Tag Archives: over-vaccination

Petition against HPV vaccines – please consider signing this petition!

The Institute for the Protection of Natural Health (Institut pour la Protection de la Santé Naturelle), based in Brussels, in conjunction with French oncologist and surgeon Professor Henri Joyeux, has launched a French petition against the HPV vaccines Gardasil and Cervarix.

This petition has currently raised 359,840 signatures. Originally, the goal was to reach 500,000 signatures then submit the petition to government authorities in France. However, interest in this petition has expanded to other countries where medical professionals, scientists and medical consumers are also seriously questioning universal HPV vaccination programs.

Due to so many requests from people outside France who wish to sign the petition, Professor Joyeux and the Institute for the Protection of Natural Health have agreed to open their petition to every country in the world.

If you are concerned that HPV vaccines are of questionable value, please access and sign the petition via this link: http://petition.ipsn.eu/papillomavirus/?utm_source=VIDEO&utm_medium=Newsletter-gratuite&utm_campaign=201409-29-HPV_VdT

The petition is in French, but an English translation is available, see below.

You need only fill in four boxes: Your first name, last name, postal code (or country if you do not live in France) and your email address.

More information is available on the SaneVax website, including details of concerns raised by Professor Joyeux: http://sanevax.org/french-petition-hpv-vaccines/

Also refer to my previous post HPV vaccine promotion and government interference for more background on the questionable implementation of HPV vaccination in Australia

Please consider signing the French petition against HPV vaccines, we need to challenge questionable HPV vaccination on an international basis.

_____________________________________________

English translation of the French petition against HPV vaccines:

Sign the petition by clicking on this link

Institut Pour La Protection de la Santé Naturelle

The right to alternative treatment

NO to widespread vaccination of children against HPV

Petition

For the attention of The President of the French Republic, The French Minister of Health and Social Affairs, and the French Minister of National Education

Mr. President, Mme Health and Social Affairs Minister, Mme. National Education Minister,

On the 15^th of September 2014, the French High Council for Public Health published a statement recommending that:

HPV (human papillomavirus) vaccination should be introduced in French schools in an attempt to prevent cervical cancer and other sexually-transmitted diseases;

If necessary, the starting age for vaccination of both young girls and young boys would be lowered to 9.

This plan has aroused very deep concern in the French people and the medical profession.

There are a very large number of us who fear that our schools are being used as a front for a widespread HPV vaccination campaign targeting our children, without providing families transparent information on the effectiveness and risks of this vaccine and without allowing them to consider the pros and cons.

May we remind you that the analysis of pharmacovigilance data revealed 26,675 cases of serious adverse effects connected with these vaccines, including 113 cases of multiple sclerosis.

May we also remind you that the only method which has been proven to prevent cervical cancer is the Pap smear. If precancerous lesions are found, they can then be treated.

The vaccine however does not confer 100% protection, far from it. All medical sources concur on this point. It is a very dangerous situation if vaccinated individuals go off thinking that they are fully protected.

We the undersigned therefore demand that the plan for widespread HPV vaccination in French schools be stopped:

Until reasonable vaccine effectiveness has been proven;

Until we are aware of and can control all the adverse effects of these vaccines;

Until we can be assured that such widespread vaccination will not cause a drop in Pap smear screening, the only proven method of preventing cervical cancer.

This is the only way to protect a large number of children from unnecessary accidents and considerable suffering. You will also be making a step towards maintaining the trust of parents and keeping necessary peace in our schools.

Yours sincerely,

Number of Signatures

Request for retraction of the Cochrane Vaccines Field systematic review re vaccine safety and aluminium

Further to my previous posts re my letters to Professor Peter Gøtzsche challenging a systematic review prepared by members of the Cochrane Vaccines Field, i.e. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence.

I have now forwarded a letter to Mr John McConnell, editor of The Lancet Infectious Diseases, suggesting this so-called ‘systematic review’ should be retracted, see full letter below:

_______________________________________

11 August 2014

Mr McConnell

I write to you to challenge a systematic review prepared by members of the Cochrane Vaccines Field[1] , i.e. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence, published in The Lancet Infectious Diseases in February 2004 (behind the paywall).[2]

I have already forwarded letters on this matter to Professor Peter Gøtzsche, co-founder of The Cochrane Collaboration. Please see attached letters dated 8 July 2014 and 17 July 2014. My letters to The Cochrane Collaboration are also published on my website: https://over-vaccination.net/cochrane-collaboration/

I request that The Lancet Infectious Diseases take urgent action to re-evaluate this review prepared by members of the Cochrane Vaccines Field.

In my opinion this so-called ‘systematic review’ should be retracted by The Lancet Infectious Diseases.

I suggest this review has facilitated poorly evidenced acceptance of the safety of aluminium-adjuvanted vaccines. As a consequence, an increasing number of aluminium-adjuvanted vaccines are being added to vaccination schedules around the world e.g. multiple doses of diphtheria, tetanus and pertussis vaccines, and multiple doses of human papillomavirus (HPV) vaccine, amongst others. The meningococcal B vaccine is the latest to be promoted.[3] The long-term cumulative effects of the ever-growing list of vaccine products are unknown.

In their systematic review, authors Tom Jefferson, Melanie Rudin and Carlo Di Pietrantonj state: “We found no evidence that aluminium salts in vaccines cause any serious or long-lasting adverse events.” They also admit that: “Overall, the methodological quality of included studies was low”. Bizarrely, Jefferson et al conclude: “Despite a lack of good-quality evidence we do not recommend that any further research on this topic is undertaken.”[4]

From my layperson’s perspective, Jefferson et al’s ‘systematic review’ is an example of ‘garbage in, garbage out’.

Professor Christopher Exley of Keele University has raised this matter with your journal previously. In a letter published in The Lancet Infectious Diseases in June 2004[5] (behind the paywall) he noted:

“I was surprised that the authors were able to conclude from their review that further research in this field was unnecessary. It would seem to me that this conclusion did not adequately reflect the findings of the limited resource base underpinning the review. The authors criticised the quality of the data they had available to them and yet these data were still deemed sufficient to support such a strong conclusion. In addition, the authors made no reference to the fact that aluminium-based adjuvants contribute to the recipients systemic body burden of aluminium. We now know that aluminium in adjuvants is dissolved and transported throughout the body, including the brain[6] and we cannot discount the biological availability of this aluminium. It is a sobering thought that aluminium adjuvants have not had to pass any of the safety trials that would be expected of any drug or treatment. Their application is historical and this should not necessarily be equated with their safety. There is no consensus as to whether it is safe to introduce aluminium in prophylaxis or otherwise, and until the requisite research is carried out it is misleading to conclude that aluminium adjuvants are safe for all to use.” (My emphasis.)

Professor Exley followed up with another letter published in The Lancet Infectious Diseases in April 2006[7] (behind the paywall) in which he stated:

“In 2004, I commented in The Lancet Infectious Diseases that it was too early to conclude that aluminium adjuvants were safe for all to use.[8] This opinion has been strengthened by recent research highlighting delayed hypersensitivity to aluminium in children who have received aluminium-adsorbed vaccines.[9]^,[10] Contact allergy to aluminium has been known for some time[11], although delayed hypersensitivity to aluminium is a recently recognised phenomenon of unknown aetiology. The observation that the body retains a “memory” of previous exposure to aluminium (as an adjuvant) is intrigiuing and may support research that reported the development of anti-aluminium monoclonal antibodies.[12] Delayed hypersensitivity to aluminium raises a number of issues relating to the biological availability of this environmental toxin, perhaps not least of which, and pertinent to this moment in time, is the plan to improve the immunogenicity of (bird) flu vaccine by using aluminium-based adjuvants.[13] It is my opinion that substantially increased use of aluminium-adsorbed vaccines should be put on hold until research has demonstrated their safety, if not to all then to most individuals.” (My emphasis.)

It appears to me Jefferson et al’s systematic review was biased from the outset, and that the goal was to defend the use of aluminium adjuvants, i.e.: “Assessment of the safety of aluminium in vaccines is important because replacement of aluminium compounds in currently licensed vaccines would necessitate the introduction of a completely new compound that would have to be investigated before licensing. No obvious candidates to replace aluminium are available, so withdrawal for safety reasons would severely affect the immunogenicity and protective effect of some currently licensed vaccines and threaten immunisation programmes worldwide.”[14] (My emphasis.)

This Cochrane Vaccines Field review plays into the hands of vaccine manufacturers who are keen to develop a mass market for lucrative vaccine products. A World Health Organisation presentation acknowledges that vaccines are “becoming an engine for the pharmaceutical industry”, creating a global market with a “spectacular growth rate”, growing in value from US$5 billion in 2000 to almost US$24 billion in 2013, and projected to rise to US$100 billion by 2025.[15]

Aggressive vaccine marketing by the pharmaceutical industry and conflicted industry-affiliated ‘experts’ is threatening citizens’ bodily autonomy. It’s time there was an objective look at the burgeoning vaccine market and independent consideration of whether mass vaccination with all these lucrative vaccine products is justifiable. The potential conflicts of interests of academics working in the areas of vaccine development and promotion, and the influence of these academics on government policy, needs to be examined.

We need an investigation into the relationships between governments, the vaccine industry, and the industry’s handmaidens in the scientific/medical establishment, but who can we trust to do that? The mainstream media has generally been completely useless on this matter, and incapable of providing critical analysis, merely supporting the status quo.[16]

Likewise medical journals appear to be stalwart promoters for the pharmaceutical industry, and are beset by their own financial conflicts of interest in selling the literature and advertising medical products. The Lancet’s editor, Richard Horton, has confessed that: “Journals have devolved into information laundering operations for the pharmaceutical industry”.[17] In his book Deadly medicines and organised crime: How big pharma has corrupted healthcare, The Cochrane Collaboration’s Peter Gøtzsche notes: “Sadly, and although there are notable exceptions, our medical journals contribute substantially to the corruption of medical science.”[18]

But of course even The Cochrane Collaboration is not above reproach. It is mystifying that an organisation which promises “to promote evidence-informed health decision-making by producing high-quality, relevant, accessible systematic reviews and other synthesised research evidence”[19] could give its name to a ‘systematic review’ of such poor quality as Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence. Can the public rely on Cochrane?

Mr McConnell, I again request that The Lancet Infectious Diseases take urgent action to re-evaluate this review prepared by members of the Cochrane Vaccines Field.

In my opinion this systematic review should be retracted by The Lancet Infectious Diseases.

I request your urgent response on this matter.

Sincerely

Elizabeth Hart

https://over-vaccination.net/

*Please note, in addition to the cc list below, this letter will be circulated to other parties, and has also been published on my website.

cc:

Professor Richard Horton, Editor, The Lancet
Professor Peter Gøtzsche, The Cochrane Collaboration
Dr Tom Jefferson, Cochrane Vaccines Field
Mr Mark Wilson, CEO, The Cochrane Collaboration
Professor Paul Glasziou, Bond University
Professor Chris Del Mar, Bond University
Mr Ray Moynihan, Bond University
A/Professor Peter Doshi, University of Maryland
Dr Fiona Godlee, British Medical Journal
Professor Peter Collignon, Australian National University
Professor Christopher Exley, Keele University
Professor Chris Shaw, University of British Columbia
Dr Lucija Tomljenovic, University of British Columbia
Professor Warwick Anderson, NHMRC
Professor Ian Olver, NHMRC Australian Health Ethics Committee
Professor Ian Frazer, University of Queensland
A/Professor Ruiting Lan, University of New South Wales
Professor Lyn Gilbert, University of Sydney
Dr Linjie Zhang, Federal University of Rio Grande
Professor Ronald Schultz, Vaccination Guidelines Group, World Small Animal Veterinary Association
Professor Michael Day, Vaccination Guidelines Group, World Small Animal Veterinary Association
Professor Brian Martin, University of Wollongong
Ms Bea Mies, Independent Vaccine Investigator
Ms Monika Peichl, Independent Vaccine Investigator

References: (All links accessible as at 11 August 2014. It may be necessary to copy and paste long links into a web browser.)

[1] Cochrane Vaccines Field: “It is the intention of the Cochrane Vaccines Field to contribute to a greater global understanding of vaccine quality by facilitating the identification, assembling, analysis, synthesis, dissemination and updating of information on the effects of vaccines from single studies into reviews.”: http://vaccinesfield.cochrane.org/aims-and-activities

[2] Jefferson T, Rudin M, Di Pietrantoni C. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence. Lancet Infect Dis. 2004 Feb; 4(2):84-90: http://www.ncbi.nlm.nih.gov/pubmed/14871632 This review is also listed in the Cochrane Vaccines Field Bibliography: http://vaccinesfield.cochrane.org/bibliography-2003

[3] The Joint Committee on Vaccination and Immunisation originally rejected the Bexsero Meningitis B Vaccine see for example: Meningitis B vaccine rejected by UK – Joint Committee on Vaccination and Immunisation says there is not enough evidence to justify routine jabs with Bexsero, The Guardian, 24 July 2013: http://www.theguardian.com/society/2013/jul/24/meningitis-b-vaccine-rejected-uk This decision was subsequently overturned after a “determined campaign by doctors, health charities, a public petition and a wave of letters to Health Secretary Jeremy Hunt”: Babies to get jab on NHS against lethal meningitis B – A life-saving vaccine against deadly meningitis B will be introduced on the NHS for all babies from two months old in a dramatic U-turn announced yesterday, Express, 22 March 2014: http://www.express.co.uk/life-style/health/466236/Jeremy-Hunt-changes-NHS-baby-vaccine-policy-after-huge-letter-campaign Also refer to the JCVI position statement on use of Bexsero meningococcal B vaccine in the UK. March 2014: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/294245/JCVI_Statement_on_MenB.pdf

[4] Jefferson T, Rudin M, Di Pietrantoni C. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence. Lancet Infect Dis. 2004 Feb; 4(2):84-90: http://www.ncbi.nlm.nih.gov/pubmed/14871632

[5] Exley C. Aluminium-containing DTP vaccines. Lancet Infect Dis 2004; 4: 324.

[6] Flarend R. Absorption of aluminium from antiperspirants and vaccine adjuvants. In: Exley C. ed. Aluminium and Alzheimer’s disease. The science that describes the link. Amsterdam: Elsevier, 2001: 75-96.

[7] Exley C. Aluminium-adsorbed vaccines. Lancet Infect Dis. 2006; 6: 189.

[8] Exley C. Aluminium-containing DTP vaccines. Lancet Infect Dis 2004; 4: 324.

[9] Bergfors E, Trollfors B, Inerot A. Unexpectedly high incidence of persistent itching nodules and delayed hypersensitivity to aluminium in children after the use of adsorbed vaccines from a single manufacturer. Vaccine 2003; 22: 64-69

[10] Bergfors E, Björkelund C, Trollfors B. Nineteen cases of persistent pruritic nodules and contact allergy to aluminium after injection of commonly used aluminium-adsorbed vaccines. Eur J Pediatr 2004; 164: 691-97.

[11] Bohler-Sommeregger K, Lindemayr H. Contact sensitivity to aluminium. Contact Dermatitis 1986; 15: 278-81.

[12] Levy R, Shohat L, Solomon B. Specificity of an anti-aluminium monoclonal antibody toward free and protein-bound aluminium. J Inorg Biochem 1998; 69: 159-63.

[13] Wadman M. Race is on for flu vaccine. Nature 2005; 438: 23.

[14] Jefferson T, Rudin M, Di Pietrantoni C. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence. Lancet Infect Dis. 2004 Feb; 4(2):84-90: http://www.ncbi.nlm.nih.gov/pubmed/14871632

[15] Miloud Kaddar, Senior Adviser, Health Economist, WHO, IVB, Geneva. Gobal Vaccine Market Features and Trends: http://who.int/influenza_vaccines_plan/resources/session_10_kaddar.pdf (Powerpoint slides 5 and 6.)

[16] For example in Australia debate on vaccination has been polarised between avidly ‘pro’ and ‘anti’ forces. The media in Australia is generally supportive of the avidly ‘pro’ vaccination camp and appears to be incapable of providing objective analysis on the worth of individual vaccine products. Also refer to my letter to Professor Warwick Anderson, CEO of the National Health and Medical Research Council, which includes reference to News Corp Australia’s extraordinarily crude pro-vaccination campaign: http://users.on.net/~peter.hart/Letter_to_Warwick_Anderson_NHMRC_re_MMR_vaccination.pdf

[17] Horton R. The dawn of McScience. New York Rev Books. 2004; 51: 7-9. (As noted in Peter Gøtzsche’s book below.)

[18] Gøtzsche PC. Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare. London: Radcliffe Publishing Ltd, 2013. See Chapter 6, Conflicts of interest at medical journals.

[19] The Cochrane Collaboration – About us: http://www.cochrane.org/about-us

UPDATE: Interim response from NHMRC re vaccination policy and practice in Australia

As posted previously on Over-vaccination.net, I am forwarding letters to the National Health and Medical Research Council (NHMRC) questioning the ethics of vaccination policy and practice in Australia.

As a public record, I am publishing my correspondence with the NHMRC on this webpage: Letters to NHMRC re vaccination and ethics.

On 15 April 2014, I forwarded a letter to Professor Warwick Anderson, CEO of the NHMRC, suggesting the ethical spotlight needs to be shone on the way vaccination policy and practice is being implemented in Australia. I provided examples of the lack of transparency and accountability in the vaccination bureaucracy, including the problem of potential conflicts of interest and lack of disclosure by people involved in vaccination policy.

Previously, I forwarded two letters (19 March 2014 and 12 April 2014) to Professor Ian Olver, Chair of the NHMRC Australian Health Ethics Committee, challenging the Australian Government’s requirement for revaccination of children with a second dose of live Measles/Mumps/Rubella (MMR) vaccine, as children are likely to be immune after the first dose of effective live MMR vaccine, given at the appropriate age (i.e. after maternally derived antibodies have waned).

I have received an interim response from the NHMRC dated 20 May 2014.

In regards to my queries re the MMR vaccine second dose the NHMRC advises:

AHEC discussed your correspondence at its recent meeting on 7 May 2014. The issues you have raised in relation to the dose requirements for the MMR vaccination raise matters of both a scientific/technical nature as well as procedural matters relating to the current process. Before providing you with a considered response, AHEC wishes to seek further information from the relevant government agencies responsible for Australia’s immunisation policy and its implementation.

In an email to Professor Anderson dated 16 April 2014, I again raised the problem of the lack of transparency about members of committees and groups who provide advice to the Australian Federal Government on vaccine products, also noting that the NHMRC Australian Health Ethics Committee webpage provides no information about committee members, not even their affiliations.

In their letter dated 20 May 2014, the NHMRC responded:

In your email to Professor Anderson you raised that the declared interests of AHEC members are not publically available on the NHMRC website. Thank you for drawing this to our attention. The Office is in the process of rectifying this omission and you will be notified once these declarations are available…”

As two months have now passed since this interim response from the NHMRC, I am following up on progress on these matters.

UPDATE: Vaccine safety and aluminium – a challenge to Cochrane

Re my previous post about my letter to Professor Peter Gøtzsche, challenging a systematic review prepared by members of the Cochrane Vaccines Field, i.e. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence.

