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Tailoring pharmaceutical public relations strategies to different markets: a case study of the launching strategies of Gardasil in the U.S. and China

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Tailoring pharmaceutical public relations strategies to different markets: a case study of the launching strategies of Gardasil in the U.S. and China

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Content TAILORING PHARMACEUTICAL PUBLIC RELATIONS STRATEGIES TO DIFFERENT MARKETS A CASE STUDY OF THE LAUNCHING STRATEGIES OF GARDASIL IN THE U.S. AND CHINA by Xuelu Wu A Thesis Presented to the FACULTY OF THE USC GRADUATE SCHOOL UNIVERSITY OF SOUTHERN CALIFORNIA In Partial Fulfillment of the Requirements for the Degree MASTER OF ARTS (STRATEGIC PUBLIC RELATIONS) August 2014 Copyright 2014 Xuelu Wu ii Dedication This thesis would not have been possible without the support of my family and friends. Mom and Dad, thank you for your love and encouragement. iii Acknowledgements I would like to thank my thesis committee chair, Jerry Swerling, and my committee member Jennifer Floto and Laura Min Jackson. Their detailed feedback and directions were great inspirations to me. I am so appreciative of their guidance and encouragement not only during this process, but also throughout my graduate studies at USC. In addition, I would like to thank my former supervisors at MSD China, Jane Wu and Cleo Zhang, for providing me a wealth of knowledge and internal materials, which helped me complete this thesis. iv Table of Contents Dedication ii Acknowledgements iii List of Figures vii List of Tables viii Abstract ix Chapter One: Vaccine Market in the U.S. and China 1 I. Human Vaccine Industry 1 II. Regulatory regime and policy development 2 1. National authority and legislation 3 2. Drug registration and approval 3 3. Changes in the Regulatory Structure in the Asia-Pacific Region 4 4. Advertising 5 5. How Immunization are Recommended 7 III. The Consumer Vaccination Decision Process 9 IV. Anti-vaccine Groups/Vaccine Safety Issues 10 Chapter Two: Glossary of Terms 13 I. Vaccine 13 II. Sexually Transmitted Infection (STI) and Sexually Transmitted Disease (STD) 13 III. Human Papillomavirus (HPV) 13 IV. Cervical Cancer 14 Chaper Three: Background 16 I. Merck 16 1. Merck & Co. 16 v 2. Vioxx Crisis 17 3. MSD China 17 II. HPV Vaccine 18 1. Gardasil 18 2. Cervarix 19 3. Beijing Waitai Biological Pharmacy 20 4. The Effectiveness and Adoption of HPV Vaccine 20 Chapter Four: Review and Analysis of Merck’s Launch Strategies 22 I. The U.S. Launch 22 1. Background 22 2. Key Audience and Key Messages 23 3. Objectives 25 4. Problems and Opportunities 25 5. Strategies and Tactics 27 6. Analysis and Evaluation 32 II. The China Launch 43 1. Background 43 2. Key Audience and Key Messages 44 3. Objectives 45 4. Challenges 45 5. Strategies and Tactics 46 6. Evaluation 49 7. Recommendation 51 Conclusion 58 vi Appendix 62 Bibliography 64 vii List of Figures Fig. 1. Organizations and recommendation process of the U.S. ACIP and its partners 8 Fig. 2. The consumer vaccination decision process in the U.S. 9 Fig. 3. The consumer vaccination decision process in China 10 Fig. 4. Logo of “Shell Action” 46 viii List of Tables Table 1. Classification of HPVs 14 Table 2. Countries with HPV vaccine in immunization schedules 21 Table 3. Information campaigns and advertising campaigns 33 Table 4. Effectiveness of Merck’s messages 39 ix Abstract This thesis will conduct a comparative study of Merck & Co.’s launches of Gardasil in the U.S. and China. Gardasil is a vaccine for use in the prevention of certain sexually-transmitted types of human papillomavirus (HPV). It was introduced to the U.S. market in 2006 and is planned to enter Chinese market in 2014. By studying the multinational pharmaceutical company’s different public relations strategies and tactics during the launches in these two countries, the author will shed light on the importance of tailoring PR strategies to different markets. Audiences in different international markets can vary greatly depending on multiple factors, especially cultural background. China, as a typical emerging market, requires the company to make extra efforts to raise public awareness and deal with government relations due to that country’s cultural and lifestyle differences and inadequate regulations. Merck & Co.’s handling of its Gardasil launches in the U.S. and China will be a good reference for other multinational companies. 1 Chapter One: Vaccine Market in the U.S. and China I. Human Vaccine Industry As with all pharmaceuticals, vaccine sales are generated mainly in high-income countries. The U.S. represents the largest sales region (34.6 percent of 2009 global vaccine sales), followed by the European Union (30.4 percent), Japan (7.9 percent), China (7.4 percent), and India (6.4 percent) (Sahoo). According to “U.S. Vaccine Market – Industry Analysis, Size, Share, Growth, And Forecast 2012-2018,” the U.S. vaccine market was estimated to be worth $12.8 billion in 2012 and is expected to reach $17.4 billion by 2018. The human vaccine segment occupies about 80 percent of the U.S. vaccine market. It is quite likely that the U.S. will continue to lead the global vaccine market due to rising prevalence of infectious disease in humans and animals, and advancement in biotechnology in the region. The pediatric vaccine segment in the U.S. human vaccine market enjoys high share as well as a high growth rate. The adult and adolescent vaccine market is expected to grow moderately over the next six years due to rising awareness and increasing vaccination for HPV and such other viral diseases. Leading producers of human vaccine for the U.S. market are Sanofi-Aventis, Merck, GlaxoSmithKline, Pfizer, Sanofi-Pasture and Novartis (Transparency Market Research). According to “Research Report on Global and China Human Vaccine Industry, 2013-2017,” China has the largest population in the world, with 10 million newborns yearly. Meanwhile, the aging of Chinese society is an increasingly serious health challenge. Fast-paced economic development and increasingly frequent population immigrations inevitably widen the geographic range through which diseases spread, and increase the speed with which they do so. Accordingly, new epidemic diseases (Avian Influenza, Influenza A H1N1, etc.) are occurring more frequently 2 and spreading more rapidly (China Research and Intelligence). In China, vaccines are generally divided into two categories: Vaccine I and Vaccine II. Vaccine I, which is offered for free and is priced and purchased uniformly by the government, covers major epidemic diseases such as Hepatitis B, epidemic cerebrospinal meningitis, Tetanus, etc. The Vaccine II category includes vaccines that are inoculated voluntarily at residents’ own expense. These are independently priced and have large profit margins, but often face intense competition in the market. Frequently used Vaccine IIs include vaccines for pneumonia, varicella, Type B Haemophilus Influenzae Conjugate, Influenza, rabies and others. The Vaccine I market is occupied by state-owned enterprises, while foreign-funded enterprises and private enterprises generally occupy the Vaccine II market (China Research and Intelligence). China Research and Intelligence also reported that in 2012, the scale of Chinese vaccine market was about CNY 19 billion (about $3 billion), while the scale of the overall pharmaceutical market was about CNY 1.78 trillion (about $0.28 trillion) in the same period. The sales revenue of Chinese vaccine industry was only about 1% of that of the pharmaceutical industry, far below the global average level of 3%, estimated by CRI. There is still much space for growth. In China, there are over 30 human vaccine manufacturing enterprises with annual production of over CNY 1 billion (about $160 million) including about 40 kinds of vaccines against more than 20 kinds of viruses. With years of research and development, some private vaccine enterprises have made big breakthroughs in the Vaccine II market (China Research and Intelligence). II. Regulatory regime and policy development 3 1. National authority and legislation In the U.S., vaccines are regulated by the Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER). Vaccine developers must receive approval from CBER to both develop and sell vaccines. Immunization laws in the U.S. are not federal, but state mandates. The authority of U.S. states to promulgate regulations that protect the public health and safety is well established, having historical roots in health regulations created in the colonial states during the 18th century (Fisher). The China Food and Drug Administration (CFDA) is the national supervising authority for the pharmaceutical sector in China. It became operational in 1998 as the State Drug Administration (SDA) and was renamed China State Food and Drug Administration (SFDA) in 2004. In March 2013, it was renamed CFDA and elevated to the ministerial-level General Administration of Food and Drug. It replaced a large group of overlapping regulators with an entity similar to the Food and Drug Administration of the United States (Deloitte). Pharmaceutical regulation in China is based around the Drug Administration Law (DAL), first implemented in 1984, with the last major amendments taking place in 2001, and coming into force in September 2002. 2. Drug registration and approval According to FDA’s website, in the U.S., prior to licensure, vaccines are monitored by Investigational New Drug (IND) regulations. The vaccine developer (sponsor) must apply to conduct a clinical study by including information about: the composition of the investigational new product; the source of the investigational new product; the method of manufacture of the 4 investigational new product; and the methods used to determine the safety, purity, and potency of the investigational new product. The sponsor also must provide a summary of all laboratory and animal pre-clinical testing. A description of the proposed clinical trial and the qualifications of the investigators also are required. The endpoints for clinical approval include vaccine safety and efficacy, but safety must be demonstrated at each phase of the study. When studies are near completion and show documented promise of safety and efficacy, the sponsor may submit a Biologics License Application (BLA) to the CBER Office of Vaccines Research and Review (OVRR). The applicant must submit evidence of compliance with standards for all of the requirements. The 1992 Prescription Drug User Fee Act (PDUFA) established a two-tiered system – Standard Review and Priority Review. Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. Amendments to PDUFA established in 2002 set a 10-month goal for a standard review. Priority Review designation is given to drugs that may offer major advances in treatment, or provide a treatment where none previously existed. The goal for completing a Priority Review is six months. Drug registration in China is a complicated and time-consuming process, involving a number of regulatory bodies at various levels of government, and at various regional levels. Drug approval applications could be sent directly to the CFDA prior to 2002, but they are now initially reviewed by provincial and municipal authorities, and then passed to the CFDA for approval. The entire approval procedure generally takes between 18 and 26 months. Domestic clinical trials are mandatory for all drugs that are new to the Chinese market, as required by the Good Clinical Practice (GCP) guidelines (Deloitte). 3. Changes in the Regulatory Structure in the Asia-Pacific Region 5 According to a research report published by Kalorama Information, in Asia, the World Health Organization (WHO) reported in year that it has a new challenge – developing regulatory pathways for novel vaccines. WHO initiatives previously focused more on strengthening the regulatory agencies of countries that exercised oversight on vaccines that were imported from developed regions like the U.S. and Europe. According to WHO, the reason for the shift has been the development of more novel vaccines for use specifically in the developing nations. These vaccines may be targeted exclusively for developing countries like India or China. Another component of strengthening the regulatory process is the control or oversight of clinical trials. Because companies are testing more novel products, the number of clinical trials is increasing within the developing nations (Elder). The report also pointed out that in several Asian countries, excluding Japan, government health agencies require pharmaceutical manufacturers to have received a marketing approval by another recognized regulatory body. This means that in order to submit a product for review, a company may also be required to submit proof that their product has already been approved to marketing in another region, such as the U.S. or Europe. Companies have reported that this requirement can delay marketing by more than one year. Because of the numerous differences in registration requirements, some products have been delayed in China for up to four years following the initial approvals in the U.S. and Europe. (Elder) 4. Advertising Direct-to-consumer advertisements (DTCA) are created for and targeted at consumers instead of those in the medical community. Before the 1990s, when DTCAs were first used, drugs companies targeted physicians in an attempt to encourage them to prescribe the particular 6 drugs to their patients. However, by the mid-‘80s, pharmaceutical companies, in an attempt to give consumers a more active role in prescribing decisions, began developing paid advertisements, or DTCA (Donohue 659-699). On August 8, 1997, the FDA released the Guidance for Consumer-Directed Broadcast Advertisements. According to the guidance, the Act requires advertisements for prescription drugs and biologics to contain “information in brief summary relating to side effects, contraindications, and effectiveness” (21 U.S.C. 352(n)). The prescription drug advertising regulations (21 CFR 202.1) distinguish between print and broadcast advertisements. Print advertisements must include the brief summary, which generally contains each of the risk concepts from the product’s approved package labeling. Advertisements broadcast through media such as television, radio, or telephone communications systems must disclose the product’s major risks in either the audio or audio and visual parts of the presentation (“Direct to Consumer Advertising”). The use of DTCA has continually grown. “Expenditures for DTC advertising increased from an estimated $47 million in 1990 to nearly $2.5 billion in 2000” (Kaphingst et al. 515-528). DTC television and print advertising which is designed to market a prescription drug should also be designed to responsibly educate the consumer about that medicine and, where appropriate, the condition for which it may be prescribed. Based on the FDA guidelines, these advertisements must include informative information, but do not give up their persuasive product messages (Buttweiler). The United States, along with New Zealand, are the only countries that allow pharmaceutical companies to use DTCA (Frosch et al. 6-13). There are many controversies around DTCA. Opponents, including those in the medical profession, federal drug regulators and 7 some consumer groups, do not like DTCA because they believe it misleads consumers and prompts them to ask for prescriptions that they may not need, or for ones that are more expensive than the alternatives (Donohue 659-699, Frosch et al. 6-13). Proponents, such as pharmaceutical companies and those in favor of consumer and patients rights, find DTCA valuable because they provide empowerment to consumers and are perceived as a good source of information that can educate people about healthcare and treatments (Donohue 659-699, Frosch et al. 6-13). In China, pharmaceutical advertisements must be approved by CFDA as well as by the local authorities in the provinces or municipalities where they are to be broadcasted or published. According to the research by AC Nielsen, the pharmaceutical industry is one of the highest spenders on advertising in China. However, China is cracking down on pharmaceutical advertising after a string of complaints from the public. In addition, pharmaceutical advertising is now the subject of more concerted efforts to raise standards. Under the Chinese regulations, guarantees of efficacy and the use of patients and medical professionals to promote treatments are prohibited. Actors portraying medical experts or patients in radio and television promotions are also banned (Deloitte). 