DTC) advertising of pharmaceuticals in recent years. Studies suggest the average patient spends much more time each year viewing DTC ads than discussing medicines with their doctor. Psychotropic agents are some of the most heavily advertised classes of medications. Little is known of the impact this has had on the field of psychiatry and clinical practice. 

Learning Objectives:
• Understand the historic context of direct-to-consumer (DTC) advertising including the recent, dramatic growth in DTC advertisements. 
• Review survey data of psychiatrists concerning various aspects of DTC advertisements, including personal experience, impact on clinical practice, and educational value.
• Appreciate potential benefits and drawbacks of DTC advertisements as they relate to psychiatric practice.


Target Audience:
Primary care physicians and psychiatrists.


CME Accreditation Statement:
This activity has been planned and implemented in accordance with the Essentials and Standards of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the Mount Sinai School of Medicine and MBL Communications, Inc. The Mount Sinai School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation: The Mount Sinai School of Medicine designates this educational activity for a maximum of 3 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Faculty Disclosure Policy Statement: It is the policy of the Mount Sinai School of Medicine to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material.

This activity has been peer-reviewed and approved by James C.-Y. Chou, MD, associate professor of psychiatry at the Mount Sinai School of Medicine, and Norman Sussman, MD, editor of Primary Psychiatry and professor of psychiatry at New York University School of Medicine. Review Date: October 6, 2008.

Dr. Sussman reports no affiliation with or financial interest in any organization that may pose a conflict of interest. Dr. Chou receives honoraria from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, and Pfizer.

To receive credit for this activity: Read this article and the two CME-designated accompanying articles, reflect on the information presented, and then complete the CME posttest and evaluation. To obtain credits, you should score 70% or better. Early submission of this posttest is encouraged: please submit this posttest by November 1, 2010 to be eligible for credit.

Release date: November 1, 2008. Termination date: November 30, 2010. The estimated time to complete all three articles and the posttest is 3 hours.

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Primary Psychiatry. 2008;15(11):67-71

 

Dr. Bhanji is clinical associate professor at the University of Calgary in Alberta, Canada. Dr. Baron is professor and chair in the Department of Psychiatry at Temple University School of Medicine in Philadelphia, Pennsylvania. Dr. Lacy is Chief of the Behavioral Health Clinic in Ft. Stewart, Georgia. Drs. Gross and Goin are professors of clinical psychiatry at the University of Southern California Keck School of Medicine in Los Angeles. Dr. Sumner is senior vice president and chief medical officer at the BioBehavioral Diagnostics Company in Cambridge, Massachusetts and clinical associate professor of Behavioral Medicine and Psychiatry at West Virginia University School of Medicine in Morgantown. Dr. Fischer is Schizophrenia Research Fellow at the Maryland Psychiatric Research Center at the University of Maryland School of Medicine in Baltimore. Dr. Slaby is clinical professor of psychiatry at New York University in New York City.

Disclosures: The authors report no affiliation with or financial interest in any organization that may pose a conflict of interest.
Please direct all correspondence to: Benjamin Lacy, MD, Chief, Behavioral Health Clinic, 1061 Harmon Ave Ste 1d03, Ft. Stewart, GA 31314-5611; Tel: 912-767-1641; Fax: 912-767-3507.


Abstract

Direct-to-consumer (DTC) advertising of pharmaceuticals has historically been a controversial subject. DTC marketing involves stakeholders from the pharmaceutical industry, medical and healthcare sectors, public groups, and others. Concerns regarding DTC marketing, including its influence on prescribing practices, and drug expenditures, are the subject of continuing debate. Little is known about how mental health providers perceive the role of DTC marketing in their practices. The authors surveyed 114 psychiatric physicians to assess their perspectives on the merits and risks of DTC marketing. The results of the survey provide a perspective on the views of psychiatrists concerning DTC marketing.

Introduction

Direct-to-consumer (DTC) advertising of pharmaceuticals is a topic sparking considerable debate among drug manufacturers, federal agencies, consumer groups, managed care organizations, and physicians.1-3 Since 1995, this issue has become more intense following the United States Food and Drug Administration’s decision allowing greater freedom of advertising requirements.4

Of all groups involved in the debate, physicians are often caught in the middle.1,5,6 While they are perceived by a majority of stakeholders as knowledgeable experts in diseases and treatment, they are also perceived as “drug pushers” by some consumers groups.7,8 DTC advertising not only reinforces this misperception, but it also leads to internal conflicts among doctors when their patients demand specific medications. Many third party payers have restricted drug formularies, and conflicts may occur when patients request specific advertised medications not covered by their insurance.1

