Chapter Twenty-Three

Assessing Drug Promotions

Robert D. Beckett • Genevieve Lynn Ness

Learning Objectives

After completing this chapter, the reader will be able to

• Define drug promotions.

• List World Health Organization (WHO) recommendations for appropriate drug promotions.

• Describe the role of the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP).

• Determine whether a piece of direct-to-consumer advertising (DTCA) has been cited in FDA warning letters to companies.

• Describe the allowed content for a specific type of DTCA.

• Evaluate a given piece of DTCA based on FDA and Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines.

• Report a drug promotion concern using the Bad Ad program.

• Evaluate the appropriateness of a piece of drug promotion designed for a health care professional.

• List system and individual strategies that may be used to combat proliferation of misinformation in drug promotions.

• Identify logical fallacies used in drug promotion, when given an interaction with a pharmaceutical industry representative.

• Describe the goals and design of academic detailing programs.

• Describe the clinical, economic, and humanistic effects of academic detailing.

Key Concepts

Introduction

Drug promotion is defined by the World Health Organization (WHO) as material or information provided by drug manufacturers with the ultimate goal of increasing prescribing or purchasing of medications. Every year, the pharmaceutical industry spends billions of dollars advertising their medications to the public and to health care professionals.^1–11 In 2012, about $27 billion was spent on drug promotion in the United States (U.S.) alone.¹² The channels companies use to promote their products include medical journals, newspapers, radio, television, magazines, Web sites, social media, search engine marketing, distributed promotional materials, billboards, direct mailings, medication samples, and sales representatives.^{2,7,10,13–15}

Health care professionals and consumers may not recognize the impact drug promotion can have on individual behavior.⁷ The literature has reported increased prescribing patterns, rapid implementation of new medications, and an increase in inappropriate prescribing among physicians who utilize promotional materials to obtain drug information.⁷ The effect of medication promotion on overall public health remains uncertain. WHO suggests clinical trials be conducted to assess the correlation of drug promotion with inappropriate prescribing and the occurrence of adverse events, to identify the public health outcomes of drug promotion.⁷ For these reasons, health care professionals must be prepared to critically interpret and evaluate verbal and written drug promotions. In particular, pharmacists play an important role as an interpreter of drug advertisements to their patients. The following section describes the full scope of drug promotion according to WHO.

WHO Ethical Criteria for Medicinal Drug Promotion

In 1988, the WHO published criteria for the ethical promotion of medications.¹⁶ The guidelines state the promotion of drugs should comply with the national standards established by the country where the drugs are being promoted. These guidelines apply to both domestic and exported drug products. Overall, information presented for the purposes of promotion should be balanced, accurate, and current.

Advertisements targeted specifically to health care professionals should follow the approved product labeling and all writing should be clear and readable.¹⁶ A scientific summary is required when product claims are made within an advertisement directed at health care professionals. These advertisements should include generic name, brand name, amount of active ingredient per dosage form, other ingredients that can lead to allergies or adverse effects, indications, dosage form, adverse reactions, warnings and precautions, contraindications, drug interactions, additional notable interactions, manufacturer/distributor name and address, and scientific literature references. Detailed information about the scientific properties of a medication should be made available to health care professionals as appropriate.

The WHO criteria also provide information about direct-to-consumer advertising (DTCA).¹⁶ According to the WHO, DTCA should assist consumers in making decisions about nonprescription medications; however, the use of DTCA for prescription medications is not recommended. Scientific evidence must support all factual information provided. DTCA should not use fearful language or tactics and only information available in the approved labeling should be used, including the following: generic name, brand name, indications, major warnings and precautions, contraindications, and manufacturer/distributor name and address.

The WHO also outlines guidelines for pharmaceutical representatives.¹⁶ These personnel should be properly trained and retain adequate technical and medical knowledge. The information presented should only discuss the material from the approved labeling. The pharmaceutical industry is responsible for the statements made by their sales representatives and the salary of those representatives should not be influenced by the number of prescriptions written for the product they are promoting. The WHO recognizes that free samples of prescription medications can be given to prescribers in small quantities on request.

The WHO guidelines outline the proper features of drug promotion that are required to produce beneficial and accurate materials. These criteria provide the basis of drug promotion regulations and evaluative strategies, which will be discussed in more detail later in this chapter.

