Tag Archives: Merck

Petition against HPV vaccines – please consider signing this petition!

hThe 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 15th 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

Cochrane Lancet Infect DisFurther 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: Vaccine safety and aluminium – a challenge to Cochrane

Cochrane2Re 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. 29th 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.

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).

Informed Consent 3The 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

[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

[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. 10th 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.

INFORMED CONSENTAre 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.

[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

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

[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

dreamstime_xs_17754200A 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.

HPV vaccine promotion and government interference

 

hThe 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.[1]  Yet mass populations of children around the world are being coerced into HPV vaccination, while the long-term consequences of these vaccines are unknown.

We need an investigation into why these questionable vaccines are being mass-marketed, and the lack of adequate ‘informed consent’ before this medical intervention.

Let’s start by demanding an investigation into how the Gardasil HPV vaccine was fast-tracked onto the Australian vaccination schedule in 2007.

The archived fact sheet on the Australian Government Funding of Gardasil states “The Government has agreed with the recommendation of its expert advisory committee, the Pharmaceutical Benefits Advisory Committee (PBAC), that GARDASIL should be funded under the National Immunisation Program, commencing in the 2007 school year…”[2]

However the Gardasil HPV vaccine was originally rejected by the PBAC in 2006.  An article in The Australian 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”.”[3]

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.”[4]

In her report “Government response to PBAC recommendations”, Marion Haas also 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”[5] (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.”[6] 

After the Australian government’s interference in this matter, other countries adopted HPV vaccination, resulting in multi millions of dollars’ worth of sales for the makers of the HPV vaccines, i.e. Merck (Gardasil) and GlaxoSmithKline (Cervarix)[7], and royalties for Ian Frazer from sales of HPV vaccines in developed countries[8].

Ian Frazer has acknowledged that the risk of cancer associated with the HPV virus is very low[9].  Since the introduction of the National Cervical Screening Program, the mortality from cervical cancer has halved.[10]  Given the low risks associated with the HPV virus, the Australian government’s role in over-turning the PBAC’s original rejection of the Gardasil vaccine, and the lobbying involved, should be subjected to scrutiny.

It’s time for an investigation into the establishment of the lucrative international market for the questionable HPV vaccines.

For further background refer to my previous post “Is universal HPV vaccination justifiable?”

Also refer to the Sanevax website for more information on this topic, including personal reports of adverse experiences after HPV vaccination.

_________________________________

References:  (Links active as at 11 November 2013.)

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

[2] Archived Fact Sheets. Australian Government Funding of Gardasil. Updated 28 November 2006: http://archive.is/pm19

[3] 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

[4] Ibid.

[5] 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

[6] Ibid.

[7] 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

[8] “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.”

[9] See ref 1 for quote from “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] Key Statistics. National Cervical Screening Program: http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/facts