Sativex

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Sativex

Postby Brainteaser » Sun Jul 31, 2005 11:45 pm

Hi,

HarryZ, in a recent post regarding spasticity, mentioned that his wife was finding some relief from Sativex, a newly introduced product, in Canada. I thought it might be appropiate to put the subject to a new thread.

It would be good to hear more about this treatment from our Canadian friends. Presumably it can be prescribed only to people residing in Canada or can it be exported? How does the treatment rate given the level of improvement/relief, cost etc.?

Thanks & regards,
Phil.
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Cannabis

Postby bromley » Mon Aug 01, 2005 2:27 am

Phil,

By co-incidence there is an article in today's Times (UK) about cannabis / cannaboids and MS:


August 01, 2005

A strong whiff of hypocrisy
David Rowan
This morally dubious ban on medicinal cannabis is sentencing patients to a life in agony


HOW SHAMEFULLY callous is the Government’s policy on medicinal cannabis use? Just ask Pauline Taylor, a former Macmillan nurse who for 20 years has suffered increasingly debilitating pain from multiple sclerosis. Seven months ago the 53-year-old wheelchair user from Durham discovered an unapproved medication which, as she movingly recounts, “has finally given me my legs back”. Too bad for Ms Taylor, then, that her agony-deadening “magic medicine” last week became the latest officially sanctioned target in a renewed legal assault on cannabis-based pain relief. After all, as the Home Office coldly points out, the law must be enforced.

A number of volunteer networks dedicated to supplying vulnerable patients with medicinal cannabis have attracted unusually close attention from the police. Most recently, it was the turn of Ms Taylor’s suppliers, a five-year-old non-profit group based in Cumbria that enhances home-made chocolate bars with 2 per cent by weight of donated cannabis. Around a hundred “cannachoc” bars have until recently found their way across Britain each week, sent on medical proof that the recipient had MS.

Cumbrian police and the Home Office have known about the operation for years, but only now — 1,600 clients later — have the authorities decided to act. Last week three of those involved were charged with conspiracy to supply a controlled drug, an offence that carries a possible 14-year prison sentence. The timing suggests a pungent whiff of political interference.

Certainly, there remains considerable medical concern about cannabis; pot smoking has been strongly linked with an increased risk of schizophrenia, psychosis, depression and other mental disorders. The British Medical Association insists that raw cannabis is not a “suitable medicinal product”, despite the “anecdotal” claims of its efficacy. Unscientific, personal accounts they may be — yet among Britain's estimated 85,000 MS sufferers, many who in desperation have tried cannabis to relieve their symptoms perceive a clear, life-enhancing benefit.

Even the most coldhearted policy-maker would be moved by some of the tearfully grateful letters received by the chocolate supplier, which calls itself Therapeutic Help from Cannabis for Multiple Sclerosis. “Dear whoever,” writes an elderly woman in Wokingham. “Thank you so much for my first supply of cannachoc. It is wonderful. For the first time in many, many months I do not have ‘jerking’ legs in the evenings and can sit still and watch TV.”

From Essex, an elderly woman says that she can finally get to sleep again, the physical pain having temporarily subsided, “and I don’t feel any high-ness at all”. As Ms Taylor sees it, the Home Office bureaucrats whom she suspects of ordering her supply chain broken have clearly never experienced chronic, total body pain. “I’d like Charles Clarke to have my MS for 24 hours and see how he’d feel,” she says. “He has no goddam right to tell me what I can put into my body.”

The Home Secretary does seem to be on an extraordinarily ill-conceived trip. The new hard line on suppliers of medicinal cannabis echoes a wider unease within government at last year’s reclassification of the drug by David Blunkett. Before the general election the Prime Minister suggested that cannabis “isn’t quite as harmless as people make out”, and Mr Clarke wrote to the Advisory Council on the Misuse of Drugs demanding that it re-examine the reclassification in view of new health concerns. Could this current assault on medicinal use — backed by a recent Court of Appeal ruling that users have no defence of “necessity” in relieving their pain — be a deliberate attempt to distance Mr Clarke from his predecessor’s more licentious era, when the spliff became as morally tolerable as the impregnation of another man’s wife?

