Coronavirus pandemic prompts increased transparency of drug companies

The unprecedented nature of the SARS-CoV-2 coronavirus pandemic has begun to influence the transparency of drug company trials of potential COVID-19 vaccines.

On September 17th The New York Times reported that Moderna and Pfizer were releasing the protocols that describe the trial process to test a potential COVID-19 vaccine. On September 19th they reported that AstraZeneca had done the same. This heralds a significant change on the part of drug companies. Although in practice complex vaccine trial protocols would need to be interpreted by say, science journalists, in order to be understood by the wider public particularly given the multicultural nature of today’s communities in developed nations.  [See references below for protocols]

As trials have progressed to Phase III in which data on the safety and efficacy of vaccines are collated, the interest of the public has grown significantly. Intense media attention surrounded the recent pause of the Phase III trial of the vaccine being developed by AstraZeneca in partnership with scientists from Oxford University. Not surprisingly public interest has turned to pressure for more transparency as to how trials are conducted.

From July 24th to August 7th Ipsos surveyed respondents from 27 countries [PDF] on attitudes toward a COVID-19 vaccine. 74% of respondents said they would have a vaccine if it was available. The most common reason for rejecting the vaccine was concern over side effects (56%). This was followed by doubt of its effectiveness (29%). The importance of transparency surrounding Phase III trials is confirmed by the weight of these two reasons for rejecting the vaccine.

These vaccines are being developed rapidly under the gaze of a public that expects at some time to be given such a vaccine. It’s understandable that anxiety surrounding both efficacy and safety of COVID-19 vaccines existed long before the specifics of Phase III trials became public. That those specifics have become better understood due to an issue with safety does raise matters of trust within the public.

Of course the increased attention over safety and efficacy would never have arisen during development of the many so-called “alternatives” to regulated vaccines. Alternative products are not subject to reliable scrutiny and as such the acute and chronic effects are in fact undocumented or unknown. The safety and efficacy of such listed (as opposed to regulated) therapeutic products is almost always merely assumed.

Establishing trust between the public and the government and health authorities is important. Increased transparency of vaccine trials will help promote trust. Sustaining trust is significantly reliant on clear information and explanation of complicated issues that raise public concern. This is particularly true in the present environment where changing evidence may come across as inconsistency and if left unacknowledged may lead to suspicion. The proper interpretation and presentation of available information is essential.

Normally data gathered during a trial are published after the trial. However the dynamic nature of COVID-19 vaccine development and the global impact of this pandemic have already changed what may be considered normal. Added to this is information that is leaking out. The Oxford trial has recommenced on the advice of an independent safety committee. AstraZeneca announced that they “had not confirmed a diagnosis” of transverse myelitis in the study volunteer.

What has also recently become apparent is that the study was paused in July after a male volunteer who had received one dose of the vaccine developed transverse myelitis. See page 10 of this participant information sheet. There was a review by independent experts. The trial resumed after it was determined that the individual had a previously undiagnosed case of multiple sclerosis unrelated to the vaccine. Still, there was a persistent concern that AstraZeneca had not revealed in detail what had happened to the woman whose significant neurological symptoms led to the most recent trial pause.

On the September 14th edition of The Health Report Dr. Norman Swan interviewed Professor Bruce Neal, Executive Director of the George Institute Australia. The occasion was to discuss the launch of a project called Join Us. A challenging issue about Phase III trials is that drug or vaccine development may stall or fail due to lack of suitable participants. This isn’t due to drop out or resistance. Rather the cost and administrative difficulty of finding suitable participants is significant. Join Us aims to secure pre-consent to trials of a certain nature.

Whilst that’s interesting information about trials, Swan also asked Professor Neal about his thoughts on the reluctance of AstraZeneca to reveal details about the woman responsible for the second pause of the Phase III trial. Neal considered reasons to release more information. It would give a heads up to other researchers around the globe allowing them to “provide input and information into it”. However he also noted that releasing such information midway through a trial may have negative consequences.

There may be confidentiality issues as such a “severe unusual event” might lead to patient identity being leaked. Perhaps most interestingly was the observation that the trial may well end with a conclusion that the event was not an issue related to the vaccine. By then the damage is done. The public have already internalised the notion of a negative side effect. The media effort to reverse that belief is not likely to be successful.

Professor Neal stated;

And so the media surrounding the announcement of something like that is going to retain much more prominence probably than the media that tries to reel that back in and say, look, actually it wasn’t an issue. And that could have ramifications down the track when you try to get people to take the vaccine.

It’s important to note that the FDA has not allowed the AstraZeneca trial to resume in the US. The National Institutes of Health stated that it remains to be seen if the illnesses are coincidental and that, “pausing to allow for further evaluation is consistent with standard practice”.

