Sleep of the dead

A medical technique that theoretically helps recovering heroin addicts by allowing them to sleep through cold turkey is showing encouraging results. Now, to the horror of the medical fraternity, one practitioner is attempting to patent it
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Brendan Woolhead was already a heroin addict when he was terribly injured by an IRA bomb which went off by accident aboard a double-decker bus at the Aldwych in central London in February 1996. Mr Woolhead was wrongly accused of being an accomplice of the man carrying the device, but he had nothing to do with the bombing, and won pounds 200,000 from the libel case he brought.

The money was just what he needed to sort out his life. Mr Woolhead wanted to kick his heroin habit and be a good father. He wanted to provide for his girlfriend, Gillian, and five-year-old son, Alex. That was when he saw a newspaper advertisement that read: "With our help, you can stop using heroin in 24 hours!"

This was one of many methods used by an Israeli-based company, Cita International - which once traded in the UK as Medetox - to market aggressively a controversial treatment for heroin addiction. Unfortunately for Mr Woolhead, the miracle survivor of the Aldwych bomb, he died before completing the treatment.

The method, Ultra-Rapid Opiate Detoxification, (Urod), involves anaesthetising the addict through "cold turkey". During a procedure lasting up to six hours, a cocktail of up to 15 drugs, including an opiate antagonist to speed up withdrawal, keeps the patient asleep while his system is detoxified and the heroin is pushed out of the opiate receptors in the brain.

When the patient wakes up, he (or she) may be exhausted and will almost certainly feel some discomfort, but he has a head-start on tackling the addiction. During the detox, he is given carefully measured amounts of naltrexone, a drug which neutralises the brain's opiate receptors. When he is allowed home 24-36 hours later, he must continue taking naltrexone so that, even if he leaves hospital and shoots up immediately, there will be no benefit, no "high". The addict stays clean.

It is a method for which Cita and its founder, Dr Juan Legarda, a Seville- based psychologist, have spent time and money taking credit. Patients are given wild hopes of success; Urod is described as unique, new and revolutionary; employees are forced to sign contracts binding them to protect the "secret" method; and clinics around the world which buy into franchises must guarantee to spend pounds 30,000 on PR, and to treat a minimum of patients in the first six months at pounds 4,000 each.

Dr Legarda's claims have been tolerated by other researchers and psychiatrists who had used, developed and published papers on almost identical methods for longer than Cita. Their anger only erupted when Dr Legarda tried to patent it and initiated legal action against them for using it.

"I couldn't believe my eyes when I got a threatening letter from his lawyers," said Dr Colin Brewer, who, at 56, is a respected addiction specialist and former director of the Westminster Hospital's alcoholism unit. Since 1989, he has been a practitioner of what he calls Rapid Opiate Detoxification under Anaesthesia (Roda).

"A patent for a method, a technique, opened up all sorts of dangerous possibilities - to patent a drug is understandable, but to try to patent a method, a protocol, would surely be unethical. Besides, I was using it before he was. And I was introduced to it by others."

The method was pioneered in 1988 by a group of doctors at Vienna University led by Norbert Loimer. They shared their knowledge with others, like Dr Brewer of the Stapleford Centre in London, who advanced it and passed it on. Dr Loimer has since criticised Cita's ethics as "disgraceful". At a symposium on anasthaesia held in Britain last year, Dr Moshe Zerzion, Cita International's medical director, is reported to have admitted that Cita's claims to have invented the technique were "false".

In fact, Dr Legarda, a Spaniard described by colleagues as "about 40", is not a physician. He was a post-graduate student in psychology at the Maudsley Institute of Psychiatry in London. Dr Brewer has met him at the university in Vienna where Dr Loimer demonstrated the advancements in anaesthetised detoxification to him.

An inquest will reconvene in January to decide how Mr Woolhead died, but one theory is that he failed to tell the doctors treating him about head injuries sustained during the bombing. The inquest was adjourned earlier this year after Griffith Edwards, of the Maudsley Hospital, London, said the Welbeck Hospital, a London-based Cita franchisee, had made "manifestly false" claims about the treatment. A file was passed to the Crown Prosecution Service but it is unlikely that there will be charges.

The Welbeck confirmed last week that it is still detoxifying patients at pounds 4,000 a time.

OBVIOUSLY, drug companies can take out patents on the medicines they manufacture. But in this case Dr Legarda is attempting to establish a new principle: that he can patent a method of treatment. And that can obscure a more important question: does ultra-rapid opiate detoxification work?

