Loopholes allow an unapproved heroin treatment to flourish amid serious health concerns.Thirty minutes before she went to the clinic, Sarah had what she thought would be her last shot of heroin. She made sure it was a big one. Barely conscious of her surroundings, she was questioned briefly by a nurse about heroin use that day. "I said I had used a lot and the nurse said: 'Well, you will probably get very sick then."'
Nothing prepared Sarah and her parents for the next three days of delirium, pain and nausea as she went through "rapid detox" from heroin after receiving a large dose of Narcan and an implant designed to block the brain's opiate receptors, and therefore nullify, the effects of heroin.
There was no warning from the clinic, no guidance on how to deal with the overwhelming effects of the detox, no thought that maybe she was too affected by drugs to consent to having naltrexone surgically implanted in her lower abdomen.
"My parents had to keep watch over me all night. I was banging my head on things, I couldn't walk properly, couldn't talk properly, I was having muscle cramps and spasms, and then you get really depressed," Sarah said.
When she was through the detox Sarah returned to her own flat, where she used heroin almost immediately. The naltrexone implant - designed to block heroin for up to six months - worked and she felt no effect from the drug.
But there was no counselling, no help to walk away from what had been a short but tumultuous descent into heavy heroin use. The urge to use was as strong as ever.
And this is where the naltrexone fairytale - putting aside the dangers of rapid detox and the potential for fatal overdose - ends. Sarah did what many, many drug users do. She found a drug that is not blocked by naltrexone - amphetamine - and injected that. She felt the rush. She changed drugs. It's as simple as that.
It is a tempting idea, the quick fix. That is why naltrexone implants are so seductive. Better than a lifetime of heroin addiction, or being tied indefinitely to methadone or buprenorphine, naltrexone stops dead the opiate experience. In an implant, it can block heroin for up to six months. What's not to love?
It is this false hope that draws drug users in their thousands to clinics in Sydney and Perth, in search of the magic cure for the addiction that has dogged many of them for years. It works for some, mostly those surrounded by supportive friends and families, who have stable lives in jobs or study.
Many other implant users land in hospital, desperately ill, with renal failure, post-operative infections, dehydration and depression; others, like Sarah, switch to amphetamines or cocaine to bypass the implant. Some die, mostly from overdose of the very drug they are trying to quit.
And without a clinical trial, we just don't know how many it helps and how many it hurts. Without the protection of federal drug regulation, with no studies to inform us on the implant safety, effectiveness and lifespan, doctors have implanted thousands of these devices. The regulatory gaps are a duty of care failure writ large and a triumph of fervent belief over cold evidence.
Naltrexone implant treatment came to public attention through the work of Dr Andre Waismann, who used it in the 1990s on Israeli soldiers addicted to opiates used in pain management after they had been wounded. It worked for those patients, says Professor Richard Mattick, director of the National Drug and Alcohol Research Centre, because they had otherwise stable lives.
"It is a very small niche market, a minority option for a small number of patients who have good support and can step outside the drug-taking lifestyle; not the marginalised, abused, depressed, out-of-work people who are the vast majority of heroin users," Mattick says.
That the Therapeutic Goods Administration has not approved naltrexone implants for the management of opiate dependence is a "clear recognition about the lack of evidence by the TGA itself", says Mattick, who wants the endurance of implants and their effect on people's tolerance of heroin or methadone independently studied.
A clinical trial at Sir Charles Gairdner Hospital in Perth involves 70 people - half of them with implant and a placebo pill, the other half with placebo implant and active naltrexone tablet. Due to report soon, the trial's small size and the fact that it is run by doctors associated with the promotion and manufacture of the treatment leaves Mattick uneasy. "Normally you would have an arm's-length trial."
Mattick and his colleagues plan a small pilot study on sustained-release naltrexone in NSW to see if it could form part of the arsenal of an effective treatment of heroin addiction. But he is not hopeful. The Cochrane Collaboration, an international group which reviews medical evidence, found there was insufficient evidence that naltrexone implants were effective against opioid dependence. That naltrexone implants were unregistered in Australia "just doesn't look good", Mattick said.
George O'Neil, the Perth gynaecologist and obstetrician who has implanted, or overseen the implant, of naltrexone devices in thousands of people over the past decade, began his own manufacturing operation. He is able to do so because of exemptions and provisions from several federal laws.
Meanwhile, O'Neil's Go Medical Industries is licensed to manufacture naltrexone implants for use only in clinical trials - 35 people in the Sir Charles Gairdner Hospital tests, for example. Until the TGA intervened, O'Neil exported his implants overseas and interstate. "When the TGA found this breach we made immediate contact with them and we believe this practice has now ceased," a spokeswoman said.
Designed to assist short-term needs of critically ill patients, the Special Access Scheme under TGA law allows O'Neil and Ross Colquhoun- a Sydney doctor who uses naltrexone implants on his patients - to access the unapproved implant treatment. O'Neil says drug users can be classified as critically ill because a 20-year-old heroin addict is at 13 times the risk of dying of his or her peer group. "We know we can get rid of that risk of death by using naltrexone implants."
The National Health and Medical Research Council and the Department of Health and Ageing spent $1.7 million on research projects related to naltrexone implants over more than three years until April 2006.
In 2003, for example, O'Neil received $401,363 from the NHMRC to clinically trial implants. The trial was delayed because it had not secured TGA approval and had difficulties recruiting participants.
An additional $154,000 from Health and Ageing supposedly expedited the trial, and while a final report went to the TGA late last year, it included no data from the trial, the TGA spokeswoman told the
Herald.
Go Medical Industries has received $3.8 million in two AusIndustry grants under the Commercial Ready Program, and an estimated $8 million from the West Australian Government.
