Blog

  • Categories
  • Category Archives: COVID-19

    On Friday 26 June 2020 HIV i-Base published the fifth COVID-19 supplement to HIV Treatment Bulletin (HTB). Please see this link.

    All i-Base reports are free to copy and i-Base encourages wide distribution. Please credit i-Base when distributing these reports.

     

    HIV and COVID-19: a new supplement to HIV Treatment Bulletin (HTB).

    This publication reviews the latest news on COVID-19, including research that is important for care of people living with HIV.

    All articles are online as html web pages. The PDF files use a single column layout that makes it easy to read each issue on tablets and other hand held devices.

    HIV and COVID-19 no 5 – (26 June 2020)
    HIV and COVID-19 coinfections including data from South Africa, dexamethasone effective in advanced COVID-19, hydroxycholoquine not effective in UK RECOVERY study, plus updates on remdesivir and other treatments…
    Contents online. (html pages)
    HIV and COVID-19 no 5 – 26 June 2020 (PDF)

    HIV and COVID-19 no 4 – (1 June 2020)
    HIV and COVID-19 coinfections, UK access to remdesivir, convalescent plasma, interferon, famotidine, tocilizumab, concern with hydroxychloroquine, UK research plus more…
    Contents online (html pages)
    Download: HIV and COVID-19 issue 4 (PDF)

    HIV and COVID-19 no 3 – (14 May 2020)
    Latest issue includes news on latest treatments, including US approval of remdesivir, plus tentative results with other drugs that reduce immune inflammation (anakinra) – perhaps as essential as antivirals – anticoagulants, ACE inhibitors. Plus latest guidelines and no effect from BCG vaccine.
    Contents online (html pages)
    Download: HIV and COVID-19 issue 3 (PDF)

    HIV and COVID-19: no 2 – (17 April 2020)
    The second supplement of HTB with more than 30 COVID-19 reports: hydroxychloroquine studies, antivirals, transmission and prevention research, online resources.
    Contents online (html pages)
    Download: HIV and COVID-19 issue 2 (PDF)

    HIV and COVID-2019: no 1 – (27 March 2020)
    This 20-page HTB supplement compiles links to articles and resources about COVID-19 including information for managing the care of HIV positive people. It includes short reviews of key studies and early guidelines.
    Contents online. (html pages)
    Download: HIV and COVID-19 issue 1 (PDF)

    Other news and resources on COVID-19 are at: i-base.info/covid-19

    Leave a comment

    The Fire Brigades Union (FBU) has vowed to fight “unthinkable” proposals to cut the budget for the London Fire Brigade by £25m over two years, as part of the Mayor of London’s £500m saving plans.

    The FBU has condemned the “huge damage to the fire service” left over from Boris Johnson’s time as Mayor of London. Central government have so far refused to bail out the GLA’s budget shortfall accrued during the coronavirus pandemic.

    The union has criticised Mayor Sadiq Kahn for “passing on Tory cuts to the very emergency services that keep people safe” and has vowed to hold him to his commitment to protect frontline services.

    David Shek, FBU executive council member for London, said:

    “London is the epicentre of the UK’s building safety crisis and there is no safe way to manage funding cuts of this magnitude. A £25 million cut to London Fire Brigade’s funding is unthinkable and we will fight it to the bitter end.

    “We have just marked the third anniversary of the Grenfell Tower fire and in the years since have dealt with a number of fires in buildings with similar combustible materials. The dangers of cutting the fire and rescue service right now are blatantly obvious.

    “The Mayor has committed to protected frontline emergency services and we will hold him to that. We will not accept any reduction in frontline services – whether that be crewing reductions, shift changes, or a recruitment freeze. Make no mistake – any reduction in fire cover will put lives at risk.”

    Matt Wrack, FBU general secretary, said:

     “The scale of these cuts is devastating and is a gross insult to firefighters in London who have gone above and beyond to support their communities during the COVID-19 pandemic. The public will not support these cuts, and we intend to fight them.

    “Sadiq Khan made a commitment to protect vital frontline services and he must do that. The government should support regions facing financial difficulties as a result of COVID-19 but there is no excuse for a Labour Mayor to be passing on Tory cuts to the very emergency services that keep people safe across the capital.

    “Boris Johnson did huge damage to the fire and rescue service as London Mayor by pushing through the biggest cuts in history. These cuts impacted the response on the night of the Grenfell Tower fire and the London Fire Brigade has still not fully recovered. To be considering more spending cuts is downright reckless and would show contempt for the public’s safety.

    “This pandemic has demonstrated the value of the fire and rescue service and we should actually be talking about new investment to make the service better and safer. The government must step up to provide whatever financial support is necessary or the prime minister’s talk of ending austerity will ring hollow across London. If that support is not forthcoming, the Mayor must pledge to scrap these dangerous cuts.

    Joe Karp-Sawey, FBU communications officer

    Leave a comment

    Doctors in Unite are concerned at the pace of the ideologically driven moves to ease Lockdown measures. The implication is that we will have to live with a baseline prevalence Covid-19 and within the shadow of a second surge

    We have launched an open letter to the Prime Minister on the issue as we fear that the Westminster government is displaying the greatest level of recklessness in this regard.

    https://doctorsinunite.com/2020/06/21/open-letter-to-the-prime-minister-about-the-uks-covid-19-strategy-from-nhs-and-social-care-workers/

    The campaign was triggered by the experience in many other countries that are pursuing a policy of eradication of Covid-19 as far as it is practical and the Crush the Curve campaign in Ireland (North and South).

    Posted by Brian Fisher on behalf of Doctors in Unite.

     

    Leave a comment

    This paper was developed by a group of primary care clinicians for the Labour Shadow Health Team at their request. We hope it helps illuminate the next steps for primary care.

    WHAT ARE THE RISKS, OPPORTUNITIES AND CHALLENGES FACING  PRIMARY CARE PROVISION DURING AND AFTER ITS RETURN  TO A NORMAL STATE OF OPERATION?

     

    “We will be facing some tough challenges over at least the next year: managing more consultations (and clinical risk) remotely by phone or video; catching up with resurgent patient demand, catching up with the care of long-term conditions (whilst trying to protect groups of vulnerable people from a continuing threat of Covid); managing a backlog of people who need to be referred; and coping with any spikes in Covid. This comes on top of the usual (preceding) strains on limited resources and lengthening ‘winter pressures.’ I don’t think that we will be seen as ‘NHS heroes’ in a few months!”

     

    DIGITAL WORKING IS TRANSFORMING CARE

    Opportunities

    • Easier and more flexible for people and practices, so may aid GP recruitment
    • The complex and subtle nature of the consultation seems to be maintained
    • Communication across sectors can be dramatically improved. One GP described helping a patient with lymphoma – in 10mins he was able to include a Ca nurse and consultant in a conversation with the patient.
    • Telephone triage also successful
    • Bricks and mortar general practice may become less necessary
    • Combining online personalised advice with online access to records opens the way to improved self-care

    Challenges:

    • Digital can widen inequalities and disenfranchise. Experience suggests it is the elderly rather than the poor who struggle the most.
    • The best balance between remote and face-to-face is unclear. Video may be best for follow-ups.
    • Video is seldom preferred by people. The telephone or face to face are most popular.

    Actions:

    • Support the elderly to become more digitally able while ensuring that traditional approaches remain available
    • Support digital cross-sector working: GP/hospital/Social Care
    • Encourage digital mentoring to improve self-care for people with LTCs

     

    SHIFTING TO PROACTIVE WORK WITH COMMUNITIES

    Opportunities

    • The spontaneous rise in mutual community organisations has been remarkable, often outwith the traditional voluntary sector, improving safeguarding and perhaps saving lives.
    • Primary care has been able to embrace that.
    • It offers a model for the future
    • There have been many examples of successful cooperation with communities, but they have been dependent on local circumstances and local heroes.
    • The health gain comes when communities can take more control over the area and their lives
    • The NHS and local government need to create the conditions whereby communities can work collaboratively with the statutory sector sharing decisions with their communities. We need a systematic approach for mobilising civil society, working with NHS and LAs.
    • PCNs offer a good base for such cross-sector working

    Challenges:

    • Sharing decisions with communities is a difficult skill the NHS would have to learn, perhaps from LAs and housing associations.
    • Building on existing work and with councillors would be essential. No new unnecessary initiatives.

