Direct-to-consumer advertising (DTCA) is a controversial subject among the major stakeholders in the healthcare industry. DTCA refers to any advertisement directed to the final consumer of the product. In healthcare, DTCA refers to marketing campaigns directed at healthcare consumers. Historically, prescription drug and medical device advertising in the United States was directed primarily toward professionals rather than consumers. In 1997, the FDA issued a “guidance” document on mass media promotion that altered existing FDA rules and effectively permitted pharmaceutical companies to promote prescription drugs directly to consumers.9 Since then, exposure to DTCA among healthcare consumers has been ubiquitous. In a recent study, 99% of the patients who responded to a survey regarding their experiences with DTCA had seen at least one direct-to-consumer advertisement related to a pharmaceutical product.23 During the same period, pharmaceutical manufacturers spent record amounts on direct-to-consumer advertising of prescription drugs (Fig 1).24 Spending on DTCA related to prescription drugs in the United States has increased from an estimated $55 million in 1991 to $3.2 billion in 2003.15,32 Previous studies have shown patient requests for heavily advertised drugs frequently result in prescriptions for those drugs.1,15,20,31 Given the success of direct-to-consumer advertising in the pharmaceutical industry in terms of increased patient demand and sales growth, the medical technology and device industries have recently increased their use of DTCA in promoting new products. In orthopaedic surgery, physicians and hospitals are responsible for a substantial portion of DTCA.16 More recently, direct-to-consumer advertisements related to orthopaedic devices have appeared on the Internet, on television, and in newspapers and magazines. Although there are numerous studies evaluating the impact of DTCA in the pharmaceutical industry, there are no equivalent studies regarding the impact of DTCA in orthopaedic surgery.
As healthcare consumers have become savvier and information regarding healthcare choices has become more widely available, healthcare systems, hospitals, healthcare providers, insurance companies, pharmaceutical companies, and medical device manufacturers have all recognized the benefits of marketing their products and services directly to the end user. This has occurred in the setting of rapidly increased spending on healthcare in the United States. Although many factors drive the increasing cost of healthcare, policymakers have begun to investigate the impact of DTCA on healthcare spending in the US.
We present a comprehensive review of direct-to-consumer advertising (DTCA), including its history, the role of the United States Food and Drug Administration (FDA), the medical, economic and ethical issues, and its current state in the field of orthopaedic surgery. We also evaluate the current research evidence and literature related to DTCA.
Brief History of DTCA in the United States
In 1708, Boston‘s Nicholas Boone placed the first advertisement for a patent medicine in an American newspaper.32 For the next 200 years, patent medicines such as Bateman's Pectoral Drops, Turlington‘s Balsam of Life, and Dr. Benjamin Godfrey's Cordial promised to cure or treat dandruff, stomach ailments, rheumatism, baldness, and infidelity, through newspapers, magazines, and traveling medicine shows.32 As early as the 1800s, patent medicine advertisers were the largest patrons of newspaper advertising.17 By 1930, 90% of the marketing expenditures for drugs were for advertising in newspapers and popular magazines and 5% was spent on detailing, samples, and advertising in technical journals.25 The passage of the Food, Drug, and Cosmetic Act in 1938 gave the FDA authority over labeling of pharmaceutical drugs. In 1962, the Kefauver-Harris drug amendments dramatically changed the nature of pharmaceutical drug promotion with a strong push for consumer protection by requiring all advertised drugs be proven safe and effective and by transferring authority for prescription drug promotions from the Federal Trade Commission to the FDA.32 In turn, the FDA required drug advertisers to present a fair balance and brief summary of drug performance, and essentially ruled out the use of broadcast media such as radio and television.25 By 1972, there was a complete turnaround in the allocation of drug marketing expenditures with 75% of the spending on physician detailing, samples, and technical journal advertising.25
This climate began to change in the 1980s as the first product-specific direct-to-consumer print advertisements emerged.18,25,32 Simultaneously, the pharmaceutical industry began to press the FDA to relax the rules governing direct advertisements to consumers.18,25,32 In addition, the concept of individual consumer empowerment was beginning to take hold in American society.18,25,32 In 1983, the FDA intervened and imposed a moratorium on direct-to-consumer advertising.18,25,32 During the moratorium, the FDA encouraged dialogue between the key stakeholders and studied the pharmaceutical industry‘s proposal for DTCA.18,25,32 This moratorium was lifted in 1985, but the FDA maintained its original rules regarding DTCA.18,25,32 The debate and proposals continued until 1997 when the FDA issued new guidelines allowing electronic and broadcast advertising of prescription drugs.18,25,32 For the first time, the FDA allowed drug manufacturers to give the drug's name and the condition it was meant to treat without disclosing all of the products risks.18,25,32 However, they were required to mention important risks and had to state additional information was available from other sources.18,25,32 In 1999, the FDA's draft guidance was finalized for prescription drugs.
