Ocular gene transfer in the spotlight: implications of newspaper content for clinical communications

BMC Medical Ethics

Tania Bubela¹  Shelly Benjaminy¹ 

[1] Department of Public Health Sciences, School of Public Health, Edmonton Clinic Health Academy, University of Alberta, 11405 87 Ave NW, Edmonton, Alberta, Canada

关键词: Informed consent;    Ethics;    Therapeutic misconception;    Newspaper coverage;    Media;    Gene therapy;    Gene transfer;   

Others  :  863088
DOI  :  10.1186/1472-6939-15-58

 received in 2013-05-22, accepted in 2014-07-10,  发布年份 2014

【 摘 要 】

Background

Ocular gene transfer clinical trials are raising hopes for blindness treatments and attracting media attention. News media provide an accessible health information source for patients and the public, but are often criticized for overemphasizing benefits and underplaying risks of novel biomedical interventions. Overly optimistic portrayals of unproven interventions may influence public and patient expectations; the latter may cause patients to downplay risks and over-emphasize benefits, with implications for informed consent for clinical trials. We analyze the news media communications landscape about ocular gene transfer and make recommendations for improving communications between clinicians and potential trial participants in light of media coverage.

Methods

We analyzed leading newspaper articles about ocular gene transfer (1990-2012) from United States (n = 55), Canada (n = 26), and United Kingdom (n = 77) from Factiva and Canadian Newsstand databases using pre-defined coding categories. We evaluated the content of newspaper articles about ocular gene transfer for hereditary retinopathies, exploring representations of framing techniques, research design, risks/benefits, and translational timelines.

Results

The dominant frame in 61% of stories was a celebration of progress, followed by human-interest in 30% of stories. Missing from the positive frames were explanations of research design; articles conflated clinical research with treatment. Conflicts-of-interest and funding sources were similarly omitted. Attention was directed to the benefits of gene transfer, while risks were only reported in 43% of articles. A range of visual outcomes was described from slowing vision loss to cure, but the latter was the most frequently represented even though it is clinically infeasible. Despite the prominence of visual benefit portrayals, 87% of the articles failed to provide timelines for the commencement of clinical trials or for clinical implementation.

Conclusions

Our analysis confirms that despite many initiatives to improve media communications about experimental biotechnologies, media coverage remains overly optimistic and omits important information. In light of these findings, our recommendations focus on the need for clinicians account for media coverage in their communications with patients, especially in the context of clinical trial enrolment. The development of evidence-based communication strategies will facilitate informed consent and promote the ethical translation of this biotechnology.

