An i2P subscriber sent us a copy of an article that appeared in a mainstream publication a few years back.
It serves as a reminder as to how mainstream media should be working – but isn’t.
We have decided to republish this item (Item #1 in this report) to illustrate the point as to how mainstream media should be working, but currently is not.
The information is still relevant to today’s situation.
“A friend just forwarded the article below, and I thought you might find it interesting.
I’m amazed this appeared in a ‘mainstream’ paper – looked up the original which was published in 2011: https://www.theaustralian.com.au/business/companies/us-food-and-drug-administration-lashes-pharmaceutical-giant-csl-over-lab-practices/news-story/9ec128c029d387565b174e36aee1a826?sv=d565f4321934ced0a9e99eb4c5ef17b3
I wonder if they would be so willing to publish it these days, in light of No Jab, No Pay/Play legislation.
I’m surprised it is still accessible online.
I’m also amazed that the FDA would release this sort of info – given how much they’re tied up with industry.
The cynical me wonders if that might have anything to do with them protecting US corporations; or making it look like they’re actually doing their job without implicating their own industry buddies.
And this bit speaks VOLUMES: Australia’s pharmaceutical regulator, the Therapeutic Goods Administration, refused to release the findings of its own audits into CSL.
Shows just how secretive our own regulator is, and that it is also protecting industry rather than the Australian population.
Kind regards
i2P subscriber (name suppressed)”
1. The Australian: US Food and Drug Administration lashes pharmaceutical giant CSL over lab practices
SECRET audits by the powerful US Food and Drug Administration have revealed a multitude of manufacturing flaws at Australia’s biggest pharmaceutical company, CSL.
The FDA’s 2010 and 2011 audits, released to The Australian yesterday after a Freedom of Information request, cite a string of “objectionable conditions and practices” used by CSL to make vaccines.
The FDA allegations – which CSL said yesterday had been or were in the process of being resolved – include the failure of laboratory staff to wear masks while dispensing and mixing vaccines, “deficient” tests to check whether viruses were properly split to prevent side-effects and “inadequate” investigations into product failures.
The FDA documents reveal that CSL took six months to start investigating the cause of mysterious dark particles in the national stockpile of swine flu vaccine.
The most recent audit, in March, branded as “inadequate” CSL’s investigation of febrile fits among children immunised with Fluvax, its seasonal flu vaccine.
Eleven months after Fluvax was banned for young children, the FDA audit discovered CSL had not compiled an investigations report or even designated anyone to be in charge of the investigation.
Australia’s pharmaceutical regulator, the Therapeutic Goods Administration, refused to release the findings of its own audits into CSL.
And CSL insisted the FDA audits contained “observations only” rather than any final determination of compliance.
CSL, the privatised Commonwealth Serum Laboratories, has also been under fire this week after being forced to ration supplies of penicillin in its role as sole Australian supplier of the medicine.
The FDA audit findings form the basis of a “warning letter” the US regulator sent to CSL in June, threatening to revoke its US licence if it failed to address outstanding issues.
This year’s audit described as “inadequate” CSL’s investigation into the high rate of fever and convulsions among children given the Fluvax shot last year. “There was limited analysis of the manufacturing process to determine why there was a substantial increase of adverse-event reports of fever and convulsions in the 2010 southern hemisphere influenza season in comparison to previous seasons.
“There was no evaluation of testing of raw material and potential impact on manufacturing,” it said.
The audit found 15 lots of a key ingredient in CSL’s flu vaccines, the detergent sodium taurodeoxycholate, failed an “identity test” but were used regardless.
The detergent is used to split the flu viruses used to make vaccines to minimise side-effects.
The Medical Journal of Australia reported last week that CSL was “one of only a few manufacturers globally” to use the ingredient.
The FDA audit also criticised CSL’s “inadequate” investigation into the cause of dark particles that appeared in multi-dose vials of vaccines against swine and seasonal flu, produced for the US market in 2009.
“The investigation is ongoing and a root cause has not been determined,” its report said.
It also noted that CSL had manufactured products “outside the validated processes” without determining if they would remain stable until their expiry date.
It cited a “formulation error” discovered in July last year, when not enough swine flu virus was used in the vaccine against seasonal flu.
