Women are six times more likely to die from heart attacks than breast cancer. Car diovascular diseases (CVD), particularly coronary heart disease (CHD) and stroke, remain the leading causes of death of women in America and most developed coun tries, with almost 39% of all female deaths in the United States occurring from CVD. Yet fewer than one in 10 women today thinks that heart disease is her biggest health threat. Bridging this educational gap is paramount to extending the lives of American women. “Using global advertising and PR strategies with clear messaging and consistent statistics, much as we’ve seen in the successful breast cancer model, are fundamental to strengthening aware ness of this issue,” says Bob Preston, publisher of Great Health magazine. “Such initiatives must make women understand that the risk of heart attack among men and women at age 70 is equiv alent. They also need to clarify for women that this risk is not entirely modifiable through lifestyle; that is, while eating right and exercising regularly are important for overall health, they don’t necessarily protect women again heart disease. Educational efforts should also focus on how other conditions, such as blood pressure, cholesterol, diabetes, etc., affect the heart. And since genetics play a leading role in this condition, women need to understand that, regardless of lifestyle, other treatments, including medication, may be required.” According to Kalia Doner, editorinchief of Remedy and Diabetes Focus magazines at MediZine, women need all of the healthcare information they can get to make wise decisions. “At the same time, the informational content should be of the highest standard for all patients, not just women, as well as the doctors and pharmacists with whom they will be consulting,” Ms. Doner says. “Our goal is to engage, educate, and influence patients so they will see themselves at the center of a health management team.” Pharmaceutical companies can play a role in helping women know their risks. For example, last year, SanofiAventis supported the American Heart Association’s Go Red campaign, whose goal is to reduce coronary heart disease and stroke in women by 25% by 2010. In February 2007, HEART Education, research, and marketing are needed to help women understand and treat cardiovascular disease. Heart disease is the NO.1 KILLER of women BY CYNTHIA BORDA W A Woman’s PV0308 LAYOUT 2/15/08 8:44 AM Page 50 51 PharmaVOICE M a r c h 2008 HEART DISEASE in women physical inactivity result in several intermedi ate risk factors for cardiovascular disease, including hypertension, dyslipidemia, hyper glycemia, and obesity. Unfortunately for women, cardiovascular disease has long been considered predominate ly a male disease. So, historically, less attention has been focused on women and symptoms of the disease specific to them. “One of the most important challenges pharma companies have in planning their cam paigns is breaking through the perception that cardiovascular disease is primarily a male issue,” Mr. Preston says. “Because they are protected early in their lives, women continue to have a sense of their own invulnerability to heart dis ease even after menopause. Surveys indicate that heart disease education among women is their most critical need. While many companies have women’s health divisions recognizing the need for education, those with vast resources should be funding new branded and unbranded educa tional DTC/DTP initiatives.” “The perception is that males are still at higher risk than women for cardiovascular events, in part, because women have hormon al protection,” Dr. Dillaha agrees. Rather than the more commonly recognized symptoms that men incur, such as the sudden chest pain or uncomfortable pressure, women may experience shortness of breath, dizziness, nausea, indigestion, vomiting, unexplained fatigue, and back, shoulder blade, or jaw pain. Additionally, study results are beginning to emerge that show that there are gender dif ferences in the cause and progression of car diovascular disease. A study by the CedarsSinai Medical Center in Los Angeles and sponsored by the National Heart, Lung and Blood Institute indicated that as many as 3 million women previously diag nosed with healthy arteries could actually have an increased risk of heart attack after all. This study, called the Women’s Ischemia Syndrome Evaluation (WISE), found, among other things, that the standard test for