this week NHS RESERVES page 381 • MESH CLINICS page 382 • LIVERPOOL TESTING page 384

LMCs: NHS England briefed against GPs

GP leaders have demanded that NHS chair of the BMA’s General Practitioners The BMA’s Richard Vautrey England and NHS Improvement apologise Committee, writing to the NHS chief said it seemed NHS England and retract any communications that may executive, Simon Stevens, asking for had “intentionally sought have harmed their reputation or incited NHSE/I to “apologise to the profession and to create negative media coverage of primary care” complaints by implying that practices had correct damage that has been done.” not been fully involved in care of patients Vautrey wrote, “Implying within the throughout the covid-19 pandemic. press release that GPs are not providing A motion passed at the annual patients with the appointments they conference of England’s local medical need and ‘reminding’ them that they face committees on 27 November said that ‘enforcement action’ if they do not has much of NHSE/I’s communications with presented NHSE/I as antagonistic and GPs, the press, and the public had been completely out of touch with the profession. “abhorrent and insulting.” The conference It also seems to many GPs that NHSE/I has, called for NHSE/I to recognise general by using this tactic, intentionally sought to LATEST ONLINE practice’s contribution to the management create negative media coverage of primary of the pandemic and the continuation of care services. Test for HIV normal service, “particularly given the “The BMA is now hearing large numbers wherever blood is general practitioners who have died in the of reports from practices receiving taken, recommends course of their duties to the public.” complaints and many staff members being UK independent The motion added that it “deplores verbally abused by the public based on commission the habit” of briefi ng journalists before these unsupported and ill-informed media Declarations of communicating with the profession and its articles. pharma funding representatives. This refers to an episode “This is clearly unacceptable, and are still not transparent where NHSE/I briefed journalists on a letter NHSE/I must correct these inaccurate and enough, say critics it had written to all practices reminding GPs damaging stories immediately.” that patients must be off ered face-to-face More than 400 GPs have since signed Investigation into baby’s death appointments when they need them. GPs an open letter raising concerns about reveals “20 year said this led to negative media coverage and inaccurate and harmful media messages. cover-up” of care a reported rise in complaints and abuse. Elisabeth Mahase , The BMJ failures The incident led to Richard Vautrey, Cite this as: BMJ 2020;371:m4684 the bmj | 5 December 2020 379 SEVEN DAYS IN Fewer ethnic minority doctors report wo rkplace improvements during pandemic A GMC poll of 3693 doctors carried out in June and July has found that less than half (46%) of ethnic minority doctors said that the sharing of knowledge and experiences had been positively aff ected by the pandemic, whereas three fi ft hs (61%) of white doctors reported positively. The survey, published in the GMC’s annual State of Medical Education and Practice in the UK report, also showed that 68% of white doctors but 55% of ethnic minority doctors believed that teamwork between doctors had improved during the pandemic. And improvements in the speed of workplace changes were reported by 57% of white doctors but only 38% of ethnic minority doctors. GMC chief executive Charlie Massey said the fi ndings were a concern. “We know BAME [black, Asian, and minority ethnic] doctors too oft en lack the supportive and compassionate leadership that is required to thrive,” he said. “Doctors of all grades, and from all backgrounds, need and deserve the same levels of support if they are to provide the best possible care for patients, in what will continue to be diffi cult months ahead.”

MARK THOMAS/SPL Abi Rimmer, The BMJ Cite this as: BMJ 2020;371:m4666

Covid-19 said the funding would not solve good luck rather than design “common situation when Lighter restrictions didn’t longer term problems such as had helped the NHS to care for students may experience racial work, study indicates workforce shortages. patients with the disease. harassment.” It recommended Tier 1 restrictions that applied that universities review their to areas of England with lower Most of England is placed Appraisals procedures for handling rates of covid-19 before the in toughest two tiers Government pledges complaints, define clear channels most recent lockdown had Most of England would be placed “streamlined” approach for reporting incidents, and “little impact” on transmission, under high or very high alert England’s health secretary, systematically collect data on a preprint study suggested. levels when the country’s national Matt Hancock, pledged shorter reports, “including incidents that Researchers from the University lockdown ended appraisals for doctors as part of are resolved informally.” of East Anglia found that tier 2 on 2 December, a drive to reduce bureaucracy rules were effective in only around said the health in the NHS. A new appraisal Cancer half of local authority areas, while secretary, Matt format, which takes only 30 NHS pilots “liquid biopsy” stricter tier 3 restrictions seemed Hancock, on minutes to prepare and requires blood tests to be effective in most areas. But 26 November. far less supporting evidence, The NHS in England will pilot the they said that regions were not Under the has been in place since October use of an innovative blood test allocated swiftly enough to the revised tier system, areas with 2020, after appraisals were with the potential to spot more most appropriate tier and urged the toughest restrictions (tier 3) suspended in March because of than 50 types of cancer. The ministers to heed their findings as include Greater Manchester, the covid-19 pandemic. Hancock Galleri blood test, a liquid biopsy the tier system is reintroduced. Bristol, the West Midlands, and said that the process would be developed by the US company Kent. Most areas in England have retained subject to evaluation, GRAIL, can detect early stage NHS will get £3bn been placed in tier 2, including alongside other measures such cancers through a simple blood “recovery” funding Liverpool and London. Only as making professional regulation test. The pilot, which is due to The NHS will receive an extra Cornwall, the Isle of Wight, and proportionate, giving GPs more £3bn next year to help services the Isles of Scilly are in tier 1. time to focus on clinical work, and recover after the pandemic, the greater digitisation of services. UK chancellor announced in his Government failed to react spending review. Rishi Sunak said to ventilator shortage Racial harassment that this would include £1bn to The NHS managed to provide Doctors welcome action tackle the elective care backlog, care to all those patients with by universities on racism around £1.5bn to help ease covid-19 who needed mechanical The BMA welcomed a report start in mid-2021, will involve existing pressures in the NHS ventilators earlier this year offering practical guidance to 140 000 people aged 50 to 79 caused by covid-19, and around despite the government being universities on tackling racial years who have no symptoms £500m to improve access to underprepared and slow in harassment. The report by but who will have annual blood mental health services and responding to hospitals’ needs, Universities UK said that the tests for three years, together invest in the NHS workforce. a report from the parliamentary Equality and Human Rights with 25 000 people with possible Andrew Goddard, president of Public Accounts Committee Commission had identified cancer symptoms who have been the Royal College of Physicians, concluded. The MPs said that medical placements as a referred in the normal way.

