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A report has been posted by the Institute of Global Change in which Tony Blair comments on therapeutic drugs being used to treat all coronavirus patients in hospital at serious risk of illness.
Prof Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine, University of Oxford and Chief Investigator of the RECOVERY trial, said:
“This report contains many helpful proposals, including support for more people to join the RECOVERY trial. However, the suggestion in the forward by Tony Blair to allow widespread use of unproven drugs outside of clinical trials is well meaning but misguided and will only serve to slow progress towards better treatments for COVID-19. Drugs are not therapies or medicines until they have been proven, without doubt, to be safe and effective. This can only be done through clinical trials. We have learnt time and time again that observational data from routine clinical use is highly unreliable, not least because of biases in who is and who is not given particular treatments. You only have to look at what has happened with hydrxoychloroquine to see the folly of this approach. Hydroxychloroquine was promoted by President Trump, given an emergency use authorisation by the FDA, used very widely in the United States, reported as effective in observational studies, and then shown by a proper trial in the UK, the RECOVERY trial, to be completely ineffective. If we had not done this trial in the UK, the world would still be using ineffective drugs like hydroxychloroquine instead of drugs that do work like dexamethasone. An argument that trials deny ‘life-saving treatments’ has been used repeatedly during outbreaks but is fallacious. To the contrary, it is the failure to do rigorous trials that denies and delays life-saving treatments. The quickest way to save more lives is to expand research and offer access to a clinical trial to every single hospitalised COVID patient.”
Prof Martin Landray, Professor of Medicine & Epidemiology, Nuffield Department of Population Health, University of Oxford and Co-lead, RECOVERY trial, said:
“We have seen time and again during this epidemic that one simply cannot second-guess which treatments work and which do not. Clinical trials play an essential role in differentiating drugs that we hope work from those that we know actually do work.
“The RECOVERY trial is the largest randomised trial of COVID treatments in the world and has drawn praise for its scale, speed, and rigour in producing clear results that improve clinical care and save lives.
“If it wasn’t for the RECOVERY trial, we would never know that dexamethasone reduces the risk of death among patients with the severest forms of COVID – the only treatment known to do so. Within hours of that result being known, it became standard practice for NHS hospitals and worldwide.
“If it wasn’t for RECOVERY, we would still be using hydroxychloroquine and lopinavir, two treatments that were widely promoted and prescribed around the world, but which the RECOVERY trial has shown to be useless in this setting. Throwing unproven drugs at patients outside the context of a clinical trial does not help those patients (exposing them to potential harms for no gain), nor does it help future patients (since doctors are none the wiser). It also wastes resources (money, manufacturing, distribution, NHS staff time) and prevents us making the true discoveries that would save lives and get us out of the current situation.
“The UK’s RECOVERY trial is running at every NHS hospital in the country and is open to every patient admitted with COVID, regardless of age, gender, ethnicity, pregnancy, other illnesses, or location. The objective is to find those treatments that tackle the worst manifestations of this disease – treatments that shorten hospital stay, reduce the need for mechanical ventilators, and save lives. Over 15,000 patients have taken part so far –we are enormously grateful to them and their families for doing so at such a difficult time.
“The fastest way to find effective treatments is to increase the speed of enrolment. Currently around 1 in every 10 patients admitted to hospital with COVID are enrolled in RECOVERY but if we could increase that, to say 1 in every 2 patients, we would have answers by the end of November. Those treatments shown to work could then become standard NHS care in December.”
Prof Adam Finn, Professor of Paediatrics, University of Bristol, said:
“I think it would be useful to point out to Mr Blair and those reading his proposals that the only sound way to work out whether a specific treatment is safe and effective is by doing randomised controlled trials similar to the Recovery trial. Simply giving drugs to patients and watching to see what happens does not tell you whether or not they work because you have nothing to compare them with. Likewise you cannot tell whether there is a “safety issue” in any particular group of patients until you evaluate the therapy in question in a controlled randomised blinded trial that is free of bias. This is particularly important for novel therapies that have not been used previously to treat other conditions. This is not the only politician this year to have expressed opinions regarding unproven therapies and doubtless not the last and there have been some prominent doctors behaving similarly too – but if we are to avoid harming people and wasting time and resources we need to do this properly. The statement conveys the urgency of the situation. Randomised trials like Recovery and Solidarity can deliver clear answers extremely fast as long as they are well organised and able to recruit large numbers of patients rapidly – and they both are. By contrast giving treatments open-label slows everything down by leading us up blind alleys while playing roulette with our patients’ lives. I hope this message is clear enough to help sort out this muddled thinking.”
https://institute.global/policy/light-end-tunnel
All our previous output on this subject can be seen at this weblink:
www.sciencemediacentre.org/tag/covid-19
Declared interests
Prof Martin Landray:
– Co-chief investigator of the RECOVERY trial of potential treatments for COVID-19 (funded by UKRI and NIHR; contributions to supply of study treatment from Abbvie, Roche, and Regeneron).
– Research funding to University of Oxford received from Novartis, Boehringer Ingelheim, and Merck Sharp & Dohme.-
– Infrastructure and core funding received from Health Data Research UK, NIHR Oxford Biomedical Research Centre, UK Biobank Ltd, MRC Population Health Research Unit, and British Heart Foundation Centre for Research Excellence.
– Employee of University of Oxford with salary supported by Li Ka Shing Foundation, Health Data Research UK, NIHR Oxford Biomedical Research Centre, Wellcome Trust, and National Health Service.
– I do not accept personal honoraria payments directly or indirectly from the pharmaceutical, biotechnology, or food industries although reimbursement to the University of Oxford for the costs of travel and accommodation to participate in scientific meetings may be accepted. I hold no shares in and receive no consultancy payments directly or indirectly from tobacco, pharmaceutical, biotechnology, or food companies. I comply with the Independence of Research Policy of the Nuffield Department of Population Health, University of Oxford. For details see: https://www.ndph.ox.ac.uk/files/about/ndph-independence-of-research-policy-jun-20.pdf/@@download
Prof Peter Horby: “Chief Investigator of the RECOVERY trial.”
Prof Adam Finn: “No conflicts”