Danish mask study result; no statistical difference from not wearing one

Only two days after the NZ government announced mandatory mask wearing rules the much awaited Danish mask study was published, and it is conclusive; masks give no statistically significant protection from Covid19.

Here’s the study: https://www.acpjournals.org/doi/10.7326/M20-6817

Results:

A total of 3030 participants were randomly assigned to the recommendation to wear masks, and 2994 were assigned to control; 4862 completed the study. Infection with SARS-CoV-2 occurred in 42 participants recommended masks (1.8%) and 53 control participants (2.1%). The between-group difference was −0.3 percentage point (95% CI, −1.2 to 0.4 percentage point; P = 0.38) (odds ratio, 0.82 [CI, 0.54 to 1.23]; P = 0.33). Multiple imputation accounting for loss to follow-up yielded similar results. Although the difference observed was not statistically significant, the 95% CIs are compatible with a 46% reduction to a 23% increase in infection.

Conclusion:

The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use. The data were compatible with lesser degrees of self-protection.

Below is our Euler diagram summarising the findings of the Danish mask trial.

The small difference in event proportions, with a slightly higher proportion in the control group, was not distinguishable from a chance finding (“not statistically significant” is the boffin term).

This is probably the best evidence we have up to now, which is disappointing for advocates of mask use to prevent covid-19 infection. This evidence is consistent with previous trials which found no effect in trials designed to assess the effect of masks to prevent the community transmission of influenza.

Immunologist cautions on lead vaccines

17 November 2020

Byram Bridle, a viral immunologist at the University of Guelph, cautions New Zealanders that the lead vaccines against Covid19 may not be the solution they are expecting to end its isolation under the elimination strategy.

The main points of his caution are:

  1. NZ will have to wait at least two years before the Pfizer vaccine is available, because it is in strict isolation and low on the priority list for the 500m doses available in 2021.
  2. Not enough data has been released to know whether the vaccine prevents or weakens the symptoms of Covid19, or how long the protection will last.
  3. The safety data will be incomplete if it is approved for use next year, so monitoring will need to be carried out on vaccinated people for some years.
  4. The Pfizer data has not been rigorously peer-reviewed.
  5. There is no available data on the qualitative nature of the immune response. Vaccines like this can be misinterpreted by the immune system as an extracellular pathogen, which can cause them to respond poorly to natural infections with future coronaviruses.

“Pfizer’s vaccine is a RNA-vectored vaccine. This technology is relatively new and has not been approved for clinical use before. The company has been able to move surprisingly fast. If the recent data is indicative of what data from the rest of the trial will look like, there is a good chance the vaccine could receive emergency approval by early in 2021.

However, there are many nuances…”

Insufficient public data

“The study is only partially complete. There exists the possibility that the final data set will fail to secure regulatory approval (but it looks like they may be on track).

Data that accompanied the Pfizer press release was extremely superficial and, therefore, difficult to interpret. Data being collected for the Pfizer study cannot accurately be commented on until it undergoes rigorous peer review for publication in a good quality scientific journal.”

Effectiveness of protection

“90% effectiveness sounds surprisingly high. But we have no idea what the demographics look like. Although they opened the trial to high-risk people, we have no idea who contracted COVID-19. As an extreme example, if all the vaccinated volunteers that got COVID-19 were elderly and that number was not significantly different from the elderly among the non-vaccinated volunteers that got COVID-19, that would tell us that the vaccine does not work in those who need it most.

Most of the cases of COVID-19 in the study were presumably mild to moderate since no hospitalizations or deaths were reported, so we don’t know how protective the vaccine will be for those who are susceptible to severe cases.

There is no data regarding immunological memory, which is the entire point of a vaccine. If the memory response is weak or wanes too quickly, people will not be protected over the long term. This would be a fatal flaw because the global roll-out of a vaccine will take a very long time.

Pfizer hasn’t stated what the qualitative nature of the vaccine-induced immune response is. Sub-unit vaccines like theirs have been known to be misinterpreted by the immune system as being an extracellular pathogen. If that is the case, people who receive this vaccine might have a bias imprinted on their immune system that could cause them to respond to natural infections with future coronaviruses in a sub-par fashion.”

Two dose vaccine.

  • “It can be hard to get people back for a second dose. It is probably achievable in urban centres but could be hard to get the same people back 21 days later in remote and/or difficult-to-access places, especially in developing countries.
  • A vaccine that needs two doses is arguably a ‘weak’ vaccine. For this vaccine, it will take 28 days to build up sufficient protection. So there will be a one-month window during which people will remain susceptible. A better quality, single-dose vaccine could probably reduce this to 10-14 days.
  • Fewer than 500 million people could be vaccinated within a year of the vaccine being approved. The company is going to try to stockpile 50 million vaccines this year in anticipation of the vaccine being approved, and they optimistically predict that they can make 1.3 billion doses by the end of 2021. This sounds like a lot, but a two-dose regimen cuts the number of people that can be immunized in half. The person to get the 500 millionth dose will have to wait a year compared to the person who gets the first one. Some will wonder why some people get two doses while they get none. The vaccine won’t be protective unless two doses are given.”