The FDA inspectors raised the problem of black particles in multi-dose vials during an inspection of the Parkville laboratory in April last year.
The same discolouration had been detected in Australia’s stockpile of swine flu vaccine, Panvax, for which the federal government paid CSL $131 million of taxpayer funds.
Half the stockpile – 10 million doses – had to be destroyed after passing their use-by date last year, while the paediatric version was withdrawn early because the medication lost potency before the expiry date.
The FDA’s 2010 audit found CSL’s supplier of rubber stoppers had told the company they could react with the mercury in multi-dose vials and should not be used.
The TGA said it agreed with the FDA findings, but it refused to release its own audits.
2. Dr Judy Wilyman Report: Newsletter #215 and Newsletter #216
Newsletter 215 Vaccination against Multiple Diseases: This is not in the Public’s Best Interest.
26 November 2018
The Australian media is informing the public that my PhD specialises in ‘humanities’ and not public health simply because it was issued from this faculty in 2015.
However this framing of my qualification is not correct and it is misleading the public about this health information.
My PhD is in social medicine which includes the epidemiology of infectious diseases and the political and economic decisions involved in improviing public health in the community.
On the 23 October 2018 I gave a video presentation at the Vaccines and Immunisation Conference in Osaka, Japan, titled ‘Vaccination against Multiple Diseases: Is this in the Public’s Best Interest?
In this 30 min video presentation I provide the science and the politics that demonstrates that mandatory vaccination against multiple diseases is not in the public’s best interest because of our genetics and the other social determinants that are involved in the cause of infectious diseases.
Please watch this 30 min conference presentation to see the science that is being ignored in the government’s promotion of more and more vaccines to the public.
A more in-depth analysis of these arguments can be obtained from my PhD thesis ‘A critical analysis of the Australian government’s rationale for its vaccination policy.‘
My Qualifications in Social Medicine (Public Health)
In 2004 I enrolled at the University of Wollongong in the Faculty of Health and in the School of Public Health to investigate the control of infectious diseases in Australia and the science of using an increasing number of vaccines.
I completed a Master of Science degree (Population Health) in the School of Public Health in 2007.
In 2007 I requested that I complete a PhD on this topic in the School of Public Health.
The head of the School of Public Health in 2007, Professor Heather Yeatman, provided supervisors from the Social Sciences because public health is also referred to as Social Medicine.
My supervisor was in the School of Social Sciences, Media and Communication and in 2014 this school was re-named the School of Humanities and Social Inquiry and this is why my PhD was issued from ‘humanities’ even though it specialises in the science and politics of public health.
My video presentation demonstrates that Australian doctors are not being taught about the historical control of infectious diseases in developed countries or the multi-factorial causality of these diseases in the community.
Doctors are not specialists in public health.
These scientific facts mean that vaccines are not the best method of controlling infectious diseases in populations because individuals do not have the same risk of catching the infectious disease when they are exposed to the pathogen (agent).
It is also because vaccines come with a serious risk for many people because of the ingredients they contain and the genetic diversity of the population.
It has been known for decades that the pathogen (virus/bacteria) is not sufficient on its own to cause disease in any individual.
Therefore injecting every healthy individual with vaccines against multiple diseases is not the best strategy for controlling preventable diseases.
This is because vaccines themselves are causing serious chronic illnesses, death and disability in children and adults.
Infectious diseases are caused by a combination of environmental and lifestyle characteristics along with the pathogen and this determines if a person will get a serious case of the disease, a mild case or no disease at all (sub-clinical cases) after infection by the agent.
However all natural infections result in long-term immunity and good community protection.
This is where the term ‘herd immunity’ originally came from.
These facts are described in the epidemiological triangle that public health officials (not doctors) used for decades to control these diseases in the twentieth century.
These historical facts are not being taught to doctors or to school students from kindergarten to high school and this amounts to propaganda about the benefits of vaccines – not education.
It is not education because the historical facts about the control of infectious diseases using political and economic decisions to change our environment and lifestyle – before vaccines were introduced – is not being taught to health practitioners or in the Australian school education system.
Australia adopted the corporate model of health in the 1990’s and included public health under the umbrella of ‘medicine’ at this time.