5. How Immunization are Recommended In the U.S., the Advisory Committee on Immunization Practices (ACIP) is the only federal government recommending body for vaccines. It issues recommendations for vaccines that are used by healthcare providers in both public and private systems. Other institutions, such as the American Academy of Pediatrics Committee on Infectious Disease (COID, the “Red Book” committee), and the American Academy of Family Physicians collaborate to issue a single immunization schedule in the U.S. A separate committee, the National Vaccine Advisory 8 Committee (NV AC), advises the U.S. government primarily on program policies and strategies. Fig. 1. Organizations and recommendation process of the U.S. ACIP and its partners (“Vaccine Fact Book 2013”) In China, the Chinese Center for Disease Control and Prevention (CCDC) is the country’s leading public health agency, providing core advice to governmental policy makers and decision makers and guidance and assistance to national and local public health practitioners. The Expanded Programme on Immunization (EPI) works closely with the National Immunization Program, one of CCDC’s departments, to strengthen immunization systems, to improve coverage and quality, to support the implementation of targeted disease-prevention efforts (e.g., measles, viral hepatitis, polio) and to examine the potential introduction of new vaccines. 9 III. The Consumer Vaccination Decision Process To get vaccinated, an individual must (1) access the health care system, (2) discuss vaccination recommendations with a health care professional, (3) decide to get vaccinated, (4) comply with the guidelines and receive the vaccination (Angelmar and Morgon). Whereas children in high-income countries typically undergo a series of routine visits with health care professionals such as pediatricians, many children in low-income countries do not have access to the health care system. But even in high-income countries, not everybody receives health care. In the U.S., 10.5% of all children under 18 years old had no health care visit to an office or clinic within the past 12 months, rising to 43% among uninsured children (Angelmar and Morgon). Every health care visit is an opportunity to discuss vaccination needs, but while most physicians routinely check immunization at wellness or health maintenance visits, far fewer discuss vaccination during illness or acute care visits (Angelmar and Morgon). Fig. 2. The consumer vaccination decision process in the U.S. Physicians Patients Vaccination Interpersonal (family, friends) Media, Internet Direct to Consumer Academics Government 10 In China, there are two big differences in the process. First, direct-to-consumer advertising is not allowed, so patients will receive information mostly from the media and through interpersonal communication. Second, Chinese patients usually go to the hospital and see doctors after getting sick, so Chinese people seldom go to physicians for disease prevention counsel. Chinese patients are less likely to get vaccine information from the physicians. Fig. 3. The consumer vaccination decision process in China IV. Anti-vaccine Groups/Vaccine Safety Issues CDC’s website pointed out that while immunizations are among the most cost-efficient and widely used public health intervention, no vaccine can be considered 100 percent safe, despite the extensive pre-approval safety testing and post-commercialization surveillance. Differences in the way individual immune system react to a vaccine may lead to rare occasions when people are not protected following immunization or when they experience side effects. Since vaccination is such a common and memorable event, any illness following immunization may be attributed to the vaccine. While some of these reactions may be caused by the vaccine, many of them are unrelated events that occur after vaccination by coincidence. Therefore, the scientific research that attempts to distinguish true vaccine side effects from Physicians Patients Vaccination Interpersonal (family, friends) Media, Internet Academics Government 11 unrelated, chance occurrences is crucial. This knowledge is necessary in order to maintain public confidence in vaccines and immunization programs (CDC). The topic of vaccine safety became prominent in the U.S. during the mid-1970’s with increases in lawsuits filed on behalf of those allegedly injured by the diphtheria, pertussis and tetanus (DPT) vaccine. To respond to public health concerns, Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986, which, in turn, led to the creation of the National Vaccine Program Office (NVPO) within the Department of Health and Human Services (DHHS). NCVIA requires that all healthcare providers who administer vaccines containing diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, hepatitis B, Haemophilus influenza Type B and varicella provide a Vaccine Information Statement (VIS) to the vaccine recipient, their parent or legal guardian prior to each dose. Each VIS contains a brief description of the disease as well as the risks and benefits of the vaccine. The NCVIA also mandated that all healthcare providers report certain adverse events that occur following vaccination. As a result, the Vaccine Adverse Event Reporting System (V AERS) and Vaccine Safety Datalink Project (VSD) were established in 1990. V AERS provides a mechanism for the collection and analysis of adverse events associated with vaccines currently licensed in the U.S.; VSD involved forming partnerships with four large health maintenance organizations (HMOs) to continually monitor vaccine safety. The National Vaccine Injury Compensation Program, which was also created by NCVIA, compensates individuals who have been injured by vaccines on a no-fault basis (Sahoo). In China, there are no influential anti-vaccine organizations, but negative comments frequently show up on the Internet. In general, these challenges are usually directed at manufacturing quality instead of the safety of vaccines themselves. The vaccine safety issue is more often discussed by the public as a food safety issue than as a scientific or moral topic. The 12 “poisoned vaccine” controversy of December 2013 is a typical example. Six babies died after receiving hepatitis B vaccines that were given as part of a national campaign of immunization against liver disease. China’s food and drug regulator later suspended the use of all batches of a hepatitis B vaccine made by Shenzhen Kangtai Biological Products Co. Bloomberg News commented that “the deaths were the latest test of China’s ability to ensure safe food and medicine after cases of tainted baby formula, fox meat sold as mutton and thousands of dead pigs found floating in Shanghai’s main river sparked public outrage.” (Khan) On a global basis, the World Health Organization (WHO) is actively involved in ensuring the quality of vaccines. Its Department of Immunization, Vaccines and Biologicals develops global norms and standards for vaccines; provides guidelines and support to strengthen national regulatory authorities and national control laboratories; and advises on the quality, safety and efficacy of specific products that are purchased by United Nations agencies through the vaccine pre-qualification process. In 1999, the WHO established a 5-year program called the Immunization Safety Priority Project (ISPP) as a focus for addressing the challenges relating to immunization safety (Sahoo). 13 Chapter Two: Glossary of Terms I. Vaccine The word “vaccine” originates from the Latin term Variolae vaccinae (cow pox), which Edward Jenner demonstrated in 1798 could prevent smallpox in humans. Today the term vaccine applies to all biological preparations, produced from living microorganisms, that enhance immunity against disease and either prevent (prophylactic vaccines) or, in some cases, treat (therapeutic vaccines) disease. Vaccines are administered in liquid form, by injection, orally, or by intranasal routes (“Vaccine Fact Book 2013”). II. Sexually Transmitted Infection (STI) and Sexually Transmitted Disease (STD) Sexually transmitted infections (STIs) are caused by more than 30 different bacteria, viruses and parasites and are spread predominantly by sexual contact, including vaginal, anal and oral sex (WHO). Some STIs may be spread via skin-to-skin sexual contact. The organisms causing STIs can also be spread through non-sexual means such as blood products and tissue transfer. Many STIs - including chlamydia, gonorrhea, hepatitis B, HIV, HPV , HSV2 and syphilis - can also be transmitted from mother to child during pregnancy and childbirth (WHO). A person can have an STI without having obvious symptoms of disease. Therefore, the term “sexually transmitted infection” is a broader term than “sexually transmitted disease” (STD). Common symptoms of STDs include vaginal discharge, urethral discharge in men, genital ulcers, and abdominal pain. (WHO) III. Human Papillomavirus (HPV) 14 According to FDA, HPV is the name of a group of viruses that includes more than 100 different types. More than 30 of these viruses can be passed from one person to another through sexual contact. For most women, the body’s own defense system will clear the virus and they don't develop health problems. However, some types can cause cervical cancer or abnormal cells in the lining of the cervix that can sometimes progress to cancer. Other types are a major cause of genital warts. Based on the characteristics, HPV are classified into four groups. Each group may include several types. Group Site Effects Cancer-causing Common HPV Types Benign skin skin warts No 1,2 Epidermodysplasia verrucruciformis skin flat warts Yes 5,8 Genital genitals warts no (but can cause precancerous lesions) 6,11 High-risk genital genitals flat warts yes (can also cause precancerous lesions) 16, 18, 33, 45 Table 1. Classification of HPVs (Schiller et al. 246) For women who develop cervical cancer, HPV is generally the root cause. HPV is the most common sexually transmitted infection in the United States. The Centers for Disease Control and Prevention (CDC) estimates that about 6.2 million Americans become infected with genital HPV each year and that over half of all sexually active men and women become infected at some time in their lives (FDA). IV. Cervical Cancer Worldwide, cervical cancer is the second most common cancer in women, with 470,000 15 new cases annually and 233,000 deaths. A considerable increase in cervical cancer cases among 20 and 30 year old women have been noted in Asian countries over the past few years (Elder). It occurs predominantly in women between 30 and 50 years of age. The number of deaths from cervical cancer has fallen steadily over the past 40 years due to better and earlier diagnosis with the widespread use of the Pap test. Risk varies directly with an increase in the number of sexual partners, early incidence of first intercourse and exposure to certain serotypes of HPV (Elder). 16 Chaper Three: Background I. Merck 1. Merck & Co. Merck & Co., Inc. (Merck, NYSE: MRK) is a global health care company that delivers health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products, which it markets directly and through its joint ventures. The company consists of four operating segments: Pharmaceutical, Animal Health, Consumer Care and Alliances (Reuters). The company was founded in New York City in 1891 by George Merck as the U.S. branch of his family’s company – German chemical manufacturer Merck, which dates back to 1668. In 1902, he established a manufacturing facility in Rahway, N.J., which later added a research lab and served as Merck’s headquarters until the company moved to Whitehouse Station, N.J., in 1992. In 1919, Merck split off his company from its German parent, now known as Merck KGaA. He later was succeeded by son George W. Merck. The company merged with Sharp & Dohme in 1953 and converted from chemical manufacturer to a pharmaceutical research and manufacturing firm (Associated Press). The combined company adopted the trade name Merck in the United States and Canada, and Merck Sharp & Dohme (MSD) outside North America. In 2005, then-CEO Raymond Gilmartin retired following Merck’s worldwide withdrawal of Vioxx (see 2 below). Former president of manufacturing Richard Clark was named CEO and company president. Clark retired in October 2011 and Kenneth Frazier became CEO. According to its website, the company’s core values are driven by a desire to improve life, achieve scientific excellence, operate with the highest standards of integrity, expand access to the products and employ a diverse workforce that values collaboration. Merck is also known for The 17 Merck Manual, a reference widely used by doctors and scientists since 1899, and a consumer edition, which was launched in 1997 (Associated Press). 