Roll out internationally

“What about the rest of the population? As many of us have been predicting, it could take years to roll out these vaccines. Approval of a vaccine doesn’t help anyone; what matters is when it has been administered and sufficient time has passed for the immune system to respond. Of course, where in this very long timeline for the roll-out will countries that have used strict isolation to control their cases be (arguably, low on the priority list). Pfizer’s press release is essentially saying that everyone beyond the first half-million people will have to wait over 1 year. Presumably, it also means that people beyond the first billion or so may have to wait over 2 years.”

Long term safety

“Long-term safety in people is inferred based on animal models (such as rodents) that have shorter lifespans. Usually, clinical trials are done sequentially and span quite a few years. So acute and some long-term (i.e. 4 or more years) safety data would be in-hand. With the different trial stages overlapping and being run faster than normal, we will likely have less than a year’s-worth of safety data. Ultimately, the only way to be completely sure about long-term (i.e. beyond the duration of the clinical trial phase) safety in people is to monitor vaccinated people for a long period of time after the roll-out. Things like long-term kidney damage, etc. can often (but not always) be predicted/ruled out by things like blood chemistry within the acute stages.”

/ends

Covid19 elimination strategy almost abandoned

13 November 2020

Media Release

Covid Plan B has welcomed the Government’s decision not to over-react to cases of people testing positive to Covid-19 by starting another lockdown.

Simon Thornley, spokesperson for the group, says the Government appears to finally be adapting its strategy to new information about ineffectiveness of lockdowns and the low death and ill health effects of the virus.

“We support the Government’s inclination not to go back to lockdowns. Positive tests in Auckland, Christchurch and Wellington show the elimination strategy is fragile, futile and unnecessary.

“We urge the Government to be clear about why it is less fearful of Covid and more concerned by lockdowns. The public will understand and accept an admission that elimination attempts are over,” Thornley says.

Covid Plan B experts were this week published in the British Medical Journal showing the threat of Covid-19 is not what it was initially thought to be, in large part because of inaccurate recording of deaths.

Countries such as Singapore that use a strict definition of covid-19 death have very low fatality rates from the virus. Studies show that in past pandemics, coding of death certificates exaggerate fatality rates.

Estimates of covid-19 fatality are now extremely low; at 0.05% for people under seventy years old.

Statistical evidence now shows lockdowns do not reduce mortality from the virus, while causing much health and economic harm.

“Envoys from the World Health Organisation caution against the use of lockdowns since they “… have one consequence that you must never belittle and that is making poor people an awful lot poorer.

“This has happened in Auckland, where thousands turned to food banks to make ends meet. Over 50,000 people have started on the jobseeker benefit since March this year. The disproportionate economic costs of lockdown, relative to any benefits are also now apparent.

Heavily restricted borders will continue to devastate New Zealand’s tourist economy, and are leading to labour shortages, further reducing productivity. In contrast, many academics, doctors and the public are now urging their governments to focus on protection of the vulnerable, while allowing those at low risk from the virus to return to normal life.

/ends

Contact: Simon Thornley, 021 299 1752

Elimination proponent admits it means no return to normal

An early proponent of New Zealand’s elimination strategy has now admitted that the approach means the country cannot go back to normal.
In early interviews Souxsie Wiles claimed to be “excited” about vaccines for Covid19, but now says the early ones are unlikely to prevent death or transmission (see BMJ assessment of lead vaccines).
Wiles she says this is particularly problematic for New Zealand because it “stamped out” Covid19. A partially effective vaccine would not allow us to open borders and go back to normal (we presume she means that covid19 would re-enter the country and/or resume transmission).
Wiles has therefore clarified that it is New Zealand’s strategy which means New Zealand can not go back to normal.
This will be surprising and unpleasant news to most citizens. Wiles embraced the strategy and the government’s plan to eliminate and wait for a vaccine.
This is precisely the dilemma that Covid Plan B predicted would happen, and why we opposed the elimination and lockdown strategy.
We said that if elimination was the goal, our quandary was that we could not have a situation where covid19 was in transmission. Which meant we had to wait until a totally effective vaccine was available. We doubted that such a vaccine would be ready even in 2021.
In her Stuff article, Wiles seems to be happy with the idea that this isolation is the new normal. We are not.
 