【 授权许可】

   
2014 Benjaminy and Bubela; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Wilson JM: Lessons learned from the gene therapy trial for ornithine transcarbamylase deficiency. Mol Genet Metab 2009, 96(4):151-157.
• [2]Wilson RF: The death of Jesse Gelsinger: new evidence of the influence of money and prestige in human research. Am J Law Med 2010, 36(2–3):295-325.
• [3]Wolf SM, Gupta R, Kohlhepp P: Gene therapy oversight: lessons for nanobiotechnology. J Law Med Ethics 2009, 37(01):659-684.
• [4]Smith L, Byers JF: Gene transfer in the post-Gelsinger era. JONAS Healthc Law Ethics Regul 2002, 4(4):104-110.
• [5]Yarborough M, Sharp RR: Public trust and research a decade later: what have we learned since Jesse Gelsinger’s death? Mol Genet Metab 2009, 97(1):4-5.
• [6]Bainbridge JWB, Smith AJ, Barker SS, Robbie S, Henderson R, Balaggan K, Viswanathan A, Holder GE, Stockman A, Bhattacharya SS, Thrasher AJ, Fitzke FW, Carter BJ, Rubin GS, Moore AT, Ali RR: Effect of gene therapy on visual function in Leber’s congenital amaurosis. N Engl J Med 2008, 358(21):2231-2239.
• [7]Hauswirth WW, Aleman TS, Kaushal S, Cideciyan AV, Schwartz SB, Wang L, Conlon TJ, Boye SL, Flotte TR, Byrne BJ, Jacobson SG: Treatment of Leber congenital amaurosis due to RPE65 mutations by ocular subretinal injection of adeno-associated virus gene vector: short-term results of a phase I trial. Hum Gene Ther 2008, 19(10):979-990.
• [8]Maguire AM, Simonelli F, Pierce EA, Pugh EN, Mingozzi F, Bennicelli J, Banfi S, Marshall KA, Testa F, Surace EM, Rossi S, Lyubarsky A, Arruda VR, Konkle B, Stone E, Sun J, Jacobs J, Dell’Osso L, Hertle R, Ma J, Redmond TM, Zhu X, Hauck B, Zelenaia O, Shindler KS, Maguire MG, Wright JF, Volpe NJ, McDonnell JW, Auricchio A, et al.: Safety and efficacy of gene transfer for Leber’s congenital amaurosis. N Engl J Med 2008, 358(21):2240-2248.
• [9]Simonelli F, Maguire AM, Testa F, Pierce EA, Mingozzi F, Bennicelli JL, Rossi S, Marshall K, Banfi S, Surace EM, Sun J, Redmond TM, Zhu X, Shindler KS, Ying G, Ziviello C, Acerral C, Wright JF, McDonnell JW, High KA, Bennett J, Auricchio A: Gene therapy for Leber’s congenital amaurosis is safe and effective through 1.5 years after vector administration. Mol Ther 2010, 18(3):643-650.
• [10]Smith AJ, Bainbridge JW, Ali RR: Prospects for retinal gene replacement therapy. Trends Genet 2009, 25(4):156-165.
• [11]Kaplan J: Leber congenital amaurosis: from darkness to spotlight. Ophthalmic Genet 2008, 29(3):92-98.
• [12]Heon E: My child has Leber congenital amaurosis: why is he/she not eligible for gene therapy trials? J AAPOS 2009, 13(6):533-534.
• [13]Caulfield T, Condit C: Science and the sources of hype. Public Health Genomics 2012, 15(3–4):209-217.
• [14]Holtzman NA: Are genetic tests adequately regulated? Science 1999, 286(5439):409.
• [15]Gamson WA, Modigliani A: Media discourse and public opinion on nuclear power: a constructionist approach. Am J of Sociol 1989, 95(1):1-37.
• [16]Nisbet M, Goidel R: Understanding citizen perceptions of science controversy: bridging the ethnographic survey research divide. Public Underst Sci 2007, 16(4):421-440.
• [17]Nisbet MC, Brossard D, Kroepsch A: Framing science the stem cell controversy in an age of press/politics. IJPP 2003, 8(2):36-70.
• [18]Caulfield T, Zarzeczny A, McCormick J, Bubela T, Critchley C, Einsiedel E, Galipeau J, Harmon S, Huynh M, Hyun I, Illes J, Isasi R, Joly Y, Laurie G, Lomax G, Longstaff H, Mcdonald M, Murdoch C, Ogbogu U, Owen-Smith J, Pattinson S, Premji S, von Tigerstrom B, Winickoff DE: The stem cell research environment: a patchwork of patchworks. Stem Cell Rev 2009, 5(2):82-88.
• [19]Jensen E: Scientific sensationalism in American and British press coverage of therapeutic cloning. J Mass Commun Q 2012, 89(1):40-54.