assessing coro nary artery disease — the coronary angiogram — may not spot the more diffuse buildup of plaque that often forms in the smaller coronary arteries of women’s hearts. The WISE researchers found that women have “a global pattern of dysfunction in the macro and microcirculation.” Although the “diffuse atherosclerosis” that many women experience is not seen on a coronary angiogra phy, it results in abnormal resistance that lim its blood flow to the heart tissue. But without angiographic evidence of a blocked artery, a woman’s symptoms are likely to be discounted. Women do not always present with the classic symptoms of a heart attack, for example, substernal chest pain radiating into the jaw and down the left arm.Women often have nonclassical symptoms, such as nausea/ vomiting, back pain, and a generalized sense of just not feeling well. DR. RANDALL MOREADITH Cardium Therapeutics Cardiovascular Disease Stats . One in three female adults has some form of cardiovascular disease (CVD). . Since 1984, the number of CVD deaths for females has exceeded those for males. . In the United States in 2004, all cardiovascu lar diseases combined claimed the lives of 459,096 females while all forms of cancer combined killed 267,058 females. Breast cancer claimed the lives of 40,954 females; lung cancer claimed 68,461. . Almost 39%of all female deaths in Ameri ca occur from CVD,which includes coronary heart disease, stroke, and other cardiovascu lar diseases. . The death rate due to CVD is substantially higher in black women than in white women. . 38% of women compared with 25% of men will die within one year after a heart attack. Source:American Heart Association, Dallas. For more information, visit americanheart.org. as well as in previous years, the company sup ported the Spirit of Women Coalition for its annual special event called “Day of Dance for Cardiovascular Health” where 50 hospitals across the United States raised awareness among women about heart disease and stroke. The Go Red campaign includes National Wear Red Day — Feb. 1 — when Americans wear red to show their support for women’s heart disease awareness. The Heart Truth — a national awareness campaign for women about heart disease developed by the National Insti tutes of Health — uses the Red Dress as the national symbol for women and heart disease awareness. “Pharmaceutical companies can play a sig nificant role in improving the understanding for women and their risk of cardiovascular mortality,” says Larry Dillaha, M.D., executive VP and chief medical officer of Sciele Pharma. Cardiovascular disease is an allencompass ing term for several facets that increase mor bidity and eventually mortality if left untreat ed. It includes both disorders of the heart and blood vessels, such as coronary heart disease, cerebrovascular disease, peripheral arterial dis ease, rheumatic heart disease, congenital heart disease, and deep vein thrombosis and pul monary embolism. An unhealthy diet and Focusing on educating women who are heads of households hits the family’s health manager, influencing 80% of the household decision. Women of middle age have tremendous influence on their aging mothers,especially with compliance of medications. BOB PRESTON Great Health PV0308 LAYOUT 2/15/08 8:44 AM Page 51 52 M a r c h 200 8 PharmaVOICE HEART DISEASE in women Response Differences Cardiovascular drugs are approved for treating men and women, yet few have been studied to determine whether men and women respond differently. Researchers are beginning to find that there are gender differ ences between how women and men respond to cardiovascular drugs based on lower body weight, smaller organ sizes, and a higher pro portion of fat in women when compared with men. In addition, hormone levels and differ ences in metabolism may affect absorption and elimination of drugs in women. One company that is studying how gender plays a role is Cardium Therapeutics. Upon ana lyzing data from its trial using angiogenic gene therapy Generx (alferminogene tadenovec) in patients with chronic stable angina, the medical technology company found that women responded differently than men. Generx pro motes the growth of new blood vessels in the heart, thereby providing alternate routes of blood flow and oxygen delivery that the blocked vessels cannot provide. Generx is in a Phase III clinical trial enti tled AWARE (Angiogenesis in Women with Angina pectoris who are not candidates