2. Vioxx Crisis In 1999, the FDA approved Vioxx (chemical name rofecoxib), a non-steroidal anti- inflammatory drug manufactured by Merck & Co for treating arthritis. It was one of Merck’s most important drugs, with $2.5 billion in reported sales in 2003. On September 30, 2004, Merck announced that data from a clinical trial showed that patients experienced an increased risk of heart attack and other cardiovascular complications 18 months after taking Vioxx. The company then pulled Vioxx from the market worldwide in the face of widespread outrage (Collins). Making matters worse for the company was the assertion that Merck had intentionally kept findings of the risks associated with Vioxx secret while executing an aggressive direct-to- consumer advertising campaign to increase demand for the drug at the same time. The Vioxx recall is estimated to have cost Merck $2.5 billion in annual revenue. As of September 2006, Merck had spent $325 million on defense costs during the first nine months of that year alone (Siers-Poisson, “The Politics and PR of Cervical Cancer”). 3. MSD China Merck is known as MSD outside the United States and Canada. MSD China is a subsidiary of MSD, and China is one of the most critical markets for MSD’s growth strategy. It reports directly to the Merck headquarters in the United States. According to MSD China 2011-2012 Corporate Responsibility Report, MSD entered into 18 China in 1992 and currently has three manufacturing plants in Hangzhou and Shanghai. Headquartered in Shanghai, MSD China currently employs more than 5,000 people. In December 2011, an Asia R&D Headquarters was established in Beijing. Following the completion of the global merger between Merck and Schering-Plough in 2009, Michel V ounatsos became the Chairman and President of MSD China. On September 1, 2012, Pam Cheng, who previously served as chief operating officer of MSD China, was appointed president of MSD China. MSD China currently provides 403 prescription medicines and vaccines in China in 11 therapeutic categories, including cardiovascular, orthopedics, pain, dermatology, respiratory diseases, diabetes, infectious diseases, specialty care, and men’s and women’s health, among others. It offers four consumer health products in three product areas (allergy, contraceptives and dermatology), with sales through both hospitals and pharmacies. It also offers approximately 50 animal health products for the prevention, treatment and control of disease in major rural and companion animal species (“MSD China Corporate Responsibility Report”). II. HPV Vaccine 1. Gardasil Gardasil, which is made by Merck, is the only HPV vaccine that helps protect against 4 types of HPV , specifically HPV types 6, 11, 16 and 18. It was approved for use in the U.S. by the FDA on June 8, 2006. In girls and young women ages nine to 26 years, Gardasil is reported to help protect against two types of HPV (types 16 and 18), which cause about 75 percent of cervical cancer cases, and two more types (type 6 and 11) that cause approximately of genital warts cases. As such, it is the 19 only so-called quadrivalent product. In boys and young men ages nine to 26, Gardasil is reported to help protect against approximately 90 percent of genital warts cases. Gardasil is also reported to help protect girls and young women ages nine to 26 against about 70 percent of vaginal cancer cases and up to 50 percent of vulvar cancer cases. According to the Gardasil’s website (www.gardasil.com), the recommended Gardasil dosage is 0.5-mL, which is ministered in a series of three intramuscular injections over a period of six months. Reported side effects from these injections can include pain, swelling, itching, bruising, and redness at the injection site, as well as headache, fever, nausea, dizziness, vomiting, and fainting. 2. Cervarix Cervarix is an HPV vaccine manufactured by GlaxoSmithKline, a British pharmaceutical giant. It is a bivalent treatment, in that it is designed to prevent infection from HPV types 16 and 18, which cause about 70 percent of cervical cancer cases. It was approved by the U.S. FDA in 2009, for use in females nice through 25 years of age. The recommended dosage of Cervarix is three (0.5-mL each) injections over a six-month period. According to CDC, the most common reported local adverse reactions are pain, redness, and swelling at the injection site. The most common general adverse events are fatigue, headache, muscular pain (myalgia), gastrointestinal symptoms, and joint pain (arthralgia) (“VIS - Cervarix”). 20 3. Beijing Waitai Biological Pharmacy On November 12, 2013, Xiamen Innovax Biotech Co., Ltd., Beijing Wantai Biological Pharmacy’s subsidiary, received CFDA approvals of bivalent HPV (Type 6 and 11) Recombinant Vaccine (No. 2013L0372) for phase I, II, and III clinical trials (Innovax). The vaccine is mainly used for genital warts prevention. It is the third cervical cancer vaccine used in clinical trials in the world. (Ebiotrade) 4. The Effectiveness and Adoption of HPV Vaccine In clinical trials, both Gardasil and Cervarix proved highly effective (94-96%) at preventing persistent infections against corresponding HPV types. Both vaccines were nearly 100% effective at preventing cervical intraepithelial neoplasia (CIN), which is considered a precursor to cervical cancer (Schiller et al. 243-257). On the basis of favorable clinical trial data, several countries introduced HPV vaccines into national immunization programs shortly after they were licensed. Country Year added to immunization schedule Immunization schedule Australia 2007 12-13 years; catch-up in males 14-15 years until the end of this school year Austria 2006 9-15 years Belgium 2007 10-13 years Canada 2007 11-14 years (female) Denmark 2009 12 years France 2007 voluntary for girls and women 14-23 years not sexually active or sexually active < 1 year Greece 2007 mandatory for girls entering grade 7; available to girls and women 12-26 years Iceland 2011 12 years Ireland 2008 12-13 years Israel 2012 12 years Latvia 2009 12 years 21 Luxembourg 2008 12 years Macedonia 2009 12 years (female) Mexico 2008 9 years (female) Netherlands 2009 12-13 years New Zealand 2008 girls and women born after 1990; routine for girls in grade 8 or 12 years of age Norway 2009 routine for girls 12-13 years Portugal 2007 13 years Panama 2008 10 years (female) Slovenia 2009 11-12 years Spain 2007 11-14 years Sweden 2010 voluntary for girls 10-12 years Switzerland 2008 11-14 years United Kingdom 2008 routine for girls 12-13 years; catch-up for girls up to 18 years of age United States 2007 11-12 years; catch up 13-18 years Table 2. Countries with HPV vaccine in immunization schedules (“Vaccine Fact Book 2013”) 22 Chapter Four: Review and Analysis of Merck’s Launch Strategies The key goals when launching a new vaccine in a country are to achieve: (1) recommendations by the respective country’s national immunization technical advisory groups (NITAG) and medical societies, which are the most important influencers affecting the vaccine’s core prescribers; (2) a WHO recommendation and pre-qualification; (3) favorable pricing and reimbursement conditions by public and private payers; (4) strong recommendations by physicians to eligible patients, and (5) consumer willingness to be vaccinated with the vaccine (Angelmar and Morgon). For the public relations department of the company, convincing physicians and consumers of the vaccine’s benefits and making them advocates for the product are major goals and activities. The following thesis will compare different key audiences, objectives, and challenges in the U.S. and China and analyze the strategies used to launch Gardasil in these two countries. I. The U.S. Launch 1. Background On June 8, 2006, the FDA approved Gardasil as the first vaccine to prevent against HPV . Less than a month later, the ACIP unanimously recommended vaccinations for 11- and 12-year- old girls. According to the Oncology Nursing Society, the ACIP also resolved that the HPV vaccine be included in the Vaccination for Children (VFC) Program, a national effort that provides free immunizations to children who are Medicaid eligible, uninsured, underinsured, or Native American. “About 40 percent to 45 percent of the U.S. child population is included in the VFC,” said Lance Rodewald, MD, of the Immunization Services Division (Ginsberg). At the same time, Merck had to look over its shoulder at GlaxoSmithKline, which hoped to 23 launch Cervarix in late 2007. GSK’s second-to-market strategy was to let Merck pave the regulatory road and then surpass Gardasil (Ginsberg, 2006). 2. Key Audience and Key Messages Obviously it is important to clearly identify key audiences before designing, implementing, and evaluating a launch campaign. Merck had to tailor different key messages to different target groups according to their needs. First, the most obvious members of the audience were adults and the adult parents of children in Gardasil’s target age group for the vaccination. Gardasil was approved by the FDA for women aged nine to 26, and the ACIP recommended that 11- and 12-year-olds be targeted for routine vaccination. Therefore, young women aged nine to 26, and 11 to 12 in particular, would be the target group. It was important to inform these potential recipients of the risk of HPV and the product. Since the first group includes minors who were not themselves decision makers, Merck targeted the young women’s parents. The key messages included essential information about the disease and the product. Merck’s vice president, Beverly Lybrand, said, “Of course everyone understands cancer and is scared of cancer. We learned early on that moms really wanted to protect their daughters – that protective insight is important.” (Buttweiler) The third key audience was healthcare providers. They were the ones who give opinions to the patients and administer the shots. To potential vaccine recipients, physicians were experts and their opinions usually carried more weight than the information provided by pharmaceutical companies. This required that HPV educational and skill-building resources to be simultaneously developed for providers to enable them to address their patients’ HPV questions and concerns. 24 In addition, policymakers concerned about possible mandates for the vaccine were in Merck’s target audience. According to Siers-Poisson, even with FDA approval and the strong recommendation of the ACIP at the federal level, mandatory HPV vaccination was not a given since the power to enact such requirements lies in the hands of state legislators (“Women in Government”). Merck moved quickly to persuade policymakers with the authority to mandate vaccination for 11- to 12-year-old girls to endorse its vaccine. If the vaccination were to be mandated for school-aged girls, a significant sales volume would be guaranteed. Merck needed to convince policymakers that Gardasil was effective and safe, and that there were social benefits to adding the vaccine in children’s vaccine schedules. Merck also cooperated with various organizations that would be able to help deliver the vaccine to people who would not be able to afford it. For example, the Indian Council of Medical Research (ICMR) partnered with Merck to host clinical studies of Gardasil (“Merck and the ICMR Announce a Public-Private Partnership”). Merck also worked with PATH, an international nonprofit organization, with funding from a grant from the Bill & Melinda Gates Foundation, to get lower-priced doses of the vaccine to girls who would not otherwise have received it (Buttweiler). Merck needed to convince these organizations that it was a reliable and socially- responsible company that cares about global public health. It would be worthwhile for Merck to fund their campaigns and make the vaccine available to more people around the world. Merck also had pay attention to its opponents, including anti-vaccine groups, conservative groups and people who are concerned about vaccine safety issues and often regard pharmaceutical companies as profit-oriented. Finally, Merck needed to woo key influencers such as media and bloggers who could be 25 either supporters or opponents, especially women’s magazines and mommy bloggers whose readers are Merck’s primary audience – women and moms. Due to the power of social media platforms, their opinions could have strong impacts on their readers. Merck needed to provide enough information to them and convince them that Gardasil is an effective and safe vaccine that protects recipients. It is worthy of note that, on October 16, 2009, three years after its first launch, Gardasil was approved by the FDA for the prevention of genital warts due to HPV types 6 and 11 in boys and men aged nine through 26. Since this paper only focuses on the initial launch strategies, the key audience here will not include 9- to 26-year-old men, even though they are target vaccine recipients today, as well. 3. Objectives At an investor analyst meeting in December 2006, Peter Loescher, Merck’s president of global human health, outlined four company objectives for the vaccine’s debut: (1) support global policy recommendations, (2) secure broad public and private funding, (3) encourage strong uptake among healthcare providers, and (4) motivate women in the target age group (or their parents) to ask for the vaccine (Herskovits). 4. Problems and Opportunities Some studies suggest that vaccination programs might not have the public support they need. A survey conducted by researchers from the Medical College of Georgia, and published in the July 2004 issue of the Journal of Lower Genital Tract Disease found that 23% of parents of 10- to 15-year-olds surveyed did not want their children vaccinated. Another 22% were 26 undecided. Two studies published in 2004 revealed that both gynecologists and nurse practitioners were more willing to immunize adults and older teens than young adolescents (Washam). The hesitancy to administer or receive vaccines may be caused by any of several reasons. For example, Merck faced a difficult task in explaining the price of the vaccine to the public. Gardasil is not an inexpensive drug. Each vaccine shot costs $120 through private insurance or $96 through governmental programs at the federal rate. People who have insurance may only need to pay a co-payment if the vaccine is covered by their providers and those in government assistance programs might not have to pay at all, but those without insurance would have a hefty bill to pay, particularly if the vaccination was mandatory for school attendance or if there were several girls in a family. With an average cost of $360 for each girl, the expense would add up quickly for lower-income working families – the class of people who most often do not have health care through their employers but do not qualify for government assistance either (Siers- Poisson, “The Politics and PR of Cervical Cancer”). Meanwhile, Gardasil’s other key challenge – getting adolescent and pre-adolescent girls to go to the doctor – also represented a public health opportunity. “The vaccine is licensed for females 9 to 26. We decided to focus on 11- and 12-year-olds because there is a strong movement afoot to establish adolescent visits [to the doctor] at a time of life when people are not going to the physician for routine care,” said Janet Gilsdorf, MD, a professor of pediatrics and communicable diseases at the University of Michigan and chair of Merck’s HPV Working Group (Herskovits). Merck was active in lobbying policy makers to make the vaccine mandatory as a condition for enrolling in school. However, compulsory vaccination was where Merck and lawmakers were 27 likely to face their stiffest opposition from conservative and religious groups. At the center of these groups’ opposition was the belief that inoculating girls against an STD might be interpreted as an endorsement of risky sexual behavior, and give youngsters a false sense of security. These groups wanted parents, not the government, to have the final say about when and if to vaccinate their daughters. Some critics contended that a vaccine against a sexually transmitted virus would encourage teen promiscuity. “We’re against vaccinating children [for HPV],” said Kristi Hayes, director of government relations for the Abstinence Clearinghouse. This non-profit organization promotes pre-marital abstinence and monogamous marriage as the only means of preventing sexually transmitted diseases. “We don’t know what this will do to children psychologically,” Hayes said. (Washam) What Merck was facing was not only an organized conservative movement but also heightened public awareness and fears about vaccine safety and risks. Any negative news about side effects could have caused many other people to give up the idea of getting a vaccination. Merck did a lot of work to raise public awareness about the HPV disease and vaccine. Although Gardasil was approved by the FDA and launched as the first HPV vaccine, its competitor, GlaxoSmithKline’s Cervarix was also on the way. Merck needed to avoid spending huge amounts of money just to pave the way for competing products. 