Understandably some health professionals in the US remain concerned. Whilst investors were told of the second problem it has become clear that the company did not immediately alert the F.D.A. and advise them of the independent safety board’s recommendation to pause the trial. Virologist Dr. Peter Jay Hotez based at Houston’s Baylor college of Medicine has not been impressed. He claimed communication has been “horrible and unacceptable” citing the failure of UK regulators to provide rationale for resumption of the trial.

The New York Times also reported;

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the F.D.A.’s advisory committee on vaccines, said that it’s unclear how the company — or the U.K. government — determined that the second case was not related to the vaccine.

Offit has also noted that the rarity of transverse myelitis in the general public has not been reflected in the UK trial population. The extra caution we are seeing in the US is reason for the public to have increased confidence in the influence regulators have over the safety of vaccine trials. Consequently there is reason for the public to be less anxious about the safety of COVID-19 vaccines that are eventually marketed. Given that independent safety experts in the UK have advised it is safe for the Oxford trial to resume it will be very interesting to see what further evaluation by US authorities concludes.

There has been research into immunisation and the likelihood of subsequent development of transverse myelitis (TM) and acute disseminated encephalomyelitis (ADEM). Key points from the 2016 paper Acute Demyelinating Events Following Vaccines: A Case-Centered Analysis are as follows;

Results: Following nearly 64 million vaccine doses, only 7 cases of TM and 8 cases of ADEM were vaccinated during the primary exposure window 5-28 days prior to onset. For TM, there was no statistically significant increased risk of immunization. For ADEM, there was no statistically significant increased risk following any vaccine except for Tdap (adolescent and adult tetanus, reduced diphtheria, acellular pertussis) vaccine. […]

Conclusions: We found no association between TM and prior immunization. There was a possible association of ADEM with Tdap vaccine, but the excess risk is not likely to be more than 1.16 cases of ADEM per million vaccines administered.

Acknowledging vaccine safety concerns as a cause of vaccine hesitancy, in July this year Nicola Principi and Susanna Esposito published a narrative review, Do Vaccines Have a Role as a Cause Of Autoimmune Neurological Syndromes?

The authors wrote in part in their abstract;

Only well-conducted epidemiological studies with adequate evaluation of results can clarify whether a true association between vaccines and adverse event development truly exists. Autoimmune neurological syndromes that follow vaccine use are among these. […]

Literature analysis showed that most of the associations between vaccines and nervous system autoimmune syndromes that have been reported as severe adverse events following immunization are no longer evidenced when well-conducted epidemiological studies are carried out. Although the rarity of autoimmune diseases makes it difficult to strictly exclude that, albeit exceptionally, some vaccines may induce an autoimmune neurological disease, no definitive demonstration of a potential role of vaccines in causing autoimmune neurological syndromes is presently available. Consequently, the fear of neurological autoimmune disease cannot limit the use of the most important preventive measure presently available against infectious diseases.

The Institute for Vaccine Safety at Johns Hopkins University logically argues that a number of vaccines “may prevent transverse myelitis”. The institute published Do Vaccines Cause Transverse Myelitis? Last updated September 18th 2020 the article opens with the conclusion;

Natural viral infections with influenza, hepatitis A, measles, mumps and rubella and varicella have all been associated with myelitis, albeit rarely. Thus, these viral vaccines may prevent transverse myelitis by protecting against natural infection. Vaccines currently routinely recommended to the general population in the U.S. have not been shown to cause transverse myelitis.

Ultimately this research in conjunction with the cautious US approach at present does not support a contention of general recklessness in the production of this vaccine or of other potential COVID-19 vaccines.

This dynamic provides yet another blow to anti-vaccination conspiracies. Namely the contention that there is collusion between drug companies and health regulators to suppress the supposedly inherent dangers of vaccines that anti-vaxxers wrongly insist lead to an abundance of vaccine injuries. More so Dr. Paul Offit has been derided, verbally attacked and threatened by the global anti-vaccine lobby for many years as a callous profiteer of vaccines. Yet he has constantly raised a voice of caution to ensure safe COVID-19 vaccine development.

It is certain that placing the AstraZeneca trial on hold following advice from the F.D.A. is not a unique event. Rather the fact that measures employed to control the current pandemic are being played out before the public in real time has provided insight into events that are usually ignored. In the previous post I listed some other aspects of anti-vaccine conspiracy that simply cannot be sustained following media reports of the AstraZeneca/Oxford Phase III trial pause. Even cursory attention to the details of this trial has exposed the dishonesty of anti-vaxxer claims.