    Actions:

    • Jointly fund, via NHS and LA, community development workers in each PCN, working with social prescribers. They would support the statutory sector sharing decisions with their communities.
    • Primary Care to be encouraged to support community groups and community development by, for instance, enabling practice space to be used by communities.
    • Asset mapping with LA and PH colleagues would be one early step
    • Encourage and incentivise cross-sector working.

     

    PRIMARY CARE TO ACTIVELY WORK ON THE SOCIAL DETERMINANTS OF HEALTH AND HEALTH INEQUALITIES

    These have been thrown into sharp relief through the pandemic.

    Opportunities

    • Essential to make any progress on health improvement
    • Community development can assist
    • Local work on poverty, race issues, migrant issues, housing
    • Cross-sector working is essential to do this.

    Challenges

    • The independent contractor status of general practice may hinder this process.
    • Cross-sector working is difficult
    • It is political work

    Actions

    • Promote training GPs with a Special Interest in Public Health, sitting astride the PCN and LA
    • Support areas to become Marmot towns.
    • PCNs to link formally with LAs
    • Boost the status and effectiveness of Well-Being Boards
    • Borough-level linking (not merging) of LAs and NHS.

     

    PRIMARY CARE AND LONG-TERM CONDITIONS INC COVID

    Opportunities

    • The importance of community service provision has been made plain by the pandemic
    • Extensive primary care services and rehab re likely to be required for people recovering from Covid

    Challenges

    • Managing more serious illnesses outside hospital may require differently trained primary care staff such as District Nurses

    Actions:

    • Use a range of approaches to contact those who have delayed seeking help for potentially life-threatening illnesses
    • Digital self-care with remote links to home monitoring such as BP, weight, Peak Flows
    • Secondary care doing remote consultations to reduce the backlog
    • Explore a range of differently skilled staff for primary care

     

    RELAXATION OF RULES HAS BEEN HELPFUL

    Opportunities  

    • There has been relaxation of some bureaucracy
    • Flexible approaches have enabled doctors to return to the workforce.
    • These changes have enabled GPs to devote more time to patient care.

    Challenges

    • Some of this bureaucracy is useful. We don’t want wholesale deregulation: that has often been dangerous
    • It is difficult to know which parts need to be kept and which don’t.

    Actions

    • Explore with the profession which regulatory aspects need to be kept and which don’t.

     

    FUNDING, TRAINING AND STAFFING

    Challenges

    • Primary care, GPs, HVs and DNs remain substantially understaffed. This must change.
    • Different training requirements may be needed for a different future.
    • The RCN is calling for wage increases for nurses

    Actions:

    • A system to support on-going review and remodelling of workforce capacity is needed to ensure that the primary care workforce is responsive to emerging need which may increase over time.
    • Clarification of plans for student health visitors and others who have had their training disrupted during the pandemic

     

    STAFF SAFETY IN THE TIME OF COVID

    • Continued need for PPE to protect staff and patients
    • Mental health support for staff

     

    PRIMARY CARE BUILDINGS

    Challenges:

    • Many primary care buildings were inadequate before Covid
    • Many more now need redesign to cope with new patient flows and requirements for cleaning etc

    Actions:

    • Funding must be found where premises need improving
    • Consider links with housing associations

     

    BOOSTING DEMOCRACY IN THE NHS

    Challenges

    • The NHS has used the Coronavirus Act to push through significant changes to the infrastructure of ICSs. This is baking in the risks posed by them: privatisation, fragmentation and cuts.
    • Hosp reconfigurations are happening rapidly without consultation and no equality assessment

    Actions

    • Call out these dangerous changes and use them to explore new approaches to democracy. For instance:
      • PCNs run with a Board with a broad representation of opinion
      • Link PCNs and local government through local forums with budgets – a form of participatory budgeting
      • Community development would assist participatory democracy

     

    ADVANCED CARE PLANNING

    Opportunities

    • Advanced care planning will need to sensitively change for the better.
    • General practice is well- placed to have discussions that allow patients to express their wishes, which will reduce unnecessary and possibly undignified hospital admissions.

    Challenges

    • There seemed to be sporadic inappropriate behaviour from CCGs and practices issuing blanket DNR notices to care homes
    • The pandemic seemed to cast a harsh light on relationships between some practices and care homes

    Actions:

    • Patients suitable for advanced care planning conversations could be identified— perhaps informed by frailty scores — and discussed in multidisciplinary meetings as part of routine care.
    • The public need to be involved, and the sector need to emphasise that these discussions are about providing quality of care.

     

    SOURCES:

    https://www.rcn.org.uk/news-and-events/blogs/covid-19-out-of-this-crisis-we-must-build-a-better-future-for-nursing

     

    https://ihv.org.uk/our-work/publications-reports/health-visiting-during-covid-19-an-ihv-report/

     

    A brave new world: the new normal for general practice after the COVID-19 pandemic.

    https://bjgpopen.org/content/early/2020/06/01/bjgpopen20X101103

     

    https://www.rcgp.org.uk/policy/fit-for-the-future.aspx

     

    CONTRIBUTORS

    Dr Onkar Sahota

    Dr Duncan Parker

    Dr Joe McManners

    Dr Robbie Foy

    Dr Brian Fisher

     

    CONFLICTS OF INTEREST

    Dr Fisher:

    I am Clinical Director of a software company called Evergreen Life www.evergreen-life.co.uk . We are accredited by the NHS to enable people to access for free online their GP records, to book appointments and order repeat prescriptions. We try to help people stay as fit and well as possible.

    Leave a comment

    During the COVID19 pandemic, a lot of routine health provision has been suspended or reduced. As we plan to get get these back on track, lets not put prevention at the end of the  list, yet again. The SHA convened a group of its members with relevant expertise , who have developed a briefing on the risks to the public of the temporary reduction of prevention programs.

    Key Messages

    • Childhood vaccination programme: the recent increase in vaccination coverage after a long fall has now been thrown into jeopardy by COVID19, with little resilience in primary care and public health departments to systematically and actively promote catch up programmes.
    • Measles: there would be a significant risk of measles outbreaks because MMR coverage in England among children was well below the threshold required for herd immunity in most areas. Measles is highly infectious with an R0 of 16
    • Influenza vaccination programmes for children and adults will begin in September. It is vital to achieve a much higher uptake, to reduce the risks of having to manage a flu epidemic while COVID19 is still circulating.
    • Screening services should restart as soon as possible, with safety measures in place for patients and staff, and a plan for catching up all who have missed out
    • Sexual health and contraception: there is a serious risk of losing the excellent gains of the last Labour Government’s Sexual Health and Teenage Pregnancy strategies, after major cuts in the public health grant. We need a new sexual health strategy with a return to planning and collaboration rather than tendering of services
    • Prevention spend: The Government should restore public health expenditure in England to at least previous levels

    Prevention is so much better than cure: There are many prevention programmes designed to prevent and detect diseases at an early stage to stop them causing death and illness. These are some of the most highly cost-effective healthcare interventions; a review by NICE found that 85% of 200 case estimates of prevention programmes were cost effective. Vaccination programmes are the most cost-effective healthcare interventions

    Amazing efforts by staff: During the COVID19 pandemic, many services have been impacted through being suspended, or by reducing services. Some may also have been affected by the public reducing their uptake. Staff in public health programmes have been going to heroic lengths to deal with the pandemic while keeping essential preventive services going

    The paltry and reducing investment in prevention and early diagnosis is now under greater threat There is a high risk that prevention programmes will lose out for investment when finances are reduced, as will happen during the coming recession. Many of these programmes have already been deeply affected by austerity, in particular those commissioned by Local Authorities in England.

    Recovery plans: The NHS is attempting to restart, and this must be fully funded and adhere to principles of patient and staff safety and equity.  There has been a lot of great local integration and innovation in the face of a common threat, and this must be nurtured and not used as an excuse for cutting costs. Digital ways of working are not cheaper and not a replacement for face to face in many situations long term

    Emerging public health risks of suspending public health programmes FINAL

    Leave a comment

    ECONOMIC RECOVERY

    But is it also time to share ideas about the contribution the H &SC sector can make to strategies for economic renewal press for some imaginative new ideas for jobs, training and service delivery just as the PM is about to announce how the economy can revive?  Can we not present our future Health and Care Service as a part of the transformation the economy needs as it tries to get people back to work  – greener, fairer and more equal.