Direct-to-Consumer Advertising

The U.S. FDA defines DTCA as any advertisement created by a pharmaceutical company to promote products to a general audience.¹⁵ The goal of such advertising is to encourage patients to discuss a medication with their prescribers, ultimately leading to a prescription.⁹

There are many methods pharmaceutical companies use to present DTCA to patients. The two most well known are print, through magazines or newspapers, and broadcast through television. The Pharmaceutical Research and Manufacturers of America (PhRMA) defines direct-to-consumer print advertisements as “space that is bought by a company in newspaper or magazine publications targeted to patients or consumers, or a direct mail communication paid for and disseminated by a company to patients or consumers, for the purpose of presenting information about one or more of the company’s medicines.”¹⁷ The PhRMA also defines direct-to-consumer television advertisements as, “portion of television air time on broadcast or cable television that is bought by a company for the purpose of presenting information about one or more of the company’s medicines.”¹⁷

DTCA has been known to increase prescription drug profit for the pharmaceutical industry.¹⁸ Specifically, for each dollar spent on DTCA the company makes about $4.20 in sales.^9,18 One study, assessing data from 1992 to 1997, found that 32 extra diagnoses and 41 additional prescriptions for statin medications were prescribed for every $1000 spent on DTCA.⁶ In 2002, the U.S. General Accounting Office (GAO) projected that each year eight million Americans requested and received prescriptions due to DTCA.⁶ A 2009 study found that there were an additional one million physician visits and 397,025 added Irritable Bowel Syndrome (IBS) diagnoses after the promotion of tegaserod (Zelnorm^®).¹⁸ In addition, 1796 prescriptions were written for every $1 million spent on tegaserod DTCA (1041-2529, 95% confidence interval).^6,18

Based on these reports, it is not surprising that between 1996 and 2005 spending on DTCA increased from $985 million to about $4 billion.^2–4 DTCA spending peaked at $5.4 billion in 2006, and spending decreased to $4.8 and $4.3 billion in 2007 and 2010, respectively.^2,8,10,11 These recent spending decreases could be due to loss of patent on highly advertised medications, fewer products being brought to the market, an increase in consumer doubt, and budget cuts due to the recent recession.² Some of the most highly marketed products in the United States in 2009 included atorvastatin (Lipitor^®) at $247.1 million and tadalafil (Cialis^®) at $179.2 million.² From January 2007 to March 2011, the highest DTCA marketed products were atorvastatin (Lipitor^®) at $917.70 million, duloxetine (Cymbalta^®) at $820.50 million, and fluticasone/salmeterol (Advair^®) at $766.3 million.⁶

Today, most of the DTCA spending is allotted for television advertisements, which results in the average American watching about 16 hours of televised drug advertisements per year.^6,10 Interestingly, smoking cessation products, impotence medications, and antidepressant television ads have the highest changing channel rates among viewing audiences.² The ads that retain most of the television audience through the commercial include overactive bladder treatments and osteoporosis medications.²

TYPES OF DTCA

The FDA currently recognizes and outlines appropriate content for three types of DTCA: help-seeking advertisements, reminder advertisements, and product claim advertisements. The following describes each of these types of advertisements, including evaluative criteria, in detail.¹⁵

Help-seeking advertisements do not recommend a particular medication but provide information about a disease state or condition.^{6,10,15,18,19} The advertisement can describe particular symptoms, point patients to discuss their symptoms with their physicians, and offer a phone number for more information about the disease state.^19,20 These advertisements are regulated by the Federal Trade Commission (FTC) since a specific drug product is not mentioned.^19,20

Reminder advertisements do not describe the indication of a medication but do present the brand name.^{6,10,15,18,21} These particular advertisements are created with the assumption that patients are already familiar with the drug’s indication.¹⁹ Risk information is not included in these advertisements and, therefore, reminder advertisements of drugs with boxed warnings are illegal.^6,10,19,22 Any information or even implied information (through images or text) about a product’s benefits or risks is not permitted in reminder advertisements.¹⁹ For example, a medication for osteoporosis would not have an image of bones in the reminder advertisement as this implies the product’s indication.¹⁹