380 5 December 2020 | the bmj SIXTY SECONDS MEDICINE ON . . . Period products Schools, colleges, and universities NHS RESERVES Scotland becomes first in Scotland will make period products freely available RUNNING ABOUT IN CAMOUFLAGE to legislate for free access GEAR AT THE WEEKEND? Period products will be No, silly, that’s NHS army reservists. We’re obtainable free of charge in talking about NHS reserves, a similar idea Scotland for every person who but for clinical and non-clinical volunteers to needs to use them, after the support the NHS. country became the first in the world to pass legislation CLINICAL VOLUNTEERS? BUT WE’RE on the issue. A bill passed UNDERSTAFFED Well, yes, but the idea is that these unanimously in the Scottish volunteers will come from some of the 75 000 parliament requires all local clinical staff who leave the NHS every year. authorities in Scotland to ensure So they’ll come back to work—but for free. that period products are freely Drug pricing available. Schools, colleges, and Bipolar drug remains VACCINES UH-HUH. WHOSE IDEA IS THIS? universities must also make them on market after deal It was proposed by Alan Mak (below), MP for Russia reached Havant and vice chair of the Conservative available free of charge in their Priadel, a brand of lithium widely an agreement toilets, and the government has used to treat bipolar disorder, Party. Speaking in the House of Commons the power to make other public will remain on the market after with the drug on 24 November, he introduced the National

organisations do the same. a new deal was struck between company Hetero to Health Service Reserve Staff Bill. It was supported by England’s health secretary, its manufacturer, Essential Matt Hancock. Obstetrics Pharma, and the Department for produce 100 Female doctors are less Health and Social Care. The drug DON’T WE ALREADY HAVE NHS likely to support C sections company previously said that it million VOLUNTEERS? would withdraw Priadel in April doses of the Yes. Mak said that there are thought to be 2021. This led the Competition Sputnik V covid-19 around 80 000 volunteers working across and Markets Authority to launch vaccine in India. all acute care trusts in England, contributing an investigation into whether more than 13 million hours of volunteering Russia claims that each year. The bill’s aim is to formalise this. the company had “abused its preliminary data dominant position” to get patients showed its vaccine WITH A BADGE AND A UNIFORM? to switch to alternative, more While you might be joking, Mak isn’t. expensive treatments such as the to have more than Drawing comparisons with the Police company’s other drug Camcolit. Special Constabulary, he said that every NHS 95% reservist would “wear the same uniform and Pandemic policies efficacy have the same equal status as their regular Europe “must prepare [Al Jazeera] health service counterparts.” Female doctors were 25% less better” for lockdown exit WILL THEY BE TRAINED? likely to perform caesarean Governments in Europe need Mak said that NHS reservists would receive sections than male doctors, said to implement more effective “appropriate training” and that anyone a review and meta-analysis of testing, tracing, and isolation working in a clinical discipline would be international studies published policies when reopening their vetted and have to maintain the same up-to- in Obstetrics and Gynecology. economies to prevent covid date qualifi cations as the full-time staff . Although around 21% of cases from spiking again, warned deliveries are by C section, WHO the Organisation for Economic SO, THEY’D WORK WITH PATIENTS? recommends a rate of 10-15%. Co-operation and Development. Mak’s vision is that they would take on a range of roles, such as vaccinators or The report analysed 15 studies It said some European countries, telemedicine providers. “They could also of more than 1.25 million births such as Norway and Finland, provide general cover in non-specialist and 11 studies with data on had been better able to contain clinical roles if private sector staff supply 4911 obstetricians’ preferences the spread of the disease, partly agencies, locums, or staff banks were for delivery mode. Studies because of their lower population not available to help at short notice,” conducted after 2000, but not density but also because of he said. before, showed that female greater preparedness, a rapid and physicians were 25% less likely effective strategy for test, track, IT SOUNDS A LOT LIKE A JOB to favour C sections and less and trace, and stronger trust and No, no, no. Because you’re volunteering likely to perform them, even when compliance among the public. for a charity, remember. Oh, wait . . . mothers requested them without Abi Rimmer , The BMJ medical indications. Cite this as: BMJ 2020;371:m4681 Cite this as: BMJ 2020;371:m4680

the bmj | 5 December 2020 381 LMC conference News roundup from the annual meeting of England’s local medical committees, held virtually on 27 November

More investment needed, say GPs GPs called on the government to recognise it was currently “far from business as usual” in general practice and that “significantly more investment” was needed to provide the same levels of service as before the covid pandemic. In a motion passed at the EYEVINE PLEDGER / CHRISTOPHER conference GPs said that Rishi Sunak’s claim that the NHS would get whatever it needed Specialist mesh removal was “completely out of step with reality.” The motion called for the BMA’s GP Committee to centres set to open in April “push NHS England and NHS Improvement to ensure all income from item of service network of specialist surgical The review heard “harrowing” accounts contracts” was protected until after the mesh removal centres is to be of women left with serious complications. pandemic and to negotiate that no further set up around England, with The mesh is hard to remove, and only a few requirements would be demanded until a launch planned for April surgeons in the UK are able to carry out the practices had recovered from the pandemic. A2021. procedure. The move implements a recommendation The use of surgical mesh for urinary Call to renegotiate vaccine contract of a review, chaired by the Conservative incontinence was suspended in England GPs called on the BMA’s GP Committee to peer and former health minister Julia in 2018 after years of campaigning renegotiate the “funding and flexibility” Cumberlege (above), into three treatments by patient groups. The Cumberlege of the covid-19 vaccine contract, now that that caused avoidable harm. One of these review recommended that mesh not more information had come to light. The was the use of transvaginal tape and pelvic be used again until six conditions were motion said that the “conference deplores mesh to treat pelvic organ prolapse and satisfi ed, including the identifi cation and the pace and pressure” placed on the GP urinary incontinence. accreditation of specialist centres to deal Committee during the negotiations with the government and rejected the mandatory 8 am to 8 pm, seven days a week proposal High Court rules on children’s ability for the vaccine rollout. GPs said they were “best placed to decide when and to consent to taking puberty blockers how to conduct their business to ensure maximal population coverage” and said Children under 16 cannot Keira Bell, 23, who was to the administration of the public must be told faults in the vaccine consent to the use of treated as a teenager, and puberty blockers. She said programme lay with the government. puberty blockers for “Mrs A,” the mother of a that the judges were “very gender dysphoria unless 15 year old with autism doubtful” that a child aged Pay partners same as salaried GPs they can understand who was on the waiting list 14 or 15 could understand Delegates backed a motion saying any the immediate and long for treatment, challenged and weigh the long term term consequences of the service’s policy and risks and consequences pay deal where employees received a pay the treatment, which is practice on the use of of the administration of rise with no additional funding for their unlikely, the High Court in puberty blockers. They puberty blockers. employer was a failure. In July salaried GPs London has ruled. argued that children were For children of 16 and in England were told they would receive a Even for teens over 16 unable to give informed over there is a presumption 2.8% pay rise, but GP partners or trainees clinicians might well want consent for the treatment. that they have the ability were excluded because they were in the to seek court authorisation to consent to medical second year of multi-year deals. BMA GP before administering Treatment “experimental” treatment. But, “given the Committee deputy chair Mark Sanford-Wood puberty blockers, said three Victoria Sharp, president of long term consequences of said the BMA wrote to the health secretary to senior judges. the Queen’s Bench Division, the clinical interventions express disappointment that GP contractors The legal challenge sitting with Lord Justice at issue in this case, and were not being recognised for their work in was brought against the Lewis and Mrs Justice given that the treatment the pandemic. It called for the government Tavistock and Portman NHS Lieven, said it was “highly is as yet innovative and to fill the financial shortfall that GP partners Trust, which runs the UK’s unlikely” that a child aged experimental, we recognise faced in funding the pay increases for staff. only gender reassignment 13 or under would be that clinicians may well Elisabeth Mahase, Abi Rimmer, The BMJ service for young people. competent to give consent regard these as cases where