• [20]Bubela T, Hyde-Lay R, Lane S, Ogbogu U, Ouellette C, Nisbet MC, Borchelt R, Brunger F, Critchley C, Einsiedel E, Geller G, Gupta A, Hampel J, Hyde-Lay R, Jandciu EW, Jones SA, Kolopack P, Lane S, Lougheed T, Nerlich B, Ogbogu U, O’Riordan K, Ouellette C, Spear M, Strauss S, Thavaratnam T, Willemse L, Caulfield T: Science communication reconsidered. Nat Biotechnol 2009, 27(6):514-518.
• [21]Myers EF, Parrott JS, Cummins DS, Splett P: Funding source and research report quality in nutrition practice-related research. PLoS One 2011, 6(12):e28437.
• [22]Cook DM, Boyd EA, Grossmann C, Bero LA: Journalists and conflicts of interest in science: beliefs and practices. Ethics Sci Environ Polit 2009, 9:33-40.
• [23]Petersen A: The ethics of expectations: biobanks and the promise of personalised medicine. Monash Bioeth Rev 2009, 28(1):1-12.
• [24]Daugherty CK, Banik DM, Janish L, Ratain MJ: Quantitative analysis of ethical issues in phase I trials: a survey interview study of 144 advanced cancer patients. IRB 2000, 22(3):6-14.
• [25]Pentz RD, Harvey RD, Owonikoko T, Khuri FR, White M, Farmer ZL, Liu Y, Lewis C, Dashevskaya O: Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials. Cancer 2012, 118(18):4571-4578.
• [26]Alliance for audited media http://www.auditedmedia.com webcite
• [27]National Institutes of Health: ClinicalTrials.gov. http://www.clinicaltrials.gov/ct2/results/map?term=gene+therapy webcite
• [28]Bubela TM, Caulfield TA: Do the print media “hype” genetic research? A comparison of newspaper stories and peer-reviewed research papers. CMAJ 2004, 170(9):1399-1407.
• [29]Bubela T, Boon H, Caulfield T: Herbal remedy clinical trials in the media: a comparison with the coverage of conventional pharmaceuticals. BMC Med 2008, 6(1):35.
• [30]Condit CM: How geneticists can help reporters to get their story right. Nat Rev Genet 2007, 8(10):815-820.
• [31]Holtzman NA, Bernhardt BA, Mountcastle-Shah E, Rodgers JE, Tambor E, Geller G: The quality of media reports on discoveries related to human genetic diseases. Community Genet 2005, 8(3):133-144.
• [32]Nisbet MC: Framing Science: A New Paradigm in Public Engagement. In Understanding Science: New Agendas in Science Communication. Edited by Kahlor L, Stout P. New York: Taylor and Francis; 2009:40-67.
• [33]Benjaminy S, MacDonald I, Bubela T: “Is a cure in my sight?”: Multi-stakeholder perspectives on phase I choroideremia gene transfer clinical trials. Genet Med 2014, 16(5):379-385.
• [34]Neuendorf KA: The Content Analysis Guidebook. Thousand Oaks, California: Sage Publications; 2002.
• [35]Campbell J: Science Gives Blind Dogs Sight: ‘First Fruit of Genetic revolution’ Raises Hope for Fighting Other Genetic Diseases. Ottawa: The Ottawa Citizen; 2001.
• [36]Sample I: Gene Therapy Aimed at Restoring Sight for 30,000 People. London: The Guardian; 2007.
• [37]Mick H: Gene Therapy Shines Light on Blindness. Toronto: The Globe and Mail; 2008.
• [38]Willey J: Blind Will ‘see’ Within a few Days of Gene Therapy. London: The Daily Express; 2008.
• [39]Ransohoff DF, Ransohoff RM: Sensationalism in the media: when scientists and journalists may be complicit collaborators. Eff Clin Pract 2001, 4(4):185-188.
• [40]Hedgecoe A: The Politics of Personalised Medicine: Pharmacogenetics in the Clinic. Cambridge: Cambridge University Press; 2004.
• [41]Brechman JM, Lee CJ, Cappella JN: Distorting genetic research about cancer: from bench science to press release to published news. J Commun 2011, 61(3):496-513.
• [42]Ogbogu U, Du L, Rachul C, Bélanger L, Caulfield T: Chinese newspaper coverage of (unproven) stem cell therapies and their providers. Stem Cell Rev 2013, 9(2):1-8.
• [43]Horst M: Public expectations of gene therapy scientific futures and their performative effects on scientific citizenship. Sci Technol Hum Values 2007, 32(2):150-171.
• [44]Critchley CR: Public opinion and trust in scientists: the role of the research context, and the perceived motivation of stem cell researchers. Public Underst Sci 2008, 17(3):309-327.
