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8th March 2008


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LEGAL MEDICINAL CANNABIS: COLLAPSE OF A JOINT ENTERPRISE IN HOLLAND


The world's first service providing legal medicinal cannabis on a prescription is disintegrating amid chaos and recrimination after a series of bungles by the Dutch government

WHEN, after years of soul-searching, Paul Fvanhoorn decided to try cannabis to alleviate his glaucoma and his wife's crippling rheumatoid arthritis, he asked his priest if God had anything to say on the matter. A former security guard, Fvanhoorn, 71, is deeply religious. Was it sinful, he wanted to know, to buy what - even in the Netherlands - is classed as an illegal drug?


"My priest checked the Bible and said he couldn't find any reason why we shouldn't go ahead," says Fvanhoorn. "My wife, Johanna, was reluctant at first, but she was in terrible pain and I wanted it to help her. We tried it and, within five minutes, her pain went. Within a month, my sight began to get better. It was incredible."

They were results that thousands of other sufferers have reported experiencing with cannabis but there was one unwelcome side-effect; the old man's son, also a devout Christian, fell out with him. The son wanted nothing to do with illegal drugs and refused to visit a home where the weed was being used.

So imagine Fvanhoorn's delight, when, on September 4 last year, the Dutch government introduced a fully legal, licensed medicinal cannabis programme. He, and thousands others who suffered from chronic pain, multiple sclerosis, HIV and terminal cancer, could get a doctor's prescription for pharmaceutical-grade cannabis approved by the Government. Sufferers could now buy the drug legally from chemists without the stigma of skulking around smoky streetside "coffee shops" where illegally produced grass is sold while the State turns a blind eye.

The Netherlands, held in high esteem for its collective liberal conscience and caring social values, had led the way again. It had introduced the world's first legal medicinal cannabis programme at a time when countries such as the UK were dithering over pleas from sick people to let them take the drug legally. It seemed the perfect solution to a prickly problem. For many, it was a dream come true.

But 11 months on, the dream has turned into a bit of a nightmare. Remarkably, the State has managed to produce the world's only narcotics operation to run at a loss. Stockpiles of unused state "mediweed" have doubled. The two producers licensed to grow cannabis are threatening to sue the Government, while patients are turning away from legal cannabis and returning to the coffee shops and a patients' charity. The programme, you might say, is going up in smoke.

According to Fvanhoorn, and thousands like him, there are two problems with the state mediweed: "It's too expensive and it doesn't work. I dropped it straight away. Now I get it from a charity which, technically, is illegal. But at least I don't have to watch my wife suffer."

To see how we got here, we must go back to 1972. That was when Mellow Yellow, the first coffee shop to sell cannabis openly, was established. It was controversial at the time, but hundreds more soon followed (there are thought to be 1,600 today) while politicians adopted a policy of informed tolerance. It is still technically illegal to possess unprescribed cannabis in the Netherlands, as it is to grow or traffic it.

In the 1980s and 1990s, when anecdotal evidence began to emerge that smoking marijuana alleviated pain and reduced muscle spasms in multiple sclerosis sufferers, the founder of Mellow Yellow, Wernard Bruining, began canvassing his fellow coffee shop owners about the possibility of helping out real medical cases. In 1994 they founded a "mediwiet" (mediweed) programme, selling cannabis at a discount of up to 50 per cent to sufferers who provided a letter from their doctor. Patients were delighted but the Government was uneasy. Coffee shops acting as de facto pharmacists meant well, but could not guarantee the price or quality of the drugs they were selling. It was time, the politicians agreed, to introduce regulation.

