this week WOBBLE ROOMS page 297 • POPULATION TESTING page 298 • INFANT FORMULA page 300 FINNBARR WEBSTER/GETTYIMAGES “£18bn spent on opaque covid contracts”

The government failed to provide Personal protective equipment accounted The government awarded transparency when hastily awarding for 80% of the contracts awarded (more contracts worth a total of billions of pounds’ worth of contracts during than 6900) and 68% of the total value £12.3bn to PPE suppliers, the pandemic, the UK’s public spending (£12.3bn). The DHSC awarded £1.5bn many without a competitive tender process watchdog has concluded. worth of contracts to 71 suppliers, before The National Audit Offi ce said that there its process to assess applications was was also inadequate documentation on how standardised, the NAO found. the government had reached key decisions, The government also established a including why suppliers were chosen or “high priority lane” to assess potential PPE how potential confl icts of interest had been sources referred by offi cials and politicians handled. that were deemed more credible. About one The investigation found that the in 10 suppliers processed through this lane government awarded more than 8600 (47 of 493) obtained contracts, compared contracts worth £18bn by 31 July, with with less than one in 100 in the ordinary LATEST ONLINE most (worth £16.2bn) awarded by the lane (104 of 14 892). The NAO also found Innova lateral flow Department of Health and Social Care that sources of referrals to the high priority test is not fi t for (DHSC) and its national bodies. Contracts lane were not always documented. “test and release” totalling £10.5bn were awarded without a The NAO reported that many awarded strategy, say competitive tender process, the NAO found. contracts have not been published in a experts Gareth Davies, head of the NAO, said, timely manner. By 10 November details Nearly half “While we recognise these were exceptional were still missing for 55% of the 1644 of advertised circumstances, it remains essential that contracts worth more than £25 000 consultant decisions are properly documented and awarded up to the end of July. Only 25% physician posts made transparent if government is to were published within the 90 day target. left unfi lled, maintain public trust that taxpayers’ money Meg Hillier, the Labour chair of the Public census fi nds is being spent appropriately and fairly. Accounts Committee, said, “The mistakes Third covid-19 “The evidence set out in our report shows revealed by this report are likely to be only candidate vaccine that these standards of transparency and the tip of the iceberg.” will be tested in documentation were not consistently met in Gareth Iacobucci, The BMJ the UK the fi rst phase of the pandemic.” Cite this as: BMJ 2020;371:m4474 the bmj | 21 November 2020 295 SEVEN DAYS IN Government faces legal action over £75m contract for covid-19 antibody tests

Legal action has been launched over the government’s award of a £75m contract for one million antibody tests to a business consortium, alleging the deal unlawfully bypassed safeguards protecting taxpayers’ money. Judicial review proceedings issued on 11 November by the Good Law Project, a not-for-profi t organisation, say the government was actively involved in setting up the UK Rapid Test Consortium and gave it £10m to manufacture testing kits. The contract to purchase the AbC-19 Rapid Tests was signed without a public tender and without evaluating the tests. This, the project argues, raises serious concerns about the maladministration of public funds. A study published this week in The BMJ (p 312) questions the test’s accuracy and suggests that, if used in real life settings, it would give a large number of false positive results. These conclusions contrast with an earlier (not yet peer reviewed) study suggesting the test gave no false positives. Jolyon Maugham (left ), director of the Good Law Project, said, “This was a £75m contract, let without competition, on the basis of profoundly flawed research.” The Department of Health and Social Care for England had not responded to requests for comment by the time The BMJ went to press. Stephen Armstrong, Cite this as: BMJ 2020;371:m4427

Covid-19 to , with support using the lateral flow test device, increasingly apparent from Care home visitors get materials for patients and health and full roll-out is expected by the 1980s, but some pregnant tests in pilot scheme professionals. the end of this week, including women were still receiving it three A pilot scheme has been primary care. However, Andy decades later. launched to provide regular Demand transparency on Robinson commented on , testing for one family member or vaccine deals, says MSF “Twice a week?? ’m a community Diabetes friend of care home residents in Médecins Sans Frontières nurse and I have not had a single “Every hospital should Hampshire, Cornwall, and Devon. called on governments to covid test since this all started.” have specialist team” Since 16 November visitors have demand transparency from drug Another tweet said, “Strange. All hospitals in England should been offered either polymerase companies on vaccine licensing Whilst working both frontline NHS have a specialist team dedicated chain reaction tests, to do at deals, costs, trials, and data as a and now supposedly employed to caring for inpatients with home, or the 30 minute rapid condition of funding. The charity as a doctor (despite being a med diabetes, said the latest report lateral flow tests, which can be said that the UK government has student) I have never had a single from the national Getting It administered in person at care contributed £84m to support the routine covid test.” Right First Time programme. It homes before a visit. The scheme development of AstraZeneca’s found that inpatient care, type 1 is expected to be rolled out more covid-19 vaccine, and early Sodium valproate widely in December. results are expected imminently. French drug regulator is But the terms of the deal between indicted for manslaughter Clinics are set up the company and the government French judges indicted the to tackle long covid have not been made public, nor country’s drug regulator, the A network of more than 40 long those of the four deals made with National Agency for Medicine covid specialist clinics in England other vaccine companies from and Health Product Safety, are due to open at the end of which the UK has pre-ordered for “injuries and involuntary November to help patients who 350 million doses. homicides through negligence,” diabetes care, and diabetic have long term physical and accusing it of failing to do enough foot care showed the most psychological symptoms. A total NHS staff cast to keep pregnant women from significant opportunities for of £10m will fund 10 sites in doubt on twice receiving the antiepileptic drug improvement. Trusts should also the Midlands region, seven weekly testing sodium valproate. Some 17 000 ensure that every healthcare in the North East, six in each NHS England and to 30 000 children are estimated professional who dispenses, of the East of England, South NHS Improvement to have experienced congenital prescribes, or administers West, and South East, five said that all 250 000 disease, developmental delay, insulin receives training to help in London, and three in patient-facing NHS autism, or behavioural disorders reduce insulin errors in hospital, the North West. A task staff working in 34 as a result of sodium valproate and every hospital should force will also help NHS trusts in England given to their mothers since it was have an electronic system to to manage the would be tested for first sold in France in 1967. The identify people with diabetes on NHS’s approach covid-19 twice a week drug’s teratogenic risks became admission, it advised.

