Medicine and Science from The BMJ

Fresh outbreaks of covid in Europe and a wave of infections in the United States have been in the news this week, highlighting the renewed need for social distancing – but to what extent? In this edition, we explore the real-world evidence for physical distancing measures as well as the research into whether or not facemasks make us behave more recklessly. We also discuss the non-covid themes of research transparency and a BMJ investigation into the lucrative business of orphan drugs.

In light of the publication of the Independent Medicines and Medical Devices Safety Review (the Cumberlege report) in early July, which assessed the use of vaginal mesh, sodium valproate and Primodos and their associated under-acknowledged complications, this week we discuss trust between patients and doctors, and how that relationship of trust can break down when patients feel that their concerns and their pain are not being recognised and supported. We talk about the influence of racial inequalities on trust and healthcare outcomes, GPs being an advocate for their patients, and we ask what structural changes to the healthcare system need to happen to allow us to spend more time with our patients and build up that trusting relationship with them? Our guests: Karen Praeter works on the admin team of Sling the Mesh, a campaign which raises awareness of the risks of having a vaginal mesh implant, having joined two years after her own mesh implant operation in 2015 which led to painful complications. Rhea Boyd is a paediatrician at the Palo Alto Medical Foundation in California, and she is also a public health advocate and scholar.

Lockdown has been such a stressful period that many healthcare professionals developed abnormal behaviours to cope. Addiction is one such behaviour, be it to a substance – alcohol for example – or any other obsessive activity like exercise. Dr Caroline Walker, an NHS psychiatrist and therapist who has personal experience of addiction discusses the harmful behaviours to look out for and what to do about them.

This time of year we would usually be doing some podcasts from the BMJ awards - but the pandemic has delayed our plans. We’re still working on acknowledging some of the best medicine from around the UK, but in the meantime we’ve decided to give out the awards for outstanding contribution to health, and research paper of the year. In the following interview, Fiona Godlee - the BMJ’s editor in chief, talks to Marian Knight, lead author of the ANODE trial - The BMJ's research paper of the year. For more about The BMJ Awards categories and previous winners; https://thebmjawards.bmj.com/

This time of year we would usually be doing some podcasts from the BMJ awards - but the pandemic has delayed our plans. We’re still working on acknowledging some of the best medicine from around the UK, but in the meantime we’ve decided to give out the awards for outstanding contribution to health, and research paper of the year. In the following interview, Fiona Godlee - the BMJ’s editor in chief, talks to David Pencheon, director of the NHS sustainability unit about his work. For more about The BMJ Awards categories and previous winners; https://thebmjawards.bmj.com/

As the pandemic play out, we’ve seen ways in which the collection of covid data - and it’s sharing, has been flawed, with reports in the UK that local authorities haven't got granular data, and in the US that the CDC is being circumvented for data reporting. Kathleen Bachynski, assistant professor of public health at Muhlenburgh College, and Sridhar Venkatapuram, director of global health education & training at King's College London join us to discuss why data is fundamental to the social contract between the public and their government, and why undermining it is so dangerous.

Vaccines have been in the news this week - but when you dig into the stories, it turns out that the hype is about phase 1 trials. We're a long way from being sure any of the 150 possible vaccines being developed actually work. In this talk evidence we're talking to a researcher, a regulator, and a manufacturer about the way in covid-19 is upending normal vaccine development, which hurdles they'll have to reach to get onto the market, and how we'll know which one to choose when they are there. This week (1.10) We said that covid would have a knock-on effect on other treatments, and Helen looks at some research into acute coronary syndrome admissions in the UK. (6.53) Peter Doshi, assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy and an editor for The BMJ, tells us what to watch out for in the PICO for a vaccine study. (15.20) Marco Cavaleri, head of Biological Health Threats and Vaccines Strategy at the European Medicines Agency, explains what regulators are looking for when thinking about licencing a vaccine - and how covid has made different agencies around the world align their requirements. (22.22) Philip Cruz, UK head of vaccines at GSK, explains how a manufacturer tests their vaccines, and how they use adaptive study design to past regulatory hurdles and provide information for those choosing which vaccine to use. Reading list Lancet paper - COVID-19 pandemic and admission rates for and management of acute coronary syndromes in England https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31356-8/fulltext ONS Data - Deaths registered weekly in England and Wales, provisional: week ending 3 July 2020 https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsregisteredweeklyinenglandandwalesprovisional/latest The BMJ editorial - Vaccines, convalescent plasma, and monoclonal antibodies for covid-19 https://www.bmj.com/content/370/bmj.m2722 WHO report - Draft landscape of COVID-19 candidate vaccines https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines Research Methods & Reporting The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design https://www.bmj.com/content/369/bmj.m115

The signs and symptoms of racism have long permeated our society, and are embedded in our clinical practice and medical education. Recent events in the US, including the murder of George Floyd, have brought the Black Lives Matter movement to the fore of public consciousness, and have sparked outrage and protests in countries around the world. COVID-19 has exposed the inequalities in our healthcare systems, as the virus has had a disproportionate impact on some ethnic minority communities. In this week’s episode, we discuss colonial undertones to contraception policy-making, how doctors remaining silent on racial issues are seen as complicit, and the lack of diversity in learning resources used in medical schools. How can we use the current climate as a teaching moment to engage with people, clinicians and patients, about their experiences of healthcare? And how do we begin to make reparations in medicine for centuries of institutionalised racism? Our guests: Annabel Sowemimo is a community Sexual & Reproductive Health registrar, working in Leicester. She is also the founder of Decolonising Contraception and a trustee for Medact charity. Shani Scott works as a general internist at Montefiore Medical Center in the Bronx. She is an associate program director for the Moses-Weiler Internal Medicine Residency Program, and is also the co-director of Diversity & Inclusion for the Department of Medicine at Montefiore Medical Center. Joan Saddler OBE is the director of partnerships and equality at the NHS Confederation, and the co-chair of the NHS Equality & Diversity Council. She was awarded an OBE in 2007 for services to health and diversity. Resources mentioned by Jenny: NEJM Perspective, "How Medical Education is Missing the Bull's-eye" by LaShyra Nolen https://www.nejm.org/doi/full/10.1056/NEJMp1915891 America Did What?! Podcast with Blair Imani & Kate Robards Episode 1: Redlining and the GI Bill https://www.stitcher.com/podcast/america-did-what

A series of medical scandals prompted Jeremy Hunt, former UK health secretary to launch the Independent Medicines and Medical Devices Safety Review - with the explicit aim of strengthening the patient voice in order to help build a "system that listens, hears and acts – with speed, compassion and proportionality" That report is out, and describes a system that does anything but. In this podcast, Sir Cyril Chantler, the review's vice chair discusses their recommendations, for better regulation, transparency and patient advocacy in the use of medicines and medical devices. Read the full report: https://www.immdsreview.org.uk/ The BMJ report into what we must learn from mesh https://www.bmj.com/content/363/bmj.k4254

US President Donald Trump has been pushing hard for an American vaccine against Covid-19. He's named the program Operation Warp Speed, which has many people worried that safety tests will be rushed. What are the prospects for an American vaccine against Covid-19? If the US is first, will it make its vaccines available to other countries? And what if it's not first? Three American vaccine experts talk with the BMJ about prospects for an American vaccine against the new coronavirus. Joining us are; Nicole Lurrie - senior lecturer at Harvard Medical School and a strategic adviser to the foundation working on global vaccines, CEPI. Paul Offit - professor at the University of Pennsylvania, and co inventor of a rotavirus vaccine. Prashant Yadav - senior fellow at the Centre for Global Development and a lecturer at Harvard Medical School.