Background

Although currently a hot topic, DTC advertising in the US has been around for nearly 300 years.2,4 In 1708, Nicholas Boone placed the first advertisement for a patent medication in a Boston newspaper. For the next 230 years, advertisements for patented medications claiming to treat everything from dandruff to infidelity could be found in magazines, newspapers, and traveling medicine shows. In 1938, Congress passed the Food, Drug, and Cosmetic Act, which gave the FDA authority over the labeling of pharmaceuticals and the Federal Trade Commission control over their advertising. No new legislation was introduced until 1962 when the Kefauver-Harris amendments proposed the concept of consumer protectionism when dealing with pharmaceuticals. Under these amendments, authority for drug promotional advertising review was reassigned to the FDA. The FDA established requirements similar to those in existence today, ie, specifications of contraindications, effectiveness, side-effect profiles, and a cost-benefit discussion. Virtually all of the advertisements were targeted to physicians.
In 1981, the pharmaceutical industry proposed shifting marketing to include the consumer.1 At issue was the requirement to include extensive clinical information on the product, making it problematic to use television media to reach potential customers. That same year the Commissioner of the FDA, Arthur Hayes, requested the pharmaceutical industry put a voluntary moratorium on DTC advertising to allow the FDA to study their request to reduce the required disclaimers. In 1985, the FDA concluded that the existing regulations to safeguard the public interest were adequate. This ruling had the effect of postponing the growth of DTC for the next 12 years. However, 1997 marked the beginning of rapid growth in DTC advertising.9 This change in marketing was attributed to the new FDA guidelines on broadcast DTC marketing. For the first time, drug manufacturers could present the name of the product and the condition it was intended to treat, and not report all of the contraindications. The financial implications of this change in policy were enormous. In 1985, $17 million was spent on DTC marketing. By 2000, that figure rose to $2.5 billion, and $4.2 billion in 2005. In 2008, the estimated DTC marketing budget will be in the sum of $8 billion.4,8,9 Real spending on DTC advertising increased by 330% from 1996–2005.10 As of 2007, only the US and New Zealand permit DTC advertising of prescription medications.11 In countries outside the US, the pharmaceutical industry has applied pressure to relax regulations regarding DTC marketing with little success. Despite DTC advertising being banned in most non-US countries, there is growing international concern that drug companies are circumventing legislation through the use of internet advertising and “spam” E-mail.12 Pharmaceutical companies also provide “awareness campaigns” or infomercials with vague references to prescription treatments in order to improve their sales abroad.13

Impact of DTC Advertising on Prescribing in Mental Health

Research clearly indicates that DTC advertising alters prescribing behaviors and volume leading to greater drug expenditures. A systematic review of the literature by Gilbody and colleagues14 found that DTC advertisements increase both new diagnoses of a condition and the proportion of prescriptions specifically for the advertised drug. This has a compounding effect on the number of overall prescriptions for a particular drug. For example, Zachry and colleagues15 found that for every $1,000 spent on advertising a cholesterol-lowering drug, there were approximately 32 new diagnoses of hyperlipidemia and 41 additional prescriptions of the advertised cholesterol lowering drug. Another study5,16 comparing US and Canadian prescribing practices found that DTC advertisements resulted in significantly more frequent requests for specific advertised drugs. Patients making these requests were 16 times more likely to be prescribed a drug than those not making specific requests.
The topic of DTC advertising is especially pertinent to the field of psychiatry where there is a desire to decrease stigma and properly educate the public on mental illness. Approximately 20% of the 50 most advertised drugs in the US were medications used to treat psychiatric and neurologic disorders.17 Antidepressants, antipsychotics, and anticonvulsants are among the top five most heavily advertised classes of medicine. Whether DTC marketing leads to over-prescribing of more expensive non-generic drugs, as critics contend, or de-stigmatizes mental illness and promotes use of effective medications, as proponents claim, is a matter of ongoing debate.6-8,12,14-16

Method

In keeping with its mandate of examining contemporary issues in mental health, the Group for Advancement of Psychiatry (GAP) Committee on Psychopharmacology (Table 1) conducted a pilot survey study of the attitudes of psychiatric residents and psychiatric physicians on DTC marketing of medications. A questionnaire was developed by the committee to gather information about psychiatrists’ exposure, experience, and opinions regarding DTC marketing of medications.

 

The questionnaire was reviewed and approved by the GAP Executive Committee and distributed to members attending one of the organization’s semi-annual meetings. The sample was broadened to include residents and faculty in selected psychiatric training programs in Philadelphia (Temple University) and Southern California (University of Southern California; Cedars-Sinai Medical Center). The multiple choice survey was distributed at scheduled resident and faculty meetings, with voluntary completion of the questionnaire requested at the end of the meeting. Since the pilot information was obtained from small selected groups, survey return rates were not calculated. The demographics and responses of the 114 completed questionnaires are summarized below. Non-parametric and descriptive statistics were used to analyze the data.

