Credits: Art direction & cover design Julien Jarreau Production artists David Gormly, Sara Kane Publication oversight Ron Pantello Production Joseph Perciaccanto Project manager Ari Rolnick Editors David Gideon, John Kallir, Harry Sweeney Copy editor Ann Berkhausen Additional text written by John Kallir, Ron Pantello, Harry Sweeney Publication management Publication Committee, Medical Advertising Hall of Fame Copyright © 2010 The Medical Advertising Hall of Fame All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher. Published by: The Medical Advertising Hall of Fame 876 Oleander Street Boca Raton, FL 33486 ISBN: 9780615324159 Printed in China Library of Congress Catalog Card Number: 2009937974
Contents Medical Advertising Hall of Fame 2009-2010: Member Companies & Representatives / 6 Acknowledgments / 9 Foreword /II Medical Advertising Evolves / 12 Creativity / 14 Copywriters / 15 Art Directors / 16 Account Management / 17 Branding / 18 The Client / 19 The Work / 20 Adapting to the New Environment/ 22 The Science/Gilbert S. Omenn, MD, PhD/ 24 Policies and Politics/John Kamp, Esq. and Wayne L. Pines/ 42 A Perspective/Harry Sweeney/ 49 The FDA/Kenneth P Berkowitz, Esq./ 52 Going Global/Jed Beitler/ 68 The New Communications Spectrum/ 82 Professional Advertising Today/John Corcoran/ 84 The Impact of Technology/ Tom Domanico and Don Martiny/ 94 Digital Communications Emerge/ Tim Pantello and Mark Bard/ 108 A History of DTC/Frank Hone/ 120 Medical Publishing/Carroll Dowden/ 136 Excellence in the Work/ 148 Professional Advertising/ 150 Digital Promotion/ 220 DTC Advertising/ 242 Agency Self-Promotion/ 264 What the Future Holds/ 280 Medical Advertising Hall of Fame Gallery of Inductees 1997-2009/ 288 Contributing Authors/ 293 Index/ 294
Medical Advertising Hall of Fame 2009-2010 Member Companies & Representatives Scott D. Cotherman, Chairperson, MAHF Corbett Accel Healthcare Group Doug Burcin, Treasurer, MAHF Euro RSCG Life Worldwide Mr. Jay Carter Abelson-Taylor M r. Gerald Carrafiello Carrafiello Diehl & Associates, Inc. Mr. Ed W ise Cline Davis S Mann Mr. David Chapman CommonHealth Ms. Elaine Eisen Corbett Worldwide Mr. Mark Goldstone DDB Health Worldwide M r. Carroll Dowden Dowden Health Media Mr. Thomas Domanico DraftFCB Healthcare Ms. Risa Bernstein Flashpoint Medica Mr. J oe Kuchta Goble <£ Associates Mr. Philippe Deschamps GSW Worldwide Ms. Lisa Kirk Haymarket Media Mr. Robert Muratore HealthSTAR Communications, Inc. M r. Alan Imhoff International Medical News Group Ms. Lois Moran Juice Pharma Advertising Mr. Art W ilschek Massachusetts Medical Society M r. Richard Nordstrom McCann Healthcare Ms. Donna Tuths Ogilvy Healthcare NA M r. J onathan Isaacs Ogilvy Healthworld M r. Thomas L. Harrison Omnicom Group M r. Ryan Abbate Pacific Communications M r. Nick Colucci Publicis Healthcare Mr. Sam W elch Saatchi & Saatchi Healthcare Communications M r. J ohn Racik Stonefly Communications Group M r. J ed Beitler Sudler & Hennessey Ms. Carleen Kelly Surge Worldwide M r. Alan Topin Topin $ Associates Mr. Donald J. M. Phillips, Pharm.D Vox Medica M r. Peter M. Labadie Williams-Labadie M r. Steven Michaelson Wishbone/ITP 6
Acknowledgments The People Who Created Medicine Ave 2 Medicine Ave 2: The Story of Medical Advertising in America 1990-2008 is made possible by the support of the Medical Advertising Hall of Fame (MAHF). This publication fulfills the mission of the MAHF to record and preserve the industry's rich history. The MAHF appointed a publication committee to manage all activities concerning the creation and publication of Medicine Ave 2. Its members are Julien Jarreau, David Gideon, John Kallir, Ron Pantello, and Harry Sweeney. Ron Pantello, as Chairperson for the publication committee, oversaw all activities associated with the creation of Medicine Ave 2, was a contributing author, and served on the ad selection committee. David Gideon, as Executive Director for the MAHF, served as the liaison to the MAHF and editor for the publication. Julien Jarreau served as the publication's art director, charged with design, layout, and production. John Kallir served as executive editor for Medicine Ave 2 and was the last word on all copy. He was also a member of the ad selection committee. Harry Sweeney was a contributing author and editor, and served on the ad selection committee. In addition to the publication committee members, Mike Lyons assisted the ad selection committee. Special thanks to Medical Marketing & Media, which has staunchly supported the MAHF since its founding 14 years ago in its mission to preserve the history and to honor the people who built the foundations of the health communications industry; and to James Chase, MM&M's editor in chief, for his assistance providing digital materials. Without the tireless efforts of the publication committee, this book would not have been possible. After 1990 the industry became more complicated as new regulations, technologies, and emerging new science all converged. As such, to appropriately cover important industry subjects, the publication committee recognized the need for special guest authors. The MAHF expresses its appreciation to the following guest authors/experts: Gil Omenn, Jed Beitler, John Kamp, Wayne Pines, Ken Berkowitz, Tom Domanico, Don Martiny, Frank Hone, Carroll Dowden, John Corcoran, Tim Pantello and Mark Bard. The MAHF also recognizes the generosity of Euro RSCG Life and expresses appreciation to Donna Murphy and Doug Burcin for use of their personnel— especially Barry Balter, Ann Berkhausen, David Gormly, Seene Herzbrun, Sara Kane, Rebecca Karnofsky, Kelli Klasko, Barbara Kleinman, John LaBash, Joseph Perciaccanto, Alyssa Peterson, Freddy Reyes, Ari Rolnick, and Binh Tran—as well as their meeting room facilities. A special thanks to all the agencies that submitted samples of work for presentation in Medicine Ave 2. Over 850 samples were submitted; while all of these cannot appear in the publication, they will be preserved for presentation on the MAFIF Web site. And a final thanks to Pat Pantello for arranging the indexing and copyright for Medicine Ave 2. The MAHF wants to thank all who helped with this publication for seeing the value of preserving the rich history associated with medical advertising. Enjoy this labor of love! 9
