Almost two decades after the human genome was sequenced, a trickle of new genetic medicines (i.e., those that modify the expression of an individual’s genes or repair abnormal genes) has entered clinical practice, including 11 RNA therapeutics, 2 in vivo gene therapies, and 2 gene-modified cell therapies. With over 100 late-stage gene therapy trials underway and an increasing number of gene-editing technologies entering trials, it’s clear that this trickle will soon become a torrent. To fully realize the potential of these transformative technologies, there needs to be a deep understanding of the communication needs – both educational and promotional – that healthcare systems will face with their introduction. A herculean effort will be required from pharmaceutical marketers of all stripes, but particularly those in the promotional medical education (promo med-ed) space, to address the many challenges. Here are 5 considerations when developing a communications strategy for a novel genetic medicine.
#1. Genetic literacy among clinicians may not be as high as you think
Much hand-wringing always accompanies discussion of the low rates of STEM participation and poor scientific literacy in society at large, and of course, nowhere is this more evident than when it comes to comprehension of genetics. It’s important to recognize, however, that genetic literacy can also be suboptimal among healthcare professionals. 52% of clinicians were either not aware or unsure that somatic gene modifications are not passed to offspring, according to a National Organization for Rare Disorders (NORD) survey from earlier in the year. (1) This poll, which included a diverse mix of both general and specialty practitioners, also revealed that fewer than one-quarter (24%) of the respondents would feel “comfortable” or “extremely comfortable” if required to explain the difference between somatic mutations and germline mutations. Clearly, confusion about fundamental genetic concepts underlies many misconceptions about genetic medicines and will hamper physicians’ ability to understand new treatment options and counsel their patients adequately. Promo med-ed will have a major role to play in delivering educational content that addresses these gaps, clarifies misconceptions, and equips providers with the knowledge they need to understand the new classes of medicine.
#2. Early development of a simple narrative is important to provide a shared understanding of and early scientific differentiation for a novel genetic therapy
The scientific narrative for a novel genetic medicine should consist of a brief explanation of the therapeutic modality and how the treatment works in the context of the mechanism of disease. It should translate complex scientific concepts into an easy-to-understand, clinically applicable story that provides differentiation from other therapeutic approaches. While this narrative will undoubtedly evolve throughout the clinical development process, the first draft should be developed as early as the IND-enabling stage. This will create an early shared understanding that will provide a framework for consistent communications throughout clinical development and post launch. Creating a simple narrative is, of course, not simple. The first obstacle is the lack of a genetic medicine lingua franca and the inconsistent taxonomy for the various therapeutic modalities (e.g., conflation of traditional gene therapy and gene editing; the use of “CRISPR” as a synonym, rather than a synecdoche, for gene editing; and confusion between in vivo and ex vivo applications of these technologies). The increasingly crowded landscape also presents a challenge, making it difficult to stake your territory amongst the diverse and growing array of technologies, delivery mechanisms, and proprietary platforms.
Here are a few recommendations for creating an effective scientific narrative for a novel genetic medicine:
• Engage a multidisciplinary team. This should include cross-functional input (marketing, medical affairs, R&D, external relations, payer relations) on the client side and external feedback from KOLs, educators, professional and advocacy organizations.
• Relentless prioritization is needed to create a simple narrative. Identify the elements that are most important and stripping out the superfluous and tangential ones.
• Oversimplification can do more damage than good. Simplified, but poorly thought-out descriptors can obscure the benefits of a treatment approach. For example, “gene silencing” is a less-than-ideal description for the mechanism of RNA interference (RNAi) therapeutics. Although this approach “silences” the output of genes (by disrupting messenger RNA [mRNA]), the lack of specificity suggests the possibility of direct action on genes in the nucleus. This relinquishes many of the perceived benefits of RNAi therapies that distinguish them from gene therapy (e.g., greater safety, transient and reversible effect on gene expression).