 

Results

Physician Experiences with DTC Advertising

During the month preceding survey completion, respondents were asked how often they had seen a DTC advertisement. Responses varied, with 18 respondents (16%) acknowledging at most a single personal exposure to DTC advertising, 29 respondents (25%) reporting 2–5 exposures, 24 respondents (21%) reporting 6–10 contacts, and 43 respondents (38%) reporting >10 personal DTC exposures (n=114).

Types of DTC advertisements were reviewed. Of the media noted by the respondents, television was the most frequent (96% of responses). This was followed by direct mailings to physicians (76%), newspaper advertisements (57%), radio advertisements (50%), direct mailings to consumers (42%), Internet or E-mail (37%), and newspaper articles (28%). Since multiple responses were allowed, respondents checked off at least four types of DTC advertising on average.

When asked how often they were made aware of DTC advertisements by patients or colleagues in a typical month, 19 (17%) respondents reported at most one contact, 49 (43%) reported 2–5 contacts, 22 (19%) reported 6–10 contacts, and 23 (20%) reported >10 contacts (n=113).

Impact of DTC on Clinical Practice

Physician attitudes when dealing with DTC advertising in their clinical practice was surveyed. When asked how often they prescribed a patient-requested product (ie, a brand-name prescription drug), 13% of respondents replied “not at all”, while 79% indicated “sometimes.” Slightly >5% prescribed the requested medication “fairly often,” but no one reported prescribing requested medications “all the time” (n=114; Figure).

 

The authors of this article asked how respondents perceived the impact of DTC advertising on the physician-patient relationship. Fifty-two out of 114 respondents (46%) felt that DTC had neither positively nor negatively impacted the doctor-patient relationship. Forty-five (39%) reported a negative impact, whereas 12 respondents (11%) felt that DTC had affected the relationship “somewhat positively.” Only 1 respondent indicated an “overwhelmingly positive” effect, and 4 responses were “overwhelmingly negative.”

Respondents were surveyed whether DTC advertising has opened an opportunity for dialogue with patients. Here, respondents were more positive that DTC had increased dialogue. Seventy-three respondents (64%) agreed that DTC had opened up an avenue for more dialogue, whereas twenty-five (22%) disagreed. Sixteen (14%) indicated that DTC had no impact.

With respect to whether DTC advertising had improved patient compliance, most respondents (67%) did not feel that it had any effect on compliance. Twenty-four percent thought it had a positive benefit, whereas 9% indicated it had a negative impact on medication compliance.

Attitudes on DTC Advertising as an Educational Tool

The opinions of respondents on DTC as an educational tool revealed that 19% felt that DTC advertising had improved patient awareness of mental illness “a fair amount” or “overwhelmingly so.” Eighty-one percent reported that DTC improved mental illness awareness only “somewhat” or “not at all.”

Similar opinions were expressed about DTC advertising’s impact on patient awareness of treatment options. Twenty percent indicated that patient awareness of treatment options had improved at least a fair amount, whereas 80% felt it had helped somewhat or not at all. The opinions on patient awareness of treatment options did not differ between male and female respondents.

The impact of DTC advertising in reducing stigma for mental illness was also surveyed. Fifty-seven percent felt that DTC advertising had decreased stigma, with an additional 3% believing that DTC advertising had strongly decreased stigma. In comparison, 36% thought DTC advertising had no impact, and 4% reported that DTC advertising had increased stigma on mental illness.

Opinions Regarding DTC Regulations

Participants were asked for opinions regarding the present regulations covering DTC advertisement. Seventy- eight percent of respondents were not satisfied with current regulations and felt that DTC advertising should be regulated differently. The remainder were either neutral (19%) or disagreed with making any changes (3%).

When asked who should regulate DTC advertising, respondents were invited to choose multiple responses. One hundred thirteen responders gave 166 responses. In descending order, they chose regulation by government associations (49%), medical associations (37%), pharmaceutical industry (9%), third-party payers (1%), and others (4%).

Regarding additional information to be included in DTC advertising, improved side-effect information was the most frequent selection (61%). This was followed by non-pharmacologic treatment options (50%), cost (48%), and information on differential diagnoses (47%).