for Revascularization) clinical study. The random ized, placebocontrolled, doubleblind AWARE study is expected to enroll about 300 women with recurrent stable angina pectoris who are not candidates for revascularization and who are receiving optimal drug therapy. “The AWARE trial was initiated specifical ly for women who have coronary artery disease that cannot be corrected using bypass surgery or angioplasty with a stent,” says Randall Morea dith, M.D., Ph.D., executive VP and chief medical officer at Cardium Therapeutics. “This gene therapy is unique in that after a onetime infusion during a routine catherization proce dure, we begin to see growth of new blood ves sels in the heart within four to eight weeks fol lowing infusion. We named the trial AWARE specifically for purposes of raising awareness in women about their cardiovascular risk. One of the things we learned from the WISE trial was that women do not have the normal symptoms of a heart attack, which are pain down the left arm or a substernal chest pain. Instead, women reported nonclassic symptoms of nausea and vomiting, shortness of breath, back pain, or just an ill feeling. In addition, data from the WISE study found that many women with positive tests for angina — such as an exercise treadmill test — did not show lesions in the coronary arteries that limit blood flow to the heart. This has led to the hypothesis that some women with angina may have coronary microvascular syndrome. The development of Generx is aimed precisely at the growth of these small vessels, and thus women may respond to this approach uniquely.” On the device side, Abbott Vascular in July 2007 began enrollment for the first clinical trial designed to study a drugeluting stent in women. The goal of the XIENCE V Spirit Women trial is to increase the understanding of A Pipeline Check AMERICA’S PHARMACEUTICAL RESEARCH COMPANIES ARE DEVELOPING 771 MEDICINES FORDISEASESTHAT DISPROPORTIONATELY AFFECT AMERICANWOMEN. THE MEDICINES INTHE PIPELINE FORWOMEN (EITHER IN CLINICALTRIALS OR AWAITING APPROVAL ATTHE FOODANDDRUGADMINISTRATION) INCLUDE: . 65 for depression and anxiety. Almost twice as many women as men suffer from these disorders. . 56 for Alzheimer’s disease, which affects more women than men because women tend to live longer. . 59 for asthma,which affected more than 20 million Americans in 2004, with the prevalence rate for women being 24% higher than for men. . 277medicines for heart disease and stroke, which kill half a million women each year. . 135 for female specific cancers, including 95 for breast cancer, 47 for ovarian cancer, and 17 for cervical cancer; there are an additional 96 medicines for lung cancer, the leading cancer killer of women. . 125 for arthritis/musculoskeletal disorders. Arthritis affects 41 million women,accounting for 70% of all rheumatoid arthritis sufferers and almost 64% of Americans with osteoarthritis. . 106 for autoimmune diseases, which collectively afflict 23.5 million Americans,most of them women. . 95 for diabetes, which is reaching epidemic proportions,particularly among women and minorities. More than 9 million women older than the age of 20 have diabetes, including onethird who do not know it. . 90 for obstetric/gynecologic conditions. Thrombosis 40 Atherosclerosis 37 Peripheral Vascular Disease 32 Hypertension 31 Heart Failure 30 Lipid Disorders 24 Heart Attack 19 Stroke 19 Acute Coronary Syndrome 16 Pulmonary Vascular Disease 15 Arrhythmia/Atrial Fibrillation 13 Coronary Artery Disease 11 Adjunctive Therapies 6 Imaging Agents 6 Angina 4 Other 26 Note:Some medicines are listed in more than one category. Medicines in Development for Heart Disease and Stroke Source:PhRMA,Washington,D.C.For more information, visit phrma.org. Women need health education information on heart disease that offers them hope and solutions and that gives them the opportunity to engage in productive conversations with their physicians and pharmacists. KALIA DONER Remedy and Diabetes Focus PV0308 LAYOUT 2/15/08 8:44 AM Page 52 Pharmaceutical companies deliver so much more than medicine. That’s why they partner with HealthEd. Our strategies support the individual needs of patients, their families, and the treatment teams who care for them. Our passion is the whole patient. Educating Patients Building Brands ph 908.654.4440 w w w . H e a lt h E d . c o m 2007 HealthEd “ It’s my diagnosis, but it’s not just me living with HIV.” 54 M a r