Page 1 of 24
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`SENJU EXHIBIT 2298
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`LUPIN V. SENJU
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`IPR2015-01105
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`Page 1 of 24
`
`SENJU EXHIBIT 2298
`LUPIN v. SENJU
`IPR2015-01105
`
`

`
`

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`TABLE or CONTENTS
`
`KEY FACTS ‘I
`
`MARKETING TO HEALTH CARE
`PROVIDERS 8: PRESCRIBING PATTERNS 3
`
`Pharmaceutical sales representatives provide
`doctors with important information about
`new treatment options that is factored
`into prescribing, but studies find that many
`other factors, including insurers’ policies,
`affect prescribing decisions, often with
`greater impact. In fact, about 2 out of
`3 medicines prescribed in the U.S. are
`generic—much higher than in nearly
`all other developed countries.
`
`INFORMATION TO HEALTH CARE PROVIDERS 5
`
`Government regulates the marketing of
`pharmaceuticals, and companies strive
`to provide reliable, valuable information.
`Delivering this information is key to making
`physicians aware of the latest advances.
`
`SAMPLES 6
`
`Samples provide many benefits to patients,
`allowing them to begin treatment sooner and
`helping them find the right medicine.
`
`"GIFTS" TO HEALTH CARE PROVIDERS 7
`
`PhRMA's member companies are committed
`to following the highest ethical standards
`and all legal requirements in their interactions
`with health care professionals. In 2008, they
`adopted a newly revised code that, among
`other things, redefines the narrow category
`of educational items company representatives
`can give to health care professionals.
`
`DTC & PHYSICIAN I PATIENT RELATIONSHIP 8
`
`Many physicians and patients report that DTC
`advertising enhances their communication.
`
`UNDERDIAGNOSIS & UNDERTREATMENT 9
`
`Studies report significant underdiagnosis
`and undertreatment of serious conditions
`that affect millions of Americans. While
`
`these conditions, such as diabetes and
`cardiovascular disease, can often be treated
`
`effectively, left untreated they generate poor
`health outcomes and high health costs for
`avoidable hospitalizations. Pharmaceutical
`marketing and promotion help address this
`problem by raising awareness of disease
`symptoms and treatments, and prompting
`patients to visit their doctor.
`
`PATIENT EDUCATION & EMPOWERMENT 12
`
`DTC advertising creates awareness of diseases
`and treatment options, helps get patients into
`needed treatment, and empowers patients
`with information.
`
`DTC 8: PRESCRIBING PATTERNS 13
`
`A majority of physicians report not feeling
`pressure to prescribe requested medications.
`In fact, many physicians recommend lifestyle
`changes and other treatments when patients
`request a specific medicine.
`
`DTC ADVERTISING & DRUG PRICES / SPENDING 15
`
`Government agencies and independent
`experts report no direct relationship between
`drug marketing and drug prices.
`
`SPENDING ON PROMOTION AND R&D 17
`
`Pharmaceutical companies are very research-
`intensive and spend significantly more on
`research and development than on marketing
`and promotion.
`
`GOVERNMENT & INDUSTRY REGULATION 19
`
`Pharmaceutical marketing is closely regulated
`by the U.S. Food and Drug Administration
`(FDA) to help assure that promotional
`materials are accurate, fairly balanced, and
`limited to information that has been approved
`by the FDA. Many pharmaceutical companies
`have also adopted voluntary pharmaceutical
`industry guidelines that lay out standards for
`interactions with health care providers and
`appropriate DTC marketing.
`
`Page 3 of 24
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`

`
`=______
`
`

`
`Underdiagnosis & Undertreatment Continued
`
`- Another RAND study published in the
`Annals of/nternal Medicine found that
`
`50°/o of all quality problems in the use of
`
`medicines was accounted for by underuse,
`
`compared to 3°/o accounted for by overuse.
`
`A Harvard University/Massachusetts
`
`General Hospital and Harris Interactive
`
`Survey found that:
`
`- 1/4 of patients who visit their doctor
`
`after seeing a DTC ad receive a new
`
`diagnosis.
`
`46% of physicians felt that DTC
`
`advertising increased patients’
`
`compliance with prescribed treatment.
