Later this year the Academy will publish the most complex policy project it has ever undertaken. Professor Sir John Tooke reflects on our forthcoming policy report.
We are looking into the way we all can best use scientific evidence to judge the potential benefits and harms of medicines. Given the scope of this topic, the findings will be relevant to everyone - from the general public to healthcare and research communities and policy makers.
Learning from medical controversies
Medical controversies over the last decade such as those around the use of statins, Tamiflu, the vaccine to prevent cervical cancer and hormone replacement therapy (HRT) have been challenging for policy makers, healthcare professionals and the research community alike and risk hindering decision-making by patients.
These high-profile debates have common themes, often relating to the accessibility and poor communication of evidence, and trust in the evidence itself, not least because of perceived conflicts of interest of those involved in its generation or communication. Academy Fellows and our stakeholders urged us to look at these issues to find ways to improve the use of scientific evidence. In 2015, with the debate about statins playing out in the headlines and in consulting rooms across the country, we also received a letter from the Chief Medical Officer asking us to look into the issues underlying this debate. It was in this context that I took on the role of Chair of the oversight group for this report.
Looking at the bigger picture
Our role was not to undertake a scientific review of the evidence pertaining to individual medicines such as statins. Others are better placed to conduct such reviews, including – as was the case for statins – rigorous and extensive academic reviews of the evidence base published in in high-quality outlets such as Cochrane or the Lancet, or the work done by the MHRA or NICE when making decisions about the safety and cost-effectiveness of medicines. Neither did we want to limit ourselves to one area of medicine. It is almost 20 years since the MMR controversy hit the news and since then there has rarely been a time there has not been heated debate around a new medicine or treatment. For our findings to have impact and enduring value they need to be applicable not just to the new treatments today, but also to those that have not yet been invented.
The way evidence is used affects us all
The need to scrutinise this area is of utmost importance. Every day hundreds of thousands of us will make decisions about medicines in consultation with our doctor, pharmacist or other medical professional.
Imagine a conversation between a GP in Manchester and a 50 year old woman experiencing severe symptoms from the menopause about the pros and cons of HRT. A GP may provide the evidence to the patient to help her decide what to do. Which evidence GPs share and the way they communicate it could be influenced by their understanding, their trust in different sources of evidence, the way evidence has been communicated to them and the current thinking about the issue in the healthcare community. They are also limited in only being able to communicate the evidence available to them and by the length of time of the consultation. How the patient perceives this evidence may in turn be shaped by the views that they brought into the consulting room, such as their own knowledge, information from the internet or the media, their experiences and that of family and friends, and their own beliefs and lifestyle.
This example illustrates just some of the many factors that impact upon the decision making process. Not only do we need to ensure the highest quality evidence is generated, but also create an environment to allow this evidence to be used, and importantly trusted, by the right people at the right time to inform their decision. It is looking at evidence both from a scientific and broader societal context that has led to the breadth, depth and complexity of this project.
An in-depth investigation
The project began in 2015 with a review into the way that evidence is generated. It expanded into a series of parallel projects brought together under an oversight group that I chair. Over a period of almost two years, we have gathered information from a wide range of sources and stakeholders to investigate how evidence could be better used to judge the potential benefits and harms of medicines. We issued a call for evidence that received responses from a range of individuals and organisations, such as medical research charities and funders. We convened a series of workshops with a variety of experts to explore issues related to conflicts of interests, ways in which scientific evidence is generated and how scientific evidence is communicated, not least in the media. We invited experts to provide oral evidence. We commissioned a survey of GPs and British adults to investigate trust in and use of medical evidence. And we held public dialogue workshops in Glasgow, Leeds and London to further understand how patients, members of the public and healthcare professionals use scientific evidence in decisions about medicines.
The project has also considered the work of other organisations trying to tackle some of these issues, such as the AllTrials campaign calling for increased openness around clinical trials, and NHS Choices, a source of information about medicines for the public and healthcare professionals.
Securing trust in evidence
One of the important themes of our dialogue with the public and the medical and research community was trust. In particular, the concerns expressed by some about conflicts of interests leading to bias in data and evidence can undermine the trustworthiness of research findings. We have tackled this issue head on by examining it in our public dialogue, with the scientific community and by running a workshop specifically looking at conflicts of interest and how they might be better managed.
