OVER-VACCINATION

Questions about vaccination policy and ethics for the NHMRC

 

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

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

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

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

See below my letter to Professor Anderson:

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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)

and Professor Brian Martin, Social Sciences, University of Wollongong

Attachments:

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.)

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[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