Professor Gøtzsche has responded to my letter, encouraging me to “submit a criticism” on this important matter.

I have forwarded a follow-up letter in this regard, which includes reference to my previous correspondence with Dr Tom Jefferson, and also draws parallels between human and animal vaccination, please see below:

______________________

17 July 2014

Professor Gøtzsche

RE: Vaccine safety and aluminium adjuvants

Thank you for your response[1] to my letter dated 8 July 2014 which challenges a systematic review prepared by the Cochrane Vaccines Field i.e. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence.[2]

In your response you encourage me to “submit a criticism” on this important matter to The Cochrane Collaboration.

As noted in my previous letter, the systematic review in question was prepared by members of the Cochrane Vaccines Field, i.e. Tom Jefferson, Melanie Rudin and Carlo Di Pietrantonj, and was published in The Lancet Infectious Diseases in 2004 (behind the paywall). The review is listed in the bibliography on the Cochrane Vaccines Field website, but is not accessible online on The Cochrane Collaboration website, so I am unable to make an online comment.

Professor Gøtzsche, as you have encouraged me to make a submission, can you please clarify how I should do this?

For your information, I originally contacted Dr Jefferson directly about this matter in March 2013. (I had previously contacted Dr Jefferson on other vaccine-related matters. He is also formally copied on my submissions re controversial ‘gain-of-function’ research[3] in the influenza industry, see my letter to the NSABB Jan 2012 and my submission to the US CDC/HHS Dec 2012.)

Please see below the contents of my email forwarded to Dr Jefferson on 24 March 2013 in regards to his systematic review of adverse events after immunisation with aluminium-containing DTP vaccines. (Given my previous correspondence with Dr Jefferson, the tone is informal. I have added some references in the endnotes):

Tom

I’m reading your review: “Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence” (The Lancet Infectious Diseases. Vol. 4 2004.)

The summary of your review concludes: “Despite a lack of good-quality evidence we do not recommend that any further research on this topic is undertaken.” (My emphasis.)

Your review notes: “The results of our review should be interpreted within the limited quantity and quality of available evidence. Within these limits, we found no evidence that aluminium salts cause any serious or long-lasting adverse events…”

So, you admit the quantity and quality of the evidence in your review was limited, but you still say that “we do not recommend that any further research on this topic is undertaken“.

Why would you say that?

I suggest you did not have enough information to say “we do not recommend that any further research on this topic is undertaken.” Your review just plays into the hands of vaccine manufacturers like GlaxoSmithKline and Merck etc who are pushing repeat revaccinations with aluminium adjuvanted vaccines of questionable value.

Vaccines with aluminium adjuvants such as DTaP (repeat ‘boosters’ being recommended for all ages) and HPV x 3 shots for children, etc are now being pushed on the population. Who knows what the cumulative effect of this repeated vaccination with these vaccines might be? Have there been any long-term studies? I would suspect no…

My investigation into companion animal vaccines has led me to be very concerned about vaccines with an aluminium adjuvant. Do I have masses of material in the “peer-reviewed literature” to back me up? No, and neither have I had the time to do a full-blown literature search, what with spending so much of my time investigating questionable MMR ‘boosters’, HPV, flu, pertussis vaccination, etc, because of all the misinformation spread by the ‘scientific’ establishment… Who would fund such research anyway?

Experts in veterinary medicine have been calling for a decrease of live and inactivated vaccination of companion animals because of the risk of adverse reaction to vaccines.[4] I’m becoming more concerned about the non-infectious/inactivated vaccines with aluminium adjuvants, (e.g. bordetella bronchiseptica with aluminium) that are given to many dogs every year, and now humans are being pressed to have regular revaccinations with aluminium adjuvanted vaccines (e.g. DTaP and HPV).

For information, see attached a presentation by Michael J Day[5], from a World Small Animal Veterinary Association Congress (2004) in which he says: “We now recognize that vaccines (particularly multicomponent, modified live products) appear to be able to trigger a range of immune-mediated and autoimmune diseases. For example, much attention has recently focused on vaccines as an initiator of immune-mediated haemolytic anaemia in the dog. The mechanism by which this effect occurs is not well investigated. In theory, three separate components of the vaccine might be involved. Many vaccines contain adjuvant (particularly alum), the function of which is, in part, to non-specifically activate the immune system. It is theoretically possible that this activation might include autoreactive lymphocytes, and as alum is very effective at stimulating antibody responses, the activation of B cells and their particular helper T cells (Th2 cells) might readily arise….” (My emphasis.)

Ref: 29th World Congress of the World Small Animal Veterinary Association October 6-9 2004, Rhodes, Greece. Michael Day is an author of the WSAVA Guidelines for Dogs and Cats, 2010: http://www.wsava.org/sites/default/files/VaccinationGuidelines2010.pdf

Also, here’s a quote from a DVM roundtable of vaccine experts, (December 1988)[6], which included Ron Schultz, Jonas Salk, Ian Tizard and others during which Ian Tizard said: “And yet, the use of poorly understood adjuvants has a long and distinguished history in vaccinology. We’ve been using alum since the 1920s and are still not sure how it works. It’s also fair to say that we’ve been very conservative in our use of adjuvants. To the best of my knowledge, alum is still the only adjuvant used in human vaccines…” (My emphasis.)

In 2013, do we yet know how alum works in vaccines?

It is interesting to note that pregnant women are currently being urged to have DTaP revaccinations because of the resurgence of pertussis. However, it has been reported that the pertussis circulating is a new strain, so what is the point of revaccinating with the existing vaccine?  Also, I don’t buy this idea of a vaccine that ‘wanes’. Either a vaccine immunises for life or forget it, we have been conned big time with these annual flu vaccinations and repeat DTaPs etc.

On the topic of pregnant women and the DTaP, it is interesting to note that vaccination guidelines for dogs say: “Should a pregnant dog be vaccinated?  Vaccination with MLV (attenuated) and/or killed (inactivated) vaccines during pregnancy should be avoided, if possible, to avoid potential injury to the fetus. There are exceptions, especially in shelters, where vaccination would be advised if the pregnant dog has never been vaccinated and there is risk of exposure to a highly pathogenic virus (e.g., CDV, CPV-2). (My emphasis.)

Reference: 2011 AAHA Canine Vaccination Guidelines: http://www.aahanet.org/PublicDocuments/CanineVaccineGuidelines.pdf

Are pregnant women being properly informed about pertussis, about the ‘new strain’, and about questionable vaccines that wane? Have the possible long-term deleterious effects of vaccination of pregnant women with aluminium adjuvanted vaccines been properly researched?  I suspect not…

Tom, I suggest your Cochrane Review of aluminium-containing DTP vaccines is a bit of a worry in that it may have created a poorly evidenced acceptance of the safety of aluminium-adjuvanted vaccines.

Cochrane Reviews don’t always get it right, as we know from Hayashi / Tamiflu…[7]

I would appreciate your response on this matter.

Regards

Elizabeth

Dr Jefferson responded to my email saying: “Very simple: it is not a Cochrane review”.[8] Obviously this brief reply was an inadequate response to the serious matters I had raised. I was also bemused by his statement that the systematic review prepared by the Cochrane Vaccines Field was “not a Cochrane review”. The review as published in The Lancet Infectious Diseases clearly identifies the authors as members of the Cochrane Vaccines Field, so surely The Cochrane Collaboration has a responsibility to be accountable for the recommendations of this review?

Professor Gøtzsche, as you have encouraged me to “submit a criticism” on this important matter, I would appreciate your advice as to how I can successfully make a submission to The Cochrane Collaboration.

I look forward to your response.

Sincerely

Elizabeth Hart

https://over-vaccination.net/

*Please note, in addition to the cc list below, this letter will be circulated to other parties, and has also been published on my website.

cc:

Dr Tom Jefferson, Cochrane Vaccines Field
Mr Mark Wilson, CEO, The Cochrane Collaboration
Professor Paul Glasziou, Bond University
Professor Chris Del Mar, Bond University
Mr Ray Moynihan, Bond University
A/Professor Peter Doshi, University of Maryland
Dr Fiona Godlee, British Medical Journal
Professor Peter Collignon, Australian National University
Professor Christopher Exley, Keele University
Professor Chris Shaw, University of British Columbia
Dr Lucija Tomljenovic, University of British Columbia
Professor Warwick Anderson, NHMRC
Professor Ian Olver, NHMRC Australian Health Ethics Committee
Professor Ian Frazer, University of Queensland
A/Professor Ruiting Lan, University of New South Wales
Professor Lyn Gilbert, University of Sydney
Dr Linjie Zhang, Federal University of Rio Grande
Professor Ronald Schultz, Vaccination Guidelines Group, World Small Animal Veterinary Association
Professor Michael Day, Vaccination Guidelines Group, World Small Animal Veterinary Association
Professor Brian Martin, University of Wollongong
Ms Bea Mies, Independent Vaccine Investigator
Ms Monika Peichl, Independent Vaccine Investigator

References: (All links accessible as at 17 July 2014. It may be necessary to copy and paste long links into a web browser.)

[1] Email from Professor Peter Gøtzsche, 9 July 2014.

[2] Jefferson T, Rudin M, Di Pietrantoni C. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence. Lancet Infect Dis. 2004 Feb; 4(2):84-90: http://www.ncbi.nlm.nih.gov/pubmed/14871632 This review is also listed in the Cochrane Vaccines Field Bibliography: http://vaccinesfield.cochrane.org/bibliography-2003

[3] A recent editorial in Nature provides an update on this controversial research: Biosafety in the balance. 25June 2014 (corrected 4 July 2014): http://www.nature.com/news/biosafety-in-the-balance-1.15447

[4] For example the World Small Animal Veterinary Association Guidelines for the Vaccination of Dogs and Cats state “we should aim to reduce the ‘vaccine load’ on individual animals in order to minimize the potential for adverse reactions to vaccine products”. The Vaccination Guidelines Group also acknowledges that “there is gross under-reporting of vaccine-associated adverse events which impedes knowledge of the ongoing safety of these products” Day MJ, Horzinek MC and Schultz RD. Journal of Small Animal Practice. Vol. 51. June 2010: http://www.wsava.org/sites/default/files/VaccinationGuidelines2010.pdf Also refer to the WSAVA Vaccination Guidelines webpage: http://www.wsava.org/guidelines/vaccination-guidelines

[5] Day MJ. Infectious Triggers of Immune-Mediated Disease. 29^th World Congress of the World Small Animal Veterinary Association. October 6-9 2004, Rhodes Greece: http://www.vin.com/proceedings/Proceedings.plx?CID=WSAVA2004&Category=&PID=8599&O=Generic

[6] Safety, efficacy heart of vaccine use; experts discuss pros, cons. DVM roundtable. DVM December 1988.

[7] Tom Jefferson. Hayashi’s Problem: Dr Keiji Hayashi’s question re Cochrane’s Tamiflu/Oseltamivir review: “We have some questions on the conclusion in your Oseltamivir review especially about the prevention of complication. You described that “Oseltamivir 150 mg daily prevented lower respiratory tract complications (OR 0.32, 95% CI 0.18 to 0.57).” (in abstract). However, we have found that this conclusion is based on the other review (Kaiser2003) and not on your own data analysis. The authors of the review were four employees of F. Hoffman-La Roche Ltd, one paid consultant to F. Hoffman-La Roche Ltd and Kaiser. We cannot find any raw data about this conclusion from your review. Kaiser’s review included 10 RCTs; two RCTs (Nicholson 2000 and Treanor 2003) were published as articles in the peer-reviewed medical journal (JAMA and Lancet), but other 8 RCTs were proceedings of congress (5 RCTs), abstracts of the congress (one RCT) and meeting (one RCT) and data on file, Hoffmann-La Roche, Inc, Nutley, NJ (one RCT). The lower respiratory tract complication rates of these articles were summarized on table: there was no significant difference between Oseltamivir and placebo, and their Odds Ratio’s (ORs) were 1.81. But ORs of other 8 RCTs were 4.37. We strongly suppose that the reviewer’s conclusion about the complications was mainly determined by these 8 RCTs, we should appraise the 8 trials rigidly. Without this process it’s difficult to conclude that oseltamivir can prevent lower respiratory tract complications.” (Powerpoint slide 12): http://chmg.cochrane.org/sites/chmg.cochrane.org/files/uploads/Jefferson_Hayashi’s%20problem.pdf

[8] Email from Tom Jefferson, 24 March 2013.

Vaccine safety and aluminium – a challenge to The Cochrane Collaboration

Internationally, The Cochrane Collaboration undertakes systematic reviews of primary research in human health care and health policy, including reviews of the effectiveness of vaccine products.

The Cochrane Collaboration declares its mission “is to promote evidence-informed health decision-making by producing high-quality, relevant, accessible systematic reviews and other synthesised research evidence”.

See below my recent letter to Professor Peter Gøtzsche, co-founder of The Cochrane Collaboration and Director of the Nordic Cochrane Centre, challenging a systematic review prepared by members of the Cochrane Vaccines Field, i.e. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence. I suggest this review has facilitated poorly evidenced acceptance of the safety of aluminium-adjuvanted vaccines.

_____________________

8 July 2014

Professor Gøtzsche

I write to you to challenge a systematic review prepared by members of the Cochrane Vaccines Field [1] , i.e. Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence.[2]

I request that The Cochrane Collaboration[3] take urgent action to re-evaluate this review prepared by members of the Cochrane Vaccines Field.

I suggest this review has facilitated poorly evidenced acceptance of the safety of aluminium-adjuvanted vaccines. As a consequence, an increasing number of aluminium-adjuvanted vaccines are being added to vaccination schedules around the world e.g. multiple doses of diphtheria, tetanus and pertussis vaccines, and multiple doses of human papillomavirus (HPV) vaccine, amongst others. The meningococcal B vaccine is the latest to be promoted.[4] The long-term cumulative effects of the ever-growing list of vaccine products are unknown.

The systematic review, co-authored by Tom Jefferson, Melanie Rudin and Carlo Di Pietrantonj, and published in The Lancet Infectious Diseases in 2004 (behind the pay-wall), concludes in the abstract: “We found no evidence that aluminium salts in vaccines cause any serious or long-lasting adverse events. Despite a lack of good-quality evidence we do not recommend that any further research on this topic is undertaken.” (My emphasis.)

More detail on this conclusion is provided in the discussion, i.e. “Our meta-analysis of the outcome data has enabled us to reach firm conclusions on the limited amount of comparative data available. Since there was no association with severe adverse events in young children or with induration in older children, we believe any association with chronic outcomes to be unlikely. The results of our review should be interpreted within the limited quantity and quality of available evidence. Within these limits, we found no evidence that aluminium salts cause any serious or long-lasting adverse events. We found no comparative evidence assessing any possible associations between exposure to aluminium adjuvants and rare and hitherto little known outcomes such as macrophagic myofasciitis.” (My emphasis.)

In their review Jefferson et al admit that: “Overall, the methodological quality of included studies was low.” And yet “despite a lack of good-quality evidence” Jefferson et al advise “we do not recommend that any further research on this topic is undertaken”.

This recommendation is bizarre, particularly as in an interview with The Telegraph in 2002 titled “Vaccines expert warns studies are useless”[5], Tom Jefferson candidly stated: “Most safety studies on childhood vaccines have not been conducted thoroughly enough to tell whether the jabs cause side effects”. Dr Jefferson said: “There is some good research, but it is overwhelmed by the bad. The public has been let down because the proper studies have not been done.” Perhaps reluctant to “anger public health officials in Britain and elsewhere, who fear that any discussion will undermine parents’ confidence in national vaccination programmes”, The Telegraph article reports Dr Jefferson “emphasised that there was no evidence to suggest that any vaccine now in use was dangerous” but said “there was a “dearth” of sound studies on the risks and benefits” and “as a result, the information available on the safety of vaccines that are routinely given to babies and toddlers was “simply inadequate”.” It was reported Dr Jefferson “was especially concerned…because future vaccination programmes were likely to involve giving children “five, six, even seven vaccines all at once”.” Which of course is exactly what happens now, see for example vaccination schedules in the US[6], the UK[7] and Australia[8] .

Given Dr Jefferson’s apparent appreciation of the ‘dearth’ of sound studies on the risks and benefits of vaccine products, and his concern about future vaccination programmes including “five, six, even seven vaccines all at once”, it is unaccountable that he and his colleagues could conclude in their strategic review “we do not recommend that any further research on this topic is undertaken”.

From my layperson’s perspective, Jefferson et al’s ‘systematic review’ is an example of ‘garbage in, garbage out’.

It appears to me this systematic review was biased from the outset, and that the goal was to defend the use of aluminium adjuvants, i.e.: “Assessment of the safety of aluminium in vaccines is important because replacement of aluminium compounds in currently licensed vaccines would necessitate the introduction of a completely new compound that would have to be investigated before licensing. No obvious candidates to replace aluminium are available, so withdrawal for safety reasons would severely affect the immunogenicity and protective effect of some currently licensed vaccines and threaten immunisation programmes worldwide.” (My emphasis.)

In 2009, Associated Press reported: “Vaccines now are viewed as a crucial path to growth, as drug companies look for ways to offset a slowing of prescription-medicine sales amid intensifying generic competition and government pressure to restrain prices under the federal health-care overhaul”.[10] An article published in New Scientist in late 2011 says: “No longer the unprofitable runt of the pharmaceutical family, vaccines are fast becoming the industry’s breadwinner…While the rest of the pharmaceutical sector struggles to keep afloat as expiring patents send profits plummeting, the vaccine industry has become remarkably buoyant.”[11] In 2012, FierceVaccines noted: “Thanks in part to the adult influenza market and vaccines such as Gardasil and Prevnar, the global vaccines market has enjoyed a decidedly solid boost in revenue.”[12]

Vaccine products of dubious value are being pressed upon the community. For instance, Merck and GlaxoSmithKline are pushing universal vaccination with the questionable human papillomavirus vaccines Gardasil and Cervarix, despite the fact the co-inventor of the technology enabling the HPV vaccines, Professor Ian Frazer, has acknowledged that the risk of cancer associated with the HPV virus is very low. (Refer to my webpage on HPV vaccination[13] for more background.)

Similarly multiple revaccinations with the diphtheria, tetanus and acellular pertussis vaccines are also being ‘recommended’, which means they are effectively mandated for children.[14] For example, according to the US vaccination schedule, as well as the primary vaccination series at two, four and six months, this vaccination combination is ‘recommended’ again between 15-18 months, a fifth shot between 4-6 years, and another shot between 11-12 years.[15]

In regards to pertussis/whooping cough outbreaks, in March 2012, the UNSW Newsroom reported: “Australia’s prolonged whooping cough epidemic has entered a disturbing new phase, with a study showing a new strain or genotype capable of evading the vaccine may be responsible for the sharp rise in the number of cases…The new genotype also has been detected in other countries, suggesting it has the potential to spark epidemics elsewhere and should be closely monitored…”[16]

One of the researchers, A/Professor Ruiting Lan said: “The vaccine is still the best way to reduce the transmission of the disease and reduce cases, but it appears to be less effective against the new strain and immunity wanes more rapidly. We need to look at changes to the vaccine itself or increase the number of boosters”. (My emphasis.)