Trust in evidence extends to the findings of this report. We know, for our findings to be trustworthy, we need to be transparent about our own processes. We have extensive information about the way this project was conducted on our website and where possible we have also taken the step of publishing the individual and organisation-wide responses to our requests for evidence. We have already, or will publish soon, reports detailing the findings from all our evidence-gathering events. The report has also been reviewed by an independent group of seven reviewers external to the Academy before being approved by our Council. Throughout the project, we have ensured that potential, perceived or actual conflicts of interest have been appropriately managed. All working group members were asked to declare their interests, which are listed on our website and in the report. Stakeholders, including working group and Council members, with a potential, perceived or actual conflict of interest were excluded from discussions at events or Council meetings.
The trustworthiness of our findings may also relate to the expertise that we have harnessed. The individual projects and the oversight group have involved prominent experts in the field of medical science, but also other leading academics, patient representatives, doctors including GPs, and a journalist. Public engagement was central to this project and included a comprehensive attitudes survey led by ComRes as well as extensive deliberative dialogue sessions in partnership with Ipsos MORI that engaged diverse public audiences including patients and carers. We also used this high-quality engagement to draw in the views of healthcare professionals such as GPs, pharmacists and nurses. We worked with organisations such as the Wellcome Trust and the Science Media Centre to harness views from stakeholders such as journalists, press officers and the research community. As well as depending on a broad understanding of the spectrum of opinion, we did not shy away from engaging with those who find themselves fierce proponents or campaigners for a particular point of view – such as those who are currently hugely concerned about a climate of over- or under- medication. By addressing conflicts of interest and the role of data from industry in informing healthcare decisions, we maintain we have tackled some of the most polarising debates of the day.
We value those who have contributed to this report
We would like to thank all of those members of the public, healthcare professionals, researchers, science communicators, research funders, policy makers and journalists who contributed their views to this work. We would also like to thank Arthritis Research UK, the British Heart Foundation, the British Pharmacological Society, the British Society for Immunology, the Medical Research Council, the Naji Foundation and the National Institute of Health Research Health Technology Assessment Programme for their financial contributions towards this project and for trusting the Academy to undertake this significant piece of work independently from their influence.
Though the scale of this project is quite unlike anything we have tackled before, we believe that we have – within inevitable constraints of time and resources – undertaken a thorough and robust investigation of the issues. The report will feature recommendations that we believe will lead to enhanced generation, communication and trustworthiness of scientific evidence.
Evidence is not a panacea, but is important to many
Of course, we know that decisions about healthcare are not made on the basis of scientific evidence alone – and that having accessible and clear evidence will not be a panacea to easy decision-making about medicines. Not only that, but we appreciate there are many in the so called ‘post truth’ society that do not value evidence or expertise – it is not our role to convince them otherwise.
What our investigations have suggested, however, is that there are many people, including patients and healthcare professionals who might already use scientific evidence, who would like to make greater use of evidence to inform their decisions, but who are not able to do so easily in the current infrastructure. We hope the recommendations in our report will help them in the future and elevate the role that high quality, trustworthy evidence plays in the process.
We are aware that we will launch this report into a highly charged and complicated landscape, and we understand that not everyone will approve the way we approached the project or the recommendations we produce. But it is precisely this heated and polarised environment that makes this project so essential at this time, and we trust that our report will draw attention to the issues that need to be addressed and provide a robust and evidence-based backdrop to the as yet unforeseen healthcare debates of the future.
We believe that, as a society, we will not make the best choices about medicines and get the most value from medical science until we have a better ecosystem to promote and disseminate high-quality evidence. For this reason, this project will continue to be high priority for the Academy this year even after the publication of the report in the spring.
Professor Sir John Tooke FMedSci is the Chair of the Oversight Group for the Academy’s workstream on improving the use of scientific evidence to judge the potential benefits and harms of medicines.
For more information about this project, and to keep up to date with the latest developments, visit our evidence hub. To find out more about how you can support the work of the Academy of Medical Sciences, click here.