This has allowed the pharmaceutical companies to influence both the education of doctors about infectious diseases and vaccines, and to influence the promotion of vaccines to the community through the media.
This has involved over-stating the benefits of vaccines and under-reporting the risks of vaccines.
Public-private partnerships have been established in Australia and these alliances allow corporations, (such as the pharmaceutical companies) to have influence in the framing of the risks and benefits of vaccines and the risk of infectious diseases in the media.
This has been permitted because vaccination is classified as a ‘non-core health issue‘ (like sunscreens) (ch 4 of my PhD), and this means that corporations can influence their promotion to the public in the media.
This is why the media is incorrectly framing my PhD thesis to the public as being in ‘humanities’ (not public health) and why they are dismissing it as a ‘conspiracy theory’ to the public instead of describing to you the over-whelming evidence of the influence of the pharmaceutical companies in every aspect of the development and promotion of vaccines to the Australian government and the community.
The pharmaceutical /medical complex does not want you to see the science and the politics in my PhD with any credibility because they have significant vested interests in these government policies which are being promoted at the expense of human health and human rights in Australia.
Newsletter 216 ‘Anti-vax activist charges $4000 for ‘expert report’ By Jane Hansen (Daily Telegraph)
3 December 2018
On the 24 November 2018 Jane Hansen from Murdoch media’s Daily Telegraph wrote a false and derogatory article about my university research and work as an expert witness in court cases.
This article was titled ‘Anti-vax activist charges $4000 for ‘expert report’ and Ms Hansen did not give me an opportunity to respond to the unsubstantiated information that she provided in this article.
To date I have been involved in two Australian court cases involving parents who disagree about whether to vaccinate their children and I did not charge $4000 for an expert witness report.
Jane Hansen has framed me as an ‘anti-vax activist’ with a PhD degree in ‘humanities’.
This information is false and misleading.
I am an independent academic providing expert witness reports to support the case for choice in vaccination.
Journalists, and the public, are being misinformed about the specific area of my PhD.
My PhD is in the control of infectious diseases in populations – a specific area of public health that is called Social Medicine.
This is why the media was so important in controlling infectious diseases in the mid-1900’s – before most vaccines existed.
Here is the correct information about my qualifications that Jane Hansen did not provide to the public and politicians about my university research and work:
- My Master of Science Degree (Population Health) was completed in the UOW School of Public Health.
When I requested that I continue my research with a PhD in 2007 in the School of Public Health, the head of this school would not provide supervisors in this school.
Instead she recommended that I complete this research in the School of Social Sciences.
This area of public health is called Social Medicine. - Whilst my PhD has been awarded in the School of Humanities and Social Inquiry my expertise is in Social Medicine –
This field involves the epidemiology of infectious diseases.
That is, the science of describing the occurrence of infectious diseases in populations and their control by political and economic decisions.
In addition, Jane Hansen has falsely claimed that my PhD argues that ‘vaccination is a conspiracy’ and that my PhD was awarded ‘amidst harsh criticism from the scientific and medical community.
This is defamatory and it is misleading the public about this important health information.
The criticism of my research in the media has been from the powerful medical-industry lobby group activists and Hansen has not informed the public that my PhD is supported by many scientists, doctors and public health experts.
Jane Hansen has permitted a Friends of Science in Medicine activist, John Dwyer, to provide a false claim about my research that openly attempts to interfere with the official legal procedures for court hearings.
He is quoted as saying ‘if courts allow Dr. Wilyman to be an expert witness there is something wrong with the legal system’.
John Dwyer is attempting to influence the legal process with unsubstantiated comments about my qualifications.
This is followed by Jane Hansen herself declaring that ‘Dr. Wilyman’s research was not credible’.
It is a very serious issue when journalists take it upon themselves to declare university research as ‘not credible’.
In this case Jane Hansen is providing false and misleading health information to the public that is necessary to prevent serious harm and death in human populations.
The purposeful presentation of misleading health information is a serious offence.
These false statements have resulted in the health minister, Greg Hunt, incorrectly telling the public that they should listen to ‘undisputed medical advice‘ when doctors are not experts in social medicine.
This is a very sad situation in Australia where many parents are now coerced into using ~16 vaccines to use childcare facilities and to receive thousands of dollars in social welfare benefits.
