Evidence-based medicine no more?

Chris Winchester

In a pre-COVID-19 world, this week would have seen evidence-based medicine experts gather in Toronto for EBM Live 2020. However, like many other meetings during the pandemic, it has been postponed. Here, I reflect on last year’s meeting and pharma’s journey in improving the reporting of clinical trials.

In July 2019, expert researchers, clinicians and patients gathered in Oxford to discuss the current state of evidence-based medicine (EBM) and set directions for the future. As in previous years, I joined them. As one of the few pharma representatives at EBM Live, I was privileged to have an outsider’s view, and it gives me no pleasure to report that EBM feels to be running out of steam. The EBM movement has indeed transformed healthcare but, in some ways, is now a victim of its own success. Despite efforts to move on, many in the field are still fighting the same old battles. So, what does the picture really look like for pharma today? This blog post sets out my personal opinions.

In little over 25 years since the concept came to prominence, EBM has changed the way in which medicine is practised around the world. I have enormous respect for the achievements of the movement; for example, systematic reviews, meta-analyses and indirect treatment comparisons are now mainstays of decision-making about the availability and use of new medicines. As a sometime systematic reviewer myself, I know the excitement of seeing a clear pattern emerging from complex data and the joy of using a rigorous methodology to reveal something that no one has seen before.

Much of the programme at EBM Live was devoted to calling out bad behaviour within pharma, as in previous years. These stories, while shocking, are old. In fact, even the examples I hadn’t heard before were never less than 10 years old. I understand the sense of betrayal felt by EBM practitioners who believe their hard work was subverted by unscrupulous behaviour within certain pharma companies. That said, now is the time to move on.

Pharma has cleaned up its act beyond all recognition. At Oxford PharmaGenesis, we have sought to bring perceptions about pharma up to date. We have attended EBM Live (formerly Evidence Live) for 4 years, contributing to presentations, workshops and informal discussions. In 2016, we presented data showing that professional medical writing support is associated with more timely and complete reporting of clinical trials. In 2018, we presented an analysis demonstrating that pharma companies have transformed their disclosure performance, with higher rates of disclosure observed for pharma (74%) than for non-pharma sponsors (46%). Indeed, Ben Goldacre and colleagues from the Centre for EBM at the University of Oxford are showing that pharma companies are commonly reporting 100% of their clinical trials, with no evidence that they are driving outcome switching or other questionable practices. As Ben told me with characteristic circumspection, “Nobody is doing well. Nobody is meeting patients’ expectations. But pharma is currently performing better than academia in many quarters, and this should be celebrated. We must capitalize on it.”

EBM practitioners should now embrace initiatives that seek to make progress in the field. I was glad to be able to provide input to two such initiatives at previous EBM Live workshops, namely the Declaration to Improve Biomedical & Health Research and the EBM Manifesto 2.0. Such initiatives are advancing of the field of EBM by encouraging engagement between diverse stakeholders and should include the perspectives of pharma companies, which generate so much of the evidence on which EBM depends. Sustained scrutiny of pharma companies by experts in the EBM field was transformative. It played a crucial role in the transformation of pharma’s disclosure performance, leading to billion-dollar fines and sweeping policy changes. And yet, the repetition of old war stories about pharma dating back 15 years or more contributes to a feeling of stasis in the field – that nothing is ever going to change. Although many of the problems that EBM Live raises will, to some extent, always be with us, reporting of trials by pharma is an area where the field can be justly proud of its achievement. If EBM practitioners take time to celebrate this, then they will learn lessons for driving future change and, most importantly, remain motivated and relevant in the decades to come.