Physicians Attitudes Toward Dtc

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Papers Physicians’ attitudes toward direct-to-consumer prescription drug marketing Received (in revised form): 25th October, 2006

Michael Friedman joined Purdue Pharma L.P. in 1985 as Vice President and Assistant to the President and Chairman. Prior to that, he spent 12 years in Sales and Marketing at Hilti Inc, where he held positions of increasing responsibility including Vice President of Marketing and Chief Operating Officer of Hilti’s Pneumatic Fastening Systems Division. At Purdue, he was named Group Vice President in 1988, Executive Vice President and Chief Operating Officer in 1999 and President and CEO of Purdue Pharma in 2003. In this position, he directs and guides all company operations, including among others sales, marketing, licensing and business development and research and development. He holds a BA degree from Brooklyn College, an MBA from the University of Connecticut and a doctoral degree from Pace University.

James Gould is Professor of Marketing at Pace University and has an MS and PhD from Cornell University. His academic interests include the Assessment of Integrated Media Communications Programs, Interactive Communications, Consumer and Trade Promotions, Performance of Direct Response Medium, Analysis of Price Behavior in Stock, Bond and Commodity Markets; Neural Network Analysis. He is on the Board of Directors at MarketFax. Inc and the Executive Board of the Westchester Cornell University Alumni Association.

Keywords advertising, doctors, DTC, patients, pharmaceuticals, pharmacists Abstract This paper examines attitudes of physicians toward direct-to-consumer advertising (DTCA) of prescription drugs. Physician awareness of DTCA continues at a very high level, although, negative attitudes may impair its usefulness. This study identified shortcomings of DTCA and physician concerns that could be addressed by marketers. For example, three quarters of physicians agree strongly or somewhat that DTCA does not provide adequate information on the risks and benefits of advertised products. More than half of the physicians (53 per cent) believe DTCA results in many patients requesting unnecessary prescriptions and an even greater percentage (66 per cent) believe DTCA creates a preference for brands when lower-cost generics would be sufficient. The negativism of physicians should cause marketers to ask if their return on DTCA is worth the cost. Journal of Medical Marketing (2007) 7, 33–44. doi:10.1057/palgrave.jmm.5050063

and (3) the impact of DTCA on physicians’ behaviour, and also seeks to identify areas for future research.

INTRODUCTION

Michael Friedman Purdue Pharma L.P. One Stamford Forum Stamford, CT 06901, USA Tel: + 1 (203) 588 7290 Fax: + 1 (203) 588 6211 e-mail: michael.friedman@ pharma.com

This paper is a study of physicians’ attitudes toward direct-to-consumer advertising (DTCA) of prescription drugs. This is an exploratory study of physicians to assess: (1) their current state of knowledge regarding DTCA; (2) the effectiveness of DTCA tactics or methods

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BACKGROUND Domestic sales of the US pharmaceutical industry were $242bn for the four quarters ending Q1 20051 and physician

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prescribing of approximately 3.5bn prescriptions drives this market.1 The prescription drug market grew at doubledigit rates from 1996 to 2003, then at 8.3 per cent during 2004 and at a 7.1 per cent annual rate in the first quarter of 2005.1 The process of developing and patenting a new pharmaceutical product is long and expensive. From discovery of a drug compound to launch of a new pharmaceutical product takes approximately seven years and costs more than $800m dollars.2 The time to the second entry of a patented competitive product in a class has shortened, in recent years, from eight years in the 1970s to less than two years between 1995 and 1998.2 When a patent expires, additional competitive products, in the form of ‘generic’ versions of the product, are marketed at prices well below the price of the branded product. Marketing of pharmaceutical products is complex because the purchase process is fragmented among a variety of parties and subject to rigorous governmental regulations. In its simplest form, the decision process involves a physician who recommends a product and writes a prescription, a pharmacist who dispenses the prescription to a patient and the patient who consumes the product. This process is complicated by the role of various prescription-drug benefit providers who are the principal payees for these products. The buying process is different for generic products than for patented brand-name pharmaceuticals. For example, wholesalers and chains usually determine which generic brand will be available at retail pharmacies. Physicians, who play a major role in the selection of branded pharmaceutical products, play almost no role in determining the brand of generic dispensed by a pharmacist.