Well before the trial pause led to media attention, public anxiety and now transparency of drug companies, the importance of trust in accepting a COVID-19 vaccine had been raised in Australia. Prime Minister Scott Morrison made a significant mistake with respect to public confidence in vaccine development and uptake. In August he announced that Australia had signed a deal to produce the vaccine being developed at Oxford University if Phase III trials were successful.

His mistake was to add that it would be “as mandatory as you can possibly make it”. Morrison realised the mistake and in under a day had produced the anticipated walk back. Nonetheless the many anti-science and anti-reason groups that are feverishly misrepresenting the motives of governments and health authorities during this pandemic were delighted. Within hours of Morrison’s announcement the AVN published a video mocking the notion of “safe and effective” vaccines whilst contending they “had always known this was coming”.

There were of course no “walk backs” from the AVN when Morrison corrected his position. Pushing fear of mandatory vaccination has always translated to profit for this group and Scott Morrison had done them a favour. Say no to mandatory vaccination read the back of a T-Shirt weeks later in Perth during Australia-wide “solidarity” rallies. Messages on social media continue in the same vein. Still, the reality is that messages and memes on mandatory vaccination would be common had Scott Morrison made no such statement.

Any harm done to the uptake of a COVID-19 vaccine in Australia is likely negligible. A survey conducted in April found that just under 86% of Australians aged over 18 would get a COVID-19 vaccine. 4.9% would not whilst 9.4% were indifferent. These figures are promising but were collated before the widely publicised pause in the AstraZeneca trial and increased public reflection on the safety of a COVID-19 vaccine. Survey responses were to the statement, If a COVID-19 vaccine becomes available, I will get it.

Ipsos published their global attitudes results on September 1st, indicating an 88% uptake of a COVID-19 vaccine in Australia. 59% strongly agree and 28% somewhat agree with the statement, If a vaccine for COVID-19 were available, I would get it. Only China and Brazil were more likely to accept a vaccine. These figures were also collated before the pause in the AstraZeneca trial. Follow this link to read Key Findings for Australia.

Another area that’s causing anxiety is the posturing of Donald Trump toward authorising a COVID-19 vaccine before the upcoming election. Consider the measure of Trump for a moment. He will tempt the voters with the promise of a vaccine in weeks. However it is more realistic to expect a safe and effective COVID-19 vaccine in months. These promises demand a disregard for vaccine safety. Yet in March 2014 Trump was tweeting in support of the mythical vaccine/autism link, a bogus view that bemoans a lack of vaccine safety. After the last election, research fraud and vaccine/autism profiteer Andrew Wakefield attended an inaugural ball from which he posted a social media video calling for an overhaul of the CDC.

Others have long ago considered the measure of Trump in regard to the election and a COVID-19 vaccine promise. In early June University of Pennsylvania professors Dr. Paul Offit and Dr. Ezekiel Emanuel wrote an opinion piece in The New York Times entitled Could Trump turn a vaccine into a campaign stunt?

It included;

In a desperate search for a boost, he could release a coronavirus vaccine that has not been shown to be safe and effective as an October surprise. […]

Given how this president has behaved, this incredibly dangerous scenario is not far-fetched. In a desperate search for a political boost, he could release a coronavirus vaccine before it had been thoroughly tested and shown to be safe and effective. […]

Thousands of Americans have already died as Donald Trump has perpetually postponed effective public health interventions and made poor therapeutic recommendations. We must be on alert to prevent him from corrupting the rigorous assessment of safety and effectiveness of Covid-19 vaccines in order to pull an October vaccine surprise to try to win re-election.

At the beginning of the second week of September the CEOs of nine drug companies, arguably competing in the development of a COVID-19 vaccine, signed a pledge to stand with science and not launch such a vaccine until it met “high ethical standards and sound scientific principles”. The pledge statement as it appears on Pfizers website is in references below. It came at a time when public health specialists and scientists expressed concern that the Trump administration was pressuring regulators to authorise a vaccine before the November 3rd election.

The New York Times reported;

The joint statement by competitors was seen as an effort to restore public trust as President Trump has pushed for a vaccine before the presidential election.

An out-take from the pledge from Pfizer’s website is as follows;

Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

  • Always make the safety and well-being of vaccinated individuals our top priority.
  • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
  • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
  • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.

Yes to the cynical eye this may seem to present the pharmaceutical CEOs as really great guys. However I recommend reading the entire Biopharma Leaders Unite pledge. More to the point with increased transparency the public and the media have an invested interest to see a suitable outcome here. This pledge is certainly a step up from Fauci saying he has “confidence and some faith” that the COVID-19 vaccine approval won’t be political.

