First-in-human gene therapy clinical trials in the media: Exploring patient narratives

1. Introduction

Biotechnological advancements in gene therapy have attracted considerable media attention in feature articles, videos, and radio and podcast episodes. Media coverage plays a pivotal role in disseminating the progress of clinical trials and developing public understanding of scientific advances (Stapleton and Torres Yabar, 2023). Through the content and framing of the reporting, the media influences the public understanding of scientific advancements and the biotechnology enterprise (Nisbet and Lewenstein, 2002). Some of the media reporting on gene therapy has also included the direct accounts of people living with various illnesses who have participated in publicly and privately sponsored gene therapy clinical trials (Urnov, 2022). Today’s media attention to gene therapy is unique as the technological landscape of gene therapy and patient perspectives have significantly changed. Gene therapy clinical research has matured to include multiple novel gene-based methods like gene addition with viral and non-viral vectors and gene editing with novel technologies like CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) and RNA therapy. These developments at the bench have led to an increasing amount of first-in-human gene therapy clinical trials at the bedside. These trials have generated scientific and public interest because of the promise that these therapies will allow individuals affected by genetic conditions to be included in genetic clinical research and see greater success in treatment efficacy (Conroy, 2022; Mani, 2021). As more individuals engage with gene therapies, patient narratives have become central in media reporting about these scientific developments rather than just expert voices.

Directly engaging the narratives of individuals living with genetic conditions is necessary because they can provide direct accounts of perceptions and lived experiences of engaging with these therapies; however, the use of direct patient voices in media reporting is rarely systematically studied. The inclusion of patient narratives in media coverage gives individuals who will be most affected by these emerging therapies a space to voice their perceptions of these technologies and experiences of participating in these clinical trials. In sharing narratives, patients may receive therapeutic benefits from sharing their experience of illness with listeners (often physicians) who have a special role in honoring patients by listening (Frank, 1998). Furthermore, while narratives included in media reports may empower patients, these narratives also play a role in increasing patient and public understanding and shaping policy (Stapleton and Torres Yabar, 2023). Furthermore, media articles serve as a form of health communication. Research has shown that people living with various genetic conditions learn about these clinical trials from the media, online, from patient advocacy groups, or through their physicians and may be influenced to enroll based on the information they access (Sinha et al., 2021). As such, interrogating the content is a helpful avenue to understand what individuals may learn about these emerging genetic therapies. Furthermore, other content analysis research has shown gene therapy reporting can impact informed consent discussions for clinical trials (Benjaminy and Bubela, 2014).

Media reporting that highlights the accounts of patients serve not only as testimony but also as a vehicle for informing, persuading, and influencing public and institutional perspectives. While media articles are often written independently of contributions from these institutions developing gene-based therapies, positive representations of emerging genetic technologies can garner community and public support that could positively influence the perception of genetic therapies. For example, previous content analyses have found that media reporting on biotechnological advances has been overwhelmingly positive (Caulfield, 2004; Kamenova and Caulfield, 2015; Nisbet and Lewenstein, 2002; Petersen, 2001; Racine et al., 2006). In addition, research on press coverage of biotechnologies has highlighted the connections between media, science, and industry and how all three industries are incentivized to positively promote scientific stories in the press (Caulfield, 2004; Nisbet and Lewenstein, 2002).

While past scholarship has focused on the role of institutional or journalistic distortion that produces hype, little research has focused on how patient expressions can contribute to optimistic narratives of gene therapy and how media amplifies these narratives. In previous research into the ethics of patient storytelling in clinical settings, less attention has been paid to how such narratives appear and function in media reporting—particularly in ways that may promote hope, downplay risk, or re-inforce expectations of cure (Frank, 2019). While Frank’s work focuses on clinical communication, his emphasis on narrative ownership and the ethical importance of honoring patient stories raises broader questions about how these stories are told and received in public media contexts. The foregrounding of patient narratives carries powerful messages of hope, transformation, and possibility, and these narratives may contribute to public expectations about gene therapy that could overhype the realities of these technologies. Investigating patient stories could amplify whether patient stories become vehicles for hype because their hope is selectively amplified. Research has shown that media sensationalism influences public opinion by establishing unrealistic and largely positive expectations of the scope, scale, or timeline of scientific discovery, otherwise known as scientific hype-making (Master and Resnik, 2013). Given the well-established history documenting the cultural obsession of DNA and genes, media reporting on gene therapy may play a role in scientific hype-making about gene therapy (Nelkin and Lindee, 2010). Furthermore, the use of patient narratives may further this hype-making as research has found that narrative-formatted stories produce more public compassion for vulnerable individuals experiencing health-related dilemmas than non-narrative formats (Oliver et al., 2012). While generating enthusiasm or interest in biotechnology may be a reasonable goal of scientific communication, centering questions of hope and hype is crucial as the presence of hype may undermine other goals of communication, such as facilitating trust between scientists and the public (Intemann, 2022).