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MARKETERS’ TASKS Because of this complexity, marketers interact with different parties who specify, deliver, consume and pay for the product within a regulated framework that often specifies a specific product or brand and constrains those involved. Physicians, patients, pharmacists and payees have somewhat different objectives, and each is a target for a different set of marketing tactics and strategies. Patented prescription products compete with other available pharmaceutical products and with generics. Some of these competitive products could be patentprotected branded or generic products that are not the same drug substances but treat the same condition. In this complex, competitive environment, marketing is based on product features as perceived by the various parties involved in the process as well as on cost. DTCA could influence patients to request, physicians to prescribe or pharmacists to suggest a specific advertised product. DTCA has been criticised for encouraging the use of advertised products, rather than branded or generic alternatives that might cost less.

HISTORICAL PERSPECTIVE OF DTCA The first reported advertisement for a patent medicine appeared in a Boston newspaper in 1708. By the early 1800s, the press and the pharmaceutical industry had developed a strong symbiotic relationship.3 To enable pharmaceutical companies to comply with current laws, the pharmaceutical industry asked the Food and Drug Administration (FDA) to provide guidelines for DTCA in 1981. The first modern-day DTCA for a prescription drug appeared in Readers Digest that same year. Early ads focused on drugs that treated less serious conditions,

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Physicians’ attitudes toward DTCA

such as a 1983 television campaign for Boots’ Rufen arthritis pain medication.4 Concerned that the public health consequences of DTCA were unknown, the FDA initiated a voluntary moratorium on such advertising in 1983.5 The FDA lifted this moratorium in 1985, publishing a notice in the Federal Register indicating that existing regulations were sufficient to protect consumers. The first print ads for drugs that treated more serious conditions, such as epilepsy and migraine, appeared in the 1990s.6 Such ads were required to ‘present a fair balance of benefit and risk information’ and contain a ‘brief summary’ of comprehensive risk information.7 DTCA spending grew rapidly from $791m in 1996 to $3.2bn in 2003 (from 1.2 to 2.2 per cent of sales), and to $4.5bn in 2004.8 Because of a variety of factors, including criticism of the industry and of DTCA, some experts expect DTCA spending to remain flat or even decline in 2005.9 From 1996 to 2003, office-based promotion to physicians grew from $2.3bn to more than $4.4bn, and all promotion to professionals grew from $8.4bn to $13.2bn (from 12.9 to 11.8 per cent of sales).10 The amount of DTCA used varies considerably among and within classes of drugs.11

MARKET PARTICIPANTS

pharmaceutical company sales representatives, journal advertisements, formulary programmes administered by prescription drug benefit managers, internet marketing campaigns and sampling.

Pharmaceutical companies Pharmaceutical companies market their products to physicians as the principal ‘prescribers’ of a course of treatment for a patient. In recent years, however, physicians’ choices and control of prescribing have been diminished as a result of formularies imposed by payees, including managed care and state Medicaid programs.

Payors Payors promote patient and physician preferences through established listings of drugs allowed (formularies), lower or zero ‘co-pays’ for generic drugs, and lower copays for ‘preferred brands’.13. In addition, brands achieve preferred status by offering rebates to payors that lower their net acquisition costs.

Consumers Consumers are the end users to whom DTCA is directed. Expectations are that consumers viewing DTCA will discuss their condition and/or request a prescription for the advertised product from their doctor.

Physicians There are approximately 650,000 physicians in the US.12 All physicians are authorised to prescribe prescription products, and in some states, Physician Assistants and Nurse Practitioners are also authorised. A physician’s decision as to which product(s) to prescribe should normatively be based upon medical need, safety, efficacy, price, reimbursement and other factors. Physicians are the targets of direct-mail campaigns, personalised detailing by

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The industry On 21st July, 2005, PhRMA, the industry trade association, announced that its Board of Directors had given preliminary approval to DTCA guidelines. These guidelines, which came into effect in January 2006, state that companies should promote health and disease awareness as part of their DTCA and recommend that manufacturers educate physicians about a particular product before a DTCA campaign begins. The guidelines also

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recommend that television commercials should be targeted ‘for audience and age appropriateness’, and they encourage DTCA to include information about patient assistance programmes.14

US congressional activity Members of Congress have been critical of DTCA. In July 2001, the Senate’ Subcommittee on Consumer Affairs, Foreign Commerce and Tourism held a hearing on the subject but no legislative action was taken as a result of that hearing. Some members of Congress have claimed that DTCA has increased drug costs for consumers and certain federal programmes such as Medicaid. They asked the US General Accounting Office (GAO), to study the effect of DTCA on medical costs. Major findings of the GAO report were: Pharmaceutical companies spend more on R&D than on all drug promotional activities, including DTCA. DTCA appears to increase prescription drug spending and utilisation. Most of the spending increase for heavily advertised drugs is the result of increased utilisation, not price increases. Five per cent of consumers have both requested and received from their physician a prescription for a particular drug in response to seeing a DTCA advertisement’. Among legislative proposals that have been floated but not enacted are elimination of tax deductions to advertisers for the costs of DTCA, mandating comparative research on the effectiveness and safety of drugs, legislative change to allow FDA to require review and approval of DTCA prior to use, banning of DTCA, establishing limits on timing and placement of advertisements, expanding FDA enforcement activity and cutting the level of Medicare reimbursement given to marketers for more heavily advertised drugs.15,16