296 21 November 2020 | the bmj SIXTY SECONDS MEDICINE ON . . . Smoking WOBBLE ROOMS Tobacco’s influence on UK policy grew in 2019 WHAT’S THIS, THE SORRY STATE OF The UK dropped from first to NHS BUILDINGS? fourth place in a global ranking No, this is a positive story. Wobble rooms table measuring how well are spaces where NHS staff can take a short break when things get too much. They’ve governments fared in 2019 at Tobacco lobbyists improved their influence on government in 2019 popped up across the country this year to preventing tobacco companies off er support during the pandemic. from interfering in policy and legislation. University of Bath in September 2019. Chaand SO STAFF CAN HAVE A WOBBLE? researchers, who led the work Nagpaul, chair of the BMA GPs Yes, exactly! As consultant psychiatrist Richard Duggins at Cumbria, with Action on Smoking and council, called on the government This year Health and others, highlighted to provide an urgent plan to help Northumberland, Tyne and Wear NHS the need for a legally binding and services cope this winter, backed 3793 Foundation Trust told The BMJ in April, publicly accessible lobby register. by appropriate funding. “Wobble rooms provide psychological fi rst In 2019 the UK scored 32 out doctors accepted aid as staff rise to challenges and adapt of 100, up from 26 in 2018 (the Family courts a GP training quickly. They care for those who care and help to make the unbearable bearable.” lower the number, the better the Allow medical experts to post, exceeding country is doing). give evidence remotely the mandatory HOW? Medical experts in family court target of 3250 and Well, at Duggins’s trust the rooms are Emergency surgery cases should be allowed to give stocked with drinks, food, and other nice Frail patients miss out on evidence from their hospitals, up things. There is a flipchart where staff can geriatrician input 40% share their feelings, messages of support, or said a working group of judges, on the 2700 Among 24 800 patients who royal colleges, and doctors’ things to be grateful for. Drop-in, facilitated had emergency bowel surgery representatives set up to tackle a recruited in 2014 staff support groups are also delivered there. in NHS hospitals shortage of doctors [Health Education ANYTHING ELSE? in England and willing to act as England] Homerton University Hospital Trust in London Wales in 2019 the experts in cases has a rule in its wobble room (in a converted 30 day mortality involving children. library space) that you aren’t allowed to talk reduced from This shortage was about covid-19. They’ve also had a visiting 11.8% in 2013 to “likely in some dog for some pet therapy. 9.3%, an audit by cases to be harmful I’M JELL-OUS the Royal College of Anaesthetists to children,” they said. The group Don’t be, you can get your own. Rachel found, but it was 18% among also recommended extending Pilling, cofounder of 15 seconds, 30 minutes frail patients aged over 65. the 26 week timescale to close (15s30m.co.uk ), which aims to increase joy To tackle this gap the report cases, as well as better training, at work, has put together some guidance recommends that all clinicians mentoring, and feedback. on how to do it, and it couldn’t be simpler. formally assess and document Step 1 is “write ‘wobble room’ on a piece of frailty in patients aged over 65 HIV prevention paper” and step 2 is “stick it on a door.” and that geriatricians should be Injection is “more effective embedded in general surgery. than daily pill” WHAT IF I’M NOT ON SITE? A phase III trial comparing a Virtual wobble rooms also exist. At Duggins’s trust, online spaces are off ered to teams to Waiting lists long acting form of the drug discuss the pandemic’s emotional Surgery waits of more than cabotegravir, taken as an impact. These sessions are off ered 52 weeks hit new high injection every eight weeks, by the trust’s Schwartz team. The number of people in England and daily oral Truvada will waiting more than 52 weeks end early, as interim analysis WILL THEY VANISH WHEN for elective treatment reached showed that cabotegravir was COVID DOES? 139 545 in September, 107 89% more effective. This comes Hopefully not. Duggins’s colleague, times the number in September after a similar study in men clinical nurse specialist Karen 2019 (1305). Figures from NHS and transgender women was Richardson, says their rooms England also showed that, in stopped in July after it found that continue to be used regularly—24 September, 1.72 million people incidence of HIV was 66% lower hours a day, seven days a week. “There’s been a decision to keep some of them had been waiting more than 18 in the injection group than in the permanently, so this is great news,” she says. weeks to start treatment, down Truvada group (0.41% v 1.22%). from 1.96 million the previous Abi Rimmer, The BMJ month but up from 672 112 Cite this as: BMJ 2020;371:m4459 Cite this as: BMJ 2020;371:m4461

the bmj | 21 November 2020 297 COVID-19

he government has NEWS ANALYSIS announced that 67 areas in England will be given access to rapid diagnostic Government ramps up Ttests for covid-19 in a major expansion of its Operation “Moonshot” mass testing Moonshot mass testing programme. Birmingham, Bristol, Manchester, With covid diagnostic testing set to be rolled out across England, Newcastle, and parts of London will be among the areas given access to Gareth Iacobucc i examines the latest developments lateral fl ow tests, which give results in 10 to 30 minutes, to test asymptomatic for rolling out what amounted to an spent £500m on procuring. populations for covid-19. The “extraordinary experiment across the However, one concern is that expansion follows a pilot in Liverpool whole of England where the purpose is although lateral fl ow tests are rapid that began on 6 November. far from clear.” they are not as good as polymerase The latest fi gures, shared with The She added, “Normally, if you were chain reaction (PCR) testing. An BMJ , show that as of 16 November the going to do a screening programme interim evaluation by Public Health pilot had tested 100 000 asymptomatic like this, you would start by asking the England’s Porton Down laboratory people, of whom 700 (0.7%) tested advice of the UK National Screening and the University of Oxford that positive for covid-19. The poor Committee . . . to understand its compared lateral fl ow antigen tests The government has also started detection feasibility and to try to get some handle with PCR tests found that, overall, the to roll out twice weekly testing for all rate of the on the harms, benefi ts, and costs. Innova lateral test detected covid-19 NHS staff and is planning to introduce test makes “We do not know, based on current in 76.8% of cases. mass testing of students between it entirely evidence,” Pollock added, “whether 30 November and 6 December. screening the general population Performance unsuitable for for SARS-CoV-2 will increase or But performance varied with settings. One in 10 of an area’s population the safe “test decrease disease transmission, It detected 79.2% (95% confi dence England’s health secretary, Matt and release” hospitalisations, and deaths. interval 72.8% to 84.6%) of cases Hancock, said NHS Test and Trace of people from “Detection and isolation of when done by laboratory scientists, would be sending out 600 000 lateral lockdown asymptomatic cases could potentially 73% (64.3% to 80.5%) when done by fl ow tests to directors of public health, Jon Deeks decrease disease transmission, trained healthcare workers, but only enabling each area to test 10% of but false reassurance from missed 58% (52.3% to 62.6%) when done by its population a week. The devolved cases could potentially increase self-trained members of the public. nations will also be able to test 10% of transmission, if people then engage in The evaluation also reported their populations each week. more risky behaviour.” a 0.32% false positive rate from “Mass testing is a vital tool to help lateral fl ow tests across several studies us control this virus and get life more “Diversion of resources” analysed. normal,” Hancock said. Mass screening proposals also risk Jon Deeks, professor of biostatistics But some experts remain sceptical causing harm through “signifi cant at Birmingham University, said, about the eff ectiveness and the ethics diversion of healthcare resources,” “While this is a very low rate, the of mass testing. Pollock said. numbers of false positives can still Allyson Pollock, professor of public Soldiers and NHS But Matt Ashton, director of public outnumber the number of cases health at Newcastle University, said staff set up a test health in Liverpool, said, “In the detected when used in mass screening there was “insuffi cient evidence” site in Liverpool middle of a pandemic with technology where very few will have the virus. developing rapidly, I think you have “For example, if 100 000 people are to try things. This is not going to be a tested in a city where the prevalence perfect scientifi c experiment; it’s not a of covid is 400 per 100 000, assuming well designed screening programme at the Innova test has a sensitivity of a national level. It’s a pilot to test out 58% and specifi city of 99.6% (as per new approaches” the testing centre performance), these Ashton said the pilot’s purpose fi gures predict the test will give 630 was to try to identify where the virus test positives. However, only 230 of was in Liverpool and to cut chains of these will have covid; 400 of them will transmission. It would also provide be false positives.” national learning about how mass He added, “The poor detection rate testing works, how the test itself of the test makes it entirely unsuitable works, and where it could be most for the government’s claim that it will eff ective. allow the safe ‘test and release’ of Liverpool is using the Innova lateral people from lockdown and students

PETER BYRNE/PA fl ow tests, which the government has from university.”

