Temperatures are rising in the stoush between federal and state health officials over who was to blame for an inadequate response when evidence began to emerge that young children in WA were suffering febrile convulsions after having the influenza vaccine Fluvax.

As previously reported at Croakey, in August a report by a former WA chief medical officer, Professor  Bryant Stokes, raised many concerns about surveillance and reporting of adverse events and communications between state and federal health authorities.

The report made a number of recommendations, including calling for the federal Department of Health and Ageing to “formally review and address any perceived or real concerns in peak bodies with regard to conflict of interest”, and also called for consumers to be given more accurate information about vaccine content, testing and safety.

The TGA has finally released a detailed response to the report, and it takes a hefty swipe at Stokes and his conclusions. The TGA’s response seems unlikely to achieve progress on at least one of the Stokes review’s recommendations – the development of “an open, trusting and transparent partnership” between federal and state health authorities. This was needed, his report suggested, as the current relationships “are not functional”.

It’s worth reading the full TGA statement but this extract from the conclusion gives a sense of not only the content but the tone.

Sadly, perhaps due to the short timeframe in which the Stokes Review was conducted and the lack of direct interaction with the investigating authorities, it contains significant errors, misinterpretations and flawed conclusions. Moreover, it fails to address the major issues arising from a program of childhood influenza vaccination that is unique in Australia.

The childhood influenza vaccine trial program implemented by the WA Department of Health was associated with a higher than expected rate of side effects in 2010 than in previous years. Despite a lack of specific monitoring processes within WA to effectively manage a program outside national vaccine program guidelines, the relevant Commonwealth authorities responded in a timely and effective manner to prevent further harm and investigate the cause of the adverse events.

The statement seems unlikely to allay wider concerns about the TGA, if this Consumers Health Forum statement released today about the “long overdue explanation”  is any guide.

The CHF (which has previously been critical of the TGA’s handling of this issue) calls on COAG to examine “clear failures in communications” between state and territory-based health authorities and the TGA.

CHF president Carol Bennett said:

Taking the TGA response on face value, it begs the question ‘what chance does the general public has (sic) of understanding the current adverse events reporting system if a former West Australian Chief Medical Officer is taken to task for his failures in comprehension?’  It is deeply disturbing that a system put in place over many years to protect the health of our citizens is so confusing and poorly understood, that experts in the field are struggling to understand how it works.  Consumers certainly have little chance.

Both the TGA and Professor Stokes’ reports identify clear communication breakdowns between state and federal regulatory authorities.

Clearly this is a major health and safety issue that should be addressed with some urgency at the highest levels of government – COAG – to prevent future problems that threaten to undermine confidence in vaccination programs critical to public health…

It is time that the TGA emerges from its cocoon and presents the public with a transparent and accessible profile that builds the confidence needed in the excellent work we know they are doing.  Just reminding the public every few years when something goes wrong that it has strong safety mechanisms in place is not enough.

For more coverage:

Medical Observer

6minutes

Meanwhile, another TGA statement on its investigations into the reasons for the Fluvax problems says its “working hypothesis” is that:

The content of neuraminidase appears to be higher in the H1N1 strain used in the 2010 seasonal vaccine. Excess neuraminidase enzyme activity may be pyrogenic and may thus be contributing to the increase in febrile reactions in young children receiving the vaccine for the first time. While the different brands of seasonal influenza vaccines are utilising the same strains of virus, there are differences in manufacturing processes that may result in different levels of activity of the neuraminidase enzyme, which in turn may result in different cytokine responses and degrees of pyrogenicity. Although the extensive analyses undertaken to date have generated this working hypothesis, further investigation is required to confirm that this is in fact the biological basis for the excess cases of fever and febrile convulsions seen during the 2010 influenza season.

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Update, 20 Oct: Time for an independent umpire in this boxing match

The TGA must really be feeling under attack, given the size of the boxing gloves it is wielding – and not only as evidenced in the report described above.

In this letter published recently in the journal Eurosurveillance, the TGA’s Dr Ruth Lopert takes a group of researchers to task in no uncertain terms.

The researchers (from the Victorian Infectious Diseases Reference Laboratory and the WA Health Department) had previously published this study estimating that the use of CSL influenza vaccines in young children in WA might have caused two to three hospital admissions due to febrile convulsions for every hospital admission due to influenza prevented.

Lopert said that “the analysis is misleading and the authors’ conclusions must be considered unsound”. “Of even greater concern, however, is the unnecessary and damaging impact simplistic analyses can have on public confidence in childhood immunisation programmes in general and the consequences of immunisation recommendations being ignored out of fear and misinformation,” she wrote.

Lopert said the authors failed to recognise the obvious and significant differences between being hospitalised for overnight observation following a febrile convulsion and being admitted to intensive care units in respiratory failure as a result of influenza infection.

She also wrote: “Though not mentioned in the article, it might be relevant in any analysis of its conclusions to note that the authors were directly involved in the design and oversight of the population-based clinical trial that is the subject of the article (i.e. the administration of influenza vaccine to all children under the age of five years occurring only in Western Australia). The vast majority of adverse events referred to occurred in West Australian children participating in this trial in which influenza vaccination of young children was extended beyond the relevant national recommendation.”

The authors’ response to Lopert’s critique is interesting, particularly in light of the latest TGA report attacking the Stokes review.

They said they examined hospital admissions for febrile convulsion within 24 hours of receipt of seasonal influenza vaccine because hospital admission (or prolongation of hospital admission) is one of the four serious adverse events following immunisation identified by the World Health Organization.

They acknowledged that hospital admission for febrile convulsion may be shorter than hospital admission for influenza and that associated morbidity may be different, but suggested it is important not to underestimate the impact of either cause of hospital admission.

In response to the suggestion that they had undeclared conflicts of interest, the researchers wrote: “Three of the four authors of our article are involved in the Western Australian programme aimed at assessing the public health impact of providing seasonal influenza vaccines to children aged less than five years. We believe that our involvement in promoting a vaccination programme to protect children from influenza, while being prepared to examine both the risks and the benefits of this programme, does not constitute a conflict of interest.”

The authors also state – contrary to the implication of the TGA report released yesterday – that the WA program is not a trial. “… Western Australia has conducted a population-wide vaccination programme aimed at assessing the public health benefits of providing greater access to influenza vaccines for children under five years of age. This is not a clinical trial, but a programme using influenza vaccines licensed for use pre-school aged children, evaluated by observational studies. It is consistent with recommendations in the Australian Immunisation Handbook which states: ‘Annual influenza vaccination is recommended for any person > 6 months of age who wishes to reduce the likelihood of becoming ill with influenza’.  Universal vaccination of healthy children in this age cohort has been recommended by the Advisory Committee on Immunization Practices in the United States since 2006.  Moreover a study from South Australia supports the need to evaluate a policy of providing influenza vaccine to healthy children, as well as those with known underlying conditions. The study demonstrated that 81% of children aged less than five years admitted to hospital with influenza between 1996 and 2006 had no documented risk factor that increased their risk of a serious outcome following infection.”

It’s really looking like time that some heavyweights were called in to sort out this boxing match. An independent umpire might be helpful.

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