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Consumer group calls for action on systemic problems highlighted by flu vaccine safety debacle

The previous Croakey post raising concerns about the response of health authorities to adverse events associated with seasonal influenza vaccination of young children rang a bell with the Consumers Health Forum.

The Forum’s executive director, Carol Bennett, has called for urgent action – by COAG, if necessary. The TGA’s mission statement of ‘safeguarding public health and safety in Australia’ is sounding very hollow, she says.

Carol Bennett writes:

The report commissioned by the WA Minister for Health into ‘The public health response to adverse events to the seasonal flu vaccine’ clearly highlights the failure of Commonwealth and State authorities to protect the safety of Australian children.

The final report by Professor Bryant Stokes notes, ‘it is clear that governance and the current reporting system needs correction and a timely process put in place’.

This WA report details the very disturbing bungling that resulted from the systemic lack of accountability or responsibility among multiple government bodies, including those at a state and federal level.

Key issues highlighted by the report reflect concerns that have been repeatedly raised at a national level by health consumer organisations, including CHF, over the last decade.

In particular they point to the failure of the Federal government’s key regulatory body, the Therapeutic Goods Administration (TGA), to fulfil the following tasks adequately:

1. There must be a system that provides clear information to consumers (not just health professionals) that enables them to make informed decisions about these kinds of vaccines based on available evidence and in recognition of the limitations of that evidence.

2. There must be a well recognised, ‘one stop’ and easy to access point for reporting of adverse events by consumers (not just health professionals) when things go wrong.

3. The community expects that these reports will be acted on in a timely way by the body charged with the very important responsibility of protecting public safety.   This includes taking appropriate steps to withdraw a vaccination where necessary, as well as more proactive assessment and monitoring.

4. There must be publicly accessible reports of all adverse events and the actions taken to address them.

5. If there are problems with state-run organisations or poor communications with the TGA, (as is obvious from this report) this needs to be resolved as a matter of urgency at the next Council of Australian Government (COAG) meeting.

The WA report presents the voices of parents whose children had suffered febrile convulsions following the administration of the Fluvax vaccine (although the link is yet to be confirmed).

It describes the shock and confusion that these people felt when they discovered that the system they trusted to protect the safety of their children had failed them through a range of inadequate responses.

These include the failure of the Swineflu Helpline to respond to their calls, being given the ‘run around’ when trying to find out where they could report their incidents, product information that was inconsistent with the information given to health providers, and a lack of a timely responses to reports of adverse events.

The result is a justifiable lack of confidence by health consumers in the systems that are supposed to provide some assurance that these products are safe, monitored and reviewed.

Ultimately, the experience with this vaccination program could well prove to be a turning point public health officials dread.  It could lead to a reduction in vaccination in the general community due to concerns about safety, even where these concerns might be minimal and the benefits of community vaccination programs may be well documented.

While the TGA is aware of the need for reform of its processes and has taken some positive steps forward in recent times, it is yet to move out of the shadow of the Department of Health and Ageing, develop a positive public profile and step up to take responsibility for ensuring that there is an effective monitoring and feedback process in place for all therapeutic goods.

The TGA’s mission statement talks about: ‘safeguarding public health and safety in Australia’.

This report shows just how hollow these words can be, particularly for those parents left wondering why they did not have the information they needed about the safety of this vaccine for young children.  On the basis of the available information, these parents chose to give their children a vaccine that may have resulted in very severe adverse reactions.

The Australian community deserve better from the primary health regulator in this country.

Related Posts

Comments 3

  1. Christine says:

    Carol Bennett is right to call for better reporting and proper transparency of adverse events following immunisation.

    The recent measles epidemics in the UK, with thousands of cases and 2 deaths (2006 and 2008) demonstrate only too clearly what happens when there is a loss of public confidence in vaccination. While it’s now clear that there is no link between MMR vaccine and autism, and Wakefield fraudulent from the start, the damage has been done and will take a long time to heal.

    Without good reporting, analysis and, most of all, transparency with mature risk communication, public confidence in vaccine safety will continue to be eroded, with dire consequences. The WA report says that the TGA is conflicted and shouldn’t be both the vaccine regulator and the body responsible for monitoring adverse events. Australia needs a new separate and independent body, along the lines of the Centers for Disease Control in the US.

  2. billybob7788 says:

    Gosh Christine,

    You seem all knowing – pity Wakefield was smeared. His only wrong doing was his mthods were a bit lax, but his outcomes were still sound. I gues sif you literally have million sod dollars riding on a key plank of social engineering policy, people will do damn near anything to protect it…..smearing included.

    Now oh wise one, how about this series of 2007 graphs from the Australian Dept of Health that shows massive decline of diseases well BEFORE vaccines were even introduced?

    http://www.health.gov.au/internet/main/publishing.nsf/Content/cda-cdi31suppl.htm~cda-cdi31suppl-apx1.htm

    “The questionable contribution of medical measures to the decline of mortality in the United States in the twentieth century“. McKinlay JB, McKinlay SM, Milbank Mem Fund Q Health Soc. 1977 Summer; 55(3): 405-28.

    Logic says – decline of disease before vaccine logically means vaccine did not cause delcine of disease. Nutrition and sewers and general health improvement caused decline of disease.

    Bit of an inconvenient truth for you.

    Also, do people realise the whooping cough toxin is used in animal tests to promote analphalaxis ( alergic reaction ) in animals? Logic says then it should work in humans too. Gosh and if we use a nut based “soup” for the vaccine base, do you think anaphalytic agent + nut base = nut allergy? Nah…too much of a coincidence…….

    Oh…and if Wakefield is right, might the MMR = autism might make sense when we now have 1 in 140 kids autistic, up from 1 in 10000 say 30 years ago right after the vaccines started being pushed on kids in massive numbers in the 1980s?

    Coincidence?

    Surely not……

    Enjoy!!

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Oceania EcoHealth Symposium 2013
PHAA conference 2013
2014 conferences
#IPCHIV14
AIDA Conference 2014
Congress Lowitja 2014
CRANAplus conference 2014
Cultural Solutions - Healing Foundation forum 2014
Lowitja Institute Continuous Quality Improvement conference 2014
National Suicide Prevention Conference 2014
Racism and children/youth health symposium 2014
Rural & Remote Health Scientific Symposium 2014
2015 conferences
#CPHCEforum
#CRANAplus15
#HSR15
#NRHC15
#OTCC15
Population Health Congress 2015
2016 conferences
#AHHAsim16
#AHMRC16
#ANROWS2016
#ATSISPEP
#AusCanIndigenousWellness
#cphce2016
#CPHCEforum16
#CRANAplus2016
#IAMRA2016
#LowitjaConf2016
#PreventObesity16
#TowardsRecovery
#VMIAC16
#WearablesCEH
#WICC2016
2017 conferences
#17APCC
#ACEM17
#AIDAconf2017
#BTH20
#CATSINaM17
#ClimateHealthStrategy
#IAHAConf17
#IDS17
#LBQWHC17
#LivingOurWay
#OKtoAskAu
#OTCC2017
#ResearchTranslation17
#TheMHS2017
#VMIACConf17
#WCPH2017
Australian Palliative Care Conference
2018 conferences
#6rrhss
#ACEM18
#AHPA2018
#ATSISPC18
#CPHCE
#MHED18
#NDISMentalHealth
#Nurseforce
#OKToAsk2018
#RANZCOG18
#ResearchIntoPolicy
#VHAawards
#VMIACAwards18
#WISPC18
2019 Conferences
#ACEM19
#CPHCE19
#EquallyWellAust