Day: 13 April 2021

What’s the Truth About Budesonide?

Since Lockdown Sceptics reported on Sunday about the remarkable effectiveness of the common asthma treatment Budesonide against COVID-19 – cutting serious disease by 90% according to a study published in the Lancet – a new study has appeared underlining its effectiveness as a Covid treatment.

The first study was part of the STOIC trial at Oxford University and found that 10 of the 73 symptomatic Covid patients in the control group required urgent medical care (e.g. hospitalisation) compared to just one of the 73 symptomatic Covid patients who inhaled Budesonide twice a day. This translates to 87% effectiveness in preventing serious disease. One limitation of the study was that few of the participants were high risk or elderly, with an average age of 45; another was that it was small.

The new study is from the PRINCIPLE trial, also based at Oxford, and uses a larger group (751 using Budesonide, 1,028 in the control group), all of whom are either over 65 or over 50 with a risk-increasing underlying health condition. It found that Budesonide reduced a patient’s time to recovery by an average of three days (11 days compared to 14), and also reduced the chances of a relapse within 28 days.

Disappointingly, however, those who took Budesonide were only slightly less likely to be admitted to hospital – 8.5% compared with 10.3% – and this result was not statistically significant (though the trial is to be expanded which may address this issue).

Professor Richard Hobbs of Oxford University, who co-leads the trial, said: “For the first time we have high-quality evidence of an effective treatment that can be rolled out across the community for people who are at most risk of developing more severe illness from COVID-19. Unlike other proven treatments, Budesonide is effective as a treatment at home and during the early stages of the illness. This is a significant milestone for this pandemic and a major achievement for community-based research.”

On Monday, an alert was sent to the NHS saying the drug can now be used off-label for the treatment of COVID-19 for the over-65s and at-risk over-50s, the Telegraph reports.

This is good news. However, not everyone is convinced. The ‘Swiss Doctor’ notes that the trials have financial ties to Budesonide manufacturer AstraZeneca, and that the results are not as impressive as the newspaper reports might suggest. For example, they use “soft” rather than “hard” endpoints.

In both trials, Budesonide achieved no significant improvement in any “hard endpoint”: in the PRINCIPLE trial, there was no significant difference in hospitalisations, deaths, hospital assessment without admission, oxygen administration, and ICU admission. In the Oxford [STOIC] trial, there was no significant difference in the proportion of people and days with an oxygen saturation below 94%, PCR cycle threshold increase, and FluPRO-measured symptom resolution.

The “soft” endpoints were “self-reported recovery” in PRINCIPLE and “urgent care visits” in STOIC, of which only one patient was actually hospitalised and required oxygen.

The ‘Swiss Doctor’ does concede that there was some indication of benefit to the high-risk in the PRINCIPLE trial: hospitalisation/death risk was lower (8.5% vs 10.3%), oxygen requirement was lower (5.8% vs 8.4%), and ICU admission was lower (1.2% vs 2.2%). However, the trial will need to expand if these differences are to gain statistical significance.

The positive results for Budesonide are certainly welcome, as is the news that the NHS has been given the green light to prescribe it for high-risk groups. Though why not for the low risk under-65s as well? In the STOIC trial it cut the need for urgent care to close to zero in that group. Is that not a worthwhile medical intervention, particularly with all the worry about ‘long Covid’?

It’s fair to say that the 17% reduction in hospitalisation/death among the high risk is disappointing when compared to the impressive 87% reduction in urgent care among the low risk. But it’s still an improvement, and the other indicators – shorter recovery time, reduced need for oxygen and intensive care – are also encouraging.

I should add that what we’re really waiting for are high quality results on the highly promising Ivermectin that are deemed acceptable to the health regulators so that drug can become generally available. No rush, guys. Not like people are dying or anything.

Quarter of Covid Deaths Not Caused by Virus

Almost a quarter of registered Covid deaths are people dying ‘with’ Covid rather than ‘from’ it, new official figures show. The Telegraph has more.

The latest figures from the Office for National Statistics (ONS) show that 23% of coronavirus deaths registered are now people who have died “with” the virus rather than “from” an infection.

This means that, while the person who died will have tested positive for Covid, that was not the primary cause of their death recorded on the death certificate.

Other data also shows an increasingly positive picture of the state of the pandemic in the UK.