I wrote to A/Professor Lan[17], asking him to clarify how increasing the number of ‘boosters’ of the existing vaccine protects against the new strain. Professor Lan did not deign to respond to my enquiry. I subsequently tried to contact his colleague Professor Lyn Gilbert[18] but again received no response.

I also raised the matter with Dr Linjie Zhang[19], an author of the Cochrane Review: Acellular vaccines for preventing whooping cough in children.[20] Dr Zhang also failed to respond, yet another example of the lack of accountability of the academic community to the concerns of citizens re the promotion of vaccine products.

In the US[21], the UK[22] and Australia[23] pregnant women are being urged to be vaccinated with a dose of diphtheria, tetanus and pertussis vaccine, even though it is admitted that “specific safety data are limited”.[24] Other close contacts of young infants are also encouraged to be vaccinated, i.e. the ‘cocoon strategy’.[25] What evidence is there to support this strategy? Certainly repeated ‘boosters’ throughout life with these vaccines must be a profit boost for vaccine manufacturers.

Meanwhile others are raising questions about the safety of aluminium adjuvants in vaccine products, e.g. Professor Christopher Exley[26], Dr Lucija Tomljenovic and Professor Chris Shaw.[27]

I suggest it is time to critically consider the ever-growing list of vaccine products and revaccinations being added to vaccine schedules.

Is it possible an over-use of vaccine products may have long-term repercussions similar to the over-use of antibiotics?[28] Who can we rely upon to objectively review the burgeoning global vaccine product market? Certainly I have no confidence in the international ‘vaccination claque’ which pushes an ever-growing list of vaccine products.[29] As I outline in my recent letter to Professor Warwick Anderson, CEO of Australia’s National Health and Medical Research Council (NHMRC), the ethical spotlight needs to be shone on the way vaccination policy and practice is being implemented.[30] In my letter I provide examples of the lack of transparency and accountability in the vaccination bureaucracy, including the potential conflicts of interest and lack of disclosure by people involved in vaccination policy in Australia. My arguments are also relevant internationally.

Professor Gøtzsche, The Cochrane Collaboration’s stated mission is “to promote evidence-informed health decision-making by producing high-quality, relevant, accessible systematic reviews and other synthesised research evidence”.[31] The Cochrane Collaboration has a reputation to maintain and it doesn’t always get it right the first time, as we know from Hayashi/Tamiflu.[32] [33] I suggest The Cochrane Collaboration cast a more critical eye on the growing list of lucrative vaccine products.

I request your urgent attention to the matters I have raised.

Sincerely

Elizabeth Hart

https://over-vaccination.net/

*Please note, in addition to the cc list below, this letter will be circulated to other parties, and has also been published on my website.

cc:

Dr Tom Jefferson, Cochrane Vaccines Field
Mr Mark Wilson, CEO, The Cochrane Collaboration
Professor Paul Glasziou, Bond University
Professor Chris Del Mar, Bond University
Mr Ray Moynihan, Bond University
A/Professor Peter Doshi, University of Maryland
Dr Fiona Godlee, British Medical Journal
Professor Peter Collignon, Australian National University
Professor Christopher Exley, Keele University
Professor Chris Shaw, University of British Columbia
Dr L Tomljenovic, University of British Columbia
Professor Warwick Anderson, NHMRC
Professor Ian Olver, NHMRC Australian Health Ethics Committee
Professor Ian Frazer, University of Queensland
A/Professor Ruiting Lan, University of New South Wales
Professor Lyn Gilbert, University of Sydney
Dr Linjie Zhang, Federal University of Rio Grande
Professor Ronald Schultz, Vaccination Guidelines Group, World Small Animal Veterinary Association
Professor Michael Day, Vaccination Guidelines Group, World Small Animal Veterinary Association
Professor Brian Martin, University of Wollongong
Ms Bea Mies, Independent Vaccine Investigator
Ms Monika Peichl, Independent Vaccine Investigator

References: (All links accessible as at 7 July 2014. It may be necessary to copy and paste long links into a web browser.)

[3] The Cochrane Collaboration: “Cochrane is a global independent network of health practitioners, researchers, patient advocates and others, responding to the challenge of making the vast amounts of evidence generated through research useful for informing decisions about health. We are a not-for-profit organisation with collaborators from over 120 countries working together to produce credible, accessible health information that is free from commercial sponsorship and other conflicts of interest.”http://www.cochrane.org/about-us

[4] The Joint Committee on Vaccination and Immunisation originally rejected the Bexsero Meningitis B Vaccine see for example: Meningitis B vaccine rejected by UK – Joint Committee on Vaccination and Immunisation says there is not enough evidence to justify routine jabs with Bexsero, The Guardian, 24 July 2013: http://www.theguardian.com/society/2013/jul/24/meningitis-b-vaccine-rejected-uk This decision was subsequently overturned after a “determined campaign by doctors, health charities, a public petition and a wave of letters to Health Secretary Jeremy Hunt”: Babies to get jab on NHS against lethal meningitis B – A life-saving vaccine against deadly meningitis B will be introduced on the NHS for all babies from two months old in a dramatic U-turn announced yesterday, Express, 22 March 2014: http://www.express.co.uk/life-style/health/466236/Jeremy-Hunt-changes-NHS-baby-vaccine-policy-after-huge-letter-campaign Also refer to the JCVI position statement on use of Bexsero meningococcal B vaccine in the UK. March 2014: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/294245/JCVI_Statement_on_MenB.pdf

[5] Lorraine Fraser. Vaccines expert warns studies are useless. The Telegraph, 27 October 2002: http://www.telegraph.co.uk/news/uknews/1411417/Vaccines-expert-warns-studies-are-useless.html

[6] Centers for Disease Control and Prevention. Immunization Schedules. Birth-18 Years & “Catch-up” Immunization Schedules, United States 2014: http://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html

[7] The NHS vaccination schedule: http://www.nhs.uk/Conditions/vaccinations/Pages/vaccination-schedule-age-checklist.aspx

[8] National Immunisation Program Schedule from 1 July 2013: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/nips-ctn

[9] Miloud Kaddar, Senior Adviser, Health Economist, WHO, IVB, Geneva. Gobal Vaccine Market Features and Trends: http://who.int/influenza_vaccines_plan/resources/session_10_kaddar.pdf (Powerpoint slides 5 and 6.)

[10] Linda A Johnson. Vaccines become drugmakers’ profit boosters. Pharmaceutical companies drawn to development of vaccines for variety of diseases. The Columbus Dispatch, 30 November 2009: http://www.dispatch.com/content/stories/business/2009/11/30/vaccine_revolution.ART_ART_11-30-09_A10_7NFQQE7.html

[11] Deborah MacKenzie. Vaccines enjoy a healthy return. NewScientist, 28 September 2011: http://www.newscientist.com/article/dn20877-vaccines-enjoy-a-healthy-return.html#.U7Np2vmSz-s

[12] Alison Bryant. 20 Top-selling Vaccines – H1 2012. FierceVaccines, 25 September 2012: http://www.fiercevaccines.com/special-report/20-top-selling-vaccines/2012-09-25

[13] Human papillomavirus (HPV) vaccination: https://over-vaccination.net/questionable-vaccines/hpv-vax/

[14] I suggest vaccination ‘recommendations’ are effectively vaccination mandates. For example, in the US the Advisory Committee on Immunization Practices (ACIP) makes vaccination ‘recommendations’: http://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf which translate into vaccination ‘requirements’: http://www2a.cdc.gov/nip/schoolsurv/schimmrqmt.asp In Australia, parents of children have to “meet certain immunisation requirements” to obtain “immunisation related payments for parents”: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/related-payments

[15] Centers for Disease Control and Prevention. Immunization Schedules. Birth-18 Years & “Catch-up” Immunization Schedules, United States 2014: http://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html

[16] UNSW Australia Newsroom. Sharp rise in cases of new strain of whooping cough, 21 March 2012: https://newsroom.unsw.edu.au/news/health/sharp-rise-cases-new-strain-whooping-cough

[17] Email to Associate Professor Ruiting Lan, 4 December 2012: http://users.on.net/~peter.hart/Enquiry_re_JID_Report_pertussis_epidemic.pdf

[18] Email to Professor Lyn Gilbert, 11 December 2012: http://users.on.net/~peter.hart/Whooping_cough_enquiry.pdf

[19] Email to Dr Linjie Zhang, 11 December 2012: http://users.on.net/~peter.hart/Enquiry_re_pertussis_vaccination_Cochrane.pdf

[20] Zhang L, Prietsch SOM, Axelsson I, Halperin SA. Acellular vaccines for preventing whooping cough in children. Cochrane Database of Systematic Reviews 2012, Issue 3. Art. No.: CD001478. DOI: 10.1002/14651858.CD001478.pub5. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001478.pub5/abstract

[21] Centers for Disease Control and Prevention. Tdap Vaccine – What You Need to Know. “Pregnant women should get a dose of Tdap during every pregnancy, to protect the newborn from pertussis.”: http://www.cdc.gov/vaccines/hcp/vis/vis-statements/tdap.pdf

[22] Whooping cough vaccination in pregnancy. NHS Choices. “Pregnant women can safely help protect their babies by getting vaccinated against whooping cough (pertussis) when they are 28-38 weeks pregnant.” http://www.nhs.uk/conditions/pregnancy-and-baby/pages/whooping-cough-vaccination-pregnant.aspx#safe

[23]4.12 Pertussis. The Australian Immunisation Handbook 10^th Edition 2013. “dTpa vaccine is recommended as a single dose, given either during pre-pregnancy planning, or as soon as possible after delivery of the infant (preferably before hospital discharge). Alternatively, dTpa can be given to women during the third trimester of pregnancy…”: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook10-4-12

[24] 4.12.8 Pregnancy and breastfeeding (re pertussis vaccination). The Australian Immunisation Handbook 10^th Edition 2013. While attempting to justify vaccination of pregnant women, this section also acknowledges “…specific safety data are limited”: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook10-4-12

[25] 4.12.7 Recommendations (re pertussis vaccination). Persons in contact with infants and others at increased risk from pertussis: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook10-4-12

[26] See for example: Exley C et al. A role for the body burden of aluminium in vaccine-associated macrophagic myofasciitis and chronic fatigue syndrome. Medical Hypotheses. Vol. 72, Iss. 2, Feb. 2009, pp 135-139.

[27] See for example: Tomljenovic L and Shaw CA. Aluminium Vaccine Adjuvants: Are they Safe? Current Medicinal Chemistry, 2011, 18, pp 2630-2637; and Shaw CA and Tomljenovic L. Aluminium in the central nervous system (CNS): toxicity in humans and animals, vaccine adjuvants, and autoimmunity. Immunologic Research, 2013, July 56 (2-3) pp 304-316.

[28] In regards to overuse of antibiotics see for example: PM’s plan on antibiotics not urgent enough, reports says, BBC News Health, 7 July 2014: http://www.bbc.com/news/health-28165152 This is a topic to watch very carefully, particularly in regards to vested interests, as apparently the solution to overuse of antibiotics is…more antibiotics, e.g. “What this demands, according to academic and industry experts, is a new business model that rewards drug firms for developing new antibiotics even if they are rarely used.” How to fix a broken market in antibiotics, Reuters, 6 July 2014: http://in.reuters.com/article/2014/07/06/uk-health-antibiotics-idINKBN0FB0AE20140706 Also see: UPDATE1 – Cameron enlists ex-Goldman economist in global superbug fight, Reuters, 2 July 2014: http://www.reuters.com/article/2014/07/02/health-antibiotics-idUSL6N0PD25O20140702

[29] I suggest the ‘vaccination claque’ consists of the network of vaccine manufacturers, vaccination committees and groups, academics, bureaucrats, and organisations such as the World Health Organisation, US Centers for Disease Control and Prevention, US National Institutes of Health, the GAVI Alliance, the Bill & Melinda Gates Foundation, National Health and Medical Research Council etc. This is a powerful network and potential conflicts of interest need to be scrutinised.

[30] Letter to Professor Warwick Anderson, CEO, National Health and Medical Research Council (NHMRC), re Vaccination policy and practice in Australia, dated 15 April 2014: http://users.on.net/~peter.hart/Letter_to_Warwick_Anderson_NHMRC_re_MMR_vaccination.pdf

[31] The Cochrane Collaboration – About us – Our Mission: http://www.cochrane.org/about-us

[32] Tom Jefferson. Hayashi’s Problem: Dr Keiji Hayashi’s question re Cochrane’s Tamiflu/Oseltamivir review: “We have some questions on the conclusion in your Oseltamivir review especially about the prevention of complication. You described that “Oseltamivir 150 mg daily prevented lower respiratory tract complications (OR 0.32, 95% CI 0.18 to 0.57).” (in abstract). However, we have found that this conclusion is based on the other review (Kaiser2003) and not on your own data analysis. The authors of the review were four employees of F. Hoffman-La Roche Ltd, one paid consultant to F. Hoffman-La Roche Ltd and Kaiser. We cannot find any raw data about this conclusion from your review. Kaiser’s review included 10 RCTs; two RCTs (Nicholson 2000 and Treanor 2003) were published as articles in the peer-reviewed medical journal (JAMA and Lancet), but other 8 RCTs were proceedings of congress (5 RCTs), abstracts of the congress (one RCT) and meeting (one RCT) and data on file, Hoffmann-La Roche, Inc, Nutley, NJ (one RCT). The lower respiratory tract complication rates of these articles were summarized on table: there was no significant difference between Oseltamivir and placebo, and their Odds Ratio’s (ORs) were 1.81. But ORs of other 8 RCTs were 4.37. We strongly suppose that the reviewer’s conclusion about the complications was mainly determined by these 8 RCTs, we should appraise the 8 trials rigidly. Without this process it’s difficult to conclude that oseltamivir can prevent lower respiratory tract complications.” (Powerpoint slide 12): http://chmg.cochrane.org/sites/chmg.cochrane.org/files/uploads/Jefferson_Hayashi’s%20problem.pdf

[33] Martin Enserink. Armed With New Data, Researchers Again Challenge Effectiveness of Antiflu Drug. ScienceInsider. 9 April 2014: http://news.sciencemag.org/health/2014/04/armed-new-data-researchers-again-challenge-effectiveness-antiflu-drug

French Vaccine Debates – UPDATE

Re my previous post France: Aluminium adjuvants and HPV vaccines up for debate (21 May 2014), refer to the SaneVax website for updates, see hyperlinks below:

French Vaccine Debates: What immediate measures are required? (4 June 2014)

France Debates Vaccine Safety: (30 May 2014)

France: Aluminium adjuvants and HPV vaccines up for debate

A recent press release from SaneVax reports:

The use of aluminum adjuvants and HPV vaccines’ benefit versus risk profile will be under intense scrutiny and open scientific debate on May 22, 2014.

Stakeholders from both sides of the vaccine debate will have an opportunity to present their case to members of the French Parliament, French Senate, health authorities, medical professionals and the public due to massive efforts on the part of E3M, a non-governmental organization of patients with MMF (macrophagic myofasciitis), and OSTA, a Parliamentary Office for Evaluation of Scientific and Technological Choice.

Obviously, the French government cares enough about the health and well-being of their citizens to listen to both sides of the vaccine debate – the very same ‘debate’ that government health officials in other countries claim doesn’t exist…

Read more on the SaneVax website: France: Aluminium adjuvants and HPV vaccines up for debate

The MMR second dose – an email to the President of the Australian Medical Association

Children continue to be vaccinated with two doses of the live Measles/Mumps/Rubella (MMR) vaccine, without their parents being properly informed about their options by healthcare providers.

In this regard, I have forwarded an email to Dr Steve Hambleton, President of the Australian Medical Association, see below.

_____________________________________________________________

2 May 2014

Dr Hambleton

Please see attached two letters I have recently forwarded to the NHMRC Australian Health Ethics Committee challenging the Australian Government’s requirement for revaccination of children with a second dose of live Measles/Mumps/Rubella (MMR) vaccine. (Letters dated 12 April 2014 and 19 March 2014.)

My letter to Professor Warwick Anderson, CEO of the NHMRC, suggesting the ethical spotlight needs to be shone on the way vaccination policy and practice is being implemented in Australia, is also attached for your information. (Letter dated 15 April 2014.)

In regards to MMR vaccination, to summarise, according to the GSK PRIORIX Product Information Leaflet, most seronegative individuals are likely to seroconvert after the first dose of effective live Measles/Mumps/Rubella (MMR) vaccine.

I question whether valid consent is being obtained before revaccination with the second dose of live MMR vaccine. For example, The Australian Immunisation Handbook (10th edition) provides criteria for consent to vaccination to be legally valid, i.e.:

It must be given by a person with legal capacity, and of sufficient intellectual capacity to understand the implications of being vaccinated.
It must be given voluntarily in the absence of undue pressure, coercion or manipulation.
It must cover the specific procedure that is to be performed.
It can only be given after the potential risks and benefits of the relevant vaccine, risks of not having it and any alternative options have been explained to the individual.

(My emphasis.)

Ironically, while an antibody titre test after live MMR vaccination would provide an opportunity to verify immunisation, parents in Australia are not being informed of this option at this time.

I question why parents aren’t provided with this evidence-based option, instead of being coerced into having two doses of live MMR vaccine for their children, as ‘recommended’ on the National Immunisation Program Schedule. It is possible that some careful parents might prefer to pay for antibody titre testing, rather than have their child revaccinated with a likely unnecessary second dose of live MMR vaccine.

In the state of New Jersey in the US, there is an “Antibody Titer Law” which gives parents a choice of an antibody titre test BEFORE they consent to a second dose of measles/mumps/rubella vaccine (see pamphlet attached.) Why aren’t all parents being informed about this option?

Parents of small children might be surprised to discover that vaccination ‘best practice’ for companion animals is now more advanced than that for children, with international vaccination guidelines for dogs re live vaccines recommending antibody titre testing rather than an arbitrary ‘booster’, i.e. “…the principles of ‘evidence-based veterinary medicine’ would dictate that testing for antibody status (for either pups or adult dogs) is a better practice than simply administering a vaccine booster on the basis that this should be ‘safe and cost less’”.

Dr Hambleton, an article in The Daily Telegraph (2 January 2014) notes that you applaud the new laws in New South Wales re vaccination. I suggest the AMA’s support for News Corp Australia’s extraordinarily crude ‘no jab, no play’ campaign is extremely problematic in that this authoritarian stance is forcing likely already immune children to have an arbitrary second dose of live MMR vaccine, without their parents being properly informed of their options.

I question the ethics of coercing parents to have vaccinations of questionable benefit for their children. I request your consideration of the matters I have raised, including my letters to the NHMRC, and your urgent response on this matter.

Sincerely

Elizabeth Hart

* Please note this correspondence will be circulated to other parties.

Over-vaccination of dogs with parvovirus and other vaccines remains prevalent practice

Dogs in Australia and elsewhere continue to be grossly over-vaccinated. These companion animals and their owners are being exploited by the veterinary industry.

See below my recent email on this matter to Ms Kareena Arthy, Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority (APVMA).

The APVMA is the body responsible for ‘regulating’ veterinary vaccine products in Australia.