`
`By treating patients according to guidelines
`
`and by eliminating the underuse of
`
`high blood pressure medicines, 89,000
`lives could be saved and 420,000
`
`hospitalizations avoided annually.
`(See pgs 94 1)
`
`Patient Education
`
`~ A 2007 KRC Research survey found that:
`
`o
`
`1 in 4 consumers sought more
`
`DTC 8: Prescribing Patterns
`
`~ A 2006 Government Accountability Office
`
`(GAO) report found that only 2—7°/o of
`consumers who saw a DTC advertisement
`
`requested and ultimately received a
`
`prescription for the advertised drug.
`
`» A 2002 study on the effect of DTC
`
`advertising on demand for pharmaceuticals
`
`revealed that DTC advertising may increase
`
`demand for a particular brand drug, but
`
`only if it has a ’’favorable status” on the
`
`insurer's formulary.
`(See pgs 13-14)
`
`DTC Advertising & Drug Prices / Spending
`
`= According to the Federal Trade
`
`Commission, "[DTC advertising] can
`
`empower consumers to manage their own
`
`health care by providing information that
`
`will help them, with the assistance of their
`
`doctors, to make better informed decisions
`
`about their treatment options. . .Consumers
`
`receive these benefits from DTC advertising
`
`with little, if any, evidence that such
`
`advertising increases prescription drug
`
`information after seeing a DTC ad.
`
`prices.” [Emphasis Added]
`
`- 4 in 5 consumers agree that
`
`advertising for prescription medicines
`
`can educate people about health
`
`conditions and treatment options.
`
`= A Prevention Magazine physician
`
`survey found that 70% of doctors feel
`
`that ads help educate patients about
`available treatments. 67°/o felt that the
`
`advertisements helped them have better
`
`"The pharmaceutical industry is one of the
`most research-intensive industries in the
`
`United States. Pharmaceutical firms invest
`
`as much as five times more in research and
`
`development, relative to their sales, than
`
`the average U.S. manufacturing firm.”
`— Congressional Budget Office, 2006
`
`~ Total promotional spending 2006 —
`$12.0 billion
`
`discussions with their patients.
`
`- DTC — $4.8 billion
`
`7<
`l‘|'1
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`
`- Office promotion, hospital promotion,
`
`and journal advertising — $7.2 billion
`
`A Total R&D spending 2007 ~ $58.8 billion
`(See pgs 15-I6)
`
`-T The FDA's 2004 survey showed that in
`
`88°/o of cases when patients ask their
`
`physicians about a medicine as a result
`
`of seeing a DTC advertisement, they
`
`have the condition that the drug treats.
`
`A Prevention Magazine patient survey
`
`found that 80% of patients who see
`medicines advertised on television are
`
`aware of the risk information presented,
`
`compared to 66°/o aware of the benefits.
`(See pg 12)
`
`Page 5 of 24
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`
`MARKETING TO HEALTH CARE
`
`PROVIDERS & PRESCRIBING PATTERNS
`
`Pharmaceutical sales representatives provide doctors with important information
`
`about new treatment options that is factored into prescribing, but studies find
`
`that many other factors, including insurers’ policies, affect prescribing decisions,
`
`often with greater impact. In fact, about 2 out of 3 medicines prescribed in the
`
`US. are generic—much higher than in nearly all other developed countries.
`
`CHART 1: Factors Physicians Consider in Prescribing Medicines
`Percent Saying Great Deal or Some Influence on Prescribing Decisions
`
`Olnkal knowledge A
`experience
`Patlenfs unique situation
`
`Peer-reviewed journals
`
`Clinical practice auldellnes
`
`Colleagues A peers
`
`Patient‘: flnandai status
`
`Patlerlfscavuagelibrmialary
`Information from
`pharmaceutical co. reps
`Patient‘: personal options
`
`Prior authorization restrictions
`
`Amount ofthe co-pay
`
`to. I PBM Rem
`
`°
`
`I Great Deal
`
`V‘
`
`Source: Pharmaceutical Research and Manufacturers or America, KRC Research: Survey of Physicians’ Opinions About
`Pharmaceutical and Biotech Research Compan_vActivities and Information, n=501, 2008.