In 2000 the Office of Medicinal Cannabis, part of the Dutch Ministry of Health, Welfare and Sport, was set up. After three years of trials the current system was introduced, with two proven and respectable Dutch growers, the Stichting Institute of Medicinal Marijuana (SIMM) and Bedrocan, being given five-year contracts by the government to produce up to 500kg and 200kg of cannabis a year respectively. To make the scheme legal, the Dutch government had to abide by a UN convention requiring it to set itself up as a monopoly grower and supplier of the drug. For James Burton, SIMM's director, this meant that his dream of providing legal cannabis to sick people could become a financially viable reality. For years, Burton, 56, an American Vietnam veteran, had been growing and supplying medicinal cannabis to Dutch doctors, hospitals and individual sufferers with the tacit understanding of the Rotterdam police. A genetic disorder in males in his family had resulted in his father and two brothers going blind with glaucoma; he believed smoking marijuana had saved his sight, and wanted others to benefit. Now he had his chance - or so he thought.

"Hell, if you are one of two people licensed to produce something for a monopoly, you're pretty financially secure, right? Wrong," he says. Burton, a passionate advocate of medicinal cannabis, became a cause célèbre in the US in 1987, when he was jailed for a year for growing the drug to save his sight. When I meet him he is standing chest-deep among his cannabis plants at a secret growing facility. The air is thick with the pungent smell of marijuana, but there is something else in the atmosphere: anger.

"The Government has screwed things up to the extent that I'm losing €10,000 (£6,800) a month," he says." I've had to warn patients that my product doesn't work but the Government won't let me produce anything better. I plan to sue the Office of Medicinal Cannabis for wrecking my business and, unless things change drastically, I plan to pull out of it all in December."

So what went wrong? Burton agrees with Fvanhoorn: price and quality. The latter - at least for medicinal users - is determined by levels of cannabinoids in the plants. These are compounds that react with receptors in the brain that control pain and mood. Varieties of cannabis have more than 60 different cannabinoids, but the two that seem to help MS, cancer and glaucoma sufferers most are tetrahydrocannabinol (THC) and cannabidiol (CBD).

Burton claims that when the Government had his plants tested before deciding which he should grow for the programme, the testing was flawed. The company testing for the Government, Dutch-based TNO, one of Europe's biggest analytical research organisations, reported that one of his strains, SIMM 18, contained 13 per cent THC and 8 per cent CBD.

"We can produce much higher levels of THC, but 8 per cent CBD was very high indeed," says Burton."CBD is thought to act as a muscle relaxant, but it hasn't got the psychoactive effects of THC; it doesn't make you high. So for MS sufferers, this was going to be fantastic.The Government told us to grow that one; we signed a five-year contract and began producing. "

Subsequent tests, after Burton had committed himself to producing for five years, showed that the actual level of CBD in SIMM 18 was only 0.7 per cent. TNO said this week that no one was available to discuss Burton's allegations, but he has put the company on notice that he plans to sue.

Researchers at the University of Leiden have confirmed that different tests have come up with different results. Assistant Professor Arno Hazekamp, who has been analysing cannabis plants for seven years, says: "There is still no standard method for analysis of cannabis anywhere in the world; when one type is tested by different labs they usually come up with different results. It's because of the plant's complexity."

This is scant consolation for Burton. "I care about the patients, so I've had to warn them that my product isn't all we thought it was," he says. "Who's going to buy it now? According to sales at pharmacies, very few people indeed."

When he signed his contract with the Office of Medicinal Cannabis, Burton had to commit himself to producing up to 500kg of the drug a year. He moved into a 2,500 square metre greenhouse complex with underfloor heating and computer-controlled ventilation and lighting systems. There are guard dogs, razor wire, intruder alarms and 24-hour security. It all costs money.

Yet far from the hundreds of kilograms he was expecting to produce, Burton is being asked for 3kg a month. So is Bedrocan. This is because the state weed isn't selling, and that's where the pricing comes in. Even though Burton supplies the drug to the programme at just €2.5 a gram, the cost of packaging, distribution, a profit for the pharmacists and VAT brings the cost to patients up to almost €9 a gram. In coffee shops the average price is around €6. Much of the cost, around €3.50 a gram, goes on packaging that irradiates the product to sterilise it but does not vacuum-seal it in a way that keeps in moisture. Burton says this makes it dry and unappealing to smokers. He insists that he could package it in a better way for 70 cents a gramme. The packaging company, Fagron, says it is simply working to government specifications.

