Vaccination Part 4 : The ‘Science Says’ Myth

This is the fourth time I have blogged on the subject of vaccination, the last three all being in 2015 when the Australian Federal and State Governments started approving ‘No Jab No Play’ and ‘No Jab No Pay’ legislation following a Murdoch Media campaign and even using the Murdoch’s language.

The blog has been inspired by recent activity in Australia with another Australian State namely South Australia proposing to adopt ‘No Jab No Play’ legislation that bans unvaccinated children from preschool and day care centres, and some controversy as the movie Vaxxed has been screened at public showings around Australia.

What concerns me is the ignorance of many of the public commentators who quote the matter as settled by science, without actually quoting any science. Far too few people actually understand what science is and can do, and I’d like to simply throw some light onto that subject, so that ignorant public figures can no longer get away with using science as a sledge hammer without actually quoting or understanding any science.

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My Position is Pro-Truth

My first blog on the subject went absolutely viral generating 30,000 views, or more than 1 in 1,000 Australians, plus thousands of international readers. The reason it went viral is that after years of a vaccine war in Social Media where you were either classified yourself as Pro-Vaccine or Anti-Vaccine, and where the abuse between the two camps was truly ugly, I proposed that we all need to stop digging into trenches and taking sides, and actually seek truth, because the truth is it is a very long way from a black and white issue.

The message came at the right time and atypically for the subject, I got very little debate from anyone, which is rare on this subject.

On today’s subject I remain in the Pro-Truth camp. I am not writing this blog to attack the Pro-Vax camp, but I will say they are the most guilty of regularly quoting science without actually quoting any science. My objective is for this field to be one where there is far more rational discussion, and far less propaganda and one sided communication.

My Credentials to offer an opinion

The perspective I bring to this subject is as a former Senior Executive in the Medical and Science space for 15+ years, variously as a Chief Financial Officer, Chief Operating Officer, and for a time as a Vice President with Product Commercialisation responsibilities. While my university and post-graduate training was in business, leadership, and governance, rather than science, my roles were always very broad and operational and thus I was immersed and swimming around in science for the 15+ years I was in the industry. I have chaired a committee that in record time developed and worked with the US FDA to release a West Nile Virus ELISA Test in time for the 2003 summer, I’ve lead teams seeking US FDA and Australian TGA Clearance for Medical Products and sat across the table in those meetings from FDA and TGA Technical Staff. I’ve read hundreds of peer reviewed scientific publications in the fields we operated in.

Equally importantly and bringing perhaps a perspective most people don’t have, I have had the commercial responsibilities working with CEO’s and other VPs in the businesses to launch medical products in markets, and seen the IP Strategies, market strategies, and the influence these things have on the science. I’ve negotiated the contracts with University Commercialisation entities, and Consulting Contracts with Professors.

But aside form these two things I am a person with an intellect and a good dose of common sense, and that is all you need to see through the propaganda from both sides of the vaccine war.

Recent Events

Lets take a look at an example of some of the types of reporting and commentary that gives rise to my concerns. There are many examples, but I want to get to the meat of our subject, namely science.

In a propoganda video placed at the start of a News Corporation (Murdoch’s) article on the South Australian Legislation the video concludes with a statement that “Health Authorities say the actual risks are very small, about 3 in 10,000 Children given the Measles, Mumps and Rubella vaccine developed short lived side effects.”

If you go the the actual package insert for Merck’s MMRII vaccine, that regulators require as part of any approval, it’s mandated Adverse Effects section on Page 6, 7 and 8 includes as well as many other risks “Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals (see CONTRAINDICATIONS).” Among the more extreme other adverse reactions reported are Encephalitis, Aseptic Meningitis, and Acute hemorrhagic edema of infancy.

If you read my third blog on this subject Vaccination Part 3 : Vaccine Injury, a rare glimpse of the tip of the iceberg and watch the video of a Congressional Briefing on Vaccine Damages, you will see two things, the Vaccine Court in the US deals with extreme Adverse Reactions including death, and go to great lengths to deny causation as much as they can,  as the government is responsible for damages claims having exempted vaccine manufacturers from legal liability.

It seems to me that at the very least death is more than a short lived side effect, and the regulators consider it a real enough relationship to the vaccination event to mandate it’s inclusion in the package insert, yet in the public commentary it becomes inconvenient data that is swept aside.