5. Strategies and Tactics Although studies have shown that people were at first reluctant to receive the vaccine, one study found that, after reading a one-page information sheet about HPV , 20 percent of parents who initially opposed the vaccine said they wanted it for their children, and 65 percent of 28 undecided parents said they would now have their children vaccinated (Washam). Obviously, through PR campaigns, Merck could provide enough information to educate and attract its target audience. Gardasil’s launch campaign could be divided into two phases: disease awareness part and the branded part. 5.1 Phase I: “Make the Connection” Since Gardasil had not yet been approved by FDA, Merck could not mention the name Gardasil in its initial campaign. “Make the Connection” was designed to inform people about the connection between HPV and cervical cancer. Surveys found that less than 20% of people knew about the link, according to Beverly Lybrand, vice president and general manager for Gardasil at Merck Vaccines Division. This was a great opportunity for Merck to become the public authority on the subject of HPV and its link to cervical cancer through public health education messages. Lybrand stated, “after discovering the tremendously low awareness, communicating the link between HPV and cervical cancer became the primary focus of the campaign” (Herskovits). “Make the Connection” was launched on September 30, 2005. It was a public education campaign sponsored by the Cancer Research and Prevention Foundation (CRPF) and Step Up Women’s Network with support from Merck. CRPF is a non-profit organization that funds cancer prevention research, education and outreach programs throughout the United States. Step Up Women’s Network is a non-profit membership organization that provides empowerment programs, such as health education advocacy and professional mentoring, for underserved teenage girls (Shipley). “Make the Connection” used beaded bracelet kits to symbolize the connection –stringing 29 together the beads was like stringing together the facts about HPV and cervical cancer. Stacy London, host of TLC’s What Not to Wear and former Vogue fashion journalist, designed the bead kits (Shipley). Girls could order a free bracelet kit over the Internet or over the phone at 888-4- HPV-CONNECT (888-447-8366) and could learn about the disease from the accompanying educational packet. The bracelet beading was also regarded as a way to bring women together to learn about this important health issue. For every bracelet kit ordered, Merck donated one dollar to CRPF, up to $100,000, for cervical cancer awareness and screening programs among medically underserved women (Siers-Poisson, “Research, Develop, and Sell”). The organizers enlisted TV actresses including Beverly Mitchell from the series “7th Heaven” and Elisabeth Rohm from “Law and Order.” The stars showed up at events wearing the bracelets. Step Up Women’s Network’s webpage for the campaign featured a photo of Maria Shriver, the wife of then-Governor Arnold Schwarzenegger (R), wearing the bracelets at a California Governor’s Conference on Women and Families (Zimm and Blum). The name of the campaign was later changed to “Make the Commitment.” On the website, women could sign the following pledge: “I, (your name), am making the commitment to talk with my healthcare professional in January about ways that I can prevent cervical cancer, including getting regular cervical cancer screenings.” Since January is designated Cervical Health Awareness Month in the U.S., this pledge by women to talk with their doctors about cervical cancer would ensure that medical practitioners were being approached from all sides – from Merck’s drug representatives and from patients (Siers-Poisson, “Research, Develop, and Sell”). In the first quarter of 2006, Merck reported it spent $107.3 million on all of its advertising, including $841,000 for Internet ads on the human papillomavirus, according to TNS Media 30 Intelligence, which provides research on ad spending. In April, Merck bought 295 TV advertising spots for its campaign, followed by 788 in May. Richard Haupt, executive director of medical affairs in Merck’s vaccine division, said in an interview that the company had “invested in public affairs and consumer education more than we’ve done for any vaccine in the past” (Zimm and Blum). The “HPV and Cervical Cancer Awareness Press Coverage” page of the Step Up Women’s Network website (www.suwn.org/womenshealth.aspx) stated that “campaign messages reached an audience of 563 million with coverage from Redbook, Elle, Self, etc., during 2006 to 2007.” This step was made to look like a simple health awareness campaign and did not involve any television advertisements, but instead focused on driving consumer visits to a website. The maketheconnection.org website strictly shared information about the disease. 5.2 Phase II: “Tell Someone” “Tell Someone” was the second part of the disease awareness campaign that preceded the FDA approval of Gardasil. This campaign encouraged young women to tell a friend or family member about the link between HPV and cervical cancer. Lybrand noted that “Tell Someone” tapped into “women’s natural inclination” as talkers and sharers. In no uncertain terms, women were told: don’t ignore this, don’t be shy, talk about it. Actresses in TV ads spoke directly to the camera, as if speaking directly to a friend, family member, or simply another girl who needed to know. Sitting in front of their own computers, girls could send out personalized “Tell Someone” e-cards imprinted with girls lining up to use the phone or gossiping together at a beauty salon and stamped with the question: “Did you know that cervical cancer is caused by certain types of a common virus?” (Herskovits) 31 The TV advertisement showed Merck’s logo and did not mention Gardasil or an HPV vaccine. 5.3 Phase III: “One Less” While continuing disease education programs including “Make the Connection” and “Tell Someone,” Merck launched another national campaign called “One Less” on November 23, 2006. While the previous campaigns raised awareness of HPV , the “One Less” campaign focused on introducing the new vaccine Gardasil and empowered audience members to want to become (or help their daughters want to become) “one less” person who would have to battle cervical cancer. It was a crucial step in driving people from “awareness” and “interests” to “desire” and “action.” Pediatricians and OB-GYNs received advance notice that the campaign would be happening. One large North Jersey pediatric practice sent postcards to parents of age-appropriate daughters alerting them that it had the vaccine in stock (Peterson). “The idea was really to deliver on the strong and powerful message of empowerment,” Lybrand said (Herskovits). “One Less” was an emotion-laced campaign. A group of defiant girls announced that they each wanted to be “one less” victim of cervical cancer. These characters are not depicted as victims, but rather as budding young women taking control over their health and their lives (Applebaum). Filmed in a gritty, documentary style, the ads interspersed information about Gardasil between scenes of teenagers at play or hanging out on city streets. One spot opens with a female skateboarder; another features a boxer. Images stream by of girls hanging out together or with their mothers, who, along with the narrators, delineate the limits of Gardasil and potential side effects of the vaccine (Applebaum). 32 6. Analysis and Evaluation Merck’s 2006 financial results showed that total sales of Gardasil were $155 million for the fourth quarter and $235 million for the year. Its strong performance helped Merck gain solid sales growth. Its total vaccine sales were $683 million for the fourth quarter, representing growth of over 100% compared to the fourth quarter of 2005. Vaccine sales for 2006 were $1.9 billion, representing growth of 69% over full year 2005. Gardasil’s launch campaign won many awards. Pharmaceutical Executive magazine selected Gardasil as its first annual “Brand of the Year” in 2007 and praised that “by combining innovative science, strategic commercialization and savvy disease education, Team Gardasil created a campaign that evoked Merck in its prime - and made strides toward stamping out cervical cancer.” The “Tell Someone” campaign won the “Public Health Award” at the 9th Pharmaceutical Advertising and Marketing Excellence Awards (PhAME), which are “presented annually to the consumer marketing advertisement that can demonstrate the most positive impact on patient/public health.” The “Tell Someone” campaign also received the first place award for “Best Multicultural Campaign” for its Spanish-language campaign, which raised awareness among Hispanic women about HPV and its link to cervical cancer. (“Prime Access Wins”) 6.1 Information Campaign vs. Advertising Campaign Perloff divides campaigns into two basic types - information and advertising (see table 3). The most important distinction between information campaigns and advertising campaigns is the purpose. Information campaigns are intended to change the audience’s attitudes, beliefs, and behaviors rather than directing the audience to purchase a specific product. They are generally 33 designed to promote social issues or public health. Information Campaigns Advertising Campaigns Purpose is to promote social ideas or improve health Purpose is to sell a product Some advertisements, but also uses non-paid media news releases Relies on paid messages Interpersonal and organizational communication plays a more important role Mass communication is the primary means for disseminating the message Often try to convince an audience not to do something, e.g. not to smoke or not to use a product Try to convince someone to buy a product than an idea Target audience is 15% of the population that is least likely to change Target audience is the mainstream population More controversial and touches more closely on values Less controversial Table 3. Information campaigns and advertising campaigns (Perloff) The whole promotional campaign for Gardasil does not seem to fit either category, because it merged a typical information campaign about public health (“Make the Connection” and “Tell Someone”) with a product campaign (“One Less” and “I Chose”) (Buttweiler). Merck’s research ahead of the campaign showed that it was dealing with a situation in which only five percent women and girls surveyed could make the link between HPV and cervical cancer. After the “Make the Connection” and “Tell Someone” campaigns, awareness “rocketed to approaching an excess of 50 percent,” says Lybrand. “That was the key metric in terms of whether ‘Make the Connection’ was resonating” (Herskovits). Georges Benjamin, executive director of the Washington-based American Public Health Association, supported Merck’s promotional strategies. He said in an interview with Bloomberg, “I have seen the ads on TV and I am fine with the fact they are investing in educating the public 34 and would like to see more of the pharmaceutical industry do more of that without pushing a product.” (Zimm and Blum) The FDA’s approval of Gardasil in June 2006 allowed Merck to establish a substantial lead over its competitor GlaxoSmithKline, which had its HPV vaccine, Cervarix, pending approval by the FDA. All of the strategies used during Gardasil’s launch laid the foundation for its future leading position in the market. 6.2 Sponsorship Although Merck emphasizes corporate social responsibility, people still tend to have stereotyped opinions about pharmaceutical companies. For Gardasil, Merck adopted a “non- profit partnership model,” which was a smart way to keep distance from product promotions. Partnering with non-profit organizations, especially those that have patients’ health and women’s issues as their primary concerns, helped Merck reach audiences that may have been suspicious of the motivations of a pharmaceutical company. 