Daily death figures by “date of death” reveal that Britain has had no more than 28 deaths a day since the beginning of April, even though the government-announced deaths have been as high as 60.

This is because the Government gives a daily update on deaths based on the number reported that day, which can include deaths from days or weeks previously and therefore may not reflect the true decline in deaths. On Tuesday, the Government announced that there had been 23 further deaths.

Worth reading in full.

Bridge to Nowhere

There follows a guest post by Professor Roger Watson and Dr Niall McCrae.

Suicide is always a tragic event and information is not easy to obtain. This is for good reason, to prevent ‘hot spots’ being advertised and to reduce copycat events. Nevertheless, any landmark with altitude attracts suicide attempts and very few survivals. Sadly, the Humber Bridge is one such spot and only the most notable are reported such as double suicides, for example, and attempted double suicides involving a mother and child.

Since the Humber Bridge opened in 1981 there have been over 200 suicides, which approximates to just below five annually. Merely five persons survived the fall. In the most recent complete annual figures we can find, from a 2019 study of suicides in Hull, three were attributed to jumping from the structure dubbed “the bridge to nowhere”. But the toll appears to have risen sharply under the COVID-19 regime.

In the last month alone there were six deaths from suicide on the Humber Bridge, many of them young people. This has prompted the closure of the footpaths and cycling commuters from Lincolnshire into East Yorkshire have to make special arrangements to cross the bridge to and from work. In none of the reports do we see any specific mention of the impact of lockdown; this is hardly surprising as the local newspapers have tended, like the mainstream media, to be “on message” regarding the need for COVID-19 restrictions. Were he still alive, we would be minded to consult Philip Larkin on this human calamity, and its callous cause.

Nicola Sturgeon Speeds up Scottish Lockdown Roadmap

There is “every reason for optimism” in Scotland because of its vaccine rollout, according to Nicola Sturgeon, as the next step of the country’s exit from lockdown has been brought forward. The Mail has the story.

The First Minister said from Friday stay local rules are being dropped in Scotland, and six people from six different households will be allowed to meet outdoors – with under-12s not included in the numbers.

Ms Sturgeon also confirmed that that non-essential shops will be allowed to open from April 26th – and boasted there will also be limited hospitality permitted indoors, three weeks earlier than in England.

The move, announced at a briefing in Edinburgh, could increase pressure on Boris Johnson to accelerate the pace south of the border.

However, the PM insisted earlier that although infections and deaths are tumbling people must still be “cautious” about using new-found freedoms.

The Scottish Tories pointed out that Ms Sturgeon’s previous plan was “slow” and welcomed her recognition it was “safe” to go faster. 

Ms Sturgeon said “significant progress” has been made in reducing the number of Covid cases in Scotland.

Figures are now at their lowest since September, and have fallen by 40% in the past two weeks.

“We are now extremely confident that those parts of the country currently in Level 4 will move to Level 3 on April 26th, that’s now less that two weeks away,” she said.

“That means, amongst other things, that on that day shops will fully reopen, pubs, cafes and restaurants will also be able to fully open outdoors on April 26th and will be able to open indoors on that date, but on a restricted basis.”

Despite the success of England’s vaccine rollout, and the fact that Covid cases have all but vanished in many areas across the country, the Government is showing an unwillingness to speed up the exit from lockdown.

The Mail’s report is worth reading in full.

Mick Jagger Comes Out as a Lockdown Sceptic

A number of famous musicians have nailed their colours to the good ship lockdown sceptics in the past 12 months, including Van Morrison and Eric Clapton, but none quite as illustrious as the latest addition to our ranks: Sir Mick Jagger. The Rolling Stones frontman has released a song today called “Eazy Sleazy“, a collaboration with David Grohl of the Foo Fighters. “It’s a song that I wrote about coming out of lockdown, with some much needed optimism,” says Jagger.