Product claim advertisements require more detail and should contain the drug name, the indication, as well as a balance between the risks and benefits associated with the product.^{6,10,15,18,19,21} Specifically, printed product claim advertisements should include a brief summary that provides details about all of the risk information listed in the FDA-approved labeling.^10,19 Printed advertisements must also include a reference to the FDA MedWatch program for patients to report side effects to the medication.¹⁹ Product claim advertisements that are broadcasted either by television, radio, or phone are not required to include the brief summary of risk information.^2,15,19 Instead, television advertisements are required to contain a major statement of the main risks associated with the product, which can be presented verbally.^{8,10,19,21,23} In addition, when broadcast advertisements do not include all risk information listed in the labeling, the advertisement is expected to provide resources patients can consult to obtain the full prescribing information.¹⁹ For example, the advertisement can refer a patient to consult with their health care professional, call a toll-free number, visit the product Web site, or refer to a printed advertisement that contains more detailed information.^15,19,23 This is known as the adequate provision requirement.^3,10,19 Information DTCAs are not required to include is listed in Table 23–1.²⁴

TABLE 23–1. INFORMATION NOT REQUIRED FOR INCLUSION IN DTCA²⁴

Tone and themes of DTCA can vary.^21,23 Many advertisements only portray characters after successfully taking the product; similarly, advertisements tend to portray the product as a facilitator of healthy or recreational activities.²¹ Most advertisements rely on emotional, rather than logical appeals; these emotional appeals could be positive, negative, or both. One study used content analysis to describe major themes present in advertisements, finding that promotion, prevention, individualism, collectivism, cheerfulness, quiescence, dejection, agitation, fear, and affection were all prevalent.²³

DTCA LEGISLATION

Currently, among developed countries, DTCA is only permitted in the United States and New Zealand.^{6,10,15,18,21} New Zealand relies on self-regulation of DTCA by the pharmaceutical companies; however, in the United States the FDA is responsible for overseeing DTCA.⁶

The FDA’s authority over prescription drug advertising targeted to health care professionals was established in 1962 by the Kefauver-Harris Amendment.^3,10,25 Shortly after, in 1969, the FDA released regulations requiring drug advertisements to be accurate and not misleading; contain a brief summary of indications, adverse effects, warnings, and contraindications; be fair balanced; and include only factual information about the product’s advertised uses.^{7,10,23,26,27} Television advertisements were also required to contain the brief summary, which made these ads too lengthy for broadcast.²

The FDA first allowed companies to promote their products directly to consumers in 1985.^3,10,11 In 1997, the FDA released a draft guidance that stated television advertisements no longer required the brief summary; however, the guidance did require a major statement of the main safety risks and referral to a source for detailed information about the product.^{1,2,8,10,15,23} This guidance was finalized in 1999.^3,10 In addition, printed product claim advertisements were required to include the entire prescribing information prior to the release of 2004 regulations stating that only a simplified brief summary is required.¹⁰ However, patient mailings, brochures, and other drug company materials that promote a drug product still require the full FDA-approved prescribing information if any such materials mention the benefits of the medication.¹⁹ In 2007, the Food and Drug Administration Amendments Act (FDAAA) required the MedWatch reporting statement to be added to all printed advertisements, which states: “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.”^19,28 Today, prescription drug advertising regulations can be found in title 21, volume 4, part 202 of the Code of Federal Regulations (CFR).²⁷

To ensure that DTCAs are following FDA guidelines and to protect consumers from false information, the FDA maintains a surveillance and enforcement program through their Office of Prescription Drug Promotion (OPDP) division.¹⁵ It is important to remember that the FDA has the authority only over prescription medication DTCA.²⁴ Nonprescription DTCA and help-seeking ads are regulated by the FTC.^19,20,24 In addition, the FDA does not require pharmaceutical companies to submit DTCA prior to its distribution or being aired.²⁴ However, the FDA does require advertisements be submitted for review as soon as they are released to the public.^6,9,24

If the FDA discovers that a DTCA is not in compliance with the set of laws in place, warning letters can be issued to the pharmaceutical company, requesting the removal of the advertisement and to address the material that violates the law.^9,24 These letters are publically available on the FDA’s Warning Letters Web site.^24,29 If the advertisement has created a severe threat on public health, the FDA can also request the company to correct the advertisement and publish or broadcast the corrected version.²⁴ In rare cases, the FDA may bring criminal charges against the company in court and seize the company’s drug supply.²⁴ The FDA does not have authority to levy fines on pharmaceutical companies for DTCA violations.⁹