c h 200 8 PharmaVOICE HEART DISEASE in women how heart disease affects women and to assess the performance of the XIENCE V Everolimus Eluting Coronary Stent System in women with previously untreated coronary artery lesions. The trial is being conducted in Europe, Asia Pacific, Canada, and Latin America and will enroll about 2,000 women. “The biggest challenge is to find study sites that are appreciative of the cardiovascular issues between the two genders,” says Jules Mitchel, Ph.D., president of Target Health. “Recruiting women for the studies is also a challenge. Women still do not consider cardiovascular disease as a major health issue.” Although the National Institutes of Health has established requirements for equal inclu sion of women in clinical studies, the under representation of women in cardiovascular clinical trials continues to be an issue. Women are less willing to participate in car diovascular prevention trials, as well as other clinical studies, than men, because they per ceive a greater risk of harm, new research sug gests. The authors say this perception must be overcome so that men and women can be included equally in clinical studies. The report, published in the May 14, 2007, issue of the Archives of Internal Medicine, was conducted by Harvard School of Public Health. “For a long time, the issue of underenroll ment of women in clinical trials has been thorny for the medical establishment,” Mr. Preston says. “But as more women are enrolled in CVD clinical trials as study subjects, more data are available that document women’s risks and assess the role of various interven tions. Companies can initiate educational and PR initiatives that increase awareness, compli Women influence up to 80% of healthcare decisions for their households, and have more than $1.2 trillion in buying power, yet many marketers default to generalizations and stereotypes when devel oping brand campaigns aimed at women. The most successful campaigns are the ones that connect the most strongly with their target customer. But to do that, marketers need to know the woman they are speaking to, not just how she thinks, but what she feels and what matters to her.They need to know what will shift her mindset from “why?” to “why not?” when considering the brand. Most existing market research methods don’t go deep enough to reveal the key beliefs that drive women’s behavior. By changing the way marketers gather cus tomer insights, they can gain new perspec tives on women that will enable them to create deeper brand connections.Below are a few recomm nded approaches. . OFFER HIGHLY PERSONALIZED FORMATS If focus group participants are inperson, then why not the observers? The oneway mir ror creates tremendous anxiety for participants whomay assume they are being judged or crit icized. By bringing the observers into the room, participants can see that they are respectful and interested in the valuable information women have to share. Better yet, make the focus group location a place where women naturally gather and share advice and opinions with friends, like a living room. . PROVIDE COMPLETE ANONYMITY Moderated proprietary chat rooms let par ticipants say what they really think while being anonymous. This creates an environment where they can confess behaviors that don’t fol low social expectations or decisions that are highly personal. Women are more likely to say, “Okay, here’s the real deal” when they are com pletely comfortable. . ELIMINATETHE MIDDLE MAN Allow women to reflect in private and record firsthand video journal entries without speaking to a moderator. This approach, used frequently by reality TV shows,enables women to provide honest feedback in a highly person alized setting, where they don’t feel judged. Their body languageoften tells as muchas their words. In addition to the above methods suggest ed for structuring market research, the follow ing are thoughts to keep in mind when uncov ering insight about women’s beliefs and behaviors. . UNDERSTAND SELFPERCEPTIONS Behaviors link into selfperceptions, which are difficult to learn from direct inquiry. Apply the principles of psychology along with “walking in her shoes”to uncov er hardwiring and subconscious attitudes women themselves might not be aware of. Empathology is not just about understand ing her, but understanding how she sees herself. . CONSIDERTHE UNIQUE POINT OF SALE For prescription products, treatment decisions are reliant on