Nothing of the sort, insists the Home Office. Any decision to bring charges is a matter for the Crown Prosecution Service. The CPS, in turn, says it would act only after receiving a file from the police, and that on no account would there be a political decision to prosecute. Because cannabis remains illegal, that decision would rest simply on the quality of evidence and whether it would be “in the public interest”.

Forget passing the joint: this is passing the buck until any logic fades into an embarrassing blur. For all the “public interest” in breaking up these altruistic if unauthorised networks, the practical consequence of prosecution will be simply to send the “clients” — typically elderly, middle-class, otherwise law-abiding citizens — to criminal dealers. Or, alternatively, to lead them to suffer in silence until an “official” cannabis-based medicine is approved for use. Based on recent experience, they could be waiting some time.

This has always been the favoured get-out clause, from the Health Department to the Home Office. Because users of raw cannabis risk addiction and chronic health effects, ministers point out, only a properly tested medical preparation can be allowed. All that is needed is the approval of the Medicines and Healthcare products Regulatory Agency (MHRA).

So where is the MHRA’s approval for the most promising cannabis-based medication under development, a mouth spray extensively tested by the British company GW Pharmaceuticals? In April, Canada gave the spray formal approval. It was expected to gain its UK licence long before now — but, well, the MHRA just needs a few more test results before it can be absolutely certain.

Bureaucracies, by their nature, favour delays over decision-making. People, on the other hand, feel the intense, life-shattering pain of disease very much in the here and now. Those unfortunate enough to have MS — or Aids, arthritis and any other severe condition where cannabis may alleviate symptoms — should surely be allowed to bear the risk of side effects and possible long-term damage in exchange for the pain control that cannabis might bring.

Until a legal medicine is made available, how can it make moral sense for the authorities to target the well-intentioned volunteers offering a short-term alternative?

End of article



Back in May the UK Gov (in fact a government agency) gave £2 million to expand a study looking at the possible benefits of cannabis / cannaboids for those with secondary MS.

http://news.bbc.co.uk/1/hi/england/devon/4575349.stm


The UK MS Society website recently had an advert asking for participation in a trial for spasticity. The company involved is GW which manufactures Sativex so the trial treatment probably involves cannabis / cannaboids.

Given all of this - I think it would be worth having a separate section (as is done for Rebif, Copaxone etc) for cannabis / cannaboid treatments.

I am the most law-abiding, anti-drug person you can imagine (never taken anything) and I recognise that the use of cannabis / cannaboids for medical reasons is forbidden in many countries. However, given the range of research being undertaken and the drugs e.g. Sativex which are available in some countries, sharing experience might be useful.

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Re: Sativex

Postby HarryZ » Mon Aug 01, 2005 12:18 pm

Phil,

Marg has been using Sativex for about two weeks now. She has used it sparingly and has been experimenting at when to take it. So far it has helped some back pain that she has been experiencing lately and has all but stopped her leg jumping episodes of spasticity. Those could keep her up half the night and were terribly disruptive.

What it hasn't done so far is stopped her severe leg spasms which come and go at random. Marg is still trying to determine when it's best to take the Sativex to minimize these spasms. One positive result here....she has been able to sleep 5-6 hours a night before the leg spasms wake her up. Prior to the Sativex, 2-4 hours of sleep was about the max before spasm time!

So far, Canada is the only country in the world to approve Sativex. Bayer Canada, the distributors, are keeping a VERY close watch on how patients are handling the drug. I called them the other day to check out an issue of Marg getting more pain in her back since starting the drug. The rep I spoke to immediately told me that this would be reported as an "incident" and logged for data purposes. I was asking him what mechanism Sativex used to help Spasticity. He was able to call me back shortly and state that the drug altered the calcium channels on the CR1 receptor. Without going into a lot of detail, this has the potential to cause Marg problems because she uses Prokarin which also effects how calcium is handled in your system. End up with too low a calcium level and you'll end up with more spasms...something she really doesn't need. We have since found out that one can compensate for this by increasing her calcium intake.

As for exporting Sativex...it certainly isn't allowed at this time and I've heard from some people that a US citizen would not even be allowed to bring it back legally into the US even though he/she got the drug through proper channels in Canada.

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