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

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

Application of Protection Motivation Theory to Clinical Trial Enrolment for Pediatric Chronic Conditions

Background Parents of children living with chronic but manageable conditions hope for improved therapies or cures, including Advanced Therapy Medicinal Products (ATMPs). Multiple pediatric clinical trials for ATMPs are underway, but the risk profile of ATMPs for chronic conditions is largely unknown and likely different than for terminal pediatric illnesses. Applying Protection Motivation Theory modified to the context of pediatric ATMP clinical trial enrollment, our study analyses information needs of parents of children living with chronic manageable conditions: Type 1 Diabetes (T1D) or Inherited Retinal Diseases (IRD). Methods We conducted semi-structured interviews with 15 parents of children living with T1D and 14 parents of children living with an IRD about: a) family background and the diagnostic experience; b) awareness of gene and stem cell therapy research and clinical trials for T1D and IRD; c) information sources on trials and responses to that information; d) attitudes to trial participation, including internationally; e) understanding of trial purpose and process; and f) any experiences with trial participation. We then discussed a pediatric ATMP clinical trial information sheet, which we developed with experts. We applied directed qualitative content analysis, based on PMT, to examine the information preferences of parents in deciding whether to enrol their children in stem cell or gene therapy clinical trials. Results Parents balanced trial risks against their child’s ability to cope with the chronic condition. The better the child’s ability to cope with vision impairment or insulin management, the less likely parents were to assume trial risks. Conversely, if the child struggled with his/her vision loss, parents were more likely to be interested in trial participation, but only if the risks were low and likelihood for potential benefit was high. Conclusions Fear of adverse events as part of threat appraisal was the predominant consideration for parents in considering whether to enroll their child living with a manageable, chronic condition in a pediatric clinical trial of an ATMP. This consideration outweighed potential benefits and severity of their child’s condition. Parents called for available safety data and fulsome communication processes that would enable them to make informed decisions about clinical trial enrolment on behalf of their children

The mouse that trolled (again)

We welcome the opportunity to respond to the commentaries on our paper-The Mouse that Trolled-by Hardy, Sarnoff, and Cordova and Feldman. Their comments are academic criticism in the very best sense. We also take the opportunity to update on recent legal actions, which we had not predicted. This opportunity enriches our narrative history of the patenting of the APPswe mutation for early onset Alzheimer\u27s disease, and we hope the continued saga is of interest

The Mouse That Trolled: The Long and Tortuous History of a Gene Mutation Patent That Became an Expensive Impediment to Alzheimer\u27s Research

This case study presents the tale of the academic discovery of a rare mutation for early-onset Alzheimer\u27s disease that was patented by a sole inventor and licensed to a non-practicing entity (NPE), the Alzheimer\u27s Institute of America (AIA). Our aims are (1) to relate this story about patents, research tools, and impediments to medical progress, and (2) to inform ongoing debates about how patents affect research, disposition of university inventions, and the distribution of benefits from publicly funded research. We present an account of the hunt for Alzheimer\u27s genes, their patenting, assignment, and enforcement based on literature, litigation records and judicial decisions. While AIA\u27s litigation eventually failed, its suits against 18 defendants, including one university, one foundation, and three non-profit organizations were costly in court years, legal fees, and expert time. Reasons for the failure included non-disclosure of co-inventors, State laws on ownership and assignment of university inventions, and enablement. We discuss the policy implications of the litigation, questioning the value of patents in the research ecosystem and the role of NPEs (“patent trolls”) in biotechnological innovation. The case illustrates tactics that may be deployed against NPEs, including, avenues to invalidate patent claims, Authorization and Consent, legislative reforms specifically targeting NPEs, reforms in the America Invents Act, and judicial action and rules for judicial proceedings. In the highly competitive research environment of Alzheimer\u27s genetics in the 1990s, patents played a minor, subordinate role in spurring innovation. The case produces a mixed message about the patent system. It illustrates many mistakes in how patents were obtained, administered, and enforced, but, eventually, the legal system rectified these mistakes, albeit slowly, laboriously, and at great cost

Let’s Do Better: Public Representations of COVID-19 Science

COVID science is being both done and circulated at a furious pace. While it is inspiring to see the research community responding so vigorously to the pandemic crisis, all this activity has also created a churning sea of bad data, conflicting results, and exaggerated headlines. With representations of science becoming increasingly polarized, twisted and hyped, there is growing concern that the relevant science is being represented to the public in a manner that may cause confusion, inappropriate expectations, and the erosion of public trust. Here we explore some of the key issues associated with the representations of science in the context of the COVID-19 pandemic. Many of these issues are not new. But the COVID-19 pandemic has placed a spotlight on the biomedical research process and amplified the adverse ramifications of poor public communication. We need to do better. As such, we conclude with ten recommendations aimed at key actors involved in the communication of COVID-19 science, including government, funders, universities, publishers, media and the research communities

Faisons mieux les choses : représentation publique de la science sur la COVID-19

Les recherches scientifiques sur la COVID-19 sont à la fois menées et diffusées à une cadence effrénée. Bien qu’il soit inspirant de voir la communauté de la recherche répondre avec autant de vigueur à la crise causée par la pandémie, toute cette activité a par ailleurs engendré un chaos de mauvaises données, de résultats contradictoires et de manchettes exagérées. Alors que la polarisation, la déformation et la médiatisation des résultats scientifiques s’intensifient chaque jour, les inquiétudes se font de plus en plus sentir quant à la perspective que la science pertinente soit présentée au public d’une manière qui puisse causer de la confusion, créer de fausses attentes et éroder la confiance du public. Dans cette note, nous explorons les principaux enjeux associés à la présentation de la science dans le contexte de la pandémie de la COVID-19. Plusieurs de ces enjeux ne sont pas nouveaux. Mais la pandémie de la COVID-19 a braqué les projecteurs sur le processus de la recherche biomédicale et a amplifié les ramifications néfastes des problèmes de communication publique. Nous devons faire mieux. À ce titre, nous conclurons ce rapport en formulant dix recommandations qui s’adressent aux acteurs clés qui interviennent dans la communication de la science sur la COVID-19, notamment les gouvernements, les bailleurs de fonds, les universités, les éditeurs, les médias et les communautés de recherche

Amici Brief of Certain Academics in Law, Medicine, Health Policy, and Clinical Genetics in Support of Petitioners

Brief of Amici Curiae ("friend of the court") submitted by certain academics in law, medicine, health policy, and clinical genetics in support of petitioners on petition for a Writ of Certiorari (No. 11-725

Knowledge Management and the Contextualisation of Intellectual Property Rights in Innovation Systems

Support for this research was provided by Genome Canada through the Ontario Genomics Institute and Genome Alberta © David Castle et al 2010.Peer reviewedPublisher PD

Amici Curiae Brief for Academics in Law, Medicine, Health Policy, and Clinical Genetics in Support of Neither Party

Amicus ("friend of the court") brief written by Drs. E. Richard Gold, Tania Bubela, Robert Cook-Deegan, James Evans, Julian Kinderlerer, and Dianne Nicol, in support of neither party (Supreme Court Case Docket No. 12-398