Foreword The Medical Advertising Hall of Fame is pleased to present the second installment chronicling the progress of our industry, Medicine Ave 2. This volume is dedicated to those advancing our industry with their passion and drive, integrity, creativity, and dedication to enhancing and extending human life, in service to the healthcare industry. The Medical Advertising Hall of Fame was founded in 1996 for the purpose of recording the history of medical advertising and to honor those individuals who have created this industry. Recently, the mission of the organization was extended to help attract new talent to the medical advertising profession by providing students in leading educational institutions with a comprehensive description of the role the profession serves and the career opportunities that exist within the industry. Attracting future leaders is as important to our organization's mission as is recognizing the leaders of the past. Significant developments and achievements in our profession have occurred since publication of the first installment of this series, Medicine Avenue: The Story of Medical Advertising in America. Scientific advancements and regulatory practices have continued to define and influence our industry, but there also has been significant progress in how and to whom we communicate about healthcare products and services. The past two decades have seen the rise and expansion of direct-to- consumer advertising, the emergence of digital and interactive communications, and the proliferation of global brand building, among other advancements. Moreover, there have been fundamental changes to the structures of medical advertising agencies and publishers. Ours has evolved into a diverse and multilayered profession, the leadership for which has moved from the early pioneers whose names adorned their agencies to corporate-owned entities within large, globally diverse holding companies comprised of professional business managers. It is against this dynamic that we tell the story and paint the picture of the past two decades in the advancement of medical advertising through Medicine Ave 2. Scott D. Cotherman Chairperson Medical Advertising Hall of Fame 11
Medicine Ave 2 is the story of medical advertising—and a celebration of the industry's creative product—from 1990 to 2008. During this dynamic period, the creative product evolved as new customers forced price pressure on pharmaceutical manufacturers. The pharmaceutical industry responded by expanding direct-to-consumer (DTC) advertising in the hopes of increasing patient demand regardless of price. This was accompanied by an explosion of direct-to-patient promotion in support of the DTC efforts, as well as the emergence of digital media. At the same time, advances in technology changed how the advertising industry produced the creative product, resulting in an increase in efficiency. All the while, scientific innovation continued, yielding many new products, and making 1990 through 2008 a boom era for our industry. Medicine Ave 2 presents some of the best creative work from this period, as judged by those who crafted the creative product during their careers. Given the tremendous volume of work delivered, the selected representations are but a sample of the creative output of some very talented professionals during very dynamic times. Enjoy! Ron Pantello 13
Medicine Ave 2 In the medical advertising world, the creative product is designed to present facts and information which will persuade customers to prefer one brand or service over another. In that sense, nothing has changed over time. Ideas—or better stated, big ideas— remain the most important contribution of medical advertising agencies. Regardless of budget constraints, clients always find money for big ideas. Such ideas can come from any corner of the agency: account services, copy, art, marketing research. Today's ideas can, and should, take many forms, and must manifest themselves in everything an agency does. Big medical ideas are always based on sound medical and scientific knowledge and must be strategic. Big ideas must be customer-centric, flexible, persuasive, and most of all distinctive. Such big ideas are now translated across all media formats and reflect the product's branding. All great creative work, regardless of format, must evoke some customer emotion, be it a smile, a nod of agreement or even a tear. Once you own the customer's emotions the sale is made. Medicine Ave 2 is proud to present some great creative product, representing the best our industry has to offer. 14
M e d i c a l A dvertising Evo l v e s op/writers Beginning in the 1990s the pressure on copywriters dramatically increased. Not only must the modern-day medical copywriter he a competent writer with a sound understanding of science and medicine, he or she must he able to write for the emerging new media. In addition to traditional medical journal ads and sales aids, today's medical copywriters are called upon to execute television commercials, radio, online, customer relationship marketing tools and more. Regardless of the medium, the copywriter still has to face that ominous blank page (or computer screen). The writer knows he has only a precious few seconds and even fewer words to capture a customer's imagination and make him want more. One venerable copywriter said, "Great copy should always make you feel a little uncomfortable, grabbing some customer emotion," forcing you to see the brand in new and different ways. Copywriters sit at the crossroads of knowledge, insight, and strategy, leading the way to commercial persuasion. No easy task. 15
M e d i c i n e A ve 2 medical art direction. Art directors are now called upon to create images for various new media. The traditional compelling single visual element in support of great copy remains a focus, but now art directors must also create a noisy brand landing page on the internet while remaining true to their art. Not surprisingly, art directors enthusiastically took on this new graphic challenge, leading the way toward redefining medical art direction while maintaining the all-important graphic branding. No challenge seemed too large. Medical art directors took full advantage of technological advances to hone their craft. What once took weeks to produce now takes just days or hours. New computer graphics packages broadened the art director's palette of available tools. These innovations were ultimately used by agency management for new business presentations. When all is said and done, great creative work always involves a great copywriter and a great art director collaborating to produce a persuasive piece of advertising that is a commercial success. Some things never change. 16
