Ben Hills investigates
Doctors at Westmead Hospital could hardly believe the response – it was more the sort of crowd you would expect at a pop concert than a medical briefing. More than 1,000 people crammed into four lecture-theatres to watch the presentation on closed-circuit TV, another 250 were turned away at the door, and several thousand more telephoned to express interest.
The audience one night last month consisted of heroin addicts, their friends and families, and the subject was something in which they had a life-or-death interest: how to qualify for a place in the electronic lottery that will choose the 560 “guinea pigs” for the world’s most comprehensive clinical trial of what has been claimed to be the most important advance in the treatment of opiate dependency since methadone.
For more than a year, Sydney’s drug underworld has been buzzing with rumours of a “new” method pioneered in Israel, under which addicts can be weaned off heroin, not by undergoing a week or more of the agonies of “cold turkey” but by the painless administration under anaesthetic of a drug called naltrexone. It sounded too good to be true – go to sleep hooked, wake up four hours later straight.
Of course, the Westmead doctors are quick to point out, it is not quite as simple as that. “There are no miracle cures – it is hard work,” insists Dr Yugan Mudaliar, head of the hospital’s intensive-care unit where the first group of volunteers will next week begin the $600,000 government-funded trial.
To stay free from craving, the patients will have to take a dose of the drug every day, initially for a year, perhaps forever. Even the most optimistic studies published so far indicate that almost half those who undergo the procedure known as UROD (Ultra-Rapid Opiate Detoxification) relapse back to using drugs within 12 months.
If the Westmead trial confirms these figures, however, naltrexone will turn out to be by far the most successful treatment for drug addiction that science has yet devised. Other methods (including methadone, an opium “substitute” on which many become dependent) claim no more than a 5 to 15 per cent “success rate” for what many doctors such as Dr Mudaliar now regard as a “chronic, relapsing brain disorder”.
Existing approaches – criminal sanctions, millions spent on rehabilitation programs – have comprehensively failed to slow the rising tide of addiction. Some studies estimate that heroin use in Australia has almost doubled in the past decade; the number of users is put at anywhere from 100,000 to 200,000.
The mystery is that since naltrexone was invented in 1963 and has been used in treating more than 10,000 addicts over the past decade, why has it taken until now for a full-scale trial, with rigorous scientific protocols, to be implemented at a major public teaching hospital? And why, even now, does legal action threaten to jeopardise this important public health project?
The answer lies in an extraordinary saga of claim and counter-claim of scientific skulduggery, and legal action around the world over the “rights” to use the naltrexone treatment, as a small Dutch-based company attempts to establish a worldwide chain of naltrexone franchises to cash in on the potential market of hundreds of millions of dollars. That company is called CITA International.
“I thought it was us businessmen who are supposed to be dirty,” chuckles Jacob “Cookie” Gershony down the line from Tel Aviv. “But we look like church boys compared with some of the doctors I have met.
Gershony is a canny Israeli entrepreneur with interests in China, including drip irrigation and a canning factory. Two years ago, with some partners including seven Wall Street investors, he paid $US1.5 million for the international rights (excluding Israel, Spain and Mexico) to the naltrexone treatment developed by the Tel Aviv-based Centre for the Investigation and Treatment of Addiction – a treatment for which an international patent had been applied.
CITA had been founded some years earlier by a Basque psychologist, Dr Juan Jose Lagarda, who had learnt of naltrexone from the medical literature and from visiting a hospital in Vienna where its use in drug detoxification had been pioneered. He began using it from a clinic in Seville, then “went international” in 1993 when he teamed up with his brother-in-law, a Brazilian-born doctor living in Israel, Andre Waismann.
Although the treatment had been around for more than a decade, CITA added something new – brilliant publicity. After adulatory write-ups in Israeli newspapers and magazines (“revolutionary medical treat-ment is achieving astounding success,” said the Jerusalem Report), CITA’s Tel Aviv clinic was besieged by the families of heroin addicts, prepared to pay anything from $US6,500 to $US8,000 for the treatment.
The news spread rapidly internationally. In 1995, Lagarda and Waismann arranged to lease an abandoned private hospital in Milan for what they hyped as “Operation Hope” – there were scenes of “mass hysteria” as more than 700 addicts camped outside the building demanding treatment, according to Yossi Ghinsberg, a CITA executive.
“It was madness,” says Ghinsberg, 38, an Israeli philos-ophy graduate who now holds the CITA “franchise” for Aus-tralia. “They were putting them [patients] through in two shifts a day – it was a miracle no-one died. After three days the police came and put locks on the gates.”
Other clinics around the world met with mixed fortunes. The CITA method is still avail-able in Switzerland, Mexico, Israel, Spain and the United States, where four hospitals are franchised to use it. But clinics in Athens and Hainan (China) have been closed, and plans to expand to Thailand have been put on hold following the country’s economic crisis.
Gershony says that the fran-chising arrangements vary from country to country – in the US, Cita International owns the local franchise 100 per cent; in Belgium it is a 50-50 co-venture; in Italy it was a “royalty” of $US1,500 a head.
There are also performance targets – Dr Colin Brewer, a London drug addiction special-ist, has written to the medical journal The Lancet that the contract for the British franchise “contained an especially objec-tionable clause requiring CITA-UK to treat a minimum of 240 patients in six months or risk losing its franchise”.
To date, about 10,000 people have been treated worldwide at an average cost of $9,000 a head, half of them in Dr Waismann’s Tel Aviv clinic, which has changed its business name to Megama and is involved in a bitter legal dispute with CITA over its rights to teach the naltrexone technique.
But Gershony denies that there are huge profits involved, and says that the company has spent more than $US5 million promoting the treatment world-wide in the past two years. What peeves him is that, almost unanimously, the medical pro-fession refuses to accept that anyone can “patent” a medical treatment.