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In the 2004 Presidential race, DTCA became a campaign issue when candidate Howard Dean called for a ban on DTCA of prescription drugs and a cut in the level of Medicare reimbursement given to marketers for more heavily advertised drugs.17

LITERATURE REVIEW Physicians’ opinions of DTCA have changed with the passage of time. A 1998 position paper by the American College of Physicians supported increased consumer awareness but questioned whether information provided by DTCA is accurate or the best means to achieve this goal. The American Medical Association (AMA), which has generally been opposed to many aspects of DTCA, announced that it plans to study the effect of DTCA on patient–physician relationships and healthcare costs.4,18 Lipsky and Taylor19 surveyed 454 physicians representing a systematic sampling of members of the American Academy of Family Physicians (AAFP). They concluded that physicians had a high awareness of DTCA, since 95 per cent had encountered this type of advertising personally. Eighty per cent of the respondents, however, felt that print DTCA was not ‘a good idea’, and ‘84 per cent expressed negative feelings about television and radio advertising’. These physicians indicated that they felt DTCA was misleading and biased. The FDA conducted an extensive survey of office-based physicians in 2002.20 Major findings were: Many physicians (41 per cent) believed DTCA could play a positive role in their interactions with patients. Fifty-three per cent felt it led to better discussions with their patients, 42 per cent said it made their patients more aware of treatment options and 10 per cent said it had informed and educated patients. Eighteen

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Physicians’ attitudes toward DTCA

per cent indicated that DTCA had led to problems with patients, including physician time spent correcting misperceptions (41 per cent), patients requesting drugs they did not need (26 per cent) and patients wanting a drug rather than a treatment (9 per cent). Physicians were divided about whether DTCA had a positive or negative effect on their practices. One-third were positive, another third neutral and another third negative. This is, however, ‘less negative’ than was found in the Lipsky–Taylor study. Interestingly, general practitioners were more negative than specialists. Seventy per cent of primary care physicians and 60 per cent of specialists felt that DTCA confused patients about the relative risks and benefits of drugs. IMS Health conducted a nationwide study of 2,300 physicians across 16 specialties regarding their attitudes toward DTCA.21 Fifteen per cent had positive views of DTCA, while 33 per cent were neutral and 52 per cent disapproved. This same survey reported that 70 per cent of the physicians were ‘more likely to prescribe a brand name product medication based on a patient request when they had a sample to give the patient’. Weissman et al.22 surveyed 643 office physicians. This study found that 77 per cent of physicians ‘agree somewhat or strongly’ that DTCA encourages patients to seek treatments they do not need; 80 per cent feel that DTCA does not provide information on risks and benefits in a balanced manner and 32 per cent ‘agree somewhat or strongly’ that DTCA makes patients less confident in the physician’s judgment. Mintzes et al.23 surveyed 1,431 patients and 78 physicians in Vancouver, British Columbia and Sacramento California. Major findings were: although DTCA for prescription drugs is not allowed in Canada, 87 per cent of the Vancouver patients had seen such advertising; 7 per

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cent of the Sacramento patients requested advertised drugs compared with 3 per cent in Vancouver; physicians responded to most of the requests for advertised drugs (72 per cent in Vancouver and 78 per cent in Sacramento). The authors concluded that more advertising leads to more requests for advertised medicines and more prescriptions. Donohue and Berndt24 studied 25,716 cases on the effect of DTCA on the use of antidepressants (Donohue Ernst, 2004). They concluded that DTCA had little effect on the choice of antidepressant, although it did influence the choice of treatments for patients with anxiety disorders — a different diagnosis. Dubois25 studied the use of statins, a class of drugs that lower cholesterol.26,27 Patients receiving statins were assigned to 1 of 7 categories representing cardiovascular risk. Dubois concluded that, even though there was significant promotion of statins during the time period covered by the study, there was no change in the cardiovascular risk profile of the patients who received statins. In addition, 95 per cent of the statin users had existing heart disease or risk factors for development. He found: ‘Despite DTC promotion, [there was] no apparent increase in the unnecessary use of this medication class’. Kravitz et al.28 conducted a study in which actors made 298 visits to 152 family physicians and general internists, either making a specific request for the antidepression medication ‘Paxil’ or stating that they saw an ad for a medication without mentioning the brand. Actors exhibiting signs of general depression who mentioned the brand received a prescription (not necessarily for the product requested) 53 per cent of the time, those who made a general request for medication received medication 76 per cent of the time and those who made no request, received medication 31 per cent

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of the time. Similar results were found in patients who exhibited adjustment disorders.