M e d i c a l A dvertising E vo l v e s agency. As the "face" of the agency, these professionals must balance their agency's needs with those of their client. They must have a genuine passion and respect for the creative product, understand the science behind the brand, be fully informed about new media and be gatekeepers for the "brand," while ensuring that all agency activity delivers a profit. Today's account management team must interface with as many as ten product managers on a single brand. Often these product managers are responsible for various marketing disciplines and media, all competing for their "fair" share of the brand's promotional budget. Facing such politically charged situations, the account management team must have the courage to remain media neutral, always acting in the brand's best interest. Account managers serve many masters in an increasingly complex and dynamic marketplace. They must be knowledgeable, decisive, flexible, and aware of their dual obligations. 17
One of the agency's main responsibilities remains turning a client's product—a molecule, machine, or service—into a professional brand. Every major medical advertising agency takes a lead in creating a brand that has a distinctive identity, a personality that's a part of its enduring image. The net result of the branding process is the brand essence, which is a distillation of the brand identity and encapsulation of the brand values. It encompasses how customers feel about the brand, how they perceive its qualities and benefits. The brand essence becomes the framework for the brand culture and for all communications. Given the increasing use of integrated communication approaches, branding is one of the most important aspects of a commercially successful product. Done properly, branding is the cement that guarantees that a brand's identity will survive and thrive no matter where the professional or patient encounters it. The medical advertising agency must always be the safekeeper of the brand.
M e d i c a l A dvertising E vo l v e s 1 \. courageous client great advertising will not be seen." Today, clients are faced with a multitude of marketing issues that advertising and promotion cannot answer. As a result, many clients now rank advertising agencies lower on the scale of what's important for a brand's success. It is the medical advertising industry's job to reengineer our offerings, creating communication innovations so compelling that the agency becomes a client's indispensable business partner. If this is done well, clients will take ownership in the agency's ideas, thus solidifying the client/agency relationship. Even in today's complex market and economy, confounded by industry consolidation, there are plenty of good clients looking for answers. Many of Medicine Ave 2's advertising examples are testaments to courageous clients who are willing to innovate alongside their agency partners. Together with our clients, we must continue to create work that captures our customers' imaginations. In doing so, we will serve ourselves, our clients and our industry well. Be courageous. 19
The creative product depicted in Medicine Ave 2 is the work of many talented writers, art directors and account teams. Medicine Ave 2 recognizes that the 1990s and the 2000s ushered in an array of new media that challenged traditional medical advertising professionals. Our industry responded by finding ways to use the new media to better serve our clients and their customers. Clearly, such innovations as direct-to-consumer advertising, direct-to-patient promotion, customer relationship marketing, wellness programs, and of course digital medias have made great contributions to healthcare. Therefore, Medicine Ave 2 includes both the story of these new media and examples of work appearing in them. While all the new media evolved from fad to necessity, traditional medical advertising continued its winning ways. Medicine Ave 2 presents the outstanding medical advertising of the past two decades, featuring the emergence of new therapeutic categories representing major scientific breakthroughs. Medicine Ave 2 is intended to be a celebration of our creativity, our industry and its people. 4^
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It is difficult to overestimate the quantity, quality, and speed of change that have occurred in the healthcare communications environment since 1990. The research community raced to achieve the spectacular basic scientific, clinical, and diagnostic advances outlined by Gilbert S. Omenn in 'The Science." At the same time, elected officials in the United States grappled with issues of universal access to healthcare in the face of spiraling costs and debated ideas for the reform of health financing. They also tested the various levers of control, as described in both "Policies and Politics" by John Kamp, Esq. and Wayne L. Pines, and "The FDA" by Kenneth P Berkowitz, Esq. During this same period, the regulated industries—pharmaceutical, biotechnology, diagnostics, and medical device manufacturing—consolidated their holdings and expanded their reach around the world, prompting the communications service industries to follow suit. In the face of such sweeping change, traditional advertising agencies morphed into multidisciplinary, centrally managed global networks—as detailed by Jed Beitler in "Going Global"—providing a seemingly ever- expanding menu of highly specialized communications services based on new behavioral science discoveries and new technologies. What follows is a close look at the environment within which medical communications firms have had to exist, survive, and prosper over the last two decades. Despite more budgetary and regulatory controls, and integration into a global environment, the industry has persisted in its primary function—bringing information to healthcare professionals and patients about the ever-growing treatment options available to them. Harry Sweeney 23
