Science at warp speed: Medical research during the COVID-19 pandemic – Melanie Gentgall

In this episode of JBI Dialogues we welcome one of the authors of an article in the journal’s new symposium on the social and ethical implications of the COVID-19 pandemic. 

Melanie Gentgall is founding CEO of PRAXIS Australia, an independent not-for-profit that was created to promote excellence in research and research ethics review, design and conduct in Australia and internationally.

Together with Wendy Lipworth, Ian Kerridge, and Cameron Stewart, Melanie co-authored the article “Science at Warp Speed: Medical Research, Publication, and Translation During the COVID-19 Pandemic”. Here she talks about that work and recent developments, including new announcements made about the promise of multiple experimental COVID-19 vaccines.

Article abstract: In response to the COVID-19 pandemic, there has been a rapid growth in research focused on developing vaccines and therapies. In this context, the need for speed is taken for granted, and the scientific process has adapted to accommodate this. On the surface, attempts to speed up the research enterprise appear to be a good thing. It is, however, important to consider what, if anything, might be lost when biomedical innovation is sped up. In this article we use the case of a study recently retracted from the Lancet to illustrate the potential risks and harms associated with speeding up science. We then argue that, with appropriate governance mechanisms in place (and adequately resourced), it should be quite possible to both speed up science and remain attentive to scientific quality and integrity.

Links / resources

• The complete collection of the Journal of Bioethical Inquiry COVID-19 symposium articles -   Part 1 and Part 2 
• Direct link to the #Free2Read article discussed in the episode: Science at Warp Speed: Medical Research, Publication, and Translation During the COVID-19 Pandemic,  by Wendy Lipworth, Melanie Gentgall, Ian Kerridge, and Cameron Stewart
• Therapeutic Goods Administration statement, 18 November 2020, COVID-19 vaccine provisional determinations 

Image:  Aldon Scott McLeod from FreeImages

Transcript

Edwina: 0:00

Hello and welcome back to JBI Dialogues, presented by the Journal of Bioethical Inquiry as a multidisciplinary space to connect academic professional and community voices in conversation about its published research and up and coming issues and practices in bioethics. My name is Edwina Light, and I'm the digital content editor at the JBI. In this episode of JBI dialogues, we welcome one of the authors of an article in the Journal's new symposium on the social and ethical implications of the COVID-19 pandemic. Melanie Gentgall is founding CEO of Praxis Australia, an independent not-for-profit that was created to promote excellence in research and research ethics, review, design, and conduct in Australia and internationally. Together with Wendy Lipworth, Ian Kerridge and Cameron Stewart, Melanie co-authored the article"Science at warp speed: medical research, publication, and translation during the COVID-19 pandemic". And she's here today to talk about that work and some recent developments. Melanie, thank you for speaking with me today.

Melanie: 0:58

Thanks so much for inviting me to join you, Edwina. It's an absolute pleasure.

Edwina: 1:01

Wonderful. This week, and we're talking in late November, 2020, there've been new announcements about the promise of multiple experimental COVID-19 vaccines, raising much hope and a lot of questions. Now, your article examines the rapid growth in research focused on developing COVID-19 vaccines and therapies, and how the scientific process is adapting to the need for speed. Perhaps before we get into some of the details about... and more recent developments, could you give us a brief overview of the article? What is it about?

Melanie: 1:34

Of course Edwina. And so essentially the paper that we wrote wrote was really a reflection on how rapidly science and innovation has had to move to respond to the demands of the pandemic. But importantly, it really highlights a case study that was very much in the media, as well as in the scientific domains, around an important case study authored by a group, and we'll call it the Surgisphere case, where it really identified how the risks of science at warp speed were triangulated as a result of attempts to rapidly disseminate information. And it resulted in dangerous changes in policy, alterations to good scientific practice and also a significant risk to many people, including those who were using hydroxychloroquine, which was the drug involved in this particular case, for normal treatment for conditions outside of COVID-19. So the paper really serves to highlight that whilst there are improvements to our therapeutic development, timelines are absolutely critical and I don't think anybody would disagree with that. But there are also really inflection points that highlight where the noted benefits may be outweighed by the risks. And this is something that industry regulators and the scientific fraternity more largely really have to recognize in our race to find safe and effective treatments, to help us combat this current global health crisis. The one in a hundred years crisis, as it's been regarded by many.