298 21 November 2020 | the bmj The government has proposed a mass testing programme for students Moderna vaccine is to enable them to return home this “nearly 95% effective” D URHAM UNIVERSITY’S Christmas while minimising the risk PILOT OF RAPID FLOW of spreading the disease. England’s The government has secured five million doses of the TESTING NHS Test and Trace will distribute covid-19 vaccine candidate mRNA-1273 from the US lateral fl ow tests, with priority given to company Moderna after interim analysis of its phase III has been mass areas with higher rates of covid. trial showed it was 94.5% effective. testing the use of lateral flow tests If the vaccine meets standards of effectiveness and since 26 October. Unlike other university pilots, it has trained Lack of study protocols safety and is approved by the UK regulator, it could be students and staff to self-administer Some universities such as Oxford delivered as early as spring, with the potential to procure the tests. It was initially rolled out to and Durham are already trialling more doses next year, a government statement said. two of Durham’s 17 colleges, and the their own rapid lateral fl ow testing The trial’s data safety monitoring board—which was university eventually plans to test arrangements. Pollock said she was appointed by the US National Institutes of Health— everybody who wishes to be tested opposed to universities participating carried out the analysis, based on 95 covid cases, of once a week. in pilots that lacked study protocols. which 90 were observed in the placebo group. Jacqui Ramagge, executive dean for “Universities are meant to be the The trial enrolled more than 30 000 US participants, science, who has been overseeing the heart of academic integrity and good including 7000 aged over 65 and 5000 under 65 with pilot, said it had been set up science,” she said. “This high risk chronic diseases. More than a third (37%) of to evaluate service delivery. is a huge experiment, and the participants were not white, with 6000 identifying as This means that testing universities should not be Hispanic and more than 3000 as black. Of the 95 people and entering of results is rolling this out.” with covid, 15 were over 65, 12 Hispanic, four black, voluntary, and the number of But Jacqui Ramagge (left), three Asian American, and one multiracial. voids, positives, or negatives is not known. executive dean for science The news came just over a week after Pfizer at Durham University, who announced that interim analysis showed its vaccine Ramagge said, “The [lateral has been overseeing the candidate was more than 90% effective. Neither Pfizer flow] devices have been validated. The question is around university’s pilot for rapid testing of nor Moderna have published full results, only releasing how often they should be used and students and staff (box), said there information in press releases. how confident one is that one is still was a “balance to be had” when As well as meeting the trial’s primary endpoint negative even after taking a test. No testing new approaches. (prevention of symptomatic covid-19 disease), the test grants you immunity. “Our pilot is not a research exercise. monitoring board looked at a secondary endpoint of “Students who test positive are It’s a service evaluation which is prevention of severe disease. There asked to seek a confirmatory primarily aimed at identifying the were 11 severe cases of covid-19, all PCR test. We have behavioural logistical and other impediments to reported in the placebo group. psychologists working with us. running at scale,” she said. Peter Openshaw, professor of Clearly communications to students “Until we have a vaccine, experimental medicine at Imperial are vital.” mass testing seems to be the best College London, said, “This boosts solution, particularly with certain optimism that we will have a choice Deeks said the evidence “raises demographics where there’s a higher of vaccines in the next few months. serious concerns that the benefi ts are prevalence of asymptomatic cases.” “Moderna has announced the likely to be few, with serious risks of The government seems determined vaccine can be kept in a conventional freezer for up to harm from the public being misled to press ahead with mass testing six months and that once thawed can be kept for up to 30 by the unjustifi ed claims of high and has invited bidders to apply for days in a standard refrigerator. This makes the vaccine performance of this test from the three tenders, worth £43bn in total, much easier to deliver.” It has been reported that the government.” to help deliver rapid testing across Pfizer candidate needs to be stored at −70°C. Ashton said that the Liverpool pilot the country. One of these tenders is No significant safety concerns about the Moderna was sending confi rmatory PCR testing for a contract worth £912m to supply candidate have been reported, and a review of solicited by post to people who tested positive lateral fl ow tests. adverse events found it was generally well tolerated. on the lateral fl ow test and was Pollock voiced dismay at these Eleanor Riley, professor of immunology and infectious carrying out daily quality assurance fi gures. “It is a scandalous use disease at Edinburgh University, said, “The safety data tests to understand the Innova’s of money and public funds to be look promising. The side effects appear to be in line with performance. awarding these contracts without those typically seen for other adult vaccinations. ” “We know that no test is perfect. good evidence that the tests work,” Elisabeth Mahase, The BMJ Cite this as: BMJ 2020;371:m4471 You will get false positives and false she said. negatives. In terms of false negatives, Innova was approached for a we’re in a national lockdown and comment but had not replied before THE TRIAL enrolled more than our information is quite clear that The BMJ went to press. 30 000 US participants, including people aren’t allowed to behave Gareth Iacobucci, The BMJ diff erently as a result of that negative Cite this as: BMJ 2020;371:m4460 7000 aged over 65 and 5000 under 65 with test,” he said. PERSONAL VIEW, page 316 high risk chronic diseases the bmj | 21 November 2020 299 COVID-19