    How? New kinds of training and apprenticeships to provide career pathways to and between professions, and between health and social care that will be attractive to the many unemployed and to school leavers? Apprenticeships to help with retrofitting hospitals and health care sites to make them carbon neutral? New forms of procurement in the health sector which create social benefit (see how our failing garment industry has turned to scrubs)? Buying from independent local food producers helping create a more sustainable agriculture? A complete rethink of transport for hospital staff and patients now that we must get more cars off the road? I am sure others can do better at spotting ways in which the sector as well as needing more money  can be a  contributor to the new kind of society in which we want to live.

    TEST, TRACE, ISOLATE

    Test, contact trace and isolate   Our local members, SHA and Defend our NHS Wirral are hopping mad about the way the government has deliberately side-lined local public health, university facilities and even the Crick Institute – all those skilled personnel in favour of the multi million contracts being handed without scrutiny to their cronies like Serco, G4S etal.  And they are making such a complete hash of it too with their apps, call centres and unskilled minimum wage staff   Families are bereaved, valuable lives dust-binned.


    The track and trace system looks to be the next government disaster in their mismanagement of this pandemic.

    Firstly, I was astonished they gave up so early on trace and trace, particularly in areas outside of London and Birmingham that had low prevalence in March and early April. It does seem to have been a mixture of poor coordination, absence of preparation for the testing ( when you dont have a vaccine or a treatment but you have a test….)

    That they have not used the ‘down time’ to establish organised units around PHE and DPH units seems a missed opportunity.

    Contact tracing is specialist sensitive work; TB, food poisoning and sexual health. Trust and local knowledge are vital particularly if the tail end of the epidemic is to prevent break through outbreaks – this is the daily work of a health protection department.

    Setting up an entirely new system at this time seems folly, rather than building and expanding/ scaling up from existing established core services. This is what was done for H1N1 in 2009. From a report in Bloomberg this seems to be what has happened n Germany.

    I suspect there is going to be a delay in transfer of results – which with this disease’s ‘sneaky symptomless infectious period will make the system inefficient in getting on top of local breakthrough outbreaks, that will have a particular situational (going on a BLM demo) or organisational ( in say a post sorting room) context where investigation will be most effectively carried out through a local control centre of a health protection team.

    Information Governance and Track, Trace and Isolate

    The question that the team should pursue is ; what is the arrangements for information governance and has the

    System established by the central scheme been reviewed against Caldicott Guardian principles. (Is the track and trace part of the NHS system of protecting patient confidentiality.)? Dido Harding who leads the English programme has form with poor information governance  – she was CEO with Talk Talk when over 4 million

    Clients got their personal data hacked.

    Dido Harding

    Why Harding was appointed should also be pursued; she is a horse racing enthusiast, like Matt Hancock and is a Jockey Club Board member that will have supported the running of the Cheltenham Festival. A chance to catch the horse that bolted. But best person to lead?


    As a semi-retired GP and having lost access to my normal work following lockdown I decided to join the ranks of the (I understand) 6000 or so professionals signed up for the Test and Trace scheme. I received some welcoming emails from NHS Professionals (NHSP) and also Sitel, the call centre contractor responsible for the system. I was told I could log into NHSP’s training platform but after numerous attempts, my credentials did not work. After an hour on hold to a helpline, I was told that I needed instead to access the training modules on eLFH. I duly did this and completed several mandatory training (safeguarding, information governance, etc.) modules and some online presentations on how the system works. as well as some documents with the script I was supposed to follow in given circumstances.

    I was all ready to start contacting people who had received positive tests and, using the proscribed script, check with them who their recent contacts had been. At 8 o’clock last Monday I duly logged into the four software platforms I needed for this work and was informed I had no contacts to call. I therefore sat and did some emails, looked at some more training material and at the end of the 4 hour shift had still had no- one to call.

    I was disappointed with this experience but decided as this was supposed to be the first day the system went live (before Matt Hancock had decided he could announce it was live the previous Thursday) it was too early to have picked up many positive cases. I had another shift booked on Wednesday and duly logged in again to find there was 1 case to call. I brought up this record and called the number- it went to voicemail. I called again a minute or two later, still voicemail, so I left the message according to the script and scheduled a call back a couple of hours later. The appointed time arrived and the case was no longer on my list…  I hope someone else had picked up the case and called. The rest of the four hour shift turned up no more cases.

    I decided I needed to book some more shifts so looked at the NHSP calendar; there were no shifts available for the next two weeks. I did manage to find a shift to book in a couple of weeks’ time but looking again now, there is nothing available for the whole of the rest of June or July.

    Maybe this system is working so efficiently they’ve got more contact tracers than they need or, more likely, the system just isn’t picking up all the positive tests and feeding them through and it is yet another example of Tory ‘world beating’ hype.

    CONTRACTS WITH PRIVATE COMPANIES

    • What private companies have been awarded contracts to provide goods or services to or on behalf of the NHS between February and the current date?
    • What goods or services have each of these contracts been for?
    • What is the value of each of of these contracts?

    Why are we giving public money to private companies like Serco, which has been fined for defrauding govt, when many scientists argue that university and NHS public labs could as quickly cope with the tests?   Is it because they have contributed to the Tory party?  What about accountability to the British people?

    PEOPLE WITH LEARNING DISABILITIES

    • How many people with learning disabilities living in either i) NHS or ii) private hospitals or iii) care homes have died with covid-19
    • What is the excess death rate for people with learning disabilities in each of the above settings for the period February – End of May 2020?

    RELEASING PROFESSIONAL STAFF AT THE NO 10 MEETING

    Another point I think the team should push is releasing the professional staff from their daily ‘lockdown’ in No 10 at their press conference. Ministers should do this on their own and officials should operate to traditional civil service principles – heard but not seen.  With crumbling trust of the politicians, it is infecting professional staff; CMO etc.

    OPENING SCHOOLS

    How is it possible to open schools and unlock when testing and tracing is not up and running efficiently?

    EXCESS DEATHS

    Can Labour question why excess deaths last week showed that UK has the highest figures for deaths after Peru in the world? Not quite the excellent response the PM is arguing.

    TAKE THE NHS OUT OF ANY TRADE DEALS WITH THE US

    The faith and gratitude expressed to our NHS staff in the present pandemic is beyond belief, and CV19 is the unwelcome political experiment to have tested state versus private efficiency and enterprise in health care. In the light of this will you be insisting that the government withdraw the NHS from any participation in Trade talks with the USA – it is not even Trade, after all. I have suggested to our MP that a legal instrument is needed to protect it.*

    To Craig Mackinlay MP: Public support for our NHS must be near total at the present time as the only way of saving millions of lives from Covid19. By contrast , the USA has effectively no health service. Worse still the USA cut two thirds of its hospital beds in the last 45 years, because they were ‘unprofitable’ . US health costs are soaring by 2,4% cumulatively per year. 28 million USA citizens have no health whatsoever. Last year half of all citizens cancelled or delayed their medical care because of cost. This is third world health in the richest state in the world

    Our government recently published its Trade Bill – the legislation that sets out the basis of future trade negotiations after Brexit. Unfortunately, it currently does not contain any protection whatsoever for our NHS, despite Boris Johnson’s repeated promises.

    I am writing to ask you to table or support any amendments to the trade bill to introduce specific protections for our NHS. Right now, it is automatically “on the table” in trade talks, and this won’t change until it is explicitly taken off in the trade bill. We cannot risk our NHS which is performing so magnificently in this crisis, to be sold off to a US medical insurance company.

    Clapping hands on the street won’t protect it: only our democratic representatives can do that. Please help save our NHS.

    1 Comment

    The degree of failure in this study is not an unfortunate scientific event. It is a terrible failure, reports Simon Collins at HIV i-Base

    Simon Collins, HIV i-Base

    On 5 June 2020, the large randomised RECOVERY study announced that hydroxychloroquine (HCQ) will no longer be used to treat COVID-19. [1]

    The results show that hundreds of people died – both taking HCQ and in the comparison group receiving no investigational drugs – and yet the study was only closed because of a safety request by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

    This very large study – with more than 11,000 participants – should have been looking for early signals that experimental treatment might be effective. Instead, the results announced yesterday call for an urgent analysis of other ongoing arms plus immediate use of drugs that are now known to be effective.

