When the drug naltrexone is swallowed, it blocks the action of heroin for about two days. Australians first heard about naltrexone as a new treatment for heroin dependence in 1997.
In the late 1990s, Dr George O’Neil, a Perth obstetrician, became a strong advocate of naltrexone in the treatment of heroin dependence and established a growing clinical service to provide this treatment to the soaring numbers demanding it. Dr O’Neil began to recognise the limitations of depending on drug dependent patients to administer naltrexone to themselves. When only taken intermittently, naltrexone was not only ineffective but also dangerous. Dr O’Neil began producing naltrexone implants and then inserting these surgically into some thousands of patients.
There has been considerable controversy in Australia for almost a decade because naltrexone implants have continued to be used very widely despite never having been approved by the relevant regulatory body, the Therapeutic Goods Administration (TGA). There has also been concern about the fact that Dr. O’Neil’s manufacture of naltrexone implants has never met the required regulatory standards.
On 22 October Ms Jane Halton, Secretary, Department of Health and Ageing, gave evidence to the Senate Standing Committee on Community Affairs. She said:
I can tell you that there has been a very long conversation with Dr O’Neil about the need to ensure that, if he is manufacturing, he meets good manufacturing practice. That has not happened, and the TGA is basically discharging its regulatory responsibilities in its dialogue with Dr O’Neil.
Ms Halton added:
…as has been pointed out to Dr O’Neil I do not know how many times, he can ensure that his manufacturing practice meets the standard that is required of every other manufacturer in this country. I do not think that is unreasonable.
Not only is Dr O’Neil not meeting required good manufacturing practice in production of his naltrexone implants, but the TGA and the Department of Health and Ageing may have been aware of this for some time. If that is so, why then have the TGA and the Department of Health and Ageing taken so long to act?
It has been well accepted since the thalidomide disaster that medical treatments should only be registered and provided in Australia if they have been proven to be effective and safe. 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. There is a good case for conducting naltrexone research in Australia but not for officialdom to tolerate an unregistered treatment which has also never met required manufacturing standards.
Australia has a good international name in health policy and regulation. Losing that reputation would inevitably have significant international consequences.
Two problems with this article.
1. Dr Alex Wodak is the head of Australia’s drug legalisation movement who has agitated for years to have illicit drugs dispensed by pharmacies to addicts. We would not expect the most objective view of this issue as a result.
2. I can recall talking to one of Australia’s most experienced addiction medicine specialists from a Sydney Hospital some years ago who expressed disdain of the drug legalisation lobby’s attempt to slander Naltrexone implants as a treatment. His statement was that Naltrexone was a substance that had been tested, approved and proven over 30 years, and implant technology had been tested, approved and proven over the years. His view was that Naltrexone implants were only a totality of two already proven subtances/technologies and that the legalisation lobby’s attempts to agitate with the TGA was only an attempt to villify and block someone who actually wanted to get people off drugs, rather than maintain them indefinitely on substitutes.
Alex Wodak writes:’ “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 goes on: “There is a good case for conducting naltrexone research in Australia”.
Given some of the comments this has 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!
Terry Wrong, you are a goose and as usual, provide no medical evidence whatsoever.
Apart from being rejected twice by the Federal Governments Advisory Group on pharmaceuticals, The TGA’s Special Access Scheme under which the naltrexone program runs, is often used as a route to bypass standard scrutiny.
This has been written about several times including the Age, the Medical Journal of Australia and the ABC.
The most noted was when associate professor Robert Ali published an article in the Medical Journal of Australia that criticised the TGA, for failing to properly vet naltrexone implants, which have not been approved for use in Australia.
“That was shown to be unsafe with significantly higher rates of death because while on naltrexone, former heroin users lost their tolerance to heroin and if they stopped taking their naltrexone the one that blocked the heroin and went back onto the drug in the amounts they were used to in the past, they experienced overdoses and some of them were fatal.”
-ABC’s “The Health Report” with Doctor Norman Swan
Quack!
I agree that it is very odd that the authorities seem to turn a blind eye to this issue and to claims that a disturbing number of the young junkies being treated by Dr O’Neil fall pregnant, which is not surprising since O’Neil first encountered the drug in his role as an obstetrician where it is used to INCREASE FERTILITY.
Young women just coming out of heroin addiction are rarely at a stage in their lives where preganancy is ideal and I wonder how many shake their drug habits because they are pregnant and suddenly have to change their life plans to accomodate babies.
This is the question research needs to answer.
I have heard that the staff at the clinic hand out a lot of condoms, which indicates and awareness of the problem, but that there are still a lot of strung out young mothers-to-be coming out of the clinic.
As troubling as the authority’s blind eye is the media’s blind eye. This story has been rattling around for years and yet it gets sporadic and rare media attention with little to no follow through. I worry that this is a result of a low level of understanding of the regulatory processes by mass media journalists and editors.
Neglect of the story could also be a result of cognitive dissonance about the clash of sterotypes between the common media image of a young junkie and the stereotype of a responsible mother. It may be deemed unthinkable that a young junkie is capable of making sensible decisions about drying out and being good mother, and yet this may be a very helpful story for people who are trying to find away out of drug use. It could not only work as a story of inspiration for individuals, it may make others in the community more accepting and prepared to be helpful.
Many drugs have been approved by the FDA and the TGA, often with pressure brought to bear by the pharmaceutical companies producing them, and subsequently a number have been found to cause great harm – so I wouldn’t regard these “highly qualified” agencies as infallible. Attacking Dr Wodak because he supports legalisation and therefore isn’t impartial, well, are we to accept that the pharmaceutical companies are impartial? Yeah, right.