A fifth of patients need NEWS ANALYSIS psychiatric help months Food banks and infant after contracting covid formula: what’s best? Almost one in five people in the US with covid-19 received a psychiatric diagnosis in the three months Doctors and campaigners criticise a charity’s call to allow afterwards, a study has shown. it to pass on breast milk substitutes. Jacqui Wise reports The rate of diagnosis was significantly higher than that seen after other health events such as other respiratory Feed, a Scottish charity set up food because of the pandemic. T h e tract infections, the researchers found. by a group of mothers, has been guidance recommends that local For the study, published in the Lancet Psychiatry, campaigning for a change to authorities have a clear pathway for researchers from the University of Oxford and the health guidance issued by Unicef UK, which the distribution of infant formula and research network TriNetX examined the anonymised recommends that food banks should that food banks should refer families records of just over 62 000 patients who had covid-19 not distribute infant formula. to statutory services, including health diagnosed between 20 January and 1 August. Overall, Feed’s campaign was reported in visitors and social services, if they are 18.1% of patients received a psychiatric diagnosis in the the Sunday Times under the headline, concerned that babies are in danger of 14 to 90 days after covid-19 was confirmed. For a quarter “Food banks’ ban on formula leaves not being fed. of these patients it was the first time a mental health babies to go hungry.” The article said condition had been observed. the guidance was causing food banks Possible harms The study reported that, in patients with no pre- to refuse donations and mothers to “Babies are too vulnerable and the existing psychiatric conditions, having a covid-19 water down formula or give unsuitable consequences too serious for families diagnosis was associated with an increased incidence porridge or cow’s milk. to have to rely on donations, which of psychiatric diagnosis However, Unicef said the article could be the wrong type of formula in the next 14 to 90 contained inaccuracies and that its or not enough for their baby’s days, when compared guidance was being misinterpreted. needs,” said Sue Ashmore, director with other health events Its Baby Friendly Initiative, in of the initiative. “Families in this (hazard ratio 2.1 (95% partnership with the charity First situation need the support of trained confidence interval 1.8 to Steps Nutrition and the National professionals like health visitors who 2.5) v influenza; 1.7 (1.5 Infant Feeding Network, updated its can ensure access to a sustainable to 1.9) v other respiratory guidance for local authorities in May supply of infant formula.” tract infections). after concerns that some families may Christoff er van Tulleken, honorary be unable to aff ord infant formula or senior lecturer at University College Anxiety Anxiety disorders were the most frequently reported psychiatric diagnoses. Among people aged over 65 the O vercentralised response was study also found an increased risk of dementia diagnosis when compared with the control health events, with an poorly communicated, say peers incidence of 1.6% (1.2% to 2.1%). People with pre-existing psychiatric disorders were The government’s pandemic sector, said the Lords public found to be more likely to contract covid than those response was “hampered services committee. The peers without (relative risk 1.65 (1.59 to 1.71); P<0.001), even by overcentralised, poorly called on the government to after other risk factors for infection were accounted for. coordinated, and poorly commit to an interim sustainable The researchers said lifestyle factors, such as smoking, communicated” policies and by funding settlement for adult and a reduced adherence to measures the sidelining of local services, social care, and to publish its may explain this finding, although it could also be down a House of Lords committee has long awaited white paper on the to medicine or the “proinflammatory state postulated to concluded. sector “as a matter of urgency.” occur in some forms of psychiatric disorder.” The pandemic “accentuated In the fi rst comprehensive The study had some limitations, including that it systemic frailties” in the care analysis of how public services did not look at whether patients had been admitted to responded to the pandemic, hospital or intensive care. Additionally, the researchers the committee said years of were unable to look at “long covid.” underfunding had left local Til Wykes, vice dean of psychology and systems services ill equipped to cope sciences at King’s College London, said similar levels of and “fundamental weaknesses” mental health disorders after covid had been seen in the must be tackled to make services UK population. “This is clearly the tip of an iceberg,” she resilient enough to withstand said. “We need to develop as many different, accessible future crises. forms of mental health support as possible.” The government, which has Elisabeth Mahase, The BMJ Cite this as: BMJ 2020;371:m4386 promised a public inquiry into its

300 21 November 2020 | the bmj it has “no confl ict of interest, real or perceived, with any company or organisation that directly or indirectly profi ts from infant feeding.” In a recent letter to the Lancet , Babies are too doctors expressed concern that the vulnerable

DAN KITTWOOD/GETTYIMAGESDAN infant formula industry was actively and the London, who has written for The BMJ addition to current pathways for access exploiting the covid-19 pandemic to consequences about infant formula, agreed. “If you to infant formula, food and baby banks increase sales, in violation of the WHO too serious have untrained people giving out an should be facilitated to safely provide International Code of Marketing of for families to infant’s sole source of nutrition then fi rst infant formula milk for formula Breast-milk Substitutes. have to rely on you will unquestionably do harm,” he fed babies experiencing food poverty.” Amy Brown, professor of child donations said. “If a family is coming to a food public health at Swansea University, Sue Ashmore bank saying they can’t aff ord to feed Families in crisis carried out an online survey of 1360 their baby then this should be a red She said, “There tends to be confusion mothers who had breastfed during the fl ag that they need professional help over the interpretation of current fi rst UK lockdown. Some 80% reported and not just the sticking plaster of a tin Unicef UK guidelines by health being contacted by formula companies of formula.” boards and local authorities across on social media despite the WHO code Helen Crawley of the First Steps Scotland and the UK. As a result, forbidding formula manufacturers Nutrition Trust sits on the London families in crisis are not being referred from directly contacting mothers. Food Board, which has worked with to organisations that include direct “Companies have stepped up this local authorities during lockdown. formula provision as part of their key activity during the pandemic,” Brown She said, “We have heard that some services, thus cutting off a crucial told The BMJ. “These were women who families who ask for formula have pathway of support for families.” weren’t seeking out information on Families need children over the age of 1 year who do Unicef said that, if a food bank formula, but it kept popping up in their professional not need it; that some families want it was struggling to make an immediate feeds because they had expressed an help and not for people they know who they think referral, an emergency payment could interest in breastfeeding. just the sticking may need it—with kind intent but not be given to the family to enable them to “There appears to be a loophole plaster of a necessarily a need; and that, where buy their baby’s usual infant formula. here, as companies are not directly tin of formula there is genuine need, this may be a But McNee said that operational allowed to promote their products, but Christoffer van safeguarding issue that needs much constraints mean this was not an they claim that they are helping with Tulleken greater input than a tin of formula.” option for many food and baby banks. breastfeeding.” Feed’s cofounder, Rosie McNee, Feed was registered as a charity Jacqui Wise, London told The BMJ, “Feed believes that, in in May and declares on its website Cite this as: BMJ 2020;371:m4449

pandemic response, declined to Thousands of “invisible” to tackle health, care, and pandemic has both exposed give oral evidence, and its off er to children fell through gaps educational inequalities.” and worsened the inequalities give written evidence arrived too between social and education Death rates were higher that have shamed us for too late, the report said. services Lords report among black and other ethnic long. We need a renewed Committee chairwoman Hilary minority groups, which “suff ered focus on preventive health, Armstrong said, “There should loss of thousands of older and disproportionately because of better provision of local be no return to the pre-covid-19 disabled people.” health inequalities and unequal services providing accessible status quo. The fi ght against The report said many deaths access to services,” they noted. healthcare and advice to all health inequality should be a from covid could have been communities, and a ‘health in all priority for the government.” avoided had preventive public Children hit hard policies’ approach where every health services been better Also hit harder were children, government policy is designed “Poor relation” funded. Death rates were higher with hundreds of thousands of with its potential impact on She added, “The government’s among people with avoidable “invisible” youngsters falling health and wellbeing in mind. pandemic planning identifi ed health conditions, which are through gaps between social “While the NHS, local that social care would need more prevalent in deprived and education services across authorities, and social care signifi cant support during an communities. England, the peers said. Only services have demonstrated outbreak of a disease like covid- The peers called on the one in 10 of those defi ned as real innovation and tireless 19, yet social care was the poor government to recognise the vulnerable went to school or commitment, this good work relation to the NHS when it came “vital role of preventive public early years education during will be lost unless we see real to funding during lockdown. services in reducing deep and lockdown, and there was “not investment to boost staffi ng levels Discharging people from hospital ongoing inequalities exacerbated enough support for prevention and capacity, and an end to the into care settings without testing by covid-19” and to introduce a and early intervention services.” excessive centralisation.” and with inadequate personal “race equality strategy that would The BMA’s chair of council, Clare Dyer, The BMJ protective equipment led to the apply across public services Chaand Nagpaul, said, “The Cite this as: BMJ 2020;371:m4445

the bmj | 21 November 2020 301 THE BIG PICTURE Young people pay floral tribute to NHS