To look at some actual data from the National Vaccine Injury Compensation Program, on Page 5 of the Report that indicates how many injuries and how many deaths have been the subject of compensation claims (which is only those who have taken legal action, and excludes those who have not). There were a total of 17,097 Compensations Claims for Injury, and 1,232 for death for the period summarised between 1st Oct 1988 and 5th July 2017. Of those deaths 61 followed an MMR vaccination that the Murdoch video portrays as having only “short lived side effects”.

If you review the claims accepted by the vaccine court they didn’t share the data of what proportion of the deaths damages claims were accepted, my bet would be a very high percentage as the degree of damage is irrefutable. For MMR of cases concluded 296 were accepted and 555 Dismissed, which in no way means the dismissed cases were proven false, the burden of proof in vaccine court is very high as was covered in Part 3 of my Blog Series on Vaccination.

What the vaccine court outcomes show is that the deaths classified in Vaccine Product Inserts as “a causal relationship has not been established”, in the vaccine court in many cases have accepted a causal relationship sufficient to pay out damages in a court that shows a reluctance to do so.

That says to me that saying “Science says vaccines are safe” might not be supported by the data. Clearly the death rate is low, however the death rate is being obscured, and pretended away, using meaningless “Science Says Propaganda”. If your argument is some people die by vaccine, but more are saved, then make that argument, but don’t lie, and then legislate away the right of a parent to make a choice.

What is Science?

As I’ve said, the thing I take issue with is the broad generalisations like “The science is settled, vaccines are safe”.

So, lets look at what science is, and what science can tell us.

The Oxford Dictionary defines Science as follows: “The intellectual and practical activity encompassing the systematic study of the structure and behaviour of the physical and natural world through observation and experiment.”

It seems relevant too, to look at the Scientific Method, which wikipedia defines in summary as follows: “The scientific method is a body of techniques for investigating phenomena, acquiring new knowledge, or correcting and integrating previous knowledge.[2] To be termed scientific, a method of inquiry is commonly based on empirical or measurable evidence subject to specific principles of reasoning.[3] The Oxford Dictionaries Online define the scientific method as “a method or procedure that has characterized natural science since the 17th century, consisting in systematic observation, measurement, and experiment, and the formulation, testing, and modification of hypotheses“.[4] Experiments need to be designed to test hypotheses. The most important part of the scientific method is the experiment.”

Science then is the accumulation of the many pieces of science conducted by many scientific researchers. A piece of science will generally be found in a peer reviewed publication, and in Medicine will be indexed on resources like PubMed managed by the US National Library of Medicine and the National Institutes of Health.

Science then is a plethora of experiments described in peer reviewed publications. Each publication is built around an experiment, and makes observations and draws conclusions to formulate a hypothesis.

Conclusions in science can only ever be hypotheses. There is what exists, which unquestionably exists, and there is science’s ability at any point in time with the state of it’s measurement tools to try to model and measure what is.

So much of what makes up our world and the universe actually exists at a sub-atomic level, where scientists have many theories, and not a great deal of agreement. There will always be levels of measurement that will be beyond humanity.

Let’s be clear though, science does not and cannot make broad pronouncements like “All vaccines are safe”, there has never been such a study and it would be impossible to perform such an analysis.

What Can a Study Tell and What Can’t it Tell?

One of the issues with science is it finds what it goes looking for, and sometimes not, but it never finds what it was not looking for.

Let’s look at a study taken at random from a search of Pub Med using the following terms “Safety Vaccine Measles Mumps Rubella”. The study was the 6th article on the resulting list, and the first that was an actual safety study on a vaccine, and is available here as an Abstract on PubMed ‘Active safety monitoring of measles-mumps-rubella vaccine in the National Immunisation Programme of Sri Lanka’ or here for the full study in the ‘Ceylon Medical Journal’.

The abstract describes the Method for the study as follows :

“The data presented here were obtained from a cohort event monitoring study. It was carried out in the Jaffna Regional Directorate of Health Services area from November 2012 to December 2014. A representative sample of 3002 infants who received MMR immunisation were actively followed up for adverse events (AE) using over the phone interviews, self-reporting, and home or hospital visits up to 45 days. All AEs were reviewed by two investigators independently in two step-wise processes to detect the AEFIc. Seven AEFIc were detected using standard case definitions and onset time limit criteria. They were subjected to further analysis to describe the incidence rates and characteristics.”