PHYSICIAN’S DTCA STUDY Objectives of this study were to determine: (1) Adequacy of DTCA content: Does DTCA provide sufficient information on risks and side effects? Does DTCA provide sufficient information to enable patients to decide whether to discuss a drug with their physicians? Does DTCA help patients make better decisions about their health? Does DTCA confuse patients? (2) DTCA influence on patient/physician roles and behaviour: Does DTCA help make patients aware of new drugs? Has DTCA disrupted the patient/physician relationship in the US? Does DTCA cause tension between the physician and the patient? Does DTCA lead patients to inappropriately pressure physicians to prescribe unnecessary drugs? Does DTCA encourage consumers to seek medical advice for conditions that might otherwise go untreated? (3) DTCA influence on prescribing: Does patient awareness created by DTCA accelerate the adoption of new drugs? Does DTCA create a preference for brands in cases where generics would be sufficient? Does DTCA cause patients to ask for unnecessary prescriptions? Does DTCA promote compliance with treatment regimens? Does DTCA lead to patients getting unnecessary medications?

Methodology A nationwide survey of physicians was conducted to obtain their attitudes toward DTCA (Table 1). A total of 416 completed questionnaires were collected by Purdue pharmaceutical sales

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representatives who were selected randomly, and selection process was used to select physicians for inclusion in the study. The questionnaire was pilot-tested to identify ambiguities or issues in administration. A copy of the questionnaire is located in the appendix.

The sample Physicians were located throughout the country, were representative of a variety of medical specialties, and varied by the number of years they practiced medicine (Table 2).

KEY FINDINGS There is a high level of awareness of DTCA among physicians: Only 12 respondents (3 per cent) had not seen an ad on television during the last three months while only 11 respondents (3 per cent) had not seen ads for prescription drugs in magazines during the last three months. Physicians, especially younger ones, are exposed to DTCA on the internet: Twothirds of physicians (68 per cent) reported seeing ads on the internet during the last three months. Most physicians are negative about DTCA: This negative view could reinforce existing societal pressures against the pharmaceutical industry: Only 20 per cent of physician respondents (82) agreed strongly or somewhat that that they ‘liked seeing ads directed at consumers for prescription drugs’. Despite the fact that 65 per cent of doctors agreed that DTCA encourages patients to seek medical attention for conditions that might otherwise go untreated, only 22 per cent agreed with the statement: ‘DTCA of prescription products is a good thing’. Younger doctors were, however, less negative (2 test, p < 0.01). Interestingly, specialists were more positive about DTCA than family/general doctors and pain specialists (2 test, p = 0.05).

© 2007 Palgrave Macmillan Ltd 1745-7904 $30.00

Physicians’ attitudes toward DTCA Table 1: Survey questions 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

Have you seen or heard any ads for prescription drugs on television during the last three months? Y/N Have you seen any ads for prescription drugs in magazines during the last three months? Y/N Have you seen or heard any ads for prescription drugs on the internet during the last three months? Y/N I like seeing ads directed to consumers for prescription drugs. Agree/disagree etc Direct-to-consumer advertisements for prescription drugs help make my patients aware of new drugs. Agree/disagree etc Direct-to-consumer advertisements for prescription drugs give enough information for a patient to decide whether to discuss the drug with a doctor. Agree/disagree etc Direct-to-consumers advertisements for prescription drugs help my patients make better decisions about their health. Agree/disagree etc Direct-to-consumer advertisements for prescription drugs do not give enough information about the possible risks and negative effects of using the drug. Agree/disagree etc Direct-to-consumer advertising of prescription products causes patients to ask for unnecessary prescriptions. Direct-to-consumer advertising leads to patients getting unnecessary prescriptions from their doctors. Agree/disagree etc Direct-to-consumer advertising creates tension between me and my patients. Agree/disagree etc Overall, direct-to-consumer advertising of prescription products is a good thing. Agree/disagree etc Direct-to-consumer advertising encourages patients to seek medical attention for conditions that might otherwise go untreated. Agree/disagree etc Direct-to-consumer advertising creates an incorrect preference for brands in cases where a generic product would be sufficient. Agree/disagree etc When my patients make a request for specific brand I respond to my patients’ requests for brands they see advertised X? per cent of the time. Direct-to-consumer advertising confuses patients. Agree/disagree etc Has patient awareness caused by direct-to-consumer advertising led to more rapid adoption of new drugs? Y/N Does direct-to-consumer advertising improve patient compliance? Y/N Direct-to-consumer advertising leads to patients inappropriately pressuring physicians to prescribe unnecessary drugs? Y/N Medical specialty? Years in practice?