`
`Pharmaceutical marketing to health care
`
`patient’s unique situation. Journal articles, clinical
`
`providers is an important part of keeping
`
`guidelines and formularies are all factors that
`
`physicians up-to-date about new treatments and
`
`physicians consider more than pharmaceutical
`
`their risks and benefits. However, it is only one
`
`company representatives2[See Chart 1].
`
`factor among many in the health care system.
`For instance, health plans may strongly
`
`Two Surveys, one by The Boston Consulting
`Group (BCG) and the other by the Tufts
`
`influence prescribing through formulary design
`
`Center for the Study of Drug Development,
`
`and utilization management strategies, among
`
`echoed these findings. In the BCG survey,
`
`other factors. A recent KRC Research survey
`
`54% of physicians reported that formularies
`
`sponsored by PhRMA found that by far the most
`
`have a major impact on prescribing decisions,
`
`important factors in prescribing are a physician's
`
`50% identified peers, and 47% identified
`
`clinical knowledge and experience and the
`
`clinical guidelines, compared to 14% who
`
`’ KRC Research, ‘Physicians’ Opinions About Pharmaceutical and Biotech Research Company Activities and lnfomiationf n=501, 2008, sponsored by Pharmaceutical Research
`and Manufacturers of America.
`
`3
`
`THE FACTS ABOUT PHARMACEUTICAL MARKETING & PROMOTION
`
`Page 6 of 24
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`
`said pharmaceutical representatives have a
`
`a study in Health Affairs noted that physician
`
`major impact? The Tufts Center for the Study
`
`counterdetailing by insurance companies and
`
`of Drug Development found that among
`
`pharmacy benefit managers to encourage the
`
`factors influencing prescribing decisions in 2007,
`
`use of generics is ”gaining momentum.” In the
`
`physicians considered the following to be "very
`
`public sector, some Medicaid programs have
`
`important": continuing medical education
`
`recently hired physicians and pharmacists to visit
`
`(68%), information from peers (43%), and
`
`doctors’ offices and encourage them to prescribe
`
`payer's decisions (37%). Only 13% of physicians
`
`generics? Counterdetailing by payers and their
`
`considered information from pharmaceutical
`
`agents to influence prescribing decisions is not
`
`companies "very important "‘
`
`subject to FDA regulation, while detailing by
`
`Research published in Health Affairs reports that
`
`pharmaceutical companies is FDA—regulated.
`
`one-third of physicians do not always discuss
`
`Counterdetailing is only one of many payer
`
`treatment options when those options would
`
`tactics to influence physician prescribing. The
`
`not be covered by the patient’s insurer.‘
`
`It is also important to note that approximately
`
`67% of all prescriptions dispensed in the
`
`U.S. in 2007 were for generic drugs,‘ up
`
`from 49% in 2000.7 Moreover, the U.S. has
`
`one of the highest generic market shares of
`
`any developed country.” These facts clearly
`
`demonstrate that the regulated information
`
`conveyed through pharmaceutical company
`
`marketing of brand medicines is only one of
`
`many factors that physicians consider when
`
`making prescribing decisions.
`
`The range of influences on prescribing extends
`
`beyond those identified above. For example,
`
`Health Affairs study also reported that Blue
`Cross Blue Shield of Florida sends letters to
`
`doctors who are low prescribers of generics.
`
`In addition, other health plans plan to
`
`distribute generic drug samples to contracted
`
`physicians.‘° According to The Wall Street
`
`Journal, during a three-month program in
`
`2007, Blue Cross Blue Shield of Michigan paid
`
`doctors for switching patients from the brand
`
`statin they had been taking to a different
`
`statin’s generic copy.“ The physician survey by
`
`KRC Research found that 80% of physicians
`
`have been asked by an insurer to switch a
`
`prescription to a different drug—not merely a
`
`generic copy of the drug they prescribed.”
`
`CHART 2: Brand and Generic Shares of Prescriptions Filled: 1996-2007
`
`
`
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`
`2 [~03
`
`2 61- 2 -
`
`Source: PhRMA Analysis of National Prescription Audit" data from IMS Health, data through 3"’ Quarter of 2007.
