Category Archives: NHMRC Australian Health Ethics Committee

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

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

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

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

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

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

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

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

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

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

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

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

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

 

 

UPDATE: NHMRC Ethics Committee and the MMR second dose

Ethics and vax

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

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

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

_________________________________________________________

12 April 2014

Professor Olver

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

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

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

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

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

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

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

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

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

Sincerely

Elizabeth Hart                         

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

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

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

and Professor Brian Martin, Social Sciences, University of Wollongong

Attachments:

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

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

_______________________________________________

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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

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

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

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