M e d i c i n e A ve 2 Communications Challenges of the Life Sciences Gilbert S. Omenn MD, PhD The life sciences have been growing in the public consciousness for several decades—reflecting the introduction of antibiotics in the 1940s, the proposal of the double-helix structure for DNA in 1953, the War on Cancer in the 1970s, the periodic influenza epidemics, and the race to sequence the human genome during the 1990s.1The US public has strongly supported investment in biomedical and behavioral research, based on high expectations of benefit through better healthcare and public health measures. Some life science developments have become embroiled in larger controversies, such as important advances in reproductive health, genetically engineered crops and foods, nanobiotechnology, and embryonic stem cell biology. Public attitudes and public advocacy have played significant roles in the Congressional and Presidential commitments to invest in the life sciences, including the doubling of the budget for the National Institutes of Health between 1998 and 2003 and the $10 billion addon it received as part of the 2009 economic stimulus 24
T he S c i e n c e package. A leading force in bipartisan public/private advocacy is Research!America, whose polls have documented the strong support for biomedical research.2 We have reached what has been called "the end of the beginning" in a new era of genomics and its applications toward predictive, preventive, personalized, and participatory (P4) healthcare.3Several major challenges remain to be addressed. Many believe that the scientific community needs to more meaningfully engage the general public to help people understand what is being done scientifically and medically and elicit their help in directing national priorities. In the face of many competing priorities for federal investment, we also must find a way to sustain adequate levels of funding for what can be characterized as the most productive life sciences R&D agenda in the world. Funding support may well be bolstered by efforts within the scientific community to translate basic scientific advances into effective and efficient clinical applications—and to see to it that proven therapies, especially cost effective therapies, find their way quickly into patient care in everyday practice. Finally, we must provide perspective on the conflicts between increasing demands for healthcare, and the willingness and ability of consumers, taxpayers, and employers to pay for healthcare whose costs continue to grow much faster than the general economy or the tax base. Understanding the New Science of Genomics as an Enginefor Advancing Research According to Francis Collins, while on leave from the University of Michigan to direct the National Human Genome Research Institute of the National Institutes of Health, "Mapping the human genetic terrain may rank with the great expeditions of Lewis and Clark, Edmund Hillary, and the Apollo Program."4 (Collins was ■II III I III! mi niEiiiiiiiim mi i i n u n i ■mu i nmni i 11mi ■■ihiihb him llllill IBIIII till IHil I ■IIHIIBMI1IIII III II Hill I llllill hi minima Section of the human genome 25
nominated in July 2009 by President Obama to become Director of the NIH.) In a commencement address in December 2000, I observed to the graduating class that, if the key advice of the 1969 movie The Graduate was to work in "plastics," the key advice of this decade is to work in genomics—the study of all of our genes and their functions, instead of just one gene at a time. (The comment created quite a buzz during the reception as parents and graduates asked about the term and its meaning!) The near completion of the human genome sequence in 2001 has since fueled many associated advances in genetics, medicine, and public health. One big surprise of the human genome sequence is that there are many fewer genes than previously expected, about 20,000 instead of 50,000 to 100,000. This finding put the focus on the protein products coded for by the genes; there are an estimated 1 million types of proteins, the effector molecules of our cells and bodies. The corresponding research on all the proteins is called "proteomics."3 The Human Genome Project demonstrated the importance of appropriately funding enabling technologies—synthesizing and sequencing DNA and proteins with automation and miniaturization. These technology platforms made the Genome Project feasible. Traditionally, we thought about science leading to technologies and then commercial or medical applications. Now we realize that technological advances may be essential to even conceive of the scientific aims. Furthermore, the decision to include in the Genome Project many other species along with humans (a hot issue in the late 1980s) has been amply rewarded with many insights from comparative genomic analysis. And the requirements for computational advances have
attracted engineers, mathematicians, cyberneticists, and other new colleagues to this clearly multidisciplinary effort to understand living things and their ailments. The Vicissitudes of Research Funding at NIFt The Genome Project was sustained during a fallow period of funding for NIH in the early and mid 1990s. Huge federal budget deficits in the early 1990s led to several years of depressing projections about the NIH budget, with minimal annual increases—less than consumer inflation. In contrast, the conclusion of the Genome Project coincided with a remarkable step-up in the funding for the NIH, the major health research agency of the federal government, as well as increases in R&D funding from the private sector. A concerted, broad appeal to Congress underscored the need to catch up and make bigger investments, given the scientific opportunities not just in genomics but also in imaging, neurosciences, and many other fields. Funding First, an advocacy arm of the Lasker Charitable Trusts, supported an analysis by prominent economists that attributed enormous net returns to investments in NIH research.6The result was a bipartisan commitment to double the NIH budget from SI3.6 billion to $27 billion between 1998 and 2003—a compounded annual rate of 14.4 percent—with a major component for bioterrorism-related research and development.7 During the same period, worldwide R&D expenditures by pharmaceutical and bioteclmology companies surged, with most of the increase taking place in the US, where expenditures from research-based members of the Pharmaceutical Research and Manufacturers of America (PhRMA) alone increased from $21 billion to $34 billion. The new message was clear: In the face of popular demand for increased access to clinical services, across-the-board funding of innovation in science and