So what do patients think? Ger De Zwaan, the chairman of Stichting Patientenbelangen Medicinale Marihuana (PMM), a popular charity that illegally supplies about 1,500 medical users, says they are turning their backs on it. "We were delighted when the scheme came in," he says. "It meant that our work was done here. But soon it became clear that it wasn't. Our members tried it, said it was too expensive and didn't work, and most are coming back to us.

"It isn't unusual for MS sufferers or terminal cancer patients to use 50g a month. We manage to supply consistent, good quality cannabis at €3 to €4 a gramme. That's expensive enough, up to €200 a month. But imagine that cost on the state scheme? It's around €450 a month."

That much money is prohibitive for many patients, especially given that the state "sick fund", into which 75 per cent of the population contributes, does not reimburse sufferers. And people on higher incomes, who have private health insurance, find some companies pay, some don't, while others pay varying proportions. Hany Janssen, 35, an MS sufferer of 18 years, could be one of the "lucky" ones. Her insurance would cover her for the first €900 of her treatment each year - but she chooses to pay from her own pocket. "I tried the government mediweed, but it doesn't work," she says. "Cannabis has worked wonders for me, controlling pain and muscle spasms. But when I took the prescription cannabis I got the muscle spasms again and could barely walk."

The bad news is that PMM, to whom she has returned for her medicine, could now be closed down. For while Burton has set his legal sights on the government and TNO, Bedrocan has engaged lawyers to target the Rotterdam state prosecutor for not enforcing the Government's monopoly against illegal distributors such as PMM.

Tjalling Erkelens, Bedrocan's director, says his product, which is stronger than SIMM's, is efficacious, but while illegal distributors are still operating, he, too, is running at a €10,000 loss each month. "The State can't expect us to incur all these costs while people can get it from PMM and coffee shops for half the price," he argues. "There are problems, but the programme could survive if they could be sorted out."

The head of the Office of Medicinal Cannabis agrees. Willem Scholten admits that his five-strong operation is running at a loss (he won't say how much), but insists that it could break even next year. It is hard to see how, given that he expected 10,000 users but has attracted fewer than 1,500. He has just doubled stockpiles from four months to eight months, an unsold backlog that the Dutch media gleefully describes as the mediweed mountain. "We are supplying an effective, pure and consistent product," he says. "It's bound to be more expensive. Coffee shops can't guarantee such high-quality cannabis."

The scheme will reviewed in September. Scholten believes it will go from strength to strength, others that it will be scrapped. Bruining, the Mellow Yellow man who dreamt up mediweed in the first place, is among the latter. He says his own coffee shop programme, which has lain almost dormant while the Government's scheme got off the ground, is enjoying a resurgence. "The Government has handled this so badly," he says. "It's almost as if it didn't want it to work. Well, lots of people do want it to work and in the past month more coffee shops have been coming to me because they want to help.

"Sure, the Government might target me, but at the moment I haven't given them a target to aim at. We're waiting to see what happens. There are too many good people out there who are determined that patients who are already suffering don't have to suffer any more."

Should cannabis be legal for medical reasons?

... AND HERE IN THE UK?

IN 2001, the UK Government expressed a willingness to consider allowing cannabis to be provided on prescription for several conditions, most notably multiple sclerosis, but as yet no drugs have been licensed. Cannabis is not available on prescription.

The Medical Research Council conducted a trial which reported last year that two thirds of MS sufferers reported experiencing relief from taking cannabis. But it added that more research was necessary.

A British commercial company, GW Pharmaceuticals, has carried out trials into nerve pain and general MS symptom relief and is awaiting a licence for an oral spray, Sativex. The drug is being appraised by the Medicines and Healthcare Products Regulatory Agency. A further trial into incontinence, funded by the MS Society, has yet to report.

Last week several MPs put down an Early Day Motion in the Commons calling on the Government "to show compassion in authorising the controlled production and prescription of cannabis for medicinal use".


Source: The Times 11/08/04