How have dire predictions for Sweden panned out?

An article in the NZ Herald on May 27, 2020 predicted Sweden would have 56,000 more COVID-19 deaths and had made “a fatal mistake”. At the time of publishing Sweden had experienced 4408 deaths.

So, how’s that prediction looking five months on?

It was wrong. The deaths have not been 56,000, but as at 23 October, 5,933.

In the past five months a further 1525 people sadly died.

Daily deaths plateaued in July, and over the following three months (23 July to 23 i.e., 92 days) 202 people – an average of just over 2 a day – have died. To put that into perspective, ca. 246 people die every day in Sweden; 77 from cardiovascular disease (Sweden’s biggest killer).

Despite an upsurge in cases (starting ca. 4th September) that now matches the peak of cases recorded in June 2020,  the average daily death since 4 September has been 1.8 deaths per day. Over the last seven days, (16 to 23 October) the daily death rate was 0.57.

Data taken from:

https://ourworldindata.org/coronavirus/country/sweden?country=~SWE

https://www.statista.com/statistics/525353/sweden-number-of-deaths/

NZ data – not many tested, not many positives

A sense of perspective on NZ Covid data

(from Jefferies et al. Lancet paper. https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(20)30225-5/fulltext)

Outer circle here is proportional to NZ population, grey is those tested. Blue is those who tested positive. Hospitalised and ICU cases too small to print.

Zeroing on test positive cases (blue circle above, now below), it is not possible from paper to know how many deaths actually went to ICU, so these cells may not be mutually exclusive…

 NZ Doctors sign statement against ‘Covid fear’

26 October 2020

A group of New Zealand health practitioners have joined a growing international movement that says Covid19 is not a sufficient threat to warrant the elimination strategy and lockdowns. 

The founding signatories felt obliged by their professional ethics to express support by signing a statement of principles that assert the low risk posed by Covid19, the availability of treatment, the dangers of Government over-reaction, and primacy of the doctor-patient relationship.

Covid Plan B spokesperson Simon Thornley praised the medical practitioners for expressing their views.

“Around the world medical specialists are speaking out. They have seen the data and seen that the initial fear is now clearly unfounded. They are seeing the damage to people’s heath caused by institutional fear and compliance, and by elimination strategies and lockdowns. Unlike too many others, they are prepared to say so.

“Their statement will signal to like-minded New Zealanders in the healthcare sector that they can and should resist, and they should reassure patients and the public.”

The group says its statement was intended to break the silence. It says New Zealand registered health practitioners who want to join the movement should sign the international Great Barrington Declaration and email Covid Plan B (info@covidplanb.co.nz).

The Great Barrington Declaration is now supported by over 11,000 medical specialists and over 30,000 medical practitioners.

Contact: Simon Thornley, 021 299 1752

GPs support Covid Plan B

26 October 2020

Registered Health Practitioners for Covid Plan B

 Statement of principles

Health is based on freedom and trust. Free human beings can decide themselves about their health.

Free societies decide in democratic discussions how to deal with their health. The NZ Bill of Rights guarantees free choice of treatment.

Fear of the pandemic makes us unfree. It makes us see vaccination and lockdowns as the only way to get back to normality.

International health data and our own experience shows that the fear engendered in the public and our patients is not proportional to the threat to their health posed by covid-19.

Therefore New Zealand’s public health and economic response to covid-19 needs reviewing. It is very likely to be more harmful than the threat posed by the virus in the medium to long term.

Doctors can help. We can develop trust through mutual respect, transparency and democratic debate. We can take action with our patients, so they are healthier and better able to fight infection, and by providing treatments if they fall ill to Covid-19.

There is nothing we have yet seen in the features of this virus that warrants it being regarded as especially dangerous above the many other viruses that are with us every day. The most practical response is the standard precautions of improving personal hygiene, physical health and improving lifestyles.

We want the public to know that the infection fatality rate of Covid-19 is currently about 0.3% once antibody levels are accounted for. The infection fatality rate of influenza, which is strongest each winter, is about 0.1%. It is also clear that the ages of people who die with Covid-19 is about the same as that from natural mortality. This information is enough to inspire us to take better care of our health, but not to drastically change our society and economy.

It is impossible to obtain information about the severity of Covid-19 infections in New Zealand, so we have had to rely on overseas research. About a third of Covid-19 positive patients have no symptoms, with about 90% of infections treated in the community, and only about 1.5% needing intensive care. In the US, almost all hospital treated cases have had other serious medical conditions and are almost all people who die with the virus are over 50 years old. Unusual or long lasting symptoms currently appear similar to a range of responses seen in other respiratory illnesses.