M e d i c i n e A ve 2 themselves generally pay only a small portion of the total cost of healthcare, but that portion is increasing technology is essential to bring the full benefits of the new biology to patients and the general public. Not surprisingly, the very rapid doubling of the NIH budget was not sustainable; the inflation-adjusted budget was basically flat for the next 5 years, resulting in NIH appropriations of just $30 billion in 2008, though estimates of private health sector R&D expenditures continued to increase to a level of $44 billion. Following the financial meltdown of 2008, the huge federal spending stimulus package of the Obama Administration, combined with the special leverage of Senator Arlen Specter of Pennsylvania, gave the NIH a special appropriation of $ 10 billion to be spent within 2 years on short-term scientific jobs, construction, and renovation. It remains to be seen what the baseline NIH budget will be in FY 2011; perhaps the most likely outcome would be about $35 billion (the 2009 baseline of $30 billion plus the average expenditures over the two years from the stimulus). Biomedical Research Advances, Healthcare Payors, and Increasing Societal Demands The currently polarized status quo is unsustainable. On one side are the growing aging population, the needs of the uninsured, the demands of the insured population for better healthcare, and new devices and drugs with high per patient prices. On the other side is the limited willingness and ability of payors to pay. Patients themselves generally pay only a small portion of the total cost of healthcare, but that portion is increasing. The rest is paid by taxpayers, who are anxious about their tax burden, and employers, who insist that their health insurance premiums are making them globally uncompetitive. The US passed one test of its capacity to meet basic coverage needs a few years ago when the Congress and 28
President Bush plugged a gaping hole in Medicare—the lack of coverage for outpatient prescriptions—by passing the Medicare Part D plan. Now, after more than 75 years of intermittent efforts and incremental advances, universal health insurance coverage has become a hot topic in Washington. It appears that the laudable goal of affordable, high quality healthcare and services for all has somewhat better prospects now than it has for decades. Despite the achievements of NIH and the larger health sciences and life sciences community in this country and elsewhere, the US is underinvested in some areas that are important to our social compact with the American people. Patients and healthcare professionals expect scientists to generate effective and safe clinical and public health advances from all the spectacular basic biomedical work. However, translating basic advances into clinical applications remains difficult. Eliciting support from healthcare insurers and managed care organizations for access to patients and funding for the costs of clinical studies and clinical trials has been difficult. Healthcare providers need research-based evidence of what works and what does not, and what is safe when used as directed and what's not, in medical care and in public health. The knowledge base underlying healthcare spending is generally inadequate, too short-term, and not generalizable to all the diverse populations of our country, let alone the world. And prevention still gets short shrift compared with diagnosis and treatment. Ideally, the biomedical, behavioral, and health services research agenda should be related to the healthcare cost equation. As noted, the social compact that yields generous support for research is based on an expectation of the benefit of improved health for the American people and people elsewhere. To honor that compact, I have five suggestions for action:
1. We should recognize the enormous cost of those conditions for which we do not yet know enough to treat affected patients effectively, let alone prevent the disorders. More of the same is not good enough for our children and grandchildren. 2. We should put more emphasis, especially with public funds, on scientifically interesting, low- cost interventions for which there may be no proprietary incentive for industry. One successful example is the fortification of flour and grains with the B vitamin folic acid since 1997. This action has greatly reduced the incidence of one of the most serious categories of birth defects— neural tube closure defects (spina bifida and anencephaly).* The cost of such fortification of cereal grains is extremely low, and everyone receives the ''treatment." Such public health advances often meet with fierce resistance from an uninformed population or others with different agendas, which must be dealt with by effective communications plans. 3. We should be aware of the very high—and increasing—costs of bringing effective new drugs to the marketplace. We need to refine the regulatory process to make approvals less costly, while simultaneously requiring post-marketing surveillance to more readily recognize adverse effects and take steps to prevent harm. New genomics and proteomics methods may well yield biomarkers useful in identifying subgroups of patients and specific molecular targets or combinations of targets for new drugs. *It was thought very likely that folic acid (and vitamin B12) administration through fortification or through supplementation to reduce circulating homocysteine levels would have the additional benefit of reducing the nation's number-one cause of death—cardiovascular diseases (heart attack, stroke, and peripheral vascular disease.)8In this case, however, no benefit was demonstrated in the research studies of risk-reduction in patients with existing heart disease.
