Stem cell research receives a great deal of attention from policymakers, the popular press, and popular culture, including social media. Given its scientific and clinical potential and the controversies that have surrounded the field, this high public profile is understandable. However, popular coverage and reporting in the medical literature are frequently far from ideal. The potential benefits of stem cell-based interventions are sometimes exaggerated and the challenges, including their clinical application and risks, are often understated. Inaccurate or incomplete representations can have tangible impacts on the expectations of the general public, patient communities, physicians, and on the setting of health and science policies. Companies and individuals marketing stem cells for unproven clinical uses exploit those inaccurate and incomplete representations.
Public Representation of Science
Recommendation 4.1: The stem cell research community should promote accurate, current, balanced, and responsive public representations of stem cell research.
The high level of public and media interest in the field provides stem cell scientists with ample opportunities to communicate their findings through a variety of popular and social media channels. The research community is encouraged to responsibly engage interactively with the public through outreach and communications and by providing opportunities for public comment and feedback on scientific advances.
While such opportunities may allow scientists to gain recognition and understanding for their work among non-specialists, they also have the potential to fuel inaccurate public perceptions about the current state of scientific progress, potential for application, and associated risks and uncertainties (Kamenova and Caulfield, 2015). Scientists, clinicians, bioethicists, science communications professionals at academic and research institutions, and industry spokespersons should strive to ensure that benefits, risks, and uncertainties of stem cell science are not understated, misrepresented or overstated (see Recommendation 126.96.36.199). Additionally, due to public interest and concern in the ethics of human pluripotent stem cell research, and in order to ensure complete transparency of research and translational activities, the origin of stem cell materials should be clearly specified in all communications.
Care should be exercised throughout the science communication process, including in the promotion of research and translation activities, as well as in the presentation of scientific results, the use of social media, and in any communication with print and broadcast media. Particular caution should be exercised when preparing press releases and other types of promotional material. Researchers should make efforts to seek timely corrections of inaccurate or misleading public representations of research projects, achievements, or goals. Scientists should also be particularly careful about disclosing research findings that have not passed peer review, as premature reporting can undermine public confidence if findings are subsequently disproven. For example, if researchers post online preprints that have not been peer-reviewed, readers should be informed of the preliminary nature of such manuscripts.
Researchers must intentionally avoid and correct inaccurate misconceptions in any communications regarding chimeras, genome editing, and other issues with a long history in the public imagination. While organoids, chimeras, embryo models, and other stem cell-based models are useful research tools offering possibilities for further scientific progress, limitations on the current state of scientific knowledge and regulatory constraints must be clearly explained in any communications with the public or media. Suggestions that any of the current in vitro models can recapitulate an intact embryo, human sentience or integrated brain function are unfounded overstatements that should be avoided and contradicted with more precise characterizations of current understanding. This is particularly relevant to brain organoids and human-animal chimeras, where any statements implying human cognitive abilities, human consciousness or self-awareness, as well as phrases or graphical representations suggesting human-like cognitive abilities risks misleading the public and sowing doubts about the legitimate nature of such research. Likewise, forward-looking statements on inherently uncertain developments, such as predictions on time required until clinical application, the likelihood of product approval, or speculation on the potential economic impact of currently unrealized technologies, must be accurate, circumspect, and restrained.
The stem cell community should work closely with communications professionals at their institution to create information resources that are easy to understand without oversimplifying, and that do not underplay risks and uncertainties or exaggerate potential benefits. Similarly, research-sponsoring institutions and communications professionals have a responsibility to ensure that any informational materials referring to research achievements adhere to these principles. Additionally, the scientists in charge of the research findings that are featured in informational materials should review and agree to the content prior to release. For potentially sensitive or high-profile cases, it is advisable to seek additional comments from independent experts to ensure objectivity and balance, place research in context of existing body of evidence, and help identify study limitations and alternative interpretations of key findings.
Communications about Clinical Trials
Recommendation 4.2: When describing clinical trials in the media or in medical communications, investigators, sponsors, and institutions should provide balance and not emphasize statistically significant secondary results when pre-specified primary efficacy results are not statistically significant.
Too often, studies reporting statistically non-significant primary outcomes are “spun” by appealing to other findings, such as statistically significant secondary outcomes (Boutron et al., 2010). Such reporting practices can distort the medical and public interpretation of trial results. When communicating clinical research results, scientists, institutions, and journalists should clearly state the pre-specified primary endpoint of the study and whether or not it was reached with statistical significance. This standard should apply to conference abstracts, press releases directed at investors and other parties, and peer-reviewed publications.
Clinical trials designed to evaluate safety and efficacy should not be described using language that might suggest their primary intent to be the delivery of care, as this may lead to confusion about the risk/benefit ratio of study participation (see also Recommendation 188.8.131.52). Communications about ongoing studies should explain that clinical efficacy is not established, and that the results may reveal the intervention to be ineffective or, in some cases, harmful.
Scientists should collaborate with patient and advocacy groups promote a clear understanding of the clinical research process and the current state of progress in developing stem cell-based treatments for specific medical conditions. Accordingly, all involved in clinical research, including not only investigators and sponsoring institutions but also patients, study participants, funding bodies, families and advocacy groups, should exercise caution when communicating with the public. Additionally, researchers should exercise great care when making forward-looking statements regarding the potential outcome of any study.
Communications about Clinical Care
Recommendation 4.3: The provision of information to patients considering stem cell-based interventions must be consistent with the primacy of patient welfare, scientific and ethical integrity.
The provision of accurate information on risks, limitations, possible benefits, and available alternatives to patients is essential in the delivery of healthcare. Provision of clinical information, including recommendations on use, should center on the importance of consultation with medical professionals directly familiar with the individual patient’s case, and the seeking of independent expert opinion. The goal of clinical communications is to enable autonomous, well-informed decision-making by patients.
Language suggesting that novel interventions are “curative” should be avoided in the absence of evidence of complete or permanent relief of a disease or condition. A cure means that individuals do not experience ongoing morbidity or adverse effects from the disease or condition targeted by the intervention. Cures must be validated with long-term studies demonstrating that the treated patients have a similar annual death rate from all causes to that of the disease-free population group of the same sex and age distribution (Easson et al., 1963; Frei et al., 1971; Ravi et al., 2018).
Given the novelty of stem cell-based interventions and the fact that many countries do not have well-established regulatory pathways governing the introduction of novel medical products into clinical use, clinicians should exercise restraint in their communications regarding the clinical utility of such treatments. The use of patient anecdotes, testimonials or other language that could be construed as promotional, promissory, or suggestive of clinical effectiveness in reference to stem cell-based interventions for which efficacy has not been established is to be avoided. In the event that new stem cell-based interventions are authorized for use for a specified indication, care must be taken to avoid communications that might indicate or suggest to patients that such intervention is efficacious for other indications.
Regulatory and law enforcement authorities are encouraged to investigate and, when appropriate, restrict unsupported marketing claims made by commercial actors, to the extent that these violate relevant consumer protection, truth in advertising, securities, and commerce laws within a given jurisdiction.
When approved stem cell products are used for off-label indications, communications should clearly specify that such interventions will be used on an off-label basis. Such communications should explain the difference between administering products according to the marketing labels approved by regulatory bodies and off-label use that lacks such approval. Many countries have legal restrictions concerning marketing claims related to off-label use. Such constraints are intended to ensure that advertising claims are evidence-based and promotional rhetoric does not go beyond credible safety and efficacy data and related regulatory approvals.