Comments on: Some questions for governments on naltrexone implants http://www.crikey.com.au/2009/03/02/some-questions-for-governments-on-naltrexone-implants/ now with extra source Sun, 12 Feb 2012 06:21:51 +0000 hourly 1 http://wordpress.org/?v=3.2.1 By: Rod MacQueen http://www.crikey.com.au/2009/03/02/some-questions-for-governments-on-naltrexone-implants/#comment-6696 Rod MacQueen Thu, 01 Jan 1970 10:00:00 +0000 #comment-6696 Sorry if this is an old story - I have been away and have just found Alex Wodak's posting - but it is an ongoing and important story. I originally wrote to the TGA 10 or more years ago asking what evidence there was to support naltrexone being used as a 'life saving" medication. I am still waiting for the evidence. At about that time, Italy was in the thrall of a new cancer cure guru, Dr Di Bella, whose unproven treatment was so popular that Courts legislated it must be used, and paid for by the state if needed. Public rallies and meetings were held supporting Di Bella and condemning the rigid controlling medical profession. In response, the profession conducted phase 11 trials "planned, conducted and concluded in less than 10 months" which gave "the Italian scientific community a solid base for the ongoing debate" (see BMJ 1999, 318: 224). The trials showed the treatment did not work, and it has now disappeared. <br />So, we are forced to ask the question, is it acceptable to require a lower level of evidence when treating drug users compared to people with cancer? Both are sick and vulnerable, both need evidence based treatments and protection by good legislation. If the Italians were able to address this issue in 10 months, why have we not done so in 10 years? If there is a role for naltrexone in opioid dependence, let's define it, and if not, let's stop offering false hope. Sorry if this is an old story - I have been away and have just found Alex Wodak’s posting - but it is an ongoing and important story. I originally wrote to the TGA 10 or more years ago asking what evidence there was to support naltrexone being used as a ‘life saving” medication. I am still waiting for the evidence. At about that time, Italy was in the thrall of a new cancer cure guru, Dr Di Bella, whose unproven treatment was so popular that Courts legislated it must be used, and paid for by the state if needed. Public rallies and meetings were held supporting Di Bella and condemning the rigid controlling medical profession. In response, the profession conducted phase 11 trials “planned, conducted and concluded in less than 10 months” which gave “the Italian scientific community a solid base for the ongoing debate” (see BMJ 1999, 318: 224). The trials showed the treatment did not work, and it has now disappeared.
So, we are forced to ask the question, is it acceptable to require a lower level of evidence when treating drug users compared to people with cancer? Both are sick and vulnerable, both need evidence based treatments and protection by good legislation. If the Italians were able to address this issue in 10 months, why have we not done so in 10 years? If there is a role for naltrexone in opioid dependence, let’s define it, and if not, let’s stop offering false hope.

]]> By: Gavin Mooney http://www.crikey.com.au/2009/03/02/some-questions-for-governments-on-naltrexone-implants/#comment-6697 Gavin Mooney Thu, 01 Jan 1970 10:00:00 +0000 #comment-6697 On a previous occasion on Crikey, Alex Wodak wrote:' "If there is uncertainty about treatment effectiveness and safety but there is a plausible case for providing the novel treatment, rigorous research meeting required scientific and ethical standards is required". He went on: "There is a good case for conducting naltrexone research in Australia".<br /><br />Given some of the comments that provoked on Crikey and the lengthy controversy surrounding this treatment, why does NHMRC not set up urgently a rigorous independent inquiry into naltrexone implants? Why does Nicola Roxon not get on to this? We need to know. It may well work well or it may be doing harm. Why not find out - which given the quotes above seems to be what Dr Wodak is suggesting! On a previous occasion on Crikey, Alex Wodak wrote:’ “If there is uncertainty about treatment effectiveness and safety but there is a plausible case for providing the novel treatment, rigorous research meeting required scientific and ethical standards is required”. He went on: “There is a good case for conducting naltrexone research in Australia”.

Given some of the comments that provoked on Crikey and the lengthy controversy surrounding this treatment, why does NHMRC not set up urgently a rigorous independent inquiry into naltrexone implants? Why does Nicola Roxon not get on to this? We need to know. It may well work well or it may be doing harm. Why not find out - which given the quotes above seems to be what Dr Wodak is suggesting!

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