Table 2: Demographics and medical specialty of respondents Location

Number

%

Northwest Midwest South West

76 102 153 85

18 24 37 20

Years practicing medicine 1–5 6–10 11–15 16–20 21+

42 99 100 77 89

10 24 25 18 21

Medical specialty FP/GP/IM30 Specialists (excl. pain) Pain doctors Missing Total

Total USA29 Frequency

%

Study sample Frequency

%

185,982 440,169 58,126 0 684,277

27 64 9 0 100

248 111 48 9 416

60 27 12 2 100

This negative view may in part be due to the perception by 78 per cent of octors surveyed (315) that DTCA confuses

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their patients. In addition, one of the purported benefits of DTCA is that it leads to improved compliance. Since only

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13 per cent of physician respondents (52) agreed that DTCA improved compliance, the physician respondent generally did not perceive this benefit of DTCA, or perhaps others. One criticism of DTCA is that it increases the rate of adoption of new drugs. Fifty-four per cent of doctors surveyed agreed that DTCA has led to more rapid adoption of new drugs.31 This is consistent with the finding that 78 per cent of physician respondents agreed somewhat or strongly that DTCA helps make their patients aware of new drugs. Physicians do not feel DTCA provides adequate and accurate information: Only 27 per cent of physicians (112) agreed with the statement: ‘DTCA gives patients enough information to decide whether to discuss a drug with their physician’ while 76 per cent (314) agreed somewhat or strongly that DTCA ‘does not give patients enough information about the possible risks and benefits of using the drug’. More than half of the physicians believed that DTCA leads to patients asking for and receiving unnecessary prescriptions, and an even greater percentage believed that DTCA created a preference for brands where a generic would be sufficient: Fifty-three per cent of doctors surveyed (222) agreed strongly or somewhat that DTCA led to patients getting unnecessary prescriptions from their doctors. It is important to note that 66 per cent of doctors surveyed (275) felt that DTCA created an incorrect preference for brands in cases where a generic would be sufficient. Such a displacement of generics could be a source of considerable ill will from payors and cost-conscious doctors. Notwithstanding these views, when a patient makes a request, more than 45 per cent of doctors surveyed will respond with the requested brand more than 50 per cent of the time (172 of 392 respondents). DTCA creates tension between patients and physicians, and a majority of

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physicians believe that DTCA results in patients inappropriately pressuring physicians: One-hundred seventy-eight doctors (43 per cent) agreed strongly or somewhat that DTCA created tension between themselves and their patients, and 299 (73 per cent) felt that DTCA led patients to inappropriately pressure their physicians to prescribe drugs and this view was more prevalent among primary care physicians than specialists (2 test, p = 0.05). The findings from this study indicate that the majority of physicians are negative about DTCA. Their negativism may impair the economic value and utility of this type of advertising in the future. It may also stimulate political attacks that could result in the imposition of restrictions that would reduce the utility of DTCA as a commercial or public policy instrument. This negative view possibly results from the manner in which DTCA is currently practiced. For example, new industry guidelines ask marketers to delay using DTCA until an adequate amount of time has been spent educating health professionals about a new medicine. In addition, marketers have been criticised for not adequately addressing disease awareness programming and for focusing their ads on promoting their brands.

CONCLUSIONS Table 3 summarises the major study questions and issues as well as answers based on findings provided by this study. Some of the benefits envisioned in the early days of DTCA have been realised. Patients have become more informed and empowered. They are seeing doctors for treatment as a result of DTCA, thus reducing the incidence of under-treatment. It, however, remains unclear whether DTCA has improved the delivery of value in healthcare. More research needs to be done to quantify the benefits of DTCA,

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Physicians’ attitudes toward DTCA

Table 3: Summary of responses to major questions/issues regarding physicians’ attitudes towards DTCA for prescription drugs

1

DTCA questions and issues

Study finding

Is the information content of DTCA adequate? (a) Does DTCA provide sufficient information on risks and side effects? (b) Does DTCA provide sufficient information to enable patients to decide whether to discuss a drug with their physicians?