Recently there has been a decrease in the number of DTCA regulatory actions by the FDA.¹⁰ Critics say this could be the result of decreased FDA supervision or, in contrast, could be due to better compliance with DTCA laws.¹⁰ Another added factor is that all warning letters must be reviewed and approved by the FDA’s Office of Chief Counsel, which was mandated by the Secretary of Health and Human Services (HHS) in 2002.¹⁰ This action alone may have resulted in a decline in the number of promotional-related warning letters issued between 2001 and 2002, 68 and 28, respectively.¹⁰ In addition, the FDA has limited staff to review DTCA.¹⁰ Fewer than six FDA employees were assigned to review more than 15,000 brochures and DTCA in 2006.¹⁰ Since then, the OPDP staff has increased to accommodate the growing number of advertisements to review.

There is still a need for FDA guidelines in regard to online promotion of prescription medications.¹⁰ After warning letters issued from the FDA in 2009 stating that online search engine results need to include risk information since the drug name and indication is mentioned, the pharmaceutical companies now only include either the name of the drug or the indication in search engine links.¹⁰

Since studies have reported a lack of consumer awareness of the FDA role in DTCA oversight, it is vital for health care professionals to monitor and evaluate DTCA.^6,10

PhRMA GUIDING PRINCIPLES FOR DTCA

With the increasing role of DTCA in health care, the PhRMA established guiding principles for DTCA of prescription medications.¹⁷ These principles are voluntary, but do serve as guidance for pharmaceutical companies to create accurate, educational, and encouraging DTCAs that follow FDA regulations.¹⁷ See Table 23–2 for an overview of the PhRMA principles. A commitment to follow the PhRMA guiding principles and completion of an annual certification entitles the company to be identifiable as a signatory company and be recognized by PhRMA online.¹⁷

TABLE 23–2. PhRMA GUIDING PRINCIPLES FOR DTCA¹⁷

SUPPORT OF DTCA

Supporters of DTCA believe these advertisements serve a public health need.^6,15,17 Through DTCA patients become educated about different disease states, which can assist them in making better treatment decisions and create more knowledgeable patients in the health care environment.^{1,6,10,11,17,26} A related point is that DTCA can help improve the quality of patient–professional interactions and help patients identify meaningful questions to ask of their health care providers, as well as improve adherence to prescribed treatment.^6,10,15,17 DTCA provides patients with information about treatment options available early on, which can result in lower health care costs.¹⁰ Similarly, DTCA may also increase appropriate care for underdiagnosed diseases.^1,6,10,15,17 It has been asserted that if medication therapy is started sooner because of DTCA in a disease that could eventually lead to surgery if not treated, health care costs can be saved.¹⁰ However, there is limited data to support this claim.¹⁰ Supporters mention that DTCA can lower drug prices due to increased competition between products.¹⁰ DTCA also has been credited with reducing the stigma of certain diseases making them acceptable for discussion (e.g., psychiatric disorders).^6,10,11,15

OPPOSITION TO DTCA

In contrast, many who oppose DTCA express its potential threat to public health.¹⁵ DTCAs could contain inaccurate or misleading information in addition to inadequate information about adverse effects and risks.^1,15 Sixty-five percent of physicians reported that patients tend to underestimate the risks and overemphasize the benefits of a drug, mostly after viewing a television advertisement.⁹ A study analyzing television drug advertisements found that patients remembered the benefits of a drug more easily than the risks.⁹ This may be due to the dominance of visual messages over audio when presented jointly and the fact that much of the safety information is presented verbally in television advertisements.¹⁰ Patients may also overemphasize a product’s benefits because DTCA is known to exaggerate the happiness achieved with a medication.¹⁰