While hope and hype may limit patient and public understanding, media reports may also circumvent hype by telling the lived experiences of patients with these conditions. For example, research exploring reporting on genetic therapies such as CRISPR (Shivram et al., 2021) has found that coverage in online news media articles and television segments is focused more on controversy or ethical debates rather than technical information about the technology (Stapleton and Torres Yabar, 2023). Furthermore, research into patient perceptions of gene-based therapies suggests that experiences are not unilaterally positive, with community members expressing worries about the process, short and long-term effects, and larger unknowns about the technologies (Persaud et al., 2019).

While media reports have significant direct and indirect impacts on empowering patients, sharing updates on the advancements of clinical trials, and public understandability, to date, significant research attention has not been given to a critical understanding of the themes emerging from media coverage that includes the accounts of people with various illnesses receiving gene therapies. This article contributes to emerging conversations about how media stories, by highlighting patient experiences, may reinforce themes of transformation, redemption, or cure. At the same time, these narratives may also complicate hype by foregrounding emotional ambiguity, precarity, and the real-world costs of participation. To explore this dynamic, we conducted a critical content analysis that explores themes found in US media articles of first-in-human gene therapy and gene editing clinical trials published between 2017 and 2022.

2. Methods

We performed a critical content analysis (Carvalho, 2008; Macnamara, 2005; Short, 2016; Webster et al., 2020) of feature articles published in US news media sources from January 2017 to April 2022 that follow patients involved in one of the first-in-human clinical trials of genetic therapies. Critical content analysis foregrounds social and cultural contexts during content analysis to recognize the presence of power dynamics and potential biases. As people living with chronic genetic conditions already represent a vulnerable population because of the unique clinical and social complications that they face, utilizing a critical analysis acknowledges this vulnerability and puts our findings in a framework that recognizes this relevant social and historical context.

Preliminary searching for “gene editing” and “gene therapy” was conducted using the Google search engine and prominent US-based news media websites (such as the Associated Press, National Public Radio (NPR), and the New York Times) to develop an initial list of genetic conditions under investigation for potential gene therapy. Conditions were derived from our preliminary searches and included in our search terms to capture as many articles as possible. These search terms are listed in the box at the bottom of Figure 1. To obtain our article set, we conducted two comprehensive searches, one using the LexisNexis electronic database which searches major US newspapers and news transcripts, and an external search conducted in US-based news media websites not included in LexisNexis (see Figure 1). We define feature articles as web-based articles, video transcripts, radio transcripts, podcast transcripts, and episode summaries published on US news media sources. Our search, which covered a period of up to 5 years, began in 2017 to mark a wave of new approaches in the field of gene therapy with the first US Food and Drug Administration (FDA) approvals of gene therapies for the market (Marchione, 2017). Multiple searches through various formats of reporting, including major US newspapers, news transcripts, and blogs/magazines, were completed to retrieve eligible articles for our analysis. Stock stories and obituaries were excluded, and all search parameters were held constant.

OPEN IN VIEWER

Figure 1.

Article search and selection flow diagram.

Initial LexisNexis search results retrieved 345 articles for major US newspapers and 531 results for news transcripts (see Figure 1). In addition to these searches, search terms including “gene editing” and “gene therapy” were used to search for articles on news websites that were not included in the LexisNexis database. Notably, a series of articles from the NPR organization were collected with this approach.

After obtaining our search results, we further sorted articles based on our inclusion and exclusion criteria. Articles were included if they explicitly followed the story of one individual and their experience in a first-in-human gene therapy or gene editing clinical trial. We defined “following an individual’s experience” as including extensive commentary (at least four sentences) from one or two patients about their experience before/during/after receiving gene editing. We excluded articles from non-US media sources. We also excluded chimeric antigen receptor (CAR)-T-cell therapies and other cancer applications to focus solely on the application of gene therapy to genetic conditions. Furthermore, we excluded articles that only included stand-alone quotes from patients involved in a clinical trial, without a significant portion of the article dedicated to their story, or articles that did not specifically feature the story of an individual and their experience in a first-in-human gene editing clinical trial. Our final data set included 43 eligible articles.