Physicians generally do not think so. 76% of physicians feel DTCA does not provide sufficient information on risks and side effects. 27% of physicians feel DTCA does provide sufficient information to enable patients to decide whether to discuss a drug with their physicians. 19% of physicians feel DTCA does help patients make better decisions about their health. 78% of physicians feel DTCA does confuse patients.

(c) (d) 2

3

Does DTCA help patients make better decisions about their health? Does DTCA confuse patients?

DTCA influence on the patient/physician roles and behavior? (a) Does DTCA help make patients aware of new drugs? (b) Does DTCA cause tension between the physician and the patient? (c) Does DTCA lead patients to inappropriately pressure physicians to prescribe unnecessary drugs? (d) Does DTCA encourage consumers to seek medical advice for conditions that might otherwise go untreated? How has DTCA influenced on prescribing behavior? (a) Does DTCA promote compliance with their treatment regimens? (b) Does patient awareness created by DTCA accelerate the adoption of new drugs? (c) Does DTCA lead to patients getting unnecessary medications? (d)

Will physicians respond to patient requests for specific brands?

(e)

Does DTCA create an incorrect preference for brands, in cases where generics would be sufficient? Does DTCA cause patients to ask for unnecessary prescriptions? Does DTCA promote compliance with patient’s treatment regimens?

4

Opinions (a) Do physicians feel that DTCA is useful, and why?

including whether it has improved drug treatment and compliance, and what effect it has had on the physician/patient

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78% of physicians feel that DTCA does help make patients aware of new drugs 43% of physicians feel that DTCA does cause tension between the physician and the patient 72% of physicians feel that DTCA does lead patients to inappropriately pressure physicians to prescribe unnecessary drugs 64% of doctors feel that DTCA does encourage consumers to seek medical advice for conditions that might otherwise go untreated.

13% of physicians feel that DTCA does promote compliance with their treatment regimens 54% of physicians feel that DTCA does accelerate the adoption of new drugs. Yes. Physicians do frequently respond to patient requests, and DTCA often creates a preference for brands where a generic would be sufficient. When a patient makes a request, more than 45% of doctors will respond with the requested medicine more than 50% of the time. 66% of physicians feel that DTCA does create an incorrect preference for brands, in cases where generics would be sufficient. 86% of physicians feel that DTCA does cause patients to ask for unnecessary prescriptions. Only 13% of physicians feel that DTCA promotes compliance. 23% agree somewhat or strongly that DTCA is a good thing. 20% agree somewhat or strongly that they like seeing DTCA.

relationship. Physicians report that patients pressure them to prescribe inappropriate or unnecessary drugs, that patients are confused

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by DTCA and that DTCA does not provide adequate information on risk and benefits. It has also been argued DTCA increases patient risk from new drugs. The task of marketers and policy makers will be to refine DTCA to improve its effectiveness as a commercial and health policy tool. Given the image and past practices of the pharmaceutical industry, this is a formidable task. In light of this, the industry must consider whether this form of advertising is worth its cost. Without confirmation that patients, physicians, pharmacists and payors believe that DTCA contributes to public health, it is unlikely that DTCA, as we know it, will be allowed to continue. Members of Congress are questioning the value of DTCA, and without meaningful change they or the FDA may take action to stop or severely curtail it. Recent self-imposed industry guidelines may be the beginning of such positive change. It is also important to consider that advertisers and regulators may be asking DTCA to accomplish more than is possible. In this context, the industry and the FDA need to decide whether it is practical to provide adequate risk and benefit information in the space or time allowed for an advertisement. Perhaps the goal should be simpler. For example, to inform the patient about a new treatment for a disease, to provide some limited information about the disease and to stimulate people to see their doctors. This study indicates that the internet is a growing source of prescription drug information for physicians. The industry should examine the growing importance of the internet and its utility as a tool for communicating detailed information that meets physicians’ needs (and consumers’ needs) at all levels of education, as well as FDA requirements for communication of risks and benefits in fair balance. It may be that the internet will provide a vehicle for improving the risk/benefit