The NHS is celebrated in this four storey mural in east London, created to serve as a reminder of the local community’s gratitude to the health service and its diverse and international workforce. The Shoreditch installation was created by Rich Mix, a local arts and community hub, in partnership with a street art for social justice project, Paint the Change. Entitled 200 Nationalities, One NHS, it features a portrait of a young Londoner, an NHS health worker, and dozens of drawings and paintings of flowers crowdsourced from across the UK. The mural, the 50th produced by Paint the Change across the world, was co-created with the help of young people across east London in pre-lockdown workshops. It also uses images created by people around the world in digital workshops hosted by the Paint the Change team, award winning street artist ATMA, and celebrated youth mentor Efe Ezekiel. Judith Kilvington, chief executive of Rich Mix, said, “An incredible array of flowers were submitted, many accompanied by moving notes of how the NHS and frontline workers have helped so many families and individuals get through this pandemic.” Alison Shepherd , The BMJ Cite this as: BMJ 2020;371:m4458

302 21 November 2020 | the bmj the bmj

| 21 November 2020 303

WWW.PAINTTHECHANGE.ME INVESTIGATION Testing times for the government’s favoured antibody kit The UK has spent millions of pounds developing a rapid test to help build up a picture of how the novel coronavirus has spread across the country. But questions are now being raised over its accuracy and the opaque procurement system that shut competitors out. Stephen Armstrong reports

n September, TThehe AbC-19AbC-19 uses a small drop of blood from a only for surveillance studies, to help announced Operation ttestest usesuses a fi nger prick and shows results in 20 build a picture of how the virus has Moonshot, an attempt to use ssmallmall dropdrop ofof minutes, without the need to send a spread across the country, rather mass testing for covid-19 bbloodlood ffromrom a sample to a laboratory. than for home testing use. I “to identify people who are ffingeringer pprickrick The consortium was awarded When, in October, the government negative so we can allow them to aandnd showsshows £10m by the government to buy announced its decision to purchase behave in a more normal way, in components to manufacture test kits one million AbC-19 tests for use the knowledge they cannot infect rresultsesults iinn in June, and towards the end of July in surveillance studies in a £75m anyone else.” New tests, Johnson 220 minutes0 minutes press reports claimed that ministers contract award without public said, “which are simple, quick, and were “making plans to distribute tender, it prompted a legal action scalable will become available.” millions of free coronavirus over the maladministration of public A consortium of businesses— antibody tests after a version backed funds. Judicial review proceedings including Abingdon Health, BBI by the government passed its fi rst issued by the Good Law Project, Group, CIGA Healthcare, and Omega major trials.” a non-profi t legal organisation, Diagnostics—was assembled in April On 10 June, however, the head of claim that the lack of public by John Bell, professor of medicine NHS Test and Trace, , tender and failure to evaluate the at Oxford University and the said that not enough was known accuracy of the tests coupled with government’s life sciences adviser, about what level of protection the government’s active fi nancial to create a test kit that could “be read coronavirus antibodies provided. involvement in the consortium and by the person at home or on their In July, a study by King’s College awarding of the contract without an mobile phone camera.” London found a signifi cant drop in open tender mean that the purchase Out of this group, called the UK antibody potency after three months. is unlawful. Rapid Testing Consortium, came Plans were scaled back and the focus The legal action issued on the AbC-19 rapid antibody test. It adjusted towards an antibody test 11 November coincided with 2020

March 5 April 8 April 9 July 30 July John Bell (right) Bell posts a blog Government announces the Initial trials of The AbC-19 appointed head of post called Trouble UK Rapid Test Consortium, Abingdon Health’s rapid test is the National Covid in Testing Land, a business consortium AbC-19 antibody CE marked for Testing Scientific writing that “None including Oxford University, test fills the professional use Advisory Panel and of the tests we have Abingdon Health, BBI company with and is registered chair of the new test validated would Solutions, and CIGA “confidence” with the MHRA approvals group, meet the criteria for Healthcare, charged with declaring which assesses virus a good test as agreed designing and developing conformity with diagnostic tests and with the MHRA. This a new antibody test to recommended recommends which is not a good result determine whether people requirements to procure for test suppliers or have developed immunity at scale for us” after contracting the virus

304 21 November 2020 | the bmj The BMJ’s publication of an test manufacturers reach a minimum and chair of its covid-19 taskforce, evaluation of AbC-19 by Public Health standard of 98% sensitivity (ability says that it is vital to get real world England (PHE), fi nding that one in to correctly identify a true positive estimates of how a test might fi ve people with positive results on sample) and specifi city (ability to perform, as PHE had done. “At a the test could be wrongly told that correctly identify a true negative time when reliable, eff ective testing they had covid-19 (see p 312). sample). Abingdon Health reported is vital to our ability to contain the Commenting on the signifi cance of that its test had a sensitivity of 98% covid-19 pandemic, and when the the fi ndings, Dipender Gill, clinical and specifi city of 100%, so was government is proposing to spend research fellow at Imperial College, within recommended standards. many millions on novel tests, it is London, said: “The covid-19 pandemic The only published evidence hugely important that represents an unprecedented on the accuracy of AbC-19, before independent assessment of the The wrong test challenge, and governments around the publication of The BMJ paper context-relevant performance choice has the the world are under pressure to this week, was a preprint article, of antibody or antigen tests is potential to do take decisive action. However, even not yet peer reviewed, reporting available prior to purchasing,” considerable if taken with the best intentions, results from a study led at Ulster Richardson says. harm the wrong choice has the potential University. The study was funded by In October, the Department of Dipender Gill to do considerable harm. High members of the UK Rapid Testing Health and Social Care announced the quality evidence must be considered Consortium and led by professors Jim purchase of one million AbC-19 tests transparently, in consultation with McLaughlin and Tara Moore, who from the UK Rapid Testing Consortium experts. Such data should be sought were recruited as consultants in April to support national surveillance when they are not already available.” by CIGA Healthcare, a member of studies. In the press release, dated So how did AbC-19 end up as the consortium. They found the test 6 October, health minister Lord Bethell the government’s antibody test to have 97.7% sensitivity and 100% is said to be, “thrilled by the product, of choice to support nationwide specifi city. The study’s methodology both for Britain and export markets surveillance studies among tens of has been criticised, including by around the world.” thousands of people, and how can academics brought together by the we be sure that it is the best test Science Media Centre, because it Suppression of results the market has to off er? Tracing the screened out blood samples that were story highlights the opaqueness and diffi cult to classify as real positives Emails seen by The BMJ show that It is hugely lack of accountability that’s become or not. This approach will tend to offi cials at the department knew important common during the pandemic. overestimate test accuracy. about the disappointing results of independent By contrast, the large scale PHE the PHE study before making the assessment is Fast track approval study, using 4842 blood samples, announcement. The emails also available prior published in The BMJ , found the show how the department blocked to purchasing The AbC-19 test did not have to wait test had clinical sensitivity of publication of a preprint of the PHE Sylvia for independent evaluation before 92.5% and specifi city 97.9% if study. Richardson getting a CE mark for professional use using known positive and negative The plan, according to a in July. Instead, the MHRA rules allow samples, with sensitivity falling to Department of Health and Social the manufacturers to self-assess the 84.7% among cases with unknown Care email dated 25 September, test using fi gures posted on Abingdon infection status, as would be the was for “minimal mention” of Health’s website. The Medicines case in real life settings. the PHE study in Lord Bethell’s and Healthcare Products Regulatory Sylvia Richardson, the Royal announcement, “but we do need to Agency (MHRA) recommends that Statistical Society’s president elect mention it as we will get asked.”

