How did naltrexone slip through the regulatory net?
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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:
Ms Halton added:
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. |
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15 Comments
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.
In response to Peer Lindholdt:
“Methadone is not the answer, it is the official less expensive excuse. Never mind the side effects.”
Naltrexone has a very nasty side effect as well … Death.
Obviously the “correct literature” Terry Wright is referring too is the one that proves his arguement, not the wrong literature that shows the safety and efficacy of Naltrexone.
“Maybe Mr Wright should actually look at the literature and data as well, rather than make ludicrious comments like Naltrexone causes death. Tell that to all the herion addicts the drug has saved!”
LOL.
Only a lack of desire to look up the correct “literature and data” can be responsible for ignoring the facts and making silly comments like above.
Naltrexone HAS indeed been responsible for many deaths. Was that explained by Dr. Reece and Dr. O’Neil to the parents of the deceased patients who it helped kill!
Also, as Mike Smith pointed out, “Attacking Dr Wodak because he supports legalisation and therefore isn’t impartial” is absurd. Why is it that anyone who questions the practices of those working for Dr. God is accused of not wanting what’s best for addicts? Maybe if drug use and treatment was dealt with as medical issue like it should be instead of a moral deficiency, the anti-Harm Minimisation crowd might be out of a job.
And don’t get me started on the Big Pharma sub agency called the FDA…
Is it a question of safety or bureaucracy? The risks and costs of “commercial” grade heroin justify Dr O’Neill’s innovative approach - nothing else seems to have the same success rate. Applied universally, this approach could save lives and a great deal of money, and reduce the demand for illegal heroin. Can Dr Wodak offer a more effective solution?
I have no doubt that when a heroin user stops taking oral Naltrexone they are at risk of dying. That is the whole concept behind the use of Naltrexone in an implant so it slow releases gradually decreases the dose, so tolerance isn’t an issue. Isn’t that what we are talking about here from the intial blog from Dr Wodak? Maybe provide releveant data to the blog rather than to fuel your own Naltrexone witch hunt.
Why is the medical fraternity so adverse to trialing alternatives to methadone for opiate dependence? Not only that when someone like Dr.O’Neil tries they do everything in their power to shut him down! The medical fraternity should be helping people like Dr.O’Neil not hindering them. Dr.Wodak, you are a doctor and should be well aware of the legislation that permits a doctor and a patient to undergo an unregistered treatment if the patient has a condition which is likely to cause sudden or immediate death, so don’t act like Dr.O’Neil’s life saving work over the last decade is a mistake. 2ng/mmol of naltrexone and 10ng/mmol of naltrexol(metabolite) is proven to block the affects of 500mg of Diamorphine (heroin). I don’t know about you Dr.Wodak but that sounds like harm reduction to me.
It is not clear if the director of Alcohol and Drug Service at St Vincent’s Hospital in Sydney, Dr Alex Wodak is opposed to the use of Naltrexone in the treatment of heroin addiction or only concerned that Dr O’Neil’s naltrexone implants have not been approved by the Therapeutic Goods Administration (TGA). While he states that thousands of implants have been performed on addicts, he fails to provide any evidence that they have in any way caused harm to the patients. He provides no statistics on or evidence of their success or failure, none about any harmful effects. He is simply concerned that their manufacture has not been cleared by the TGA. The fact that thousands of addicts have been cured by Naltrexone treatment is not his concern. Only due process is.
Westmead Hospital has run one of the worlds most successful Naltrexone programs for nearly 10 years. At the time I spoke the head of the program, their succesrate was around 80%. My daughter was prevented from joining it because we lived in the wrong suburb. The only other treatments available in Sydney were Methadone or cold turkey. Now nine years later she is still addicted to Methadone and I have little doubt this continues to be the only treatment dished out at St Vincents and other Sydney hospitals and treatment centers.
Rather than clinging to red tape, maybe Dr Wodak, using the extensive research and clinical facilities he has at his disposal, should have investigated Dr. O’Niel’s implants and maybe even helped to perfect them. Imagine what progress might have been made in the ten years they have been in use.
Methadone is not the answer, it is the official less expensive excuse. Never mind the side effects.
In response to Terry Wright that “the side effect to Naltrexone is death”.
Why is it then oral naltrexone and injectable naltrexone has been approved by both the FDA and TGA for treatment for alcoholism and opiate addiction? Obviously after reviewing all the data available these highly qualified regulatory authorities didn’t draw the same conclusion. Maybe Mr Wright should actually look at the literature and data as well, rather than make ludicrious comments like Naltrexone causes death. Tell that to all the herion addicts the drug has saved!
How can the likes of Dr. George O’Neil and Dr. Stuart Reece be allowed to get away with this? They are both responsible for multiple deaths and many, many overdoses from their naltrexone treatment but somehow are overlooked by the health authorities. Why?
These people lack the support from most of the medical industry but are the pin up boys for the religious right. Of course they have the full support of Drug Free Australia (DFA) and other opponents of Harm Minimisation who don’t give a toss about the actual patients but rather their own selfish agendas.
The damage done by their “cure from God” is an example of what happens when a medical issue like drug addiction is left to politicians and the ideology.
It’s the 21st century for God’s sake! How is it that facts, research and evidence is still overridden by junk science, religious rhetoric and political posturing. We might have come a long way scientifically but our drug polices are still in the dark ages.
Addiction is a medical diagnosis … not a moral issue. Until we realise this, many more people will suffer and die unnecessarily.
Naltrexone is the tip of the iceberg. The real scandal is that the authorities allow foreign companies to sell medical devices here without jumping the same hoops applying to local companies. We have a small but vibrant medical device industry which has spawned some outstanding international successes like Cochlear and Resmed. Standards are necessary and important, but so is innovation and a fair go. Something is out of whack when local manufacturers trying to do the right thing are suffer from costs and delays as they wait in the queue for an Australian approval. And then apparently a serious offender who doesnt meet the required standards continues operating without any effective action being taken. Is the ACCC listening?