Avoiding Undue Influence

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Autumn Konopka

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Thought leaders — scientific and clinical experts — play a pivotal role in helping pharma companies identify key topics of interest to physicians. Depending on their role, these KOLs provide launch and sales support or play a critical role in continuing medical education. They provide solid, evidenced-based education that translates science into practical application and informs their colleagues about new, cutting-edge information. The relationship between pharma companies and thought leaders is changing in light of regulations that aim to address conflicts of interest, and industry experts say there is a need for strategic planning when reaching out to these experts. Relationships with thought leaders are migrating more toward partnerships as opposed to providing brand recognition in the field, says Jim Melton, CEO of PMPN. “Because these relationships are highly regulated, developing these people as trusted advisors requires companies to let them say what they think,” he says. Thought leaders have a message to convey, says Lawrence Sherman, CEO of Physicians Academy for Clinical and Management Excellence. “When a thought leader truly speaks his own mind, physicians often respond very well,” he says. “But these folks also are interested in learning new things and figuring out why their patients act the way they do. A pharma company can help them discover that.” Working with thought leaders should not be a “tactic,” says Charlie Buckwell, CEO of Complete Medical Group. “There should be an approach that realistically links almost every aspect of the brand portfolio, from R&D to sales,” he says. “It ought to be a principal driver of communication strategy development and delivery.” According to Jon Easter, director of pharmaceutical research for Best Practices, all thought leaders are not created equal. “A mature approach to thought-leader development differentiates types of thought leaders according to their potential,” he says. Pharmaceutical leaders should consider taking a well-planned and nurturing approach to the development of thought leaders, suggests Mario R. Nacinovich Jr., senior VP of Fission Communications. He says that in order for the industry to be more successful, we need to appropriately use key opinion leaders (KOLs), initially by offering them the most appropriate opportunities that match their expertise and/or interests. A common mistake, he says, is to send a KOL to the podium when, for example, that individual may be more interested and comfortable working on research or publications. “These leaders may be not the most adaptable or amenable, but they’ll do it because that’s the way to gain entry and to be noticed for future considerations,” he explains. Mr. Buckwell says it is surprising to see how many brand teams, even those with an extensive history in a category, have little idea who the thought leaders are or what their practice profiles are. He says a key challenge is the continued need to drive an appreciation of thought-leader development as a rigorous discipline requiring careful planning and adequate tools. The key aspect of the culture shift required is to move thought-leader relationships from being regarded as a “personal asset” to being regarded as a “company asset,” which needs to be managed like any other highly valuable resource. Thought Leaders and Medical Education Most experts agree that thought leaders play a pivotal role in CME by helping pharma companies identify key topics of interest and by pushing education providers to offer compelling, relevant content. In fact, many thought leaders are forming educational foundations, says Heidi L. Liston, Pharm.D., senior VP and general manager of DiMedix LLC. “These individuals may sit on pharma advisory boards and therefore have the opportunity to take their learnings from those advisory boards and propose CME programs,” she says. “Commonly, these are top-level experts and individuals with whom pharma wants to maintain relationships.” Dr. Liston says for some pharma companies, this is not perceived to be a conflict of interest but rather an innovative means to build relationships with top experts through the CME medium. “Still, other pharma companies, especially in light of the intense scrutiny on CME, view supporting this type of relationship as posing an increased risk for noncompliance,” Dr. Liston says. Mr. Buckwell says there has been a decrease in advisory boards, which used to be a mainstay of thought-leader development. “In today’s regulatory environment, advisory boards are rigorously scrutinized with respect to number and purpose,” he says. “We have responded to this new reality by developing a model that incorporates thought leaders at the regional and national level for content development. This serves a dual purpose of not only developing content that is more readily adopted by an audience because of its peer-to-peer nature, but also maintaining a portfolio of ongoing face-to-face contact that is crucial.” When the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) introduced compliance regulations for pharmaceutical manufacturers in 2003, one of the key elements of that program was the insistence that pharmaceutical marketing efforts be completely firewalled from accredited medical-education programs. The purpose of the separation is to promote fair, balanced continuing medical education that does not reflect the bias of any pharmaceutical sponsor. “CME educates healthcare providers about advances and standards of practice