Articles that met our eligibility criteria were coded for major themes and participant demographic data. Our thematic analysis began with pilot coding of five articles inductively for themes emerging from the text through a conventional approach. As defined by Hsieh and Shannon (2005), when using a conventional approach “[r]esearchers avoid using preconceived categories . . . instead allowing the categories and names for categories to flow from the data” (p. 1279). Once the themes were identified and translated into the codebook, coding proceeded deductively using these themes. In addition to coding for themes and sub-themes across the article text, we also coded for speaker voice, specifically focused on the direct quotations of patients and their families involved in gene therapy clinical trials and the direct quotations of scientific figures (basic scientists, clinical scientists, physicians, bioethicists, etc.). We subsequently analyzed whether the frequency or content of themes differed based on speaker voice. The justification for this comes from Arthur Frank’s (1998) work exploring the structure and meaning of illness narratives, and specifically his contention that the ill person’s voice is often challenged by that of the physician or their proxy.

Two coders (RW and HR) independently coded all articles using NVivo 12 Pro software. Upon the conclusion of coding, NVivo libraries were merged and coding comparisons were run to ensure consistency between coders (measured by less than 10% disagreement). Across all codes analyzed below, average inter-coder percent disagreement was 3.4%.

To aid in the presentation of our results, all articles were assigned an identification number. In addition, we removed information that identifies trial participants, scientists, company representatives, reporters, and so on, which were included in the original quotations presented below. This de-identification was done in order to focus on the themes and not the specifics of each case.

3. Results

Thematic differences by voice

In addition to thematic content, two speaker voices—optimism and caution—emerged differently across our article set depending on who was speaking. Frames captured quotations directly from either trial participants or scientific figures involved in or adjacent to the trials. Across all articles, we saw that scientific figures were directly quoted more often under theme 3 (Risks of Gene Therapy) while patients and their proxy figures were directly quoted under themes 1 (Impacts of Living with the Genetic Condition) and 2 (Consequences of Receiving Gene Therapy Treatment). A breakdown of these numbers is provided in Table 1.

OPEN IN VIEWER

Table 1.

Voices represented by theme.

	Patient Voices	Scientific Voices	Total
Theme One	106 references	23 references	129 references
Theme Two	158 references	68 references	229 references
Theme Three	47 references	103 references	150 references

A dominant theme among trial participants was hope in face of the uncertain trial results (theme two), both for finally having options after so many years of nothing, as well as for potential that their participation in these early trials might help others in the future.

“Not just for me but for other people. This would be mind-blowing,” [Participant] says. “I can’t imagine the lives that could be saved if this thing actually works. Yeah, oh my God. Just to not have to deal with that pain anymore is enough.” (Article 26)

“It’s kind of humbling to be the first to test this,” said [Participant], who has a metabolic disease called Hunter syndrome. “I’m willing to take that risk. Hopefully it will help me and other people.” (Article 7)

In contrast, the voices of the scientific figures included across most articles and genetic conditions were more ambivalent and cautious in their optimism. Scientific figures often demonstrated restraint in the celebration and management of their expectations while considering the promising results of the trials.

[Scientist] and other researchers caution, however, that the results involve just one patient who was only recently treated. It is far too soon to answer the most crucial questions: Will the modified-cell treatment continue to improve the patient’s health? Will the treatment keep working? Will it help her live longer? Is it safe in the long term? ‘We are hoping it is’ a success, [Scientist] says. But ‘it is still too early to celebrate.’ (Article 32)

[Scientist]: Make no mistake, we’re talking about very cutting-edge research where the certainty about all the outcomes is not entirely there. We can look back at the history of gene therapy and see there have been some tragedies. (Article 33)

Despite this overall tone of restraint, some scientific figures were more boldly optimistic. One scientist featured in two Hunter Syndrome articles was quoted saying, “[G]ene editing’s promise is too great to ignore. ‘So far there’s been no evidence that this is going to be dangerous . . . Now is not the time to get scared’” (Articles 3, 7). Another figure in a SCID article proclaimed “‘Gene therapy has been shown to work, the efficacy has been shown. And it’s safe . . . The confidence has come. Now we have to follow it up’” (Article 16).