Earlier in the year it was reported that a significant number of Americans are likely to refuse a COVID-19 vaccine. A robust anti-vaccination lobby and rising numbers of the vaccine hesitant mean that the number of Americans who accept the vaccine may be insufficient to sustain herd immunity, which may require between 50 – 70% of the population to be immune. The more recent Ipsos survey found 67% of US citizens would have the vaccine.

Exactly how many must be vaccinated to achieve herd immunity is still uncertain. The WHO suggest 95%. Mathematical modelling reflecting age and social activity level produces a herd immunity “illustration” as low as 43%. Other reports suggest a vaccine uptake of over 70% is needed. The Mayo clinic point out that reaching this level of immunity through infection and not vaccination would overwhelm the health system and cause millions of deaths.

Thus there is ample reason to hope greater transparency of vaccine trials leads to justified improved confidence in the safety and efficacy of COVID-19 vaccines and increased uptake. Of course given the speed of current COVID-19 vaccine trials let us also hope that the vaccines that make it to market are extremely safe and splendidly effective. The fewer challenges that accompany immunisation on a global scale the better.

Another area that is getting more scrutiny if not exactly transparency is that of vaccine nationalism. This term refers to agreements between governments and vaccine manufacturers that ensure developed nations have secure access to vaccines for their entire population before they are available for other nations. With COVID-19 this may result in a delay in vaccinating health workers in developing nations, individuals at high risk of severe disease or death and those living in a region of a sudden dangerous cluster.

COVID-19 is a global pandemic. Yet we are faced with a situation where wealthy nations will be able to vaccinate their populations whilst countries that rely on aid organisations will be unable to vaccinate health workers and at-risk populations without organised help. A recent Science Friction podcast looks at the ways in which this problem can be combated. Australia’s Friends of Science in Medicine actively support equitable access to “COVID-19 vaccines and related health technologies”.

No doubt the anti-vaccine lobby will use information in the trial protocols in the same way they use vaccine package inserts. Thanks to exceptional cognitive dissonance they will list reasons as to why information from vaccine manufacturers can’t be trusted whilst using that same information to defend these reasons. The good news is that as we’ve seen, increased transparency and media attention has exposed tenets of anti-vaccine conspiracy and beliefs as vacuous and fallacious. On these points it’s a case of watch this space.

In conclusion it can be seen that the increase in transparency of COVID-19 vaccine development should indeed serve to increase public trust and confidence in the quality of eligible vaccines. I cannot finish without stressing again that the safety and efficacy elements of Phase III trials do not apply to the raft of concoctions marketed as alternatives to medicine. All consumers should seek reputable sources of information and beware of the many hoax “cures” of COVID-19. Discuss any novel plans to manage or prevent COVID-19 with a registered medical practitioner.

Finally whilst the importance of transparency with respect to vaccine trials has become clear, it was also confirmed by the Ipsos global survey on attitudes to a COVID-19 vaccine. The most common reasons for intending to refuse a vaccine are safety followed by efficacy. The establishment of which is the very aim of Phase III trials.


REFERENCES

Phase 3 clinical trial of investigational vaccine for COVID-19 begins

Moderna Clinical Trial Protocol – SARS-CoV-2 vaccine

Pfizer Clinical Trial Protocol – SARS-CoV-2 RNA vaccine

AstraZeneca Clinical Trial Protocol – COVID-19 vaccine

Oxford Vaccine Trials – Participant Information Sheet: COV002 (July 2020)

Oxford Vaccine Trials – Participant Information Sheet: COV002 (Sept. 2020)

Willingness to vaccinate against COVID-19 in Australia

9 in 10 Australians say they would get vaccinated for COVID-19 – Ipsos

Global attitudes on a COVID-19 vaccine – Ipsos [PDF]

A future vaccination campaign against COVID-19 at risk of vaccine hesitancy and politicisation

Biopharma Leaders Unite To Stand With Science – Pfizer

Moderna and Pfizer reveal secret blueprints for coronavirus vaccine trials – NYT

AstraZeneca under fire for vaccine safety releases trial blueprints – NYT

Do Vaccines Cause Transverse Myelitis? – Institute for Vaccine Safety, John Hopkins University Dept. of International Health

Acute demyelinating events following vaccines: a case-centered analysis
– DOI: 10.1093/cid/ciw607

Do vaccines have a role as a cause of autoimmune neurological syndromes?
– DOI: 10.3389/fpubh.2020.00361

FSM supports equitable access to COVID-19 vaccines

Vaccine nationalism threatens global plan to distribute COVID-19 shots fairly

The rise of vaccine nationalism – should we be worried? – ABC Podcast

Herd Immunity: Understanding COVID-19 – DOI: 10.1016/j.immuni.2020.04.012

Call to action on anti-vaccination bus tour

© Australian Skeptics Inc.