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ratio of DTCA. The reasons for this are as follows: (1) the interactive nature of the internet enables marketers to design audience-specific information and to quickly move to relevant information for different audiences; (2) the internet is a growing source of information for consumers and is already a significant source of information for physicians and pharmacists and (3) the functionality of the internet enables perceptual and learning processes that are not available in current television and magazine formats. This is probably due to the fact that most of the drugs advertised through DTCA are the high-volume maintenance drugs prescribed by family and general practice doctors. As a result, these are the doctors who are likely to be facing most of the patient questions, challenges and pressures from their patients. This study also identifies specific shortcomings and concerns that could be addressed by DTCA marketers. For example, many physicians feel that DTCA is confusing patients and contributing to tension in the doctor’s office. Marketers could implement programmes to educate patients and physicians on the role of DTCA and better integrate physicians into their programming, thereby reducing tension or pressure in the doctor’s office. The majority of physicians do not believe that DTCA provides adequate information on the risks and benefits of advertised products. Marketers could study ways of improving the manner in which this information is presented and implement changes to ensure better comprehension and retention. Such changes would have to be developed in collaboration with the FDA. Physicians may be negative about DTCA because they believe that it contributes to rising healthcare costs. This notion is supported by the survey findings

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Physicians’ attitudes toward DTCA

that DTCA causes consumers to make appointments they would not otherwise make, to obtain prescriptions they would not otherwise obtain and to ask physicians for branded products in cases where lower-cost generics would be satisfactory. More than half of the physicians polled believe that DTCA led to patients getting unnecessary prescriptions from their doctors, and an even greater percentage (68 per cent) believed that DTCA created a preference for brands where generics would be sufficient. While these findings may lead one to conclude that DTCA raises drug costs, especially if people are prescribed drugs they do not need, it is unclear whether on the whole DTCA contributes to increased healthcare costs. A study of all the information necessary to make such a determination is beyond the scope of this study. This study does not include data for offsetting savings to the healthcare system or other benefits arising from circumstances in which (1) a patient became aware of a medical problem and sought early treatment as a result of viewing DTCA; (2) a patient was given a more appropriate, modern medicine as a result of viewing DTCA and asking a doctor, (3) early use of medicine resulted in avoidance of costs for more expensive therapy and (4) use of medicine enabled a patient to resume work and other activities earlier than might otherwise have been the case.

FUTURE RESEARCH The risk/cost benefit relationship of DTCA needs to be better understood. Issues requiring further study on the risk side are as follows: (1) Many physicians believe that DTCA leads to patients getting unnecessary

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prescriptions. This is consistent with the acknowledgement by a large proportion of the doctors surveyed that patients will frequently get what they request. (2) If DTCA creates a preference for brands where a generic would be sufficient, it would be adding unnecessarily to the cost of prescription drugs for the population at large. The extent of unnecessary prescribing and replacement of lower-cost generics caused by DTCA needs to be better understood. (3) DTCA does cause some consumers to visit doctors. It is unclear whether these visits contribute to the general health and well being of society or are just costing money.

Possible beneficial aspects of DTCA requiring further study are: (1) The degree to which DTCA helps or informs patients to make better decision about their health (2) Benefits of increased use of medications to avoid other more costly treatments and (3) Benefits of early intervention in some diseases where patients visit physicians as a result of DTCA. Increasingly negative physician attitudes toward DTCA suggest the need for further study. For example, why do physicians feel that DTCA is causing tension in the doctor’s office? What can be done about this? The manner in which to best address concerns regarding the adequacy of DTCA to communicate required information, especially on risk and benefits, needs further study. Disclaimer: This paper reflects findings from this study and not necessarily the opinions of Purdue Pharma.