_____________________________________________________________

23 April 2014

Ms Arthy

Further to my previous extensive correspondence with the APVMA and others on the subject of over-vaccination of dogs. (Please refer to hyperlinked list of correspondence below, including correspondence with Dr Allen Bryce, Executive Director of the APVMA’s Veterinary Medicines Program. My colleague Bea Mies has also undertaken extensive correspondence on this matter.)

The APVMA’s Position Statement – Vaccination Protocols for Dogs and Cats, last amended in September 2010, notes: “The APVMA does not support the retention of label statements that direct or imply a universal need for life-long annual revaccinations with core vaccines. The APVMA supports the AVA’s vaccination policy and is of the view that product labels should be amended to align with that policy. The APVMA is working with vaccine registrants with a view to updating labels.” (My emphasis.)

It is now April 2014 and still core vaccine products with an annual revaccination ‘recommendation’ remain on the market. For example Virbac Australia’s Canigen C4 DHA2PPI Quadrivalent Living Vaccine states: “An annual booster is recommended”. (Note: The label for Virbac’s Canigen DHA2P Trivalent Living Vaccine is currently not accessible on the PUBCRIS website.)

On what evidence is this ‘recommendation’ for an ‘annual booster’ with core vaccines based?

In August 2013, I forwarded a letter to Professor Ronald Schultz of the World Small Animal Veterinary Association’s Vaccination Guidelines Group, challenging the confusing and misleading use of the term ‘booster’ in relation to canine core modified live virus (MLV) vaccines for parvovirus, distemper virus and adenovirus, suggesting that use of the term ‘booster’ is resulting in extensive over-vaccination of already immune dogs. My letter can be accessed via this link: http://users.on.net/~peter.hart/Query_re_MLV_boosters.pdf

In his email response of 22 August 2013, Professor Schultz said: “I agree that the term “booster” is misleading in that many of the already immune dogs probably receive no beneficial “booster effect” from an infectious vaccine because the virus (e.g. CDV, CPV-2, CAV-2)* is immediately neutralized. Therefore, it cannot infect the cells and replicate! It is only in those dogs that have no viral antibody that the vaccine will booster the immune system, both the cellular and humoral response to the virus. It is these antibody negative dogs that I recommend revaccinating, not dogs with detectable antibody. There are, however, components of the vaccines that are almost always boostered such as fetal bovine serum components and other extraneous proteins that are in all vaccines. Obviously, these are components of the vaccine we don’t want to boost especially in a dog that genetically is predisposed to an adverse reaction (e.g. hypersensitivity). That is why we are trying to prevent annual revaccination with the Core Vaccines that provide long term immunity in a majority of most dogs, but not all!” (*Note: CDV, CPV-2 and CAV-2 are the canine diseases distemper virus, parvovirus and adenovirus [hepatitis]).

It is my strong suspicion that annual revaccination of dogs with core MLV vaccine products remains prevalent practice in Australia. See for example the attached article published in Dogs NSW in September 2013: “The Deadly Canine Parvovirus – Is Your Dog At Risk?”. My response to this article is attached. Also attached is the response by pro-annual vaccination vet Robert Zammit, and Virbac/ASAVA’s Mark Kelman.

See also this ‘Vaccination Guide’ from Greencross Vets which recommends revaccination every year with core vaccines for distemper, hepatitis and parvovirus (and non-core vaccines parainfluenza and bordetella).

Pet owners and their pets are being grossly exploited by the prevalent practice of over-vaccination due to the non-evidence based revaccination ‘recommendations’ on APVMA approved core MLV vaccine product labels. I also strongly suspect most pet owners are not being informed of the option of in-clinic and lab-based antibody titre testing to verify a response to core MLV vaccination.

Ms Arthy, on what evidence does the APVMA continue to re-register canine core MLV vaccine products which recommend repeated revaccination of adult dogs?

I request your urgent response on this matter.

Sincerely

Elizabeth Hart

See below hyperlinks to some of my correspondence, submissions and articles on over-vaccination of pets:

Key documents:

Over-vaccination of pets – an unethical practice (16 June 2009). My essay summarises the issue of over-vaccination of pets.
Is over-vaccination harming our pets? Are vets making our pets sick? (13 April 2009). My detailed and fully-referenced report was tabled at a special meeting convened by the Australian Pesticides and Veterinary Medicines Authority on 15 April 2009 to discuss the problem of unnecessary vaccination of pets.

Correspondence with the Australian Pesticides and Veterinary Medicines Authority (APVMA), Australian Veterinary Association (AVA), and others:

Email to James Suter, Australian Pesticides and Veterinary Medicines Authority (20 April 2011) with further questions re the APVMA’s responses to adverse experience reports being marked ‘COMMERCIAL-IN-CONFIDENCE’.
Email to Australian Veterinary Boards (19 May 2011) enquiring if the APVMA’s Position Statement on Vaccination Protocols for Dogs and Cats had been circulated to veterinarians, as requested by the APVMA in September 2010.
Open letter to Barry Smyth, President of the Australian Veterinary Association; Peter Punch, Chair of the Australasian Veterinary Boards Council; Eva Bennet-Jenkins, CEO, Australian Pesticides and Veterinary Medicines Authority (26 March 2011): A formal complaint re the continuing calls for already immune animals to be needlessly, and possibly harmfully, revaccinated.
Email to James Suter, Australian Pesticides and Veterinary Medicines Authority (6 March 2011) “Request for information re adverse experience reporting / possible conflicts of interest”.
Email to Allen Bryce, Australian Pesticides and Veterinary Medicines Authority (31 January 2011) re adverse experiences after vaccination
Open letter to the veterinary profession and industry (9 August 2010) re use of the media to promote over-servicing in the veterinary profession- unnecessary, and possibly harmful, vaccination of companion animals.
Response to Allen Bryce (23 June 2010), Program Manager, Veterinary Medicines, Australian Pesticides and Veterinary Medicines Authority re unnecessary, and possibly harmful, vaccination of companion animals, and the APVMA’s Position Statement on Vaccination Protocols for Dogs and Cats.
Open letter to Allen Bryce (17 June 2010), Program Manager, Veterinary Medicines, Australian Pesticides and Veterinary Medicines Authority re unnecessary, and possibly harmful vaccination of companion animals, and the APVMA’s Position Statement on Vaccination Protocols for Dogs and Cats.
Open letter to Mark Lawrie (May 2010) (Immediate Past) President of the Australian Veterinary Association re over-servicing in the veterinary profession – unnecessary, and possibly harmful, vaccination of companion animals (6 May 2010, with an update added on pages 3-4 on 23 May 2010).
Open letter to the Australian Pesticides and Veterinary Medicines Authority (24 January 2010), Australian Veterinary Association, Australian Small Animal Veterinary Association, and Competition and Consumer Policy Division, The Treasury re unnecessary vaccination of pets and the APVMA’s Position Statement on Vaccination Protocols for Dogs and Cats.
Open letter to the Australian Pesticides and Veterinary Medicines Authority (8 January 2010), Australian Veterinary Association and Australian Small Animal Veterinary Association re unnecessary vaccination of pets and the APVMA’s Position Statement on Vaccination Protocols for Dogs and Cats.
Open letter to the Australian Pesticides and Veterinary Medicines Authority (22 December 2009), Australian Veterinary Association and Australian Small Animal Veterinary Association re over-vaccination of pets / APVMA Position Statement / vaccine product labelling issues.
Is over-vaccination harming our pets? Are vets making our pets sick? (13 April 2009). This detailed and fully-referenced report was tabled at a special meeting convened by the APVMA on 15 April 2009 to discuss the problem of unnecessary vaccination of pets.

Correspondence with the UK Veterinary Medicines Directorate (VMD):

Email to Anna-Maria Brady, UK Veterinary Medicines Directorate (23 June 2011)requesting evidence to support the veterinary industry’s call for revaccination of pets.
Email to Anna-Maria Brady, UK Veterinary Medicines Directorate (15 May 2011) with questions re core vaccine product labelling in regards to duration of immunity.
Email to Anna-Maria Brady, UK Veterinary Medicines Directorate (1 April 2011)providing a pet owner’s perspective on pet vaccination.
More emails on this topic are accessible on the VMD website:http://www.vmd.defra.gov.uk/public/vaccines_letters.aspx#hart

Correspondence with Virbac Animal Health (Disease WatchDog):

Email to Mark Kelman, Virbac / Australian Small Animal Veterinary Association (7 February 2011) re further questions about the Virbac Disease WatchDog
Email to Mark Kelman, Virbac / Australian Small Animal Veterinary Association (26 January 2011) re alarming statistics regarding parvovirus and the Virbac Disease WatchDog.
Email to Mark Kelman, Virbac / Australian Small Animal Veterinary Association (31 July 2010), re canine vaccination protocols.

Submissions on the subject of unnecessary vaccination of pets:

A Submission to the Royal College of Veterinary Surgeons (24 June 2011), on the Draft Code of Professional Conduct for Veterinary Surgeons.
A Submission on the National Scheme for Assessment, Registration and Control of Use of Agricultural and Veterinary Chemicals Discussion Paper in relation to “Unnecessary, and Possibly Harmful, Use of Companion Animal Vaccines” (10 February 2010).
Submission to Craig Emerson MP (17 July 2009), Minister for Competition Policy and Consumer Affairs, on the Consumer Voices Issues Paper: “Request for consumer protection for consumers of veterinary services in Australia”.

Correspondence to Members of Parliament:

Email to Senator Joe Ludwig, Minister responsible for the APVMA (26 November 2011), complaining about the failure of ‘self-regulation’ of veterinarians.
Letter to Craig Emerson MP (4 July 2010), Federal Minister for Competition Policy and Consumer Affairs re submission on the Consumer Voices Issues Paper: “Request for consumer protection for consumers of veterinary services in Australia”.
Letter to Tony Burke MP (17 June 2010), Federal Minister responsible for the Australian Pesticides and Veterinary Medicines Authority, re unnecessary, and possibly harmful, vaccination of companion animals, and the APVMA’s Position Statement on Vaccination Protocols for Dogs and Cats (17 June 2010).

Articles and summaries re over-vaccination of pets:

The Australian campaign for ethical and evidence-based vaccination of companion animals (February 2012)
Vaccination failure! There is a potential for maternally derived antibodies (MDA) to interfere with a puppy’s response to core vaccination. (Article published in the May 2011 edition of National Dog).
Important Information for Dog Owners – Vaccination Update July 2010 (An earlier version of this article was also published in National Dog Volume 13, No. 6).
Letter to the Editor of The Veterinarian magazine (8 June 2010) Response to Aine Seavers’ article “Three-year vaccination intervals: a different view from the parvo trenches of practice-land”.
Letter to the Editor of The Veterinarian magazine (7 June 2010): ‘A pet owner’s perspective of the vaccination controversy’.
Too many needles ! Unnecessary vaccination exposed (February 2010. Article published in National Dog in April 2010).
The over-vaccination controversy continues (Article published in National Dog in December 2009).
Over-vaccination: Are vets making our pets sick? (June 2009. Article published in National Dog in July 2009).
Over-vaccination of pets – an unethical practice (16 June 2009). This essay summarises the issue of over-vaccination of pets.

Media reports re over-vaccination of pets:

Media reports re over-vaccination of pets in Australia August –October 2010
Examples of reports in the Australian media about parvovirus outbreaks during the period Dec 2009 to March 2011.

Questions about vaccination policy and ethics for the NHMRC

On 15 April 2014, I forwarded a letter to Professor Warwick Anderson, CEO of the National Health and Medical Research Council (NHMRC).

One of the functions of the NHMRC is to provide ethical guidance on health and medical research issues.

In my letter to Professor Anderson, I suggest the ethical spotlight needs to be shone on the way vaccination policy and practice is being implemented in Australia, and I provide examples of the lack of transparency and accountability in the vaccination bureaucracy.

In particular, I raise the problem of potential conflicts of interest and lack of disclosure by people involved in vaccination policy, followed by an example of parents being coerced into having a vaccine product for their children (i.e. the live Measles/Mumps/Rubella (MMR) vaccine second dose) without being properly informed about this vaccine, and their options.

See below my letter to Professor Anderson:

_____________________________________________________

15 April 2014

Professor Anderson

RE: Vaccination policy and practice in Australia

Professor Anderson, one of the functions of the NHMRC is to provide ethical guidance on health and medical research issues.[1]

I suggest the ethical spotlight needs to be shone on the way vaccination policy and practice is being implemented in Australia, and I request that you urgently address this matter.

In this regard, I provide two examples of the lack of transparency and accountability in the vaccination bureaucracy.

1. Potential conflicts of interest and lack of disclosure

Various committees and groups provide advice to the Australian Federal Government on vaccine products which can result in the addition of new vaccine products to the national vaccination schedule.

These groups wield enormous power. The members of these groups are part of a process that results in effectively mandating medical interventions (i.e. vaccinations) for healthy people. The decisions these people make affect not only children and adults in Australia, but can also impact internationally as the ripple effect of their decisions spreads around the world.[2]

The powerful influence of these groups raises serious political and ethical questions about their impact on the bodily integrity of citizens, particularly ‘pre-citizens’, i.e. children.

As the decisions of these committees can result in massive sales of vaccine products for pharmaceutical companies, it is vital that the process of adding vaccine products to the national vaccination schedule is open and transparent, and that any potential ‘conflicts of interest’ of the members of these groups are accessible for public perusal.

For example, a register detailing the history of any relationships with the vaccine industry, e.g. research grants, consultancies, honorariums, committee memberships, plus any shareholdings in vaccine companies, royalties received, directorships etc, must be publicly accessible. If a member indicates they have no potential conflicts of interest, this must be clearly recorded.

At this time, publicly accessible information on potential conflicts of interest for members of vaccination committees and groups is severely lacking in Australia. I suggest this lack of transparency contravenes The Australian Code for the Responsible Conduct of Research, in particular sections 4.9 “Disclose research support accurately” and 7. “Conflicts of interest”.[3]

For example, since December 2012[4], I have been asking Professor Suzanne Cory, President of the Australian Academy of Science, for public access to disclosure statements for members of the Working Group and Oversight Committee for “The Science of Immunisation: Questions and Answers” publication, which was funded by the Australian Federal Government’s Department of Health and Ageing. Despite promises that this matter is being addressed, as at 14 April 2014, disclosure information is still not provided on the Academy’s The Science of Immunisation: Questions and Answers webpage.

Similarly, on 26 November 2011 I asked then Federal Health Minister Nicola Roxon for details of membership of the Australian Technical Advisory Group on Immunisation (ATAGI), including their professional affiliations, and including any links with the pharmaceutical industry. While names of members of ATAGI and their affiliations are now published on the Immunise Australia website[5], there is still no disclosure information about potential conflicts of interest.[6] I also raised this subject with Professor Terry Nolan, Chair of ATAGI, but he failed to address the matter.[7]

There is also a lack of transparency about other committees involved with vaccine products. For instance the Therapeutic Goods Administration (TGA)’s webpage for the Advisory Committee on the Safety of Vaccines (ACSOV) provides a list of members and affiliations, but there is little clarity re potential conflicts of interest of these people.[8] In fact, it is very surprising to discover that this advisory committee on the safety of vaccines is chaired by Dr Nicole Gilroy, who is also a member of ATAGI.[9] Is it appropriate to have a person involved with the appraisal of vaccine products for the national schedule also to be in a position to evaluate post-marketing safety issues? I suggest that this is inappropriate and that there is a potential for conflict of interest here.

Another example of lack of transparency is the Pharmaceutical Benefits Advisory Committee (PBAC) webpage[10], which lists members of the PBAC and their affiliations, but again provides lilttle clarity re potential conflicts of interest of these people.

Then there is the Australian Influenza Vaccine Committee (AVIC), which recommends influenza viruses to be used in the composition of influenza vaccines. There are currently no details of membership of this committee provided on the AVIC webpage on the TGA website, let alone disclosure of potential conflicts of interest.[11] I have requested that the TGA provide publicly accessible information about this committee on the TGA website. I am awaiting developments on this request.

These examples indicate there is a serious problem with a lack of disclosure of conflicts of interest that needs to be addressed. Inter-relationships between these groups should also be investigated.

2. Government ‘requirements’ for vaccination to access family tax benefits – e.g. the Measles/Mumps/Rubella (MMR) vaccine second dose

Recently I have forwarded two letters to Professor Ian Olver, Chair of the NHMRC Australian Health Ethics Committee, challenging the Australian Government’s requirement for revaccination of children with a second dose of live MMR vaccine, as children are likely to be immune after the first dose of effective live MMR vaccine, given at the appropriate age (i.e. after maternally derived antibodies have waned). (I have previously raised this matter with then Federal Minister for Health, Tanya Plibersek (see letter dated 28 June 2012), and also the Chair of ATAGI, Professor Terry Nolan (see email dated 11 March 2013). My entirely unsatisfactory experience in this correspondence is described on my website.)

Copies of my letters to the NHMRC AHEC are attached and are also accessible via the following hyperlinks: Letter dated 12 April 2014 and Letter dated 19 March 2014.

Please note that my letter dated 12 April 2014 includes reference to Dr Jeannette Young, who is a member of the Council of NHMRC by dint of her role as Queensland’s Chief Medical Officer[12]. My letter criticises a letter forwarded by Dr Young to 13,117 parents in Queensland which stated: “Two doses of measles containing vaccine are needed to provide a high level of protection.” An article in The Courier-Mail on 15 April 2014, “Federal Health Department plan to send out vaccination reminder letters”, also refers to Dr Young’s letter to parents. I suggest it is misleading to tell parents that “two doses of measles containing vaccine are needed to provide a high level of protection”. As I have argued in my letters to the NHMRC AHEC, it is likely that one dose of effective GSK PRIORIX live MMR vaccine will provide protection for previously seronegative subjects, and this can be verified by antibody titre testing.

Professor Anderson, vaccination/immunisation is an important ethical and political issue. We are on a slippery slope when potentially conflicted government vaccination bureaucracies dictate questionable medical interventions for citizens (including ‘pre-citizens’, i.e. children).

It has been my experience that it is very difficult to question vaccination policy and practice in Australia, particularly due to the hostile climate created by the media. For example, in an extraordinarily crude campaign, News Corp Australia media is being used as a blunt instrument to bully parents into meek compliance with all vaccination ‘requirements’ stipulated by the government’s vaccination bureaucracy.[13] Scientists Sir Gus Nossal[14] and Professor Ian Frazer[15] have played a part in this campaign. Crikey’s Bernard Keane also suggests “should we ban anti-vaccination talk?”[16] Journalists in this country appear to be ill-equipped to critically analyse complex vaccination/immunisation issues, and instead are responsible for fostering a discourse which is polarised and not conducive to thoughtful discussion.[17]

Professor Anderson, Jillian Barr, Director of the NHMRC Health and Research Ethics Section, has advised me my submissions about the live MMR vaccine second dose will be considered by the NHMRC AHEC at its next meeting in early May 2014. I request that you also seriously consider the matters I have raised in this letter about disclosure of conflicts of interest, and evidence-based vaccination policy and practice.