If you watch this YouTube version of the song, complete with the lyrics, you’ll find a number of anti-lockdown messages:

We took it on the chin
The numbers were so grim
Bossed around by pricks
Stiffen upper lips

Pacing in the yard
You’re trying to take the Mick
You must think I’m really thick
Looking at the graphs
With a magnifying glass
Cancel all the tours
Football’s fake applause

No more travel brochures
Virtual premiers
I’ve got nothing left to wear

Looking out from these prison walls
You got to rob Peter if you’re paying Paul
But it’s easy, easy
Everything’s going to get really freaky
Alright, on the night

Soon it’ll be a memory you’re trying to remember to forget…

That’s a pretty mask
But never take a chance
Tik Tok stupid dance
Took a Samba class

I landed on my ass
Trying to write a tune
You better hook me up to Zoom
See my poncey books
Teach myself to cook
Way too much TV
It’s lobotomising me

Think I’ve put on weight
I’ll have another drink
Then I’ll clean the kitchen sink

We’ll escape from these prison walls
Open the windows and open the doors
But it’s easy, easy
Everything’s going to get really freaky
Alright, on the night
It’s gonna be a garden of earthly delights
Yeah it’s easy, sleazy
Everything’s smooth and greasy

Easy, believe me
It’ll only be a memory you’re trying to remember to forget

However, lest you think Jagger has become a full-blown conspiracy theorist, there’s a swipe at some of the crazier fringes of lockdown scepticism in the final verse:

Shooting the vaccine
Bill Gates is in my blood stream
It’s mind control
The earth is flat and cold
It’s never warming up
The Arctic’s turned to slush
The second’s coming late
And there’s aliens in the deep state

Covid Testing Firm Cutting PCR Travel Test Cost to £60

A major UK Covid testing firm is set to halve the cost of its PCR test kit for travel to £60. This means that when overseas travel returns, testing costs will add almost £250 to the bill for a family of four (returning from a “green list” country) as opposed to almost £500 – a more feasible, yet still hefty sum. The Independent has the story.

Randox, based in Northern Ireland, says it will offer the test for just £60 to airline passengers – though the Independent understands negotiations are not yet complete.

At present international leisure travel from the UK is illegal. The Government has indicated it will allow overseas trips from May 17th – but says that all returning travellers must take at least one PCR test after arrival.

These tests, which require specialist equipment to analyse, typically cost £120 – representing almost £500 for a family of four.

The County Antrim firm is the first to announce a significant cut.

The Managing Director of Randox, Dr Peter FitzGerald, said: “In recognition of the needs of both the travel industry and the British public at this unprecedented time, Randox will reduce the all-inclusive cost of PCR testing for those in the UK undertaking international travel to £60 per test.

“We can see the pressures faced by both the travel industry and the general public and are committed to effective and economical testing to support holidaymakers and those undertaking international travel.” 

Even those travelling to “green list” countries on the Government’s “traffic light” system will have to take one test when returning to the UK, as the Telegraph recently reported.

Travellers who want to visit countries on the safe “green list” will still be expected to pay for gold standard PCR tests on their return to the UK…

People who have been fully vaccinated will still be required to take the PCR tests on or before the second day of their arrival back in the UK because of Government concerns that “green list” countries could still harbour new Covid variants.

Holidaymakers arriving from those countries will not have to spend any time in quarantine under the new traffic light system, which is expected to replace the current ban on foreign travel from May 17th.

The Independent’s report is worth reading in full.

Outdoor Sports Events Should Be Open to All, Including the Unvaccinated

Last week, the UK’s sports bodies wrote a joint letter to the leaders of the main political parties. It warned that the return of some spectators from May 17th will be “insufficient to end sport’s Covid financial crisis” because attendance will be capped at 25% of capacity in larger venues.

“Looking ahead to June 21,” the letter went on, “we support the Government’s ambition to secure the full return of fans, without restrictions if possible.” However, it also said, “All of our sports can see the benefit that a Covid certification process offers in getting more fans safely back to their sport as quickly as possible.”

In other words: the sports bodies want to get fans back into bleachers as soon as possible, preferably without restrictions, but if using vaccine passports is what it takes, then so be it.

However, my reading of the evidence is that vaccine passports would provide little benefit at outdoor sports events (which I assume covers most such events). And given objections that have been raised on grounds of privacy and non-discrimination, mandating them for all sports events seems like a very unwise idea.

To begin with, the percentage of people with COVID-19 antibodies is now well above 50% in England and Wales, as this chart from the ONS indicates:

The percentage will be even higher by May 17th, when spectators can finally return to stadiums. And it will be higher still when the next football season begins in August. Due to the seasonality of COVID-19, transmission is likely to be low over the summer, so by the time restrictions might be needed in September, a very large percentage of people will have some form of immunity.