It is splitting families and making parents very anxious about the forced medication of healthy people without public and transparent debate.
Most adults have never used the vaccines that are now being required for entry into many childcare centres/welfare benefits.
This is because the vaccines have only been developed in the last two decades when the diseases were not a serious risk to the majority of the population.
Australians are being labelled derogatively in the Murdoch/Fairfax media as ‘anti-vaxxers’ if they choose to question the over-vaccination of the population and the removal of our right to choose what we inject into our own bodies in preventative health i.e. these are mandated drugs for healthy people.
Here are the serious risks of vaccines that doctors are not revealing to patients because they are not taught this information in their medical education.
This education is being influenced by pharmaceutical funding and there is an industry bias in clinical and political decisions being made about the use of vaccines.
For 15 years I have researched and advocated for choice in vaccination without receiving any government funding, or any other funding, for this important health research.
In order to do this I had to give up my paid position as a teacher and fund my own website to present my research in (to date) 216 voluntary newsletters.
This is because the mainstream Australian media will not report on the science and politics that demonstrates:
- The serious risks of vaccines and
- The evidence that vaccines do not create herd immunity to control these diseases.
Jane Hansen’s media article is defamatory and she is providing false and misleading health information to the public.
Bachelor of Science, University of NSW
Diploma of Education (Science), University of Wollongong
Master of Science (Population Health), Faculty of Health Sciences, School of Public Health, University of Wollongong.
PhD in The Science and Politics of the Australian Government’s Vaccination Program, UOW School of Humanities and Social Inquiry.
Website Vaccination Decisions
3. Robert Kennedy’s Children’s Health Defence: The CDC Claims the Flu Shot Reduces Mortality in the Elderly. But Where’s the Evidence?
By Jeremy R. Hammond, Guest Contributor, Children’s Health Defense
The US Centers for Disease Control and Prevention (CDC) recommends that everyone aged six months and up, including pregnant women, get an annual influenza vaccine.
The two fundamental assumptions underlying the CDC’s policy are that vaccination reduces transmission of the virus and reduces the risk of potentially deadly complications.
Yet multiple reviews of the scientific literature have concluded that there is no good scientific evidence to support the CDC’s claims.
Notwithstanding the science, to increase demand for the pharmaceutical companies’ influenza vaccine products, the CDC makes use of fear marketing, asserting as fact that tens of thousands of people die each year from the flu, even though the CDC’s numbers are actually estimates that are controversial because they are based on dubious assumptions that appear to result in a great overestimation of the negative impact of influenza on societal health.
The primary justification for the CDC’s flu vaccine policy is the assumption that it significantly reduces the mortality rate among people aged 65 and older, the group at highest risk of potentially deadly complications from the flu.
The CDC declares to the public that the vaccine does so as though this was a scientifically proven fact.
Yet, the reality is that the CDC’s bold claim that the vaccine greatly reduces the risk of death among the elderly has been thoroughly discredited by the scientific community.
The Implausibility of the CDC’s Claims
Concerns about the CDC’s mortality claim were raised by researchers from the National Institutes of Health (NIH) in a study published in April 2005 in Archives of Internal Medicine (now JAMA Internal Medicine).
Their concern was prompted by the observation that, despite a considerable increase in vaccination coverage among people aged 65 or older—from at most 20 percent before 1980 to 65 percent in 2001—pneumonia and influenza mortality rates had actually substantially risen.
That is to say, to quote a review published in Virology Journal in 2008, contrary to the CDC’s claims of a great beneficial effect on mortality, “influenza mortality and hospitalization rates for older Americans significantly increased in the 80s and 90s, during the same time that influenza vaccination rates for elderly Americans dramatically increased.” (Emphasis added.)
As the authors of the 2005 NIH study commented, this result was “surprising” since vaccination was supposed to be “highly effective at reducing influenza-related mortality”—an assumption underlying CDC policy that “has never been studied in clinical trials”.
Relying instead on post-marketing observational studies of the general population, the CDC has claimed that vaccine efficacy in preventing influenza-related deaths is as high as 80 percent.
