As mentioned previously, the WA government recently released an important report reviewing the responses of health authorities after children in WA suffered febrile convulsions following seasonal influenza vaccination.
The report is damning, suggesting that health authorities did not respond quickly and appropriately, and it makes several recommendations for improving national reporting and surveillance measures for adverse events following vaccination.
In releasing the review, the WA health minister Kim Hames confirmed there was a particular problem with the CSL vaccine, Fluvax, and promised a “major overhaul” of the way information about vaccinations is recorded and collected.
The review also noted concerns about perceived conflicts of interest, because of the links of some members of peak immunisation bodies with pharmaceutical companies, and called 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”.
The review also called for consumers to be given more accurate information about vaccine content, testing and safety, noting that the product information for CSL’s Fluvax did not mention side effects of vomiting and diarrhoea, which was in the professional information.
It was “unacceptable”, the review said, that vaccination providers were not quickly and properly informed of the concerns about adverse events. The review also called for the Department of Health and Ageing to separate the roles of vaccine regulation and surveillance, as happens in the US, instead of both being under the Therapeutic Goods Administration.
It recommended the development of “an open, trusting and transparent partnership” between federal and state health authorities, as the current relationships “are not functional”.
“The stake holders in WA were left with the view that the TGA did not respond to the concerns raised in a timely manner,” the review said. “State health officials were frustrated by the perceived lack of engagement and leadership shown by the TGA in providing advice to WA on the decision to suspend the campaign. However, as previously stated, the TGA had not received the AEFIs (adverse events following immunisation) reports in a timely way.”
It was an important report and deserved more national media coverage than it got. Then again it was an election campaign. But it is telling that GP magazines Australian Doctor and Medical Observer made it a page-one story with headlines such as “flu vax fiasco” and “flu vaccine debacle”.
When researching a short news story for the BMJ, I emailed the federal Department of Health and Ageing media unit with an open-ended request for a response: “Can you pls advise how the Department and TGA are going to respond to the concerns raised in the review?”
Recently I received a follow-up email from an obviously irate PR person asking why the department’s response was not included in the BMJ article.
This is what I replied: “The WA report raised serious issues and made major recommendations. Your comment did not respond to any of these issues. Instead it just continued the tit-for-tat dispute between WA Health and the TGA already outlined in the report. If you had been able to provide a considered response to the review’s various recommendations — whether the department would inquire into the conflicts of interests of its immunisation policy advisers or review the TGA structure, for example, then I would have tried to include the response in my limited word count. I presume the response given to me is also what you gave to Australian Doctor and Medical Observer, judging by the comments attributed to the TGA in their articles. It is disappointing that the department and TGA’s public response was so defensive rather constructive or considering the public interest issues involved. It does not make me feel confident that the report will receive due consideration. I am very happy to be proven wrong on this, however. Perhaps the Department or TGA will release a detailed response to each of the report’s findings and recommendations? This I would be happy to report, including at Croakey.”
Let us hope that the inquiry by Nobel laureate Professor Peter Doherty into the problems associated with the vaccine is looking more broadly than at simply the science involved. Let us hope he is also investigating the broader policy issues, and that his report will be as frankly spoken and freely available as the WA one. Hopefully his report will be given the courtesy of a proper response…