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An update on influenza, vaccination and other recent controversies

Herewith, a series of updates of recent news and views in the world of influenza, vaccination etc (including a rather stiff serve directed at the Federal Department of Health and Ageing…)

Federal response to WA influenza vaccination review is sorely lacking

As mentioned at Croakey 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 a number of 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 stakeholders 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 immunization) 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 both GP magazines, Australian Doctor and Medical Observer, made it a page one story with headlines like “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 immunization policy advisors 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…

***

Call for no fault compensation for children harmed by immunisation

On related issues, the Public Health Association of Australia’s conference in Adelaide last week passed a resolution calling for a no fault compensation scheme for children who suffer serious side effects from immunisation.

The resolution was put by Melbourne University’s Associate Professor Heath Kelly, who described how 19 countries around the world have recognised that children suffering from these rare events are compensated through no-fault compensation schemes.

Germany was the first country to establish such a scheme in 1961 and Hungary most recently implemented its scheme in 2005.

No fault implies that an adverse event occurred following correct administration of a properly manufactured vaccine. Because no fault is involved, Kelly argued that recourse to the adversarial legal system is inappropriate.

He told the conference that the guiding ethical principle of no fault compensation is that of redistributive justice. This is a critical issue for immunisation programs because immunising an individual also benefits the community. When sufficiently many individuals are immunised, herd immunity protects the whole community.

If an individual suffers an adverse event following receipt of a properly manufactured and administered vaccine that has been recommended and funded by the community, Kelly argues that it is only fair that the community should provide for that individual.

A long overdue update of Australia’s National Immunisation Strategy is currently underway. It will be interesting to see if this issue is addressed.

***

Media alert: industry-funded campaign about to hit the airwaves

The Influenza Specialist Group is distributing a press release promoting influenza vaccination and the use of antivirals, and warning that “influenza is on the increase”. In the very small print of the release is mention that the organisation “receives funding from industry.”

Let’s see if any of the subsequent media reports mention that the PR campaign being mounted by Burson-Marsteller’s Melbourne office (which is distributing the press release) is on behalf of  “a group funded by companies with an interest in promoting influenza and related treatments and products”.

They should.

***

A downside of vaccine industry marketing

A study recently reported in the New England Journal of Medicine asked US policy makers about the factors influencing the implementation of policies around Merck’s human papillomavirus (HPV) vaccine, Gardasil, including whether it should be mandated for schoolgirls.

Among the many factors identified, the researchers said there had been “consternation over the involvement of the vaccine’s manufacturer, Merck, in the policy process”.

They wrote: “Merck undertook a multifaceted marketing campaign to promote the passage of mandate legislation. Representatives of the company met with legislators and hired political consultants to promote the vaccine. Merck also provided unrestricted funds to Women in Government, a national organization of female legislators. Many of the bills to require HPV vaccination were introduced by Women in Government members.

“Although Merck’s lobbying was a key catalyst in the initial push for mandates, many stakeholders came to view the company’s efforts as a liability. As media coverage called attention to the company’s aggressive tactics, suspicion grew that policy decisions were not being based on the product’s merits, and people who were otherwise supportive pulled back. The belief that mandate bills were an effort to make money for the company overshadowed whatever principled arguments might exist for them.”

In other words, industry marketing can have the unintended consequence of undermining public and policymaker confidence in vaccines.

***

Fallout from the swine flu pandemic continues

Alan Cassels, a drug policy researcher at the University of Victoria in Canada, writes about concerns about the “appalling” role of industry in influencing pandemic policy. “Do we really want a world authority taking advice from experts who had declarable financial and research ties with companies selling antivirals and influenza vaccines?” he says.