Edwina: 3:17

Now you highlighted three potential failures in discussing that study, in that case, related to the speed of how research is conducted and reviewed. Failures of methodological rigor, failures of journal review, and failures to manage competing interests. What are the key questions and challenges related to those failures?

Melanie: 3:35

Look, I think this is a really important case because it highlights, as you said, a number of systemic failures and, and has also called those that have been involved in the discussion and release of this particular case into levels of accountability. But importantly, it's really helped us to identify where there are significant areas for improvement and also a need for greater transparency. So I think there are a couple of key questions that it raised. And the first one is really what is the role of governments and media and ensuring that misinformation or hype as it's been termed doesn't result in accelerated and extensive public access to treatments that haven't been rigorously tested and, and it also questions, the safeguards that are traditional safety nets and which, which of those really can't be usurped in our race to find efficient and effective treatments against traditional timelines. The second that I think it's really called into play, there's the role of our scientific journals that have traditionally been trusted for their editorial robustness. And it also questions our peer review systems and what is their role to ensure that critical and sensitive publications like this are rigorously assessed for validity before rush to publications. And we've seen a lot of preprints and other cases, particularly around the three vaccine candidates that we have currently as being touted as being safe and effective treatments that are, that are being released without the kinds of scientific data and rigorous approach to quality and integrity that we would normally expect from, you know, these sorts of candidates that will impact, you know, many millions of people across the globe. So I think it's also called our scientific journals into a level of accountability around, why did it actually take so long in this particular case for them to come to the party and retract the information, given that there was such a strong global call from the scientific community about the rigorousness of the data that was being, that was being presented in these papers? And it really highlights the issues around competing interests that scientists, the scientific sector more broadly, but also, our journals, are really victim to. The other item that I think it highlights is the role of the co-authors. And, and this is a reflection on researchers more generally. And what role did they play in their inadequate scrutinization of the data sets and the methodologies prior to the publication of this pivotal study? What were their competing interests that would cause them to risk their reputations and public wellbeing? And what does this tell us more broadly about the system and how it operates? We've heard, you know, for many years, the focus is really around publish or perish. So, what are the motivators for researchers and people like Desai, who was the author of the Surgisphere case, and how can we disrupt those systems when we've failed to do that really historically in the past. And finally, I think it also calls us to question our aims to minimize bureaucratic ties in an effort to maximize efficiency and minimize harm. And how do we balance these things? Because this is a very delicate balance and this case really highlights the challenges of how we can attempt to balance those risks and harms against our need for public protection.

Edwina: 7:30

Some very important questions, as you say, and all continuing to play out. You wrote the article in August, it's been published just recently as part of this special symposium, and, as you're saying, as science and policy in this area continues to develop, how have you been able to maybe put some of the ideas from your paper to work in response, I suppose, to some of the challenges that you've just outlined.