a connected dia logue between patient and physician that is ultimately played out in the doctor’s office. Attitudes, emotions, unsaid objec tions, and assumptions can prevent ideal dialogues that influence your brand in many ways. It will be critical to ensure a connected dialogue between patients and their healthcare providers. The insightful research that follows as a result of these tactics will paint a portrait of the target audience’s mindset. Marketers will understand who she is, who she aspires to be, how she thinks, what she feels, and what matters to her. And in the process it will expose the current beliefs driving behaviors. Source:Pink Tank,a division of GSWWorldwide,Westerville,Ohio.For more information, visit gsww.com. By changing the way marketers gather customer insights, they can gain new perspectives on women that will enable them to create deeper brand connections. Gretchen Goffe, Senior VP, Consulting Practice for Pink Tank, a division of GSW Worldwide Marketing to Women: Science Plus Art PV0308 LAYOUT 2/15/08 8:44 AM Page 54 Pink Tank is a diverse group of brand counselors with expertise in creating a brand voice to which women respond. In fact, we’d be happy to share our 5 keys to finding the female voice with you at your request. Does your brand feel like the perfect fit? Contact us at [email protected]. A great brand can only feel like a perfect fit if it feels right emotionally as well as functionally. Is your brand resonating as well as it could with female influencers? Compromises, assumptions, and generalizations often get in the way of making deeper connections. And brand potential goes unrealized. Functional perfection isn’t always alluring to women. 29971_ncgsmc_shoe_ad_phvc_fa.ind1 1 2/14/08 1:36:23 PM 56 M a r c h 200 8 PharmaVOICE HEART DISEASE in women Heart Disease Awareness: Prevalence Among American Women READERS OFHEALTH EDUCATION MAGAZINES ARE MOREKNOWLEDGEABLE ABOUTTHE FACTS ABOUTHEARTDISEASE INWOMEN African American women are more likely than white women to die from a heart attack or stroke Existing heart disease is undiagnosed in half of the women who have a first heart attack Women are less likely to receive aggressive treatment for heart disease than men Women are less likely to survive heart attacks than men Women with diabetes are 2 to 3 times more likely to have a heart attack Heart disease is the leading cause of death in American women 56 56 56 49 54 53 42 42 32 45 44 41 Engaged in regular exercise Engaged in a diet program to lower cholesterol levels Took special vitamins Engaged in a diet program to lower salt intake Engaged in a diet program to lower blood glucose levels Followed doctor’s advice for prevention of heart disease Stopped smoking MOREWOMENWHOREADHEALTH EDUCATION MAGAZINESTAKE AVARIETY OFACTIONS TO REDUCETHEIR RISK OFHEARTDISEASE 56 46 8 8 MediZine readers U.S. Population 29 54 45 41 39 52 35 23 26 17 WOMENWHO READHEALTH EDUCATION MAGAZINES ARE MORE LIKELYTO BE MORE INFORMED ABOUTHEARTDISEASE INWOMEN Informed about heart disease in women 71% 18% 13% 58% Very well informed about heart disease in women READERS OFHEALTH EDUCATION ARE MORE LIKELYTO HAVETALKEDTOTHEIR DOCTORS ABOUTTHEIR RISK OFHEARTDISEASE Initiated the discussion about heart disease with their doctor 34% 30% 40% 35% Doctor discussed heart disease with them WOMENWHO READHEALTH EDUCATION MAGAZINES FEEL MOREATRISK FOR HEART DISEASE 44% 39% MEDIZINE CONDUCTEDANONLINE STUDY IN JANUARY 2008TO GAUGEHOW INFORMEDTHEREADERSOFHEALTH EDUCATION MAGAZINES ARETOTHE FACTTHATTHE LEADING CAUSE OFDEATH IN AMERICANWOMEN IS HEART DISEASE. Notes:MediZine deployed an online survey on Jan. 29, 2008, to 30,000 women 40+ readers.The MediZine study generated 3,859 usable responses within 48 hours of deployment.The same questionnaire was emailed to a national panel of 10,000 randomly selected sample of women 40+; this study generated 282 usable responses. Source:MediZine LLC, Proprietary Research, January 2008, New York. For more information about this study, contact Suzanne Polizzie at [email protected]. PV0308 LAYOUT 2/15/08 8:44 AM Page 56 57 PharmaVOICE M a r c h 2008 HEART DISEASE in women ance, and persistency incorporating data results from these studies. This can be done through programs that are entertaining as well as educational. People love quizzes and puz zles, which can be disseminated in different venues such as in magazines, in medical offices, even at sports