• Well-chosen metaphors are essential. These powerful linguistic tools can promote understanding, increase retention of information and make abstract concepts more tangible.
• Pressure-test the scientific narrative with linguists and bioethicists. These experts are not typically involved in this process but their inclusion is appropriate considering the challenge of communicating on what are essentially promissory technologies with many uncertainties. They will be able to assess whether the language used is optimal, free of unwitting bias, and effective. Indeed, a lively discourse among bioethicists on the language used to communicate CRISPR has already been underway for several years.
#3. Prescribers of genetic medicines will need to develop many skills outside of their specialty area, and this will require extensive education
Consider a hematologist who manages patients with hemophilia after the first liver-directed adeno-associated virus (AAV)-based gene therapy becomes available. In addition to achieving greater fluency in the concepts of genetic medicine, this provider will need to understand, be able to apply in clinical practice, and be able to counsel patients on several concepts that are more familiar to immunologists and hepatologists, such as monitoring for immune responses to AAV (via surrogate markers including factor expression and liver transaminases), understanding when to initiate immunosuppression, and long-term evaluation of liver health.
#4. To effectively counsel patients, prescribers of genetic medicines will need to become skilled communicators
Nowadays, physicians are required to counsel patients about their health care in a spirit of shared decision-making that informs and empowers them in their treatment decisions. Unfortunately, studies have reported that – despite their apparent best efforts – many physicians fail to communicate clearly with patients, often overwhelming them with unnecessary information. (2) Clinicians will increasingly need both a confident understanding of and a clear lexicon with which to communicate about numerous genetic medicine approaches. They will be required to explain the therapeutic modality, mechanism of action, and potential benefits and risks with a clarity and simplicity that ensures meaningful informed consent. (3) Preconceptions about the extent and duration of treatment benefit from gene therapies (whether they will be “curative” or merely provide a long-term benefit) will need to be managed. Immunological counseling will also be involved, with the need to explain potential non-eligibility for treatment (due to pre-existing immunity to viral vectors) and the reasons for long-term immune surveillance.
Even physicians who understand the new genetic medicine approaches may struggle to communicate the relevant information clearly to their patients. A possible reason for this is the “curse of knowledge” – a cognitive bias in which experts find it difficult to communicate information clearly because they project their own knowledge of a topic onto others. This makes it challenging for them to reconstruct their prior state of mind in which they did not understand the topic.
#5. Strong storytelling, ambitious omnichannel medical education programs, and a suite of HCP resources to facilitate counseling of patients is needed
An effective communications strategy for a novel genetic medicine will need to be a multi-pronged approach. I suggest it should include the following:
• Strong storytelling for effective education of clinicians. Equipping providers with ready-made stories that they can use for counseling their patients is also, I believe, the answer to the curse of knowledge.
• Resources to facilitate conversations with patients. These should focus on translating science into a simple clinical conversation and should adhere to the World Health Organization’s principles for effective communications.
• Scientific visualization and animation. These are critical, both for educational reasons (they can be effective in bringing abstract or complex concepts to life) and promotional purposes (to create a distinct brand identity in the crowded landscape).
• Creation of “snackable content.” These smaller parcels of more easily digestible information can help to surface key themes and messages, prevent the audience from feeling overwhelmed, and are also an important component of outreach via social media channels. This approach will be particularly important for educating on genetic medicines.
• Co-creation of materials with clinicians and educators. This will enhance the credibility, authenticity, and effectiveness of medical education programs.
1. Gene Therapy Survey Highlights: Knowledge Gaps And Educational Opportunities. Supplement to Neurology Reviews. March 2020.
2. Ubel PA, Scherr KA, Fagerlin A. Empowerment Failure: How Shortcomings in Physician Communication Unwittingly Undermine Patient Autonomy. Am J Bioeth. 2017;17(11):31-39.
3. Desine S, et al. AJOB Empir Bioeth. 2020;11(4):195-207.