4. We should recognize that academic medical centers, facing constraints on payments for clinical care, will be less able to support the environment for grant-funded research. Increases at NIH may be small compared with the squeeze on Medicare and Medicaid payments. 5. We should invest in learning what works and what does not, and what is safe and what is not, in clinical care. We must make our healthcare much more patient-centered, recognizing the importance of chronic care for common conditions, and encourage patients, families, and other caregivers to become more knowledgeable so that they may contribute actively to the management of these conditions. In the 2009 economic stimulus package, the federal government appropriated $19 billion to subsidize and incentivize purchase and installation of electronic medical records and computerized recording and monitoring of physicians' orders for lab tests, x-rays/imaging procedures, and prescriptions, plus $1.1 billion for comparative effectiveness research. Both of these approaches may be helpful in building institutional capability and making better clinical decisions.910 Performing Translational Research and Communicating its Value To meet the descriptive needs of the increasingly multidisciplinary new sciences, a new concept— translational research—has sprung into existence at the NIH as part of the initiative to "re-engineer the clinical research enterprise."1 The NIH stimulates transformative changes in research and training through highly competitive institutional Clinical and Translational Science Awards, of which there were 46 by July 2009, with a plan to increase to 60 around the country. The Institute of Medicine (IOM) Clinical Research
Roundtable defined two stages of translational research. The first, from bench to bedside or clinic (Tl), utilizes knowledge from the basic sciences to produce new drugs, devices, and treatment options for patients. Tl requires a wide array of partnerships, especially as disease burden has shifted from acute conditions to coordinated management of chronic conditions of ambulatory patients in the community. The second (T2) is the translation of results from clinical studies into everyday clinical practice and decision making. Changing behaviors, helping patients make informed choices, providing reminders and creating point-of-decision support tools, and many other forms of communications outreach to achieve translation of results represent the diffusion-of-innovation activities that have been at the heart of medical advertising since its inception. Readers from the medical advertising community will recognize this description of the T2 enterprise as requiring mastery of the implementation science of fielding and evaluating interventions in real- world settings, drawing upon such disciplines as demographics, clinical epidemiology, communication theory, decision analysis, organizational theory, marketing, system redesign, survey research, and informatics. How the medical advertising and communications sector facilitates Tl and T2 translational research and improvements in healthcare will depend on four additional areas of research: clinical, multidisciplinary, prevention, and health services. Clinical Research For at least 30 years NIH directors have lamented the decline in the numbers of physician-scientists and in the proportion of research based on studies of patients and
The Science populations, as contrasted with studies of animals or isolated molecules. In many ways, studies with human volunteer participants or patients are much more complicated than basic laboratory studies. This is due in part to the many physiological and pathological variables, and in part to a stringent process of protection of the privacy of research participants under institutional review boards (IRBs). The IRB process of review and approval of proposed studies and of well-documented informed consent from participants is essential, yet challenging for individual researchers and costly for the institutions. External funding for additional staff and infrastructure frequently is quite inadequate. Privacy requirements mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) put additional cost burdens on clinical research. Despite the rapidly rising bill for pharmaceuticals and the seeming avalanche of direct-to-consumer advertising about new drugs from pharmaceutical and biotechnology companies, the yield of new drug candidates and new approved drugs has diminished. There has been rather limited benefit so far from genomics in drug development. While the molecularly targeted cancer drugs (Herceptin for certain breast cancers and Gleevec for a specific form of leukemia) have been touted like overnight "hits" produced by the new biology, these agents actually were developed quite a few years earlier and initially were considered failures in trials for much more common conditions. The overriding challenge for clinical research is to go from reductionist work on the roles of specific genes, to work on the functions of those genes and their products in the whole body of an animal, and then to address both favorable and adverse effects. Evidence to support clear communications about the risks and 33
M e d i c i n e A ve 2 benefits is essential. The euphoria about individualized or personalized medical care faces practical problems. These problems are due to marked variation not just in individual genetic background, but also, very importantly, in diet, metabolism, personal behaviors (such as smoking, alcohol use, physical activity, and sexual activity), environmental, chemical and microbial exposures, co-existing medical conditions, and the use of pharmaceuticals and nutraceuticals. Such variation will make many proposed genetic tests insufficiently specific and sensitive to be useful, unless the information about genetic variation can be coupled with information about these other, nongenetic variables.3The promise of such discoveries has led some entrepreneurs to offer genotyping services direct to consumers—some say prematurely—prompting legislative calls for consumer protections. The regulatory and legal challenges involved in communicating such matters are daunting. Multidisciplinary Research True multidisciplinary/interdisciplinary project teams and large-scale projects are essential for certain kinds of life science research goals. The Human Genome Project is a notable example. The development of sequencing and synthesizing technologies and machines, automation with robots, and large-scale computation made all the difference in the timetable, and even the feasibility of any timetable. The interface between these teams and multidisciplinary communications and regulatory teams also is likely to become much more complex. Multidisciplinary organizations in every sector present particular challenges, as each discipline has its own "rules of engagement." Excellent cross-disciplinary training is not easy. In the academic community with 34