By Tim Mendham

July 19th 2020

Australian Skeptics has issued a warning and call to action to Australian media, medical professionals, and local councils regarding the current anti-vaccination ‘revival’ tour of rural and regional Australia:

VAXXED Bus
Delivers COVID-19 Conspiracies and Bad Advice

The so-called “VAXXED” bus is currently touring Australia, spreading misinformation about vaccination at local ‘revival-style’ meetings, often in regional venues owned or managed by local councils or schools. This big black bus carries the logo of the “Australian Vaccination-risks Network” (AVN), an organisation whose leaders have:
● Claimed COVID-19 is nothing more than a bad cold.(1)
● Encouraged people to take photos in hospitals to show COVID-19 is not serious.(2)
● Discouraged face masks for COVID-19 and stated temperature testing is crazy and stupid.(3)
● Likened vaccination to rape.(4)
● Claimed microchips could be injected into the population via vaccines.(5)
● Promoted the falsehood that contrails from aircraft – which they call “Chemtrails” – are used to poison the population.(6)
● Spread the discredited falsehood that vaccines lead to autism.(7)
● Propagated the myth that SIDS and the fatal injuries suffered by some babies who were shaken to death are really the results of vaccines.(8)

With the recent resurgence of COVID-19 in parts of the country, now is not the time to have anyone spread disinformation about the pandemic or vaccine preventable diseases. It is clear from their own statements that the organisers of this tour do not take the threat of COVID-19 seriously.

In 2014, the NSW Health Care Complaints Commission issued a public warning against this organisation, stating in part:

Warning – The Commission has established that AVN does not provide reliable information in relation to certain vaccines and vaccination more generally. The Commission considers that AVN’s dissemination of misleading, misrepresented and incorrect information about vaccination engenders fear and alarm and is likely to detrimentally affect the clinical management or care of its readers.(9)

MEDICAL PROFESSIONALS: Should be aware that the VAXXED Bus may be visiting their area. This will mean that current and potential patients may be exposed to dangerous misinformation that can have deleterious if not fatal consequences. Anti-vaccine messages should be actively resisted, and we encourage local medical professionals to take a stand on this issue, either via local media, social media or whatever public avenues exist in their area.

MEDIA: We advise the media to take great care when covering the VAXXED Bus and the Australian Vaccination-risks Network. They use the tactic of “tell both sides of the story”, also known as “False Balance”, a misrepresentation that the ABC’s Media Watch has covered with regard to this organisation in 2012(10). The media are advised to focus on the more bizarre conspiracy theories propagated, but are under no obligation to give this group the oxygen they seek.

LOCAL COUNCILS: Should consider very carefully the possible consequences of hiring out venues to this organisation. With parts of regional Australia recording a worrying low level of vaccination in a time of a global pandemic, encouraging parents not to vaccinate their children is irresponsible.

“We have one of the safest outcomes when it comes to preventable diseases in the world, because of our strong immunisation program, and anti-vaxxers should just butt out. Vaccination has saved lives, it’s safe, it’s effective and anyone that tried to create any other discussion against it is really trying to harm the Australian public”
– Australian Medical Association President Dr Tony Bartone (Radio 2GB 20/04/2020)

“…there has been somewhat of an upsurge in paranoid and sort of unhinged behaviours.”
– AMA state president (SA) Dr Chris Moy (ABC NEWS 21/05/2020)

“It is concerning that the reports that I have received are that some people believe that coronavirus is a conspiracy or that it won’t impact on them.”
– Victoria’s Health Minister Jenny Mikakos (7 News July 2020)

References

1. The Australian Vaccination-risks Network is one group which has moved to downplay the significance of coronavirus, with spokeswoman Meryl Dorey saying the virus “is just the common cold”. “The cold can kill anyone if they’re sick to begin with and coronavirus is no different,” she said on a Facebook video on Sunday. She said people have been “fooled” by a “fear campaign on the silly sheep media”.
https://7news.com.au/lifestyle/health-wellbeing/anti-vaxxers-downplay-common-cold-like-coronavirus-amid-fears-of-forced-vaccinations-c-725089

2. Dorey questioned the COVID-19 pandemic saying: “Are you being lied to?” Requesting that followers “take your phones and pop into the local hospital” and “Let us know how crowded it is — or is not. Is coronavirus really overwhelming our nation or is our nation overwhelming us with lies and killing our economy and us?”
Hansen, Jane (3 April 2020). “Anti-vaxxers deny COVID-19 pandemic, urge others to ignore isolation advice”. The Sunday Telegraph. Sydney NSW.