A few years later, direct-to-consumer advertisements for medical devices and technologies began to appear. In 2003, orthopaedic implant manufacturers began to run advertisements for regaining youthful function in patients‘ arthritic knees.2,25 In orthopaedics, particularly in the field of total joint replacement and minimally invasive techniques, DTCA has been used to promote new techniques and technologies.7,25 The FDA responded to this new trend by issuing new guidelines for consumer-directed advertisements of restricted devices including orthopaedic implants. However, the draft guidance is currently in development and has not been finalized.
Potential Benefits of DTCA in Healthcare
The central issue regarding the benefits of direct-to-consumer advertising is patient empowerment in-and ownership of-their own healthcare decision making. Advocates of DTCA argue health information for consumers that is accessible, accurate, and motivating is beneficial if it leads to a greater number of more productive physician-patient encounters.14 Supporters argue this is consistent with the societal trend of consumer and patient empowerment in the provision of healthcare. It helps create a level of partnership between patients and physicians unprecedented in modern medicine because it provides valuable information that educates patients regarding their illness and treatment options. Supporters of DTCA argue the information asymmetry that has characterized the patient-physician relationship in the past is changing for the better.3,8,14,15,31
Proponents of DTCA also point out it provides consumers with valuable information that increases public awareness regarding potentially debilitating illnesses, thereby increasing the likelihood patients will seek medical attention and be compliant with treatment recommendations for a particular ailment.3,8,14,15,31 Donohue et al8 suggest di-rect-to-consumer advertising of antidepressants was associated with an increase in the number of people diagnosed with depression who initiated medication therapy. Furthermore, they suggest advertisements in the context of depression may increase adherence to medical therapy. Hollon et al12 found women who were familiar with the drugs used in osteoporosis prevention and treatment through exposure to DTCA were more likely to request a bone mineral density test than women who were not familiar with these drugs.
Additionally, for conditions associated with social stigma, such as depression and erectile dysfunction, advertising may reduce negative views associated with the treatment; thus DTCA not only calls attention to untreated disorders, but also aids in destigmatizing diseases.8,15
Overall, the potential benefits of DTCA seem legitimate. However, the main concern is whether these benefits outweigh the potential negative consequences associated with DTCA. Proponents of DTCA argue these benefits far outweigh the risks.
Concerns Regarding DTCA in Healthcare
Opponents of DTCA argue it does not educate consumers because the information is biased. They point out DTCA cannot simultaneously fulfill goals of educating consumers and increasing pharmaceutical sales.3,13,15,20,23,24 Furthermore, advertisements often omit, minimize, and obscure the risks associated with a particular drug, device, or surgical procedure.3,13,15,20,23,24 Bhattacharyya et al6 found only seven of 50 claims made in orthopaedic print advertisements were well supported by scientific data. One common occurrence noted, particularly in the adult reconstruction category, was an exaggeration of the results.6
Another argument against DTCA is many healthcare consumers are not sophisticated enough to understand risk as it is presented to the medical community.5,23,24,30,35 Furthermore, even among the more sophisticated healthcare consumers, conceptions of risk are often inaccurate due to the incomplete or inaccurate risk statements provided in most advertisements.5,23,24,30,35 Opponents also argue it inappropriately and/or misleadingly increases consumer demand for specific treatment modalities or brands, leading to increased and inappropriate utilization of resources and technology.3,13,15,20,23,24
DTCA also can strain the doctor-patient relationship, especially within the current heightened medicolegal environment, and potentially diminish the role of the physician in clinical decision making.5,23,24,30,35 For example, the discussion of such advertisements can lengthen office visits and cause physician resentment if a great deal of time is required to discuss inappropriate patient requests or if the request is harmful and in direct conflict with the physicians‘ ethical code of conduct.1,21,23 In addition, patients are often unhappy if their request is denied and may suspect the physician is of unfamiliar with the new drug or technique or has an ulterior motive to cut costs.5,7,23
Overall, there are major criticisms of DTCA. The question remains whether they are just criticisms of innovation as some of the proponents suggest, or whether they pose real risks to the practice of medicine. Regardless of the answers to these questions, these issues must be addressed appropriately to protect the sanctity of the doctor-patient relationship and the overall wellbeing of patients.