Furthermore, to support its claim of an enormous benefit, the CDC has relied on a meta-analysis of observational studies that concluded that vaccination reduces the number of flu-season deaths from any cause among the elderly “by an astonishing 50%.”
In their own study, however, the NIH researchers found that, over the course of thirty-three flu seasons, influenza-related deaths were on average only about 5 percent and “always less than 10% of the total number of winter deaths among the elderly.”
The obvious question was: How could it be possible for the influenza vaccine to reduce by half deaths during winter from any cause when no more than one-tenth of deaths in any given flu season could be attributed to influenza?
The most obvious answer was that it couldn’t, and so the researchers examined more closely the methodology of the observational studies that the CDC was relying upon.
The conclusion they drew from doing so was that the CDC’s implausible numbers were due to a systemic bias in those studies.
There was a “disparity among vaccination” in these studies between cohorts that received a flu vaccine and those that didn’t.
Specifically, it wasn’t that vaccinated individuals were less likely to die, but that sick elderly people whose frail condition made them more likely to die during the coming flu season were less likely to get a flu shot.
Faced with this identification of a systemic bias in their methodology and despite the obvious implausibility of its own claims, the CDC’s response was to question the methodology of the NIH researchers’ study while reiterating its unshaken faith in the studies it was relying upon to promote the flu vaccine.
Notwithstanding the lack of science to support the statement, and no doubt prompted by the need for government agencies to show solidarity on public vaccine policy, the CDC and NIH subsequently published a joint statement claiming that the seasonal flu shot was the best way to protect old people from dying.
Ironically, and tellingly, while commenting on the lack of evidence that the vaccine was preventing deaths among the elderly and the observed increase in mortality, the NIH researchers in their 2005 study had also acknowledged the effectiveness of naturally acquired immunity at reducing mortality (emphasis added):
“The sharp decline in influenza-related deaths among people aged 65 to 74 years in the years immediately after A(H3N2) viruses emerged in the 1968 pandemic was most likely due to the acquisition of natural immunity to these viruses.
Because of this strong natural immunization effect, by 1980, relatively few deaths in this age group (about 5000 per year) were left to prevent.
We found a similar pattern in influenza-related mortality rates among persons aged 45 to 64 years, an age group with substantially lower vaccine coverage.
Together with the flat excess mortality rates after 1980, this suggests that influenza vaccination of persons aged 45 to 74 years provided little or no mortality benefit beyond natural immunisation acquired during the first decade of emergence of the A(H3N2) virus.”
The way the NIH’s joint statement with the CDC contrasted with its own research findings is a remarkable illustration of the institutionalized cognitive dissonance that exists when it comes to public vaccine policy.
The CDC’s Mortality Claims Further Debunked
Numerous additional studies have since been published highlighting the lack of credibility of the CDC’s claims about the vaccine’s effectiveness.
A systematic review published in The Lancet in October 2005 found a “modest” effect of the vaccine on mortality, but its authors—which included lead author Tom Jefferson, a top researcher for the Cochrane Collaboration—cautioned that this finding must be interpreted in light of the apparent systemic bias of the observational studies.
They likewise attributed the perceived effect of the vaccine to a difference in vaccination rates among the cohorts “and the resulting selection bias”.
Randomized controlled trials could minimize any such bias, they observed, but the evidence from such studies was “scant and badly reported.”
Hence, placebo-controlled trials were needed to “clarify the effects of influenza vaccines in individuals”.
The problem was that such studies were considered impossible “on ethical grounds” due to the fact that mass vaccination was already recommended as a matter of public policy.
In other words, the science wasn’t done before the CDC made its universal vaccination recommendation, and now they refuse to do the science on the grounds that government technocrats have already made up their minds that everyone aged six months and up should get an annual flu shot.
The lead author of the 2005 NIH study, Lone Simonsen, was also coauthor with W. Paul Glezen of a commentary in the International Journal of Epidemiology in 2006 that reiterated the problems with the CDC’s claims. Although the vaccination rate for elderly people had increased by as much as 67 percent from 1989 to 1997, there was no evidence that vaccination reduced hospitalizations or deaths.
On the contrary, “mortality and hospitalization rates continued to increase rather than decline”.
The studies the CDC cited to support its claim of a dramatic reduction in mortality suffered from a selection bias that resulted in “substantial overestimation of vaccine benefits.”