6.3 Communication Channel Friedman and Shepeard conducted research on the general public’s knowledge, attitudes, and beliefs regarding HPV and a hypothetical HPV vaccine and explored their communication preferences for channels, tones, settings, and sources of HPV-related information. They found that people would generally seek HPV information from the same channels primarily used to obtain other health information: the Internet and their health care providers. Women mentioned gynecologists as their providers of choice for receiving sexual health information. Participants also mentioned clinics, schools, magazines, local television news, and national television 35 advertisements as appropriate vehicles and settings for delivering this information. Friedman and Shepeard’s research suggests that “the general public can be effectively reached through the Internet and interpersonal, print, and broadcast media, with targeted channels, sources, and settings by race/ethnicity and gender.” Social media was not yet well developed back in 2006. Merck gave full play to the Internet by establishing informative websites in every campaign. The website, maketheconnection.org played an important role in the “Make the Connection” campaign. It was the place from which people ordered bracelets, which were the symbol of “connection” in the campaign. The website also served well as an educational resource where people could learn about HPV and its link to cervical cancer. However, Merck did not keep the domain of maketheconnection.org. It is not clear when or why Merck gave up the domain, but the author would suggest that it keep it and use it to redirect visitors to updated websites. In contrast, tell-someone.com and oneless.com remain alive after the campaigns. The former now redirects visitors to hpv.com, an informative website maintained by Merck. The latter is now tied to gardasil.com, focusing on introducing the vaccine. It is hard to occupy an advantage point in the information era, but Merck kept its leading position in the HPV vaccine market by registering these domains. Merck closely tied itself to authoritative disease education. When potential audience members search for HPV on the Internet, they will find the information provided by Merck ranked first. By keeping the domain names, which are the same as the promotional campaigns’ slogans, Merck has made full use of the success of its previous efforts. Additionally, healthcare professionals are important bridges between consumers and the product. Merck realized the importance of these professionals. The launch of the vaccine also gave the company its first opportunity to unveil its new model for reaching out to physicians. 36 Having already pledged to cap the head count of its sales force, Merck redeployed representatives to cover the growing vaccine division. Professional outreach included online channels like video-detailing as well as encouraging physician-to-physician communication (Herskovits). Merck provided unrestricted educational grants to professional societies to help physicians address issues ranging from vaccine inventory to legally-required patient forms, to reimbursement. Vendors specializing in continuing medical education also identified experts who could communicate with other physicians about the vaccine. “We developed resources to help offices understand the logistical side,” Haupt said. “We tried to give them as much information about the disease as we could” (Herskovits). 6.4 Effectiveness of the Messages Gardasil’s series of campaign were coherent and well-organized. The narrative began by revealing the connection between HPV and cervical cancer. Once women were informed, the next campaign instructed them to share that newfound information with other women. Finally, the campaign introduced Gardasil as the answer to cervical cancer prevention. Messages should be carefully designed and tested with audiences to determine effective content and framing strategies. Consideration should be given to targeting messages by gender and age to ensure that HPV prevention and detection information is relevant to audiences and reaches those who need it most. Efforts should also consider stratifying audiences by relationship status (single/monogamous) and parental status (children/no children), as these factors may influence HPV information needs (Friedman and Shepeard). Friedman and Shepeard’s research showed that parents, whether single or married, want to 37 learn more about HPV to educate their children. Single participants also wanted to learn more about HPV to protect themselves. In contrast, married participants did not perceive themselves to be at risk for HPV and did not feel that HPV information would be personally relevant to them. A study on parental vaccine acceptability showed that parents who feel their child is susceptible to HPV or cervical cancer, worry about HPV or sexually transmitted infections, believe the vaccine is efficacious and will afford benefits, and perceive few barriers to accessing the vaccine are more likely to report a willingness to vaccinate (Fernandez et al.). Focus group participants wanted to know most about what HPV is: its symptoms, transmission, consequences, and testing options and whether is curable, treatable, or life- threatening. Participants also expressed the need for factual information to be delivered using a serious tone in clear, simple language. They wanted real-life examples to which they could relate. There were mixed reactions to the use of scare tactics, which were seen as being potentially effective but likely to instill unnecessary panic about a subject that is “scary enough on [its] own.” Friedman and Shepeard suggested, “The information should be serious in tone and delivered by someone who has dealt with the consequences of HPV and can share his or her personal experience.” Previous research indicated that many providers are (a) not up-to-date on HPV natural history, epidemiology, prevention, treatment or vaccination; (b) unable to answer basic patient questions about HPV transmission and natural history; (c) uncomfortable addressing patient concerns about HPV acquisition and sex partners; and (d) confused about the recommended screening and management practices for HPV-associated conditions (Montano et al.). “We had to tailor our education efforts to different provider groups and integrate them so they could talk to one another,” said Rick Haupt, M.D., executive director of Merck’s vaccine 38 and infectious diseases unit. For example, he noted, “A gynecologist can tell a pediatrician how bad HPV is for women, but the pediatrician has to explain how to get children into a vaccination program” (Washam). Merck realized that education efforts had to be tailored to at least three different specialties. Pediatricians knew how to give vaccinations but many were less versed in the nuances of HPV . Gynecologists were familiar with the disease but their practices were not set up to offer vaccinations. Family practitioners skewed somewhere in the middle. Special efforts were also needed to reach minority groups, which is a unique and important characteristic in the U.S. population. People in these groups tend to trust messages from members of their own communities. To examine the effectiveness of Merck’s messages, the author designed the following matrix (see table 4). Factors that mentioned in Friedman and Shepeard’s research were used to test two important websites from Gardasil’s campaign (hpv.com and Gardasil.com), and paid media in V ogue (see appendix.) hpv.com gardasil.com V ogue ad Target Audience Potential recipients (9- to 26- year-olds) X X X Parents X X X Physicians Minority groups X Pictures on the home page include Latino, African and Caucasian teenagers Content HPV Symptoms X X X Infected people X X X Transmission X X X Consequences X X X Testing options X 39 Prevention X Treatment X Product (Gardasil) Recipients X X Indications X X Safety information/ side effect X X Price and health plan information X Company Merck X X X Real-life examples Tone Informative, emotional Informative Informative Interactive Elements “Share this page” X Link X To gardasil.com X To fda.gov X To gardasil.com, 1-800- GARDASIL Useful tools X Creating a list of questions to ask health care professional X Reminder of vaccination schedule Visual aid Flash X Pictures X X Videos X X Table 4. Effectiveness of Merck’s messages Merck provided clear and simple information about HPV and Gardasil, which is adequate for a product like vaccine. In its websites, Merck paid attention to tailoring the education efforts to different audience groups, and encouraging readers to share with each other and talk to health care professionals. The messages covered most factors that people are eager to know. However, no real-life stories were told in the websites. If Merck could invite some people to tell their stories, it would seem to be more reliable and make people feel connected. 6.5 Dealing with Crisis and Criticism 40 Merck’s PR strategies repeatedly came under criticism. During the pre-approval stages, Merck put the focus on public health education with no mention that there was a product on the way. Gary Ruskin, executive director of Commercial Alert, a consumer group based in Portland, Oregon that is critical of drug company advertising, said Merck’s promotional website on the viral connection to cervical cancer was “deceptive and dishonest.” He said, “Merck doesn’t tell you why the sites exists, which is to sell Gardasil” (Zimm and Blum). Facing that challenge, Kelly Dougherty, Merck’s spokeswoman, said the campaign was not about Gardasil. She said in an e-mail to Bloomberg that “this campaign is part of a broad and longstanding Merck public health commitment to encourage education about the disease.” (Zimm and Blum) After Gardasil was launched, criticisms were mainly concentrated in three areas: (1) vaccine safety, (2) psychological side-effects (vaccines may bring a false sense of security), and (3) politics (is it appropriate to mandate the vaccine for middle-school-aged girls?). A vaccine is a preventive measure. If worries about safety were to spread, they could lead more people to avoid vaccinations and instead adopt a wait-and-see attitude. Any side effects that occur after the vaccination would be related to the vaccine. Although existing cases have been unproven to be directly related to the vaccination, they can still affect potential recipients’ decisions. On some mommy blogs and web forums, comments vary. Annette’s post on “Circle of Moms” (www.circleofmoms.com/welcome-to-circle-of-moms/gardasil-203256) is a typical one, which says, “I have chosen not to get them (two daughters) Gardasil vaccines. I just don’t feel like there has been enough research on the long term effects. My pediatrician left the decision up to me, he does ask every time I take them in. When I asked him about long term effects he said they have been giving it in Europe for many years with minimal problems, but still not enough 41 information for me.” Moms and young women also face anti-vaccine organizations, which are routine opponents of all vaccines, and “victims” of Gardasil. Some critics are worried that “Merck’s profit motive has led them to willingly allow and encourage exaggeration of the significant value of this vaccine with an overblown and harmful interpretation of it in the media and general public.” Siers-Poisson stated that “by overhyping its potential, Merck is contributing to a dangerous misconception and creating the risk that women will feel it is less important to have regular Pap screenings – the tried and true, and very effective method for early detection and treatment of pre-cancerous conditions. It would be a tragic irony if women’s infection and mortality rates from the disease actually increase due to the belief that they are completely protected against cervical cancer.” (“Profit Knows No Borders”) A false sense of security might not only lead to a decline in the reliable and proven diagnostic tools available but also increase promiscuity among adolescents. Merck dealt with such opposition very actively. Early in 2006, Merck successfully headed off opposition to Gardasil from conservative groups by meeting with representatives from organizations such as the Family Research Council, a Washington-based group that advocates abstinence from sex before marriage. Leaders of abstinence organizations said they supported the vaccine and would only oppose efforts to make the shot mandatory (Zimm and Blum). Efforts to mandate HPV vaccination were criticized heavily. In addition to critics of the vaccine itself, some public health officials who favored the vaccine stated that the movement to make it mandatory had come too fast. People were worried about the political deals going on behind the scenes. Take Texas as an example. On February 2, 2007, Governor Rick Perry, a conservative Christian, against the wishes of his conservative base and to the surprise of critics, signed an 42 executive order mandating HPV vaccination for girls entering seventh grade (Siers-Poisson, “Women in Government”). Details of his several ties to Merck and the organization Women in Government then became public. According to its website, Women in Government is a national 501(c)(3), non-profit, bi-partisan organization of female state legislators providing leadership opportunities, networking, expert forums, and educational resources to address and resolve complex public policy issues. The Associated Press reported that one of the drug company’s three lobbyists in Texas was Mike Toomey, Perry’s former chief of staff. His current chief of staff’s mother-in-law, Republican Texas state representative Dianne White Delisi, was a state director for Women in Government. Perry also reportedly received $6,000 from Merck’s political action committee during his re-election campaign. The state of Texas allows parents to opt out of inoculations by filing an affidavit objecting to a vaccine for religious or philosophical reasons. Even with such provisions, however, conservative groups say vaccination requirements interfere with parents’ rights to make medical decisions for their children (Cabluck). Reacting to the furor from some parents, advocacy groups, and public health experts, Merck announced on February 20, 2007, that it would stop lobbying state legislatures to require the use of Gardasil. According to The New York Times, Merck also said that it made the decision after realizing that its lobbying campaign had fueled objections across the country that could undermine adoption of the vaccine. Dr. Richard M. Haupt, executive director for medical affairs in Merck’s vaccine division, said the company had acted after hearing from public health officials and medical organizations that its campaign was counterproductive. “They believe the timing for the school requirements is not right,” Dr. Haupt said, “Our goal is to prevent cervical cancer. Our goal is to reach as many females as possible. Right now, school requirements and 43 Merck’s involvement in that are being viewed as a distraction to that goal.” (Pollack and Saul) Facing this crisis, Merck adopted a strategy of “retreating in order to advance,” which redeemed its image over time. Dr. Larry K. Pickering, executive secretary of the ACIP, and Debbie Halvorson, the Democratic majority leader of the Illinois State Senate, applauded Merck’s decision to stop lobbying. In an interview with The New York Times, Dr. Pickering said that while the vaccine was useful, more data on its safety, effectiveness, and cost was needed, and Halvorson said that she would continue to press for the bill, but her position had nothing to do with Merck (Pollack and Saul). II. The China Launch 1. Background In July of 2010, MSD China and Sinopharm signed a cooperation agreement on the Gardasil vaccine and several others with a focus on marketing Merck products in China (Davies et al.). On October 18, 2012, MSD China and Chongqing Zhifei Biological Products announced that they would work together to supply, promote, and distribute MSD’s cervical cancer vaccine, Gardasil. Chongqing Zhifei Biological Products Co., Ltd. is a Chinese firm that engages in the research, development, production, and sales of vaccines in China. It was founded in 2001 and is based in Chongqing, China (“Company Overview of Chongqing Zhifei”). MSD planned to launch Gardasil in China a long time ago. Early in 2010, Amei Wu, director of MSD China’s vaccine division, said in a National Cervical Cancer Cooperative Group Meeting that Gardasil was expected to complete its Phase III clinical trial before the end of 2011 and would get marketing authorization in 2012 for mainland China (Xu and Li). 