Economic Implications of DTCA
As with most issues on this topic, there are two sides to the debate regarding the economic implications of DTCA. Opponents point to growing evidence direct-to-consumer advertisements prompt consumers to demand newer and more expensive medicines, increasing prescription drug use and spending.9 Furthermore, opponents of DTCA claim physician compliance with this inappropriate demand creates an environment of inappropriate use of technology, decreased quality of care, and inefficient utilization of valuable and limited healthcare resources, including physician time.7-9,11,15,17,19,20,25,32 They assert all of these factors add to the rising indirect costs to the US healthcare system.
Proponents of DTCA argue that, although drug spending may be increasing due to direct-to-consumer advertising, it will eventually lead to a decrease in overall healthcare costs.7-9,11,15,17,19,20,25,32 They assert the rise in drug spending is mostly because advertisements compel people to seek treatment for previously untreated conditions. Thus, the savings from reduced hospitalizations and surgical interventions, if otherwise left untreated, more than offsets the increased drug spending. DTCA prompts the initiation of medication therapy and facilitates drug compliance, which is cost-effective relative to the costs of untreated illness, hospitalization, and surgery.7-9,11,15,17,19,20,25,32 Furthermore, they contend the patients' requests balance the financial incentives given to physicians.14
Other Ethical Considerations in DTCA
Patient misconceptions about the nature of direct-to-consumer advertisements are a major concern. Many patients believe only the safest and most effective therapies can be advertised. One group of patients studied thought only “completely safe” prescription drugs could be advertised directly to the consumer.3 Many patients also assume drug advertising is meticulously regulated by the FDA. Perhaps most concerning is the perception the FDA reviews all drug advertisements before they are aired or published. A recent study found approximately 50% of patients thought direct-to-consumer advertisements had to be submitted and approved by the government for prior approval.3 These misconceptions leave the consumer particularly vulnerable, because they often fail to do the research necessary to bridge the information gaps and lapses that may be present in an advertisement. In a study by the Kaiser Foundation, 64% of people surveyed indicated they trusted the information about the health condition in advertisements for healthcare related products and services.28
Another ethical dilemma is most advertisements, including drug-related advertisements, target human emotions and vulnerability.4,33 Woloshin et al33 investigated the content of pharmaceutical DCTA in 10 US magazines and reported in 67 unique advertisements, 45 (67%) included emotional appeals as a promotional technique. More advertisements, 58 of the 67 (87%), described the benefit of medication with vague, qualitative terms rather than with data. Direct-to-consumer advertisements are more common in popular magazines aimed at women. Given the impact of DTCA on demand for specific products and services depends on the extent patients can influence clinical and objective decisions, the use of emotional appeals in advertising is worrisome.
Medical ethics is different from business ethics. For physicians and surgeons, “first do no harm” is a critical tenet of medical ethics, and the development of a strong patient-physician relationship is considered essential in providing high-quality patient care. However, ethical business practices focus on avoiding unlawful and improper conduct that may harm the organization, its shareholders, and customers, while simultaneously exercising a fiduciary obligation to shareholders. Direct-to-consumer advertising seems to bring these two ethics paradigms in direct conflict with each other.