    The press release states that people receiving HCQ did no better than people who were given no additional drugs – also called the standard of care. Actually, it is not that HCQ didn’t make enough difference for the results to be significantly better. It looks like people taking HCQ did worse than adding nothing, at least numerically. It is very worrying that this analysis was only carried out because of a request by the MHRA.

    For the main study endpoint – the number of people still alive after 28 days – approximately 25.7% of the 1542 people who received HCQ died compared to 23.5% of the 3132 people who were given no treatment. In a study this large, this signal of no active benefit from an experimental treatment should have been found much earlier. There were also apparently no benefit in other measures, such as length of hospital stay or other clinical factors.

    How many deaths were these researchers going to allow to continue before they would have stopped the study themselves? Almost 400 people in the HCQ arm and more than 700 people in the control arm died and the study still planned to continue?

    Many researchers will not be surprised at the lack of effect with HCQ – but they should be shocked at the time taken to hear this result. Over the last few weeks, other studies have been published showing that HCQ was unlikely to work. [2-6]

    One of these – a very large study published in the Lancet reported that HCQ was not effective, and prompted the RECOVERY study to look at their own results. And they came back saying their study should continue unchanged. [7]

    Anyone reading that letter from the RECOVERY researchers on 22 May 2020, would expect results to perhaps already show a trend towards benefit from HCQ. This would support continuing to allow participants to take a risk until the study reached a conclusion that was statistically significant.

    Instead, nothing close to a benefit could have been happening. It doesn’t even matter that the Lancet study has since been retracted – another complicated story [8, 9] – the important thing is that three weeks ago the RECOVERY study insisted that their data supported continuing to use HCQ.

    Today’s results showing no suggestion of benefit are important for several reasons.

    Firstly, the large RECOVERY study is continuing with other single therapy arms, some of which have even less evidence than HCQ to show they might work. These include monotherapy (single drug) using an old HIV drug called lopinavir/r (LPV/r). Actually, in March 2020, an earlier randomised study was published showing no benefit from lopinavir/r. [10]  For RECOVERY to be continuing with this drug, it needs to already be showing a strong trend towards benefit. Anything less, and LPV/r should also be pulled like HCQ. The RECOVERY study should not be looking for small marginal benefits, but for clear signals that the experimental drugs are considerably better than standard of care.

    RECOVERY is also studying a single antibiotic called azithromycin (AZM). Actually, previous studies claiming a benefit from HCQ used it together with AZM. This does not make it plausible that AZM monotherapy will be a success. Again, anything less than clear benefit compared to standard of care, and this arm should be pulled too. And with a study this large, the results should have been available weeks ago. This shouldn’t need a prompt letter from the MHRA over safety. The DSMB in the RECOVERY study, should be analysing every death, with a low threshold of benefit to continue and a similarly low threshold to stop.

    Secondly, the statistical plans and timeline for analysing early results should be part of the RECOVERY study protocol – as it is for other major studies. The protocol should publish the start/stop criteria and the thresholds that are being used. It is not good enough for the study to say, as it currently does, that it will look at the results every two weeks. If this is the case, why has it taken an MHRA directive to look again now?

    Thirdly, we need to remember the context for COVID-19. Large numbers of participants who are already hospitalised have trusted the researchers to take experimental drugs that have some chance of working (and the chance of no drugs). By joining RECOVERY, people are by default not joining another study – and the UK already has another 20 or so ongoing treatment trials. [11]

    Finally, on 26 May 2020, the new availability of remdesivir, a proven treatment for COVID-19, should have led this to be offered to all participants in RECOVERY. Based on published results from the large randomised ACTT study showing remdesivir to be effective, the MHRA announced a compassionate access programme to enable widespread access. It is also notable that the conclusions of the ACTT paper emphasise the importance of using combination treatment with more than one investigational drug. The RECOVERY has not made any announcement for the use of combination therapy. [12, 13, 14]

    An established principal in ethical research, at least from HIV studies, is that no study participant should use less than current standard of care. When the standard of care changes, research studies need to rapidly change too, to ensure their participants do not use anything less.

    The RECOVERY researchers have publicised how quickly they launched their study. They also claim that early signals will be acted on quickly to stop ineffective drugs and to prioritise newly effective ones. If this was really true, it shouldn’t have taken a request from the MHRA to look again at the HCQ arm. The investigators and the independent data and safety monitoring board (DSMB) for the study should have done this already. The study should also have publicised whether more recent compounds with positive data have been considered – for example using anticoagulants or ACE inhibitors or the anti-rheumatoid anakinra. [15, 16, 17]

    The fact that RECOVERY didn’t stop the HCQ arm based on its own analysis plan, nor announce plans to look at other ongoing arms, are a concern for the study overall, and especially for participants who put their trust in these researchers.

    The press release concludes “These data convincingly rule out any meaningful mortality benefit of hydroxychloroquine in patients hospitalised with COVID-19”. If this is really the case, then slightly less convincing data should have been enough to stop this study arm much earlier and allowed participants the option to use other drugs that stood a better chance of benefit.

    COMMENT

    The degree of failure in this study is not an unfortunate scientific event.

    It is a terrible failure.

    Many of these issues, including on the data plans and timeline, the decision to continue using HCQ and access to remdesivir were raised by email with the RECOVERY coinvestigator Peter W Horby on 24 May 2020. This email has neither been acknowledged nor answered.

    Instead, hundreds of people have died using an intervention that has no signal of benefit, or because they were randomised to standard of care with no potentially active treatment.

    These results should prompt an urgent review of the other study arms in the RECOVERY study and an investigation for why such ineffective treatment continued for so long. Even though the study says the DSMB have been reviewing results every two weeks, the predefined rules to close or continue a study might not be appropriate – but as these have been excluded from the protocol it is difficult to comment. 

    This study – and no doubt others – should be using drugs that have a better indication of efficacy.

    Study participants deserve better.

    References

    1. RECOVERY trial statement. Statement from the Chief Investigators of the Randomised Evaluation of COVid-19 thERapY (RECOVERY) Trial on hydroxychloroquine. (5 June 2020).
      https://www.recoverytrial.net/files/hcq-recovery-statement-050620-final-002.pdf
    2. Molina JM et al. No evidence of rapid antiviral clearance or clinical benefit with the combination of hydroxychloroquine and azithromycin in patients with severe COVID-19 infection. Médecine et Maladies Infectieuses (2020), doi: 10.1016/j.medmal.2020.03.006.
      https://www.sciencedirect.com/science/article/pii/S0399077X20300858
    3. Geleris J et al. Observational study of hydroxychloroquine in hospitalized patients with Covid-19. DOI: 10.1056/NEJMoa2012410. (7 May 2020).
      https://www.nejm.org/doi/full/10.1056/NEJMoa2012410
    4. MagagnoliJ et al. Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19. DOI: 10.1101/2020.04.16.20065920. (23 April 2020).
      https://www.medrxiv.org/content/10.1101/2020.04.16.20065920v2
    5. Maisonnasse P et al. Hydroxychloroquine in the treatment and prophylaxis of SARS-CoV-2 infection in non- human primates. Nature Research. In Review. (6 May 2020).
      https://www.researchsquare.com/article/rs-27223/v1
    6. Prescrire. Covid-19 and hydroxychloroquine (Plaquenil): new data show no evidence of efficacy.
      https://english.prescrire.org/en/81/168/58639/0/NewsDetails.aspx
    7. RECOVERY trial statement. Recruitment to the RECOVERY trial (including the Hydroxychloroquine arm) REMAINS OPEN. (22 May 2020).
      https://www.recoverytrial.net/files/professional-downloads/recovery_noticetoinvestigators_2020-05-24_1422.pdf(PDF)
    8. Lancet retraction: “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis” (4 June 2020).
      https://www.thelancet.com/lancet/article/s0140673620313246 (web)
      https://marlin-prod.literatumonline.com/pb-assets/Lancet/pdfs/S0140673620313246.pdf(PDF)
      http://i-base.info/htb/37988 (i-Base report)
    9. Collins S. RETRACTED – Re: No benefit from hydroxychloroquine with or without macrolide antibiotics in analysis of 96000 patients. HTB (1 June 2020).
      http://i-base.info/htb/37988
    10. Cao B et al. A trial of lopinavir–ritonavir in adults hospitalized with severe Covid-19. NEJM. DOI: 10.1056/NEJMoa2001282. (18 March 2020).
      https://www.nejm.org/doi/full/10.1056/NEJMoa2001282 
    11. Collins S. UK guidelines for the treatment of COVID-19: UK prioritises 42 studies. HTB (1 June 2020).
      http://i-base.info/htb/38094
    12. Beigel JH et al. Remdesivir for the treatment of covid-19 – preliminary report. NEJM. DOI: 10.1056/NEJMoa2007764. (22 May 2020).
      https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
    13. MHRA. MHRA issues a scientific opinion for the first medicine to treat COVID-19 in the UK. (26 May 2020).
      https://www.gov.uk/government/news/mhra-supports-the-use-of-remdesivir-as-the-first-medicine-to-treat-covid-19-in-the-uk
    14. MHRA. Early access to medicines scheme (EAMS) scientific opinion: remdesivir in the treatment of patients hospitalised with suspected or laboratory-confirmed SARS-CoV-2 infection who meet the clinical criteria. (26 May 2020).
      https://www.gov.uk/government/publications/early-access-to-medicines-scheme-eams-scientific-opinion-remdesivir-in-the-treatment-of-patients-hospitalised-with-suspected-or-laboratory-confirme
    15. Collins S. Anticoagulants associated with improved survival rates in people hospitalised with COVID-19. HTB (14 May 2020).
      http://i-base.info/htb/37794
    16. Mascolini M. ACE inhibitors and angiotensin receptor blockers for hypertension tied to lower death risk with COVID-19. HTB (14 May 2020).
      http://i-base.info/htb/37884
    17. Rheumatoid arthritis drug anakinra in small study to treat COVID-19. HTB (14 May 2020).
      http://i-base.info/htb/37863
    Leave a comment