Sincerely

Elizabeth Hart

*Please note this letter will be circulated to other parties, and has also been published on my website.

cc: Members of the NHMRC Australian Health Ethics Committee (AHEC)

Professor Ian Olver,Chair
Dr Gary Allen
Professor Vicki Anderson
Professor Samar Aoun
Professor Susan Dodds
Associate Professor Ian Kerridge
Dr Tammy Kimpton
Rabbi Aviva Kipen
Reverend Kevin McGovern
Professor John McGrath AM
Dr Eleanor Milligan
Professor Robin Mortimer
Ms Kay Oke
Professor Margaret Otlowski
Professor Debra Rickwood
Professor Wendy Rogers
Professor Loane Skene

and Professor Brian Martin, Social Sciences, University of Wollongong

Attachments:

Letter re the MMR vaccine second dose to NHMRC AHEC dated 19 March 2014
Letter re the MMR vaccine second dose to NHMRC AHEC dated 12 April 2014

References: (All links accessible as at 15 April 2014. It may be necessary to copy and paste long links in a web browser.) (Note – reference list updated and amended from original letter.)

____________________________________________________

[1] “NHMRC plays a pivotal role in providing independent advice on the complementary functions of funding health and medical research, providing ethical guidance on health and medical research issues, and providing health advice.” NHMRC CEO Warwick Anderson AM: https://www.nhmrc.gov.au/about/nhmrc-senior-staff/nhmrc-ceo-warwick-anderson-am

[2] For example Australia has been a leader in implementing HPV vaccination for boys and girls. HPV vaccination is now being implemented around the world. See my webpage questioning HPV vaccination for further background: https://over-vaccination.net/questionable-vaccines/hpv-vax/

[3] Australian Code for the Responsible Conduct of Research. Jointly issued by the National Health and Medical Research Council, the Australian Research Council and Universities Australia. 2007: https://www.nhmrc.gov.au/guidelines/publications/r39

[4] My webpage on the Australian Academy of Science provides background on my experience in seeking disclosure statements for members of the Working Group and Oversight Committee for The Science of Immunisation: Questions and Answers publication: https://over-vaccination.net/the-experts/australian-academy-of-science/

[5] Australian Technical Advisory Group on Immunisation (ATAGI): http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/advisory-bodies

[6] I also raised this matter with then Federal Health Minister Tanya Plibersek in an email dated 23 January 2012.

[7] In an email query regarding the second MMR vaccine dose addressed to Professor Terry Nolan, Chair of ATAGI, I also raised questions about ‘declarations of interest’ for ATAGI members: http://users.on.net/~peter.hart/Email_to_Prof_Terry_Nolan_ATAGI_MMR_11_March_2013.pdf

[8] Advisory Committee on the Safety of Vaccines (ACSOV): http://www.tga.gov.au/about/committees-acsov.htm#.U0y3_PmSz-t

[9] Dr Nicole Gilroy is listed as a voting member of the Australian Technical Advisory Group on Immunisation (ATAGI): http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/advisory-bodies

[10] Pharmaceutical Benefits Advisory Committee (PBAC): http://www.pbs.gov.au/info/industry/listing/participants/pbac

[11] Australian Influenza Vaccine Committee (AVIC): http://www.tga.gov.au/about/committees-aivc.htm#.U0y76fmSz-t

[12] Council of NHMRC: https://www.nhmrc.gov.au/about/council-nhmrc

[13] See for example these recent articles published in News Corp Australia media written by journalists who obviously lack knowledge about the complexity of individual vaccine products:

Federal Health Department plan to send out vaccination reminder letters. The Courier-Mail, 15 April 2014: http://www.couriermail.com.au/news/queensland/federal-health-department-plan-to-send-out-vaccination-reminder-letters/story-fnihsrf2-1226884311106
OPINION: A shot of common sense on vaccination required. The Courier-Mail, 15 April 2014: http://www.couriermail.com.au/news/opinion/opinion-a-shot-of-common-sense-on-vaccination-required/story-fnihsr9v-1226884152907
Chief Health Officer Dr Jeannette Young supports The Courier-Mail push to improve Queensland vaccination rates. The Courier-Mail, 14 April 2014: http://www.couriermail.com.au/news/queensland/chief-health-officer-dr-jeannette-young-supports-the-couriermail-push-to-improve-queensland-vaccination-rates/story-fnihsrf2-1226882832724
McCaffery family back push for greater vaccination rates across Queensland following the death of precious daughter Dana. The Courier-Mail, 14 April 2014: http://www.couriermail.com.au/news/queensland/mccaffery-family-back-push-for-greater-vaccination-rates-across-queensland-following-the-death-of-precious-daughter-dana/story-fnihsrf2-1226882844012
A third of the Australian Vaccination Skeptics Network’s members are medical professionals. The Sunday Telegraph, 12 April 2014: http://www.dailytelegraph.com.au/news/nsw/a-third-of-the-australian-vaccination-skeptics-networks-members-are-medical-professionals/story-fni0cx12-1226879881819
State and federal health ministers agree that all families must support vaccination of children. The Courier-Mail, 12 April 2014: http://www.couriermail.com.au/news/queensland/state-and-federal-health-ministers-agree-that-all-families-must-support-vaccination-of-children/story-fnihsrf2-1226881380349
It’s stupid to neglect vaccinations. Herald Sun, 11 April 2014: http://www.heraldsun.com.au/news/opinion/its-stupid-to-neglect-vaccinations/story-fni0ffsx-1226881370107
EDITORIAL: Conscientious objectors to vaccination need to take stock of the big picture. The Courier-Mail, 11 April 2014: http://www.couriermail.com.au/news/opinion/editorial-conscientious-objectors-to-vaccination-need-to-take-stock-of-the-big-picture/story-fnihsr9v-1226880339579
Doctors want vaccination reforms for childcare centres. The Courier-Mail, 11 April 2014: http://www.couriermail.com.au/news/queensland/doctors-want-vaccination-reforms-for-childcare-centres/story-fnihsrf2-1226880381081 (Also reported on The Australian website.)
Health Minister Lawrence Springborg set to block ‘conscientious objection’ excuse for vaccination refusers. The Courier-Mail, 9 April 2014: http://www.couriermail.com.au/news/queensland/health-minister-lawrence-springborg-set-to-block-conscientious-objection-excuse-for-vaccination-refusers/story-fnihsrf2-1226878219971

[14] Scientists call for end of handouts to parents who don’t vaccinate children. The Telegraph, 6 April 2014: http://www.dailytelegraph.com.au/news/nsw/scientists-call-for-end-of-handouts-to-parents-who-dont-vaccinate-children/story-fni0cx12-1226874673399 (Also reported on The Australian website.)

[15] Common childhood infections such as whooping cough are not gone but some parents still reject vaccination. The Courier-Mail, 11 April 2014: http://www.couriermail.com.au/news/opinion/common-childhood-infections-such-as-whooping-cough-are-not-gone-but-some-parents-still-reject-vaccination/story-fnihsr9v-1226880265364

[16] A hard case of harmful speech: should we ban anti-vaccination talk? Crikey, 9 April 2014: http://www.crikey.com.au/2014/04/09/a-hard-case-of-harmful-speech-should-we-ban-anti-vaccination-talk/

[17] Professor Brian Martin provides an eloquent summary in his article “On the suppression of vaccination dissent” where he argues: “Suppression of dissent, through its chilling effect, can skew public debates, by discouraging participation. In Australia, critics of vaccination have become aware that if they become visible, they are potentially subject to denigration and complaints. Because of the level of personal abuse by pro-vaccinationists, many of those who might take a middle-of-the-road perspective, perhaps being slightly critical of some aspects of vaccine policy, are discouraged from expressing their views. The result is a highly polarized public discourse that is not conducive to the sort of careful deliberation desirable for addressing complex issues.” (My emphasis.) On the suppression of vaccination dissent. Science & Engineering Ethics. March 2014, doi 10.1007/s11948-014-9530-3 http://www.bmartin.cc/pubs/14see.html

UPDATE: NHMRC Ethics Committee and the MMR second dose

On 19 March 2014, I forwarded a letter to Professor Ian Olver, Chair of the NHMRC Australian Health Ethics Committee, challenging the Australian Government’s requirement for revaccination of children with a second dose of live MMR vaccine, as children are likely to be immune after the first dose of effective live MMR vaccine, given at the appropriate age (i.e. after maternally derived antibodies have waned).

Jillian Barr, Director of the NHMRC Health and Research Ethics Section, has acknowledged receipt of my submission regarding the MMR second dose, and advised that this matter will be considered by the NHMRC Australian Health Ethics Committee at its next meeting in early May 2014.

In the meantime, I have forwarded another letter re the MMR second dose to Professor Olver and his AHEC colleagues, see below:

_________________________________________________________

12 April 2014

Professor Olver

RE: Measles/Mumps/Rubella (MMR) vaccination – refer to my previous letter dated 19 March 2014

Professor Olver, in my previous letter to you, I argued that most children are likely to be immune after the first dose of effective live Measles/Mumps/Rubella (MMR) vaccine, and I challenged the Australian government’s requirement for children to have a second dose of live Measles/Mumps/Rubella (MMR) vaccine, which is linked to obtaining Immunisation Related Payments for Parents.

In my letter I questioned the ethics of coercing parents to have vaccinations of questionable benefit for their children.

In this regard I draw your attention to a ‘MEASLES ALERT’ letter (see attached), forwarded to 13,117 parents in Queensland by Chief Health Officer Dr Jeannette Young in September 2013, which tells these parents that “Two doses of measles containing vaccine are needed to provide a high level of protection.” This advice was also included in a Queensland Government media statement[1] and reported in an article published in The Courier-Mail on 14 October 2013: “Vaccination no-shows prompt top-level measles outbreak warning”[2]

Professor Olver, I suggest it is misleading to tell parents that “two doses of measles containing vaccine are needed to provide a high level of protection”. As I argued in my previous letter, it is likely one dose of effective GSK PRIORIX live MMR vaccine is likely to provide protection for previously seronegative subjects.

A response to live MMR vaccination can be verified by antibody titre testing. I suggest there may be some cautious parents who would prefer to have an antibody titre test for their child rather than an arbitrary live MMR revaccination, and who might be willing to pay for an antibody titre test themselves. Yet, in contravention of The Australian Immunisation Handbook’s criteria for consent to vaccination to be legally valid, i.e. that any alternative options be explained to the individual,[3] it appears healthcare providers are not informing parents about the option of antibody titre testing.

In another jurisdiction, the state of New Jersey in the United States, the health department provides information on antibody titre testing. The Antibody Titer Law (Holly’s Law)[4] allows parents to seek testing to determine a child’s immunity to measles, mumps and rubella before receiving the second dose of MMR vaccine. The law was enacted in response to the death of five year old Holly Marie Stavola who died of encephalopathy which she developed seven days after receiving her second dose of MMR vaccine.[5] Holly’s family campaigned for this law, wishing they had known about the option of the antibody titre test before Holly’s arbitrary revaccination with the second dose of live MMR vaccine.[6]

All parents should be informed about the option of antibody titre testing to verify a response to live MMR vaccination. All parents should be informed of the reportedly high seroconversion rates after live MMR vaccination at the appropriate age. All parents should be properly informed about the risks and benefits of individual vaccine products. This is not happening. Instead, the media is being used as a blunt instrument to bully parents into unquestioning compliance with all vaccination ‘requirements’ mandated by the government’s vaccination bureaucracy and the vaccine industry, see for example:

Scientists call for end of handouts to parents who don’t vaccinate children, The Telegraph, 6 April 2014[7]
Doctors want revaccination reforms for childcare centres, The Australian, 11 April 2014[8]
Peter Dutton considers plan to withhold family tax benefits if children aren’t immunised, ABC News, 11 April 2014[9]

Professor Olver, we are on a slippery slope when governments dictate questionable medical interventions for citizens (including ‘pre-citizens’, i.e. children). The arbitrary second dose of the MMR vaccine, often inappropriately described as a ‘booster’[10], is a questionable medical intervention. Vaccination/immunisation is a complex matter that requires thoughtful discussion, not the polarised discourse currently evident in Australia.[11] I request that you and your AHEC colleagues urgently consider this matter.

Sincerely

Elizabeth Hart

*Please note this letter will be circulated to other parties.

cc: Members of the NHMRC Australian Health Ethics Committee (AHEC)

Dr Gary Allen
Professor Vicki Anderson
Professor Samar Aoun
Professor Susan Dodds
Associate Professor Ian Kerridge
Dr Tammy Kimpton
Rabbi Aviva Kipen
Reverend Kevin McGovern
Professor John McGrath AM
Dr Eleanor Milligan
Professor Robin Mortimer
Ms Kay Oke
Professor Margaret Otlowski
Professor Debra Rickwood
Professor Wendy Rogers
Professor Loane Skene

and Professor Brian Martin, Social Sciences, University of Wollongong

Attachments:

Measles Alert. Letter to parents/carers from Dr Jeannette Young, Chief Health Officer, Queensland Government Department of Health, 17 September 2013.
Antibody Titer Law – Information for Parents pamphlet. The Antibody Titer Law gives parents a choice BEFORE they consent to a second dose of measles, mumps and rubella vaccine.

References: (All links accessible as at 12 April 2014. It may be necessary to copy and paste long links in a web browser.)

_______________________________________________

[1] Queensland Department of Health Media Statement, 14 October 2013.

[2] Vaccination no-shows prompt top-level measles outbreak warning. The Courier Mail, 14 October 2013: http://www.couriermail.com.au/news/queensland/vaccination-noshows-prompt-toplevel-measles-outbreak-warning/story-fnihsrf2-1226739273248

[3] 2.1.3 Valid Consent. 2.1 Pre-vaccination. The Australian Immunisation Handbook. 10th Edition 2013:

http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook10-2-1

[4] Antibody Titer Law – Information for Parents. (Holly’s Law) (NJSA 26:2N-8-11), passed on January 14, 2004, concerns vaccination of children with the Measles, Mumps, Rubella (MMR) vaccine. The law allows parents to seek testing to determine a child’s immunity to measles, mumps, and rubella, before receiving the second dose of the vaccine. This brochure has been prepared by the New Jersey Department of Health and Senior Services to assist parents in making the decisions related to the MMR vaccine and the test: http://www.state.nj.us/health/cd/documents/antibody_titer_law.pdf

[5] HopeFromHolly. Providing NJ physicians and pParents with more knowledge about childhood vaccines: http://hopefromholly.com/blog/our-purpose/

[6] Holly’s story – Holly Marie Stavola, January 18, 1995 – February 4, 2000:

http://hopefromholly.com/blog/category/holly-stavola/

[7] Scientists call for end of handouts to parents who don’t vaccinate children. The Telegraph, 6 April 2014: http://www.dailytelegraph.com.au/news/nsw/scientists-call-for-end-of-handouts-to-parents-who-dont-vaccinate-children/story-fni0cx12-1226874673399

[8] Doctors want vaccination reforms for childcare centres. The Australian, 11 April 2014: http://www.theaustralian.com.au/news/doctors-want-vaccination-reforms-for-childcare-centres/story-e6frg6n6-1226880381081

[9] Peter Dutton considers plan to withhold family tax benefits if children aren’t immunised. ABC News, 11 April 2014: http://www.abc.net.au/news/2014-04-11/govt-may-withhold-family-tax-benefit-if-children-not-vaccinated/5382054

[10] For example the NPS Medicinewise website states: “Separate vaccines for measles, mumps and rubella are not available in Australia. So the combined measles, mumps and rubella (MMR) vaccine is given in a single injection with a second booster dose.” http://www.nps.org.au/medicines/immune-system/vaccines-and-immunisation/for-individuals/vaccines-a-z/measles-mumps-and-rubella-mmr

[11] In his article “On the suppression of vaccination dissent”, Professor Brian Martin says: “Suppression of dissent, through its chilling effect, can skew public debates, by discouraging participation. In Australia, critics of vaccination have become aware that if they become visible, they are potentially subject to denigration and complaints. Because of the level of personal abuse by pro-vaccinationists, many of those who might take a middle-of-the road perspective, perhaps being slightly critical of some aspects of vaccine policy, are discouraged from expressing their views. The result is a highly polarized public discourse that is not conducive to the sort of careful deliberation desirable for addressing complex issues.” (My emphasis.) Source: Science & Engineering Ethics. March 2014, doi 10.1007/s11948-014-95303 http://www.bmartin.cc/pubs/14see.html

Measles/Mumps/Rubella (MMR) vaccination and ‘informed consent’ – a letter to the NHMRC Australian Health Ethics Committee

Further to my letter to the US Advisory Committee on Immunization Practices, challenging government mandated revaccination of children with the second dose of live Measles/Mumps/Rubella (MMR) vaccine.

I have now forwarded a letter on this matter to the NHMRC Australian Health Ethics Committee, challenging the Australian Government’s requirement for revaccination of children with a second dose of live MMR vaccine, as children are likely to be immune after the first dose of effective live MMR vaccine, given at the appropriate age (i.e. after maternally derived antibodies have waned).

The medical establishment, pharmaceutical industry, and governments are imposing an ever-increasing amount of lucrative vaccine products on healthy people. Vaccines are medical interventions and it is imperative that citizens give their ‘informed consent’ to these interventions. Children, i.e. ‘pre-citizens’, also have a right to bodily integrity, and it is essential that parents are properly informed before medical interventions for their children.

See below my detailed letter forwarded to Professor Ian Olver, Chair of the NHMRC Australian Health Ethics Committee. The letter has also been forwarded to each member of the committee, see membership list also noted below.

______________________________________________

19 March 2014

Professor Olver

RE: The Australian Government’s requirement for revaccination of children with a second dose of live Measles/Mumps/Rubella (MMR) vaccine / lack of ‘informed consent’ / adverse events

The Australian Government’s National Immunisation Program Schedule stipulates that children receive two doses of live measles/mumps/rubella (MMR) vaccines[1], and meeting this requirement is linked to obtaining Immunisation Related Payments for Parents.[2]

However, according to the GlaxoSmithKline PRIORIX Product Information leaflet, most seronegative children are likely to be immune after one dose of live MMR vaccine.[3]

I question whether parents are being given the opportunity to properly give their ‘informed consent’ to the second dose of the live MMR vaccine (or the MMR+varicella i.e. GlaxoSmithKline PRIORIX-TETRA MMRV vaccine) for their children. This question is particularly pertinent as adverse events have been reported after MMR and MMRV vaccination.

I request that the NHMRC Australian Health Ethics Committee respond to me on this matter, and I provide further supporting information below.

According to the PRIORIX Product Information Leaflet, in “a more recent study comparing the formulation of PRIORIX (albumin-free) with the previous formulation containing albumin, antibodies against measles, mumps and rubella were detected in 98.4, 94.8 and 100% of previously seronegative subjects (n=191)”. The leaflet also contains similarly high seroconversion rates from earlier studies.[4]

The PRIORIX Product Information Leaflet notes that: “Seroconversion has been shown to equate with protection against each of the measles, mumps and rubella viruses.”[5] The National Immunisation Program Schedule recommends the first MMR vaccination at 12 months of age[6], so presumably it is expected that most children will be seronegative at this age, i.e. maternally derived antibodies will have waned.