3. On Face Masks for COVID-19: “… a piece of cheese cloth… something with lots and lots of holes in it is the best to wear.”
On Temperature Testing for COVID-19: “…. temperature testing, that’s just crazy….” “It is so stupid. It just shows the extent of stupidity that our government, our medical community and our media are displaying.”
Meryl Dorey, Under the Wire – https://www.bitchute.com/video/K77QIp3HJQyP (49min 20sec mark)

4. A controversial anti-vaccination group has likened vaccines that prevent disease to rape, drawing condemnation even from some its own supporters.
https://www.smh.com.au/national/australian-vaccination-skeptics-network-compares-vaccines-to-rape-20150422-1mr0wk.html

5. “The next and most logical step is the use of microchips which will contain all of the same information contained on smart cards but which will be injected into us and read and updated from a distance.”
http://web.archive.org/web/20010406083421/avn.org.au/big.htm

6. “The number of chemtrails sprayed over the #CDCWhistleblower #VAXtruth rally was shocking! Many of the protesters were sickened. Stop it NOW!”
Twitter @nocompulsoryvac – 1:15am – 27 Oct 2016

7. Meryl Dorey: “All vaccinations in the medical literature have been linked with the possibility of causing autism, not just the measles/mumps/rubella vaccine.”
https://www.abc.net.au/mediawatch/episodes/false-balance-leads-to-confusion/9973912

8. Anti-vaxxers come up with their most abhorrent lie yet. – “So Shaken Baby Syndrome again, like SIDS, is a waste basket. It is a way of blaming the family for what may have been caused by the medical community.”
https://www.mamamia.com.au/avn

9. The NSW Health Care Complaints Commission – Public statement – warning about the Australian Vaccination-skeptics Network, Inc. (‘AVN’), formerly known as Australian Vaccination Network Inc.
https://tinyurl.com/p6o4yy8

10. False balance leads to confusion (Media Watch ABC October 2012) https://www.abc.net.au/mediawatch/episodes/false-balance-leads-to-confusion/9973912

For reliable information about COVID-19: https://www.health.gov.au
For reliable information about vaccination: https://www.health.gov.au/health-topics/immunisation


Once again please note this post is © Australian Skeptics and the original can be sourced here.

In 2015 Bill Gates advised on the need to prepare for a global pandemic

In 2015 Bill Gates gave a TED Talk on the importance of preparedness for a global pandemic caused by “a highly infectious virus”.

An Ebola epidemic that began in December 2013, and continued until 2016, had by that time killed around 10,000 people in West Africa. Gates cites three reasons as to why there weren’t more deaths. 1.) The selfless work by front line health workers including locating infected persons and preventing further spread (see Contact Tracing below). 2.) Ebola is not an airborne virus and by the time those who are infected become contagious, most are so ill as to be bedridden. 3.) The virus did not reach many urban areas and this directly kept the number of cases lower than had Ebola spread throughout urban communities.

Yet he also refers to what he calls “a global failure”. Noting the slowness of response. The failure to study treatment approaches, diagnostics and the application of epidemiological and medical tools.

In what has been shown to be an uncomfortably prescient statement Gates notes;

So next time, we might not be so lucky. You can have a virus where people feel well enough while they’re infectious that they get on a plane or they go to a market.

Gates uses the Spanish Flu of 1918 to demonstrate how quickly an airborne virus can spread. He observes that the World Bank have estimated that a global flu epidemic will cause a drop in global wealth of “over three trillion dollars” and there would be “millions and millions of deaths”.

It’s important to note that the present reality with COVID-19 is not absolutely reflected in Gates’ TED Talk. Trends of global financial impact have not yet played out. Total fatalities will be disturbing and many may lose friends and loved ones, yet the prediction of “millions and millions” of deaths is not a current reality.

Nonetheless the reason that the capacity to reduce morbidity and mortality – to flatten the curve – is in our hands is indeed touched on by Gates. Just after the five minute mark he speaks of our ability to use certain tools to create an effective response system. Science and technology. The use of cell phones to inform the public. Satellite maps to inform on the movement of people. Advances in biology and research that will support rapid turnaround of drugs and vaccines to fit the pathogen responsible for the pandemic.

As I touched on above another factor discussed but not labelled as such by Gates, that is presently more robustly employed to reduce the spread of COVID-19 is Contact Tracing. Gates talks about locating infected persons and preventing further spread. In May 2017 African Health Sciences published a review of contact tracing in containing the 2014 Ebola outbreak. However with an airborne coronavirus this has proven, as expected, to be enormously more complicated.

At the time of writing there exists a spectrum of tactics in various countries, with some considered invasive to privacy. Israel has passed emergency laws to allow its security agency, Shin Bet to tap peoples phones without a warrant.