Four articles published by The New York Times centered on a participant who at 16 was the youngest to be included in the breakthrough sickle cell gene therapy trials. Unlike many other trial participants, she did not express optimism and excitement about her participation in early trials. Directly juxtaposed to the reporter’s remark that “She’s kind of a pioneer,” she expressed ambivalence in being among the first to receive this therapy:

I was scared. I didn’t want to do it because I didn’t want to be, like, the first person to go through it. But then, I kind of got over it. I was like, I’m going to be better. I’m going to have a better life. (Article 34)

While we observed throughout our article set that hope and optimism were typically expressed by trial participants, in this article they were primarily expressed through her family’s voice.

4. Discussion

Media articles about gene therapy trials are including patient stories. However, little research has systematically examined the themes that emerge in media reporting about gene therapy trials. Understanding how patient narratives are presented may impact both how people living with rare genetic diseases understand the potential of gene therapy technologies and, more broadly, our understanding of how everyday communication like media reporting may contribute to conceptions of health, illness, and gene-based technologies. In this content analysis, we examined language use and identified thematic content. We found that content was focused around three themes: (1) Impacts of Living with the Genetic Condition, (2) Consequences of Receiving Gene Therapy Treatment, and (3) Risks of Gene Therapy. We also identified that thematic differences in optimism and caution varied by whether the person living with illness or a clinician/researcher was speaking, respectively. We frame the discussion of these results through scientific hype, patient hope, and media reporting.

One major thematic finding in theme two (Consequences of Receiving Gene Therapy Treatment), is the inconsistent use of curative and experimental language throughout media reporting and how it serves as a potential source of public confusion about gene therapy. Metaphors used in reporting and public discourse around new technologies influence how the public frames the benefits and risks of these technologies and understands them to work (O’Keefe et al., 2015). The use of curative language in the reporting may imply more definitive results than the science of early-phase clinical trials can or is intended to provide, contributing to therapeutic or curative misconception (Baffoe-Bonnie et al., 2023; O’Keefe et al., 2015; Rennie et al., 2015). While early patient success stories have dominated news media reporting, the long-term effects of these therapies will not be fully known for many years. The suspension of a gene therapy trial in early 2021 due to the development of secondary malignancies in several unidentified participants served as a jarring reminder of the uncertainty of these novel trials (Kolta, 2021; Larkin, 2023; NHLBI, 2021; uniQure, 2021). Misrepresentation or hyperbole can be harmful for individuals living with genetic conditions that are included in first-in-human gene therapy trials, as many of these conditions are rare and have limited or non-existent available treatments. Pushing patients and families to take any kind of action, even at the expense of their physical, mental, and psychosocial wellbeing, is part of what bioethicist Gail Geller (2019) calls a “tyranny of hope,” a promise that scientific breakthrough will become a “cure or effective therapeutic intervention” (p. 3). Thus, including curative language may prematurely promise the long-term efficacy of gene therapy and create premature enthusiasm that contributes to scientific hype.

When examining which factors in a story shape public understanding of new biotechnologies, previous analysis of popular US media highlights the need to devote attention to what is present in reporting and what is left out (Banner, 2017; O’Keefe et al., 2015). While the cost of gene therapy post-clinical trials will be a major access barrier, many articles in our analysis did not mention the projected costs of these treatments or the challenges of equitable integration of these therapies into clinical care should they be approved. Furthermore, the results reported under theme one (Impacts of Living with the Genetic Condition) and theme three (Risks of Gene Therapy—Ethical Considerations) often emphasized the historical lack of treatment options available for many genetic diseases, suggesting that accessibility and equity in treatment would be an important component of future therapeutic options. As regulatory approvals accelerate, research, at times conducted by those who work with gene therapy companies, has begun to justify the unprecedented cost of treatment estimates with comparisons to the lifetime costs of living with genetic conditions (DeMartino et al., 2021; Johnson et al., 2023). The omission of these details serves to further the construction of scientific hype and the staging of science for the public as an answer to clinical and social inequities (Van Dooren and Noordegraaf, 2020).

