Tag Archives: GlaxoSmithKline

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 evidenceCan 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.

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.

Evidence based 2

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.)

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.[9]

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.)

[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 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 10th 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 10th 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

France: Aluminium adjuvants and HPV vaccines up for debate

A recent press release from SaneVax reports:

syringeThe 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

Informed Consent 3Children 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.:

  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.  

(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.

Questions about vaccination policy and ethics for the NHMRC

Questions for 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:

[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