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Questions about swine flu response keep mounting

It’s only about a month ago that an editorial in the New England Journal of Medicine on pandemic influenza vaccine policy, freely available here, warned that globally, “demand for influenza vaccine greatly exceeds supply”.

Which just goes to show that you should be sceptical about what you read in even the most prestigious of medical journals. In the past week or so, there has been been a spate of media reports about the global oversupply of vaccine, and the efforts of various countries to offload their expensive stockpiles.

The Wall Street Journal health blog has reported that the US cut its order from the Australian manufacturer CSL by more than half, to 14 million doses. The US is allowed to change the quantity of its order under its contract with CSL — though not all countries have similar terms in their contracts. Australia, it seems, did not manage to negotiate such an arrangement, and has unused stock worth some tens of millions of dollars, according to some analysts’ estimates.

The WSJ blog also reported that the UK is trying to recoup some of the £500 million it spent ordering H1N1 vaccine from Baxter and GlaxoSmithKline. The government initially ordered enough vaccine to cover the entire population. But, as elsewhere, the relatively mild nature of the pandemic has contributed to low demand.

The French government had planned on using 94 million individual shots to give two doses of the swine-flu vaccine to most of the country’s 65 million people. But it recently said that it was canceling 50 million orders. The Netherlands, Germany, Spain and Switzerland have also been backing off their vaccine orders, and the Financial Times recently reported that the manufacturers face “significantly lower flu vaccine sales than forecast” as government buyers seek to renegotiate their purchase contracts.

Not surprisingly, questions are beginning to be asked, in the highest places.

According to the BBC, the World Health Organisation (WHO) is to review its handling of the swine flu pandemic, following charges from some European politicians that it exaggerated the dangers of swine flu. The WHO has committed to a review of its management of the pandemic by  independent experts, with the results to be made public.

Meanwhile, the Council of Europe is planning an investigation into whether pharmaceutical companies influenced public health officials to spend money unnecessarily.

Later this month, its assembly will debate a resolution drafted by the Council’s health committee chair, Wolfgang Wodarg, (a German epidemiologist turned MP) which states that “in order to promote their patented drugs and vaccines against flu, pharmaceutical companies influenced scientists and official agencies responsible for public health standards to alarm governments worldwide and make them squander tight health resources for inefficient vaccine strategies, and needlessly expose millions of healthy people to the risk of an unknown amount of side-effects of insufficiently-tested vaccines.”

Similar questions about conflicts of interest in the policy process are also being asked on the other side of the Atlantic. The Centers for Disease Control and Prevention has been criticised for doing a poor job of screening medical experts for conflicts of interest when they are providing advice on vaccines, according to a report detailed last month in the New York Times.

Most of the experts who served on advisory panels in 2007 to evaluate vaccines for flu and cervical cancer had potential conflicts that were never resolved, the report said.

The report found that 64 percent of the advisers had potential conflicts of interest that were never identified or were left unresolved by the centers. Thirteen percent failed to have an appropriate conflicts form on file at the agency at all, which should have barred their participation in the meetings entirely. Most of the advisers identified by the report had either a job or a grant from a company or other entity whose interests were affected by the committees’ discussions, and a considerable number also owned stock in such companies.

It seems there are plenty of questions in search of some answers in the wake of the pandemic response.

One is whether Australia will get an independent, transparent and public review of its response to the pandemic. One of many issues such a review might examine is the role of industry in driving policy, and the management of advisors’ conflicts of interest.

When I raised similar issues in a Crikey article last year, it was assumed by some of those promoting vaccination as well as by some of those in anti-vaccination groups that I am “anti-vaccination”.  Nothing could be further from the truth.

I do believe, however, that vaccines and vaccine policies generally should be subject to the same questions and scrutiny as any other interventions. This is not such a radical idea; even the National Health and Hospitals Reform Commission final report recommended something similar, that there should be “consistent evaluation of medical care, pharmaceuticals, prevention and population health interventions, medical devices and prostheses, allied health and complementary medicine.”

Unfortunately, the current climate inhibits such questioning. On one hand, this reflects concerns amongst some in the public health community that asking such questions in public might feed into anti-vaccinationists’ campaigns.

