The findings of this review should be of interest to clinical trialists, advocates and policy makers. The media are important communicators of information and can raise awareness of emerging issues concerning health and risk[57
] We observed that the media brought forth a variety of concerns related to the conduct of the trials in both Cambodia and Cameroon. In several instances these concerns were not supported by evidence and were possibly inaccurate. We also observed that the media involved stakeholders to a comparatively small degree, suggesting that the viewpoints they reported may not accurately represent the views of all those concerned about the conduct of the trial. Given the potential impact of the media reporting on the conduct of future tenofovir trials, the nature of their reporting deserves closer scrutiny.
There are several limitations to consider in interpreting our review. Although we systematically searched many databases and extensively searched the Internet, it is possible that we were unable to identify some reports. Our searches were limited to the English and French languages, and as both Cambodia and Cameroon have media in other languages, we may have missed articles published in their respective languages. We conducted a content analysis to identify issues that we deemed trial related. It is possible that other issues exist, and that other individuals were interviewed, but were not reported in the articles. There are also several strengths to consider in interpreting our review. This is, we believe, the first systematic review to assess media reporting related to the closed trials. We conducted extensive searches and extracted data independently, in duplicate, to remove investigator driven biases. We spoke with representatives from each stakeholder group to determine if they were aware of additional reports, as well as searched the CDC reports.
The media reports consistently reported concerns with ethical issues in the conduct of the trials. Both the Cambodian reports and the Cameroon reports cite access to appropriate standards of care for those who become infected during the trial and appropriate standard of prophylaxis. Indeed these same issues are being echoed in the impending trial of tenofovir in drug users in Thailand[9
]. Further to this, most media reports regarding both trials reported that participants were not fully aware of the risks involved with participation. Clinical trialist's planning prevention trials, whether of chemoprophylaxis or microbicides should be aware that many populations are not in situations in which to make informed decisions about clinical trial methodologies and the risks related to trial participation. Enrolling these communities in developing nations requires the establishment of community advisory boards and gender advisory boards, to ensure that the information is being provided, and interpreted, in an accurate manner[58
The tenofovir trial media attention does however, have implications for prevention trials, such as HIV vaccines. Prevention methods are urgently needed to stem the onslaught of new HIV infections. Novel interventions, such as vaccines, microbicides, or chemoprophylaxis, will all require clinical trial validation. The media reporting of the tenofovir trials may threaten trial recruitment and potentially stigmatize trial participation.
There are important qualitative differences between the media reports of the trial in Cambodia compared to the trial in Cameroon. It is important to note that the trial in Cambodia was closed before recruiting any participants, whereas the trial in Cameroon had met its recruitment goals (n = 400). Most criticisms regarding the trial in Cambodia related to a lack of access to adequate care during the trials and post-trial, for those who may become infected. These concerns for potential infections appeared to be the overriding concerns as activists cited that these trials would be conducted to a different level of protection and insurance if they were conducted in a developed country. The articles addressing the trial closure in Cameroon were somewhat different and were largely based on reports of trial misconduct, in the context of inadequate informed consent, inadequate access to counseling and inadequate access to male and female condoms. The trials did however; have overlapping concerns about the ethical standards for trials in developing nations compared to Western nations and the protection of the participants human rights.
The tenofovir trials raise important questions about the relationship between researchers, participants and activists[60
]. With worldwide media attention, these trial closures demonstrate the ability of activists to engage the media and bring about important consequences for the conduct of trials. Activists are experienced at bringing about change and have strong lobbying potential that can impact researchers and the HIV community. The activist communities have substantial experience using the media to address topics of importance in HIV and are well-educated regarding ethical standards and trial designs. Indeed, it is important to note that several of the ethical issues raised in the media reports: standard of care, access to proven prophylaxis and access to treatment for seroconverters; have not yet been resolved within the academic community [61
The Media, accuracy of communication and influence on policy
The media plays an important role at the interface of science and policy. Indeed, the media has been utilized to change behaviour in HIV public health campaigns[60
]. Most scientists and non-scientists receive information from media sources [63
]. One policy making model specifically addresses this issue and describes how information is generated by researchers and then disseminated by advocacy networks and the media [64
]. The information provided by the media is eventually interpreted by policy makers and government officials, and those informally involved, such as patient groups and stakeholder groups. Although media information provides weak levels of evidence, multiple sources of media information may strengthen personal inferences. The interpretation of this information is influenced by the value systems of the individuals receiving the information.
This review displays the important role that the media play in knowledge dissemination, and the responsibilities that they have in accurate reporting. In our review, 20 reports did not acknowledge interviewing any stakeholder and in no case did any report interview those supporting the trials and those against the trials. It is impossible to determine the extent to which the allegations made regarding the trials were wholly inaccurate. Our review contributes to a large body of evidence indicating that the media at times misrepresents scientific information and presents the science in a varied manner [65
], as in the case of the trial in Cameroon where the reports suggest inadequate counseling and informed consent sheets that were not available in the local languages, issues that were not upheld by the ministry of health. It should be noted however, that not only standard news sources, but also academic news sources were susceptible to inaccuracies in their reporting. In one case, a top academic journal reported tenofovir to be a vaccine trial[31
Indeed the media plays an important role in highlighting HIV issues so that it remains of topic of high profile and can be used as a strategy to convey AIDS awareness and prevention[60
]. The media has a responsibility to report in a factual and objective manner [66
]. Media agencies should be engaged to educate them on trial protocols and ethics so that reporting can be discriminating. The International AIDS Vaccine Initiative (IAVI) has now initiated training with journalists to ensure knowledgeable reporting related to vaccines [67
]. This seems like a logical step towards ensuring adequate reporting of prevention trials.
We recommend further analysis of this emerging issue of media reporting of contentious clinical trials. The impact of such reporting, as we have described, clearly demonstrates that it deserves closer attention. Next steps would engaging journalists involved in the reporting to determine what strategies clinical trialists, participants and stakeholders could utilize to improve reporting. An analysis of the strategies used by stakeholders to provide information to the media and the relative successes of these strategies would also be worth studying.