• [45]Kimmelman J: Gene Transfer and the Ethics of First-in-Human Research: Lost in Translation. Cambridge: Cambridge University Press; 2010.
• [46]Tsfati Y, Cohen J, Gunther AC: The influence of presumed media influence on news about science and scientists. Sci Commun 2011, 33(2):143-166.
• [47]Henderson L, Kitzinger J: The human drama of genetics: ‘hard’ and ‘soft’ media representations of inherited breast cancer. Sociol Health Illn 1999, 21(5):560-578.
• [48]McKeever BW: News framing of autism understanding media advocacy and the combating Autism Act. Sci Commun 2013, 35(2):213-240.
• [49]Kitzinger J, Williams C: Forecasting science futures: legitimising hope and calming fears in the embryo stem cell debate. Soc Sci Med 2005, 61(3):731-740.
• [50]Petersen A: Biofantasies: genetics and medicine in the print news media. Soc Sci Med 2001, 52(8):1255-1268.
• [51]Jensen E: Mediating subpolitics in US and UK science news. Public Underst Sci 2012, 21(1):68-83.
• [52]Nisbet MC, Scheufele DA: What’s next for science communication? Promising directions and lingering distractions. Am J Bot 2009, 96(10):1767-1778.
• [53]Racine E, Waldman S, Rosenberg J, Illes J: Contemporary neuroscience in the media. Soc Sci Med 2010, 71(4):725-733.
• [54]Critchley CR, Nicol D: Understanding the impact of commercialization on public support for scientific research: is it about the funding source or the organization conducting the research? Public Underst Sci 2011, 20(3):347-366.
• [55]Vicsek L: Costs and benefits of stem cell research and treatment: media presentation and audience understanding in Hungary. Sci Commun 2011, 33(3):309-340.
• [56]Caulfield T, McGuire AL: Direct-to-consumer genetic testing: perceptions, problems, and policy responses. Annu Rev Med 2012, 63:23-33.
• [57]Condit C: What is ‘public opinion’ about genetics? Nat Rev Genet 2001, 2(10):811-815.
• [58]Wilde A, Bonfiglioli C, Meiser B, Mitchell PB, Schofield PR: Portrayal of psychiatric genetics in Australian print news media, 1996–2009. Med J Aust 2011, 195(7):401-404.
• [59]Robillard JM, Whiteley L, Johnson TW, Lim J, Wasserman WW, Illes J: Utilizing social media to study information-seeking and ethical issues in gene therapy. J Med Internet Res 2013, 15(3):e44.
• [60]Acland GM, Aguirre GD, Ray J, Zhang Q, Aleman TS, Cideciyan AV, Pearce-Kelling SE, Anand V, Zeng Y, Maguire AM, Jacobson SG, Hauswirth WW, Bennett J: Gene therapy restores vision in a canine model of childhood blindness. Nat Genet 2001, 28(1):92-95.
• [61]Appelbaum PS, Roth LH, Lidz C: The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 1982, 5(3–4):3-4.
• [62]Horng S, Grady C: Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB 2003, 25(1):11-16.
• [63]Pentz RD, Flamm AL, Sugarman J, Cohen MZ, Ayers GD, Herbst RS, Abbruzzese JL: Study of the media’s potential influence on prospective research participants’ understanding of and motivations for participation in a high-profile phase I trial. J Clin Oncol 2002, 20(18):3785-3791.
• [64]Jacobson SG, Aleman TS, Cideciyan AV, Sumaroka A, Schwartz SB, Windsor EAM, Traboulsi EI, Heon E, Pittler SJ, Milam AH, Maguire AM, Placzewski K, Stone EM, Bennett J: Identifying photoreceptors in blind eyes caused by RPE65 mutations: prerequisite for human gene therapy success. Proc Natl Acad Sci U S A 2005, 102(17):6177-6182.
• [65]Cideciyan AV, Jacobson SG, Beltran WA, Sumaroka A, Swider M, Iwabe S, Roman AJ, Olivares MB, Schwartz SB, Komáromy AM, Hauswirth WW, Aguirre GD: Human retinal gene therapy for Leber congenital amaurosis shows advancing retinal degeneration despite enduring visual improvement. Proc Natl Acad Sci U S A 2013, 110(6):E517-E525.
• [66]Kimmelman J: Ethics of cancer gene transfer clinical research. Methods Mol Biol 2009, 542:423-445.
• [67]Reimer J, Borgelt E, Illes J: In pursuit of “informed hope” in the stem cell discourse. Am J Bioeth 2010, 10(5):31-32.