O'Neil's website boasts that 85 per cent of patients are "living an opiate-free lifestyle five years after treatment". In an interview, however, he admits it is difficult to follow up many of his patients because of chaotic lifestyles. When pressed about the rate of complications in patients who receive naltrexone implants, O'Neil uses figures he later acknowledges cannot be backed up by peer-reviewed clinical studies or trials. "If you are using appropriate antibiotics you would see less than one-in-100 with acute infections, and about one-in-40 patients get admitted for fluid replacement."
It is a very different picture from that related to the
Herald. We were told of instances of infections at the site of the implant, the lack of post-implant care, the dangerous chaos of rapid detox, or the more serious complications in 12 patients in two Sydney hospitals over one year detailed last year in
The Medical Journal of Australia.
Paul Haber, medical director of drug health services at Sydney South West Area Health Service and co-author of that journal report, described severe withdrawals, severe disorientation, vomiting, diarrhoea and acute renal failure in people who had just had their implants.
"Untreated it could be life-threatening," Haber warns.
"We had a case in hospital for six days - he'd just been discharged from the clinic where the naltrexone had been implanted. His wife was driving him home, he was thrashing around, confused, she was scared to drive the car and pulled into the hospital emergency department," says Haber now. "My question is, how can you discharge someone in that condition?"
Haber's concern, like many medical experts, is the use of the Special Access Scheme - meant to be used for the terminally ill - to allow this treatment.
"The mortality rate from drug addiction would not be significantly higher than severe hypertension, diabetes or many other medical conditions, so I have found it difficult to understand what is happening with respect to those [Special Access Scheme] exemptions," he says.
Colquhoun imports his implants from China. The TGA requires his confirmation that the implants meet Good Manufacturing Practice as set out in TGA law.
Colquhoun says he is frustrated that his six applications for funding for clinical trials have been knocked back. He says the Health Care Complaints Commission, having thoroughly investigated him over the years, has found no cause for concern.
Tony Trimingham, who founded Family Drug Support in 1997 after his son Damien died of a heroin overdose, scoffs at the notion of naltrexone as magic bullet.
"Right from the word go, I had my doubts about naltrexone," Trimingham says. "I have seen too many people in absolute disaster because of naltrexone.
"There is no miracle cure. Achieving freedom from dependence is a long road, there are no short cuts … a naltrexone implant may block the physical receptors [of heroin] but it does not do anything at all about the emotional or social factors."
Sarah, who used amphetamines to get around her naltrexone implant, is philosophical about paying $5000 for an untested treatment. Now drug-free and on a long-term treatment program that combines drug replacement therapy with counselling, she looks back with regret at her naltrexone implant. "I would never recommend it for anyone I know," she says.
Source: The Sidney Morning Herald, April 11, 2009
http://www.smh.com.au/national/in-for-the-quick-fix-20090410-a2w5.html?page=-1After reading the above article I had to share it with you. No regulations. Here in the United States we are fortunate to have Federal Regulations, the FDA, Clinical Trials..
Can you imagine living in a place where you don't know what to expect from your treatment or no warning of how you might feel.
Let me hear what you think.
Home 
We'd all love to simply have our addiction just be removed & go back to the life we were living before the addiction (the devil) took hold of our very souls. If there was a surgery that informed opiate addicts that if they just had this simple surgery, they'd be "normal" again. It'd sure be a tempting option... But without knowing the long term effects & in my own opinion, there's so much more to the addiction "diagnosis" than just the physical aspects, that too much of my brain would have to be removed for any possibility of success. As I cannot live without three quarters of the brain. haha Anyways, my point being, I could certainly understand the desire to try nearly anything to be able to leave my addiction behind me for good, but as I said, in my own personal opinion, there is too much to addiction for this or any magic potion to cure it. Sure the Suboxone has been a God sent medication for the physical aspects of our addictions, but what about the rest of it? Are these people expected to simply be "cured" of their demons just by removing some of the physical aspects?? Still going on with my opinion, but I believe that "society" has the misperception that when an addict finally admits & chooses recovery, goes to a rehab or treatment center (especially inpatient rehab), but are then expected to be "cured" when they return to normal everyday life again. 
They seem to have no idea regarding the battle that the addict is still struggling with or why this person isn't just "fixed" after returning. It's a daily battle forever- as we all know or we wouldn't even be bothering with coming here, going to counseling or any further type of group sessions, etc. I know for a positive fact that I am not cured & that there are moments that my addictive habits are as strong as ever. Though, now I have tools to get through those type of moments. Please remind me to tell you a story about my addiction simply taking charge for no reasoning whatsoever. It was a stupid, thoughtless act that I have no good reasoning or excuses for. (I did not relapse, but was still amazed by the mental power of this disease.) It's a very powerful mind disease, obviously, as well as the physical parts of it. Not like I'm telling anyone here anything that they don't already know...
Point of the story, Steven started using Meth, as to not need the same amount of pills that his tolerance had been built up to throughout the day & nights. He couldn't get out of bed without two 80's & it was only getting worse & worse. (we all know that story!) So, he cut way down on the Oxycontins by also using Meth along with them (and Zanax, Soma, Adderall, cocaine, etc...) 
Before his regular family dinner, he'd always participated in passing out turkeys, etc to the less fortunate & he hadn't shown up, which was not like him. He was an amazing man with a horrible habit. Such a waste... He was also 33 years old, as I am, & we'd laugh because he was a few months older than myself. No matter how old we kept on getting, I was still younger.. I still cry for Steven & his parents, as he was their only child & he was a good man. (just with a BAD habit!) Every Thanksgiving must be a living hell for them. 