`3Boston Consulting Group, 2002 BCG Proprietary Physician Survey, n=399, 2002.
`‘Tufts Center for the Study of Drug Development, Outlook 2008, (Tufts CSDD: Boston, 2008).
`5 M. Wynia et al., " Do Physicians Not Offer Useful Services Because of Coverage Restrictions?," laea/rl7Afla/'rs 22, no.4 (July/August 2003): 190-197.
`5 Pharmaceutical Research and Manufacturers ofAmerica, Analysis afNar/'onalPrescn‘pIianAua’it"' data from IMS Health, data through 3rd Quarter of 2007.
`7 IMS Health, October, 2007.
`‘ M. Danzon and MF. Furukawa, "Price and Availability of Pharmaceuticals: Evidence from Nine Countries,” I-lea/I/2A/fa/rs Web Exclusive 29 October 2003,
`httpzllcontent.healthaffairs.orglcgilreprint/hlthaff.w3.52ivi (accessed 25 March 2008).
`9}. Malkin et al., "The Changing Face of Pharmacy Benefit Design," I/ea/thAf/airs23, no.1 (2004) 194-199, page 198.
`'0 lbid.
`" V. Fuhrmans, "Doctors Paid To Prescribe Generic Pills,’ The Wall Street/ouma/, 24 January 2008.
`‘1 KRC Research, "Physicians' 0pinionsAbout Pharmaceutical and Biotech Research Company Activities and Information,’ n=501, 2008, sponsored by
`Pharmaceutical Research and Manufacturers ofAmerica.
`
`Page 7 of 24
`
`

`
`INFORMATION TO HEALTH CARE PROVIDERS
`Government regulates the marketing of pharmaceuticals, and companies
`strive to provide reliable, valuable information. Delivering this information
`is key to making physicians aware of the latest advances.
`“There is a clear need for interactions between
`
`physicians and the pharmaceutical industry
`to ensure the free fl ow of valid scientifi c
`information. When the information is accurate
`and complete, physicians have the necessary
`tools to make the right prescribing decisions.”20
` – American Medical Association, Testimony
`
`economist David Cutler and then-Stanford researcher
`Mark McClellan. Through promotional activities for a
`then-new treatment for depression, “Manufacturers
`of SSRIs [depression medications] encouraged
`doctors to watch for depression and the reduced
`stigma afforded by the new medications induced
`patients to seek help.”17 As a result, diagnosis and
`treatment for depression doubled over the 1990s.
`However, underdiagnosis and undertreatment remain
`high: 16.2% of Americans suffer from a depressive
`disorder, of those, only 51.6% receive treatment.18
`
`Physicians evaluate information from a range of sources,
`including continuing medical education, journal articles,
`clinical practice guidelines, and company representatives.
`They consider many aspects of information from
`representatives to be useful: 95% say information about
`drug interactions is useful, 95% value information about
`the latest drugs and treatments, 92% fi nd answers to
`specifi c questions they have useful, and 90% appreciate
`information about patient assistance programs.19
`
`According to the Institute of Medicine, science
`and technology have been advancing at an
`unprecedented pace in recent years.13 Despite this,
`diffusion into practice is slow: One study found that
`medical research takes 17 years to be incorporated
`into clinical practice.14 Pharmaceutical marketing
`plays a valuable role by delivering the newest
`information on medicines to physicians and helping
`to translate new technologies into practice.
`
`This information must be reliable. State and federal
`government regulations govern the marketing of
`products, and serious consequences exist for non-
`compliance. Only a product’s scientifi cally proven
`properties, verifi ed by the FDA, can be discussed
`in its marketing. Furthermore, pharmaceutical
`representatives strive to provide the most accurate
`information in order to build credibility and earn the
`trust of physicians over time.
`
`Published research has looked at whether
`physicians see value in pharmaceutical
`promotional and marketing efforts. A 2008 KRC
`Research survey reported that nearly 90% of
`physicians were either very satisfi ed (29%) or
`somewhat satisfi ed (59%) with the information
`they received from company representatives.15 A
`2002 BCG survey yielded similar results.16
`
`The value of disseminating information to
`physicians is evident in a study by Harvard
`
`13 Institute of Medicine, Crossing the Chasm: A New Health System for the 21st Century, (Washington, DC: National Academy Press, March 2001).