    Firefighters’ work responding to the COVID-19 pandemic has been extended until July, as the UK continues to battle coronavirus.

    The Fire Brigades Union (FBU), National Fire Chiefs Council (NFCC), and National Employers agreed the extension to the national agreement stating that the virus “continues to be a risk in our communities. It comes despite the government moving to ease lockdown restrictions.

    The agreement, first reached on 26 March, has allowed firefighters to assist ambulance services, deliver vital supplies to the elderly and vulnerable, and move the bodies of the deceased. Since then, a number of further activities have been agreed, including assembling personal protective equipment (PPE) and training care home staff in infection, prevention and control.

    The work has now been extended to 15 July and could be extended until 26 August.

    But the Tripartite Group – as the FBU, NFCC and National Employers are known – has raised concerns about variation in local risk assessments, with the latest agreement stating that “the hazards do not vary across fire and rescue areas”.

    National risk assessments are now to be produced for all fourteen agreed activities, to be implemented locally by fire and rescue services. If successful, the agreement will be extended until 26 August.

    Firefighters working in ambulances, mortuaries, hospitals, and care homes should be detached from their normal fire service location, the Tripartite Group recommended, and services should halt any coronavirus response work outside of the agreement until activities can be agreed at a national level.

    New COVID-19 testing guidelines for fire and rescue personnel have also been agreed, requiring a test after 3 days of removal from detachment for coronavirus response duty. Staff will not be permitted to return to fire stations until they have tested negative.

    Matt Wrack, FBU general secretary, said:

    “You need only look at the horrific death toll in our care homes to see that this pandemic is not over yet. The government may be easing restrictions, but firefighters are still needed to respond to this serious threat.

    “We are concerned about the variation in risk assessments between services, as well as attempts by some fire chiefs to force firefighters into work outside of the agreement. The co-operation seen in most fire and rescue services has been extremely encouraging, but these steps are needed to make sure our members are safe and that safety standards are consistent.

    “Firefighters’ work so far in this pandemic has been extraordinary and will have undoubtedly saved lives and helped to keep the NHS on its feet. The threat to our communities is still severe, so we’re doing what we can to ensure firefighters can continue helping them through this crisis.”

    Joe Karp-Sawey, FBU communications officer

    1 Comment

    Class and race are the biggest factors in determining those that have died or been taken ill by Covid-19, Unite, Britain and Ireland’s largest union, said today (Tuesday 2 June).

    Unite called for a raft of policies to tackle the ‘systemic failures’ that has led to the disproportionate death toll amongst the Black, Asian and minority ethnic (BAME) communities and also the poorest groups in society

    The union was commenting on Public Health England’s report Disparities in the risk and outcomes of Covid-19 which highlighted those groups that had been hardest hit in terms of mortality due to coronavirus.

    Unite assistant general secretary Gail Cartmail said: “This report shines a searing light that reveals the pandemic in the UK is intrinsically linked disproportionately to class and race.

    “These wide disparities are detailed in this data and point to age, race and income and accompanying health inequalities as key determinants as to whom has been the worst affected by Covid-19.

    “This has been amplified among those in undervalued occupations and jobs where zero hours’ contracts and precarious employment are the norm.

    “Working hard to provide for your families is no defence against Covid-19 for these groups – these systemic failures need to be tackled urgently and that work should start now.

    “No one policy size fits all, but such an agenda should include ethnically sensitive risk assessments and income guarantees for workers who through ‘test, track and trace’ would otherwise be reliant on statutory sick pay (SSP), while in isolation.

    “The Real Living Wage should be the basic minimum for those in ‘at risk’ occupations as an interim measure, with a commitment to sectoral bargaining for care workers and the guarantee of the necessary funding.

    “All these measures are achievable with government support. If austerity is over, as ministers claim, the best defence against the inequalities which the report exposes is to narrow the income gap and invest in public services with priority to social care.

    “The pandemic has shown that the crisis in social care can no long be pushed into the political long grass. The lack of testing for residents and staff, and also the shortage of PPE, in care homes has wreaked a terrible toll on the elderly who have died in their thousands due to Covid-19.

    “Social care can no longer be regarded as the poor relation when it comes to funding from the budgets of central and local government – a ministerial blueprint for social care should be a top priority as we emerge from the lockdown.

    “Poverty is the parent of disease and Covid-19 has been a willing accomplice in this respect. Once this pandemic has passed, we need to look as a country anew to how we can recalibrate economic and social policies to create a fairer society.

    “All these issues must be investigated in depth when the post-pandemic public inquiry takes place, which will be needed in the interests of accountability, openness and transparency.”

    The PHE report said that those parts of UK society most affected included the elderly; Black, Asian and minority ethnic (BAME) populations generally and those BAME NHS staff on the frontline in particular; those with underlying conditions, such as diabetes and dementia; those living in care homes; and those from deprived communities.

    Twitter: @unitetheunion

    Facebook: unitetheunion1

    Web: unitetheunion.org

    Unite is Britain and Ireland’s largest union with members working across all sectors of the economy. The general secretary is Len McCluskey.

     

     

    1 Comment

    This is a collective statement on behalf of SHA bringing together public health evidence and other opinions on a key Covid policy issue.

    The Westminster Government announced on May 10th that:

    “As a result of the huge efforts everyone has made to adhere to strict social distancing measures, the transmission rate of coronavirus has decreased. We therefore anticipate, with further progress, that we may be able, from the week commencing 1 June, to welcome back more children to early years, school, and further education settings. We will only do this provided that the five key tests set by the government justify the changes at the time, including that the rate of infection is decreasing. As a result, we are asking schools, colleges, and childcare providers to plan on this basis, ahead of confirmation that these tests are met”

    We believe that the 5 tests will not be fully met by June 1st and that this announcement was premature. This decision has been taken without transparency about the evidence that has been used on the direct and indirect health impacts. We now see French schools having to reclose.

    We also believe that the Government should have attempted to agree a consensus with Local Authorities and Teaching Unions before announcing a country wide directive around schools in general. The announcement has left schools without clear expectations, without a structure for managing this. We understand that many Local Authorities and schools will now have to seek the skills and information to figure this all out themselves. We believe that this uncertainly will lead to decisions that could adversely affect the health of children, teachers, families, and vulnerable people in their communities. We do not want a repeat of the mistakes in respect of care homes.

    In addition, it breaks the consensus across the four nations in the UK and shows little regard for regional variation or for impacts on inequities in health outcomes for everyone, and educational outcomes for children. Educational opportunities are a powerful determinant of long-term health outcomes.

    The SHA believes that the education sector has been systematically under-resourced and discouraged by this Government since 2010 under austerity, which leaves many schools with insufficient staff, increasing class sizes and inadequate environments that are less able to meet the stringent conditions to enable them to open as safely as possible in such a short timescale.

