Notice given 3 February 2012

1531  Senator Abetz: To ask the Minister representing the Minister for Health—

(1) What communication (verbal or written) took place between the Chief Executive Officer (CEO) of the National Health and Medical Research Council (NHMRC) and the departmental Secretary, Ms Jane Halton, in the lead up to the CEO commissioning a literature review on the subject of naltrexone implants.

(2) Given that the CEO of NHMRC states in a letter to Western Australian MLA Peter Abetz that the Secretary asked him to prepare the naltrexone literature review, did the Minister have any communication with the Secretary seeking such a review.

(3) Prior to the document ‘Naltrexone implant treatment for opioid dependence - Literature Review’ being made public on the NHMRC website, did the Minister’s office have any communication with any officer of NHMRC concerning the content of the review.

(4) Did the Minister or her staff make any representation to any staff or officials of NHMRC requesting that there be no naltrexone experts in the group established to examine the literature relating to naltrexone implants.

(5) Does the Minister condone the failure by NHMRC to follow its own guidelines, in particular, when it failed to:

(a) involve any active naltrexone experts in the review process; and

 (b) identify any authors or reviewers of the literature review, particularly given that the NHMRC website states in the ‘Joint NHMRC/AVCC Statement and Guidelines on Research Practice (1997)’ document, ‘Any part of an article critical to its main conclusion must be the responsibility of at least one author. An author’s role in a research output must be sufficient for that person to take public responsibility for at least that part of the output in that person’s area of expertise’.

(6) Who made the decision to first place, and then keep, the naltrexone literature review in the guidelines section of the NHMRC website given that it is clearly not a guidelines document.

(7) Given that Professor Gary Hulse of the University of Western Australia found that the use of naltrexone implants resulted in a reduction of opioid overdoses (from 21 in the 6 months prior to insertion of naltrexone implants to 0 in the 6 months after insertion):

(a) on what basis did the NHMRC reviewers come to the conclusion that this was not statistically significant, particularly when Professor Hulse and others assert that this is significant at the P<0.0001 level;

(b) can the name of the person who contributed the opinion to the review that the result was not statistically significant be provided; and

(c) will the Minister instruct NHMRC to have an expert check if Professor Hulse’s work is statistically significant.

(8) With reference to statements made by Ms Halton during the 2008-09 Budget estimates hearing of the Community Affairs Committee on 22 October 2008, in particular, that Dr George O’Neil had no interest in good manufacturing practice (GMP) despite Dr O’Neil lodging his first GMP applications in 2003 and 2004 and being granted a GMP licence in 2005, from what source was this information gathered.

(9) Why were no Australian or international experts on naltrexone or naltrexone implants consulted or involved in the production of the NHMRC literature review.

(10) Did Dr Alex Wodak have any involvement in the:

(a) request for a literature review on naltrexone implants;

(b) writing of the review; or

(c) peer reviewing of this literature review.

(11) Given that Professor Philipp Lobmaier of the Norwegian Centre for Addiction Research, regarded as the most eminent world authority on naltrexone implants, has described the NHMRC literature review as being in the category of an ‘ideologically motivated position paper’, will the Minister urge NHMRC to withdraw this document until a full inquiry into the irregularities in its production has been made public.

(12) Can the Minister assure the public that all future literature reviews published on the NHMRC website will be produced in keeping with its protocols.

 (13) Will the Minister ensure that NHMRC submits the literature review to world experts for revision as a matter of urgency.

(14) How long will the Minister tolerate the continuing display of this flawed document on the NHMRC website.