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What does Fed Health have to say on the Tamiflu story? Not much…

Earlier today, I put a series of questions to the Federal Health Department/TGA arising from the BMJ series raising concerns about Tamiflu, pandemic policies etc, as outlined in the previous post.

These were the questions (put together in a bit of a mad rush, as you can probably tell) and sent to the department’s media office at 9.39am with an eye to my 11.30am deadline:

1.        Will the Fed Health Dept and TGA review policy on the registration and/or use of these drugs?
2.        What are the implications for the pandemic plan?
3.        The publication raises far broader concerns than Tamiflu, with the BMJ editorial raising concerns about drug regulators more broadly being too trusting of data provided by manufacturers. This review has found that one of the reviews widely used to guide policy is based largely on unpublished and unreliable data. Will the TGA be taking any action in response to the review?
4.        One of the review’s authors, Australian academic Prof Chris Del Mar, says one of the implications is that pandemic response has put too much emphasis on Tamiflu and vaccines (when there are questions about effectiveness of both), rather than physical barriers, which are backed by better evidence. What is the Dept’s response to this?
5.        Any other points you’d like to make?

This is the email response that landed at 1.30pm:

From a spokesperson for the Australian Government Department of Health and Ageing:

Australia’s policy on the registration of medicines is evidence based and is based on well-developed, internationally accepted criteria.  Prior to approval there is a rigorous critical review of all evidence and data by independent reviewers.

Australia’s pandemic plan is multi-faceted using a range of public health measures and not just anti-viral drugs.  This includes home quarantine, public awareness of droplet spread, treatment and physical barriers to vulnerable contacts as well as use of vaccines. Our antiviral stockpile includes both Tamiflu and Relenza.

All these actions are complimentary without reliance on one method.

Australian use of anti-virals has been targeted and measured and directed to those most at risk of poor health outcomes and is a different approach to that in the UK

It should also be noted that the Cochrane reviewers concluded that: “neuraminidase inhibitors have modest effectiveness against the symptoms of influenza in otherwise healthy adults.  The drugs are effective post-exposure against laboratory confirmed influenza”  This is consistent with the approved indications. The reviewers noted the need for further trials to resolve uncertainties.

Now I think we have to cut the Department some slack – this is a complex and challenging issue and they didn’t have much time to respond. And my questions could have been better put.

Even so, I think the response is incredibly uninspiring, smacks of defensiveness, and doesn’t acknowledge the seriousness of the concerns raised not only by the review, but also by the accompanying articles, including the BMJ editorial.

Researchers who received fast-tracked NHMRC funding as part of Australia’s response to the H1N1 pandemic will meet for a two-day workshop starting in Canberra tomorrow.

Chris Del Mar will be presenting the findings of the Cochrane review. Will the gathered researchers – who will of course be pushing their own particular barrows and research interests – come up with a more enlightening response to the review than the Department has managed thus far?

If so, we hope that some of those attending will let Croakey readers know…

Related Posts

Comments 3

  1. Ian Cheong says:

    The small benefits of tamiflu have been known since its introduction in the market. A global economic crisis enabled a global swine flu epidemic to be a welcome political distraction, which the media swallowed whole. The tamiflu stockpile from the bird flu epidemic scare was going out of date and likely to end up in the bin. Better to use it for some benefit than bin it for none. Can’t see the cochrane review changes much on tamiflu. We’re still missing quality data on morbidity and mortality rates from swine flu.

  2. Croakey says:

    Ian, in one sense you’re right that the review simply reinforces much of what was already known about the state of evidence on Tamiflu. But in one important respect it does change things, saying that there is no evidence to show that Tamiflu reduces serious complications in otherwise healthy people. Why I was so peeved by the Fed Health Dept’s response is that the national pandemic health management plan says “that the early use of NI antiviral medication (i.e. started
    within 48 hours of onset of symptoms) is anticipated to result in reduction:
    (a) in pneumonia in at risk adult population by 40%
    (b) in pneumonia in previously healthy adults by 50%
    (c) in pneumonia in children by 40%
    (d) in otitis media in children by 30%. ”
    I thought at the very least, the dept could have said they would examine the new Cochrane review and have another look at their own policies. Either that, or they should tell us what evidence they have (that the Cochrane team could not find) to back up the figures they are using above.

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