NALTREXONE: AN INSTANT FIX?

Medical opinion is split on Naltrexone, hailed as an instant fix for
opiate addiction. But experts agree it was unleashed too soon on
uneducated GPs and is causing more problems than it cures. DEBORAH
SNOW reports.

It was talked about as a "wonder drug", the "anti-craving" drug. A
"magic bullet" which would kill heroin addiction with a single
treatment. When it first hit this country in a big way 18 months ago,
it was to be the dream cure. Desperate families shelled out thousands,
sometimes tens of thousands of dollars, to pursue the dream. Now many
have been left surveying ashes.

Naltrexone was always going to fall short of the hype. But recently, a
substantial swing of opinion has set in among many drug and alcohol
experts.

The first faint voices of dissent have swollen into a chorus of
concern - concern about the way the drug is still promoted in some
quarters as a fast and sure-fire cure for opiate addiction, and
concern about the way the Federal Government, wittingly or not, has
helped feed the myth.

The Prime Minister, John Howard, has said he would like to see the
drug fast-tracked onto the Pharmaceutical Benefits Scheme to
dramatically lower its cost - a move some experts feel is premature,
and potentially wasteful of scarce public funds.

At stake in all this is not just dollars and reputations, but lives.
Many frontline workers are disturbed at a small but persistent
phenomenon of patients coming off Naltrexone and overdosing on opiates
shortly afterwards. Dr Richard Mattick, of the Commonwealth-funded
National Drug and Alcohol Research Centre (NDARC), believes there may
be 20 to 30 such cases before the coroner.

Leading sceptic Dr James Bell says: "We have enough research in
Australia to say Naltrexone is of limited value [for opiate addicts].
Overseas evidence suggests only about 10 per cent do well on it. It's
a useful addition to the therapeutic armamentarium. But it's been oversold."

Bell, director of the Langton Drug and Alcohol Clinic in Surry Hills,
was one of the first Australian doctors to use the drug and says his
own detailed study, to be published soon in the Australian Medical
Journal, will broadly correspond with overseas findings.

Alison Ritter, director of research for the Turning Point Drug and
Alcohol Centre in Melbourne, echoes his assessment. "Going on overseas
experience, Naltrexone will be of primary use for people with alcohol
problems. There will be a small proportion of heroin users who will
find it useful. But it will be a very small proportion."

Even NDARC, the federally funded body which is co-ordinating data from
trials around the country, is counselling caution. The centre's Erol
Digiusto warns that "in a year's time we will find some of the
enthusiasm was premature".

Ironically, such warnings are gathering strength just as the Federal
Government is making the drug more widely available.

Until the start of this year, Naltrexone was tightly controlled by the
Therapeutic Goods Administration (TGA), an independent arm of the
Commonwealth Health Department in Canberra.

Doctors could not legally use it unless they were taking part in a
select group of hospital-based clinical trials, or had gained
Canberra's permission under the so-called Special Access Scheme, which
required them to seek approval from the TGA on a patient-by-patient
basis.

All that changed in January. The TGA and Australian Drug Evaluation
Committee abolished those controls and decreed that any GP around the
country could prescribe the drug. Overnight, says Dr Ray Seidler, a
Kings Cross GP with a large drug and alcohol practice, it became "open
slather".

Seidler warns that unless doctors know what they're doing with
Naltrexone, prescribing it for heroin addicts is "fraught with
danger". The risks stem not from any inherent unsafety of the drug
itself - on its own it is safer than many other routinely prescribed
medications - but in its interactions with other drugs that percolate
through the world of the opiate addict (mainly heroin and methadone).

Naltrexone has two main applications for treating heroin addiction.
The first is to achieve rapid detoxication, flushing the drug through
the body to cleanse it of opiates. The procedure is often performed in
a hospital under general anaesthetic or sedation, to spare patients
the worst symptoms of physical withdrawal. It is this form of "rapid
detox" which attracted such fanfare when the drug was introduced here.
Addicts were wheeled out to pronounce themselves "cured" within hours
of undergoing the procedure.

The second major use for Naltrexone is maintenance - keeping an addict
heroin-free once he or she is clean. This is the context in which GPs
are permitted to prescribe it.

Yet, as many experience-worn users would attest, getting off heroin is
the relatively easy part, especially if done under sedation or
anaesthetic. Staying off is the real challenge.

Seidler is dismissive of clinics which hold out Naltrexone as a simple
"cure". He says: "I've seen people who've been through three rapid
detoxifications in the space of five months, paying $3,000 to $5,000 a
time. It's just like going through revolving doors."

Naltrexone is an opiate antagonist, which means it locks onto the
opiate receptors in the brain and blocks the action of substances like
heroin or methadone. Most evidence suggests it does reduce craving for
opiates. But there remains a psychological and social dimension to
addiction that Naltrexone cannot tackle.

Unlike methadone (a legally prescribed opiate given to addicts in
place of heroin), Naltrexone produces no "high". It is not addictive.
It can't always eliminate that desire for the "rush" that heroin
addicts often describe.

Maryanne Campbell, a former heroin user who runs a counselling service
in Canberra, argues that Naltrexone is "a good 'middle-class' drug -
it suits people with strong psycho-social support, and with money. But
it does not tackle the problem that many use drugs to get the 'rush'."