Meanwhile, the online publication 6minutes has picked up on two recent studies suggesting that the swine flu toll is less than that of seasonal influenza – something we’ve heard some saying before. One group of researchers is quoted as saying it would be prudent to reflect on the unprecedented levels of resources that were directed at fighting pandemic influenza and focus more on the enormous impact of ‘uncelebrated’ seasonal influenza…

***
Update

Doctors call for vaccine transparency

That’s a page 3 headline in the 27 August edition of Australian Doctor. The story reports on comments made at the Adelaide conference including:

• Suggestions the Australian Technical Advisory Group on Immunisation should follow the example of its US counterpart, which posts live webcasts of all its meetings, along with detailed minutes of the deliberations. (Great idea! And why don’t we see this happening much more widely – perhaps something for the NHMRC, for example)

• Dr Paul Effler, from the WA Department of Health, calling for the immunisation community to get its “own house in order in terms of vaccine safety and transparency”. He said: “We need to avoid perceived conflicts of interest in vaccine decision-making,” he said.

• Dr Jim Buttery, head of the Victorian adverse events surveillance service, said any public perception of a delay in addressing safety issues could damage confidence in vaccination. He recommended better information-sharing between governments and standardised adverse event reporting systems.

These are, of course, not only issues for vaccination. Croakey was struck recently by the openness of the US regulatory processes when addressing safety concerns around the diabetes drug Avandia. We knew who said what during the FDA panel hearing. This was useful to know, especially when there subsequently was an investigation of the industry ties of some of the experts involved.

***

Update: Statement from a spokeswoman for the Dept of Health and Ageing (Aug 26):

The Therapeutic Goods Administration (TGA) has advised today that all stocks of the pandemic influenza vaccine for children, Panvax H1N1 2009 Junior, supplied in 0.25 ml pre-filled syringes, should now be considered expired.

This follows stability testing by the TGA of the vaccine which showed a decline in potency in the Panvax supplied in 0.25 ml pre-filled syringes.

The TGA has informed the manufacturer, CSL, that its registered 12 month shelf life can no longer be supported and the shelf life has been reduced to 6 months.

Panvax in multidose vials is not affected, nor are the trivalent seasonal influenza vaccines.

The safety of the vaccine is also not affected.

Any child who has had their course of Panvax Jr (2 doses) will be immune and new vaccinations can proceed by using the vaccine contained in multidose vials.

http://www.healthemergency.gov.au/internet/healthemergency/publishing.nsf

Comments 8

  1. Trevor Kerr says:

    Perhaps the Doherty report will try to examine the instructions given to parents of vaccinated children, because there is no hint of it in the Stokes report. Yet, parental behaviour post-vaccination is the key element in effective surveillance. The essential tool in surveillance is the thermometer and, like any tool, standards would apply to measurement.
    So, the parents would have been, and still are, and always have been, told to ‘keep an eye’ on the kiddies and bring them back if there is a problem. Untold thousands of parents would dismiss mild fevers as trivial, some would try taking temperatures, but many would not have a blind clue. Who knows? Based on the known levels of health literacy, it’s predictable that a program of surveillance is crippled from the start. Since surveillance is nobbled by known facts and ignorance, and the Stokes report does not seem to address the complicating factors, interested outsiders like me are entitled to ask what the hell is going on? Who benefits from instituting a “program” of surveillance that’s guaranteed, by its lack of design, to not bring to notice the majority of side effects?
    This subject has been aired in a letter to the national newspaper on Mar 11 2009, and worth repeating here.
    The National Health and Medical Research Council is the arbiter of concerns about our medical research.
    Its administration was the subject of a bill before the Australian parliament in 2006. During the second reading debate, Julia Gillard noted: “Our third concern is in the area of disclosure of interests. We note that the minister is not required to be advised if a member of the council has disclosed an interest.
    “We consider it the responsibility of the minister to know if a member or members disclose an interest.
    “We regard this as a basic accountability issue.”
    The NHMRC does not have provision for public disclosure of the financial interests of its members and officers.
    In view of promises of break-through therapies, the rising costs of health care and the contentious nature of stem-cell research, it is high time the Government compelled the NHMRC to operate with the highest standards of transparency and accountability.

    Perhaps someone can comment on whether the NHMRC is “looking at” procedures to improve accountability.

  2. Doctor Whom says:

    aah – so we can expect an enlightened policy debate arising from either pressure from Big Pharma or “activism” from the no vacs homeopathy hippies from Northern NSW and Queensland. I’m tired.

  3. Melissa Sweet says:

    Hope you got some sleep DW…And I hope that Croakey wasn’t keeping you up too late

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