The omission of the nuance of gene therapy in furthering sociotechnical imaginaries—collectively held visions of desirable futures shaped by science and technology—is seen in the case of SCD in our data set (Jasanoff and Kim, 2013). While the first wave of media reporting on gene therapy technologies focused on patient experiences and risks (for example, the case involving a fatal outcome following gene therapy) (Arnold, 2021; Check, 2002; Couzin and Kaiser, 2005; Ledford, 2022; Wang and Doudna, 2023), our analysis of included articles highlights how the current wave of reporting has centered on SCD. SCD, though found in people of all descent, predominantly impacts people of African descent in the United States (Kato et al., 2018). Research shows that SCD has been historically neglected and racialized by scientific and medical research communities (Smith et al., 2022); however, its genetic mechanism positioned the disease as a central target of new gene therapies. Our work underscored how the newfound attention directed toward gene therapy for SCD has been met with celebration and suggestions that gene therapy can undo clinical and social harms. However, several other scholars question whether gene editing and other cutting-edge approaches will be available and accessible to most people living with the condition (Cornetta et al., 2022; Creary, 2021).

We found, across conditions, that individuals expressed hope in the transformative potential of gene therapy. When media articles serve as primary sites of public engagement with these therapies, the amplification of hopeful patient narratives—particularly without discussion of cost, limited trial access, or long-term uncertainty—may contribute to a subtler form of scientific hype. We call this narrative hype: the accumulation and repetition of emotionally compelling patient-centered storytelling that aligns with promissory discourse, shaping public expectations even in the absence of overt exaggeration. At the center of these stories are what we describe as embodied promises—narratives rooted in the felt experience of living with a genetic condition and the hope for transformation. Drawing from Menary’s concept of embodied narratives, we understand these expressions not as abstract scripts but as meaning-making grounded in pain, precarity, and the possibility of cure (Menary, 2008). When media amplify these embodied promises without context, they may be enrolled into broader sociotechnical imaginaries of biomedical progress. Our contribution builds on scholarship in science and technology studies on expectations in biotechnology (Brown and Michael, 2003), promissory narratives (Lupton, 2017), and the persuasive power of personal storytelling in health communication (Oliver et al., 2012), offering narrative hype and embodied promises as conceptual tools to analyze how hope circulates in contemporary reporting on gene therapy.

Cautionary scientific voices were found alongside optimistic patient voices. While our data show that hype is not unchallenged, these cautionary voices are outweighed or overshadowed by frequent, emotionally compelling patient expressions of hope. This justification reflects what scholar Arthur Frank (1998) calls the “restitution narrative,” which is a narrative form exemplified by the search for a cure and return to a state of health (p. 201). While Frank’s work focuses on physician-patient communication, its relevance extends to media representations that favor hopeful transformation over complexity and uncertainty. Our findings suggest that media reporting, even when not overtly hyperbolic, may participate in the production of narrative forms that lean toward resolution and redemptive transformation. This may contribute to an ecosystem of expectations around gene therapy that exceed the evidence base, leading to public mistrust in science. Recognizing this dynamic is essential for developing more responsible scientific communication, especially in reporting early-stage clinical trials that may subsequently suffer setbacks. This shift in reporting aims not to dampen patient voices but to situate them within the larger realities of therapeutic development, access, and uncertainty—and, in doing so, support more ethically attuned and trust-sustaining forms of scientific communication.

5. Conclusion

Our content analysis of patient narratives in media reporting following first-in-human clinical trials found that reporting discussed the impacts of living with a genetic condition, the consequences of gene therapy, and the risks of gene therapy. We also found that while both patients and scientists expressed optimism, media reporting more frequently amplified patient hope, overshadowing the more cautious tones expressed by scientific voices. Since other patients in the research economy value experiential knowledge, patient narratives may influence decision-making and support for gene therapy (Sinha et al., 2021). Beyond the patient community, this experiential knowledge is valued by investors and researchers in the economy as well, evidenced by the fact that patients involved in gene therapy trials are also called in to speak at medical conferences and governmental regulatory meetings seeking to approve or reject the therapies. Furthermore, patient narratives influence public perception of the potential impact of these technologies that may shape policy related to approval, pricing, and access. Ultimately, our findings suggest that greater attention is needed to how media reporting on genetic technologies uses patient narratives and the narrative forms it promotes. Without careful attention, patient narratives can be transformed from sites of personal empowerment to drivers of scientific hype that further an imagination of gene therapy that is not always realized.

Supplemental Material