382 5 December 2020 | the bmj with complications and removal. Asymptomatic covid Centres will have to record all procedures on a national database, may not be infectious, and all those involving implants will have to be entered on a national Wuhan study finds registry, along with organised follow-up and an audit of outcomes. There is concern that these are A mass screening programme of more than 10 million Surgeons will have to demonstrate the same surgeons who put the residents of Wuhan, China, performed after SARS- competence to perform complex mesh in Kath Sansom CoV-2 was brought under control, has identified 300 vaginal mesh removal surgery, and asymptomatic cases of covid-19, none of which was only those with expertise in complex Yorkshire, the North West, the East infectious. The findings cannot be extrapolated to pelvic surgery will be allowed to of England, London, the Midlands, countries where outbreaks have not been brought perform the techniques. the South East, and the South West— under control successfully, said the authors of the Kath Sansom of the patients’ met on 20 November to agree the report, published in Nature Communications. campaigning group Sling the Mesh standards all the centres will adopt. The researchers used PCR testing to screen for viral called the centres a “step in the right Clinicians from Scotland and Northern RNA among 10 million participants aged between direction,” but added, “Members of Ireland, which are establishing their 10 and 89. Trained staff interviewed participants the group want to see a national mesh own specialist centres, were also on their history of covid-19. Asymptomatic positive removal training scheme.” Sansom invited to the summit. cases were defined as people who had a positive said some members had been waiting Cumberlege told The BMJ , “We result on screening with neither a history of covid-19 for removal for more than two years. want to make sure those who do diagnosis nor any clinical symptoms at the time of the these operations are not only skilled nucleic acid testing. The researchers found no “viable Agreed standards to do them but do them regularly. virus” in cultures Setting up the centres for complex We thought it was important there from asymptomatic surgery “doesn’t mean they have the was a consensus as to the best way of samples. correct skills to do it,” she said. “There removing mesh. Further swab is concern that these are the same “It’s an extremely diffi cult thing tests of 1174 close surgeons who put the mesh in, the to try to achieve. In time, they will. contacts of the same surgeons who said mesh wasn’t Whether they can achieve it by April is 300 asymptomatic a problem.” another matter.” positive cases were Representatives from the seven Clare Dyer, The BMJ all negative. centres—covering the North East and Cite this as: BMJ 2020;371:m4589 The researchers said their findings did not show that the virus couldn’t be passed on by asymptomatic carriers, and they didn’t suggest that the authorisation of the the implications of taking their findings were generalisable. They said that strict court should be sought prior puberty blockers alone . . . in measures such as mask wearing, hand washing, to commencing the clinical our view this does not refl ect social distancing, and lockdown helped to reduce treatment,” said Sharp. the reality. The evidence the virulence of SARS-CoV-2 in Wuhan and that Bell took puberty blockers shows that the vast majority asymptomatic people there may have low viral loads. at age 15 or16 and later of children who take puberty Fujian Song, from Norwich Medical School, who was given male hormones blockers move on to take collaborated with colleagues in Wuhan on the The legal and had her breasts cross sex hormones, that research, said, “The asymptomatic cases identified in challenge removed. She has since stages 1 and 2 are two stages the screening programme were truly asymptomatic, was brought “retransitioned” back to her of one clinical pathway and, as none of them showed clinical symptoms before against the original female sex. Sharp once on that pathway, it is or during their follow-up isolation.” But he added, said that puberty blockers extremely rare for a child to “There is plenty of evidence elsewhere showing that Tavistock and had been prescribed to get off it.” people infected with covid-19 may be temporarily Portman NHS children as young as 10. The judges emphasised asymptomatic and infectious, before going on to Trust, which that they were not develop symptoms.” runs the UK’s Single clinical pathway deciding on the benefi ts Using antibody testing, the researchers found only gender The trust, and other trusts or disbenefi ts of giving that almost two thirds of the asymptomatic cases reassignment to which it referred patients puberty blockers for gender had previously had covid-19. “With the centralised service for for treatment, had argued dysphoria, whether in the isolation and treatment of all covid-19 cases during young people that taking hormone short or long term, but the lockdown period in Wuhan, the risk of residents blockers and later cross sex only on the circumstances being infected in the community has been greatly hormones were entirely in which a child was reduced. When susceptible residents are exposed to separate stages of treatment. competent to give valid a low dose of virus, they may tend to be asymptomatic Sharp concluded, “It is consent to treatment. as a result of their own immunity,” wrote the authors. said therefore the child Clare Dyer , The BMJ Shaun Griffin, London needs only to understand Cite this as: BMJ 2020;371:m4699 Cite this as: BMJ 2020;371:m4695 the bmj | 5 December 2020 383 COVID TESTING

NEWS ANALYSIS Concerns persist about purpose, ethics, and effect of rapid testing in Liverpool

The government says the city’s pilot is a great success and plans to off er rapid lateral fl ow tests to other areas with high covid rates. But the scheme raises more questions than answers, fi nds Jacqui Wise

iverpool started its cases will be missed. He said, of the Institute of Population Lack of transparency community testing “Statements that these cases Health at the University of Much of the criticism has pilot on 6 November, do not matter as they will not Liverpool, who is one of the focused on the general lack of with all residents be infectious are not based on senior clinicians involved in information about the pilot. L and workers off ered evidence. Infectious cases will analysing the data, said the pilot “Why haven’t they published repeat covid-19 testing, even if be missed, and we need to know scheme has been misrepresented. their protocol, what information they have no covid symptoms, how many.” “The city was clear with the sheets were given to the public, “to fi nd more positive cases and government from the start that we and was proper informed break chains of transmission.” What was the scheme’s purpose? sought community open access consent obtained?” Pollock Whether the scheme has indeed There has been confusion over testing to underpin a targeted asked. “They have torn up the contributed substantially to a the purpose of the testing in approach and not untargeted rulebook on research governance fall in infection rates remains Liverpool and whether it is, in mass testing,” he told The BMJ. and ethics.” uncertain, and it has been fact, screening. At fi rst the term He says that what the scheme In response, Buchan said that criticised over the lack of mass testing was widely used by is doing is not screening but an they have evaluation plans for transparency, the accuracy of the government and on Liverpool urgent public health intervention. each sub-project, shared with the tests being used, and costs City Council’s website, although Buchan said that Liverpool the Department of Health and and potential harms. the scheme is now was pursuing “SMART” Social Care and reviewed weekly. This week Liverpool more often referred to testing: systematic, meaningful He points out that academic was moved out of as community testing. asymptomatic repeated testing. input was requested for service the toughest tier 3 Allyson Pollock, This has three components: evaluation and not for research restrictions and into director of the test to protect (where testing but that researchers have sought tier 2 at the end of the Newcastle University is accessible to the whole ethical approvals for fi eldwork. national lockdown. Centre for Excellence community but can focus on He notes that economic Boris Johnson and in Regulatory Science, people at highest risk, such evaluation was less relevant, England’s health is among experts who as care home visitors), test to because test kits had already secretary, Matt The Innova test’s have been calling release (to enable people to exit been purchased and his team Hancock, both claimed sensitivity can be for clarity about the quarantine earlier), and test was carrying out “after-action this was down to the as low as 58% purpose of the testing. to enable (to allow a return to research”—evaluating a success of the testing She said that what activities). complex heath intervention. Live pilot, and they urged other tier 3 is happening is population Buchan said the pilot was dashboards are updated every 30 areas to use lateral fl ow tests to screening of asymptomatic just completing its fi rst phase, minutes and emailed in reports drive down infection rates. people, which is not endorsed by which was about making testing twice daily. Public reports will be “But we haven’t learnt the World Health Organization accessible to all members of the made soon. anything from Liverpool, as or the government’s SAGE community. It was about to enter nothing has been put in the committee. “There is very little phase 2, which is about targeting Has the testing reduced covid? public domain,” said Jon Deeks, evidence on asymptomatic areas of high need, such as care There is no doubt that the professor of biostatistics at transmission. And testing home visiting, and release from prevalence of covid-19 has come Birmingham University and asymptomatic people is likely to lockdown. down rapidly, from almost 700 leader of Cochrane’s covid test be of only marginal benefi t.” per 100 000 population in mid- evaluation activities. “We only She added, “The whole thing October to 137.7 per 100 000 on know the number of positive seems extraordinarily rushed 26 November. However, Liverpool tests, and we don’t know the and poorly thought through. was the fi rst area to go into tier 3 number of false positives or false It appears they are making it restrictions on 14 October. “Boris negatives.” Deeks is particularly up as they go along, and they Johnson’s claim that rates are concerned about the sensitivity have marginalised experts coming down in Liverpool due to of the Innova lateral fl ow test, who could have off ered help, the testing is not good science,” which can be as low as 58% such as the National Screening said Deeks. “Liverpool was ahead when used by the public, Committee.” of other areas of the country on meaning that as many as half of However, Iain Buchan, dean their wave, and their fi gures had