The Results of the study per the Abstract were as as follows:

“Of the 2398 (80%) infants who completed follow up of 45 days, 1321 infants experienced 2621 AEFI. Of them 209 were classified as AEFIc. Incidence of AEFIc was 87/ 1000 immunisation. They were mainly nonserious and resolved completely. There were no fatal or life threatening AEFIs. Incidence per 1000 immunisations; allergic reactions 0.83, injection site reactions 4.58, fever100.4° F or lasting more than  3 days 9.59, macular papular rash 2.92, parotitis 2.92 and generalised convulsions 1.25.”

Finally the conclusion per the Abstract was as follows:

“The MMR vaccine used in NIP of Sri Lanka had low incidence of AEFIc and were mainly non-serious in nature.”

So lets take a look at what the publication’s Abstract (Summary) tells us. Fundamentally the Study Investigators followed up selected adverse events following immunisation which have consistent causal association (AEFIc) with MeaslesMumpsRubella (MMR) vaccination. Of the 3,002 infants, 1,321 experienced 2,621 Adverse Events, and only 209 of these were classified as having a Causal Association. Very little is said in the publication about the 92% of Adverse Events that fall outside those deemed to be those that have ‘consistent causal association’, which does bother me as a place where ‘off message’ data could be hidden if there were influencers involved with a desire to hide data that would concern the public. However lets move on as my point is to understand what science does and does not look at.

Clearly the method is human observation, and interviews with parents. If an event has stood out it has been reported, and if it is deemed causal and of interest it has been taken down into that selection.

What has the study not done? The study has not taken tests of all kinds of bodily systems and functions and sought to measure whether there was an impact.

By the method of this study (human observation), which is to my knowledge the most common approach in Vaccine Safety studies, only events significant enough to cause an immediate and major difference observable to the parent or the Study Investigator or associated clinicians is recorded in the data.

A drop in IQ would not be picked up, damage to bone density would not be picked up, damage to the digestive system would not be picked up unless it created something else immediately that stood out to the parent, investigator or clinician.

Thus this study does not, and cannot conclude accurately the the vaccine is safe and has no material negative effects, it can only draw conclusions about what was observed. Science is ill equipped to draw comprehensive and definitive conclusions about even one vaccine, let alone getting out a broad brush and painting all vaccines as safe. The work has not been done, and could not be resourced.

This study was typical of most vaccine safety studies and observed patients for only 45 days following vaccination. Some scholars do longer longitudinal studies to watch for longer term effects, these the FDA Refers to as Phase IV Post Market studies and occur generally after approval of a vaccine as problems emerge in patients and are reported through the Vaccine Adverse Events Reporting System (VAERS). So yes, to some degree the FDA and CDC would rather get a vaccine into the market to support Public Health objectives than wait years more and make sure the risk of the vaccine was lower. Again, there may be reasons for that and the argument again is more lives saved than lost, but again they are not truthful in the propaganda.

Drug Approvals versus Vaccine Approvals

From the FDA’s website, you can read here about the approval process for a vaccine. The FDA suggests in paragraph 2 on this page as follows : “Vaccine clinical development follows the same general pathway as for drugs and other biologics.”

There is in fact a difference between the approval process for most drugs and that for vaccines. A vaccine study occurs just like the Sri Lanka study referenced above. All patients are administered the vaccine and the effects are measured and monitored as per the study design.

For most drugs there are control groups assigned, as outlined in this publication on PubMed on Placebo Controlled Trials. It means one group of patients with the disease the drug is targeting receive a Placebo instead of the drug and become a ‘Control Group’, while the other group receive the drug and can be the subjects in whom the effectiveness and safety of the drug are assessed against the Control Group.

As outlined in the paper on Control Groups, there are ethical considerations that mean sometimes it is quite ethically questionable to use a Control Group, who don’t know they are the ones not getting a real drug, and who have pinned their hopes for survival on being healed with the support of the drug after running out of other options. Never the less Control Groups are used extensively, and are a key part of how the effectiveness of the drug is measured.

Interestingly there is no requirement for Control Groups in Vaccine Studies. The reason it’s interesting is that there is a much reduced ethical argument not to have them for vaccines. The studies are generally short like the 45 days of the one above, and if it is that important to vaccinate the patient ethically they can be vaccinated soon after the study.