So patients often relapse. And this is the moment of peril. Addicts
stop their treatment often without grasping that Naltrexone has
dramatically reduced their tolerance for opiates. Suddenly they have
the same vulnerability as someone who is using for the first time. The
dose of heroin or methadone their body may have coped with before
becomes potentially lethal.

Says Campbell: "It can lead to terrible overdoses due to people either
shooting up too much because they can't get an effect, or people coming off
Naltrexone, forgetting that their tolerance has gone right down, taking
their 'normal' heroin dose and overdosing."

Rigorous counselling and check-ups become vital. For those not
well-versed in the sub-culture associated with opiate addiction, it
can be a minefield.

Some well-meaning "corner GPs" also seem unaware of the need for a
patient to be fully detoxed before starting Naltrexone tablets. (A
standard prescription gives a month's supply at a cost of about $230.)

Doctors untrained in taking detailed histories from addicts (who are
often vague as to their last hit, or who may have an incentive to
fudge the truth in front of family members) may not detect that a
patient still has opiates in his or her system. Once those people
start on Naltrexone, they are pitched into acute and precipitate withdrawal.

Dr Peter Cox, a consultant at Sydney's Westmead Hospital, recalls a
couple coming into the casualty department undergoing violent
withdrawals. They had been prescribed Naltrexone by a doctor who was
unaware they were not opiate-free. Both were, says Cox, "quite
prostrate, vomiting and dehydrated".

Tony Trimingham, who runs a counselling service for families of
addicts, also says Naltrexone is prompting complaints from parents
dissatisfied with their GPs' handling and knowledge of the medication.
He plans to flag the problem at the Drug Summit.

Dr James Bell backs up the concerns. In one case he knows of, an
addict who obtained Naltrexone on prescription and tried to detox at
home wound up in intensive care for four days.

In another recent case, a young man who had been on a methadone
maintenance program underwent rapid Naltrexone detoxification at a
private clinic. He then obtained a maintenance prescription and
continued taking both Naltrexone and methadone, unaware the
combination was potentially fatal. Discovering his mistake two weeks
later (by which time the cocktail would, according to Bell, have been
making him feel ill), he stopped the Naltrexone but continued the
methadone. He died of an overdose a day or two later, when the
Naltrexone finally washed out of his system, leaving the opiate unopposed.

These cases highlight the huge variations in knowledge from one doctor
to the next. Dr Richard Mattick lays the blame partly at the media's
door: "The media put out that this is a cure for heroin dependency.
Doctors in the community share lots of lay views, and are not
necessarily very well informed. They bring their lay views to bear and
prescribe in a manner which is inappropriate."

The Royal Australian College of General Practitioners agrees. Dr Sue
Whicker, the RACGP's acting research director, told the Herald: "From a
college perspective, I would be prepared to say that there is not enough
education and training in connection with the use of Naltrexone among a
majority of prescribers."

She revealed that some college members tried to alert Federal
authorities to the problem before the TGA cleared the drug for general
use. They suggested that clear national guidelines for GPs be put in
place before the drug's general release - a suggestion that fell on
deaf ears. It is a gap that NDARC is now scrabbling to fill.

Asked if general release had been premature, Whicker replied: "Many
GPs who have specialised in drug and alcohol work would support that
statement."

The TGA refused to comment on Whicker's claims. Repeated phone calls
to the office of Federal Health Minister, Dr Michael Wooldridge, drew
no response, apart from a comment that "telling doctors how to be
doctors" was a "State responsibility".

To its credit, the company that distributes Naltrexone in Australia, the
Melbourne-based Orphan Australia, has put considerable effort into
organising seminars for doctors, and preparing and distributing information.
Orphan's managing director, Alastair Young, says the drug's main use will be
for alcohol. And: "Yes, we could have arranged for more trial programs, yes,
we could have done more advertising, but I would argue that whatever we did,
we could not stop some doctors from acting irresponsibly."

He resents the revisionism now dogging Naltrexone, some of which he
puts down to "vested interests".

"There are lots of people out there with hidden agendas who want to
see Naltrexone fail," he says.

"There's a very established methadone community in Australia which
supports an 'opiate-to-opiate' lifestyle. Some people in the treatment
community won't accept that it is possible to have opiate-free
alternatives. They think it's easier to decriminalise."

Young also argues that overdosing on opiates is a risk for anyone
who's been abstinent for any length of time.

Dr Aidan Foy, head of drug and alcohol services at Newcastle's Mater
Misericordiae Hospital, falls half-way between the two camps.

He says his own, admittedly small, recent pilot study of 44 former
addicts taking Naltrexone had yielded a promising 31 per cent success
rate after 12 months. Now he needed to follow up with a rigorous
double-blind trial.

But he fears the Government's decision to allow general release of the
drug without first ensuring the completion of controlled maintenance
trials may have muddied the waters for good. Widespread inappropriate
prescribing, he says, stands to give the drug a bad name, at least for
opiate treatment.

"Here is a drug of real promise which may be squandered because of
irresponsible use," he says. "The general release was premature. There
was no need for it. I presume it was done because of public pressure.
Now, because of the rush to use this drug, we may end up losing it."