Opponents of DTCA state that FDA regulations are too lenient because the pharmaceutical companies are only held responsible for the information presented in DTCA if there is a violation.¹⁰ As a result, some advertisements presented have inappropriate information included. For example, in 1996 only 65% of newspaper and magazine DTCA were reported to be fair balanced.⁷ Unfortunately, consumers will remember the information presented in an ad even if there are violations.¹⁰ The PhRMA has released DTCA guidelines that suggest companies should submit DTCA to the FDA for review prior to distribution; however, these guidelines are optional and unenforceable.¹⁰

The content of DTCA is usually not written in lay person language (i.e., an eighth-grade reading level), making it challenging for consumers to understand the content.¹⁰ Along these lines the use of words such as usually, mild, may, etc., to describe safety information may lead to consumer confusion about the exact meaning of these terms.¹⁰

There have also been multiple reports of statistical overexaggeration of product benefits in advertisements.³⁰ Particularly, in DCTA, this paper points out that only two of 67 advertisements in U.S. magazines presented results of the promoted drug verses placebo as absolute rates of clinical outcomes. Other advertisements only presented data in the form of relative risk reduction (RRR); absolute risk reduction (ARR) was not included (see Chapters 5 and 8 for further information about RRR and ARR). Some provided references to clinical studies, but did not provide any data from the studies in the advertisements. One additional advertisement claimed that the promoted drug provided a clinical cure compared to competitors, but did not explain exactly what was defined as a clinical cure. In a study assessing 16 advertisements, only one ad provided adverse effect frequency using quantitative methods, two presented using comparative relationships, and the majority used a qualitative approach.³⁰ Prevalence of the disease state the product is treating is also rarely reported in advertisements. In a study from 2004, only three of 31 advertisements provided disease state prevalence information.³⁰

Due to DTCA, there has been an increase in patients requesting advertised medications during their provider visits.⁷ This can lead to the undermining of health care professional authority and hinder the provider–patient relationships.^3,6,10,11 This has been reported in the literature by 30% of patients and 39% of physicians who participated in a national survey.¹⁰ In particular, if a physician refuses to prescribe a medication that the patient is requesting, the patient is more likely to switch physicians.¹⁰ This pressure on prescribers from consumers can increase the risk of inappropriate prescribing.^{3,4,6,10,11,15} An FDA study reported about 50% of physicians felt some pressure to prescribe a particular medication after a patient reported seeing a DTCA for the product.^9,26 One study found that during physician visits, 40% of patients requested a medication they saw on a DTCA and about 50% of the requests were granted by the doctor.¹⁰ However, a study conducted in 2006 reported that of the patients who requested a medication due to a DTCA, only about 2% to 7% received a prescription for the product in the end.¹⁰ It has been reported that patients may try to fit the type of patient who is presented in the DTCA, which can also lead to inappropriate prescribing and diagnosis, and ultimately unnecessary side effects.^6,10 A study found that about half of physicians, participating in a focus group discussion, presumed that patients diagnosed themselves accurately based on DTCA.⁶ Also, this increase in unnecessary prescribing can lead to an increase in prescription drug spending.⁸

The added time for providers and patients to discuss DTCA during scheduled appointments could take away from other important aspects of the appointment and lead to negative patient outcomes.¹¹ DTCA can lead to unnecessary physician visits and make patients believe they have a particular disease.^1,8,10 For example, critics blame DTCA for converting menopause from a normal life process into an insufficient hormone disease.¹⁰

In addition, use of DTCA to advertise me-too drugs can increase health care costs since many patients will request the brand name drug when there may be inexpensive generic options available.^4,10,15 A study found that patients were more likely to switch from lansoprazole to omeprazole in areas that were more exposed to DTCA since omeprazole was advertised via DTCA and lansoprazole was not.⁶ The expense of DTCA may also drive up the consumer costs for the product as pharmaceutical companies increase prices to compensate for advertising costs.⁵ For example, one study found that the cost of clopidogrel increased by $0.40 (12%) per unit after the launch of the DTCA campaign.^5,6 In a study assessing television DTCA, the high-cost medications had longer air time for the ads (60 seconds) compared to medium cost medications (47.9 seconds).¹

Critics mention that the safety information required in the DTCA could cause patients to have concerns about the safety of a medication and may lead to issues with patient compliance.¹⁰ However, most of the time DTCA is released to the public before the majority of the safety information is collected (i.e., postmarketing surveillance).¹⁰ For example, rofecoxib (Vioxx^®

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