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 This review has found that one of the reviews widely used to guide policy is based largely on unpublished and unreliable data.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…