The method has supporters and detractors. Dr Brewer has enjoyed success with about 400 patients under anaesthetised detoxification, but he does not use it for every addict. Properly-administered in intensive-care surroundings, he believes it gives the chance of kicking the habit safely to the small percentage of addicts who cannot face up to 10 days of sweating, vomiting, diarrhoea, pain and despair involved in ordinary "cold turkey". Unlike Cita, Dr Brewer does not claim the method represents a cure.

"It is only the beginning," he said. "Many patients are still very ill for weeks afterwards and still need medical support. The real advance is the development of naltrexone implants. When patients were required to take tablets, they could miss them out and get back on heroin. Now we give them implants, they can't miss out on their medicine; heroin simply has no effect for them."

In Singapore's notorious Changi prison, 75 per cent of addicts treated with naltrexone remained clean after 12 months; previously, the rate was 25 per cent. After release, 50 per cent of prisoners not treated with naltrexone re-offended, while only 25 per cent of those on the treatment ended up back inside.

Dr Brewer points out that this success rate is achieved without anaesthetised withdrawal; and that Cita's attribution of success to anaesthesia is disingenuous. Nevertheless, there are those for whom traditional cold turkey is too much to bear.

Helen, who is 32, has been an addict for 15 years. She had tried to get through traditional detoxification four times before opting for rapid anaesthetised detoxification. Unlike many users, she was holding down a job as a credit analyst; she had a four-year-old son and a partner who knew about, but despaired of, her habit.

"I was living a double life," she said. "I was spending between pounds 70 and pounds 200 a week on heroin and I was also on methadone [a prescribed synthetic heroin substitute]. I tried over and over again to kick it, but each time I would just come straight out and get a fix."

Eventually she read about detoxification under anaesthetic and persuaded her doctor to get her the treatment on the NHS with Dr Brewer. "It was hard - no miracle cure by any means - and I was sick for weeks afterwards," she said.

"What was different was the aftercare. I was given whatever prescription drugs I needed to get me through the way I felt, to get me up, to get me to work, to help me sleep. But it was all controlled and I'm off them all now.

"The real success was the naltrexone implants. Once they were implanted - in a tiny incision above my bikini line - that's it. There's no point taking any heroin. They last between four and six weeks and I'm about to get my last one to see me through Christmas. After that, I won't need any more. Life is good, I'm clean and have no desire to go back ever again."

The treatment received by Helen - and up to 10,000 like her worldwide - is now under attack from two quarters, despite there being only four recorded deaths as a result of it. First, from Dr Legarda's threats of legal action, and, second, by professional doubts about its safety.

In a paper published recently in the British Medical Journal, Dr John Strang, director of the National Addiction Centre at the Maudsley Institute of Psychiatry, criticised a lack of controlled research into detoxification under anaesthesia. He concluded: "Until there is adequate evidence of effectiveness and safety for this technique, it should be used only in clinical trials."

That advice has now been echoed to the Home Office by the Advisory Council on the Misuse of Drugs, although it is unlikely to lead to a ban. The Home Office said "guidelines" would follow instead.

ATTEMPTS to contact Dr Legarda in Seville and Israel failed last week, but his lawyers in Madrid, Uryas patent attorneys, said the patent application was going ahead. "The international patent application was filed this year," said Ralph Gauger, the lawyer handling the case. "It will take four to five years to be considered and, in the meantime, the method is 'patent pending'. Applications are not normally made for patents to apply medication but we think this one stands a good chance."

When told that other clinicians claimed to have written about the method first, Mr Gauger said: "If that is the case, then their papers will show up while the application is being researched and the patent will not be granted."

In the meantime, however, people wanting to use the method are applying for franchises from Cita. Several clinics are now using the method on a franchise basis around the world, and to protect those franchises, letters threatening doctors had been sent to clinics in Britain, America and Germany.

The British Medical Association said last week that it firmly opposed the patenting of methods of treatment. "We would certainly be very concerned if medical procedures were to be patented," said a spokeswoman. "The whole ethos of medical advancement is that methods and procedures are shared, published and judged by one's peers to the advantage of patients."

The anger Dr Legarda's tactics provoke is best summed up by his brother- in-law, Dr Andre Waismann, who has used the treatment on more than 4,000 patients in Tel Aviv. He was once involved in Cita International until he quarrelled with Dr Legarda about secrecy and exploitation. "Nobody should 'own' medical treatments," he said last week. "This procedure can help cure patients of addiction. That is something that should be shared, not exploited."

Dr Waismann is involved in a series of legal arguments with Dr Legarda over the rights to the method, the use of his name in Cita's promotions, and his willingness to teach it to others. Last year, he invited seven doctors to his clinic from Australia to pass on the method. When Dr Legarda heard, he tried to take out injunctions preventing the information from being passed on.

Fortunately for medicine, the litigious Dr Legarda failed.