in the diagnosis and management of a disease state; promotional education focuses learning toward a given product or brand,” Dr. Liston explains. “In today’s environment, fair and balanced CME supported by pharma is a new reality because of firewalls between marketing and medical affairs.” According to Marsha Meyer, senior VP of clinical information at CME LLC, physicians and other clinicians require a lifelong learning approach to continuing medical education. “Opposed to a series of independent courses, they want education that caters to their particular knowledge levels and schedules,” she says. “Continuing medical education should always be about the same thing: identifying a gap between ideal and actual clinician knowledge levels about a disease state, securing funding, and providing education to close or narrow that gap.” But since the firewalls went up — and because thought-leader management programs generally straddle the marketing and clinical side — thought leaders may be viewed with skepticism by their colleagues, suggests Robert Nauman, principal of BioPharma Advisors Network. “The question that plagues pharma today is whether a thought leader will be seen as an advocate of that company’s product and, if so, lose credibility in the minds of his or her peers,” Mr. Nauman explains. “My fear is clinicians will have to make a choice whether to practice medicine or be a thought leader to avoid regulatory issues.” It’s important that pharmaceutical companies sales and marketing departments, as well as medical affairs, adhere to the firewall provisions and don’t overstep regulatory boundaries. “I’ve done a tremendous amount of work with physicians at the community level talking about medical education, and there’s an inherent skepticism of anything that comes from a company,” says Gary Schwebach, Ph.D., founding principal of G & S Research Inc. “Pharmaceutical companies have to figure out what topics practitioners need to know about and fund CME that addresses those topics.” In 2004, the accredited CME industry was valued at more than $2 billion, according to the Accreditation Council for Continuing Medical Education’s (ACCME) annual report for that year. More than half of the industry’s funding came from commercial supporters, primarily pharmaceutical firms. “Physicians want information from an unbiased source; the best source for this information, however, is often the company that developed the drug,” Dr. Schwebach says. “The challenge is to provide this company-based knowledge to the community in a way that is acceptable to regulators and community physicians.” Finding a Place for the MSL Another vehicle through which pharmaceutical companies seek to provide fair, balanced education to physicians and thought leaders is the medical science liaison (MSL) function. MSLs are most often individuals with scientific degrees — M.D.s, Ph.D.s, and Pharm.D.s — who serve as the educational interface between the pharmaceutical companies and the healthcare providers. Best Practices LLC recently conducted a study to uncover what best practices are being used by pharmaceutical companies to identify and recruit thought leaders. Field-based medical specialists, or medical science liaisons, can be a critical link between a pharmaceutical firm and its thought leaders. Best Practices’ analysts found that successful pharmaceutical companies employ key strategies to develop their field-based programs as a means for attracting and retaining the most desirable thought leaders. Best Practices research also found that leading companies have separate internal recruiting groups with independent budgets. These recruiting groups are encouraged to find ways of accommodating their target candidates. “Best Practices research indicates that 37% of medical science liaisons call on thought leaders at a frequency of one to two visits per month,” Mr. Easter explains. “Field-based liaison alignment also can support the commercial business, as many organizations align liaison territories with the sales organization to facilitate field communication.” MSL teams are organizationally connected to an overarching commercial organization through the company’s thought-leader management function. A current trend, however, has the formal MSL programs emerging from under the marketing umbrella to establish groups independent of marketing’s influence. A recent report by Medical Science Liaison Institute and Cutting Edge Research found that 60% of participating pharmaceutical companies structure their field-based MSL programs under medical affairs to further accentuate the function’s scientific emphasis. Companies do this to create an unbiased resource to help opinion leaders expand research within their specialty or therapeutic area. “MSLs form that critical education and communication link between the pharmaceutical industry and the healthcare providers,” says Robin L. Winter-Sperry, M.D., president and CEO of Scientific Advantage LLC. “They are the source, in most cases, for high-quality, fair, and balanced information about a company’s products and scientific endeavors.” Nevertheless, many in the CME world see little room for MSLs in accredited education programs. “MSLs do not have a role in CME,” adds Deborah Wood, president and CEO of Deborah Wood Associates and its subsidiary, CME Enterprise. “The only exception would be for the CME provider to request, in writing, MSLs to assist in the distribution of brochures or flyers announcing a program.” “In our experience, CME activities have been developed as part of a joint effort between an assembled board of subject matter experts, program managers, and faculty