Despite the fact it appears one dose of PRIORIX MMR live vaccine is likely to provide protection for previously seronegative subjects, the PRIORIX Product Information Leaflet indicates two doses are to be given, i.e. “The Australian NH&MRC Immunisation Handbook recommendations for MMR vaccination are as follows: MMR vaccine is recommended for all children at 12 months of age and again at 4-6 years of age unless there is a genuine contraindication.”[7]

It is notable that neither the PRIORIX[8] nor the PRIORIX-TETRA[9] Consumer Medicine Information leaflets contain information on the reportedly high seroconversion rates after live MMR vaccination. Does this indicate that parents are not being informed of the reportedly high seroconversion rates after vaccination of previously seronegative children with the PRIORIX MMR vaccine product?

It is also notable that there is no reference to the option of antibody titre testing to verify a response to MMR vaccination in either the Consumer Medicines Information leaflet or the Product Information leaflet for PRIORIX or PRIORIX-TETRA.

What are the ramifications here for ‘informed consent’?

The Australian Immunisation Handbook provides criteria for consent to vaccination to be legally valid, i.e.:

1. It must be given by a person with legal capacity, and of sufficient intellectual capacity to understand the implications of being vaccinated.

2. It must be given voluntarily in the absence of undue pressure, coercion or manipulation.

3. It must cover the specific procedure that is to be performed.

4. It can only be given after the potential risks and benefits of the relevant vaccine, risks of not having it and any alternative options have been explained to the individual.[10]

Professor Olver, I question whether parents are being properly informed by healthcare providers before administration of the second dose of measles, mumps and rubella vaccine, (whether via the MMR or MMRV injection).

In regards to point 2 above, I suggest parents are being pressured/coerced/manipulated to have the vaccine via the reward of Immunisation Related Payments. While the Immunise Australia website notes that “benefits can be received without a child being fully immunised”[11] this is only the case after completion of an Immunisation exemption: Medical contraindication form[12] or Immunisation exemption: Conscientious objection form[13]. I suggest that neither of these forms in their current format is appropriate in the case of the questionable second dose of the live MMR vaccine.

In regards to point 4 above, I question whether parents are being properly informed of the potential risks and benefits of the second dose of the MMR vaccine. There are no benefits to the child if the child is already immune after the first dose. There are risks, i.e. possible side effects, as detailed in the PRIORIX and PRIORIX-TETRA Consumer Medicine Information leaflets and Product Information leaflets. Are healthcare providers bringing this information to the attention of parents (and others)?

Reports of adverse events after MMR and MMRV vaccination have been submitted to the TGA’s Database of Adverse Events.[14] (Refer to reports attached.) For example a TGA list of adverse events after vaccination with PRIORIX, generated for the dates 1 January 2012 to 20 November 2013, indicates 674 adverse event reports were made in that period. 253 of these cases occurred in four year olds. Other age groups, (including adults), also reported adverse events after vaccination with PRIORIX. As it is likely many of these children had already been vaccinated with PRIORIX at 12 months of age and were likely already immune, (if the PRIORIX MMR vaccine is as effective as claimed), they underwent revaccination for no benefit.

The MMRV vaccine was added to the Australian Government’s National Immunisation Program Schedule in July 2013[15], for vaccination of children at 18 months of age, after vaccination with the MMR at 12 months of age. A TGA adverse event list generated for the dates 1 July 2013 to 20 November 2013 shows 80 reports of adverse events after vaccination with the PRIORIX-TETRA MMRV vaccine product. If the children involved in these reports had already been vaccinated with the PRIORIX MMR vaccine at 12 months of age, again it is likely they were already immune to measles/mumps/rubella.

It should be recognised that adverse events after vaccination are likely to be under-reported. The TGA acknowledges that reporting of adverse events to the TGA is voluntary, and that there is under-reporting in Australia, and around the world.[16] In regards to the lack of safety information for the MMR vaccine, the Cochrane Collaboration’s systematic review of MMR vaccination notes: “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”[17]

Again in relation to point 4 above, I also question whether “alternative options”, e.g. antibody titre testing to verify a response to MMR vaccination, are being explained to parents by healthcare providers. It is possible that some careful parents might prefer to pay for antibody titre testing, rather than have their child revaccinated with a probably unnecessary second dose of live MMR vaccine.

Parents of small children might be surprised to discover that vaccination ‘best practice’ for companion animals is now more advanced than that for children, with international vaccination guidelines for dogs re live vaccines recommending antibody titre testing rather than an arbitrary ‘booster’, i.e.: “…the principles of ‘evidence-based veterinary medicine’ would dictate that testing for antibody status (for either pups or adult dogs) is a better practice than simply administering a vaccine booster on the basis that this should be ‘safe and cost less’”.[18]

Professor Olver, I question the ethics of coercing parents to have vaccinations of questionable benefit for their children. According to the vaccine manufacturer’s data, it appears most seronegative individuals are likely to be immune after the first dose of MMR vaccine. It appears likely from TGA adverse event database information that children (and possibly adults) have suffered after revaccination with a second dose of MMR vaccine. I suggest there has been inadequate research undertaken on the possibly deleterious long-term effects of repeated vaccination, and so unnecessary vaccination should be avoided.

As the Australian Health Ethics Committee is responsible to advise the NHMRC on ethical issues relating to health, I would appreciate your urgent response on this matter to my email address elizmhart@gmail.com

Sincerely

Elizabeth Hart

*Please note this letter will be circulated to other parties.

cc: Members of the NHMRC Australian Health Ethics Committee (AHEC)

Dr Gary Allen
Professor Vicki Anderson
Professor Samar Aoun
Professor Susan Dodds
Associate Professor Ian Kerridge
Dr Tammy Kimpton
Rabbi Aviva Kipen
Reverend Kevin McGovern
Professor John McGrath AM
Dr Eleanor Milligan
Professor Robin Mortimer
Ms Kay Oke
Professor Margaret Otlowski
Professor Debra Rickwood
Professor Wendy Rogers
Professor Loane Skene

and Professor Brian Martin, Social Sciences, University of Wollongong

References: (All links accessible as at 19 March 2014.)

[1] National Immunisation Program Schedule from 1 July 2013: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/nips-ctn

[2] Immunise Australia Program. Immunisation Related Payments for Parents. (Webpage dated 12 September 2013): http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/related-payments

[3] GlaxoSmithKline PRIORIX Product Information:

https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-05279-3

[4] Ibid.

[5] Ibid.

[6] National Immunisation Program Schedule from 1 July 2013: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/nips-ctn

[7] GlaxoSmithKline PRIORIX Product Information:

https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-05279-3

[8] GlaxoSmithKline PRIORIX Consumer Medicine Information Leaflet: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-CMI-05278-3

[9] GlaxoSmithKline PRIORIX-TETRA Consumer Medicine Information Leaflet: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2013-CMI-01069-1

[10] 2.1.3 Valid Consent. 2.1 Pre-vaccination. The Australian Immunisation Handbook. 10^th Edition 2013: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/handbook10-2-1

[11] Immunise Australia Program. Immunisation Related Payments for Parents. (Webpage dated 12 September 2013): http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/related-payments

[12] Immunisation exemption: Medical contraindication form: http://www.humanservices.gov.au/spw/customer/forms/resources/immu11.1310p.pdf on the Department of Human Services website: http://www.humanservices.gov.au/customer/forms/immu11

[13] Immunisation exemption: Conscientious objection form: http://www.humanservices.gov.au/spw/customer/forms/resources/immu12-1302en.pdf on the Department of Human Services website: http://www.humanservices.gov.au/customer/forms/immu12

[14] Adverse event information for medicines and medical devices can be accessed in the TGA’s Database of Adverse Notifications (DAEN): http://www.tga.gov.au/safety/daen.htm#.UyjVXfmSz-t

[15] National Immunisation Program Schedule from 1 July 2013: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/nips-ctn

[16] “Adverse event reports from consumers and health professionals to the TGA are voluntary, so there is under-reporting by these groups of adverse events related to therapeutic goods in Australia. This is the same around the world.” About the DAEN – medicines: http://www.tga.gov.au/safety/daen-about.htm#.UyglSfmSz-t

[17] Demicheli V, Rivetti A, Debalini MG, Di Pietrantonj C. Vaccines for measles, mumps and rubella in children. Cochrane

Database of Systematic Reviews 2012, Issue 2. Art. No.: CD004407. DOI: 10.1002/14651858.CD004407.pub3.

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004407.pub3/abstract

[18] See page 7 under “Serological Testing to Determine the Duration of Immunity (DOI)” in Day, M.J., Horzinek, M.C., Schultz, R.D. World Small Animal Veterinary Association’s (WSAVA) Guidelines for the Vaccination of Dogs and Cats. Journal of Small Animal Practice. Vol. 51. June 2010: http://www.wsava.org/sites/default/files/VaccinationGuidelines2010.pdf

International Medical Researchers Issue Warning about HPV Vaccine Side Effects

Further to my previous post Adverse events after HPV vaccination – international symposium held in Japan, February 2014.

SaneVax reports the international symposium and associated events have “sparked a high-profile debate over HPV vaccine safety, efficacy and need…”

Read more on the Sanevax website.

‘Informed consent’ and the Measles/Mumps/Rubella (MMR) vaccine – challenging the US Advisory Committee on Immunization Practices

As I have argued previously on Over-vaccination.net, it’s likely that most children will be immune after the first dose of the live Measles/Mumps/Rubella (MMR) vaccine.

However, mass populations of already immune children are being arbitrarily revaccinated with a second dose of the live MMR vaccine because a small proportion of children may not have responded to the first dose.

In other words, millions of children are being over-vaccinated with the second dose of live MMR vaccine.

Are parents being given the opportunity to properly give their ‘informed consent’ to the second dose of live Measles/Mumps/Rubella (MMR) vaccine?

See below my letter forwarded to Professor Jonathan Temte, Chair of the US Advisory Committee on Immunization Practices, challenging government mandated revaccination of children with the live MMR vaccine second dose.

_________________________________________

5 March 2014

Professor Temte

CHALLENGING MANDATED REVACCINATION OF CHILDREN WITH THE MEASLES/MUMPS/RUBELLA (MMR) VACCINE ‘BOOSTER’ SECOND DOSE

The Advisory Committee on Immunization Practices recommends that children in the United States receive two doses of live measles/mumps/rubella (MMR) vaccines at 12-15 months and 4-6 years.[1] As a result of the ACIP’s recommendation, two MMR vaccine doses are mandated in many US states.[2]

However, according to the Merck M-M-R II Information Sheet, most seronegative children are likely to be immune after one dose of live MMR vaccine.[3]

In regards to measles vaccination, the Advisory Committee on Immunization Practices report on MMR vaccination (June 2013) admits that: “The second dose of measles-containing vaccine primarily was intended to induce immunity in the small percentage of persons who did not seroconvert after vaccination with the first dose of vaccine (primary vaccine failure).”[4]

Given that most children are likely to be immunised after the first dose of live MMR vaccine, I question whether parents are being given the opportunity to properly give their ‘informed consent’ to the second dose of live MMR vaccine, also often described as a ‘booster’.[5] This question is particularly pertinent as adverse events have been reported after MMR vaccination.

I request that the Advisory Committee on Immunization Practices respond to me on this matter, and I provide further supporting information below.

According to the Information Sheet for Merck’s M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) “clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that M-M-R II is highly immunogenic and generally well tolerated. In these studies, a single injection of the vaccine induced measles hemagglutination-inhibition (HI) antibodies in 95%, mumps neutralizing antibodies in 96%, and rubella HI antibodies in 99% of susceptible persons.”[6] (My emphasis.)

The Merck M-M-R II Information Sheet also notes: “…a small percentage (1-5%) of vaccinees may fail to seroconvert after the primary dose”.[7] It is my understanding that failure to seroconvert after vaccination with the primary dose is most likely due to interference of maternally derived antibodies, i.e. if the child is vaccinated at an age before maternally derived antibodies have waned. Other reasons could be problems with the effectiveness of the vaccine product that results in vaccine failure, or that the individual is a poor responder.

No reference to published details of the “clinical studies of 284 triple seronegative children” is provided in Merck’s M-M-R II Information Sheet. However, the ACIP report on MMR vaccination appears to support Merck’s information re the high seroconversion rate after primary vaccination, particularly in regards to the measles and rubella components of the MMR vaccine, (although there appears to be some ambiguity about the effectiveness of the mumps component of the MMR vaccine).[8]

Are healthcare providers informing parents (and other individuals) of the high likelihood of seroconversion after the first dose of live MMR vaccine, i.e. that most vaccinees are likely to be immune after the first dose of live MMR vaccine, given at the appropriate age?

Are healthcare providers informing parents (and other individuals) of the option of antibody titre testing to verify a response to MMR vaccination? It is possible that some careful parents (and other individuals) may prefer to pay for antibody titre testing before having the medical intervention of repeated MMR vaccination. Parents of small children (and other individuals) might be surprised to discover that vaccination ‘best practice’ for companion animals is now more advanced than that for children, with international vaccination guidelines for dogs re live vaccines recommending antibody titre testing rather than an arbitrary ‘booster’, i.e. “…the principles of ‘evidence-based veterinary medicine’ would dictate that testing for antibody status (for either pups or adult dogs) is a better practice than simply administering a vaccine booster on the basis that this should be ‘safe and cost less’”.[9]

The blanket recommendation for two live MMR vaccine doses by the Advisory Committee on Immunization Practices appears to be at odds with the Authorizing Legislation of the US National Vaccine Injury Compensation Program, Sec. 300aa-26, i.e. legal representatives of any child or any individual receiving a vaccine set forth in the Vaccine Injury Table should be provided with information on the vaccine, including “a concise description of the benefits of the vaccine” and “a concise description of the risks associated with the vaccine”.[10]

In regards to “a concise description of the benefits of the vaccine”, there are no benefits to the individual if the individual is already immune. Most children are likely to be immune after the first live MMR vaccine dose, particularly the measles and rubella components. This can be verified with an antibody titre test for those parents/individuals who want evidence of a response.

In regards to “a concise description of the risks associated with the vaccine”, there are risks, i.e. possible adverse reactions, as detailed in the Merck M-M-R II Information Sheet.[11] Reports of adverse events after MMR vaccination have also been submitted to VAERS (the Vaccine Adverse Event Reporting System).[12] Are healthcare providers bringing this information to the attention of parents (and other individuals)?

The VAERS database contains reports of children of four years and over who have experienced adverse events after vaccination with the MMR vaccine. As it is likely many of these children had already been vaccinated with an MMR vaccine at 12-15 months of age, they were likely already immune (i.e. if the Merck M-M-R II vaccine is as effective as claimed), and they underwent revaccination for no benefit. (It is also notable that reports of adults suffering adverse events after MMR vaccination are recorded in the VAERS database, which again raises the question whether these people were offered the option of antibody titre testing before MMR vaccination.)

VAERS is a passive surveillance system to which adverse events after vaccination are voluntarily reported. The FDA has acknowledged that “VAERS is a crude tool” and that adverse events are likely to be under-reported.[13] In regards to the lack of safety information re the MMR vaccine, the Cochrane Collaboration’s systematic review of MMR vaccination notes: “The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.”[14] I suggest there has been inadequate research undertaken on the possibly deleterious long-term effects of repeated vaccination, and that unnecessary vaccination should be avoided.

Professor Temte, I again question whether parents (and other individuals) are being properly informed by healthcare providers about MMR vaccination, in accordance with the Authorizing Legislation of the US National Vaccine Injury Compensation Program, Sec. 300aa-26, and whether ‘informed consent’ is being obtained before this medical intervention.

As the US Advisory Committee on Immunization Practices is responsible for making recommendations on vaccine use, recommendations which have far-reaching impact not just in the United States, but are also influential around the world, I would appreciate your urgent response on this matter to my email address eliz.hart25@gmail.com

Sincerely

Elizabeth Hart

*Please note this letter will be circulated to other parties.

References: (All links accessible as at 5 March 2014.)

[1] Recommended Immunization Schedules for Persons Aged 0 Through 18 Years, United States, 2014: http://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf

[2] Centers for Disease Control and Prevention. School and Childcare Vaccination Surveys. School Vaccination Requirements, Exemptions & Web links: http://www2a.cdc.gov/nip/schoolsurv/schimmrqmt.asp

[3] Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. M-M-R^®II. (Measles, Mumps, and Rubella Virus Vaccine Live). Information Sheet. 9912202: http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf

[4] Prevention of Measles, Rubella, Congenital Rubella Syndrome, and Mumps, 2013. Summary Recommendations of the Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report. Vol. 62, No.4. June 14, 2013: http://www.cdc.gov/mmwr/pdf/rr/rr6204.pdf (See page 3.)

[5] For example, the CDC “Measles Vaccination: Who Needs It?” webpage states: “A second dose of the vaccine is recommended to protect those 5% who did not develop immunity in the first dose and to give “booster” effect to those who did develop an immune response.” http://www.cdc.gov/vaccines/vpd-vac/measles/vacc-in-short.htm I question the benefit of this so-called ‘booster’ effect for children who are already immune, particularly to measles and rubella.

[6] Op cit. M-M-R^®II. Information Sheet: http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf

[7] Ibid.

[8] Op cit. Prevention of Measles, Rubella, Congenital Rubella Syndrome, and Mumps: http://www.cdc.gov/mmwr/pdf/rr/rr6204.pdf (See pages 7-11.)

[9] Day, M.J., Horzinek, M.C., Schultz, R.D. World Small Animal Veterinary Association’s (WSAVA) Guidelines for the Vaccination of Dogs and Cats. Journal of Small Animal Practice. Vol. 51. June 2010: http://www.wsava.org/sites/default/files/VaccinationGuidelines2010.pdf (See page 7.)

[10] 300aa-26. Vaccine information. National Vaccine Injury Compensation Program: http://www.hrsa.gov/vaccinecompensation/authoringleg.pdf

[11] Op cit. M-M-R^®II. Information Sheet: http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf

[12] Vaccine Adverse Event Reporting System (VAERS): http://vaers.hhs.gov/data/index

[13] http://www.fda.gov/downloads/Safety/MedWatch/UCM168497.pdf

[14] Demicheli V, Rivetti A, Debalini MG, Di Pietrantonj C. Vaccines for measles, mumps and rubella in children. Cochrane Database of Systematic Reviews 2012, Issue 2. Art. No.: CD004407. DOI: 10.1002/14651858.CD004407.pub3. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004407.pub3/abstract

Adverse events after HPV vaccination – international symposium held in Japan, February 2014

A recent SaneVax release reports: Breaking news from Japan: International symposium on the adverse reactions experienced by those vaccinated with human papillomavirus vaccines

Well done to SaneVax for their efforts in helping organise this international symposium, and for their support for people who have suffered adverse events after HPV vaccination.

It’s time for an investigation into the government lobbying and aggressive global marketing for this very questionable and experimental vaccine product. See Over-vaccination.net’s webpage on HPV vaccination for more background.

Vaccination – a climate change commentator enters the fray…

Professor Clive Hamilton, a commentator on the climate change debate, has taken it upon himself to draw parallels with dissent on vaccination practice in his article “Climate and vaccine deniers are the same: beyond persuasion”, published on the university and CSIRO funded The Conversation website.

The Conversation promises “we only allow authors to write on a subject on which they have proven expertise…” but what expertise does Clive Hamilton have on the subject of vaccination/immunisation? There is no indication of any expertise in this area in his profile on The Conversation website.