1 October 9 October 12 November A team at Ulster University—led by The Department PHE evaluation two members of the UK Rapid Testing of Health and of AbC-19 Consortium—publishes a preprint Social Care published in assessing antibody test performance as confirms a The BMJ well as an assessment of the UK Rapid £10m contract Testing Consortium’s AbC-19 award notice to Abingdon 1 October 6 October Government Health regarding PHE evaluation of AbC-19 finds that announces a £75m deal “components and the accuracy of the antibody test might with the UK Rapid Testing materials” for be considerably lower than previously Consortium for one million covid-19 “lateral suggested. The Department of Health and antibody tests flow” tests Social Care stops publication of the preprint

the bmj | 21 November 2020 305 PHE staff warned that there were the accuracy of a test can in principle Every lateral fl ow test was “signifi cant risks” in not publishing be corrected for. Test errors could be rejected for failing to meet the the PHE evaluation showing the low dangerous, however, if individuals MHRA recommended standard, accuracy of the tests and asked if receive their test results and change which requires 98% sensitivity and holding back the results had been their behaviour based on this—due specifi city, despite British made tests agreed by ministers. In an email on to a belief that they are immune from receiving approval in Europe and the 1 October, PHE asked whether this the virus. For now, any individual US. strategy—of holding back results— who receives a positive antibody test Yet, in early May, the government had been agreed. “Is everyone result should interpret it with caution agreed to spend £13.5m buying aligned on the handling—ministers, and not change their behaviour as a Roche’s antibody tests three days spads, etc?” it asked. The department result.”5 I’m thrilled before scientists at PHE’s Porton replied, “Yes everyone is aligned Abingdon Health said in a by the Down laboratory released a study as far as I know. No. 10 [Downing statement to The BMJ: “Our customer product, both that found the test was 84% Street, the prime minister’s offi ce] [the Department of Health and for Britain sensitive—less accurate than some of now aligned.” Social Care] is satisfi ed with the and export the rejected lateral fl ow tests. Asked whether he was aware that performance of the test, as is UK markets “There is no process, no tender the PHE preprint had been blocked, Rapid Testing Consortium, and will around the available, no opportunity to bid,” Lord Bethell did not reply before The continue to roll out the use of the world said one manufacturer who wished to BMJ went to press. product.” Lord Bethell remain anonymous. “There are rapid When questioned by The BMJ, the The government is currently tests from British companies being Department of Health and Social conducting nine surveillance studies bought by governments around the Care denied that it had blocked including the UK Biobank SARS- world that could have been deployed publication and said that it had CoV-2 serology study with 20 000 here six months ago.” planned to submit the PHE study families who self-administer fi nger “What is most incomprehensible to The BMJ for peer review with prick blood samples once a month, is the price. Lateral fl ow is quick a view to publication. It added and the REACT 2 study, which and easy to use, and cheap to that it had bought the AbC-19 measures antibody levels in 150 000 make—that’s the beauty of it. At test for surveillance studies only. people using fi nger prick testing. If these volumes the government “They were never intended for, the AbC-19 test were to be deployed should be paying closer to £3 and have never been issued for, in one of these studies, one in fi ve (compared to approximately £10)— widespread public use. This robust positive results may be incorrect. especially as they’ve already given evaluation was carried out by PHE Joshua Moon, research fellow [UK Rapid Testing Consortium] at the Department’s request before in the Science Policy Research However £10m upfront for components and any purchase was made, and Unit at University of Sussex, adds: amazed you are procuring directly.” PHE approved the test for use in “Although the idea of a pinprick test are by this Jolyon Maugham QC, director surveillance studies.” is very useful in measuring disease bestiary of of the Good Law Project, said, The PHE study says that the AbC- spread and assessing public health incompetence, “However amazed you are by this 19 test might be accurate enough for interventions, overestimating the you’re not bestiary of incompetence, you’re not serosurveillance to gauge the level of level of covid-19 in the community amazed amazed enough. infection in the population, but only by 20% makes you wonder what the enough “This [the AbC-19 test contract] if the test’s accuracy improved, the use case for this test could be.” Jolyon was a £75m contract, let without relation between the test and future Maugham competition, on the basis of immunity was better understood, Tender subject profoundly fl awed research,” he told and the diffi culty non-professionals The BMJ, “And what we then get is might have accurately reading British rapid antibody test a government that knows of these the test was accounted for. manufacturers have fl aws and tries to suppress their In a press release issued been frustrated at publication.” by the Science Media the government’s Richardson of the Royal Statistical Centre on 7 October, procurement Society says that there are lessons Hayley Jones, senior process. Over spring to be taken from this case: “More lecturer in medical and summer, transparency—undertaking robust statistics, University of many submitted evaluations more quickly, publishing Bristol, said: “When rapid lateral fl ow the results in a timely manner, using antibody tests immunoassay tests and acting on them—would help for surveillance to the government’s the Government implement a cost purposes (to estimate new test approvals eff ective testing strategy.” what proportion of group, set up Stephen Armstrong, freelance journalist, a population has specifi cally to assess London [email protected] been infected or has covid-19 diagnostic Cite this as: BMJ 2020;371:m4440 antibodies) errors in tests.  RESEARCH, p 312