384 5 December 2020 | the bmj The city was clear that we sought community open access testing, not mass testing Iain Buchan PETER BYRNE/PA already started to come down.” to reach the poorest communities could have been better used for The latest fi gures show that in the city and that in some parts tracing contacts and supporting between 6 and 26 November only 4% of residents had turned those who are isolating.” 108 304 people in Liverpool up to be tested. The government has said that were tested with lateral fl ow tests But Buchan dismissed the 4% local authorities in tier 3 “will and that 703 tested positive. In fi gure as “unfounded.” He said, be off ered support from NHS Boris Johnson’s claim that the same period 65 050 were “Uptake of lateral fl ow testing Test and Trace and the armed rates are coming down tested with PCR tests, of whom has been much higher than PCR forces to deliver a 6 week rapid due to the testing is not 2158 tested positive. But Pollock testing in deprived areas, and community testing programme.” good science Jon Deeks points out that it is impossible to more so as test site deployments But it is not clear how much know the true picture because were adapted to the signals from support local areas will be given, we don’t know whether people the data.” and from 3 December there will going for the lateral fl ow tests be 23 million people under tier 3 were truly asymptomatic or were Potential harms restrictions. pre-symptomatic, or whether Pollock believes that the harms of Maggie Rae, president of the they did have symptoms and testing have not been adequately Faculty of Public Health, said just wanted a quick test. Another considered. “Some people are that local areas would need unknown is how many of those getting false reassurance, as the much support. “We are going to The pilot scheme has testing positive on the lateral fl ow tests are not very accurate,” she be overwhelmed and will need been ridiculous and an test actually went on to have a said. “People were being told on to prioritise our actions and absurd way to go about confi rmatory PCR test. the radio that if they got a negative resources.” She expressed the mass testing Julian Peto test they could go about their view that, with the promising Is it reaching those most at risk? business.” She added that, since news on vaccines, resources An advocate of mass testing, she raised concerns, the FAQ page should be put into rolling out Julian Peto, professor of on the Liverpool council website vaccination rather than used for epidemiology at the London has been updated to include mass testing. School of Hygiene and Tropical information on false negatives, Rae did welcome the Medicine, told The BMJ, “The and it now says that a negative government’s announcement pilot scheme in Liverpool has lateral fl ow test result does not on 26 November that local been ridiculous and an absurd constitute a “green pass.” authorities will be able to decide The whole thing seems way to go about mass testing. It’s Another issue is the cost. It is how to use the lateral fl ow test extraordinarily rushed missing those in the areas that not known how much has been kits. “We have been pushing for are most aff ected.” He added, spent on the pilot in Liverpool, more local determination and and poorly thought “They have been inundated with which has involved 2000 army more targeted testing, otherwise through Alyson Pollock the worried well, and those in personnel. But the government it has the potential to widen the most deprived areas are not recently advertised a contract for inequalities,” she said. coming forward.” £912m to deliver rapid testing Jacqui Wise, London A report on BBC’s Newsnight across the country. “This is Cite this as: BMJ 2020;371:m4690 programme on 23 November said costing huge amounts of money podcast Hear Calum Semple of that the testing pilot was failing and resources,” says Pollock. “It Liverpool University on bmj.com

IT IS NOT KNOWN how much has been spent on the pilot in We have been pushing for Liverpool, which has involved 2000 army personnel. But the government recently more local determination and more targeted testing advertised a contract for £912m to deliver rapid testing across the country Maggie Rae the bmj | 5 December 2020 385 EDITORIAL NHS reorganisation after the pandemic Major structural change should not be part of the plan for recovery

ew legislation for pragmatic approach makes sense— the NHS in England though even the NHS’s more seems to be back on limited proposals risk unintended the agenda. Media disruption and may replace one set N stories emerged in the of workarounds with another.2 summer that the prime minister was It is unclear how seriously considering proposals for a major government is considering more NHS reorganisation—including widespread reform, or what the changes to bring national NHS reorganisation of public health bodies under closer political control.3 agencies may mean for NHS NHS commentators are calling for responsibilities. It is much clearer, legislation to give greater power to however, that any moves to local leaders to reorganise care as the bring NHS England under closer NHS recovers from the pandemic. 4 ministerial control would be rooted And changes to the English public in politics rather than evidence. health system currently being The NHS has faced the most considered by government—set in If the For politicians, the motivation diffi cult year in its history and is motion by the poorly timed decision government for new NHS legislation may be heading into what is likely to be to abolish Public Health England is interested diff erent. Like NHS England, the its bleakest winter. The challenges back in August—include returning health secretary seems convinced of facing the NHS when it emerges from in reform, a 8 some public health responsibilities better place the benefi ts of collaboration. But the the pandemic are enormous. The to the NHS.5 government may also see legislation backlog of unmet healthcare need is The rationale for legislation to look would as a route to gain tighter control over substantial.14 NHS staffi ng shortages depends on whom you ask—and be adult social the day-to-day workings of the NHS— stand at over 100 000—and could involves a mix of policy and politics. care something the 2012 act sought to double over the next fi ve years. 15 For NHS leaders, the argument is that loosen. Public services also face the challenge the rules governing the NHS make it NHS England has become the de of reducing the gaping health harder to deliver the improvements facto headquarters for NHS strategy inequalities exacerbated by covid-19. promised in the long term plan— under Simon Stevens (photo), its Major structural reorganisation of the including better integration between chief executive. The previous health NHS would not be the answer to these health and social care and a greater secretary, Jeremy Hunt, has said problems—and would probably make focus on disease prevention. he never felt he “lacked a power to them harder to fi x. Analysts of institutions often focus give direction” to the NHS under If the government is interested in on the interaction between the “rules the 2012 act.9 But perhaps the structural reform, a better place to in form”—the formal rules that govern incumbent feels less powerful. look would be adult social care in how systems work on paper—and Reform to bring NHS England under England. The pandemic has taken the “rules in use”—the way things closer political control may also a grim toll on social care users and actually work in practice.6 The Health help build a narrative, ahead of any staff , and central government action and Social Care Act 2012 introduced covid-19 public inquiry, that arm’s to support the sector has been too rules to encourage competition length bodies—not government—are slow and inadequate.16 Covid-19 within the health system. In reality, to blame for England’s pandemic has exposed longstanding political NHS leaders embraced collaboration performance. neglect—including historical instead, establishing sustainability underfunding, chronic workforce and transformation partnerships Politics over evidence problems, and high levels of unmet and integrated care systems to lead NHS reorganisations happen need. Fundamental reform is needed local service changes. But these frequently but appear to deliver to transform the current threadbare partnerships have no formal powers, little benefi t. 10-13 They can also safety net into a system that off ers and rules on competitive tendering bring additional costs, destabilise much more generous and eff ective can hold back collaboration. services and relationships, and divert state protection for vulnerable resources away from patient care. people and their carers. Hugh Alderwick, head of policy , Health NHS England has called for targeted Cite this as: BMJ 2020;371:m4468 Foundation, London, UK legislation rather than wholesale 1 Find the full version with references at [email protected] reorganisation of the NHS. This http://dx.doi.org/10.1136/bmj.m4468