What’s more, evidence suggests that the vast majority of infections occur indoors. This is because wind quickly disperses the virus in outdoor environments, and viral particles degrade more quickly when exposed to sunlight.

In Ireland, only 0.1% of infections could be traced to outdoor activities (though this doesn’t include all the associated indoor activities, such as travel to and from events). And despite England’s packed beaches last summer, the epidemiologist (and SAGE member) Mark Woolhouse told MPs there were “no outbreaks” linked to beaches.

A systematic review of five studies published in The Journal of Infectious Diseases found that less than 10% of infections occurred outdoors. And a recent study published in Environmental Research concluded that “the probability of airborne transmission due to respiratory aerosol is very low in outdoor conditions”.

Chris Whitty has said, “The evidence is very clear that outdoor spaces are safer than indoors.” And a paper by the PHE Transmission group notes, “Evidence continues to suggest that the vast majority of transmission happens in indoor spaces.”

Before the UK’s hugely successful vaccine rollout, the risk of outdoor transmission was low. By the time sports venues re-open on May 17th, the risk will be even lower. While there are some circumstances where Covid certification makes sense (like visiting relatives in care homes), attending outdoor sports events is not one of them. Instead of spending more time checking fans at the entrance, venues would be better off improving ventilation in high-risk spaces.

It’s time to get fans back into stadiums – but they should only have to show a ticket on their way in.

US Calls For Pause on Johnson & Johnson Vaccine Due to Clotting Fears

Federal health agencies in America have called for the rollout of the Johnson & Johnson (J&J) vaccine to be paused immediately due to some recipients developing rare blood clotting disorders within two weeks of being vaccinated. So far, nearly seven million people in the US have received shots of the J&J vaccine, which is not currently used in the UK. Six US recipients of the vaccine have developed disorders involving blood clots, all of them women aged 18-48. The New York Times has the story.

Federal health agencies on Tuesday called for an immediate pause in use of J&J’s single-dose coronavirus vaccine after six recipients in the US developed a rare disorder involving blood clots within about two weeks of vaccination.

All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalised in critical condition. …

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr Peter Marks, Director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement. “Right now, these adverse events appear to be extremely rare.”

While the move was framed as a recommendation to health practitioners in the states, the Federal Government is expected to pause administration of the vaccine at all federally-run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same.

Scientists with the FDA and CDC will jointly examine possible links between the vaccine and the disorder and determine whether the FDA should continue to authorise use of the vaccine for all adults or limit the authorisation. An emergency meeting of the CDC’s outside advisory committee has been scheduled for Wednesday.

While the majority of the US’s vaccine supply comes from other sources, it is expected that this pause could “substantially complicate” the nation’s vaccination efforts. The move comes after Europe’s medicines regulator announced last week that it was reviewing possible links between the vaccine and rare blood clots. The jab is expected to be approved for use in the UK “within days“, with 30 million doses having already been ordered by the Government.

J&J said the following in a news release:

We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid vaccines. At present, no clear causal relationship has been established between these rare events and the J&J Covid vaccine.

The New York Times’s article is worth reading in full.

Stop Press: The European rollout of the vaccine has now been paused, according to a statement released by Johnson & Johnson. The company said: “We have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe.”

Boris Johnson Says Lockdown Not Vaccines Responsible for Drop in Covid Cases and Deaths

Has Boris lost his faith in the vaccines? That’s certainly the impression you’d get from what he has said this morning. Speaking in 10 Downing Street, the Prime Minister said:

The numbers are down of infections and hospitalisations and deaths. But it is very, very important for everybody to understand that the reduction in these numbers in hospitalisations and in deaths and infections has not been achieved by the vaccination programme. People don’t, I think, appreciate that it’s the lockdown that has been overwhelmingly important in delivering this improvement in the pandemic and in the figures that we’re seeing. And so, yes of course the vaccination programme has helped, but the bulk of the work in reducing the disease has been done by the lockdown. So, as we unlock, the result will inevitably be that we will see more infection, sadly we will see more hospitalisation and deaths, and people have just got to understand that.

Notice that he didn’t say it’s a matter of waiting for the vaccines to take effect. It now appears that, regardless of vaccinations operating at full power, the Prime Minister thinks “inevitably” we will see more infection, hospitalisation and death.