306 the bmj | 21 November 2020 EDITORIAL Covid-19: suppression of science When good science is suppressed by the medical-political complex, people die

oliticians and tests, treatments, and vaccines. 17 governments are Government appointees are able to suppressing science. ignore or cherry pick science and P They do so in the indulge in anti-competitive practices public interest, they that favour their own products and say, to accelerate availability of those of friends and associates.18 diagnostics and treatments. They do How might science be safeguarded so to support innovation, to bring in these exceptional times? The fi rst products to market at unprecedented step is full disclosure of competing speed. Both of these reasons are interests from government, partly plausible. But the underlying politicians, scientifi c advisers, and behaviour is troubling. appointees. The next step is full Science is being suppressed for transparency about decision making political and fi nancial gain. Covid- Politicisation to research published this week systems, processes, and knowing 19 has unleashed state corruption of science, by The BMJ, which fi nds that the who is accountable for what. on a grand scale, and it is harmful government procured an antibody Once transparency and 1 enthusiastically to public health. Politicians and deployed test that in real world tests falls well accountability are established as industry are responsible for this short of performance claims made by norms, individuals should ideally by some of opportunistic embezzlement. So too its manufacturers. 12 13 Researchers only be employed by the government are scientists and health experts. history’s worst from PHE and collaborating in areas unrelated to their competing The UK’s pandemic response autocrats, institutions sensibly pushed to interest. If such a strict rule becomes provides at least four examples of is now publish their study fi ndings before the impractical, minimum good practice suppression of science or scientists. commonplace government committed to buying a is that people with competing First, the membership, research, and in democracies million of these tests but were blocked interests must not be involved in deliberations of the Scientifi c Advisory by the health department and the decisions on products and policies in Group for Emergencies (SAGE) prime minister’s offi ce. 14 Why was which they have a fi nancial interest. were initially secret until a press it important to procure this product Importantly, suppressing science, leak forced transparency.2 The leak without due scrutiny? As if to prove whether by delaying publication, revealed inappropriate involvement a point, PHE then unsuccessfully cherry picking favourable research, or of government advisers in SAGE, attempted to block The BMJ ’s press gagging scientists, is a danger to public while exposing under-representation release about the research paper. health, causing deaths by exposing from public health, clinical care, people to unsafe or ineff ective women, and ethnic minorities.3 4 Scrutiny, transparency interventions and preventing them Next, a Public Health England Politicians often claim to follow from benefi ting from better ones. (PHE) report on covid-19 and the science, but that misses the When entangled with commercial inequalities. The report’s publication point. Science is rarely absolute. A decisions it is also maladministration was delayed by England’s better approach is for politicians, of taxpayers’ money. Department of Health; a section the publicly appointed decision Politicisation of science was on ethnic minorities was initially makers, to be informed or guided enthusiastically deployed by some of withheld and then, following a by science when they decide policy history’s worst autocrats and dictators, public outcry, was published as part for their public. and it is now regrettably commonplace of a follow-up report.5 6 Authors from But that approach retains public in democracies.20 The medical political PHE were instructed not to talk to and professional trust only if science complex tends towards suppression the media. Third, on 15 October, is available for scrutiny and free of science to aggrandise and enrich the editor of the Lancet complained of political interference, and if those in power. And, as the powerful that an author of a research paper, the system is transparent and not become more successful, richer, and a UK government scientist, was compromised by confl icts of interest. further intoxicated with power, the blocked by the government from The UK’s pandemic response relies inconvenient truths of science are speaking to media because of a too heavily on scientists and other suppressed. When good science is 7 “diffi cult political landscape.” Kamran Abbasi, government appointees with worrying suppressed, people die. Now, a new example concerns executive editor, The competing interests, including Cite this as: BMJ 2020;371:m4425 point-of-care antibody testing for BMJ, London, UK shareholdings in companies that 8 Find the full version with references at covid-19. The incident relates [email protected] manufacture covid-19 diagnostic http://dx.doi.org/10.1136/bmj.m4425 the bmj | 21 November 2020 307 How will Brexit affect the healthcare workforce? As part of a series as we near the end of the Brexit transition period, May van Schalkwyk and colleagues look at the potential impact of leaving the EU on NHS and social care staff

Do we have good data on how Have more EU doctors left the UK Some regions face particular staffi ng many EU doctors work in the UK? in recent years or are fewer now challenges—such as Northern Ireland, which coming to the UK? draws on the same labour market for health Data are collected on the nationality of workers as the Republic of Ireland, with NHS staff , but there are questions about Over the past two years the overall number considerable cross border working. The wider the accuracy of some of these data of staff from the EU working in the NHS in environment for immigrant labour should and a number of other problems with England has remained stable, at around also be considered, as it’s likely to aff ect EU the arrangements around how they’re 5.5% of all staff . The picture for doctors and other overseas citizens coming to the UK. maintained and updated. specifi cally is also one of relative stability, All NHS employees have an electronic in data from both NHS Digital (for which EU What effect might Brexit, deal or staff record containing their details, doctors are defi ned by nationality on NHS no deal, have on the NHS’s ability and this includes their nationality when records) and the GMC (for which EU doctors to recruit doctors from the EU? recruited. However, the information is are defi ned by country of qualifi cation). For monitored in separate systems in each instance, NHS Digital data show that 490 EU There are many uncertainties around this, of the four nations (in England, it’s the doctors left NHS trusts in England in March and they make it diffi cult to predict future responsibility of NHS Digital). There’s and April 2019, and 432 did so in March and levels of medical migration. also no obligation for NHS workers who April 2020. First, will the restrictions on free acquire British nationality to update The NHS Digital and the GMC fi gures show movement for EU citizens be sustainable? their information, and there’s no record that, although the number of EU qualifi ed There is widespread recognition that a no of whether this has happened. So, some doctors has increased over the past two years, deal or minimalist Brexit deal can only be a doctors may be misclassifi ed as not having the rate of this increase has been lower than temporary situation given the disruption it British nationality (because they haven’t among overseas doctors from outside the EU. will create, and UK governments in the future updated their records), while others The number of EU qualifi ed doctors increased will face a permanent economic incentive to won’t be recorded as coming from the EU by 2.9% in 2018-19 and by 8.2% in 2019-20, change course. More widely, although the (because they have updated their records). whereas the number of overseas qualifi ed UK government has placed stricter migration It’s also not clear how the system deals doctors from outside the EU rose by 7.4% and controls at the centre of its case for Brexit, with dual nationals, including the large 13.2% over those two periods. in the longer term it may have diffi culty number with joint UK and Irish nationality. However, doctors don’t work in isolation sustaining this as it tries to negotiate trade The GMC also monitors the movement from other staff , so we also need to think deals with countries such as India, which will of doctors to and from all four UK nations. about staffi ng across the entire health and want greater opportunities for their citizens However, the only indicator of national social care system, including support staff , to come to the UK. affi liation in the GMC record is the country research scientists, nurses, and social NHS Employers and the Institute for of primary qualifi cation. Thus, British care staff . From 2018 to 2020 the overall Public Policy Research have both raised citizens qualifying abroad would be headcount of EU nurses and health visitors in concerns about the impact of the new points considered overseas graduates, while NHS trusts in England has slightly decreased, based immigration system on recruitment to EU citizens qualifying in the UK would be although numbers from the rest of the world social care. In addition, the BMA has called UK graduates. are increasing in a more sustained manner. for the UK government to establish a fl exible

