Eric Abetz (Tasmania, Liberal Party, Shadow Minister for Employment and Workplace Relations) Share this | Link to this | Hansard source

asked the Minister representing the Minister for Health and Ageing, upon notice, on 16 August 2011:

With reference to the National Health and Medical Research Council (NHMRC) document, Naltrexone implant treatment for opioid dependence: Literature Review:

(1) Given that the paper by Professor Hulse (Hulse, 2005), reported that hospital presentations for opioid overdose stopped in the 6 months following implants, with a reduction from 21 (6 months pre implantation) to zero overdoses (6 months post), a change that Professor Hulse believes to be significant, with a p value of 0.0001: Why then did the NHMRC document state that Hulse 'found no significant change in risk of opioid overdose from six months pre treatment to six months post treatment for implant or control groups', and if this statement is false or misleading, will the NHMRC rescind this document and re-establish the rights of those at risk of premature death.

(2) Given that experimental medicine can be used for either: (a) producing new information; or (b) patient treatment to reduce the risk of premature death (Special Access Scheme, Therapeutic Goods Administration): (a) Why then does the document make recommendations that Naltrexone implants 'should only be used in the context of a well conducted RCT', which has had the effect of removing Naltrexone patient services in Melbourne due to the loss of insurance cover for Naltrexone treatment; and (b) will the NHMRC therefore rescind this document and re-establish the rights of those at risk of premature death.

(3) Can the NHMRC explain why they did not follow their own guidelines (http://www.nhmrc.gov.au/guidelines/how-nhmrc-develops-its-guidelines) in the development of this document, specifically: (a) '4. The draft guidelines are put out for public consultation, as required by the NHMRC Act; and (b) '7. NHMRC may choose to have a peer review of the guidelines. If so, they are sent to a number of experts in the subject area for their opinion, primarily on the evidence base used for the guidelines'; and given that this should have included experts in the field of Naltrexone medicine, will the NHMRC rescind this document and re-establish the rights of those at risk of premature death.

(4) Given that, under the NHMRC guidelines, 'the main principles of guideline development is that they should be based on the best available evidence' and that: (a) Professor Hulse's RCT confirmed that Naltrexone implants were significantly better than oral Naltrexone at preventing return to heroin use (Hulse, 2009); and (b) opioid overdose deaths are reduced by 25 times when comparing implant Naltrexone to oral Naltrexone in the    4 months post detox; if the NHMRC document had explained that oral naltrexone failed when compared with implant naltrexone to prevent return to opiate use under the heading on effectiveness and findings would then the removal of rights of patients at risk of premature death to the more effective treatment (implants) not have been promoted, and will the NHMRC therefore rescind this document in light of this new information.

(5) Given that the current cost to the Western Australian Government for detox services is $7 000 to $8 000 per patient and the Fresh Start Recovery Programme currently receives $6 150 from the Western Australian Government for the treatment of Western Australian patients receiving detox services, with the closure of detox services in other parts of Australia as a result of the findings of this document, will the Commonwealth provide funding for non-Western Australian patients seeking detox treatment, who now have to travel to Perth to be treated at the Fresh Start Recovery Programme.

Joe Ludwig (Queensland, Australian Labor Party, Manager of Government Business in the Senate) Share this | Link to 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.