On the other hand, it suits manufacturers’ sales objectives to discourage such questioning, and to be able to label any who do raise such questions as anti-vaccinationists or anti-public health. Let’s not forget that vaccines are an increasingly profitable business, as per CSL’s latest results and these industry analyses.

Finally, let’s return to the beginning – that NEJM editorial, whose final comment does remain apt. It concluded that “the need to make timely decisions must be balanced with thoughtful, transparent debate and openness to changing direction as new data emerge.

So there’s my wish for the New Year – for policy makers and public health experts who are committed to “thoughtful, transparent debate and openness to changing direction as new data emerge”.

Without some honest and open reflection about where we’ve been, it may be harder to find our way in the future, and to ensure public confidence in future public health messages.

Comments 10

  1. Trevor Kerr says:

    As for the H1N1 vaccine in Australia, it’s all water under a rolled-gold bridge.
    How about turning the focus to Chlamydia (as a cause of human STIs)? It’s being beaten up by the SMH, so maybe there’s something on the horizon. The “something” as sure as heck will not be Ansell’s share price, or a DoHA initiative to get more sex hygiene in schools. It sure would be interesting to line up all the parties in the STI domain, and determine which were in direct opposition to others. For instance, how would the makers of test kits be rated for their contributions to prevention? The same question could have been asked about HPV, but, again, a torrent of cash under another solid-gold, tax-payer funded bridge to share-holder value.

  2. Trevor Kerr says:

    From Australian Prescriber, Dec09, p166.

    “The actual effectiveness of the vaccine to protect against influenza A H1N1 virus will not be known until after a mass immunisation program has taken place. Vulnerable groups of patients such as pregnant women, children, the elderly and people with impaired immunity were not included in the trial so it is not known how the vaccine will perform in these individuals.”

    Who is looking after the post-marketing surveillance?

  3. Trevor Kerr says:

    Says here http://www.businessweek.com/ap/financialnews/D9D725F01.htm (Merck upgraded on drug pipeline, shares rise) that one of their new drugs is “staph infection vaccine V710”.
    Expect a white-coat special at 6.30, explaining the deadly consequences of “staph infection”, but no comment on the basics of prevention, like better hand hygiene.

    Also, at http://www.dailyfinance.com/story/surging-merck-seeks-to-expand-use-of-hpv-vaccine-to-older-women/19317147/
    “In June 2006, Gardasil was approved for females aged 9 to 26 to protect against human papillomavirus, which causes cervical cancer and genital warts. Since then, Merck has been trying to get those approvals expanded. In September 2009, Merck received approval to market Gardasil for males aged 9 to 26. But earlier, the FDA withheld approval for its use by women from 27 to 45, asking Merck to submit data when a 48-month study is completed. However, according to a shorter study published in June, Gardasil was 90% effective in preventing infection in women from 24 to 45.”
    Preventing infection? So, mature, fun-loving women don’t have to use barrier protection any more?

  4. Trevor Kerr says:

    In passing, Sunlight Foundation has their Real Time Congress iPhone app. Three clicks across to Senate reports, GAO, is ‘Brand-Name Prescription Drug Pricing: Lack of Therapeutically Equivalent Drugs and Limited Competition May Contribute to Extraordinary Price Increases’.
    Sunlight also wrote on ‘Database used to track contractor fraud poorly managed, filled with inaccuracies’.

  5. Croakey says:

    An interesting post on related issues – the WHO, global pandemic response, role of pharma etc – which was put up at two US public health blogs: http://thepumphandle.wordpress.com/2010/01/13/who-prepares-to-don-a-hair-shirt/

    Well worth a read

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Croakey Conference News Service 2013 – 2019
2013 conferences
Australian Centre for Health Services Innovation Forum 2013
Australian Health Promotion Association Conference 2013
Closing the Credibility Gap 2013
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Health Workforce Australia 2013
International Health Literacy Network Conference 2013
NACCHO Summit 2013
National Rural Health Conference 2013
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2014 conferences
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AIDA Conference 2014
Congress Lowitja 2014
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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
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2015 conferences
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Population Health Congress 2015
2016 conferences
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2017 conferences
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