The PM added that “at the moment” he couldn’t see “any reason” to change his roadmap for easing lockdown restrictions.

At Lockdown Sceptics, of course, we can give him several reasons for getting a move on. Florida, Texas, Georgia, South Dakota, South Carolina and Mississippi for starters. These states all currently have no restrictions at all, whether because they never had them (South Dakota), because they removed them after the first wave in the spring (Georgia and South Carolina) or in the autumn (Florida), or because they lifted them in the last few weeks (Mississippi and Texas). If lockdown is what brings infections down, what has brought them down in these states?

The claim that lockdowns “control” the coronavirus has no basis in the data or in the evidence-based (as opposed to model-based) scientific literature. No evidence-based study has found a statistically significant relationship between the severity or timing of interventions and Covid cases or death counts. It is “fake news”, to use the current parlance, and scientists and politicians need to stop repeating it as though doing so can make it true.

Looking just at the UK, it’s clear from the data that new daily infections peaked and began to fall before the lockdowns on all three occasions. Chris Whitty even admitted as much to MPs in July in relation to the first lockdown.

According to ONS data, new infections in the winter surge in England peaked in the week ending December 26th, nearly two weeks before the January lockdown and right in the middle of Christmas mingling that was predicted to cause a spike.

This image has an empty alt attribute; its file name is England-ONS-new-infections.png

If lockdowns control the coronavirus then how can this be explained?

On one level it should be welcome that Boris is candidly admitting that the vaccines will not prevent all infections, hospitalisations and deaths. But then no one ever thought they would. The aim was just to make endemic Covid no worse than the usual pathogens we face, which many people believed requires effective vaccines. Now we have vaccines, there is no excuse not to lift restrictions, particularly seeing that places which have remained fully open even without vaccines have not seen catastrophic consequences, and often fared better than places with strict lockdowns.

COVID-19 outbreaks have consistently shown themselves to be self-limiting, regardless of what measures are or are not imposed. In some places the outbreaks are more severe, in some places less so. As with other similar seasonal respiratory pathogens this will be due to a combination of seasonality, the development of population immunity (including from vaccines, where available), the effectiveness of treatments, population density, and numerous other factors that might affect a population’s susceptibility to a particular pathogen. But on no occasion have the models attributing the differences to lockdowns been validated by empirical data.

As the Government appears to be preparing to pivot away from its vaccines-will-save-us narrative, the big danger is that what we get instead is not a freedom that accepts governments cannot prevent all evils, but a future of indefinite restrictions, periodically tightened and loosened, as the myth persists that only such measures are holding back the flood. If we are no longer to see the vaccines as our saviour, it is imperative that the Government shift to a zero restrictions approach, not a zero Covid one, and set us free without further delay.

Cold Weather Takes Shine Off Reopening

According to a retail analyst Springboard, shopping activity didn’t return to pre-pandemic levels yesterday thanks to the cold weather. Meanwhile, only two in five pubs opened in England due to the lack of suitable outside space. The Times has more.

Britain’s notoriously fickle spring weather dampened the high street’s recovery yesterday as lockdown restrictions were eased.

People going to shops, pubs and restaurants for the first time in more than three months endured cold conditions and even snow. On the south coast, temperatures were as low as 5C, half the usual average for the time of year. Little Rissington in Gloucestershire recorded 4cm of snow.

Shoppers who braved the cold appeared to be preparing to party. John Lewis reported that decanters, tumblers and highball glasses were “by far” the most popular purchases yesterday morning, with champagne and gift bags the two next most popular categories.

Some stores, such as Primark and Ikea, had queues first thing, but the number of people visiting high streets overall was a quarter lower than the equivalent day two years ago.

The retail analyst Springboard said that shopping centres had fared better, although they were still down on a normal day, suggesting that the weather had been a deterrent for many people.

Clive Black, a retail analyst at Shore Capital, said: “The cold and snow will have kept an awful lot of people at home, particularly older people. That said, the pandemic is still casting a long shadow over retail.

“Shoppers are more cautious and the shift online represents a big structural challenge to high street stores.”

The British Beer and Pub Association estimated that only two in five pubs reopened yesterday because most venues lack a big enough outdoor space to trade profitably. It acknowledged that the cold weather would have deterred some customers.

You can read the article here.