clubs.” Mr. Preston suggests that such quizzes could be based on a “women’s cardiovascular risk assessment model” and might ask a vari ety of preventive health questions such as, are you a smoker or have you had your blood pres sure or cholesterol levels tested within the last 12 months; health status questions, such as do you know what your blood pressure and cholesterol levels are and are they are high, low, or average; nonmodifiable risk factor questions about family history or reproductive status; and opinion questions in a trueorfalse format such as I am immune from heart dis ease because I exercise regularly, etc. The Market It is not surprising that both antihyperten sive and antidyslipidemic medications are among the highest prescribed in the United States. According to Urch Publishing, the global cardiovascular market was valued at $89.7 billion in 2005. It was dominated by the antihypertensives with 48% of the market share. Antidyslipidemics came in second with more than 33% of the market. Of the top 20 products by global cardio vascular sales in 2005, all generated annual sales in excess of $1 billion. IMS Health data for 2006 and the first half of 2007 show renin angiotensin antagonists as being the topselling antihypertensives in the United States, with Diovan/Diovan HCT (val sartan and valsartan/hydrochlorthiazide) dom inating this category. Lipitor (atorvastatin) is the top antidyslipidemic drug for the same reporting time frame. The global cardiovascular market is fore cast to expand to $116.3 billion in 2010. The greatest rate of growth is forecast for the U.S. market, which will increase at a compound annual growth rate (CAGR) of 1.4%, com pared with the average of 1.1%. The greatest growth in cardiovascular treatments in the major pharmaceutical markets is forecast for hypertension, which will increase at a CAGR of 1.3% between 2005 and 2010. Dyslipi demia and coronary heart disease are expected to grow at rates below the average CAGR of 1.1%. # PharmaVOICE welcomes comments about this article.Email us at [email protected]. LARRY M.DILLAHA,M.D. Executive VP and Chief Medical Officer, Sciele Pharma Inc., Atlanta; Sciele Pharma is a specialty pharmaceutical company specializing in sales, marketing,and development of branded prescription products focused on cardiovascular/metabolic, women’s health, and pediatrics. For more information, visit sciele.com. KALIA DONER. EditorinChief, Remedy and Diabetes Focus magazines,published by MediZine LLC, NewYork;MediZine,a provider of consumer health educational marketing, reaches millions of healthconscious consumers annually with researchbased information that enables them to make better health decisions and lead healthier lives. For more information, visit medizine.com. Experts on this topic GRETCHEN GOFFE.Senior VP, Consulting Practice, Pink Tank,Westerville, Ohio; Pink Tank, a division of GSWWorldwide,an inVentiv health company, is a fullservice consultancy specializing in marketing to women.Pink Tank is staffed with a diverse group of brand counselors with expertise in psychology, patient advocacy,gender,and cultural studies, as well as extensive experience in marketing to leading consumer and healthcare brands.For more information, visit gsww.com. JULEST.MITCHEL,PH.D.President,Target Health Inc., NewYork;Target Health is a fullservice eCRO dedicated to all aspects of regulatory affairs, clinical research, biostatistics, data management, Internetbased clinical trials (EDC), software development, strategic planning,and drug and device development. For more information, visit targethealth.com. RANDALLW.MOREADITH,M.D.,PH.D. Executive VP and Chief Medical Officer, Cardium Therapeutics Inc., San Diego; Cardium Therapeutics is a medical technology company primarily focused on the development and commercialization of novel biologic therapeutics and medical devices for cardiovascular and ischemic disease. For more information, visit cardiumthx.com. BOB PRESTON.Publisher,Great Health magazine,Los Angeles; Great Health magazine,published by Basic Media Group and sponsored by CVS/pharmacy, is a monthly health and wellness magazine that will make its debut in May 2008.For more information, contact Bob Preston at [email protected]. The biggest challenge is to find study sites that understand cardiovascular issues in women. DR. JULES MITCHEL Target Health PV0308 LAYOUT 2/15/08 8:44 AM Page 57

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