According to the Computational Privacy Group in the case of Singapore (using TraceTogether), Taiwan and South Korea this involves using cell phones and dedicated software in the;

…recording [of] close proximity between people using Bluetooth, WiFi, or GPS data, [which] could help efficiently notify people that they have earlier been in contact with someone now diagnosed with coronavirus and should self-isolate

The CPG have published Can we fight COVID-19 without resorting to mass surveillance? which looks at both location data and contact tracing in different regions, and the technology used.

Reports in Australia have suggested that tracking the public through their phones has been considered and that the federal government is “looking to Singapore” and the TraceTogether app. Victoria’s Department of Health and Human Services has expanded contact tracing to include use of the messaging platform Whispir.

IT News reports;

The department will begin using the cloud-based platform from Thursday to regularly interact with those that have come into close contact with someone who has contracted COVID-19.

The platform, which will automate interactions between the department and select individuals, will also be used to enforce self-isolation for Victorians who have confirmed cases of the virus.

Gates was more than reasonably accurate in predicting our response. Presented without exact figures from the epidemiology and pathology of the infectious agent Gates’ description of how we could and would respond deserves high marks.

Presently we are witnessing the application of the tools at our disposal to flatten the curve of morbidity and mortality. We know that only an effective vaccine can break the back of the pandemic as it now exists. Drugs that target specific symptoms and slow or prevent the impact on COVID-19 comorbidity are greatly needed. The use of cell phone apps to both inform and trace the public is well underway.

Most importantly we have accepted that staying at home, social distancing and increasingly reducing the number of people together in public, together with effective hand washing and smothering of coughs or sneezes are vitally effective measures. Some of these measures should be employed every flu season and it’s hoped we will continue to do just that.

One imagines we will be better prepared in future for the emergence of another pandemic. Gates was right in that we needed to prepare. We see that clearly now in the need for hospital beds, ventilators and other medical equipment. He also noted the necessity of strong health systems in poor countries and presently the need for increased funding in developing nations is a reality. [AlJazeera news video]

To finish off perhaps we should focus on what Gates observed at the end of his talk;

So I think this should absolutely be a priority. There’s no need to panic. We don’t have to hoard cans of spaghetti or go down into the basement. But we need to get going, because time is not on our side.

In fact, if there’s one positive thing that can come out of the Ebola epidemic, it’s that it can serve as an early warning, a wake-up call, to get ready. If we start now, we can be ready for the next epidemic.

Of course we were not utterly unprepared for a pandemic. Far from it. There are global and national agencies throughout the world that focus on both the risk of a viral pandemic and how we can best prepare. Developing nations are closely monitored by organisations such as the WHO and the UN. Still the lack of any treatment or vaccine to prevent COVID-19 has proven to be an enormous hurdle.

Developed nations are in a better position to fund and respond to recommendations. Australia has a Health Management Plan for Pandemic Influenza, last updated in August 2019. The UK has its Pandemic Contingency/Major Infectious Diseases Outbreak Plan. Similar plans exist around the world.

An interesting dynamic in the USA at present is whilst President Trump has criticised the CDC for its response to coronavirus, he had from 2018 cut their budget for global disease management and closed government units dedicated to preventing pandemics.

Trump’s administration has also cut similar funding for the National Security Council (NSC), Department of Homeland Security (DHS), and Health and Human Services (HHS). Other cuts to CDC funding used to manage chronic disease are scheduled for 2021 and as yet have not been approved by Congress. Perhaps justifiably Trump has come under scorn for his approach to the coronavirus outbreak.

Funding for the prevention of pandemics is an essential part of a solid public health budget. Without a doubt these budgets should be designed with input from scientists. By shirking reason and evidence in their pursuit of “alternative facts” and a post truth world, the Trump administration had maneuvered itself into an increasingly perilous position.

One hopes that as we move toward the future and find ourselves past the COVID-19 pandemic that we aim to listen to the evidence, learn from the past and prepare for pandemics we cannot yet predict.


 

————————————

 

TRANSCRIPT

00:17
When I was a kid, the disaster we worried about most was a nuclear war. That’s why we had a barrel like this down in our basement, filled with cans of food and water. When the nuclear attack came, we were supposed to go downstairs, hunker down, and eat out of that barrel.

00:37
Today the greatest risk of global catastrophe doesn’t look like this. Instead, it looks like this. If anything kills over 10 million people in the next few decades, it’s most likely to be a highly infectious virus rather than a war. Not missiles, but microbes. Now, part of the reason for this is that we’ve invested a huge amount in nuclear deterrents. But we’ve actually invested very little in a system to stop an epidemic. We’re not ready for the next epidemic.

