Debate of 2020: Thornley vs Baker on Covid19 response

Finally, the debate New Zealand should have had in March 2020. Simon Thornley and Michael Baker discuss using elimination and lockdowns against Covid19.

We correct NZHerald story about NZ Journal of Primary Health Care

Our letter to the NZHerald regarding the recent story on our NZ Journal of Primary Health Care (https://www.publish.csiro.au/hc/Fulltext/HC20132).
Vaccine caution
We recently wrote a scientific article in a leading medical journal which featured prominently in a Herald news report.
Our article was not “rebuked” by the scientific adviser of the Ministry of Health. As part of the usual scholarly review process, the editor of the journal asked the ministry for comment. When one group raises questions about the work done by another, the latter is always given an opportunity to respond.
The article and the response are available for any reader.
The article seriously mischaracterises our views about Covid-19 vaccines. Our letter urges caution about the speed of the rollout of the Covid-19 vaccine, since historic vaccines for respiratory viruses, such as swine flu, have been associated with adverse effects. The associate editor of the British Medical Journal, Peter Doshi, has raised questions about the efficacy of current vaccines. None of them yet have evidence of success in reducing severe infection (hospital admission, ICU, or death) or interrupting transmission (person-to-person spread). At least, the trials could not test for these, given the compressed time-frame.
Developing and distributing these vaccines to seven billion people of the world is a non-trivial task.
This does not make the vaccines useless but does raise legitimate questions about basing our border policy on the effectiveness and wide availability of vaccines.
Finally, we caution against the types of ad hominem attacks reflected in this article. This is not the way to undertake either good science or good policy.
Simon Thornley, Ananish Chaudhuri, Gerhard Sundborn, Grant Schofield, Auckland.

The fallacy of Covid19 ‘fact checking’

Covid Plan B was ‘fact checked’ as ‘misleading’ for publishing on Facebook our article which used the existing conventional standard of statistical interpretation to find that a Danish study on mask wearing meant there was no significant benefit to wearing a mask against Covid19.

This so-called ‘fact check’ used a non-conventional approach which would mean that any study showing no significant effect of the studied intervention would mean the intervention does work.

This is clearly astounding. It reverses decades of scientific interpretation. It defies common-sense. But that is what ‘fact checking’ has become in the Covid19 era: a means of upholding the establishment policy position (using non-scientist media staffers).

It is not a means of checking facts. It is a means of denying them.

We outlined this deeply worrying development in an article in the British Medical Journal. Danish mask study: masks, media, fact checkers, and the interpretation of scientific evidence | The BMJ

Should we abandon convention altogether? If we did, we may eventually promote ineffective treatments. As an example, electrostimulation, laser therapy, and acupuncture are not generally thought to improve smoking cessation success, yet several promising pooled effects were calculated in a meta-analysis, although the majority were not“statistically significant.”

The tone of the“fact checking”piece that apparently supports mass masking as having a“small protective effect”over a conventional interpretation  as“misleading”turns usual scientific practice on its head. Pointingto observational evidence to contradict trial results is another subversion of usual epidemiological practice. While this may seem trivial, it is a subtle distortion of results and the politicisation of evidence in the covid-19 era.

Full PDF here: bmj.m4919.full

 

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