386 5 December 2020 | the bmj EDITORIAL Misinformation fuels an timicrobial resistance Damaging beliefs about antibiotics for covid-19 are widespread

ell before covid- economies 13 and almost all adults 19, the world in higher income countries have already faced an access to a digital device, and more emergent threat than half the world’s population W of antimicrobial uses social media,14 these strategies resistance, and many have sounded must include creative, regulated the alarm over further escalation online media campaigns to combat during the pandemic.1 A study from misinformation. the US, for example, showed that Some organisations, such as 71% of covid-19 patients received the World Health Organization antibiotics while only 4% had true and Nigeria Centre for Disease bacterial coinfection.2 This overuse Control,15 16 already use their digital of antibiotics may have contributed platforms to correct antimicrobial to the observed 10% increase in misinformation by discussing the resistance against several classes of ineff ectiveness of antimicrobials as antibiotics (compared with 2019) at a primary treatment for covid-19. the same institution. We must resulted in poor understanding of Others, including the Africa Centres Spread of misinformation during tackle twin this viral pandemic and its aetiology for Disease Control and Prevention epidemics has been documented pandemics of by general populations worldwide and the US National Institutes of before,3 but covid-19 has and, in some settings, medical Health and Centers for Disease covid-19 and 8 171819 brought with it a global deluge of misinformation professionals. In Australia, 44% of Control and Prevention, provide misinformation. Politicisation of respondents to a population survey general information on public the pandemic in many countries simultaneously incorrectly thought antibiotics could health measures, disease symptoms, led to politicians being a leading treat or prevent covid-19.9 associated myths, and stigma source of misinformation,4 while Misinformation aff ects clinicians but do not discuss antimicrobial initial underestimation of the and health policy makers as well use specifi cally. They should be pandemic by key public health as the public—partly fuelled by encouraged to correct this serious stakeholders led to inconsistent management controversies triggered omission. messaging and widespread public by the early release of poorly reported Concerted eff ort is also required confusion.5 A survey of online news and preliminary research fi ndings. to make sure medical providers have articles identifi ed incorrect reports Early posting of preprints has allowed rapid, timely access to evidence published in 25 languages in 87 rapid dissemination of important updates on the management of countries, roughly a fi fth of which research but also raised concerns all aspects of covid-19. Online were on cure and treatment.6 In over the public release of poorly teaching, webinars on management low and middle income countries, conducted studies and the premature algorithms, systematic reviews, and many of which already have a or inaccurate media reporting of living guidelines such as The BMJ ’s high burden of multidrug resistant unsubstantiated fi ndings that often Rapid Recommendations,20 should organisms, misinformation follows.12 Both policy makers and be developed by regional and global includes overemphasis on the role frontline clinicians struggle to keep up agencies, and made available free of antimicrobials. This includes the with rapidly evolving evidence on the to healthcare workers, allowing the use of azithromycin, which has been management of covid-19, particularly rapid dissemination of trustworthy shown repeatedly to have no effi cacy clinicians in low and middle income evidence. against covid-19.7 countries with limited access to timely, Fragile healthcare systems in Lack of basic knowledge on verifi ed sources of information. many parts of the world may not infections and their treatment has withstand the covid-19 pandemic Digital solutions if also faced with a substantial Mehreen Arshad, assistant professor, Feinberg School of Medicine, Strategies must be developed now increase in antimicrobial resistance. Northwestern University, USA [email protected] to counter the detrimental eff ect We must tackle the twin pandemics Syed Faisal Mahmood, head of infectious diseases, Aga Khan of misinformation on the use of of covid-19 and misinformation University, Pakistan antimicrobials and prevent further simultaneously. Mishal Khan, associate professor deterioration in the global crisis Cite this as: BMJ 2020;371:m4501 in antimicrobial resistance. Since Rumina Hasan, professor, London School of Hygiene and Tropical Find the full version with references at Medicine, London, UK roughly half the adults in emerging http://dx.doi.org/10.1136/bmj.m4501 the bmj | 5 December 2020 387 FEATURE Covid-19: What now for remdesivir? The spectre of past pandemics looms large over remdesivir, one of the fi rst purported treatments for covid-19. With a WHO trial fi nding little benefi t, Jeremy Hsu asks if the expensive drug is just another Tamifl u

t’s a cautionary tale worth potential to spark pandemics.34 After length of hospital stay, or need for remembering amid the disappointing results treating Ebola ventilation among hospitalised coronavirus pandemic. in 2014, remdesivir was tested in the patients.8 This represents some of the Starting in the early 2000s, early stages of the covid-19 pandemic. strongest evidence yet that remdesivir I governments spent billions of Initial trial evidence suggested that it is unlikely to be the lifesaving drug for dollars stockpiling the antiviral drug can shorten recovery times for severely the masses that many have hoped for. oseltamivir (Tamifl u) in anticipation ill hospitalised patients,5 giving it Instead, researchers are now of fl u pandemics. Years later, global attention. focusing on moderately ill patients independent researchers gained access The results were lauded by the who could still benefi t from the drug to unpublished clinical studies that National Institutes of Health (NIH) and if it’s given early. But considering the showed the drug had only a modest Paying a high an emergency use authorisation (EUA) high price, limited stock, and now eff ect on reducing the duration of price without was swiftly made by the US Food and arguably limited benefi ts, what now symptoms, had many side eff ects, and good evidence Drug Administration (FDA) in May.6 It is for remdesivir and doctors considering displayed insuffi cient data to conclude of mortality soon to be more widely available in the using it? whether it could prevent infl uenza’s benefit is a UK and Europe.7 12 most serious complications. gamble None of the randomised controlled A high price to pay Fast forward to 2020 and we have Robin Ferner trials published so far, however, remdesivir, an expensive, experimental have shown that remdesivir saves “Paying a high price for remdesivir antiviral and one of the fi rst, and signifi cantly more lives than standard without good evidence of mortality hence hyped, treatments to emerge for medical care. There is confl icting benefi t is a gamble,” says Robin covid-19. evidence about whether a fi ve or 10 day Ferner, a physician and professor of It comes from a collaboration treatment cycle leads to any clinical clinical pharmacology at the University between Gilead Sciences, the US improvement. And the World Health of Birmingham. Centers for Disease Control and Organization’s Solidarity trial—a Even before the Solidarity trial Prevention (CDC), and the US Army huge international study involving results came out, many doctors Medical Research Institute of Infectious thousands of patients—has published questioned remdesivir’s eff ectiveness, Diseases that sought to fi nd treatments interim results showing that the drug particularly considering its cost can for RNA based viruses with the has no signifi cant impact on mortality, quickly add up to millions for a single 2020