44 On May 8, 2012, “China National Plan for Non-communicable and Chronic Disease (NCD) Prevention and Treatment (2012-2015)” was issued by the Ministry of Health and 14 other ministries and state administrations in order to “develop appropriate technologies to screen for key cancers in areas with high cancer prevalence, and carry out early screenings and treatment. In accordance with the policy of national immunization programs, strengthen the vaccination of hepatitis B and human papillomavirus among high risk population for cancers.” Insiders expressed confidence about the future market size. “There are about 16 million newborn babies each year. About half of these are girls, who must receive three doses of the vaccine. According to the calculations, the largest market volume is thus about 24 million doses. However, considering the large population in China and high prices of the vaccine, the coverage would 50- to- 70 percent. So the stable market volume is at least 10 million doses,” said Wang Zilong, Vice President of Shanghai Zerun Biotech (“Chinese Firm to Promote Gardasil”). 2. Key Audience and Key Messages The “Gardasil China Pre-launch Communications Plan” identified the vaccine’s key audiences as “young women from 20-30 and mothers of teenage girls” and “reputable third parties and celebrities.” (MSD China Communications Team) The key messages designed by MSD China included: Cervical cancer is the second-most common cancer in women worldwide. HPV infection is the biggest cause of cervical cancer; HPV infection can also cause vaginal cancer, vulvar cancer, genital warts, etc. Screening and HPV vaccination are effective ways to prevent cervical cancer; The HPV vaccine can also prevent vaginal cancer, vulvar cancer, genital warts, etc. Cervical cancer is the Cervical cancer is “China Cancer 45 second-most common cancer in women, following breast cancer; There are 75,000 new cases of cervical cancer in China each year, and 34,000 women die because of it in China each year; There are, on average, 206 new cervical cancer patients every day in China, and 93 women who die of cervical cancer every day in China. currently the only malignant tumor of which people know the cause (HPV); Women have an 80% chance of being infected with HPV in their lifetime; 99% of cervical cancer patients are found to carry the HPV virus. Screening, Early Diagnosis and Early Treatment Guidelines ” point out that vaccination is the most ideal way to fundamentally prevent cervical cancer; The world’s first HPV vaccine to prevent cervical cancer was developed and launched by MSD in 2006, and it was also the first vaccine to prevent a cancer; The vaccine is now available in 127 countries and areas. 3. Objectives According to the “Gardasil China Pre-launch Communications Plan,” the objectives were to: (1) accelerate Gardasil’s approval in China; (2) demonstrate Gardasil’s competitive advantage and be positioned as an influential stakeholder in key issues; and (3) enhance public awareness of HPV and cervical cancer prevention (MSD China Communications Team). 4. Challenges Sex, especially teenage sex, is a sensitive topic in China. The Durex Global Sex Survey showed that “China is the only country in which some respondents stated that formal sex education was not necessary.” (Durex) If Chinese people are too shy to have sex education, it will be difficult to educate them about sexually transmitted diseases as well. Gardasil was launched in the U.S. three years before its main competitor Cervarix, which helped establish its leading position. However, the launch timeframes of Gardasil, Cervarix and a Chinese domestic vaccine still have not been determined. MSD China will need to differentiate Gardasil from its competitors. 46 5. Strategies and Tactics The “Gardasil China Pre-launch Communications Plan” developed the following strategies: (1) Creating an education campaign to raise awareness of HPV and the diseases it causes and of the connection between HPV and cervical cancer; (2) Driving messages by emphasizing our distinctive HPV vaccine to differentiate from competitors; (3) Using transmedia storytelling to reach different audience groups, targeting young women aged from 20-30 and mothers of teenage girls; and (4) Leveraging reputable third parties and celebrities to enhance awareness and expand influence. 5.1 “Shell Action” Fig. 4. Logo of “Shell Action” MSD China’s communications team planned an overarching campaign called “Shell Action.” The campaign logo is designed to look like an oyster shell, and the campaign was built up as a consistent platform for Gardasil’s pre- and post- launch promotion. The image of a shell is associated with protection and safety. The pearl inside the shell is usually a metaphor for women, and the shell containing the pearl is used to symbolize the uterus where new life is bred. The MSD China communications team hopes that through continuous promotional activities, the 47 shell, as a simple and clear logo, will become an important symbol of HPV education, just like the pink ribbon is for breast cancer awareness campaigns. The campaign will be divided into two parts. Before Gardasil’s launch, the campaign slogan will be “Love her, tell her.” This aims to raise the level of awareness of HPV , HPV-caused diseases, and the connection between HPV and cervical cancer. After Gardasil’s launch, the theme of “Shell Action” will be changed to “Love her, protect her.” The second stage of the campaign will focus on introducing the product, differentiating Gardasil from competitors, and educating the key audience on why the vaccination matters. “Shell Action” began in March 2013. March 8 is “Women’s Day,” so it was well timed for generating discussions on on women’s health. A Weibo joint appeal was started to create widespread attention and buzz in the market. MSD China cooperated with the Shanghai Female Journalists Committee to initiate the first Weibo post appeal as a warm-up for the campaign kick- off. Female journalists across the nation were encouraged to join in the Weibo appeal campaign and disseminate original posts with their comments. With more and more influential Weibo users involved, it became a hot topic on the Weibo platform and reached a larger audience (MSD China Communications Team, “Shell Action Communications Plan”). On June 29, the “2013 Prevention and Control of Cervical Cancer Scientific Forum” was held in Beijing. It was jointly hosted by the Women’s Health Branch of the Chinese Preventive Medicine Association (CPMA), the National Center for Chronic and Non-communicable Disease Control and Prevention, and the National Center for Maternal and Child Health Care, a subsidiary of China’s CDC. Experts from the CDC, the WHO, and major hospitals attended the Forum and announced a new consensus together, suggesting that a persistent HPV infection could be taken as a primary endpoint for the clinical efficacy of HPV vaccines in order to 48 accelerate the use of HPV vaccine in China. Seventeen journalists from 16 mainstream media platforms were also invited to interview the participating experts, covering the economy, health, medicine, and the government. The event generated 21 pieces of original reporting and 382 online pick-ups (MSD Communications Team, “Wrap-up Report”). Since the media outlets that were present at the Forum are all very influential and their readers mainly government officials and researchers, the summit could help increase its influence among policy-makers. After a series of pre-activities, the launch ceremony for “Shell Action” was held on October 10, 2013. Kenneth C. Frazier, Chairman of the Board, President, and CEO of Merck, Michael Klobuchar, Associate Vice President of Strategic Planning, and Geralyn Ritter, Senior Vice President of Corporate Responsibility, attended the event. The global senior executives’ attendance showed that the company puts a high value on its business in China and has high expectations for Gardasil’s future performance in China. Government officials from the All- China Women’s Federation (ACWF) also attended the event. MSD China announced that, in association with ACWF, it would provide education and support to 10 million women in China over the next three years (MSD Communication Team, “Shell Action Communications Plan”). These new media platforms include a mobile newspaper that targets young mothers aged 20 to 45, a “Shell Action” webpage on NetEase, a popular portal website, an official Weibo account, and a smartphone app. 5.2 Launch Stage According to “Gardasil China Pre-launch Communications Plan,” MSD China would announce the launch of Gardasil as a milestone for Chinese women’s health by bringing all influential parties together for acknowledgment and celebration, including government 49 departments such as the CDC and the Ministry of Health (MOH), associations such as China Women’s Federation, campaign ambassadors, key opinion leaders (KOLs) who are well known for advocating for the HPV vaccine’s launch, the media, and MSD representatives (MSD China Communications Team). 6. Evaluation 6.1 Identification of Key Audience According to the Durex Global Sex Survey, the average age at which a person first has sex in China is 18.3, while it is age 16.9 in the U.S. (Durex). Chinese researchers have conducted a meta-analysis of risk factors for cervical cancer in China and the U.S. that concluded that “Chinese women’s age at the time of their first sex is older than American women’s, so the time for HPV vaccination can be delayed” (Zhang). MSD China realized this cultural difference and did not copy the age criteria established in the U.S. Instead of mainly targeting mothers of 10-year-old girls, MSD China identified its target audience as “young women from 20 to 30 and mothers of teenage girls.” However, the U.S. CDC recommends Gardasil for young women under 26, and suggests that the vaccine is more effective on people before they have their first sex experience. Young women between 27 and 30 may be outside of this application scope. Besides, considering the conservative culture in China, parents seldom discuss sex with their daughters. Most Chinese parents would think adolescence is too early to protect a teenage girl from a sexually-transmitted disease. Therefore, the author recommends that “young women from 20 to 30” could be changed to “young women from 18 to 26.” Eighteen-year-olds have reached adult age and college students 50 start to make decisions on their own. They are the ideal target audience for a vaccine such as Gardasil. 6.2 Visual Communication MSD China designed a shell logo as a symbol of the promotional campaign. With this visual aid, Gardasil is closely connected to protection, and the name of the campaign, “Shell Action,” is easy to remember. However, an assessment by the author indicates that the logo is not widely used in public campaigns. So far, it has only been shown at the launching ceremony for “Shell Action.” If the public is unaware of the image, it will certainly be a waste of the idea. In subsequent campaigns, the logo should be more highlighted so as to deepen the impression of “Shell Action” among the target audience. 6.3 Slogan MSD China designed a very coherent plan. In the first part of the campaign, the pre-launch stage, the campaign slogan was “Love her, tell her,” and the theme would later be changed to “Love her, protect her.” With the same sentence pattern, the slogans are very catchy. However, the slogans both adopt a third-person perspective. They will be attractive to mothers of teenagers, but now that the key audience identified in “Gardasil China Pre-launch Communications Plan” also includes young women who are potential recipients of the vaccine, it will not be as appropriate to use “her” in the slogan. These young women who live and work in urban areas are confident and assertive. By using the third person, MSD China ignores their target audiences’ independent consciousness and may distance Gardasil from having emotional 51 resonance. 6.4 Pace of the Campaign The schedule of the “Shell Action” campaign might not be tight enough in 2013. The warm-up activity, the Weibo appeal, was held in March, 2013. The official launch of the promotional campaign was held in October, and as of April 2014, the launch date of Gardasil remains undecided by the CFDA. The ultimate goal of MSD China is to boost the sales of Gardasil in mainland China. Staying in the educational stage for too long could make the target audience lose focus. The current campaigns have told the public about the harm of cervical cancer and some of the news articles have already mentioned Gardasil as a solution. However, people who were aware of the disease and became interested in the vaccine could not find the solution to their problem – where to get Gardasil. They may have either lost concentration or gone to other countries to get the vaccination, which would not increase Gardasil’s sales in mainland China at all. This was definitely not the intention of MSD China’s Communications Department. The CFDA has been slow to approve the vaccine, and MSD China wrongly predicted the launch date of Gardasil. When the campaign was started in March 2013, MSD China expected Gardasil to be approved in the latter half of the year. This reflects the uncertainty of regulations in emerging markets. 7. Recommendation 7.1 Crisis Plan Dealing with crises was an important part of Merck’s work when launching Gardasil in the 52 U.S. In Chinese society, where big companies are more fragile, is full of crises as well. A crisis plan would help MSD China better prepare for an unexpected crisis. One potential crisis could involve damage to the corporate image. MSD’s competitor, GlaxoSmithKline, suffered a bribery scandal in China in 2013, and investigations are still ongoing. In mid-2013, the police raided GlaxoSmithKline’s China headquarters in Shanghai and seized documents. Four executives were also held on suspicions of bribery and tax fraud. The drug company first denied and finally admitted to the crime. Its drug sales slumped 61% in China in the third quarter of that year. Bribery scandals are not new to pharmaceutical companies. In 2012, American drug maker Eli Lilly agreed to pay $29 million to settle accusations that it was making improper payments to government officials and physicians in Brazil, China, Poland, and Russia. “Economic crimes, including commercial bribery and kickbacks, are one of the negative results generated in the transitional period in China,” Feng Zhanchun, a Chinese expert in public health told The New York Times in a 2013 interview. “In the midst of a transition from a planned economy to a market economy, laws and regulations are not fully in place, and medical institutions have no perfect operational mechanisms” (Barboza). After situations like these, it becomes clearer why pharmaceutical companies are not universally trusted. Even if MSD China was not involved in the scandal, it should be careful with its corporate image. Another notable problem in China is a past history of safety issues with both food and drugs. Contaminated hepatitis B vaccines manufactured by a Chinese drug maker caused six babies to die in 2013. Now, MSD China is cooperating with local Chinese drug companies to manufacture and promote Gardasil. Even if MSD has confidence in its own products, it cannot guarantee that no mistakes will happen in the manufacturing process. MSD China should monitor its partners and set a high standard to avoid potential risks. 