Medicine and Science from The BMJ

Talk Evidence covid-19 update - How will we know if a vaccine works?

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

Tackling racism with Annabel Sowemimo, Shani Scott and Joan Saddler OBE

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

Making the drug and device system fit for patients

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

What are the chances of an American vaccine?

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.

Wellbeing – how to say no

We all know that healthcare professionals are stretching themselves to provide the care that’s needed right now. But there are instances when you might find yourself out of your comfort zone or being pushed too hard or fast. When is it ok to say no to these demands?
We spoke to Kate Burnett who educates NHS staff on empowerment about how to voice your position clearly and how to reconcile the guilt you might feel of letting the side down.
www.bmj.com/wellbeing

Talk Evidence covid-19 update - drop in excess deaths, HIV drugs, academic promotion

In this week's Talk Evidence we're hearing about how the death rate has dropped below average, disappointment about HIV drugs for covid-19 treatment, a trial to reduce polypharmacy, and why academic promotions matter to everyone else.
1.35 - Carl gives us one of his death updates
3.30 - Helen asks if it’s finally time to be able to do the international comparisons we’ve been waiting for?
16.10 - New research suggests that extreme PPE prevents transmission - but PPE came with a whole range of other viral suppression measures, and they all work together.
21.30 - The Recovery trial has said that  lopinavir-ritonavir isn’t effective against covid - enough for them to stop the arm of that trial. We talk about this and more treatment evidence.
24.00 - Can a digital intervention reduce poly pharmacy? A new trial on bmj.com says no, but we talk about the composite endpoint and the way the trial is powered.
36.25 - Why academic promotion matters to non academics

Lowering the shield with Julia Marcus and Carol Liddle

The relaxation of the COVID-19 lockdown regulations is raising a lot of questions, both for doctors and for patients. This week, we discuss how the lack of clarity and coherence in public health messages over the past few months has caused anxiety and confusion for our patients, especially those who have been told to shield. We talk about GPs tailoring shielding advice to suit the individuals they treat, the politicisation of mask wearing, and the flaws of ‘abstinence-only’ health messaging. How do we balance prompting overall health, rather than just working to prevent disease, and how do we start taking baby steps towards returning to normality?
Our guests:
Julia Marcus is an infectious disease epidemiologist and Assistant Professor at Harvard Medical School’s Department of Population Medicine . She is also an HIV researcher.
Carol Liddle, a COPD patient, is a patient advocate on the panel for NACAP (National asthma and COPD audit), as well as a patient representative for the Taskforce for Lung Health, which is run by the British Lung Foundation.
Tom, Navjoyt and Jenny mentioned some resources they have found useful while looking at racism in medicine - which we have compiled into this document https://bit.ly/DBIRacismResources

David Michaels - Doubt is an industry tactic

For a long time, the BMJ has been interested in conflicts of interest and how that skews the research base.
We also heard in our podcast on "Big Tan" that science is being used to sow seeds of doubt into the association between sunbeds and skin cancer, by scrutinizing the minutiae of a research paper, but ignoring it's bigger message.
Now it's all just happening in medicine. This is an industry tactic. And to talk about that we're joined by David Michaels - who was the longest serving head of the Occupational Safety and Health Administration, and an epidemiologist and professor at the George Washington University School of Public Health.
Read The BMJ's collection - Commercial influence in health: from transparency to independence
https://www.bmj.com/commercial-influence
To find out more from David, plus his two books on the influence of industry
https://www.drdavidmichaels.com/

Covid-19 in the U.S. - returning to work in a pandemic

In the third part of our series of podcasts “Corona Virus as Seen Through a US Lens,” features editor for The BMJ, Joanne Silberner, talks to Dr. Adeline Goss about the experience of being a new mom and a hospital resident during the crisis.
In The BMJ, Dr Goss recently wrote about the challenges facing medical residents as they deal with working during the virus.
When she went on maternity leave a few months ago, nothing seemed amiss, beyond the normal stress of being a new mom. But when she returned to full time work on June 1, everything had changed. Goss kept an audio diary of her experience preparing and going back to work and we hear some of that during the podcast.
For more of The BMJ's covid-19 coverage www.bmj.com/coronavirus

Talk Evidence covid-19 update - dexamethosone, testing, rehabilitation after covid.

This week we're looking beyond the press release for dexamethasone, the long awaited review of antibody testing, and how well people are recovering after surviving acute covid-19.
(2.36) The preprint for dexamethasone is finally out - considerably after the press release. Carl digs into it to find out how good the news actually is.
(8.49) There are a couple of newly published systematic reviews on antibody testing, so we return to our testing guru Jon Deeks - professor of biostatistics at the University of Birmingham to give us an update.
(23.52)Covid-19, it became apparent as the pandemic grew, was more than a respiratory disease - there are systemic effects on almost all organs. As people are recovering from the worst ravages of the disease, the long term consequences of those effects are becoming more clear - Lynne Turner-Stokes, professor of rehabilitation medicine at King's College London.
Reading list;
Effect of Dexamethasone in Hospitalized Patients with COVID-19: Preliminary Report
https://www.medrxiv.org/content/10.1101/2020.06.22.20137273v1
Cochrane review of antibody tests for covid-19
DOI: 10.1002/14651858.CD013652
British society of rehabilitation medicine guidelines for rehab after covid-19.
https://www.bsrm.org.uk/downloads/covid-19bsrmissue1-published-27-4-2020.pdf