`14 E.A. Balas and S.A. Boren, “Managing Clinical Knowledge for Health Care Improvement,” Yearbook of Medical Informatics 2000: Patient-centered Systems, (Stuttgart, Germany: Schattauer, 2000), 65–70.
`15 KRC Research, “Physicians’ Opinions About Pharmaceutical and Biotech Research Company Activities and Information,” n=501, 2008, sponsored by Pharmaceutical Research
`and Manufacturers of America.
`16 Boston Consulting Group, 2002 BCG Proprietary Physician Survey (400 respondents), 2002, as reported in “Pharmaceutical Marketing and Promotion, Creating Access to
`Innovation,” Economic Realities in Health Care Policy 3, no. 1, (Pfi zer: 2003): 11.
`17 D. Cutler and M. McClellan, “Is Technological Change in Medicine Worth It?” Health Affairs 20, no.5 (September/October 2001): 11-29.
`18 R.C. Kessler, P. Berglund, O. Demler et al., “The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R),” The Journal of the
`American Medical Association 289, no.23 (18 June 2003): 3095-3105.
`19 KRC Research, “Physicians’ Opinions About Pharmaceutical and Biotech Research Company Activities and Information,” n=501, 2008, sponsored by Pharmaceutical Research and Manufacturers of America.
`20 American Medical Association, “Paid to Prescribe?: Exploring the Relationship Between Doctors and the Drug Industry,” Statement to the Special Committee on Aging, United
`States Senate, (Washington, DC: Statement of Robert M. Sade, 27 June 2007) http://aging.senate.gov/events/hr176rs.pdf, (accessed 29 August 2007).
`
`5 THE FACTS ABOUT PHARMACEUTICAL MARKETING & PROMOTION
`
`Page 8 of 24
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`SAMPLES
`
`Samples provide many benefits to patients, allowing them to begin
`
`treatment sooner and helping them find the right medicine.
`
`Another role that pharmaceutical promotion
`
`samples provide them with useful first-hand
`
`often plays is providing samples to physicians.
`
`experience. According to the chairman of the
`
`Doctors may distribute samples to patients for
`
`Asthma and Allergy Foundation's Medical-
`
`several reasons—for instance, to get patients
`
`Scientific Council, samples are "an important
`
`started on therapy right away, to optimize
`
`way of trying to find out which [medicines]
`
`dosing or choice of drug before committing to
`
`work for patients.”12
`
`a particular course of treatment, and sometimes
`
`to help patients who might not be able to afford
`medicines on their own.
`
`Although the main role of samples is to allow
`
`patients to try a medicine before filling a full
`
`prescription and to start treatment right away,
`
`A 2008 KRC Research survey found 69% of
`
`in some cases physicians provide samples to
`
`physicians believe free drug samples are either
`
`help patients who are financially struggling. A
`
`always useful (52%) or often useful (17%).2‘
`
`recent Kaiser Family Foundation survey found
`
`Ninety-five percent of physicians surveyed
`
`that 75% of physicians frequently (58%) or
`
`agreed that samples allow patients to start
`immediate treatment and 84% said that
`
`sometimes (17%) give patients samples to assist
`
`them with their out-of-pocket costs.” In the
`
`survey by KRC Research, 93% of physicians
`
`said drug samples helped them assist those
`
`patients who are uninsured or in need of
`financial assistance.“
`
`"[Samp|es provide] a clear and
`
`
`
`direct benefit to patients who have
`
`a medically indicated need for
`
`treatment, but lack the resources
`
`to obtain the necessary care.”25
`
`—American Medica/Association, Testimony
`
`1' KRC Research, ‘Physicians’ Opinions About Pharmaceutical and Biotech Research CompanyAct1'vities and Information,’ n=501, 2008, sponsored by Phannaceutical Research
`and Manufacturers of America.
`" J. Saranow and AD. Marcus ‘The Higher Cost of Sneezing —As Nonprescription Claritin Hits Shelves, Insurers Jack up Prices of Other Allergy Drugs,‘ Ihe WaISrreeUournaI, 10
`December 2002.