53 After realizing its industrial and social problems, MSD China should establish a communication plan so that it can deal with a crisis methodically. It should be completed by the Communications Department and Gardasil Marketing Department together. In addition to having an established spokesperson who is familiar with corporate affairs and media, a detailed investigation process should be developed. More importantly, Sinopharm and Chongqing Zhifei, MSD China’s local manufacturing and distribution partners, should be involved in the plan as well. Multinational corporations often boast about their high standards and yet may ignore the overseas partners who are closely connected to their own reputations. 7.2 Endorsement Many pharmaceutical companies utilize mottos. On Merck’s website, founder George Merck is quoted as saying, “Medicine is for the people. It is not for the profits.” His statement of goodwill is printed on the wall of MSD China’s office. Employees at pharmaceutical companies believe they are working for the benefit of human health. However, most consumers still believe “Big Pharma” is driven by profits. Therefore, being low key and seeking endorsements from reliable organizations will be good strategies for drug companies when launching new products. Vaccines are very unique products. They need to be promoted, but not in the same way as other commodities. People may buy a technology product just because it is made by a renowned brand such as Apple, but nobody chooses to get vaccinated merely because of trust in a pharmaceutical company. And, being too aggressive may lead to reverse psychology. Prescription medicine is not allowed to be advertised in China, and Chinese culture is quite reserved. Being in the public eye frequently will give people the impression that the company is 54 too anxious for success and make them doubt the effectiveness of the drug. Therefore, partnerships with reputable organizations such as women’s associations could increase the credibility of Merck’s product. But choosing partners is another difficult task. Non- government and non-profit organizations are not well developed in China. Many charities, such as the Red Cross Society of China, have been connected to bribery scandals. To reduce the risks of being affected by partners’ crises, picking organizations with reliable backgrounds is critical. 7.3 Differentiate Gardasil from its Competitors Gardasil will face fiercer competition in China than it did in the U.S. On the one hand, GlaxoSmithKline’s Cervarix is also in the clinical trial process, and it is difficult to predict which vaccine will win the race to launch first in China. If Gardasil fails to be the first, it will lose the first-mover advantage that it had in many countries, and its public awareness campaigns on HPV will have inadvertently paved the way for the competitors. On the other hand, a local Chinese pharmaceutical company, Xiamen Innovax Biotech, has also developed an HPV vaccine and entered clinical trials. Local companies always set lower prices than multinationals, and it will inevitably take part of the market. Identifying the company’s own advantages is the first step to being competitive. According to a survey conducted by FiercePharma, Gardasil is viewed by doctors as the standard of care for HPV vaccination. Among 95 physicians, 98% voted for Gardasil, while only 2% voted for Cervarix. An obstetrics and gynecology doctor said on Sermo that “I like Gardasil because the appeal of protection from types 6 and 11 is often more compelling to patients than the “cancer” causing strains 16 and 18. They are afraid of warts – which they know real people get – not cancer, which they are sure they themselves will never get.” 55 For now, Gardasil is still the only quadrivalent HPV vaccine on the market, while Cervarix and the local Chinese one are both bivalent. When Gardasil is launched, this feature could be emphasized. Along with information about cervical cancer, information about genital warts should be added to the education materials. Gardasil could be introduced as a solution to more problems. In addition to highlighting Gardasil as “the only quadrivalent vaccine,” MSD China could also add key messages such as the fact that it was “developed in the U.S.” and “has been introduced in over 100 countries and areas” to prove Gardasil’s effectiveness and reliability. These key words could also differentiate Gardasil from its local competitors. By emphasizing its success in other countries, MSD China can take back its research and development advantage even if Gardasil loses its leading position in launching time. 7.4 More Interpersonal Communication When Gardasil is launched in China, whether in 2014 or later, many young women from mainland China will have already gotten vaccinations in Hong Kong or other countries. Most of them are willing to advocate for Gardasil. For example, 25-year-old Meilin He, who was interviewed by Caijing magazine in 2012, said she had no worries about the vaccine because it had been years since Gardasil was launched so she decided to go to Hong Kong to get vaccinated (Xu and Li). Another article that was widely spread online was written by a Chinese student studying at Columbia University. After she got vaccinated at the university health center, she wrote a post introducing the vaccine and relevant diseases, which was retweeted over 1,000 times. It was not planned by MSD China, but the popularity of the post reflected the amount of people who were eager to get detailed information and the fact that consumers tend to trust 56 people around them. The practice of peer-to-peer marketing, based on personal experience can get more attention than official promotions from companies. MSD China could invite some of the early adopters to tell their own stories. To expand the influence of personal stories, it could also invite young stars ages 18 to 25 to be ambassadors and deliver information. 7.5 Further Strengthen Social Media Presence Traditional public relations activities such as hosting a health summit and a launch ceremony and inviting journalists to write news stories are still effective. However, Gardasil’s target audience is young women who seldom read or watch traditional media. To attract their attention, MSD China needs to further strengthen its social media presence, which is usually ignored by pharmaceutical companies. First, Weibo, the Chinese Twitter-like microblogging platform, is undoubtedly popular among Chinese social media users. In cooperation with the Shanghai Female Journalists Committee, MSD China has already reaped benefits during the pre-launch stage. The company could further make use of other features on Weibo, such as the daily “top ten topics list” that is shown prominently on the website. On the day of Gardasil’s launch, MSD China could invite celebrities to forward posts with the hashtag “Gardasil launch” and make the issue a top ten hot topic. The snowball effect would help Gardasil gain attention. Second, MSD China should not be restricted to proven successful promotional platforms. When most companies have realized the importance of Weibo, MSD China should expand to new social media platforms. Gardasil’s target audience is young women, a group that follows fashion and keeps up to date. Presence on newly-developed social media platforms such as 57 Weixin could help MSD China better reach its audience, especially when pharmaceuticals are usually laggers in social media. Weixin (its English-language version is called WeChat), which was launched in January 2011 and quickly amassed about 400 million registered users, is used more intimately to share text, images, and short voice messages. A person’s posts are visible only to “accepted” friends, and the kinds of information shared - photos of one’s children or random observations about the day - are typically intended only for a defined circle of friends and family. Unlike Weibo, it is used almost exclusively on Internet-enabled mobile devices, not desktops. Bloomberg BusinessWeek summarized the difference between the two platforms by saying, “to tap into the pulse of public sentiment about the news in China, check out Weibo. But Weixin may have a brighter future for viral marketing and professional networking” (Larson). Therefore, Weixin is an ideal platform for interpersonal communication. MSD China could invite people who have already been vaccinated and celebrities to share their experiences on Weixin with their circles of friends. 58 Conclusion Emerging markets have long been regarded as the “promised land” of the pharmaceutical industry. They are expected to amount to nearly a third of the global pharmaceutical market by 2016, and it is anticipated that they will play a vital role in sustainable growth in the industry. With huge populations, increasing prosperity, and improving longevity, these markets are very attractive to companies suffering from the stagnation of mature markets, patent expirations, and increased regulatory hurdles. However, although these regions offer huge untapped potential, they display a wide diversity in their stages of development, particularly with regard to their healthcare infrastructure. For this reason, there can be no “one-size-fits-all” approach to emerging markets (Buente et al.). Facing new situations, new strategies and tactics should be tailored to meet different environments. Multinational companies need to pay attention to many factors. Ghemawat pointed out that “distance between two countries can manifest itself along four basic dimensions: cultural, administrative, geographic, and economic.” First, cultural distance includes barriers due to different languages, different ethnicities, different religions and different social norms. Many industries are be affected by these attributes. In the case of Gardasil, although the vaccine is needed all over the world, the key audience and key messages vary for different countries. China could delay the vaccination age due to the average age at which people first have sex. It is also more difficult to talk about sexually- transmitted diseases in a reserved culture such as China’s. So MSD China needs to identify a new target audience and deliver new messages rather than copy what Merck has successfully done in the U.S. Markets are full of risks, but different markets have various different problems. In the U.S., 59 people are used to seeing advertisements from pharmaceutical companies, so no matter how companies try to build their reputations, many people will still connect their behavior with profits. However, in China, due to several food and drug safety controversies, people are disappointed with local businesses, so multinational companies enjoy better reputations. In the U.S., mandated HPV vaccination by the government was opposed because people did not trust politicians who might have been lobbied by the drug maker. China is going through a trust crisis with non-profit organizations and healthcare professionals after a series of bribery scandals involving the Red Cross Society of China and GlaxoSmithKline. Merck’s strategy of partnership with non-profit organizations was successful in the U.S. MSD China also adopted a similar strategy. Since non-profits are not well developed in China, the company eventually chose to cooperate with organizations with official backgrounds such as the All-China Women’s Federation, which is supported by the Communist Party of China. Only when companies realize the cultural differences between different markets can they avoid the potential risks and enter into the best alliances. Second, the regulatory environment is changing. Investments in emerging markets may be exposed to political phenomena that are not generally present in more-developed economies. Regulations in developed markets are more stable. Merck may be familiar with the U.S. FDA’s procedure for vaccine approval, but MSD China wrongly predicted the CFDA’s approval time, and Gardasil will be launched in China far later than expected. The public relations campaigns have had to be dragged out. Furthermore, compliance with local regulations is essential to long-term development in a new market. Gardasil’s promotional campaigns in the U.S. were mostly advertising-based, but Chinese regulations clearly forbidden DTC advertising, so MSD China chose public relations 60 activities such as health forums to attract attention from the media and the target audience. Third, the complexity of emerging markets lies in the countries’ sizes and huge populations. To shorten the geographic distance, Merck opened factories and an R&D center in China. Moreover, MSD China established partnerships with Sinopharm and Chongqing Zhifei, two Chinese drug makers that are familiar with local business to take charge of Gardasil’s manufacturing and distribution. Building partnerships with local firms is a common business model. By collaborating with local partners, multinationals can learn about local problems and gain insight into solutions, while at the same time, taking into account the issue of affordable access (Radjou and Prabhu). Fourth, the economic development of emerging countries is usually imbalanced: some cities are highly developed, while some areas are underdeveloped. Even if a multinational company has local offices and hires local employees, it cannot fully understand all areas in the same country. In the U.S., most products can be promoted nationwide. But Chinese consumers have lower incomes than consumer in the U.S. and a still-developing medical insurance system. Considering the economic distance, MSD China should first target first-tier and second-tier cities where people will be more likely to be able to afford Gardasil. Finally, keeping pace with new technologies is another challenge to communications teams. When Gardasil was launched in the U.S. in 2006, social media was still in its infancy. In recent years, not only have Facebook and Twitter become popular around the world but local counterparts have also been created. 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Asset Metadata