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References and Notes 1 Long, D. M. (2005). US strategic management review 2005–2009, IMS Health Incorporated and Affiliates Fairfield, Connecticut, USA. 2 Tufts Center for the Study of Drug Development (2005). Outlook 2005, Available from http://csdd.tufts. edu/InfoServices/OutlookPDFs/Outlook2005.pdf Accessed 24th October 2006. 3 Wilkes, M. S., Bell, R. A. & Kravitz, R. (2000). Direct to consumer prescription drug advertising: trends, impact, and implications. Health Affair. 19(2), 110–128. 4 Palumbo, F. B. & Mullins, C. D. (2002). The development of direct-to-consumer prescription drug advertising regulation. Food Drug Law J. 57(3), 423–443. 5 Woloshin, S., Schwartz, L. M., Tremmel, J. & Welch, H. G. (2001). Direct-to-consumer advertisements for prescription drugs: what are Americans being sold? Lancet 358(9288), 1141–1146. 6 Auton, F. (2004). The advertising of pharmaceuticals direct-to-consumers: a critical review of the literature and debate. Int. J. Advertising 23(1), 5–52. 7 Hunt, M. (1998). Direct to consumer advertising of prescription drug — a background paper. National Health Forum, The George Washington University. 8 It is important to note that these syndicated data on advertising spend are subject to error, For example, McLinden et al. (McLinden, M., Sandino, J. & Willard, T. (2004). Fast relief: the prescription generic omeprazole DTC launch. DTC Perspectives. March, 44–47) report that the published data on Kremers’ costs of their DTCA campaign for omeprazole were almost three times what they had actually spent. 9 Med Ad News Staff (2005). The new face of consumer advertising. MedAdNews (June) 1, 26–42. 10 IMS Says DTC Ads Do Job (2004 November 22). Chain Drug Rev. 26(20), 50. 11 Rosenthal, M. B., Berndt, E. R., Donohue, J. M., Frank, R. G. & Epstein, A. M. (2002). Promotion of prescription drugs to consumers. N. Engl. J. Med. 346(7), 498–505. 12 American Medical Association:http://www.ama-assn. org/ama/pub/category/2670.html. 13 Preferred brands are selected by managed care organisations and offered to patients at lower rates of co-payment, usually because these brands offer rebates or overall lower costs to the managed care organisation. 14 The Pink Sheet Daily (2005). PhRMA board gives preliminary nod to voluntary DTC guidelines. The Pink Sheet Daily, July 21. 15 Vogt, D. U. (2005). Direct to consumer advertising of prescription drugs. CRS Report for Congress, Congressional Research Service, The Library of Congress. 16 Goetzl, I. & Teinowitz, D. (2002 May 6). Drug ad pressure: DTC ads dodge bullet; no thomas curbs; outlays may flatten. Advertising Age 73, 59. 17 Teinowitrz, I. (2003 Oct 20). DTC ads become an issue in race for democratic nomination. Advertising Age 74(42), 8. 18 fdanews.com (2005). AMA to study pharmaceutical DTC Advertising, July 8.

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19 Lipsky, M. S. & Taylor, C. A. (1997). The opinions and experiences of family physicians regarding direct-to-consumer advertising. J. Fam. Pract. 45(6), 495–499. 20 Aikin, K. J., Swasy, J. L. & Braman, A. C. (2004). Patient and physician attitudes and behaviors associated with DTC promotion of prescription drugs — summary of FDA survey research results. November 19, US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluations and Research Final Report. 21 IMS Says DTC Ads Do Job (2004 November 22). Chain Drug Rev. 26(20), 50. 22 Weissmann, J. S., Blumenthal, D. & Silk, A. J. (2004). Physicians report on patient encounters involving direct-to-consumer advertising, Bethesda, MD, Health Affairs, (April 28) W4-219–W4-233 (Web Exclusive) Access http://content.healthaffairs.org/cgi/reprint/ hlthaff.w4.219v1. 23 Mintzes, B., Barer, M. L., Kravitz, R. L., Bassett, K., Lexchin, J., Kazanjian, A., Evan, R. G., Pan, R. & Marion, S. A. (2003). How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without DTCA. Canadian Med. Assoc. J. 169(5), 405–412. 24 Donohue, J. & Berndt, E. R. (2004). Effects of directto-consumer advertising on medication choice: the case of antidepressants. J. Public Policy Market. 23(2), 115–127. 25 Dubois, R. W. (2003). Pharmaceutical promotion: don’t throw out the baby with the bathwater. February 26, Web Exclusive, http://content. healthaffairs.org/cgi/content/full/hlthaff.w3.96v/DC1 and Presented at the US Food and Drug Administration Direct to Consumer Promotion Public Meeting September 22–23, 2003. 26 Dubois, R. W., Alaxander, C. M., Wade, S., Mosso, A., Markson, L., Lu, J. D., Nag, S. & Berger, M. L. (2002). Growth in use of lipid-lowering therapies: are we targeting the right patients? Amer. J. Manage. Care 8(10), 862–867. 27 Web Exclusive February 26, 2003, http://content. healthaffairs.org/cgi/content/full/hlthaff.w3.96v/DC1 presented at the US Food and Drug Administration Direct-to-Consumer Promotion Public Meeting September 22–23, 2003. 28 Kravitz, R. L., Epstein, R. M., Feldman, M. D., Franz, C. E., Azari, R., Wilkes, M. S., Hinton, L. & Franks, P. (2005). Influence of patients requests for direct-toconsumer advertised antidepressants. JAMA 293(16), 1995–2002. 29 Dendrite US Distribution of Physicians 11/1/05. 30 Family Practice/General Practice and Internal Medicine are generally regarded as the groups that are family doctors or primary care physicians. 31 This concern is based on the premise that rapid adoption is not a good thing because drugs get into larger populations more quickly than would otherwise be the case, putting more of the population at risk than if the initial experience had been limited to a smaller population.

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