See below my email response to Professor Hamilton, including reference to questionable HPV vaccination. My email has also been copied to a variety of other parties with an interest in this matter, including Andrew Jaspan, Executive Director and Editor of The Conversation, and Professor Ian Frazer, co-inventor of the technology enabling the HPV vaccines and his colleagues at the Australian Academy of Science.

___________________

From: Elizabeth Hart <eliz.hart25@gmail.com>
Date: Tue, Jan 28, 2014 at 5:06 PM
Subject: Your article on The Conversation referring to vaccination / immunisation

Professor Hamilton, re your article “Climate and vaccine deniers are the same: beyond persuasion”, published on The Conversation today, and your comment: “Scientifically there is no debate about immunisation, with every relevant health authority strongly endorsing vaccination.”

Are you aware that ‘vaccination’ and ‘immunisation’ are not the same?

Are you suggesting that citizens are not entitled to challenge ‘health authorities’ on the implementation of individual vaccine products of questionable value, e.g. human papillomavirus (HPV) vaccines?

On the subject of HPV vaccination, (which is currently implemented for boys and girls 10-15 years in Australia)[1], the Gardasil HPV vaccine was originally rejected by the Australian Pharmaceutical Benefits Advisory Committee (PBAC) in 2006.

An article published in The Australian newspaper at the time, “Howard rescues Gardasil from Abbott poison pill”, reports the PBAC rejected Gardasil because it was “too expensive and, just maybe, not what it was cracked up to be anyway”. According to the article, Tony Abbott, then the Australian Federal Health Minister “took to the airwaves, passing on PBAC’s concerns about the efficacy of Gardasil and even floating the bizarre idea that a misplaced confidence in the effectiveness of the vaccine might actually result in “an increase in cancer rates”.”[2]

According to Matthew Stevens’ report in The Australian, it took just 24 hours for the then Australian Prime Minister, John Howard, to “put an end to the nonsense”, delivering “sparkling prime ministerial endorsement to Gardasil along with a clear direction to Minister Abbott that the immunisation program should proceed. And pronto.”[3]

In her report “Government response to PBAC recommendations”, Marion Haas provides some commentary on the Australian government’s interference with the PBAC’s initial rejection of Gardasil, noting the then Prime Minister, John Howard, “intervened personally by announcing that the drug would be subsidised (ie listed) as soon as the manufacturer offered the right price. The PBAC subsequently convened a special meeting and recommended that Gardasil be listed on the PBS”[4] (Pharmaceutical Benefits Scheme).

Haas notes the main objectives “of the PBAC are to consider the effectiveness and cost-effectiveness of medicines in making recommendations to government regarding the listing of drugs for public subsidy. A perceived willingness to interfere in this process may undermine these objectives…” Government reaction which results in reversal of PBAC decisions has “the potential to send signals to manufacturers and lobby groups that a decision made by the PBAC may be reversed if sufficient public and/or political pressure is able to be brought to bear on the PBAC…this may undermine the processes used by the PBAC to determine its recommendations and hence the perceived independence of the PBAC.”[5]

Getting a vaccine on the Australian Pharmaceutical Benefits Scheme must be the ‘golden goose’ for vaccine manufacturers as this assures a mass market for their vaccine product. Other countries have also adopted HPV vaccination, impacting on millions of children around the world and resulting in multi millions of dollars’ worth of sales for Merck (Gardasil) and GlaxoSmithKline (Cervarix)[6], and royalties for entrepreneurial scientist Ian Frazer from sales of HPV vaccines in developed countries[7], and for CSL which receives royalties from sales of Gardasil.[8].

In his article published on The Conversation in July 2012, HPV vaccine technology co-inventor Ian Frazer acknowledges that the risk of cancer associated with the HPV virus is very low, i.e. “Through sexual activity, most of us will get infected with the genital papillomaviruses that can cause cancer. Fortunately, most of us get rid of them between 12 months to five years later without even knowing we’ve had the infection. Even if the infection persists, only a few individuals accumulate enough genetic mistakes in the virus-infected cell for these to acquire the properties of cancer cells.”[9]

The National Cervical Screening Program (NCSP) website notes: “HPV infection is very common and in most people it clears up naturally in about 8-14 months…Genital HPV is so common that it could be considered a normal part of being a sexually active person. Most people will have HPV at some time in their lives and never know it…A few of the many types of HPV have been linked with causing abnormalities of the cervix and in some cases the development of cancer of the cervix.” The NCSP website highlights that: “It is important to remember that most women who have HPV clear the virus naturally and do not go on to develop cervical cancer.”[10]

Since the introduction of the National Cervical Screening Program, the mortality from cervical cancer has halved.[11]

Given the low risks associated with the HPV virus, the Australian government’s role in over-turning the PBAC’s original rejection of the lucrative Gardasil vaccine, and the lobbying involved, should be subjected to scrutiny. My open letter to Chris Mitchell, Editor-in-Chief of The Australian, includes more information on this matter, ie: Is universal HPV vaccination necessary? (8 October 2012.)

Professor Hamilton, people such as yourself, with your ill-informed and unhelpful generalised comments about the complex area of vaccination/immunisation are impeding transparency and accountability for the Australian government’s implementation of questionable vaccine products. Given your position as a Professor of Public Ethics at Charles Sturt University, perhaps you should think more carefully before wading in on a matter on which you so obviously know little about.

Note: I had planned to post this response on your article on The Conversation today, but I see that comments have already closed.

Sincerely

Elizabeth Hart

References:

1. National Immunisation Program Schedule from 1 July 2013: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/nips-ctn

2. Howard rescues Gardasil from Abbott poison pill. The Australian, 11 November, 2006: http://www.theaustralian.com.au/archive/business/howard-rescues-gardasil-from-abbott-poison-pill/story-e6frg9lx-1111112503504

3. Ibid.

4. Haas, Marion. “Government response to PBAC recommendations”. Health Policy Monitor, March 2007: http://hpm.org/en/Surveys/CHERE_-_Australia/09/Government_response_to_PBAC_recommendations.html

5. Ibid.

6. FierceVaccines special report on the 20 Top-selling Vaccines – H1 2012 states that H1 2012 sales for Gardasil (Merck) were $608 million, and sales for Cervarix (GlaxoSmithKline) were $285 million: http://www.fiercevaccines.com/special-report/20-top-selling-vaccines/2012-09-25

7. “Catch cancer? No thanks, I’d rather have a shot!”. The Conversation, 10 July 2012: https://theconversation.com/catch-cancer-no-thanks-id-rather-have-a-shot-7568 The disclosure statement on this article by Ian Frazer states: “Ian Frazer as co-inventor of the technology enabling the HPV vaccines receives royalties from their sale in the developed world.”

8. CSL ups profit guidance on Gardasil sales. The Australian, 27 November 2012: http://www.theaustralian.com.au/business/companies/csl-ups-profit-guidance-on-gardasil-sales/story-fn91v9q3-1226524726672#

9. “Catch cancer? No thanks, I’d rather have a shot!”. The Conversation, 10 July 2012: https://theconversation.com/catch-cancer-no-thanks-id-rather-have-a-shot-7568

10. HPV (human papillomavirus), National Cervical Screening Program, Australian Government Department of Health and Ageing: http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/hpv

11. Key Statistics. National Cervical Screening Program: http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/facts

More re conflicts of interest and ‘the science of immunisation’…

Since December 2012 I have sought potential conflict of interest disclosures for academics associated with the Australian Academy of Science publication “The Science of Immunisation: Questions and Answers”.

See my previous posts on this subject published in May 2013 and August 2013.

On 12 November 2013, I forwarded another email on this matter to Professor Suzanne Cory, President of the Australian Academy of Science, saying:

Professor Cory

Re my previous questions about possible conflicts of interest of members of the Academy’s Science of Immunisation Working Group and Oversight Committee, and my request for disclosure statements. (Refer to email thread below.)

It is now nearly a year since I forwarded my first enquiry to you in December 2012.

In the interests of transparency and accountability, I suggest any potential conflicts of interest of members of the Working Group and Oversight Committee should be disclosed on the Academy’s Immunisation webpage: http://www.science.org.au/policy/immunisation.html I believe this would be in accordance with The Australian Code for the Responsible Conduct of Research, in particular sections 4.9 “Disclose research support accurately” and 7.2 “Conflicts of interest”: http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/r39.pdf

I have also copied the incoming President of the Academy, Professor Andrew Holmes, in this email.

Professor Cory, given the inordinate delay, I request your urgent email response on this matter.

Yours sincerely

Elizabeth Hart

On 14 November 2013, I received the following response from Dr Martin Callinan, Director Science Policy Section of the Australian Academy of Science:

Hi Elizabeth,

Thanks for your email. As discussed, including when we most recently spoke, the Academy is in the process of establishing Register of Interests to cover all our activities. Involving database, website and management system upgrades, this process has been underway for more than a year. We anticipate it being operational in March 2014. As with almost all non-government, not-for-profit organisations, our infrastructure is modest, dated and resources are increasingly scarce. We do our best.

In response to your first email, I quite agreed with you about transparency and current standards. At any one time, we have many projects and activities underway that involve 100+ Fellows and experts, all of whom contribute their time on a pro bono basis. I can assure you we are addressing our organisational need for due disclosure. It is a large systematic process being undertaken with available resources. As promised, as soon as I have a publication date I’ll give you a call to let you know in advance.

regards

martin

The lack of transparency to date on potential conflicts of interest of academics involved in Australian Academy of Science projects and activities is a serious omission.

As we are now approaching the end of January 2014, it will be interesting to see if the Australian Academy of Science’s ‘register of interests’ will finally be operational in March 2014.

Court orders girls must have MMR vaccination against their and their mother’s wishes

Recently a UK court ruled that two sisters must have the measles/mumps/rubella (MMR) vaccine against their and their mother’s wishes.

A report in Family Law Week, “Children ordered to receive MMR vaccination” (13/10/13) notes that one of the girls was vaccinated soon after her birth. Given the first dose of live MMR vaccine was effective and administered at the right age (i.e. after maternally derived antibodies had waned), it is highly likely the girl would have been immune after the first vaccine dose. This can be verified by a blood test (i.e. antibody titre testing). (See my webpage about the MMR ‘booster’ for further background.)

Have these girls and their mother been advised there is a blood test available to determine if they are already immune to measles/mumps/rubella?

How can these girls give their ‘informed consent’ before the medical intervention of vaccination if the court rules they must have this medical intervention?

This case has set a dangerous precedent.

Are we all on course for compulsory vaccination, as dictated by the state? Consider for example the prospect of mandated annual influenza vaccination. This looks like the start of a slippery slope. We need to be alert to the implications, and mindful of vested interests in the vaccine industry, governments, and the scientific/medical establishment.

See below my email forwarded to one of the solicitors involved in this matter of court ordered MMR vaccination, Philippa Dolan of Ashfords Solicitors.

______________________________________

From: Elizabeth Hart <eliz.hart25@gmail.com>
Date: Thu, Nov 14, 2013 at 11:16 PM
Subject: MMR Case
To: p.dolan@ashfords

Ms Dolan

Re the case about the two girls and the MMR vaccine in which I understand you are involved, i.e. High Court rules sisters must have MMR jab against their and their mother’s wishes: http://www.independent.co.uk/news/uk/home-news/high-court-rules-sisters-must-have-mmr-jab-against-their-and-their-mothers-wishes-8876035.html?origin=internalSearch

Note this comment in the article: “The elder daughter received the MMR jab but not a second dose, and the younger daughter did not receive either.” (My emphasis.)

The measles/mumps/rubella vaccine is a ‘live’ vaccine. When vaccinated at the right age with an effective vaccine, i.e. after maternally derived antibodies have waned, most children are likely to be immune for life. The reason given for the second dose is that a small proportion of children might not respond to the first vaccine (usually because of interference of maternally derived antibodies, or possibly because of a fault in the vaccine).

My argument is, it is not ethical to force people to have a second dose of the vaccine if they’re likely to be immune after the first dose. At the very least they should be offered the opportunity of a blood test (antibody titre test) to verify a response to the first vaccine, even if they have to pay for it themselves. I suggest there is a very important principle at stake here, particularly when the state dictates that healthy people have to have medical interventions, it’s a slippery slope….

I suggest both those girls should be offered the opportunity of a blood test to measure antibodies (although it would have been better to have had the check soon after initial vaccination). Even the second unvaccinated girl should be offered the opportunity in case she has had natural exposure to the disease.

For further background see my webpage: https://over-vaccination.net/questionable-vaccines/mmr-jab/

Also see my letter to Professor Paul Offit on this subject: http://users.on.net/~peter.hart/Letter_to_Paul_Offit_re_MMR_booster.pdf

Given the controversy about the MMR vaccine in the UK, and elsewhere, I think there could be a lot of fallout about this, there are some parents out there who I suspect would be very angry they weren’t given the opportunity of a blood test for their child, rather than an arbitrary second shot.

I request that you bring this information to the attention of the parents and children in this case, plus the presiding judge, Mrs Justice Theis.

I would appreciate your response on this matter.

Yours sincerely

Elizabeth Hart

The Conversation – a marketing arm for the university and research sector?

The university and CSIRO-funded The Conversation website(1) publishes articles promoting vaccination, but appears reluctant to provide critical analysis on the worth of individual vaccine products. Indeed critical analysis of vaccines seems to be limited to comments on articles, often by members of the general public.

The dearth of critical analysis of individual vaccines is a major failing on The Conversation website(2), particularly as the university and research sector has a vested interest in promoting lucrative vaccine products, e.g. the controversial HPV vaccine(3). This lack of objectivity undermines trust in The Conversation(4).

The Conversation claims to be “an independent source of news and views, sourced from the academic and research community” introducing “new protocols and controls to help rebuild trust in journalism”, and believing in “open access and the free-flow of information.(4) The Conversation states: “We only allow authors to write on a subject on which they have proven expertise, which they must disclose alongside their article. Authors’ funding and potential conflicts of interest must be disclosed. Failure to do so carries a risk of being banned from contributing to the site.”(4)

Given its promise to be “an independent source of news and views, sourced from the academic and research community”(4), The Conversation’s support of the Stop the Australian (Anti) Vaccination Network (SAVN)(5) bears investigation. The SAVN is a stalwart defender of mandated vaccination and will brook no dissent. While the SAVN’s raison d’etre is ostensibly to oppose the controversial Australian Vaccination Network(6) and its spokesperson Meryl Dorey, in practice SAVN supporters have taken it upon themselves to stifle and patronise anybody who dares to question vaccination practice in any way, as can be seen in The Conversation discussion threads listed below.(7)

Rachael Dunlop is an administrator of the SAVN Facebook page(8), and Vice President of Australian Skeptics Inc(9). Her articles on vaccination are published on The Conversation. Contrary to The Conversation’s assurance that “we only allow authors to write on a subject on which they have proven expertise”(4), Rachael Dunlop’s profile on The Conversation website(10) provides no indication that she has “proven expertise” in the wide range of vaccine products on the Australian National Immunisation Program Schedule(11). While Rachael Dunlop is given carte blanche to publish her opinions on vaccination on The Conversation(12), others of us relegated to the comments section are intimidated by the threat of censorship. For instance two of my comments were censored on Rachael Dunlop’s article “A view on: vaccination myths”(13).

In his support for The Conversation, Professor Peter Doherty, Nobel Laureate, says: “The whole motivation behind this was to open communication between people in our universities and institutes of higher education and the general public…None of us want to live in an ivory tower, we all want to be part of society. So how do we do that? It has been difficult to do that in conventional newspaper and media formats because they have their own priorities. So we started The Conversation…”(14)

Given The Conversation’s general reluctance to critically analyse individual vaccine products, cynics might wonder if The Conversation has its ‘own priorities’, principally to do with selling the products of the university and research sector? Is The Conversation merely a marketing arm for the university and research sector?

Vaccines of questionable value are being added to national vaccination schedules. Mass populations of children are being vaccinated against diseases which may never pose a serious threat for them, e.g. human papillomavirus(15). It is questionable whether ‘informed consent’ is being properly obtained before these medical interventions.

Vaccine products are being developed for more and more diseases e.g. novovirus(16), chlamydia(17), skin cancer(18), herpes(19), HIV(20), malaria(21) etc, etc, yet nobody has any idea of the long term cumulative effect of all these medical interventions, or ‘unintended consequences’ for disease development, consider for example the possible implications of genotype replacement with HPV vaccination(22); vaccine-related reassortment of rotavirus(23); HBV S protein mutations after vaccination(24); and increasing selection among the B. pertussis population in Australia in favor of strains carrying prn2 andptxP3 under the pressure of acellular vaccine–induced immunity(25).

Aggressive marketing by the pharmaceutical industry and industry-affiliated ‘experts’, including lobbying for compulsory vaccination with vaccines of dubious value, is threatening citizens’ autonomy. It seems we are now expected to meekly accept every vaccine product manufactured by the vaccine industry.

The increasingly lucrative vaccine industry benefits from the oppressive climate that has developed on the subject of vaccination.

The potential conflicts of interests of academics working in the areas of vaccine development and promotion, and the influence of these academics on government policy, needs to be examined. It’s time there was an investigation into the relationships between governments, the vaccine industry, and the industry’s handmaidens in the scientific/medical establishment, but who can we trust to do that? The mainstream media has generally been completely useless on this matter, and incapable of providing critical analysis, merely supporting the status quo(26), likewise The Conversation.

Citizens must be allowed to have a rational debate on this important subject to ensure public confidence in vaccination practice. All vaccination recommendations must be transparently evidence-based.

It’s time for The Conversation to lift its game on this subject and provide some objective critical analysis of individual vaccine products, and the lucrative international vaccine market.

For discussion on controversial vaccine products see:

I have provided critical comment(27*) on a number of The Conversation’s articles pertinent to vaccination, see list below:

Academics on the payroll: the advertising you don’t see
Explainer: the 2014 flu vaccine
Court decision to force MMR wasn’t in child’s best interest
China’s pharma scandal and the ethics of the global drug market
Four things you should know about HPV vaccinations
Of influenza, flu, potions and key opinion leaders (My comment on this article was censored, and subsequently restored after my complaint to The Conversation.)
A view on: vaccination myths (Two of my comments were censored on this article.)
Science and fear: a review of vaccination documentary Jabbed
With vaccination rates stable, ‘no jab, no play’ rules are beside the point
Explainer: what is the flu?
Six myths about vaccination – and why they’re wrong
Better regulation needed for kids’ flu vaccine
ACCC takes legal action over homeopathy claims
Cervical cancer screening shouldn’t start until 25
Danger, you’re at serious risk of…no, sorry, it’s all relative (Two of my comments were censored on this article)
Catch cancer? No thanks, I’d rather have a shot!
Study should dispel HPV vaccine myths
‘Toxins’ in vaccines: a potentially deadly misunderstanding
Does aluminium cause Alzheimer’s and breast cancer?
Preaching to the unconverted: immunisation risks and public health
Parents’ decisions about vaccination and the art of gentle persuasion
Measles outbreak calls for vaccination vigilance
Vaccine-resistant whooping cough takes epidemic to new level
Explainer: flu season 2012
Censoring influenza research: gagging scientists could put lives at risk
Preventing over-diagnosis: how to stop harming the healthy
No, you’re not entitled to your opinion
Yes, you are entitled to your opinion…and I want to hear it
Help needed: can you fix the science/society divide?
Peer review: Bad Pharma by Ben Goldacre
Where does misinformation come from, and what does it do?
Comments on commenting

References: (Links current as at 12 November 2013.)