Creator Wu, Xuelu (author)

Core Title Tailoring pharmaceutical public relations strategies to different markets: a case study of the launching strategies of Gardasil in the U.S. and China

School Annenberg School for Communication

Degree Master of Arts

Degree Program Strategic Public Relations

Publication Date 07/09/2014

Defense Date 05/10/2014

Publisher University of Southern California (original), University of Southern California. Libraries (digital)

Tag Gardasil,international markets,OAI-PMH Harvest,Public Relations

Format application/pdf (imt)

Language English

Contributor Electronically uploaded by the author (provenance)

Advisor Swerling, Jerry (committee chair), Floto, Jennifer D. (committee member), Jackson, Laura Min (committee member)

Creator Email xuelu_wu@hotmail.com,xueluwu@usc.edu

Permanent Link (DOI) https://doi.org/10.25549/usctheses-c3-432894

Unique identifier UC11287816

Identifier etd-WuXuelu-2639.pdf (filename),usctheses-c3-432894 (legacy record id)

Legacy Identifier etd-WuXuelu-2639.pdf

Dmrecord 432894

Document Type Thesis

Format application/pdf (imt)

Rights Wu, Xuelu

Type texts

Source University of Southern California (contributing entity), University of Southern California Dissertations and Theses (collection)

Access Conditions The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the a...

Repository Name University of Southern California Digital Library

Repository Location USC Digital Library, University of Southern California, University Park Campus MC 2810, 3434 South Grand Avenue, 2nd Floor, Los Angeles, California 90089-2810, USA