The Science which I am most familiar, evaluations of faculty for promotions still tend to penalize team efforts, compared with research advances by individual investigators. University and sometimes government laboratory promotion evaluations continue to favor single-author or first-author papers on work that can be conceived, planned, funded, conducted, and analyzed in relatively short time periods. Such institutions need to develop ways of stimulating and rewarding highly effective team efforts, thereby modeling what we are teaching. Some universities, including the University of Michigan, have introduced specific guidance on evaluating the roles of faculty critical to team science in the merit and promotion processes. Prevention Research Promoting better health and preventing diseases and injuries require a population perspective and research strategy. We have a growing and aging population. It is inevitable that healthcare will cost a lot more in future decades. One way to moderate that increase and get more value from our research expenditures is to become more effective in preventing or delaying serious illnesses and injuries. Current efforts focus mainly on diagnosis and treatment, and only minimally on prevention, in all aspects of the life sciences and health programs. Linking information about genetic variation with information about non-genetic variables of behavior, diet, metabolism, environmental exposures, and medical interventions will be essential for credible guidance about disease prevention and health promotion. The complexity of communications in this domain is obvious. While implementing the Genetic Information Non- Discrimination Act (GINA) and protecting confidentiality and privacy of personal health information, we must rrent focus mainly on diagnosis and treatment, and only minimally on prevention 35
devise effective ways to link data from environmental monitoring and behavioral surveys needed to interpret the significance of genetic variation in both the clinical and the public health setting. Moreover, we must devise appropriate ways to interpret and communicate about such information in ways that patients and caregivers can understand. Health Services Research A series of reports during the past decade from the IOM have documented medical errors causing preventable deaths, the chasm between the present overall quality of care and what we should provide, and the opportunities for leadership in the federal agencies and in other sectors to enhance quality of care and safety of patients.12'14 Comparative effectiveness and cost-effectiveness research is needed not only on individual treatments and technologies, but also on patterns of care and ways to motivate healthier patient behaviors across diverse population groups. The professional community should he committed to a healthcare system characterized by these six attributes: safe, effective, patient-centered, timely, efficient, and equitable.13 Enhancing Science and Health Literacy All of us have much to gain from a more scientifically literate and proactive general public. Those of us in the research community want people to understand what we do and what we seek to accomplish scientifically and medically. We must be willing to listen, for communication is a two-way process. In the mid-1990s, I chaired a Presidential/ Congressional Commission on Risk Assessment and Risk Management, with oversight of the full array of federal environmental, health, and safety regulatory agencies. One of the key accomplishments of our Commission
was to create a Framework for Environmental Health Risk Management, with "stakeholders" at the center of our scheme.13 We sought to get interested and affected (or potentially affected) laypeople engaged as early as possible in the process of setting the context and guiding technical assessments, before experts decided which questions needed to be addressed and which would be neglected. We held monthly hearings throughout the country over two years. Our experience was so compelling that we published a short volume for laypersons that gave examples of real situations in which public engagement had been active (sometimes in a positive way and sometimes not), and we illustrated how our framework effectively helped translate into risk communication at the community level. We found that laypeople are often impressive in their ability to evaluate and balance certain risks against other risks, risks against benefits, risks against costs, and benefit against costs. Also, to our pleasant surprise, we discovered that non-scientists often suggested practical, less extreme, and less costly ways of achieving the desired protection. The public clearly influences the national priorities for life sciences research. For decades, the advocacy of special health interests drove Congress to create new institutes at NIH and authorize special funding increases. In the late 1990s, NIH Director Harold Varmus and Research lAmerica leaders Paul Rogers and M ary Woolley led the campaign to increase support for a broad array of research related to the life sciences, not just at NIH, and not just for particular diseases or institutes. Members of Congress and others who were able to overcome narrow special-interest advocacy should be commended for recognizing that advances for any particular disease may
M e d i c i n e A ve 2 well come from unexpected quarters across highly interconnected areas of research. Opinion polls demonstrate strong bipartisan public support for investments in research to improve medical care. However, funds must be directed wisely. Of the $2.5 trillion spent on healthcare annually in this country, it is estimated that about one-fourth may go to "chasing the symptoms" of common diseases we do not yet know how to effectively treat—or prevent. Examples are the common cancers (except lung cancer, due primarily to smoking), neurodegenerative and psychiatric conditions, arthritis, and gastrointestinal disorders. Those of us who are clinicians or healthcare systems administrators must do what we can to help current patients, but we should not remain ignorant and impotent as we prepare to care for our children and grandchildren. Each of us involved in healthcare communications must be keenly aware of the delicate balance that exists between communicating just the right amount of information about emerging technologies, and prematurely overstepping the boundaries of what is known into speculative areas unsupported by data. To prevent the pendulum from swinging too far to one side or the other in policy debates over what has been called the Precautionary Principle, we must acknowledge the tension that exists between those who view advances in disciplines such as nanotechnology and the neurosciences as rampant novelty that must be regulated by "anticipatory governance," and those who call for a balanced, temperate approach that protects the public without a chilling effect on innovation—and we must work to manage that tension publicly. 38