8 April Gilead 29 April First 7 May 22 May 27 May 29 June initiates a randomised controlled Japanese Ministry ACTT-1 trial, Gilead sponsored, Gilead announces rolling new drug trial published in of Health, Labour, sponsored by NIH open label pricing for a six vial, application for the Lancet finds no and Welfare and published in Simple-Severe five day treatment remdesivir with significant difference 1 May grants regulatory NEJM , finds that a trial published course set at $2340 the FDA between remdesivir FDA gives first approval for 10 day course of in NEJM finds for governments of and placebo for emergency use remdesivir to be remdesivir shortens remdesivir shortens developed countries. hospitalised patients authorisation allowing used in patients time to clinical time to clinical But US private in China. remdesivir to be given hospitalised with improvement by improvement for insurers and the Gilead press release to patients hospitalised severe cases of five days compared moderately ill covid- US government’s announces interim with severe covid-19 covid-19 under with placebo, but 19 patients on both Medicare and findings of the ACTT-1 FDA approval was based an exceptional has no significant five day and 10 day Medicaid programmes trial on the ACTT findings approval pathway impact on mortality treatment regimens must pay $3120

388 5 December 2020 | the bmj hospital dealing with hundreds of LIMITED SUPPLIES covid-19 patients. Supplies of remdesivir remain variable A treatment cycle may take 5-10 across the world. Shortages and high days.9 A fi ve day course of treatment prices have affected the US and much for one patient costs around $2340 of Europe. Gilead has moved to boost (£1773; €1976) for government remdesivir production, but WHO has taken programmes and $3120 for private a cue from its Solidarity trial in excluding insurers, although Gilead has reached remdesivir from the list of priority drugs 2728 agreements to make cheaper generic it’s looking to supply to poor countries. versions of the drug available in low Still, Gilead has signed licensing agreements with manufacturers in Egypt, and middle income countries. For India, and Pakistan that permit the sale of generic versions of the drug comparison, Tamifl u costs less than across low and middle income countries including Bangladesh and the 293031 $75 per course of treatment to shorten Philippines. The BMJ symptom duration for patients with Gilead’s Bahar Turkoglu told , “Currently, our licensees have made generic remdesivir available to patients in need in more than 40 countries, infl uenza (generic versions of the drug and we expect this number will continue to grow over the coming months.” can cost even less). Many hospitals have also faced diffi cult decisions about which also remains unproved given that among infected animals when patients would benefi t from taking the Solidarity trial and other clinical administered after covid-19 symptoms remdesivir—a challenge further trials have shown no signifi cant begin. He notes drug toxicity concerns complicated by supply problems, mortality benefi t. As a result, the that surfaced in prior animal studies. changing regulatory advice, and Institute for Clinical and Economic “Clinical dose of remdesivir for lingering questions about clinical Review’s pricing model “suggests covid-19 is equivalent to double the eff ectiveness and safety. that remdesivir’s current US price is toxic dose in rats and monkeys which Steven Pearson, a physician and too high to align reasonably with its showed renal damage,” Hama says. president of the Institute for Clinical demonstrated benefi ts to patients,” Even in humans, the ideal way and Economic Review, a Boston based Pearson said. to study any drug is to compare its non-profi t organisation focused on Compounding matters, none of treatment outcomes in one group cost eff ectiveness analyses of medical the preclinical studies that tested with the outcomes from a control treatments and tests, has said that remdesivir on animals infected with group receiving a placebo. An early Gilead’s pricing of remdesivir is cost SARS-CoV-2 have yet established a placebo controlled trial in China eff ective only if two key assumptions record of robust safety and effi cacy, found no evidence of benefi t from hold true. “The current price would according to Rokuro Hama, a remdesivir. Instead, the FDA’s drug meet a key cost eff ectiveness threshold physician and director of the non-profi t approval announcement cites just Remdesivir’s only if it were used solely to treat Japan Institute of Pharmacovigilance one placebo controlled trial: ACTT-1 current US patients hospitalised with moderate- in Osaka, who has also extensively which was sponsored by the NIH. price is too to-severe disease and—importantly— studied Tamifl u. The FDA’s prescribing ACTT-1 showed a fi ve day course of high to align only if one still assumes that information for remdesivir currently remdesivir improved patients’ time to remdesivir saves lives,” Pearson said in includes cautionary notes about the clinical improvement, but this study reasonably 10 a statement in November. need to monitor kidney and liver also made the controversial decision to with its The fi rst assumption is undermined function in human patients.11 end the placebo treatment arm early.12 demonstrated by the fact that US regulators have Unlike some researchers who are That limited the capability to collect benefits to expanded possible use of remdesivir pushing for more human clinical trials, more data on the eff ects of remdesivir patients to patients with milder cases of the Hama prefers to fi rst see evidence and possibly see if the drug can reduce Steven Pearson disease. The second assumption that remdesivir can reduce mortality mortality rates.