A study in the International Journal of Epidemiology also published in 2006 confirmed the systemic selection bias of the observational studies.
Its authors concluded that not only had the results of those studies indicated “preferential receipt of vaccine by relatively healthy seniors”, but that the magnitude of this demonstrated bias “was sufficient to account entirely for the associations observed”. (Emphasis added.)
Influenza vaccine researcher Peter Doshi followed up with a letter to the BMJ published in November 2006 under the headline “Influenza vaccination: policy versus evidence”.
As he summed up the situation, “Not only is the evidence supporting the safety and effectiveness of influenza vaccination lacking, but there are also reasons to doubt conventional estimates of the mortality burden of influenza.”
Furthermore, “influenza vaccines impose their own particular burden—to the tune of billions of dollars annually.”
Indeed, the very high cost of yearly vaccination for large parts of the population was among the considerations of a 2014 Cochrane meta-analysis that concluded that the results of a systematic review of existing studies “provide no evidence for the utilization of vaccination against influenza in healthy adults as a routine public health measure.”
A randomized controlled trial studying the cost effectiveness of influenza vaccination in healthy adults under aged 65 and published in JAMA in 2000 found that this practice “is unlikely to provide societal economic benefit in most years”—when, according to their data, it generated greater costs than to not vaccinate.
Peter Doshi followed up in 2013 with another BMJ commentary.
After all those years, the CDC was still sticking to its claims.
And yet, if the CDC’s claims were true, it would mean “that influenza vaccines can save more lives than any other single licensed medicine on the planet.
Perhaps there is a reason CDC does not shout this from the rooftop: it’s too good to be true.
Since at least 2005, non-CDC researchers have pointed out the seeming impossibility that influenza vaccines could be preventing 50% of all deaths from all causes when influenza is estimated to only cause around 5% of all wintertime deaths.”
Despite scientists pointing out the “healthy user bias” inherent in the observational studies that the CDC relied on to support its bold claims, “CDC does not rebut or in any other way respond to these criticisms.”
“If the observational studies cannot be trusted,” Doshi asked, “what evidence is there that influenza vaccines reduce deaths of older people—the reason the policy was originally created? Virtually none….
This means that influenza vaccines are approved for use in older people despite any clinical trials demonstrating a reduction in serious outcomes.” (Emphasis added.)
“Perhaps most perplexing,” Doshi added, “is officials’ lack of interest in the absence of good quality evidence.”
He further observed how government agencies promote the flu shot by claiming it’s been proven safe. He cited the example of a YouTube video produced by the NIH in which the director of the US National Institute of Allergy and Infectious Diseases, Anthony Fauci, declared that it was “very, very, very rare” for a serious adverse event to be associated with the influenza vaccine.
Yet, “Months later, Australia suspended its influenza vaccination program in under five year olds after many (one in every 110 vaccinated) children had febrile convulsions after vaccination.
Another serious reaction to influenza vaccines—and also unexpected—occurred in Sweden and Finland, where H1N1 influenza vaccines were associated with a spike in cases of narcolepsy among adolescents (about one in every 55,000 vaccinated).
Subsequent investigations by governmental and non-governmental researchers confirmed the vaccine’s role in these serious events.”
The NIH’s presenter in the video, Anthony Fauci, also happened to be among the opponents of conducting randomized, placebo-controlled studies to determine the safety of the influenza vaccine.
“The reason? Placebo recipients would be deprived of influenza vaccines—that is, the standard of care, thanks to CDC guidelines.”
“Drug companies”, Doshi continued, “have long known that to sell some products, you would have to first sell people on the disease.”
Only, in the case of the influenza vaccine, “the salesmen are public health officials”.
Conclusion
In summary, there is no good scientific evidence to support the CDC’s claim that the influenza vaccine reduces hospitalizations or deaths among the elderly.
The types of studies the CDC has relied on to support this claim have been thoroughly discredited due to their systemic “healthy user” selection bias, and the mortality rate has observably increased along with the increase in vaccine uptake—which the CDC has encouraged with its unevidenced claims about the vaccine’s benefits, downplaying of its risks, and a marketing strategy of trying to frighten people into getting the flu shot for themselves and their family.