The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants ...have put themselves at risk. In January 2016 we published a proposal aimed at helping to create an environment in which the sharing of deidentified individual participant data becomes the norm. In response to our request for feedback we received many comments from individuals and groups.
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Some applauded the proposals while others expressed disappointment they did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the . . .
...there is real and justified fear about personal safety, fuelled by a scandalous and widespread lack of personal protective equipment (PPE). Anna Sayburn’s summary of PPE guidance from the World ...Health Organization, Public Health England, and specialist societies highlights the confusing variation (doi:10.1136/bmj.m1297), which in some cases is leading to inappropriate overuse and wastage. Lack of testing and PPE are redolent of the Ebola outbreak, say Megan Diamond and Liana Woskie on BMJ Opinion (https://bit.ly/2UOMSQS), showing that vital lessons have not been learnt.
Billed as a review into ethnic disparities and covid-19, it devotes only a small proportion of its pages to ethnicity, and, while confirming what we knew—that people from ethnic minority groups are ...more likely to become infected and to die from covid-19—it makes no attempt to explain the disparities or make recommendations for action. Covid-19 has produced a “stress test” for structural racism in healthcare and public health, say Christine Douglass and colleagues (https://blogs.bmj.com/bmj/2020/06/08/structural-racism-in-society-and-the-covid-19-stress-test). The NHS’s response in setting up a Race and Health Observatory is another (doi:10.1136/bmj.m2191).
A damning report from a people’s inquiry concludes that the government has been grossly negligent, amounting to misconduct in public office (doi:10.1136/bmj.n2955).1 And although lessons may have ...been learnt about procurement and stockpiling of personal protective equipment (doi:10.1136/bmj.n2849),2 there is now a worrying and costly fixation on unproved antiviral drugs, with echoes of the Tamiflu saga (bmj.com/tamiflu). The UK was the first country, now followed by the US (doi:10.1136/bmj.n2984),3 to approve an antiviral for covid-19, on the evidence of a single clinical trial, apparently to fulfil an “impossible promise” by politicians to have two antivirals ready for use by the autumn (doi:10.1136/bmj.n2611).4 This despite incontrovertible evidence that the virus is airborne, that a combination of masks, screens, social distancing, and ventilation can stop transmission (see our interactive graphic bmj.com/content/375/bmj-2021-065312/infographic), and that the real money must urgently go on improving indoor air quality (doi:10.1136/bmj.n2895).5 Each country has had its own reasons for failures in preparing for emergencies, including wrong assumptions about potential threats. For the UK it was flu, for the US bioterrorism, prompting stockpiles of smallpox vaccine and nerve gas antidote (doi:10.1136/bmj.n2849).2 Paradoxically perhaps, some countries in Africa have shown what can be done, using their hard won understanding of health emergencies (doi:10.1136/bmj.n2512).6 Their response included the genome sequencing that alerted the world to the new variant, omicron.
Trish Greenhalgh and colleagues recommend taking a whole person, pragmatic approach with symptom management that avoids overinvestigation.5 With so much uncertainty about the cause and course of long ...covid, a doctor’s key role is to be a witness, they say, “‘honouring the story’ of the patient whose protracted recovery is unexpected, alarming, and does not make sense.” The challenge for those in charge of our public health response to covid-19 is to make sense of this emergent information. Policies and messaging must now reflect the risks to younger people of developing prolonged illness and multiple organ damage, especially in light of other new information about the risks of airborne transmission.67 For this, we need to be able to quantify the risks through proper population surveillance and to mitigate them with effective systems of rapid testing, tracing, isolation, and support.8 In the UK, at least, such crucial traditional public health approaches still seem a long way off.9 1 Alwan NA.
Centuries of injustice have diverted wealth from Africa, leaving the continent without the necessary manufacturing infrastructure ...(https://blogs.bmj.com/bmj/2021/08/13/the-legacies-of-colonialism-putting-african-covid-19-vaccination-into-context).2 By contrast India has no shortage of manufacturing capacity, but production has been restricted to the two vaccine manufacturers with patent rights, and half of the doses produced in India are exported or given away in aid. Australia’s slow and turbulent vaccine rollout has snatched defeat from the jaws of victory, says Renza Scibilia (https://blogs.bmj.com/bmj/2021/08/12/australias-covid-19-experience-pride-before-the-fall).4 Countries in east Asia will need to achieve high vaccine coverage before relaxing other measures, say Jingyi Xiao and colleagues (https://blogs.bmj.com/bmj/2021/08/11/transitioning-from-covid-19-elimination-to-sustainable-endemicity-in-east-asia).5 Vaccines are the only foreseeable exit, they say, bridging the transition from elimination to “sustainable endemicity.” For the moment, current vaccines seem to protect against the dominant delta variant (doi:10.1136/bmj.n2029),6 reducing risk of infection, serious illness, and death, although not as well as against the original wild type or the alpha variant (doi:10.1136/bmj.n1960).7 Longitudinal data are needed to track the vaccines’ effectiveness in the face of the potential emergence of new variants (doi:10.1136/bmj.n1976).8 The lessons and challenges of covid will differ for each region and country (doi:10.1136/bmj.n1858).9 But the world will emerge safely from this pandemic only if vaccines are no longer seen as a commercial commodity.
Would we then be wrong to insist that the best standards of research integrity should nonetheless prevail ...(https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-effective-vaccines-we-need-more-details-and-the-raw-data)?1 Sadly, a picture is emerging, from one commercially contracted trial centre at least, of poor research conduct, lax data management, and a lack of regulatory oversight. Reports by a former employee of the contract research organisation that enrolled patients into Pfizer’s pivotal vaccine trial raise serious questions about the safety of participants and integrity of the data (doi:10.1136/bmj.n2635).2 We don’t yet know the impact of these problems on the trial as a whole. Before the pandemic, an estimated 40% of deaths worldwide were not registered, with under-reporting most marked in low income and fragile settings (doi:10.1136/bmj.n2239).5 The pandemic is unlikely to have made this better. Because death numbers are the basis for evaluating the progress of the pandemic and the effectiveness of public health interventions.
...the regulator has made it clear that, despite giving emergency temporary authorisation, all the usual procedures were followed.1 Now we need to make sure that the vaccination programme is ...implemented well, say Azeem Majeed and Mariam Molokhia, avoiding the “many mistakes made during other components of the government’s response” to the pandemic.2 Given that this has to be delivered alongside an expanded flu vaccination programme,3 primary care must be properly funded, with special attention to protecting those most vulnerable to infection.4 Internationally it also means ensuring fair allocation and equitable distribution.5 Legitimate questions about the vaccines will continue,6 even after the phase III results are released.7 So too will questions about how governments are making decisions. The UK’s National Audit Office has been highly critical of cronyism, saying that in times of crisis it’s even more important to have a clear approach to managing conflicts of interest. Independent Food Aid Network gives a voice to those determined to make a difference.
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