The ability to statistically compare differences between the control group population, and the vaccine population would give investigators far more information to make safety assessments.

The World Health Organisation considered the use of Control Groups in 2013 and published some guidelines in the attached report. Their recommendations are for vaccine studies to adopt them in various circumstances and provide some guidance as to when and how.

The point relative to our subject here is that this definitive science the public officials and media are so fond of quoting or misquoting is not generally even provided with Control Group Data. if meaningful analysis was conducted on critical body functions between Control Groups and the Vaccine Group the science would be far more meaningful in being able to make pronouncements about safety.

Leveraging Safety from One Vaccine to Vaccination

As we saw in the section on What is Science, science is an experiment. One experiment can give us some conclusions about what we have observed, and we come up blank on what we might not have observed, but which did exist below the lens of the Investigators. So our one experiment we can see is not the ‘be all and end all’ that can give us blanket confidence in Vaccination as a whole.

Even on one vaccine, if you read the full Sri Lankan study it talks about concerns in a Brazilian Study that were outliers versus some other studies. These things should not be dismissed as there are racial differences with vaccines, as outlined in this study on : “Associations between race, sex and immune response variations to rubella vaccination in two independent cohorts“. Even one study on one vaccine is not enough if it is on a homogeneous population.

For a video like the one on the Murdoch site referenced at the beginning of this blog to talk about Vaccination as a whole and then quote Public Health Officials with a statistic of 3 in 10,000 patients “who developed short lived side effects” as proof of safety for vaccination as a whole is ludicrous. Add to that the omission of the deaths that are reported in the MMR Vaccine Package Insert, and the 1,232 total deaths and 62 post MMR deaths listed in the vaccine National Vaccine Injury Compensation Program Report. Add to that the fact that those are only US Cases claimed in the US Vaccine Court, and that not every death in the US is likely to result in a legal claim. The claims might be 1 in 10 serious Adverse reactions, or it might be one in 1.5, none of us can know without real data.

Then extrapolate the US to Global Statistics, recognising that the developing Nations are more than likely going to get the less safe products for free or a reduced rate when developed world safety concerns over already produced products come into play, and thus it will probably be worse on a Global scale amongst those who are vaccinated. There are examples if anyone wants to challenge it. The Global Population at the time of writing is 7.4 Billion against the US Population of 326 Million or a factor of 23 times more.

Vaccine Load

There has been very little science and genuine research on vaccine load. Each manufacturer is doing their own Phase 3 Studies that are pre-market and not in any way longitudinal, but that simply shows the safety profile of one vaccine. When the vaccine schedule in Australia lists greater than 40 vaccinations to be vaccinated against up to 4 years old, where is the research (with Control Groups) that shows that is safe. I’ll be delighted if anyone can produce anything credible, and I do mean a study, referenced.

Science the Commercial Motive, & Public Health

I already blogged in Vaccination Part 2 : Commercial Motives in Science and Medicine about how there is precious little real science that is not tainted by commercial funding and motives. So in any study is very hard to know if there are actually commercial motives present, and especially in the studies conducted under the direction of manufacturers as a part of FDA Clearances and Approvals.

Beyond that though the motives in Public Health are extreme too, and dominate the CDC and FDA in the vaccination space. I worked for 7 years for a Diagnostic Test Manufacturer, and I saw epidemics drive our demand for testing, and I vividly remember the death statistics for infectious diseases such as Dengue Fever, West Nile Virus, and Malaria, and many more. Epidemiology is real, and the need to manage epidemics is real.

As I’ve said I am pro-truth and do have vaccines when I have looked at risk of the disease, risk of the vaccine, and consequence of the disease and when I come to the conclusion the vaccine makes sense.

However there is a very clear camp in Public Health that says, my job is to manage epidemiology, and if I can save 1,000 lives from disease, traded for 10 deaths from side effects, and 100 from other side effects, then Public Health wins. That’s fine for Public Health, but it does not honour a parents right to choose.

I am not going to go too deeply into the Movie Vaxxed here, I do think I will blog separately on it, as those who want to tell people how to think are dismissing the movie without even seeing it, and it is a movie which raises some very serious questions via an extremely credible whistle blower about the willingness of Public Health to suppress or twist data when it tells a story that is likely to impact public willingness to vaccinate.