Melanie: 7:54

I guess it's an important reflection to look at what's happened since that time. And there has been a lot of discussion around this case and also the issues that it highlights, and particularly around the acceleration of science during the pandemic and media and industry have really been challenged to ensure that early data is not released in ways that can give false assurances. But I'm not sure that we've really seen that be enacted when, and again, when we reflect on the media hype that has surrounded these three vaccine candidates with the release of information into public spheres, for people who don't necessarily have an understanding of what good scientific rigour really means. So we're seeing industry in the media competing currently to be the first to the line with a successful vaccine. But extensive and supportive data is not really there to support the release of this information. And, you know, when you read the many scientific conversations by many across the sector, about these particular candidates, many of them are questioning if the final data is actually robust enough to support the release of these candidates into the larger populations. And will we see a retraction of these studies? Will we see them actually be redesigned? I think until we get full transparency around each of these particular studies then we're still at a loss to understand what the overall impact of these candidates will be. But I think there's also been, you know, a significant impact to the risk of public faith in science. And that's also been well documented in lots of discussion pieces. And how, what role does the scientific industry have to ensure that there's a collective goodwill and commitment to rigorous analysis of data and robust research integrity processes that are also timely, but transparent. And I think there's a key question that we all have to ask and that is, what is our role in ensuring that we bring the public along with us in these discussions? Because they're consumers of news and consumers of information, and obviously, consumers of the end outcomes, which will be the vaccines. But I think it's probably fair to say that with the growing number of people joining the anti-vax debates and conspiracy theorists growing in number and in size and in reach that potentially the divide between public and science seems to be growing, and never has there been a time when we need that to divide to be bridged more than in these current days. And I think it's also important just to reflect on what's happened nationally, Edwina, and I note that the TGA[Therapeutic Goods Administration] just in recent days, so the TGA being our local regulator here in Australia, has released its own position statement on their role in vaccine approvals and registration, and particularly around the provisional pathway scheme, which is similar to the emergency use access scheme in the US which they HCQ[Hydroxychloroquine] case really highlighted because you know, the Trump administration called for emergency use access for this drug. But I think what's really important about the TGA release and it is pivotal and it's important for the Australian sector, because it is about restoring that trust in our regulatory processes. But how is that information actually being given to the public? What is the level of awareness and campaigns that are being given to the consumer in society, more broadly about Australia's role in making sure that we are protecting our society by making sure that our systems and processes are robust. So I think that's a really critical piece that we have to reflect on, now, but also in retrospect, when we come out of these days of the pandemic and say, what is our responsibility to the public more broadly in ways that are meaningful to them?

Edwina: 12:12

Thanks, Melanie, that's very interesting and puts it all into some context for everybody. Now in the paper you argue that it is actually possible to speed up the science and still remain attentive to scientific quality and integrity. Just to finish up, perhaps you could tell us a bit about what that means and, in particular, in the context of what you've just been talking about.

Melanie: 12:33

Yeah look, and I think there are lots of silver linings to the pandemic. And one of the things that we've seen is that there has been collaborative efforts to really improve the ways that we conduct research and the ways that we speed up development timelines. And these are all critical discussions and things that we've been trying to do to address nationally, but also internationally for many years. But it also, I think, highlights that, you know, there are barriers to collaboration and there are barriers to ours, to our scientific systems and our research systems. But it was also highlighted where there are opportunities and in global collaborative studies, such as innovative platform and adaptive design studies, like REMAP-CAP[https://www.remapcap.org/], have demonstrated where success lies. So I think we need to work better. Not just faster. We need to be thinking about how we can more effectively pool our resources and knowledge. We need those robust and transparent regulatory systems that support scientific advancements. And we also need a research ecosystem that recognizes and supports practices and processes that result in better outcomes for all. But that also recognize the risks and appreciate the role of competing interests. And I think the Surgisphere case was a really important case in point for recognizing where those competing interests lie. Not just for individuals, but also collectively. But again, importantly, I think we must do more to engage the public in ways that are meaningful to them so that we can optimize trust and reduce what we've seen has been a reduction in trust in the scientific processes more broadly.

Edwina: 14:21

Thank you, Melanie. And thank you for your time today.

Melanie: 14:24

My pleasure Edwina.

Edwina: 14:25

That was Melanie Gentgall, who together with Wendy Lipworth, Ian Kerridge and Cameron Stewart co-authored one of the wonderful new articles in our COVID-19 symposium,"Science at warp speed". Something that everyone across the globe is grappling with at the moment. And thank you for joining us for JBI dialogues. A transcript of this audio resource is available on our website, bioethicalinquiry.com, where you'll also find links to the article discussed today and as well as other JBI articles and issues. For JBI updates, subscribe on the website to our email newsletter or follow us on Twitter@bioethicinquiry. The Journal of Bioethical Inquiry is the official journal of the Australasian Association of Bioethics and Health Law and the University of Otago's Bioethics Centre. It's published by Springer Nature.