1. Partners and funders of The Conversation: https://theconversation.com/au/partners

2. Our charter – The Conversation: https://theconversation.com/au/our_charter

3. Also refer to Ian Frazer. Catch cancer? No thanks, I’d rather have a shot! The Conversation 10 July 2012: http://theconversation.com/catch-cancer-no-thanks-id-rather-have-a-shot-7568

4. Who we are – The Conversation: https://theconversation.com/au/who_we_are

5. Stop the Australian (Anti) Vaccination Network Facebook page: https://www.facebook.com/stopavn

6. Australian Vaccination Network: http://avn.org.au/

7. This has been my personal experience – see responses to Elizabeth Hart on The Conversation discussion threads listed above. As far as I am aware, editors at The Conversation have done little to address concerns about vaccines of questionable value such as the controversial HPV vaccine; the arbitrary second dose of the measles/mumps/rubella (MMR) live vaccine; annual flu vaccination and controversial ‘gain of function research’; or pertussis ‘boosters’ of the existing vaccine against the new strain.

8. The disclosure statement on Rachael Dunlop’s article “A view on: vaccination myths” on The Conversation, 28 May 2013, notes that she is “an administrator of the Stop the AVN Facebook page”: https://theconversation.com/a-view-on-vaccination-myths-14699

9. Australian Skeptics: http://www.skeptics.com.au/contact/nsw/

10. Rachael Dunlop’s profile on The Conversation website http://theconversation.com/profiles/rachael-dunlop-4133/profile_bio

11. Australian National Immunisation Program Schedule: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/nips-ctn

12. Rachael Dunlop. Six myths about vaccination – and why they’re wrong. The Conversation, 26 April 2013: http://theconversation.com/six-myths-about-vaccination-and-why-theyre-wrong-13556

13. Rachael Dunlop. A view on: vaccination myths. The Conversation, 28 May 2013: https://theconversation.com/a-view-on-vaccination-myths-14699

14. Peter Doherty: Why I support The Conversation. Video on Who we are – The Conversation, quote starting at 0.30: https://theconversation.com/au/who_we_are

15. In an article on the university and CSIRO-funded The Conversation website, titled “Catch cancer? No thanks, I’d rather have a shot!”, Professor Ian Frazer states: “Through sexual activity, most of us will get infected with the genital papillomaviruses that can cause cancer. Fortunately, most of us get rid of them between 12 months to five years later without even knowing we’ve had the infection. Even if the infection persists, only a few individuals accumulate enough genetic mistakes in the virus-infected cell for these to acquire the properties of cancer cells”. If only “a few individuals accumulate enough genetic mistakes in the virus-infected cell for these to acquire the properties of cancer cells”, is it really justifiable to coerce mass populations of children to have HPV vaccination, particularly as the long-term consequences of the HPV vaccine are unknown? Refer to this link for further background: https://over-vaccination.net/questionable-vaccines/hpv-vax/

16. Takeda’s norovirus vaccine misses endpoint in early-phase trial. FierceVaccines, 7 October 2013: http://www.fiercevaccines.com/story/takedas-norovirus-vaccine-misses-endpoint-early-phase-trial/2013-10-07

17. Igietseme JU, Eko FO, Black CM. Chlamydia vaccines: recent developments and the role of adjuvants in future formulations. Expert Rev Vaccines. 2011 Nov;10(11):1585-96: http://www.ncbi.nlm.nih.gov/pubmed/22043957

18. Professor Ian Frazer close to creating skin cancer vaccine. News.com.au, 31 July 2011: http://www.news.com.au/technology/science/skin-cancer-vaccine-hope/story-fn5fsgyc-1226105179167

19. Allied Healthcare’s herpes simplex vaccine trial under way. 17 October 2013: http://www.proactiveinvestors.com.au/companies/news/49190/allied-healthcares-herpes-simplex-vaccine-trial-under-way-49190.html

20. Breakthrough in hunt for HIV vaccine as scientists capture ENV protein. News.com.au, 2 November 2013: http://www.news.com.au/technology/science/breakthrough-in-hunt-for-hiv-vaccine/story-fn5fsgyc-1226751689734

21. New malaria vaccine has its flaws, but it’s better than nothing. The Conversation, 9 October 2013: https://theconversation.com/new-malaria-vaccine-has-its-flaws-but-its-better-than-nothing-19020

22. Pons-Salort M et al. Exploring individual HPV coinfections is essential to predict HPV-vaccination impact on genotype distribution: a model-based approach. Vaccine. 2013 Feb 6;31(8):1238-45: http://www.ncbi.nlm.nih.gov/pubmed/23246257

23. Tatiana Lundgren Rose et al. Evidence of vaccine-related reassortment of rotavirus, Brazil, 2008-2010. Emerging Infectious Diseases. Volume 19, Number 11 – November 2013: http://wwwnc.cdc.gov/eid/article/19/11/12-1407_article.htm

24. Bian T et al. Change in hepatitis B virus large surface antigen variant prevalence 13 years after implementation of a universal vaccination program in China. J. Virol. 2013 Nov;87(22):12196-206: http://www.ncbi.nlm.nih.gov/pubmed/24006443

25. Sophie Octavia et al. Newly emerging clones of Bordetella pertussis carrying prn2 and ptx3 alleles implicated in Australian pertussis epidemic in 2008-2010. J Infect Dis. (2012) 205 (8): 1220-1224: http://jid.oxfordjournals.org/content/205/8/1220

26. For example, the Murdoch media’s aggressive “No Jab, No Play” campaign contributes to the oppressive climate surrounding vaccination – “Big win for No Jab, No Play as NSW state cabinet approves tough new vaccination laws”. The Telegraph, 29 May 2013. In this climate it is difficult to raise legitimate questions about vaccination practice, e.g. questioning arbitrary revaccination of all children with the live measles/mumps/rubella (MMR) vaccine, as most children are likely to be immune after age appropriate vaccination with an effective first dose of this vaccine.

27. Elizabeth Hart, Independent Vaccine Investigator. Comments on The Conversation: https://theconversation.com/profiles/elizabeth-hart-6978/activities (*Edited to include additional articles 24 June 2014.)

More on over-vaccination of pets…

Recently the magazine Dogs NSW published a fear-mongering article, “The Deadly Canine Parvovirus – Is Your Dog At Risk”, promoting annual revaccination for parvovirus, in other words promoting gross over-vaccination of dogs.

See below my response to Dogs NSW on this matter:

Letter to the Editor of Dogs NSW:

Charlotte Long’s article “The Deadly Canine Parvovirus – Is Your Dog At Risk?” (Dogs NSW, Sept 2013) promotes annual revaccination for parvovirus and fails to address the controversy about over-vaccination of pets, which exploits companion animals and their owners.

Over-vaccination of pets was raised by the consumer watchdog CHOICE in 2010 with the article: Pet vaccination: Over-vaccinating your pet could be harmful to their health as well as your own hip pocket.[1] In July 2013 the Sydney Morning Herald reported on another CHOICE investigation which found “the three common areas for “up selling” by vets were unnecessary diagnostic tests, over-vaccinating and mark-ups on products sold by vet practices”.[2] (My emphasis.)

Many vets are failing to advise pet owners about vaccination ‘best practice’, and are failing to obtain ‘informed consent’ before vaccinating their clients’ pets.

Charlotte Long maintains the lack of information by failing to refer to the World Small Animal Veterinary Association’s Guidelines for the Vaccination of Dogs and Cats (2010), which advise that after effective vaccination with the core vaccines for parvovirus, distemper virus and adenovirus, duration of immunity “is many years and may be up to the lifetime of the pet”.[3] The WSAVA Guidelines also warn “we should aim to reduce the ‘vaccine load’ on individual animals in order to minimize the potential for adverse reactions to vaccine products”.[4]

Ms Long also ignores the option of in-surgery or lab-based titre testing to verify a response to core vaccination. The WSAVA Guidelines 2010 note “the principles of ‘evidence-based veterinary medicine’ would dictate that testing for antibody status (for either pups or adult dogs) is a better practice than simply administering a vaccine booster on the basis that this should be ‘safe and cost less’”.[5] The latest WSAVA Vaccination Guidelines for New Puppy Owners (published in May 2013) advise “the presence of circulating antibodies indicates that the dog is immune, and revaccination (with core vaccines) is not required”.[6]

Similarly there is no discussion about the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Position Statement on Vaccination Protocols for Dogs and Cats (first published in January 2010 in response to pet owners’ concerns about over-vaccination) which states “…the aim should be to ensure that all susceptible animals are vaccinated, rather than that already well-immunised animals are re-vaccinated”.[7] (My emphasis.)

The APVMA is the government regulator of veterinary vaccine products. In September 2010 the APVMA requested all eight Veterinary Boards in Australia circulate its Position Statement on Vaccination Protocols for Dogs and Cats to veterinarians in their jurisdictions. It is my understanding that some, if not all, of the Veterinary Boards, ignored this request by the government regulator, an appalling dereliction of duty.[8] As a result many pet owners still remain unaware of the APVMA’s Position Statement on Vaccination Protocols for Dogs and Cats.

The APVMA’s past failure to ensure that vaccine manufacturers’ revaccination recommendations are evidence based is at the heart of the continuing problem of over-vaccination of pets, coupled with the reluctance of many members of the veterinary profession to keep abreast of and acknowledge the latest science on duration of immunity and vaccination ‘best practice’. No wonder the World Small Animal Veterinary Association warns “there is an urgent requirement for education of practicing veterinarians in this area”.[9]

The APVMA’s Position Statement notes: “The APVMA does not support the retention of label statements that direct or imply a universal need for life-long annual revaccinations with core vaccines…The APVMA is working with vaccine registrants with a view to updating labels.”(10) (My emphasis.) However, more than three years after publication of the APVMA’s Position Statement, core vaccine products with an annual revaccination ‘recommendation’ remain on the market, e.g. Virbac’s Canigen DH_A2P (11) and Boehringer Ingelheim’s Protech C3 (12).

Another important omission in Ms Long’s article is discussion about appropriate timing of puppy vaccination, with some vaccine product labels recommending a finish at 10 or 12 weeks(13), which is in conflict with the WSAVA recommendation for a finish around 14-16 weeks. It is possible that, due to the interference of maternally derived antibodies, some puppies may remain unimmunised and unprotected with the earlier finish. (In this regard, refer to my article “Vaccination failure!”, published in the dog breeder’s magazine National Dog in 2010.[14])

In short, Charlotte Long’s article fails to include a simple and effective message to promote successful immunisation of puppies to protect against parvovirus, rather than over-vaccinating already immune dogs over and over again. Instead we are presented with a fear-mongering advertorial promoting lucrative over-vaccination of dogs on behalf of the veterinary vaccination industry.

Readers of Dogs NSW have been poorly served by Ms Long’s biased and ill-informed article. As a result it is likely many already immunised dogs will be unnecessarily revaccinated.

I request that Dogs NSW take steps to redress the misinformation it has spread in the community.

Sincerely

Elizabeth Hart

References:

1. “Pet vaccination – Over-vaccinating your pet could be harmful to their health as well as your own hip pocket.” CHOICE. Published online August 2010: http://www.choice.com.au/reviews-and-tests/household/backyard/pets/pet-vaccination/page.aspx

2. Choice urges vets to dump high fees and unnecessary charges. Sydney Morning Herald, 22 July 2013: http://www.smh.com.au/national/choice-urges-vets-to-dump-high-fees-and-unnecessary-charges-20130721-2qck5.html

3. MJ Day, MC Horzinek, RD Schultz. World Small Animal Veterinary Association’s (WSAVA) Guidelines for the Vaccination of Dogs and Cats. Journal of Small Animal Practice. Vol.51. June 2010: http://www.wsava.org/sites/default/files/VaccinationGuidelines2010.pdf Also refer to the WSAVA Vaccination Guidelines webpage: http://www.wsava.org/guidelines/vaccination-guidelines

4. Ibid.

5. Ibid.

6. WSAVA Vaccination Guidelines for New Puppy Owners. (May 2013.): I have highlighted important points in this version of the guidelines: http://users.on.net/~peter.hart/WSAVA%20Puppy%20Vax%20Guidelines%20May%202013.pdf

7. Australian Pesticides and Veterinary Medicines Authority – Position Statement – Vaccination Protocols for Dogs and Cats. 21 January 2010. Revised 25 January, 2 and 13 September 2010. http://www.apvma.gov.au/use_safely/vaccination.php

8. On 19 May 2011 I circulated an email to the veterinary boards in Australia, asking what steps they had taken to forward the APVMA’s Position Statement to registered veterinarians in their jurisdictions: http://users.on.net/~peter.hart/Email_to_Vet_Boards_May_2011.pdf The veterinary boards of Queensland and the Northern Territory advised they had taken no action to circulate the Position Statement. My enquiry was ignored by the other veterinary boards.

9. In the ‘read more’ section, the WSAVA Vaccination Guidelines Group webpage notes: “It is clear that the controversy surrounding small companion animal vaccination has not diminished and that there is an urgent requirement for education of practicing veterinarians in this area. The members of the VGG are actively engaged in delivering national and international lectures to help address this demand.” (My emphasis.) http://www.wsava.org/educational/vaccination-guidelines-group

10. Australian Pesticides and Veterinary Medicines Authority – Position Statement – Vaccination Protocols for Dogs and Cats. 21 January 2010. Revised 25 January, 2 and 13 September 2010. http://www.apvma.gov.au/use_safely/vaccination.php

11. Virbac’s Canigen DH_A2P label states: “An annual booster is recommended.” and “This product has been assessed as providing at least 12 months protection. Many factors influence the effectiveness if [sic] vaccination and the need for re-vaccination. The vaccination for an individual animal should be determined within a veterinarian-client-patient relationship, taking all these factors into account.” The label is accessible on the APVMA’s PUBCRIS database: http://www.infopest.com.au/extra/asp/infopest/nra/labels.asp?prodcode=40758

12. The ‘suggested’ revaccination ‘recommendation’ on Boehringer Ingelheim’s Protech C3 label reads: “Annual vaccination Either Protech C3 +Protech C2i and Protech Bronchi-Shield III Or Protech C4 + Protech C2i and Protech Bronchi-Shield I. Protech C3 and Protech C4 have been assessed as providing at least 12 months protection against canine distemper virus, canine adenovirus and canine parvovirus. Many factors influence the effectiveness of vaccination and the need for revaccination. The vaccination program for an individual animal should be determined within a veterinary-client-patient relationship, taking all these factors into account.” The label is accessible on the APVMA’s PUBCRIS database: http://www.infopest.com.au/extra/asp/infopest/nra/labels.asp?prodcode=51487

13. For example, Boehringer Ingelheim’s Protech C3 label suggests finishing the primary vaccination program at 10 weeks: http://www.infopest.com.au/extra/asp/infopest/nra/labels.asp?prodcode=51487 MSD Animal Health’s Nobivac DHP Continuum vaccine label recommends final puppy vaccination at 10 weeks: http://www.infopest.com.au/extra/asp/infopest/nra/labels.asp?prodcode=59043 Virbac’s Canigen DH_A2P vaccine label recommends the second primary dose at 12 weeks also stating: “In situations where high maternal antibody and potential challenge is possible an additional vaccination should be considered at 16 weeks of age.” http://www.infopest.com.au/extra/asp/infopest/nra/labels.asp?prodcode=40758

14. Elizabeth Hart. “Vaccination failure! There is a potential for maternally derived antibodies (MDA) to interfere with a puppy’s response to core vaccination.” National Dog. Vol. 14, No.5, pp 29-30 (2010): http://users.on.net/~peter.hart/Vaccination_failure!.pdf

Over-vaccination of dogs with unnecessary ‘boosters’

For those people interested in the ongoing over-vaccination of pets scandal, I recently forwarded a letter to Professor Ronald Schultz, a member of the World Small Animal Veterinary Association’s Vaccination Guidelines Group, and the American Animal Hospital Association’s Canine Vaccination Task Force, complaining about the confusing and misleading use of the term ‘booster’ in vaccination guidelines.

The email below summarises my complaint. My detailed letter can be accessed via this hyperlink: Letter to Professor Ronald Schultz re confusing and misleading use of the term ‘booster’

________________________

From: Elizabeth Hart <eliz.hart25@gmail.com>
Date: Tue, Aug 20, 2013 at 3:18 PM
Subject: Re: Confusing and misleading use of the term ‘booster’ in relation to modified live virus (MLV) vaccines

Professor Schultz

Please see attached a detailed letter addressed to you criticising the use of the confusing and misleading term ‘booster’ in vaccination guidelines issued by the WSAVA Vaccination Guidelines Group. This criticism is also relevant to the 2011 AAHA Canine Vaccination Guidelines.

As noted in my letter, I suggest use of the term ‘booster’ in relation to canine core modified live virus (MLV) vaccines for parvovirus, distemper virus and adenovirus is resulting in extensive unnecessary over-vaccination of already immune dogs.

I suspect that many pet owners are still not being informed that there is no evidence to support revaccination of already immune animals with so-called ‘booster’ shots, nor that there is the option of titre testing to verify a response to core MLV vaccination.

This is especially concerning in light of the WSAVA 2010 guidelines warning “that we should aim to reduce the ‘vaccine load’ on individual animals in order to minimize the potential for adverse reactions to vaccine products”, and the WSAVA 2013 guidelines advice that “it is important to give as few vaccines as possible…” and “…any reaction to a vaccine that is not needed is unacceptable”.

There are serious flaws in the WSAVA guidelines 2010 and 2013 which must be rectified. In addition, the 2011 AAHA Canine Vaccination Guidelines should also be subjected to review.

I request your urgent response on this matter.

Sincerely

Elizabeth Hart

*This email and letter is also being circulated to the following:

Professor Michael Day, Chairperson, WSAVA Vaccination Guidelines Group
Professor Emeritus Marian Horzinek, previous member of the WSAVA Vaccination Guidelines Group
Professor Jolle Kirpensteijn, EB Liasison, WSAVA Vaccination Guidelines Committee
Professor Hajime Tsujimoto, WSAVA Vaccination Guidelines Group
Professor Richard Squires, WSAVA Vaccination Guidelines Group
Professor Emeritus Richard Ford, member of the AAHA Canine Vaccination Guidelines Task Force
Dr Carmel Mooney, Editor of the Journal of Small Animal Practice
Dr Anna-Maria Brady, Head of Biologicals and Administration, Veterinary Medicines Directorate
Dr Allen Bryce, Executive Director, Veterinary Medicines, Australian Pesticides and Veterinary Medicines Authority
Dr Rick E. Hill, Director, Center for Veterinary Biologics, US Department of Agriculture
Professor Brian Martin, Social Sciences, University of Wollongong
Bea Mies, independent advocate for judicial vaccine use

and will also be circulated to other parties.

OVER-VACCINATION

Challenging Big Pharma's lucrative over-vaccination of people and animals

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Over-vaccination of dogs with unnecessary ‘boosters’

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