Joe Ludwig (Queensland, Australian Labor Party, Manager of Government Business in the Senate) Share this | Hansard source

The Minister for Health and Ageing has provided the following answer to the honourable senator's question:

(1) The sentence referred to in the NHMRC Literature Review is correct.

On page 40 of the Literature Review there is reference to Hulse et al. (2005), who found that ‘For emergency department presentations and hospital admissions and when data from emergency department presentations and hospital admissions were combined, there were more opioid overdoses six months pre treatment vs six months post treatment but the significance was not reported’.

Hulse et al. (2005) reported more presentations to the emergency department and hospital for opiate overdoses pre-treatment (21 overdose in 20 people [out of n=361]), which reduced to zero in the six month post-implant period, but the authors did not present any statistical calculation related to this change (and not the p value as cited in the question), meaning that this change was non-significant (as highlighted in the Literature Review). Nowhere in Hulse et al. (2005) do the authors say this was a significant result .

(2) (a) The Literature Review recommended that future research should be conducted in the context of a well-designed Randomised Clinical Trial (RCT) because RCTs “are the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome” .

By publishing its Literature Review, NHMRC translated the evidence into advice for the Australian community. NHMRC’s Literature Review has no bearing on the way in which naltrexone implants are currently regulated via the Therapeutic Goods Administration’s regulatory framework.

Medical indemnity insurers are private companies that make underwriting decisions based on their assessment of risk.

(b) Based on the answer to (a) above, NHMRC has no intention of rescinding its Literature Review.

(3) (a) NHMRC’s Literature Review is not a guideline and, therefore, NHMRC was not required to conduct public consultation prior to releasing it.

(b) The NHMRC Reference Group suggested suitable peer reviewers to provide the NHMRC with feedback on the draft Literature Review. Fifteen independent peer reviewers were invited to participate in the peer review process. Seven of those invited agreed to participate and were sent a copy of the draft document to consider, however only five submitted comments to NHMRC.

The peer reviewers provided extensive comments which were taken into account before finalising the document through the Council of NHMRC.

Given the above, NHMRC has no intention of rescinding its Literature Review.

(4) As noted in the answer to Question 3 above, the NHMRC Literature Review is not a guideline.

The Literature Review acknowledges that naltrexone implants show some efficacy. However, its conclusion was that the published scientific data is limited and that more research is needed.

Given the above, NHMRC has no intention of rescinding its Literature Review.

(5) NHMRC does not have a role in funding service delivery at a jurisdiction nor Commonwealth level and is therefore unable to respond to this question.