The truth is the Public Health motives to suppress data can be as strong as commercial motives, fed by an attitude of the people can’t be trusted with the truth. I get the concern as the lowest common denominator can be pretty disappointing, and believe it or not I truly am an optimist about human nature. However I believe a great many people are very bright and deserve truth. Very clearly by the data I have shown in this blog there is misinformation being presented to the Public, that says “All is well, Vaccines are safe, all side effects are short lived, when one of the side effects that can happen is death, and in the Sri Lanka study 1.25 in 10,000 babies have convulsions, the results of which lie in the ‘Things we haven’t looked at and can’t measure category.’

In Conclusion

Science is not god.

Science is humanity’s best attempt to understand what actually is, but it is limited by resources, ability to measure, willingness to measure, and commercial and public health motives that put money and more lives saved above the importance of the life of your child.

The Vaccine Adverse Events Reporting System and the claims made to the US Vaccine Court are evidence of very severe adverse reactions in Vaccination.

Science cannot draw a conclusion that vaccines are safe, or even that they are on the whole better for humanity when you consider more lives saved by control of epidemics that lost to deaths or severe adverse reactions.

I have worked with and for a great many wonderful scientists, and I respect the best of the profession. The best of the profession well understand the limits of science. The danger is the people who are the loud voices in the world who do not understand the limits of science, the politicians, the media, and worse the media like the Murdoch’s with well established links to the Pharma Industry (outlined in my first blog on vaccinations ) never disclosed in their public campaigns and reporting. There are probably many innocent people voicing the message of the vaccine industry and of Public Health Officials who believe the messages they are delivering, but behind them are people prepared to sacrifice lives to side effects, and unwilling to say so.

I believe in truth and transparency. If the senior Public Health officials responsible for the public narrative believe we need to accept a net gain in people saved, at the expense of a minority of children who experience severe side effects including occasional deaths, then they need to say so. Having said so though, personal sovereignty needs to be honoured and parents need to be able to make their own choices, and not be forced into compliance by legislated policy like ‘No Jab, No Play’ and No Jab, No Pay’, which are the product of vested interests media campaigns by News Corporation and the Murdoch Media, who make no disclosures in their campaigns of their links to the industry.

The Science does not say Vaccines are safe, it says of the millions of people vaccinated, the harm done seems by our ability to observe adverse effects to be a small percentage of the people. But that said, I believe I have made the case that there is a long way for science to come to truly be coming from an intent to find and eliminate all side effects, versus producing studies that get products approved, and allow Public Health to vaccinate almost all of the population.

Finally people quoting science need to actually quote the actual science, all of it, including the inconvenient deaths. Science has no single voice and no single message, and to make sense of the many perspectives it holds takes people of pure heart and no motive beyond truth.
Ura P Auckland
Writer & Blogger

 

Image Attributions:

  1. Businessman Shouting Through Megaphone‘ on ShutterStock under ShutterStock Standard License.

 

P.S. Writing this blog has taken me a full day. More time than this I do not have to devote to debating people with contrary opinions. This subject has the nature of a time sink hole with far too many ill informed people committed to myopic views.

Please Refer to my Blog Commenting Policy, and note that if you want to write verbose replies with contrary views you are best doing so on your own blog. I am however happy to hear well informed balanced and respectful views that add understanding for the readers of this blog.
Index to Vaccination Blogs:

  1. Vaccination Part 1 : A call for Pro-truth to replace Pro-Vax v Anti-Vax
  2. Vaccination Part 2 : Commercial Motives in Science and Medicine
  3. Vaccination Part 3 : Vaccine Injury, a rare glimpse of the tip of the iceberg
  4. Vaccination Part 4 : The ‘Science Says’ Myth

 

 

 

 

 

 

3 comments

  1. Nice work, Ura – there really badly needs to be study done on the long term adverse effects of vaccinations, as immune dysregulation issues can take a long time to surface. I have seen this a lot in my practice as a veterinarian. Not to mention the harm vaccination does to mitochondria. Most chronic diseases are mitochondrial diseases. I doubt any of this study will be done, as the companies that fund most of the research don;t want this area looked at, despite early studies showing that there are things that NEED to be researched further – A study on dogs showing auto-antibody production after vaccination (antibodies against the bodies own building blocks like collagen etc, which leads to autoimmune disease) – no further research has been done on this….

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