Ironically, Australia – one of the last places in the world to hear about naltrexone – will play an important part in not only determining whether it is safe and effective, but also who, if anyone, “owns” the treatment. “This will be the battleground,” says Yossi Ghinsberg.
DOCTORS like Alex Wodak, the head of drug and alcohol rehabilitation at Sydney’s St Vincent’s Hospital and a leading naltrexone sceptic, are particu-larly disturbed at the promotion of the treatment in Australia. It “began as a marketing exercise in the pages of the Women’s Weekly, not a scientific paper in the Medical Journal of Austra-lia,” he says.
The story broke in that magazine last July with the headline: “I Woke Up CURED of HEROIN.” (memo subs : cap those two words). Underneath was the story of a young Sydney addict, Joanne Frare, who had flown to Israel at the magazine’s expense and undergone the naltrexone treatment at Dr Waismann’s clinic.
She had learnt about nal-trexone from the Internet, where Dr Waismann’s home-page still claims that his treatment has a “100 per cent success-rate” and contains this extraordinary endorsement, attributed to Dan Rather, news anchor of the CBS TV network: “A miracle cure for opiate addicted people.”
Within weeks of the article appearing, hundreds of desper-ate Australians had contacted Dr Waismann. The families of more than 200, he says, had scraped up the money to fly to Israel and undergo the treat-ment. He is not at all apologetic at charging $US8,000 for a treatment which Westmead Hospital costs at $A1,500: “I know I am the best in the world – I could charge $200,000 if I want¤ and they would still come.”
Gershony, however, was furi-ous, especially when late last year a Westmead team including Dr Mudaliar and Dr Jon¤ Currie, the head of the Western Sydney Area Health Service’s drug and alcohol service, flew to Tel Aviv to study Dr Waismann’s detoxi-fication of a number of the Sydney addicts. CITA obtained an injunction from the Tel Aviv District Court – later dismissed – to try to prevent Dr Wais-mann passing on his “secrets”.
Gershony told the Herald he considers that the Westmead team is using CITA’s propri-etary information and that he will take legal action for dam-ages if their trial proceeds. Dr Currie contends that the infor-mation was already “in the public domain,” and that West-mead has developed its own treatment protocols based on studies in London and Berlin, as well as Tel Aviv.
But the naltrexone story has now acquired so much momen-tum that these fine legal points may soon be irrelevant. “The genie is now well and truly out of the bottle, and you are not going to put it back,” says Dr Currie.
“ARE Drugs Destroying Your Life?” demanded an advertise-ment in a national newspaper last month, over an illustration of a dripping hypodermic syringe. “Help is now here. High success-rate, no addictive drug substitutes, absolute discretion.”
The name at the bottom of the ad, beneath the 1,800 tele-phone number, was Rapid Detox Centre Australasia Pty Ltd, which has premises in Liverpool. It is just one of at least six private treatment cen-tres that have sprung up across Australia offering naltrexone detoxification, in this case done under sedation rather than anaesthesia.
A director of the company, an anaesthetist named Dr Siva Navaratnam, confirmed that Rapid Detox had taken over the lease of a 40-bed “day hospital” and was charging $5,000 a patient for a same-day drug detoxification treatment and aftercare. He said he was only “doing the ones who are going to die” and was making it clear to patients that “It is not a wonder drug. It is not a cure. It is a hope.”
Dr Navaratnam said he was also emphasising to anyone who took the treatment that the naltrexone would destroy their tolerance of heroin – there had already been four deaths from drug overdoses among patients who had undergone the detoxifi-cation treatment in Western Australia. “We make it very clear that if they take narcotics they will die,” he said. “If we can’t find you [for the daily naltrexone dose] we will call the police.”
Another company, CITA Australasia Pty Ltd, is also offering naltrexone treatment – but overseas, and at vastly more expense. Although it was set up with the help of Ghinsberg (who holds the Australian franchise), CITA Australasia has no connection with the international company of the same name, and pays it no royalties.
A director, the Sydney property developer Leon Fink, said he had begun sending addicts to the Cedars-Sinai Hospital in Los Angeles for detoxification. He said he was charging $15,000, plus another $6,000 or $7,000 for air fares and accommodation for the patient and a “caring other” to accompany him or her.
Fink said: “Our focus is not to rev up this hot profit centre; our aim is to persuade the NSW Government that they should massively increase the size of the trial, and that they should engage the private sector to contract to deliver people [for treatment].”
Ghinsberg, who is in dispute with Fink, has also been attempting to interest private and public hospitals in the therapy, so far with no success. He got off on the wrong foot at Westmead when (according to Dr Mudaliar) he proposed that he recruit patients for $6,000 a head, splitting the money 80-20 in Westmead’s favour – a claim Ghinsberg denies.
Other, less scrupulous, operators are taking advantage of a loophole in the law (naltrexone is not an approved drug in Australia) to profit from the treatment. Dr Currie says he has heard stories of “people coming back from overseas with suitcases of [naltrexone] tablets which they buy for 12 cents and sell to patients for $5.”
Dr Wodak is worried that this unregulated boom in naltrexone therapy may add to already-worrying overseas reports of fatalities during and after treatment, including one patient said to have choked to death on his own vomit during detoxification. As well, research on the long-term effectiveness of the treatment was “to put it bluntly, crappy”.
For every “cured” Joanne Frare there is a case like that reported by Tony Trimmingham, the head of a support group for parents of drug-addicted children, of a woman in Wollongong who sold a business she owned to take her twin daughters and one of their boyfriends to Israel for the treatment. After spending her life’s savings, she has discovered all three have returned to using heroin.