`1’ Kaiser Family Foundation, Nan'ona/SurveyalPhysia‘ans,Toplines, November 2006, http'JIwww.kff.orgkaiserpo|lsluploadl7584.pdl (accessed 10 December 2007).
`1‘ KRC Research, ‘Physicians’ Opinions About Pharmaceutical and Biotech Research CompanyActivities and Information,’ n=501, 2008, sponsored by Phannaceutical Research
`and Manufacturers of Amerim.
`“American Medical Association, ‘Paid to Prescribe}: Exploring the Relationship Retween Doctors and the Drug Industry,‘ Statement to the Special Committee anAging, (liked
`States Senate, (Washington, DC: Statement of Robert M. Sade, 27 June 2007) http:/Iagingsenategov/eventslhri76rs.pdt (accessed 29 August 2007).
`
`Page 9 of 24
`
`

`
`“GIFTS” TO HEALTH CARE PROVIDERS
`
`PhRMA’s member companies are committed to following the highest
`ethical standards and all legal requirements in their interactions with
`health care professionals. In 2008, they adopted a newly revised code
`that, among other things, redefi nes the narrow category of educational
`items company representatives can give to health care professionals.
`
`In 2008, the PhRMA Board adopted a newly
`revised Code on Interactions with Health Care
`Professionals (the “PhRMA Code”), refl ecting
`a commitment to working with health care
`professionals for the benefi t of patients. The
`PhRMA Code starts with the fundamental
`principle that a health care professional’s care
`of patients should be based—and should be
`perceived as being based—solely on each
`patient’s medical needs and the health care
`professional’s medical knowledge.
`
`The PhRMA Code reaffi rms that interactions
`between company representatives and health
`care professionals should be focused on
`providing information on products, scientifi c and
`educational information, and supporting medical
`education. Thus, the revised Code prohibits
`distribution of non-educational items, such
`as pens, mugs, and other “reminder” objects
`adorned with a company logo to health care
`professionals. The Code acknowledges that such
`items may foster misperceptions that company
`interactions with health care professionals are not
`based on informing them about medicines.
`
`Informational discussions by company
`representatives provide health care professionals
`with valuable information about new medicines
`that can lead to improved patient care. The new
`
`Code states that company representatives are
`permitted to offer an occasional meal as long
`as it is modest, and only offered in the offi ce or
`hospital setting, in conjunction with educational
`presentations. Limiting these meals to the
`offi ce or hospital setting, instead of restaurants,
`ensures that the meal is merely incidental to
`the substantive communication between the
`representative and the health care professionals
`in a professional setting.
`
`The revised PhRMA Code reaffi rms that
`representatives should not give health care
`professionals any items for personal benefi t
`or provide tickets to any recreational or
`entertainment events. It allows a company to
`engage health care professionals for bona fi de
`consulting services, provided that the company
`has a legitimate need for the services, the
`arrangement is not a reward or inducement to
`prescribe a particular medicine, and compensation
`is based on the fair market value of those services.
`
`The revised PhRMA Code contains a compliance
`mechanism, requiring companies that state their
`intentions to follow the Code to certify annually that
`they have policies and procedures in place to foster
`compliance. PhRMA will identify on its website the
`companies that intend to follow the Code and the
`status of their compliance certifi cations.
`
`7 THE FACTS ABOUT PHARMACEUTICAL MARKETING & PROMOTION
`
`Page 10 of 24
`
`

`
`
`
`

`
`UNDERDIAGNOSIS & UNDERTREATMENT
`
`Studies report signifi cant underdiagnosis and undertreatment of serious
`conditions that affect millions of Americans. While these conditions, such
`as diabetes and cardiovascular disease, can often be treated effectively, left
`untreated they generate poor health outcomes and high health costs for
`avoidable hospitalizations. Pharmaceutical marketing and promotion help
`address this problem by raising awareness of disease symptoms and
`treatments and prompting patients to see their doctor.
`
`Getting patients into needed therapy is one of
`the most important roles of DTC advertising.
`By helping to reduce underdiagnosis and
`undertreatment, DTC ads benefi t patients
`and the health care system.