    We believe that the Government should have considered the following:

    1. How risks would be minimised, and benefits maximised:
      1. In the school environment, such as through safe distancing, handwashing, and other logistic measures to minimise transmission of COVID19, where staffing levels may not be sufficient and school buildings are not always suitable. Children use their bodies to learn.
      2. To children, in particular those in deprived neighbourhoods, in vulnerable groups, children from BAME families, and those with special needs. There is no clarity on alternative arrangements that could have been much more robust to safeguard, and to ensure their nutrition, learning and emotional needs. This should not rely on schools to provide these solutions now
      3. Allowing for the full autonomy of schools and their local authorities within their safeguarding obligations on an area basis
      4. To other groups, such as teachers, communities, and vulnerable groups, and weigh these against the benefits and risks to the wider society
    1. How harm would be minimised, and benefits maximised:
      1. To children who may be missing education which is likely to have a long-term impact on those from more deprived neighbourhoods and those who are less likely to have received equitable support at home
      2. To children who become infected, including asymptomatically and to their immediate household and contacts
      3. To the wider community, especially those that have had a high incidence of COVID19 and remain at high risk of further outbreaks and resurgences. These have disproportionately affected more deprived communities and those with a high proportion of BAME people
    2. How the overall public health response would support this move:
      1. How potential school outbreaks would be identified and managed in the absence of a fully functioning test/ treat/ isolate programme, particularly as some businesses are reopening at the same time.
      2. How schools will be supported by local public health services unless further resources and decision-making powers are decentralised to allow a robust and appropriate and rapid local multi-agency response

    The SHA believes that this decision has been reached without a clear rationale on the benefits and risks, and without demonstrating that the 5 key tests have been met:

    Test one: Making sure the NHS can cope

    Test two: A ‘sustained and consistent’ fall in the daily death rate

    Test three: Rate of infection decreasing to ‘manageable levels’

    Fourth test: Ensuring supply of tests and PPE can meet future demand

    Fifth test: Being confident any adjustments would not risk a second peak that would overwhelm the NHS

    We would add a Sixth: A fully functioning test/ treat/ isolate programme

    The SHA believes that the decision has been reached without sufficient consultation with key stakeholders and before the 5 tests have been fully met. In addition, the National Education Union has set 5 tests specific to educational settings, and we support their belief that in many areas these have not been met.

    We expect a more supportive response from the Dept for Education including investment into online learning and into a revived Sure Start model.

    The SHA believes that schools should be reopened at the right time but that the Government should make the best efforts to ensure that there is a consensus for when this should happen based upon relevant expert input rather than political pressure.  This has clearly not been achieved, as it has been in other countries that have gradually opened schools.

    We encourage Local Authorities and Academy Trusts to follow the example of LAs such as Liverpool, Haringey, North of Tyne, Hartlepool, and Brighton – and devolved governments in Wales, Scotland, and NI – in making it clear that they will not reopen schools until they feel it is safe.

    Sources

    Actions for schools during the coronavirus outbreak updated 18th May. Department of Education for England

    https://www.gov.uk/government/publications/covid-19-school-closures/guidance-for-schools-about-temporarily-closing

    NEU five tests for Government before schools can re-open

    https://neu.org.uk/neu-five-tests-government-schools-can-re-open

    ONS figures reveal 65 COVID-related deaths in education workforce

    https://schoolsweek.co.uk/ons-figures-reveal-65-covid-related-deaths-in-education/

    Which occupations have the highest potential exposure to the coronavirus (COVID-19)? ONS May 11th https://www.ons.gov.uk/employmentandlabourmarket/peopleinwork/employmentandemployeetypes/articles/whichoccupationshavethehighestpotentialexposuretothecoronaviruscovid19/2020-05-11

    Coronavirus (COVID-19) related deaths by occupation, England and Wales: deaths registered up to and including 20 April 2020 May 11th https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/causesofdeath/bulletins/coronaviruscovid19relateddeathsbyoccupationenglandandwales/latest

    https://www.tes.com/news/coronavirus-doctors-back-teachers-fears-over-schools-reopening?fbclid=IwAR2JD0Np1x_lgG49xo1Hig4T9ozNto36vsG09Ue-mvAtMrTvhWVyegtphBE

    Prof John Edmunds

    https://www.theneweuropean.co.uk/top-stories/john-edmunds-tells-lords-decision-to-re-open-schools-is-political-1-6660526?utm_source=Twitter&utm_medium=Social_Icon&utm_campaign=in_article_social_icons

    Prof Devi Shridhar, Professor of Global Public Health, Edinburgh Uni &  Ines Hassan.

    https://www.theguardian.com/commentisfree/2020/may/20/british-schools-science-children-education-testing-tracing

    https://www.newschain.uk/news/young-children-will-still-socially-distance-school-health-chief-says-8334

    Schools re-close in France after 70 new Covid cases following re-opening  6-11yr classes. NB. French schools starting age is 6 not 3.

    https://www.independent.co.uk/news/world/europe/coronavirus-france-school-cases-reopen-lockdown-a9520386.html

    Comparative school age starts

    https://data.worldbank.org/indicator/SE.PRM.AGES

    NB. Denmark is also 6 and easier to manage s/d. long term impacts of formal learning too soon

    https://www.newscientist.com/article/mg22029435-000-too-much-too-young-should-schooling-start-at-age-7/#

    Formal learning in early years linked to criminality in teens

    https://www.res.org.uk/resources-page/the-impact-of-school-starting-age-on-teenage-criminality–evidence-from-denmark-.html

    Posted by Brian Fisher on behalf of the Policy Team.

    Leave a comment

    This is a collective statement on behalf of SHA bringing together public health evidence and other opinions on a key Covid policy issue.

    The government ‘s centralised programme in England for testing and tracing – and the use of outsourcing

    1. Key messages:

    • The Government has not yet passed the five tests it set itself for easing lockdown
    • The government said that it would only consider easing lockdown once the country has passed five tests. One of these tests [TEST 5] is “confidence that we can avoid a second peak of infection that overwhelms the NHS”
    • The Devolved Administrations and many scientists and public health professionals doubt whether or not we have “passed this test” They doubt we have the capacity to detect and respond to local surges in infection or control outbreaks as lockdown is eased – and that a second or even third peak of infection will occur. Policy is diverging across the UK with mixed messaging to the public and a high risk of losing a coherent and effective strategy of suppression.
    • To manage our “exit “from lock down we need to be able to recognise new cases when they occur, test and isolate people who are infected, trace and test their contacts – and to have the flexibility resource and leadership to organise responses at a local level.
    • Other countries in Europe are using phased lifting of measures, across regions and settings. The EU Roadmap states that “the lifting of measures should start with those with a local impact and be gradually extended to measures with a broader geographic coverage, taking into account national specificities. This would allow to take more effective action, tailored to local conditions where this is appropriate, and to re-impose restrictions as necessary, if a high number of new cases occurs (e.g. introducing a cordon sanitaire)” For example, why would there be a relaxation of control measures in dense urban areas with crowded public transport at the same time as some parts of the UK that have had no new confirmed cases for 18 plus days and some areas with very few cases? We need detailed stats and maps by district council of all new cases by area of residence over time (at a more granular level than unitary authorities) The Orkney Western isles and Shetland remain in lock down when they have had no cases for 18, 21 and 32 days respectively and when a cordon sanitaire could be put in place
    • Integrated response In order to lift measures while retaining control of the virus, we must identify cases rapidly, isolate and contact trace: so testing is crucial but we must have the ability to test the right people and to rapidly act on the results

    o Prevention of new cases is always better and much cheaper than critical care. Investment in hospitals to respond to COVID19 has been absolutely necessary but will always have less impact on population level health outcomes than control measures.

    o The UK has an excellent public health and primary care system, both of which have been eroded and underfunded in the last 10 years. There are skills and knowledge and capability in these that would provide an effective and efficient response to moving through the next phases of the pandemic, if invested in. However, both these sectors have been excluded and marginalised to the detriment of their local communities

    o For a “test, trace and isolate “ system of control and response to outbreaks to be effective, data must be shared and agencies need to work together at national , regional and local level , coordinate and integrate their response if it is to be effective .No one agency has the knowledge , skills, or resources to do this on their own – and Whitehall in particular needs to recognise that central control is bound to fail.