308 21 November 2020 | the bmj migration system that promotes entry into Exchange of information with EU After the end of the transition the UK for health and social care staff , as states about fitness to practise cannot period, what might still attract EU well as allowing UK trained doctors to work occur, as the UK will lose access to the doctors to work in the UK? in the EU. Internal Market Information system Second, if barriers to entry remain, The UK continues to have a strong research will potential migrants consider them too only that the UK will continue to recognise record in life sciences. However, this is expensive and burdensome? The UK’s European Economic Area and Swiss threatened by Brexit, especially if there’s no reputation among potential migrants has qualifi cations “for a temporary period” after deal—with the UK losing access to European been damaged by the government’s “hostile 1 January. This approach is consistent with Reference Networks, for example, and environment” approach and its treatment the many other areas where the UK has potential obstacles to collaboration on clinical of the Windrush generation. There’s as yet delayed making a fi nal decision for as long trials. Negotiations on the UK’s continuing little clarity about the fees that incoming as possible, going beyond the end of the inclusion in Horizon Europe, one of the most doctors will have to pay, and the Home Offi ce transition where it can. ambitious research collaborations globally, is known to view such charges as a valuable If an EU-UK trade agreement is reached, have reached an impasse. revenue stream. Workers will also need continued recognition of each other’s Since the 2016 EU referendum the reported reassurance about ease of entry for their qualifi cation frameworks for health and levels of race related hate crimes have increased spouses and dependants—and their ability to care staff will be feasible, and the EU and in the UK, and while the most recent NHS staff also work and access healthcare, as well as UK draft texts both propose a framework for survey revealed an increase in staff morale other services such as education. collaboration here. Unless the UK decides and patient safety scores, almost 40 000 of Third, for workers who are supporting to diverge signifi cantly from EU medical respondents (7.2%) reported experiencing relatives in their country of origin, the professional standards, we may see relative discrimination from patients in the past year, an declining value of the pound may mean that continuity in this context. increase from 5.8% in 2015. In a 2018 study, the value of their remissions falls. However, exchange of information about most EU doctors who were interviewed reported fi tness to practise cannot occur, as the UK that the referendum and its political aftermath What might a well negotiated will lose access to the EU’s Internal Market had given rise to feelings of uncertainty and of Brexit outcome look like, in terms of Information system because it insists on being unwanted and undervalued. EU health professionals in the UK? leaving the internal market. Increased Persuading those doctors to stay will be vigilance over fi tness to practise will therefore contingent on building confi dence that future Any form of Brexit will make the UK a be critical to maintaining care standards. work conditions will not deteriorate—and less attractive destination for EU health The outcome of the negotiations will have reassurance that they are wanted and valued. professionals. They will lack certainty about implications for working conditions. The EU May C I van Schalkwyk, NIHR doctoral research fellow , many practical issues, such as taxation, wants to secure a non-regression clause in London School of Hygiene and Tropical Medicine portability of pensions, and their right to labour standards, whereas the UK wants the [email protected] remain in the long term. ability to develop standards independently. If Tamara K Hervey, professor of EU Law, University of The UK’s refusal to issue documentation there is no agreement, erosion of employment Sheffield specifying that people with “settled status” conditions may compound the impact of Martha McCarey, researcher have the right to remain in the UK is already immigration changes on staffi ng levels. Mark Dayan, policy analyst and head of public affairs, causing problems for those seeking to However, domestic law and policy could Nuffield Trust, London access services, use banks, or rent property. embed working conditions in practice: the Pepita Barlow, assistant professor of health policy , The current guidance lacks detail, stating terms of junior doctors’ contracts in England London School of Economics Martin McKee, professor of European public health, Staff at Homerton University Hospital, east include existing working time rules based on London School of Hygiene and Tropical Medicine London, tweeted this picture in response to EU law, although these protections have long the Brexit referendum result in June 2016 been a target of Brexit supporters. Cite this as: BMJ 2020;371:m4439

the bmj | 21 November 2020 309 EDITORIAL Mass testing for covid-19 in the UK An unevaluated, underdesigned, and costly mess

apid turnaround testing for covid-19 is to be made available to everybody across England at a cost Rof £100bn. 1 This follows a still uncompleted “pilot” in Liverpool, which started on 6 November. The objective is “to demonstrate that massive asymptomatic testing can help identify far more cases and break the chain of transmission of coronavirus.”2 Participation in the pilot is voluntary. There is no call or recall. All participants receive two tests, Nobody’s making it even more critical that it is This system should be designed the standard PCR test and the rapid freedom or carefully planned; the components, with up to 10 clear objectives to deliver turnaround (within 1 hour) lateral behaviour including testing centres, contact the aim of reducing the impact of fl ow Innova test. Those with a positive should be made tracing, laboratories, and primary care covid—for example, to identify cases result in either test are asked to self- contingent on contributions, are quality assured; its more quickly or to mitigate the eff ects isolate and are registered with the total resource requirements identifi ed of deprivation on risk of infection national track and trace programme, having had a and costed; and the pilot evaluated for and poor outcomes. Progress in each which initiates contact tracing. Key novel rapid test cost eff ectiveness. objective (or lack of it) should be workers, health and social care staff , measured against explicit criteria. school staff , and children aged 11 and Shaky ground Screening programmes based on over are being targeted, but anyone The queues of people seeking tests experience and on the literature can get tested, preferably at least twice in Liverpool suggest the initial relating to complex adaptive systems 14 within two weeks. acceptability of this pilot is high, off er a model for rapid progress. This is a screening programme, not at least to some. Its ethical basis, At a minimum, there should opportunistic case fi nding. If judged however, looks shaky. The council be an immediate pause, until the against criteria drawn up by the UK’s claims, wrongly, that the test detects fundamental building blocks of National Screening Committee for infectiousness and is accurate. The this mass testing programme have appraisal of a programme’s viability, context for gaining consent has been been externally and independently eff ectiveness, and appropriateness,3 it tarnished further by the enthusiasm scrutinised by the National does not do well and has been already of some local offi cials and politicians. Screening Committee and NIHR. In roundly criticised.4 In the case of schools, the programme the meantime, nobody’s freedom Despite claims by the city council has been culpably rushed.12 or behaviour should be made that the Innova test is “very accurate There is no protocol in the contingent on having had a novel with high sensitivity and specifi city,” 2 public domain, let alone systems rapid test. It is premature to off er it has not been evaluated in these specifi cation or ethical approval. testing as the route to individuals’ conditions. The test’s own instructions The public has had no chance release from restrictions. Instead state that it should not be used to contribute, as required by the we must heed the advice of the on asymptomatic people, and a UK standards for public involvement World Health Organization and the preliminary evaluation from Porton in research.13 government’s Scientifi c Advisory Down and Oxford University 9 suggests Spending the equivalent of 77% of Group for Emergencies (SAGE), the test misses between one in two and the NHS annual revenue budget on an radically improve the woeful one in four cases. The false positive unevaluated underdesigned national performance of the “fi nd, test, trace, Mike Gill, former rate of 0.6% means that at the current programme leading to a regressive, and isolate” system, and renew the regional director prevalence in Liverpool, for every insuffi ciently supported intervention— focus on identifying symptomatic of public health, person found truly positive, at least England, London in many cases for the wrong people— people, especially among those one other may be wrongly required to mgilm1@ cannot be defended. Allowing testing sections of society most at risk. self-isolate. As prevalence drops, this gmail.com programmes to drift into use without Cite this as: BMJ 2020;371:m4436 will become much worse. Muir Gray, visiting the right system in place leads to a Find the full version with references at Evidence that this pilot will reduce professor, University mess, and the more resources invested http://dx.doi.org/10.1136/bmj.m4436 transmission is not yet established, of Oxford the bigger the mess. PERSONAL VIEW, page 316

310 21 November 2020 | the bmj