`
`For the majority of diseases, research shows
`that underdiagnosis and undertreatment are
`common.30 A landmark 2003 study conducted
`by RAND Health found that U.S. patients fail
`to receive about half of all recommended
`health care. The study found that medicines
`are underused in numerous situations
`for many conditions. Notably, for quality
`standards related to medication, patients
`on average failed to receive recommended
`care 30% of the time.31 Another RAND study
`assessed quality problems in the delivery of
`pharmacotherapy and identifi ed 50% of all
`problems as underuse of needed medicines
`while overuse accounted for 3% of problems.32
`
`Pharmaceutical marketing and promotion help
`address underuse by encouraging patients
`to talk to their doctors about conditions that
`may otherwise have gone undiagnosed or
`untreated. In fact, one survey found that 56
`million Americans in 2006 had conversations
`with their doctors after seeing a DTC ad.33
`
`A survey by Harvard University/Massachusetts
`General Hospital and Harris Interactive found
`that one-quarter of adult patients who
`visited their physician after seeing a DTC ad
`received a new diagnosis.34 Some of the most
`common new diagnoses––high cholesterol,
`hypertension, diabetes, and depression––are
`often underdiagnosed and undertreated in the
`general population [See Chart 3].
`
`The Harvard study also showed that even after
`patients leave the offi ce, the benefi ts persist:
`46% of physicians felt that DTC advertising
`increased patients’ compliance with prescribed
`treatment.35 This is an important benefi t
`
`30 See for example, J.D. Kleinke, “Access Versus Excess: Value-Based Cost Sharing for Prescription Drugs,” Health Affairs 23, no. 1 (January/February 2004): 34-47.
`31 E. A. McGlynn et al., “The Quality of Health Care Delivered to Adults in the United States,” The New England Journal of Medicine 348, no.26 (26 June 2003): 2635-2645.
`32 T.P. Higashi, G. Shekelle et al., “The quality of pharmacologic care for vulnerable older patients.” Annals of Internal Medicine 140, no. 9 (4 May 2004): 714-20.
`33 Prevention Magazine, The National Survey on Consumer Reaction to DTC Advertising of Prescription Medicines, 2007.
`34 J. S. Weissman et al., “Physicians Report on Patient Encounters Involving Direct-to-Consumer Advertising,” Health Affairs Web Exclusive, 28 April 2004, http://content.
`healthaffairs.org/cgi/reprint/hlthaff.w4.219v1 (accessed 25 March 2008).
`35 Ibid.
`
`9 THE FACTS ABOUT PHARMACEUTICAL MARKETING & PROMOTION
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`===.==2E_E_E=2=====.====_:=__
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`==_=__=E“__=;=_E=EE=__=__=E“;=;=_E_=____=_____=E“__=;=_E=EE=__=__=E“;=;=_E_=____=_
`
`
`

`
`UNDERDIAGNOSIS & UNDERTREATMENT Continued
`
`because when patients fail to take needed
`medicines as prescribed by their physicians,
`the result is worse health outcomes and higher
`hospital and nursing home costs; in fact,
`nonadherence has been estimated to cost the
`U.S. $100–300 billion annually in avoidable
`health spending and lost productivity.37
`
`An article in the New England Journal of
`Medicine found that DTC advertising is
`concentrated among a few therapeutic
`categories. These are therapeutic categories
`encompassing chronic diseases with
`many undiagnosed sufferers, such as high
`cholesterol, osteoporosis, and depression,
`or therapeutic areas in which consumers can
`often recognize their own symptoms, such
`as arthritis and seasonal allergies.
`
`Nonadherence has been estimated
`
`to cost the U.S. $100-300 billion
`
`annually in avoidable health
`
`spending and lost productivity.37
`
`Patients with one or more chronic diseases
`currently account for 85% of health care
`spending.38 Early and consistent treatment is
`key to controlling this expense. According to a
`study in the Journal of the American Board of
`Family Practice, patients with chronic disease
`were more likely to disclose health concerns
`to their doctors and seek preventive care as
`a result of seeing DTC advertisements.39
`
`Research shows that addressing the
`undertreatment gap can have great benefi ts.