Discussion

The surveyed psychiatrists had broad views on DTC advertising. Almost all were either directly or indirectly (via colleagues or by their patients) exposed to DTC advertising. Most clinicians (85%) felt that DTC advertising had a minimal or negative influence on the physician-patient relationship. However, in >80% of cases, clinicians prescribed medications “sometimes” or “all the time” when requested by their patients, and many physicians (64%) felt that DTC advertising improved the opportunity for increased dialogue with patients.

From the survey responses, DTC advertising appears to be changing the nature of the physician-patient relationship. Historically, physicians have perceived themselves as uniquely expert in medical therapeutics. DTC advertising appears to be shifting the balance with patients receiving information about medication and illness outside of the clinical encounter. Information is power and the shifting balance brings up tension and ethical dilemmas when patients request specific treatments.

The role of the pharmaceutical industry in educating consumers about specific diseases (eg, major depression or osteoporosis), may be arguably viewed as beneficial in reducing stigma and in enhancing patient compliance with treatment.4,11,12 However, our respondents did not feel that this objective was consistently met. Approximately 60% felt it was effective in decreasing stigma but only 20% thought it increased knowledge of illness and treatment options.

A significant majority of psychiatrists surveyed (78%) felt there should be changes to regulations regarding DTC advertising. This finding is consistent with other survey studies of US physicians. A survey by Robinson and colleagues18 querying American Medical Association members found that 73% of primary care and 65% specialty care physicians felt the need for improved regulations.

The authors of this article would caution generalizing from our survey because it is a small sample. Nevertheless the views expressed by the respondents appear to be consistent with the extant literature addressing this topic.5,12,13,18 The survey examined self-reported attitudes and not necessarily actual behaviors. For example, we did not confirm whether DTC advertising is generating changes in prescribing patterns. The sample size was too small to detect statistical significance, and therefore, the authors were also unable to discern clear patterns among genders or practitioners with different levels of experience. Further longitudinal studies are required to better characterize the dynamic nature of physician-patient relationship in an era of expanding advertising.

Conclusion

DTC marketing is an industry-sponsored initiative that has revolutionized how medical information and treatment options are disseminated to the public. Previously, only physicians and healthcare professionals were the target audience of pharmaceutical company advertising. In recent years, the public has increasingly become the focus of promotional marketing by the industry. The authors’ pilot survey of psychiatrists revealed that DTC advertising has the potential to improve awareness of medical conditions and decrease the stigma of mental illness. Surveyed psychiatrists believed that DTC had little significant effect on their personal prescribing practices. However, >80% of respondents reported they had prescribed medications specifically requested by their patients. Most respondents failed to endorse that DTC had a positive effect on the doctor-patient relationship, or on improved patients’ medication compliance.

Despite the finding of an ambivalent relationship of physicians with DTC advertising, certain matters are clear. The authors’ professional obligation to educate the patient remains and the need for dialogue has not decreased in the era of DTC marketing. Application of good medical practice principles including patient education must continue to guide clinician behavior. PP

References

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2.    Duke University. Should Direct-to-Consumer Advertisements of Prescription Drugs be Restricted?. Available at: www.duke.edu/~zfg/website/?C=M&O=A. Accessed September 24, 2008.
3.    Hollon MF. Direct to consumer advertising: a haphazard approach to health promotion. JAMA. 2005;293(16):2030-2033.
4.     PhRMA. Principles and Guidelines. Direct to Consumer Advertising. Available at: www.phrma.org/principles_and_guidelines/. Accessed September 24, 2008.
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10.    Donohue JM, Cevasco M, Rosenthal MB. A decade of direct-to-consumer advertising of prescription drugs. N Engl J Med. 2007;357(7):673-681.
11.    Gellad ZF, Lyles KW. Direct-to-consumer advertising of pharmaceuticals. Am J Med. 2007;120(6):475-480.
12.    Mackenzie FJ, Jordens CF, Ankeny RA, et al. Direct-to-consumer advertising under the radar: the need for realistic drugs policy in Australia. Intern Med J. 2007;37(4):224-228.
13.     ‘t Jong GW, Stricker BH, Sturkenboom MC. Marketing in the lay media and prescriptions of terbinafine in primary care. Dutch cohort study. BMJ. 2004;328(7445):931.
14.    Gilbody S, Wilson P, Watt I. Benefits and harms of direct to consumer advertising: a systematic review. Qual Saf Health Care. 2005;14(4):246-250.
15.    Zachry WM 3rd, Shepherd MD, Hinich MJ, Wilson JP, Brown CM, Lawson KA. Relationship between direct-to-consumer advertising and physician diagnosing and prescribing. Am J Health Syst Pharm. 2002;59(1):42-49.
16.    Mintzes B, Barer ML, Kravitz RL, et al. How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without legal DTCA. CMAJ. 2003;169(5):405-412.
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