3 July 10 August 28 August 1 October 8 October 15 October 22 October European Gilead FDA expands Gilead European WHO sponsored, FDA officially Commission announces emergency use takes over Commission open label approves grants conditional it has authorisation distribution buys 500k Solidarity trial remdesivir for marketing submitted to allow of remdesivir courses of (preprint) finds use in authorisation the final 21 August Gilead sponsored, remdesivir from the US remdesivir that remdesivir patients for remdesivir part of its open label trial published to be used in Department for $1.2bn has little or hospitalised to be used in new drug in JAMA finds remdesivir all patients of Health no effect on with covid-19 covid-19 patients application shortens time to clinical hospitalised and Human overall mortality,ty, with pneumonia for improvement for moderately with covid-19 Services and initiation of requiring remdesivir ill covid-19 patients on a five regardless begins selling ventilation, supplemental to the FDA day treatment regimen but of disease directly to or duration of oxygen not a 10 day regimen severity hospitals hospital stay the bmj | 5 December 2020 3893838989 Solidarity We now have over 5000 patients in the WHO’s Solidarity trial is an open label “With a disease that has infected remdesivir arm of study that does not include a control over 45 million people in nearly Solidarity that still group receiving placebo. A Gilead 200 countries and caused over one statement attempted to cast doubt on million deaths, we need trials with show no benefit Erin McCreary the Solidarity trial because of its open heterogeneous populations,” says label design that allows physicians Erin McCreary, an infectious diseases and patients to know who is taking clinical pharmacist at the University of Regulation and revelations remdesivir, despite the fact that the Pittsburgh Medical Center, who was not pharmaceutical company has touted involved in the WHO study. “Solidarity The public health emergency compelled results from other open label studies was an impressively massive trial that regulators to speed up regulatory processes and that it sponsored.13 14 is pretty much as good as it gets in a allow hospitals to make some conditional uses Solidarity was designed to look global pandemic to determine which of remdesivir before completion of the usual at harder, more objective health therapies are eff ective and which approval process. endpoints that open label clinical trials populations optimally benefi t.” The EUA enabled the drug to skip all that and would be unlikely to infl uence, such Before the Solidarity results were be used in clinics for emergencies. Remdesivir as mortality, ventilation requirements, announced, McCreary had co-authored has also sometimes been provided on a and length of hospitalisation. an editorial for JAMA summarising “compassionate use” basis at cost price under Srinivas Murthy, an intensive care the confl icting evidence from the FDA rules that permit the use of experimental and infectious diseases physician at the remdesivir studies and detailing the drugs outside of clinical trials if a doctor British Columbia Children’s Hospital in study design diff erences, including the applies.16 But there are no restrictions on how Vancouver and principal investigator recruitment of patients with varying much a pharmaceutical company can charge for the Canadian portion of Solidarity, severities of illness.15 Earlier studies once it receives either an EUA or gets formal says, “Mortality should not be aff ected had already consistently shown that approval for a new drug application. Gilead by whether a study is open label or certain subgroups of patients did not stated the compassionate use programme in the closed or placebo blinded for obvious derive benefi t from remdesivir: the more US was winding down following the EUA.17 reasons: you or your doctors can’t will severely ill patients who require high “There is always a tension between yourself into staying alive by knowing fl ow supplemental oxygen through nose withholding a drug from general use when it is you had the drug.” tubes, non-invasive ventilation through benefi cial, and protecting the public from a drug What Solidarity does to an impressive face masks, or invasive ventilation that doesn’t work or is unacceptably harmful,” extent is to evaluate remdesivir’s impact through a tube down the throat. Ferner says. in a patient population on a far bigger Solidarity continues to recruit patients to One controversial regulatory decision came scale than any previously published its ongoing study. McCreary told The BMJ, on 28 August, when the FDA expanded the studies—2750 patients who received “We now have over 5000 patients in the EUA to allow use of remdesivir in all patients a 10 day course of remdesivir came remdesivir arm of the Solidarity trial that hospitalised with covid-19, not just severe cases. from a total study population of 11 266 still show no benefi t . ” For some physicians and medical researchers, hospitalised adult patients. The number That leaves clinicians to conclude that that was a step beyond what the available of Solidarity study participants dwarfs remdesivir only benefi ts a small subset of clinical trial evidence can support. Alyssa the number involved in the ACTT-1 study moderately ill patients. McCreary says the Letourneau, an infectious disease physician that has been touted by Gilead and US drug needs to be studied in randomised and director of the antimicrobial stewardship regulators. “The number of participants trials in this subset of patients who programme at Massachusetts General Hospital in the Solidarity trial is almost fi ve times may benefi t. “We don’t have conclusive in Boston, told The BMJ on 6 October, “At this that of ACTT-1,” Hama says. evidence to say what the ideal patient price point it’s more diffi cult to give it to patients The Solidarity trial also draws population is for this drug, and it’s still a who newly qualify under the updated EUA when upon a diverse group of patients globally scarce resource (see box).” the data aren’t clear that they will benefi t.” in 405 hospitals spread across 30 The Solidarity trial is continuing Similar concerns were raised in an open letter countries. Gilead questioned the to study if remdesivir can help such by Eric Topol, director and founder of the Scripps Solidarity results because the study moderately ill patients who seem the Research Translational Center in La Jolla, “prioritised broad access, resulting most likely to benefi t from the drug (those California, which questioned the credibility of in signifi cant heterogeneity in trial requiring low fl ow oxygen but who are the FDA commissioner, citing the expanded adoption, implementation, controls, not on ventilators). There may still be a remdesivir EUA among other decisions.18 “There and patient populations.” But both chance of remdesivir delivering a mortality are insuffi cient data to support this approval, the Solidarity team and independent benefi t for such patients. “If there is an as it is based on small, open label studies with experts say that this actually represents eff ect, it’s an exceedingly small one,” subjective endpoints,” Topol wrote. “Remdesivir the strength of the study—a global test Murthy says, “But any eff ect on mortality is is an expensive drug, costing around $3000 of how remdesivir performs in complex something to note, and then policy makers per treatment, in short supply, and even its real world environments beyond the and clinicians can make a decision as to approval for severe covid-19 was based on time controlled settings of the smaller whether or not the drug needs to be rolled to recovery in a relatively small trial of just over clinical trials that came before. out in targeted populations.” 1000 patients.”

390 5 December 2020 | the bmj The European Medicines Agency had already granted conditional approval similar to the FDA’s EUA for remdesivir back in July.19 On 8 October, the European Commission followed up by signing a joint procurement framework contract with Gilead for a six month supply of up to 500 000 treatment courses of remdesivir worth $1.2bn.20 21 But what the European Commission didn’t know was that Gilead had already received a draft manuscript of the Solidarity fi ndings in September. 22 The commission only learnt about remdesivir’s lacklustre performance in Solidarity the day after it signed the contract with Gilead. To the surprise of many, on 22 October—a week Governments spent billions of dollars stockpiling tamiflu in anticipation of flu pandemics after the Solidarity results became public—the FDA offi cially approved the drug as a covid-19 The next Tamiflu? treatment for all hospitalised patients over 12 years of age. 23 FDA reviewers were aware The full story of remdesivir will not be known until Gilead releases the full clinical of the Solidarity trial data, says Chanapa study reports, as the pharmaceutical company Roche fi nally did with Tamifl u in Tantibanchachai, a press offi cer at the FDA. 2013. “It was only once we looked at the whole thing that we found the benefi ts But she added that the agency’s approval of of Tamifl u were the shortening of the duration of illness by a few hours,” says remdesivir was largely based on the NIH’s ACTT-1 Tom Jeff erson, an epidemiologist and Cochrane reviewer who is currently suing trial along with two Gilead sponsored trials. Roche under the US False Claims Act. “There was nothing credible on deaths, It is possible for the FDA to withdraw approval transmission, or hospitalisation.” of drugs for reasons of safety or eff ectiveness.24 There is a chance to avoid similar uncertainty hanging over remdesivir, But some researchers worry that the FDA approval especially with so many patients who can be enrolled in large scale clinical trials will make it harder to carry out additional studies, during the pandemic. Much will depend on whether future studies are designed to especially if some physicians are reluctant to test remdesivir’s potential eff ectiveness. withhold remdesivir from patients. “The FDA All this remains in the middle of a still raging pandemic, with alternative does not believe that the approval of remdesivir treatments now impacting discussions about remdesivir’s cost eff ectiveness. will negatively impact the clinical development of The well known, cheap, and widely available corticosteroid dexamethasone, for remdesivir,” Tantibanchachai told The BMJ . example, has been proved to reduce mortality among severely ill covid-19 patients But Derek Angus, an intensive care physician who were either on ventilators or receiving oxygen. 25 Given the apparent benefi t and chief healthcare innovation offi cer at the to reducing mortality in some cases at a cost of less than $1 per day, many experts University of Pittsburgh Medical Center, who want to see studies testing remdesivir’s eff ectiveness when given in conjunction co-authored the JAMA editorial on remdesivir with with corticosteroids. McCreary, says a potential side eff ect of the FDA And then there is remdesevir’s relative. In late August, the NIH began approval is that it will thwart or stymie the conduct investigating the potential of GS-441524, another compound owned by Gilead of further randomised controlled trials that would that is the parent nucleoside of remdesivir. Compared with remdesivir, GS-441524 otherwise be able to help delineate exactly in could be easier to synthesise and manufacture—and could cost much less. whom, and at what point in the course of disease, It could also be produced as an oral formulation—remdesivir must be given remdesivir should be used. “The lack of benefi t in intravenously—that can be administered outside hospitals earlier following the Solidarity trial only reinforces the need to better diagnosis when antiviral drugs typically show the most benefi t. Preclinical animal understand remdesivir’s eff ects,” he says. studies suggest it may also prove less toxic to many organs of the body than A Gilead representative noted that there are remdesivir and therefore could be given at higher doses with possibly improved multiple international clinical trials ongoing to therapeutic eff ect. evaluate the safety and effi cacy of remdesivir for “Gilead has done a considerable amount of safety and toxicity work on diff erent patient populations, formulations, and GS-441524, and they have data on fi le with the FDA,” says Victoria Yan, chemist in combinations with other therapies. But the at the University of Texas MD Anderson Cancer Center, who has been pushing for a company also suggested that testing remdesivir phase I trial to explore GS-441524 as a covid-19 treatment. 26 against placebo would no longer be warranted. Gilead told The BMJ that it chose to prioritise development of remdesivir over Bahar Turkoglu, senior director of public GS-441524 as a covid-19 treatment because of available evidence at the time aff airs at Gilead Sciences UK and Ireland, told from animal studies and because the company already had some safety data on The BMJ , “Now that the safety and effi cacy of remdesivir in humans from prior clinical trials focused on Ebola. But the company remdesevir has been assessed across multiple is currently investigating GS-441524 through animal studies. randomised controlled clinical trials and it is “We have initiated additional preclinical studies to further compare remdesivir considered a standard of care, it would not be and GS-441524,” Turkoglu says. “We will publish the data as soon as they become ethical to conduct a placebo controlled trial in available.” patients who would otherwise be eligible to Jeremy Hsu, Freelance journalist, New York, USA [email protected] receive this treatment.” Cite this as: BMJ 2020;371:m4457 the bmj | 5 December 2020 391 THE BMJ APPEAL 2020-21 Independent Food Aid Network gives a voice to those determined to make a difference