    o Capacity for testing should provide real time data to help monitor community transmission, link with contact tracing systems and enable local authorities to function autonomously, as well as part of a national response to this pandemic.

    o Much of the infrastructure for testing commissioned by the Government has been led centrally – much of it has been established from scratch. The original drivers for increasing testing capacity were to:

        1. Allow NHS staff to be released back to work on the front line and
        2. respond politically to the growing criticism about the UKs track record on testing o The plight of care homes and the huge death toll from COVID 19 in those institutions is a classic illustration of the failures, which result from over centralization and reliance on hierarchical control and power. This example also illustrates the potential of local government and effective leadership to understand and respond quickly to local circumstances, to innovate, and to “stitch systems “together and make them work.
    • Outsourcing in England Rather than invest or expand our existing laboratory system Ministers chose instead to outsource the provision of testing for COVID 19 in England. They used special powers to bypass normal tendering and award a string of multimillion pound contracts for delivering and processing tests to private companies such as Deloitte, Randox laboratories [£ 133 million] and involved big pharma companies such as GSK, Roche and AstraZeneca and university research teams in creating mega or “ Lighthouse “ labs. These organisations:
      1. Provide swab tests on hospital patients and COVID tests run by NHS labs and Public Health England.
      2. Collect swabs from NHS workers, social care staff and other key workers at 50 drive -in centres and 70 mobile units, which are processed and reported on through a network of 3 mega “lighthouse “ labs
      3. Send out home testing kits for eligible persons with coronavirus symptoms, aged 65 or over, or who cannot work from home
      4. Offer an “on -line portal “through which CQC registered care homes [65 +] can order test kits
      5. Issue serology and swab tests for ONS surveillance and research studies
    • Together Government claims that they can offer 100000 tests a day.

    o However when backlogs develop, they tend to operate as separate “ silos” as illustrated when 50000 tests were sent to the US rather than workload shared between them.

    o More importantly, this testing system does not provide or allow access to test data by local organisations or Public Health England.

    o More than half of tests by May12th have been done by outsourced companies and results are “disappearing into a black hole” A Health Service Journal analysis on May 13th said that recent government testing figures “suggests that in recent days around two thirds of tests have taken place under the commercial lab scheme, for which the data is not available locally. This includes more than 7,000 positive test results in the past three days, and tens of thousands over recent weeks”.

    o Most tests [except for care homes] are demand led, random in nature, and requested by individuals from a wide catchment area. As such, they do not provide useful information for detecting spikes or patterns of infection in a particular geographical area, local “hot spots” or for managing outbreaks. Furthermore, test data are not completely post coded nor are they analysed at a sub-regional or local authority level, local authorities and PHE have found it difficult to get hold of these data.

    • Real time analysis and assessment of infection

    o The Government proposes to establish a Joint Biosecurity Centre with an independent analytical function which will

    o a) provide real time analysis and assessment of infection outbreaks at a community level and collect a wide range of data to build a picture of COVID-19 infection rates across the country – from testing, environmental and workplace data to local infrastructure testing (e.g. swab tests)

    o b) have a response function that will advise on the overall prevalence of COVID-19, identify specific actions to address local spikes in infections, in partnership with local agencies and guide local actions through a clear set of protocols based on the best scientific understanding of COVID-19, and what effective local actions look like.

    o We welcome the commitment to ensure that the Joint Biosecurity Centre [JBC] works closely with local partners. We would like some input into the design of the data platform, as well as discussion about rights of data contributors to access all data sets, which are held.

    o We do not believe that the JBC should have a response function, which “guides local actions surges through a series of protocols. “

    o Lessons from the 2009 H1N1 pandemic about over centralisation and hierarchical control – delays, rigidity, lack of autonomy to act, failure to listen and respond to local intelligence need to be learnt.

    Once again, they have outsourced this analytical function to a large number of private sector organisations. The strategy states that NHS England and NHS improvement have total control over access to all NHS test data will guide and inform the COVID 19 response during lock down – but so far they have not consulted local authorities or PHE about the proposal to create this JBC or involved them in the design, access and linkage to this data store. NHS England has created difficulties and even stopped local agencies from having access to important data sets, such as 111 calls.

    o Contact tracing: Contact tracing at scale can help reduce onward transmission during release from lockdown, if properly resourced by skilled people and well organised. It is unclear how their trace and track system will be integrated with the testing system.

    We are concerned that the Government has

      1. outsourced the call centre to SERCO given its previous track record [breast cancer catch up]
      2. believe that one hour of training as call handler will be sufficient to run this online and phone based contact tracing system,
      3. place so much reliance on an experimental App for contact tracing.
      4. recruited insufficient skilled contact tracers to impact on the “R” number, not made sufficient effort to recruit people with experience of contact tracing e.g. EHOs or retired professionals to the clinical team.

    The government states that for its test and trace system to work, several systems need to be built and successfully integrated. These include:

        • widespread swab testing with rapid turn-around time, digitally-enabled to order the test and securely receive the result certification;
        • local authority public health services to bring a valuable local dimension to testing, contact tracing and support to people who need to self-isolate;
        • automated, app-based contact-tracing through the new NHS COVID-19 app to (anonymously) alert users when they have been in close contact with someone identified as having been infected;

    Conclusions

    o The Testing and Tracing infrastructure which the government has commissioned has been largely been outsourced to private sector organisations and very centralised

    o As such it is a “quick fix which is poorly designed and ill equipped to support the next stage of controlling this pandemic and involving the many agencies which need to play their part as lockdown are eased.

    o The considerable investment which has been made in these new “ temporary “ structures should be channelled over the next 2 to 3 years into building a more robust, flexible , resilient and multilevel , public health and primary care systems , capable of responding to pandemics in the future.

    Sources

    Posted by Brian Fisher on behalf of the Policy Team.

     

    Leave a comment

    The Battle of the Surcharge – won

    Finally, last Friday, the Government announced it was going to remove the surcharge that overseas NHS staff have to pay for using the service they themselves work for. This follows two years of campaigning by unions such as Unison and Unite, which between them represent over 600,000 nurses, student nurses, midwives, doctors, health visitors, healthcare assistants, paramedics, cleaners, porters, catering staff, medical secretaries, clerical and admin staff and scientific and technical staff, who are either employed by the NHS or by other organisations which provide NHS services.

    Only last Wednesday at Prime Minister’s Question Time Johnson told MPs that the extra raised £900m needed for the NHS. This has been challenged by the Institute of Fiscal Studies which put the sum at a tenth of that – £90 million. But that is irrelevant to this argument, which is that none of the overseas staff should ever have had to pay to use the NHS. The Government could focus instead on making all the big multinationals pay the taxes they avoid, just for a start.

    Unite national officer for health Colenzo Jarrett-Thorpe said: “Of all people, Boris Johnson should appreciate the wonderful and dedicated work of NHS health and social care professions, including the two non-UK nurses he singled out for particular praise in his fight for survival against coronavirus.

    Who is Dominic Cummings?

    He is not actually the Prime Minister, but appears to many to play the role of ventriloquist. He is not an MP or an elected representative of any kind. His official title is Senior Advisor to the Prime Minister, with an office in Downing Street. But he has succeeded in getting the British Public angry, which neither Boris Johnson, nor Matt Hancock, nor indeed any other member of the Government, has managed to do on anything like the same scale.

    What he has done was to behave as though the Government’s lockdown rules (which he proposed in the first place) did not apply to him, when many of us have not seen children, grandchildren and other loved ones for weeks, and too many have not even been able to say goodbye to those who were dying. And he is still refusing to admit to any wrong doing: “I think I behaved reasonably”. Up and down the country people are calling on him to resign – including more than 20 Tory MPs by Wednesday, 44 by Thursday morning with 61 criticising him. The numbers are still growing – and one Government minister has resigned over it.

    Cummings was responsible for the Brexit slogans “Get Brexit Done” and “Take Back Control”; for the campaign bus that said “We pay £350 million to the EU. Vote Leave and give it to the NHS instead” (which many of us knew was never going to happen, but some people were taken in by); for the offensive, enormous posters that said Turkey (population 75 million) was going to join the EU (implying 75 million Turkish people would be moving to Britain); and broke electoral law over spending limits, for which the campaign was fined £70,000. But not till the voting was over. The BBC website this week pointed out that Cummings was also held in contempt of Parliament for not responding to a summons to appear before, and give evidence to, the Culture, Media and Sport Select Committee. He also managed Johnson’s election campaign 2019, and is obviously very useful to the man who became Prime MInister, coming up with catchy slogans, launching a campaign against the Labour “heartlands” and advising Johnson how to handle public relations. David Cameron, a previous Tory PM, is widely quoted on twitter as saying Cummings was a “career sociopath”, while others have called him a narcissist on social media. As I am not a qualified psychiatrist I couldn’t possibly comment.