Current Role of the FDA in DTCA
The FDA remains active in the process of providing guidance to the pharmaceutical industry regarding DTCA to protect healthcare consumers. Through the draft guidance document it released in 1997 and finalized in 1999, the FDA regulates the promotion of prescription drugs, including the content of direct-to-consumer advertisements.17,18,27 These regulations require that advertisements present accurate information and fairly represent the benefits and risks of the advertised drugs. Under these regulations, pharmaceutical companies are required to submit all drug advertisements to the FDA for review, but the advertisements can run without FDA approval. To conserve resources, the FDA focuses its reviews on advertisements that will be widely circulated or are the most likely to impart misleading impressions of a drug to consumers.10
When the FDA identifies a direct-to-consumer advertisement in violation of FDA guidelines, it sends a regulatory letter to the party responsible for the advertisement, asking them to cease and desist disseminating the advertisement. From August 1997 to August 2002, the FDA issued 88 regulatory letters for DTCA violations.10 However, since 2002, FDA enforcement actions against false and misleading drug advertisements declined precipitously, falling more than 70% compared with the period from 1999 to 2000.10,29 In November, 2001, the Department of Health and Human Services (HHS) instructed the FDA that no untitled or warning letters could be issued until FDA‘s Office of the Chief Counsel (OCC) reviewed them.22 The HHS implemented this new policy to ensure all draft warning and untitled letters from FDA were reviewed for “legal sufficiency and consistency with agency policy.”22 This recent change in policy has sharply compromised the FDA's effectiveness in issuing these regulatory letters in a timely manner. Furthermore, there were often lengthy delays in enforcement actions, exposing millions of consumers to false or misleading advertisements for months before withdrawal, often after the misleading advertisement completed its broadcast life cycle.10,29 In 2003, the average delay between placement of a false and misleading advertisement and an FDA action in response to that advertisement was 177 days.10,29 The FDA‘s enforcement actions have been restricted to sending warning letters to drug manufacturers, and although the FDA has the authority to take stronger action with more effect, such as court actions or ultimately fines, as of 2004 the agency has not done so.10,29 Thus, although the FDA theoretically has the ability to monitor and limit the spread of false and misleading advertisements, the current process is highly inefficient, making the FDA's role in regulating DTCA far less effective in real terms.
DTCA Literature Review
We reviewed the published research evidence and literature available to date on the topic of DTCA in healthcare.The primary search strategy was to search the PubMed and Medline databases. Free text search terms were created around the term “direct to consumer advertising” and associated synonyms. There were no date restrictions. The reference lists of obtained studies and papers were scrutinized for further studies. All papers, studies, and literature were included.
Our search identified a total of 37 publications of which 10 studies were research based (Table 1). Seven of the 10 research-based studies were questionnaire based. Of the questionnaire-based studies, two surveyed physicians exclusively,30,35 four surveyed patients exclusively3,5,26,31 and one surveyed physicians and patients.20 One study was a systemic review of the literature.11 Another was an advertisement content review, which was also the only study related to orthopaedics.6 There was one randomized controlled trial.15 We identified no studies evaluating the impact of DTCA in orthopaedics.
DTCA in Orthopaedics
Given the success of DTCA in the pharmaceutical industry in terms of increased patient demand and sales growth, the medical technology and device industries began to experiment with DTCA beginning in 2000. Recently, there has been a substantial increase in the number of advertisements aimed directly at consumers from orthopaedic surgeons, hospitals, and orthopaedic implant manufacturers.2,7,16 Particularly in the field of total joint replacement, DTCA is being used to promote new techniques and technologies.7 Although many surgeons blame industry for the recent increase in DTCA and misleading information being provided to patients, a study by Labovitch et al16 evaluating the authorship, content, and quality of information available on the internet regarding minimally invasive (MIS) total hip replacement (THR) revealed 70% of websites related to MIS THR were authored by private physician groups and hospitals, and only 6% were authored by orthopaedic device manufacturers. The FDA has not issued a formal “guidance” document on consumer-directed advertisements related to medical devices.
The current literature on direct-to-consumer advertising in healthcare is focused almost exclusively on prescription drugs. There are major medical and economic differences between pharmaceuticals and medical devices such as orthopaedic implants. First, there is a substantial difference in price between orthopaedic implants and pharmaceutical drugs. They are sold primarily to hospitals, although surgeons are the primary decision makers and end users. Success of new technologies in the implant market requires use by early adopters and/or surgeon thought leaders. The choice of implant used to treat a particular patient requires a higher level of judgment than the choice between a branded or generic pharmaceutical drug and their use often requires additional specialized training. Lastly, the potential negative consequences to the patient and the surgeon are substantial if an inappropriate implant is chosen for a particular patient or surgery, and the choice of implant cannot be easily substituted if it is undesirable. These differences make extrapolating the findings or conclusions regarding the impact of DTCA in pharmaceuticals to the potential impact of DTCA in orthopaedic surgery difficult and at times inaccurate. Thus, the ongoing debate regarding DTCA, the recent increase in DTCA in orthopaedics, and the current lack of research evidence on this important issue has prompted the need to investigate the impact of DTCA in orthopaedics.