Conclusion Lest one think that all of these challenges are unique to our time, here is a cogent quotation from Sir William Osier, professor of medicine at Johns Hopkins University and the University of Oxford16: To wrest from nature the secrets which have perplexed philosophers in all ages, to track to their sources the cause of disease, to correlate the vast stores of knowledge, that they may be quickly available for the prevention and care of disease— these are our ambitions. Despite the technologic advances of the past 100 years, Osier's 1902 statement holds true today. We may wonder how those who follow us will view our state of knowledge and practice 100 years from now. 4
References 1. The Human Genome special issues. Nature 2001; 409:745- 959. Science 2001; 291:1145-1434. 2. Research'.America. Results of a National Poll of Public Attitudes about Medical Research. Arlington, VA, 1998. 3. Omenn GS. From human genome research to personalized healthcare. Issues in Science and Technology. Summer 2009; 51-56. 4. Collins FS. Shattuck Lecture: Medical and societal consequences of the Human Genome Project. N Engl J Med 1999; 341:28-37. 5. Pandey A, Mann M. Proteomics to study genes and genomes. Nature 2000; 405:837-846. 6. Funding First. Exceptional Returns: The Economic Value ofAmerica's Investment in Medical Research. New York, NY: Mary Woodard Lasker Charitable Trust; May 2000. 7. Omenn GS. Science and technology policies concerning the life sciences. In Teich AH, Nelson SD, Lita SJ (ed 2003 AAAS Science and Technology Yearbook, Washington DC: American Association for the Advancement of Science, Chapter X. 27th Annual AAAS Colloquium on Science and Technology Policy. 2002; 145-166. 8. Boushey CJ, Beresford SAA, Omenn GS, Motulsky AG A quantitative assessment of plasma homocysteine as a risk factor for vascular disease: probable benefits of increasing folic acid intakes. JAMA 1995; 2 74: (13) 1049-105 7. 9. Committee on Comparative Effectiveness Research Prioritization, Institute of Medicine. Initial National Priorities for Comparative Effectiveness Research. Washington, DC: National Academy Press; June 2009. 10. Benson A, Lyerly K, Abernathy A, et al. Improving Medical Decisions through Comparative Effectiveness Research: Cancer as a Case Study. Washington, DC: Friends of Cancer Research; May 2009. 11. Zerhouni EA. Translational and clinical science—time for a new vision. N Engl J Med 2005; 353:1621-1623 12. Kohn, LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington DC: National Academy Press; 1999. 13. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; July 2001.
14. Committee on Enhancing Federal Healthcare Quality Programs. Leadership by Example: Federal Agency Programs to Enhance Health Care duality. Washington, DC: National Academy Press; 2002. 15. Presidential/Congressional Commission on Risk Assessment and Risk Management. Framework for Environmental Health Risk Management. 2 vols. Washington, DC: US Government Printing Office; 1997. Available at www.riskworld.com/reports/1997. 16. Osier W. Chauvinism in medicine. Address given at the Canadian Medical Association, Montreal, September 17, 1902. Quoted by: Harvey AM. Science at the Bedside: Clinical Research in American Medicine, 1905-1945. Baltimore, MD: Johns Hopkins University Press; 1981:77.
M e d i c i n e A ve 2 John Kamp, Esq. and Wayne L. Fines For most of the history of medical advertising, the main government regulatory agencies that advertisers needed to focus on were the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA). A major transition took place with enactment of the 1962 Drug Amendments, which gave FDA the authority to regulate prescription drug advertising, a responsibility previously exercised by the FTC. For the next half century, advertisers and their agencies navigated FDA's regulations, guidances, podium pronouncements, and enforcement actions with varying degrees of success, as many of these set new policies. The main sanctions for alleged violations ranged from "Dear Doctor" or "Dear Healthcare Professional" letters to mandates for corrective advertising, with the underlying threat that the product could be seized or be the target of an injunction if the company failed to comply. Enforcement letters sometimes were accompanied by public announcements—announcements which not only created negative publicity for the company, but also 42
had the cumulative effect of creating a negative marketing image for the industry at large. Meanwhile, enforcement letters were viewed in some companies simply as an annoying but tolerable penalty that justified the business risk of undertaking aggressive promotion campaigns. In the late 1990s and into this century, new players entered the enforcement/legal picture. US federal and state governments' efforts to prevent fraud and abuse in Medicare and Medicaid programs led to a flurry of highly publicized settlements with medical products companies that cost billions of dollars in fines and required the adoption of stringent internal compliance programs. These actions stemmed primarily from two types of allegations—one was the misrepresentation by companies of their pricing information and practices, and the second was the off-label promotion of products that are purchased or reimbursed by the government. The new cases have been brought under three distinct laws: the False Claims Act, the Anti-Kickback Statute, and the Food, Drug & Cosmetic Act (FD&C Act). The first two laws include provisions for significant penalties for causing false claims for payment to be presented to the government or for providing inappropriate inducement to prescribe. Until the mid-to-late 1990s, the False Claims Act and the Anti-Kickback Statute had not been applied to the pharmaceutical and medical devices industries. The application of these statutes by the Department of Health and Human Services' (HIIS) Office of the Inspector General (OIG) and the Department of Justice, plus the states (many of which adopted their own false claims laws), raised the stakes for industry considerably. These laws can lead and have led to far greater penalties than those authorized under the FD&C Act. The use of the False Claims Act for enforcement has caused particular strife within some companies, as it
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