    Meanwhile a man called Craig Murray is a career diplomat, whose last job was as British Ambassador to Uzbekistan. He stood as an Independent in Blackburn in the 2005 General Election, opposing Jack Straw, then Foreign Secretary. And now he writes a blog in which he has drawn attention to Cummings’s presence in Castle Barnard on 12th April (allegedly testing his eyesight) which just so happens to be where the pharmaceutical giant, GlaxoSmithKline (GSK), has one of its 18 UK premises: an important research and manufacturing site. (See  https://www.craigmurray.org.uk/archves/2020/05/why-barnard-castle/ 24.05.20).

    Mary Wakefield, Cummings’s wife, who is editor of The Spectator,  published an article on 23rd April describing how ill Dominic had been for 10 days, with high fever, muscle spasms and difficult, shallow breathing. But on 5th April he was seen in his Father’s garden in Durham. On 12th April they were seen at Barnard Castle. On 14th April Cummings was back at work in London. On 14th April GlaxoSmithKline and Sanofi announced their collaborative agreement. On 19th April he was spotted again in Durham, though he has denied that he was there then. The former chancellor Sajid Javid was quoted in The Guardian (28.05.20) as saying the journey was not “necessary or justified”.

    Returning to Craig Murray, he further points out that GSK have been fined on more than one occasion for illegal behaviour eg fined £37.6 million in 2016 for bribing firms not to produce generic drugs. As a result the NHS would have had to pay more for these drugs, as generic drugs are cheaper than branded ones.

    GSK currently has 37 new medicines and 15 vaccines in development, according to its website. Its global HQ is in Brentford, Middlesex – you pass it if you drive into London on the M40, just before the turn-off for Kew. So a bit more handy for Cummings to get to from his own home, but also a bit more public. (GSK has 18 facilities in Britain and many more worldwide – offices, research labs and production facilities).

    On 14th April, 2 days after Dominic Cummings was seen in Barnard Castle, it was announced by GSK and the French firm Sanofi, which also makes vaccines, that they had signed a deal to develop and manufacture a Covid-19 vaccine. We all want that, don’t we? The long term solution to Covid-19 is a vaccine, just as measles, another viral illness that in the USA was serious enough for 48,000 people to need hospital treatment, resulted in 4-500 deaths and 1000 people developing encephalitis per year before the vaccination programme started in 1963.

    So why was Dominic Cummings not shouting about this development from the rooftops? It would, of course be illegal to use insider knowledge to buy up shares in the firms before their value on the stock market went up with the announcement of a potential vaccine for coronavirus. And indeed it might be a complete coincidence that he was nearby shortly before the announcement.

    Sanofi has developed an antigen based on recombinant DNA technology[1], which allows it to make a genetic match to proteins that occur on the surface of the coronavirus. They have called this the Spike (S) protein COVID-19 antigen[2]. The DNA sequence which encodes this antigen has been combined into the DNA of the baculovirus expression platform[3]. Sanofi has received some funding and collaboration from the US Biomedical Advanced Research and Development Authority (BARDA[4]).

    GSK will contribute its pandemic adjuvant (auxiliary) technology to the collaboration, so more vaccine doses can be produced. An adjuvant is used with the vaccine to stimulate the immune system, so that the vaccine is more efficient and longer lasting, and less of it is needed for each dose. This is an advantage when making enough vaccines to treat a pandemic.

    The firms have entered a Material Transfer Agreement to enable them to start working together immediately, with details to be firmed up in the following few weeks.

    BARDA’s website says its “mission is accomplished through successful public-private partnerships with industry to share risk, improve efficiency and accelerate development all while sustaining a marketplace that guarantees continued access to countermeasures vital to our national security.” “Our” here refers to the USA. It is not clear what advantage the USA intends to gain over the collaborative work of a British and a French firm, or whether Britain, France or indeed any other country with a serious outbreak of Covid-19, will be sharing in this.

    Cummings listed his goals as “Get Brexit done then Arpa” in a whatsapp profile mentioned on the BBC website on Monday. ARPA is the Advanced Research Projects Agency set up by the USA in 1958, which led to Silicon Valley. It is not clear what Cummings meant by this. It is clearly not a UK version of Silicon Valley – which has already been tried with variable longer term success eg in the science based firms around Cambridge, and in Silicon Glen in Scotland. But he might have in mind something like the US Cooperative Research and Development Agreement (CRADA), which was established in 1984 to encourage collaboration between firms and public sector research organisations or state agencies, and which has enabled firms to make money out of public sector research.

    An example of the CRADA was the anticancer drug taxol, or Taxol®[5], which has been very successful in treatment of ovarian, breast and other cancers, but for which patients must pay twice: first through their taxes which paid for the research supported by the National Cancer Institute and other public bodies, and second in the high prices charged for the drug, since the firm producing it (Bristol Myers Squibb, BMS) was allowed to charge a similar price to that of other anticancer drugs, which had not necessarily received public funding. Remember that in the USA patients will have to pay the cost of the drugs themselves or – if they have insurance – their insurance companies will; while the NHS will have to pay those prices for taxol imported here. There were three Congressional Hearings on this and related issues, but they did not lead to any difference in the legal status of the product or the property rights of the firm.

    Collaborative alliances have been a phenomenon in high tech industry, especially IT and biotechnology, since the early 1980s. Despite the risks of opportunistic behaviour by partners, the number of technologies and specialist fields in which firms need to keep up to date in order to innovate, has encouraged such relationships, though these have often ended in merger or acquisition, followed by new alliances in new specialisms.

    If a vaccine is successfully developed and prevents further outbreaks of flu-like conditions from this or other coronaviruses, and is available at an affordable price, then governments will consider any collaboration to have been a success. We have yet to see how the research will progress, and exactly what relationship the US government – which has contributed to the cost – or the UK or French governments – in whose countries GSK and Sanofi have their headquarters – will have to the firms in the collaborative alliance, let alone what benefit will accrue to people in other countries.

    From Vivien Walsh (Greater Manchester)

    [1] Recombinant DNA is what you get when segments of DNA from different sources are joined together. Recombinant technology = genetic engineering, which can be used to make eg human insulin, used to treat diabetes instead of the earlier treatment with insulin from cattle and pigs.

    [2] An antigen is a substance that can stimulate an immune response, ie activate the body’s infection-fighting white blood cells (lymphocytes).

    [3] A baculovirus is an insect virus. Recombinant baculoviruses can accommodate multiple “foreign” genes or large segments of “foreign” DNA. The baculovirus expression platform is used to generate recombinant proteins in insect cells at high production levels.

    [4] BARDA was established in the USA in 2006 during George W Bush’s Presidency. It is part of the Health and Human Services Office of the US Assistant Secretary for Preparedness and Response, which in turn was created the same year by the Pandemic and All Hazards Preparedness Act in the wake of Hurricane Katrina, to aid the USA in responding to chemical, biological, radiological and nuclear (CBRN) threats, to pandemic influenza (PI) and to emerging infectious diseases (EID). BARDA supports the transition of vaccines, drugs, and diagnostics from research to advanced development and consideration for approval by the Food and Drug Administration (FDA) and inclusion into the Strategic National Stockpile. BARDA’s support includes funding, technical assistance and core sevices, ranging from a clinical research organisation network to Centres for Innovation in Advanced Development and Manufacturing, and a fill-finish manufacturing network. To date, BARDA has supported 42 FDA approvals for products for products addressing CBRN, PI and EID threats. (From the various websites of the organisations mentioned)

    [5] Taxol was a natural product, extracted from the bark of taxus brevifolia, the Pacific Yew, which at the time could not be patented. It was developed by a huge network of researchers in the public sector and funded by US taxes plus the firm Bristol Myers Squibb, which manufactured and marketed it. To secure the intellectual property, BMS was allowed to trademark the name taxol in 1992, a name first given to the molecule by the chemist Monroe Wall in 1967, who first discovered its activity against cancer at the Research Triangle Institute in North Carolina.

    3 Comments