`A 2007 study in Health Affairs examined use
`of high blood pressure drugs and found that
`an additional 89,000 lives could be saved and
`420,000 hospitalizations avoided annually if
`all patients with hypertension were treated
`according to guidelines, on top of the 86,000
`lives already saved and 833,000 hospitalizations
`avoided thanks to these medicines.40
`
`In addition to improved outcomes, reducing
`underuse and increasing adherence to medicines
`can lead to cost offsets. For example, a 2005
`study by MEDCO Health found that every
`additional dollar spent as a result of improved
`adherence to medicines to treat diabetes,
`hypertension, and high cholesterol yields
`savings of $4–$7.41
`
`37 H. Shorter, “Noncompliance with medications: An economic tragedy with important implications for health care reform.” Task Force for Compliance Report, 1993; M.R.
`DiMatteo, “Variations in Patients’ Adherence to Medical Recommendations: A Quantitative Review of 50 Years of Research,” Medical Care 42, no. 3 (March 2004): 200-9.
`38 G. Anderson, analysis, prepared for PhRMA, of the Medical Expenditure Panel Survey, 2004.
`39 E. Murray et al., “Direct-to-Consumer Advertising: Public Perceptions of Its Effects on Health Behaviors, Health Care, and the Doctor-Patient Relationship,” The Journal of
`the American Board of Family Practice 17, no.1 (February 2004): 6-18.
`40 D. Cutler, et al., “The Value of Antihypertensive Drugs: A Perspective on Medical Innovation,” Health Affairs 26, no. 1 (January/February 2007): 97-110.
`41 M.C. Sokol et al., “Impact of Medication Adherence on Hospitalization Risk and Healthcare Cost,” Medical Care 43, no. 6 (June 2005): 521-530.
`
`11 THE FACTS ABOUT PHARMACEUTICAL MARKETING & PROMOTION
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`

`
`PATIENT EDUCATION & EMPOWERMENT
`
`DTC advertising creates awareness of diseases and treatment options
`
`and empowers patients with information.
`
`A major goal of DTC advertising is to inform
`and educate consumers about diseases, their
`
`symptoms, and available therapies. Research
`shows that many patients gain valuable
`
`""1 88% of C3595 When a Patient
`
`information from ads.
`
`asks their physician about a
`
`In fact, an FDA survey released in 2004 found
`
`medicine as a result of seeing a
`
`that in 88% of cases when a patient asked
`their physician about a medicine as a result
`of seeing a DTC advertisement, they had the
`
`condition that the drug treats."
`
`According to a 2007 survey conducted by
`
`KRC Research for the Advertising Coalition,
`
`DTC advertisement, they have the
`Condition that the drug treat5_~42
`
`— FDA Physician Survey, 2004
`
`"advertising for prescription medications
`
`"allow people to be more involved with their
`
`makes people better-informed patients by
`
`healthcare’’ and ’'tell people about
`
`prompting them to seek more information
`
`new treatments.”“‘
`
`about a disease or drug and helping them
`
`recognize that a problem they have can be
`treated." The research found that one in four
`
`consumers—or 59 million Americans—sought
`
`more information after seeing an ad for a
`
`medication and four in five consumers agree
`
`that advertising for prescription medications
`
`can educate people about health conditions
`and treatment Optionsfi
`This point was echoed in Prevention Magazine's
`
`2007 survey, which found that over 70%
`
`of people agree that DTC advertisements
`
`The survey also showed that DTC provides
`
`patients with information about the risks as
`
`well as benefits of medicines. Eighty percent
`
`of patients who see medicines advertised on
`television are aware of the risk information
`
`presented. Half say that they pay "a lot of
`attention" to the risk information. About 66%
`are aware of the benefits of the drug, and
`nearly a third report paying particular attention
`to this information.“
`
`" K. Aikin, J.L Swasy, A.C. Braman, ‘Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs — Summary of FDA Survey Research
`Results, Final Report.‘ (Washington, DC: U.S Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 19 November
`2004) http:IIwww.fda.govlcderIddrnadFinal%20ReponlFRfi nall 1 i9o4.pdr (accessed 30 October 2007).
`‘3 KRC Research,