DTCA has emerged as an influential factor in the delivery of healthcare as integrated health plans, hospitals, doctors, drug companies, and implant manufacturers all appealing directly to consumers in an attempt to influence their behavior and decision making.7 One of the most important functions of any organization is the marketing of their products or services to the end user. The predominant force for the marketer and the consumer is to increase the welfare for both parties, the marketer by selling their products or services, and the consumer by using those products or services to improve their quality of life.25 Consumers cannot request or buy a product of which they are not aware, so advertising plays a critical role in creating awareness and in educating consumers about the product or service. However, the healthcare industry is unique because traditional definitions of users and buyers of a product or service are not always clear. For example, orthopaedic devices and implants are prescribed and implanted by the surgeon, initially purchased by the hospital facility, ultimately paid for by the patient's insurer, and used by the patient.25
DTCA has been controversial since its inception, with proponents and opponents debating the relative value of the ads and their impact on the physician-patient relationship. The promise of DTCA lies in its potential to educate consumers and increase awareness regarding medical conditions and treatment compliance. However, this promise comes with substantial risk.29 Most troubling is the potential for DTCA to stimulate inappropriate demand for expensive and potentially harmful technologies. One way to address the potential concerns associated with DTCA is to ban DTCA altogether, a position the European Union adopted many years ago and recently reaffirmed.34 Another approach is to regulate the content of DTCA to improve their accuracy and educational content. However, FDA enforcement actions against false and misleading drug advertisements have declined precipitously, falling more than 70% between 1999 and 2002. This decline cannot be explained by a change in the number of drug advertisements reviewed by the FDA (which increased substantially) or a drop in complaints about advertising content (which remained constant).29 The added burden of regulating the recent increase of DTCA in the medical device industry will further stretch the limited resources of the FDA.
DTCA in orthopaedics is a recent phenomenon that has become a mainstay in healthcare in the US. It is highly unlikely a ban on DTCA will occur in the US given the current sociopolitical environment. Pharmaceutical and medical device companies can be expected to continue to experiment with-and expand their use of-DTCA. In the future, the industry will probably migrate toward advertisements aimed at a specific audience or target population, as opposed to current advertisements intended to appeal to a broad audience. Furthermore, the use of the internet as a medium for DTCA can be expected to continue to increase.
Prescription drugs and medical devices are inherently different from other consumer products advertised directly to the end user. They are part of a complex system of healthcare driven by science and careful human judgment, not profit motives. As such, the medical community must respond vigorously to recent trends in DTCA. The goal should be to develop evidence-based policies to improve the quality and accuracy of the advertisements, incorporating the opinions and needs of all stakeholders involved in DTCA. Orthopaedic surgeons, as an organized unit through professional societies like the American Academy of Orthopaedic Surgeons, should take a leadership role by ensuring the quality and accuracy of information provided to patients related to orthopaedic devices and procedures, including information regarding the appropriate uses and limitations of new technologies and surgical techniques.
Limitations of Current Research Techniques and Literature
Current research in DTCA is limited by several factors. One important issue is the difficulty quantifying and isolating the impact of DTCA on the healthcare consumer preferences and demand. Consumers make healthcare decisions in a complex way with several inputs in a very individual decision process. DTCA serves as one, though important, input in that decision process. Furthermore, the process of arriving at a healthcare decision can be influenced by many sources, including word of mouth recommendations, the physician‘s assessment, patients’ prior experiences, and insurance coverage. A research study regarding the impact of DTCA should identify and control these factors and potential confounders. Another limitation is the lack of access to real, unbiased data. The level of exposure to and the amount of spending on DTCA varies between markets and regions. It is often those engaged in DTCA (device manufacturers, hospitals, physicians) who collect and monitor the data and the information is often non-public and proprietary. Researchers would need to collaborate with these entities to obtain the data without compromising the integrity of the study. Due to these limitations, current research studies have attempted to use surrogate markers such as survey instruments and sales of particular drugs and devices to evaluate DTCA. While these studies are less than perfect, a true randomized control study to evaluate DTCA would be very difficult to design and would require substantial resources. Furthermore, DTCA is a topic that seems to stir emotions from all sides, and it is very important for researchers to remain unbiased in presenting the data obtained in a study.
The long-term effect of DTCA on the healthcare system and the health and wellbeing of the public remains uncertain. Ongoing monitoring and evaluation of DTCA will require extensive investigation and a substantial investment of financial and human resources. However, these investments are well worth the effort, especially given the growing influence of DTCA on modern healthcare delivery.
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