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.