drawn from academia; this structure seems to provide the kind of checks and balances that would disadvantage a single, medical-science liaison,” says Charles Isaac, CEO of Skychaser Communications Inc. On the other hand, Dr. Winter-Sperry says medical science liaisons can be an invaluable resource for educational programming by providing third-party medical education providers with necessary information about a company and its products, as needed. “In a highly complex and rapidly evolving medical community as we have in this country — with all the great resources and all the wonderful things that the pharmaceutical industry is doing — one of the best ways to make sure that physicians really know what’s going on is through continuing education and resources such as medical liaisons,” Dr. Winter-Sperry says. “We all want to make sure that everybody’s as educated as possible and that it is done professionally, within compliance and ethical standards.” PharmaVOICE welcomes comments about this article. E-mail us at feedback@pharmavoice.com. By Autumn Konopka May 2006 PharmaVOICE When a thought leader truly speaks his own mind, a group of physicians often responds very well. Lawrence Sherman Physicians Academy for Clinical and Management Excellence MSLs form a critical education and communication link between the industry and the healthcare providers. Dr. Robin Winter-Sperry Scientific Advantage LLC Physicians want information from an unbiased source. The best source, however, is often the company that developed the drug. Dr. Gary Schwebach G & S Research Inc. Continuing medical education should always be about the same thing: identifying a gap between ideal and actual clinician knowledge levels on a disease state, securing funding, and providing education to close or narrow that gap. Marsha Meyer CME LLC Pharmaceutical companies are rethinking the selection criteria for who is an advocate and what defines an advocate. Mario Nacinovich Jr. Fission Communications Developing thought leaders as trusted advisors requires companies to let them say what they think. Jim Melton PMPN aMy fear is clinicians will have to make choices about practicing medicine in their community and being considered a thought leader working with industry. Robert Nauman BioPharma Advisors Network The CME provider should supply commercial supporters with solid information on the outcomes of the educational activity. Deborah Wood Deborah Wood Associates and CME Enterprise The underlying problem is a basic lack of understanding of the term ‘thought-leader development.’ It is not a tactic but an approach that realistically should link almost every aspect of the brand portfolio, from R&D to sales. Charlie Buckwell Complete Medical Group Experts on this topic Charlie Buckwell. CEO, Complete Medical Group, Cheshire, United Kingdom; Complete Medical Group is the medical education and medical communications specialist group within McCann Healthcare Worldwide. For more information, visit complete-grp.com. Jon Easter. Director, Pharmaceutical Research, Best Practices LLC, Chapel Hill, N.C.; Best Practices is a research, consulting, and publishing firm. For more information, visit best-in-class.com. Charles Isaac. CEO and Founder, Skychaser Communications Inc., New York; Skychaser is a global digital-solutions and consulting company that develops and markets Primedicine, a hosted continuing medical education product. For more information, visit skychaseronline.com. Heidi L. Liston, Pharm.D. Senior VP and General Manager, DiMedix LLC, Warren, N.J.; DiMedix is a full-service medical-education company. For more information, visit dimedix.com. Jim Melton. CEO, PMPN, Durham, N.C.; PMPN manages medical-education programs through a network of meeting managers. For more information, visit pmpn.com. Marsha Meyer. Senior VP of Clinical Information, CME LLC, Irvine, Calif.; CME provides high-quality lifelong learning opportunities for clinicians. For more information, visit cmellc.com. Mario R. Nacinovich Jr. Senior VP, Fission Communications, New York; Fission is a full-service, global medical-education company. For more information, visit fissioncommunications.com. Robert Nauman. Principal, BioPharma Advisors Network, Cary, N.C.; BioPharma Advisors Network is a community of consultants who collaborate on ideas to maximize the impact of their advice on clients’ businesses. For more information, visit biopharmaadvisors.net. Gary Schwebach, Ph.D. Founding Principal, G & S Research Inc., Carmel, Ind.; G & S Research provides primary market-research services to pharmaceutical, biotech, medical device, and diagnostics firms worldwide. For more information, visit gs-research.com. Lawrence Sherman. CEO, The Physicians Academy for Clinical and Management Excellence, New York; The Physicians Academy partners with leading academic institutions to offer a comprehensive portfolio of educational programs for physicians. For more information, visit physiciansacademy.com. Robin L. Winter-Sperry, M.D. President and CEO, Scientific Advantage LLC, Bernardsville, N.J.; Scientific Advantage is an integrated company that specializes in the development of medical science liaison (MSL) divisions. For more information, visit scientificadvantage.com. Deborah Wood. President and CEO, Deborah Wood Associates and CME Enterprise Inc., Carmel, Ind.; CME Enterprise, the continuing medical-education subsidiary of Deborah Wood Associates, develops extensive needs assessments, executes needs-based curricula, and impacts practitioner knowledge and patient outcomes. For more information, visit cmeenterprise.com.

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