01:20
Let’s look at Ebola. I’m sure all of you read about it in the newspaper, lots of tough challenges. I followed it carefully through the case analysis tools we use to track polio eradication. And as you look at what went on, the problem wasn’t that there was a system that didn’t work well enough, the problem was that we didn’t have a system at all. In fact, there’s some pretty obvious key missing pieces.

01:51
We didn’t have a group of epidemiologists ready to go, who would have gone, seen what the disease was, seen how far it had spread. The case reports came in on paper. It was very delayed before they were put online and they were extremely inaccurate. We didn’t have a medical team ready to go. We didn’t have a way of preparing people. Now, Médecins Sans Frontières did a great job orchestrating volunteers. But even so, we were far slower than we should have been getting the thousands of workers into these countries. And a large epidemic would require us to have hundreds of thousands of workers. There was no one there to look at treatment approaches. No one to look at the diagnostics. No one to figure out what tools should be used. As an example, we could have taken the blood of survivors, processed it, and put that plasma back in people to protect them. But that was never tried.

02:53
So there was a lot that was missing. And these things are really a global failure. The WHO is funded to monitor epidemics, but not to do these things I talked about. Now, in the movies it’s quite different. There’s a group of handsome epidemiologists ready to go, they move in, they save the day, but that’s just pure Hollywood.

03:22
The failure to prepare could allow the next epidemic to be dramatically more devastating than Ebola. Let’s look at the progression of Ebola over this year. About 10,000 people died, and nearly all were in the three West African countries. There’s three reasons why it didn’t spread more. The first is that there was a lot of heroic work by the health workers. They found the people and they prevented more infections. The second is the nature of the virus. Ebola does not spread through the air. And by the time you’re contagious, most people are so sick that they’re bedridden. Third, it didn’t get into many urban areas. And that was just luck. If it had gotten into a lot more urban areas, the case numbers would have been much larger.

04:17
So next time, we might not be so lucky. You can have a virus where people feel well enough while they’re infectious that they get on a plane or they go to a market. The source of the virus could be a natural epidemic like Ebola, or it could be bioterrorism. So there are things that would literally make things a thousand times worse.

04:39
In fact, let’s look at a model of a virus spread through the air, like the Spanish Flu back in 1918. So here’s what would happen: It would spread throughout the world very, very quickly. And you can see over 30 million people died from that epidemic. So this is a serious problem. We should be concerned.

05:04
But in fact, we can build a really good response system. We have the benefits of all the science and technology that we talk about here. We’ve got cell phones to get information from the public and get information out to them. We have satellite maps where we can see where people are and where they’re moving. We have advances in biology that should dramatically change the turnaround time to look at a pathogen and be able to make drugs and vaccines that fit for that pathogen. So we can have tools, but those tools need to be put into an overall global health system. And we need preparedness.

05:41

The best lessons, I think, on how to get prepared are again, what we do for war. For soldiers, we have full-time, waiting to go. We have reserves that can scale us up to large numbers. NATO has a mobile unit that can deploy very rapidly. NATO does a lot of war games to check, are people well trained? Do they understand about fuel and logistics and the same radio frequencies? So they are absolutely ready to go. So those are the kinds of things we need to deal with an epidemic.

06:13
What are the key pieces? First, we need strong health systems in poor countries. That’s where mothers can give birth safely, kids can get all their vaccines. But, also where we’ll see the outbreak very early on. We need a medical reserve corps: lots of people who’ve got the training and background who are ready to go, with the expertise. And then we need to pair those medical people with the military. Taking advantage of the military’s ability to move fast, do logistics and secure areas. We need to do simulations, germ games, not war games, so that we see where the holes are. The last time a germ game was done in the United States was back in 2001, and it didn’t go so well. So far the score is germs: 1, people: 0. Finally, we need lots of advanced R&D in areas of vaccines and diagnostics. There are some big breakthroughs, like the Adeno-associated virus, that could work very, very quickly.

07:21
Now I don’t have an exact budget for what this would cost, but I’m quite sure it’s very modest compared to the potential harm. The World Bank estimates that if we have a worldwide flu epidemic, global wealth will go down by over three trillion dollars and we’d have millions and millions of deaths. These investments offer significant benefits beyond just being ready for the epidemic. The primary healthcare, the R&D, those things would reduce global health equity and make the world more just as well as more safe.

07:55
So I think this should absolutely be a priority. There’s no need to panic. We don’t have to hoard cans of spaghetti or go down into the basement. But we need to get going, because time is not on our side.

08:09
In fact, if there’s one positive thing that can come out of the Ebola epidemic, it’s that it can serve as an early warning, a wake-up call, to get ready. If we start now, we can be ready for the next epidemic.

08:26
Thank you.