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Do's and Don't's for Disease Awareness Programs

By Trina Stonner, RN, MSN, and Kathleen Cox, MA

Disease awareness campaigns have long been fundamental to pharmaceutical and biotechnology marketing and medical teams’ respective communication plans. As providers of disease treatments, pharmaceutical and biotechnology companies have a vested interest in accurate diagnosis, and disease awareness programming is one tool to ensure that the right patients are prescribed the right treatments at the right times. Disease awareness campaigns are particularly important for diseases in which symptoms are nonspecific, incidence is infrequent, or treatments are not curative. For these diseases, physicians and midlevel practitioners are less likely to be familiar with clinical developments or advances in the understanding of diagnostic factors and disease progression.

For example, atrial fibrillation (AF) is a common condition whose approved pharmaceutical treatment, though problematic, had not changed in more than 50 years. So, when a novel treatment that is less problematic than the current standard received FDA approval in October 2010, clinicians needed a fresh look at the condition, including findings from recent clinical trials. In addition, individuals who might benefit from treatment needed to be made aware of the symptoms that should prompt them to see their physicians. As a result, a disease awareness campaign was initiated using Web sites such as www.facingafib.com and www.stopafib.org, along with other tactics. In addition, disease state presentations were prepared for meetings of the American Heart Association, the American Academy of Family Physicians, the Heart Rhythm Society, and the American College of Cardiology, among others.

How Disease State Communications Work

Both doctors and patients place a higher value on disease state communications than those that are product specific, considering them more educational and possibly more credible. Using appropriate disease state programming throughout a product’s life cycle, pharmaceutical companies and their brand teams can: increase the number of patients correctly diagnosed with a disease; alert clinicians to factors that affect long-term disease management; motivate patients to seek treatment; enhance corporate brand equity; and improve patient outcomes. Disease awareness campaigns help establish a company’s scientific credibility while also fulfilling its ethical commitment to advance health care.

Disease state campaigns run the gamut of communication techniques. Documentaries have recently taken center stage. The first disease awareness documentary aimed at patients and shown in theaters[1] was produced in 2007, setting the stage for a number of others, including an award-winning diabetes video. Other tactics can include advertorials (ads designed to resemble editorial content), journal ads, printed handouts, Web sites, and presentations to clinicians at dinner series or association meetings. As long as the focus is on the disease and how it affects the patient diagnosed with it, the scope of a given communication tactic is only limited by the marketer’s imagination.

Because this kind of communication is "neither labeling nor advertising, it is not subject to the requirements for the disclosure of risk information and other requirements" under the Food, Drug, and Cosmetic Act.[2] Nevertheless, it can and frequently does come under FDA scrutiny. The FDA addresses disease awareness programs in its 2004 Draft Guidance for Industry: "Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms. Expected to be finalized in 2011, the guidance is intended to help drug companies and their marketing firms distinguish "between communications that are under FDA jurisdiction and those that are not." The guidance characterizes disease awareness communications as "any communications by or on behalf of a manufacturer, distributor, or retailer of a drug or device that:

  • discuss a disease or health condition;
  • if consumer-directed, advise the audience to 'see your doctor' for possible diagnosis and/or treatment;
  • if aimed at health care practitioners, encourage awareness of signs of the particular disease or health condition, or otherwise provide information to assist in the diagnosis of the particular disease or health condition;
  • do not mention a particular drug or device; and
  • do not include any representation or suggestion relating to a particular drug or device."[2]

If a disease awareness communication is combined with reminder advertising or labeling, or if such communication "is determined to, by implication, identify a particular drug or device," the FDA will consider that communication as labeling or advertising and, as such, subject to its regulation. And that’s the seam through which the FDA is opening current enforcement actions.

The confluence of disease awareness campaigns, disease-specific Web sites, patient-initiated blogs, and various social media communications has created a perfect storm for pharmaceutical marketers as they await the final guidance on disease awareness communications and the promised guidance on the emerging online and social media platforms that companies would like to include in their communications mix. In 2010, the FDA sent warning letters to one pharmaceutical company about two disease awareness Web sites. These Web sites were addressed to patients and named no drugs, but were considered by the FDA to be promotional by implication.[3,4] As a result, the Consumer Advertising Law Blog advises companies to "be careful about how connected they are to disease awareness and other informational sites. Too many connections--even despite pop-up disclaimers and the like--may cause FDA to consider the websites promotional materials ... in violation of the Federal Food, Drug, and Cosmetic Act."[4] Thus, many pharmaceutical companies submit their disease state communications to their legal and regulatory departments to ensure that no promotional line is being crossed.

How to Leverage Your Medical Team and Educational Principles

Avant Healthcare Marketing, in partnership with sponsoring company consultants, conducts a number of disease awareness programs for pharmaceutical companies each year. To avoid any promotional pitfalls, Avant’s best practices include reliance on a strong partnership with medical science and education experts from its parent company, DWA Healthcare Communications Group (DWA). Consultants from DWA’s Medical Science and Education Division (MSED) help blend the ADDIE model (Analyze, Design, Develop, Implement, and Evaluate) of educational design with the medical framework and scientific rigor required for effective disease awareness. Slide decks and other materials for disease state programs reflect adult learning principles and address identified disease awareness needs, as well as those of the targeted learner group. The process begins with a needs assessment to identify significant gaps in clinicians’ awareness of the disease state, its pathophysiology, its presentation and comorbidities, its likely progression, and treatment goals--all derived from the patient’s experience of the disease. MSED’s Chief Education Officer, Bruce Bellande, PhD, provides guidance and training in the use of the model, while the Chief Medical Officer, Murali Gopal, MD, ensures clinical relevance and professionally accepted content standards.

Based on this extensive experience and expertise, Avant developed several best practices for conducting disease awareness presentations. Do:

  • Think like an educator
  • Identify gaps in clinician knowledge about the disease state, its diagnosis, and its treatment
  • Develop learning objectives and stick to them
  • Present diagnostic and therapeutic goals to improve patients' quality of life
  • Identify potential benefits and risks of treatment vs nontreatment
  • Note relevant clinical practice guidelines
  • Include both positive and negative experiences or outcomes when using a case study or patient story
  • Make the presentation fair and balanced

In addition, there are a number of pitfalls to avoid when conducting a disease awareness presentation. Don’t:

  • Identify potential or actual drug therapies by brand or generic name
  • Identify molecular targets of clinical trials
  • Promote any one type of treatment
  • Highlight any unique mechanism of action that may identify a specific drug or be a target of current drug trials
  • Compare or contrast advantages or disadvantages of therapeutic options
  • Selectively use information that is biased in favor of or against specific treatment options
  • Venture into areas that could imply the use of treatments that have not been approved
  • Use brand colors, branding elements, or brand language
  • Attempt to track individual prescribing practices or anything other than aggregate educational outcomes

In short, base your disease state programming on the best medical evidence, address identified clinician needs, and use proven principles of adult learning and instructional design. That way, you are sure to meet your presentation’s learning objectives without exposing it to FDA scrutiny.

References


©2011 Avant Healthcare Marketing, Inc.