The BMJ’s Christmas appeal this year will support the Independent Food Aid Network, a charity that has helped independent food banks and other community meal providers throughout the pandemic, writes Jane Feinmann

he sight of a parent or guardian “standing on the doorstep with tears in their eyes, and the young person so happy that T they seem to have food at last” is an everyday experience for Alexandra McMillan. In June 2020, McMillan, who used to work as a personal trainer, set up the Legendary Community Club in Lewisham, a London borough where 37% of school children experience food insecurity. Since then, she has coordinated the distribution of more than 7500 lunches and 2200 food parcels to prevent children going hungry. “I was volunteering at the local food bank while on furlough,” she recalls. “Someone mentioned that teachers at nearby schools were dipping into their own pockets to make sure their pupils didn’t go hungry. I saw there was a need and that I could do something.” What helped, she says, was that, once established, the club became eligible for free membership of the Independent Food Aid Network (IFAN), the charity being supported by The BMJ Appeal 2020-21. The network has come into its own during the covid-19

392 5 December 2020 | the bmj the bmj

| 5 December 2020 393

RICHARD H SMITH pandemic, supporting a growing number Food poverty remains a largely IFAN’s brilliant help,” he says, “it’s very of independent food banks and other misunderstood problem, despite a straightforward. If people are hungry, we community meal providers. campaign led by Marcus Rashford feed them.” The medical profession has long At another member group—Dads House recognised that this is major public health director of First Steps Nutrition Trust. “In the Charity in Earls Court, London—Billy issue, causing “the heartbreak and pain of meantime, though, IFAN does an excellent Granaghan says that “a big increase in suff ering hunger for so many children, as job of supporting and representing anyone need is from the gig economy, manual well as higher rates of obesity, rickets, and who is out to help. Through its members, its workers, and bar staff , including men and depression, while also a ticking time bomb work is varied, diverse, and sustainable.” women, many of them single parents who for premature death from heart disease and Membership of the network has more have lost their jobs and don’t have savings diabetes in the future,” says Guddi Singh, than doubled since March and now includes for emergencies—we’ve got young people a paediatric doctor at the Mary Sheridan more than 400 independent food banks and who fi rst volunteered and now use our food Centre for Child Health at the Guy’s and St other community meal providers tackling bank.” Thomas’ NHS Foundation Trust in London. child hunger in the UK on a daily basis. Data Rather than spending funds on Singh says that food poverty remains a from May 2020 show that there has been infrastructure, IFAN only supports food largely misunderstood problem, despite a a 177% increase in the number of three aid workers who are already established. It campaign led by Marcus Rashford forcing day emergency food parcels distributed deliberately avoids contractual agreements government U-turns on free school meals. In this year, compared with the same period with national supermarkets, though the June, Rashford sent a passionate letter to all last year. Independent food banks in network’s coordinator, Sabine Goodwin, is members of parliament asking for them to Scotland reported at least twice the need quick to intervene when local supermarket reconsider their decision to end free school for emergency food parcels in April to July branch managers are “uncooperative.” dinner vouchers. “Political affi liations aside, compared with last year. “Since the onset of covid-19, IFAN has can we not all agree that no child should “We’ve seen at least twice the demand distributed over 500 small, emergency be going to bed hungry? Food poverty in due to covid-19,” says Paul O’Brien of Micah grants to its frontline member organisations England is a pandemic that could span Liverpool, a social justice charity based at ranging from £50 to £100 to enable them generations if we don’t course correct now.” Liverpool Cathedral and a longstanding to respond to increased need for their Despite its role as a network to support member of IFAN. “While we used to mainly services,” she explains. food aid providers and ensure that people cater for refugees and homeless people, it’s That kind of funding may seem a drop in who are unable to aff ord or access food now mostly working families who aren’t the ocean, but “it was enough to buy stock are able to eat, IFAN’s vision is an end to earning enough to be able to feed their to provide packed lunches for local youth the need for food banks. “They’re seen children throughout the month.” clubs before we crowdfunded for the rest,” as sticking plasters, and members want O’Brien says that IFAN provided support says McMillan. to work together to bring about changes when panic buying resulted in supply Jane Feinmann, journalist , London, UK so they are no longer needed,” explains shortages and when older volunteers were [email protected] Helen Crawley, registered nutritionist and no longer able to turn up to help. “With Cite this as: BMJ 2020;371:m4664

Support the Independent Food Aid Network’s frontline and advocacy work DONATE ONLINE: Please return to: Independent Food Aid Network, 58 Standen Road, London SW18 5TQ www.foodaidnetwork. Title Forename Surname org.uk/BMJ Through Gift Aid any donation you Address give will be worth 25% more, at Would you like IFAN to Postcode Telephone number NO extra cost to you. All you need communicate with you via to do is: email in relation to this £50 helps IFAN member organisations distribute emergency food parcels to people unable to aff ord food Tick here if you would like The donation? If yes, please £100 supports IFAN to advocate on behalf of its member organisations and campaign for change Independent Food Aid Network to add your email address. reclaim the tax you have paid on all Yes £250 supports IFANs member organisations to purchase food and other essentials to distribute on the frontline your donations made in the last four No £500 contributes to the day-to-day running of IFAN years, and any future donations you I’d like to donate £ may make. To qualify for Gift Aid, you Email address must pay as much UK income and/or I enclose a cheque /charity voucher made payable to The Independent Food Aid Network capital gains tax as The Independent Food Aid Network (and any other OR I authorise The Independent Food Aid Network to debit my Visa / Mastercard / Maestro / CAF charity card below: For information on how organisation you may support) will IFAN stores and uses Cardholder name reclaim in each tax year, currently your data visit www. 25p for every £1 you donate. If you foodaidnetwork.org.uk/ Card number pay less it is your responsibility to pay privacy-statement (Shaded boxes back any diff erence. Gift Aid will be Expiry date Start date (if shown on card) Maestro only) used to fund The Independent Food Aid Network. / / IFAN is registered with the Fundraising Regulator Signature Date Registered charity number: 1180382

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