Doctors now have many promising treatments against Covid-19, including easily available supplements like vitamin D. Internationally, the death rate is falling, in part, because we are getting better at treating the disease.

Immune function can benefit from minimising sugar and refined starch intake, eating several servings of fruit and vegetables daily, being physically active, socially connected and having sensible sun exposure to ensure adequate levels of vitamin D, avoiding tobacco and excess alcohol.

We have identified comorbidities that make people susceptible to Covid-19, such as diabetes, hypertension and raised cholesterol. We need to treat a condition in these patients called Metabolic Syndrome, which creates immune system dysfunction.

Decision makers, when assessing health strategies, compare the economic costs of a policy to its benefits. Recent assessments by economists indicate that the costs of lockdowns in New Zealand outweigh benefits by a ratio of between 90 and 200 to one. This indicates that Covid-19 has been disproportionately treated compared to critical health issues that our patients face day-to-day.

Policies that the Government should prioritise or review are:

  • Adequate resourcing of high-quality infection control and quality care in rest homes and hospitals to prevent the spread of covid-19 to vulnerable people.
  • Abandon the use of lockdowns to contain the virus. Strong evidence now indicates that these measures are disastrous economically and do little to contain viral spread.
  • Review the requirement for managed quarantine and compulsory detention for both community and hospital cases in the light of the updated lower fatality risk of the virus. This measure leads to social isolation and undue mental distress.
  • Further limits on border travel should be urgently reviewed in the light of a cost-benefit analysis.
  • Avoid any measures that lead to social isolation in the response to contain the virus.
  • Review the requirement for compulsory diagnostic tests in the light of the lower fatality rate of the virus. We believe that patients should continue to have the right to refuse medical tests, as they do for other procedures, and that the public health risk from this virus does not warrant these rights being superseded.
  • Abandon the requirement to wear masks on public transport. We believe that the best epidemiological evidence available does not support mask wearing to reduce the risk of respiratory virus transmission.
  • We believe that the doctor-patient relationship should be safe-guarded, along with the ability for doctors to see patients in-person rather than online. Online patient consultations detract from the quality of the doctor-patient relationship and raise the risk of mis-diagnosis.

As facts about the virus become self-evident, the public is wondering whether the current measures cause more harm than good. They will wonder why authorities have been unwilling to listen to, or even allow, discussion of the facts and alternative policies. We are deeply concerned that the consequence will be a loss of faith in health services, science and bureaucracy.

Foundation Signatories:

Dr Cindy de Villiers – General Practitioner, M.B.,Ch.B

Dr Matthias Seidel – Obstetrician and Gynaecologist

Dr Anne O’Reilly – General Practitioner. MB BCh FRNZCGP

Dr Rob Maunsell – General Practitioner

Dr René de Monchy – Consultant Psychiatrist

Dr Robin Kelly – General Practitioner MRCS, LRCP, FRNZCGP

Dr Tessa Jones – Integrative medical practitioner MBChB, Dip Obs, FRNZCGP, FACNEM, FABAARM

Dr Alison Goodwin – General Practitioner, MBChB, FRNZCGP

Dr Ronald Goedeke – Director of Appearance Medicine, BSc Hons MBChB

Dr Deon Claassens – General Practitioner, MBChB, Dip. SportsMed, FRNZCGP

Shane Chafin – Pharmacist,AGPP,BCACP

Dr Ulrich Doering – General Practitioner, MBChB, Dipl O&G, FRNZCGP

Dr Samantha Bailey – Research Physician MBChB (Otago)

Six months before the truth caught up with Covid19 doom-mongers

A dismaying aspect of the Western response to Covid19 is that it has been six months before some Governments and public institutions started listening a wider range of advice, and understood they must critically assess advice to decide what is in the fullest public interest.

Even then, the ‘listening’ has been piecemeal and slow. And not at all in New Zealand.

The preference for heeding the warnings of doom-mongers with the worst numbers is somewhat understandable, but it is inexcusable that leaders failed to listen to other advice, and to judge from the data for themselves.

https://www.businessinsider.com.au/boris-johnson-briefed-sw…

Schism regretted but made inevitable by first panicked over-reaction

A rule of thumb in public health, forgotten in the panicked responded to Covid19, was; If you don’t know the likely result of your intervention, don’t do it.

We heavily regret the schism in science and society over Covid19, but it was made inevitable by the first response of politicians and panickers. A determined self-selected group of people in each country promoted erroneous projections and large scale blunt interventions. And they stuck to that plan – refusing to consider alternative interpretations of data and alternative responses.

It was they that decided discussion, moderation and dissent would not be tolerated.

https://www.newshub.co.nz/home/world/2020/10/opinion-is-the-covid-19-cure-worse-than-the-disease-the-most-polarising-question-of-2020.html