Sativex can significantly reduce nerve pain in MS patients, a study has shown

Developed by GW Pharmaceuticals, Sativex is a whole plant medicinal cannabis extract indicated for relief of symptoms of multiple sclerosis (MS) and for treatment of severe neuropathic pain. Bayer has secured exclusive rights to market Sativex in the UK with the option to extend this to other countries in Europe and Commonwealth countries such as Canada. Full story. Excerpt:

TREATMENT OF SEVERE NEUROPATHIC PAIN

Neuropathic pain, which is frequently chronic, arises when neurones in the brain or peripheral nervous system become hyper-sensitised and generate abnormal or prolonged impulses. There are many causes of neuropathic pain including diabetic neuropathy, post-herpetic neuralgia, fibromyalgia, multiple sclerosis and cancer. Around 40% of cancer patients suffer some degree of neuropathic pain.

Severe neuropathic pain has proved difficult to treat and evidence suggests that none of the available drugs, mainly opioids, is effective in more than 50% of patients. Thus, it represents an area of significant unmet clinical need. The encouraging data from the Sativex phase III registration trials in multiple sclerosis patients suggest cannabis-derived medicines may have a valuable place in this sector of the pain market.

MARKETING COMMENTARY

In Europe alone there are some 500,000 MS patients on top of the 4 million experiencing neuropathic pain. This fact, together with a market poorly served by currently available drugs, presents an excellent opportunity for Sativex if the encouraging results seen in multiple sclerosis are reproduced in other patient groups. Regulatory approval of Sativex will set an important precedent for the use of cannabis-derived drugs.

Picture shows Sativex.

Further reading:

GW Pharmaceuticals Press Release 15th November 2005 - UK Named Patient Prescribing for Sativex
http://www.gwpharm.com/sativex.asp

Home Office Sativex Details

Following the GW Pharmaceuticals Press Release of 15th November 2005, several THC4MS clients have contacted the Home Office to enquire how they can obtain Sativex.

Your GP will need to apply to the Home Office to prescribe Sativex to you. Your GP will need to provide the following:

a) your personal details - full name, address, age, gender
b) a brief indication of the clinical need
c) the dosage total amount required (the manufacturer, GW Pharmaceuticals can help with this information - telephone 01980 557026 or email enquiries@gwpharm.com).

Your GP can forward this information to:
Mike Evans
Home Office, Drugs Branch,
6th Floor, Peel Building,
2 Marsham Street,
London.
SW1P 4DF

Updated 22/12/2005

The MS Society at its website has produced the following information in response to queries from people affected by MS about Sativex

What is Sativex?
Sativex is an oral spray containing a cannabis extract produced by GW Pharmaceuticals. You take it by spraying it under your tongue or to the inside of your cheeks. You can control the dose of Sativex you take by varying the number of sprays.

What symptoms will Sativex help with?
Sativex has been made available for relief of symptoms associated with MS. It has not been specified for any particular symptom. Information from GW Pharmaceuticals says clinical trials conducted in people with MS have shown promising results in the relief of spasticity, nerve pain, sleep disturbance, and bladder symptoms.

How can I get a prescription for Sativex?
As of 15 November 2005, GPs in the UK could prescribe Sativex on a 'named patient' basis for people with MS. 'Named patient' means that the prescribing GP takes the decision to prescribe it based on your individual circumstances.

Why is this drug coming from Canada?
At the moment, Sativex does not have a UK licence and is not available through normal NHS channels. However, your doctor has the right to prescribe an unlicensed medicine, under his/her own responsibility, if he or she feels that it is in the best interests of the patient.

When your doctor has agreed with the patient that Sativex is appropriate, then they simply need to write a prescription. Sativex can be supplied to a pharmacist in order to fill the prescription. The only additional information required by the pharmacist in the case of Sativex, is confirmation that Sativex is being supplied for the treatment of MS.

If your doctor requires any more information about this procedure, it can be obtained from GW Pharmaceuticals, at the number given at the bottom of the this page.

I have MS. Does this mean I am automatically entitled to get Sativex from my GP?
Your GP will take into account your particular circumstances and other factors and will make a decision based on your own case. There may be reasons that Sativex does not suit you. In clinical trials, Sativex has been used in people who have not gained adequate relief from their existing treatment. While a large proportion of people with MS are helped further during treatment with Sativex, some people may not improve at all.

Why might my GP refuse to prescribe Sativex?
Sativex is not suitable for everyone. It is also not recommended for some groups of people. For example, pregnant women, the under 18 year old age group, and those with a history of a psychotic disorder would not be eligible.

Can I get a second opinion if my GP refuses to prescribe it?
As with any treatment decision, you are entitled to a second opinion.

What are the side effects? How will it react to the other drugs I take?
GW Pharmaceuticals has prepared detailed advice to GPs on warnings and precautions related to the use of Sativex. You should discuss this with your GP.

Can I drive while taking Sativex?
You are warned not to drive or do anything that needs unimpaired judgement and coordination after taking Sativex.

Will I need to pay for Sativex?
The cost of Sativex is estimated to be around £4-£5 a day for a typical user. However, because Sativex is used according to each person's response, some people will use more, and some use less than the typical amount. Whether you have to pay for this will depend on local NHS arrangements and your GP or pharmacist can advise you further. This is in addition to standard prescription charges.

For further information
MS Helpline: 0808 800 8000

Cannabis reduces symptoms of MS - Lancet report

The claims by medical users that cannabis reduces the symptoms of MS has been confirmed by UK government trials. The study, of more than 600 patients, published in the Lancet medical journal, also provided some evidence that they boosted mobility. MS sufferers have been claiming these beneficial effects for years. This study shows that cannabis really does make these ill people feel better, these claims cannot be ignored any longer. - BBC News report
- - -

GW Pharmaceuticals:
Email enquiries@gwpharm.com
Telephone 01980 557026)

Note: I would be grateful for any feedback from readers suffering from ME/CFS/PVFS and/or Fibromyalgia re Sativex. Please leave comment or email me direct. Thanks for all other comments and emails received, much appreciated. Sorry, can't keep up with replies as well as blogging.

Moving toward normal

Moving toward normal In a long battle with chronic fatigue syndrome, writer talks of her day-to-day victories and medical progress.

By JOAN MORRIS Contra Costa Times
Published Friday, July 7, 2006

Dorothy Wall's Oakland, Calif., home, not far from the University of California, Berkeley campus, is a model of linear simplicity.

Bookshelves line the walls in perfectly straight lines, and the furnishings are sparse both in number and design. The hardwood floors that diffuse the glow of the afternoon sun are arranged in rows of narrow planks.

It is the home of an organized mind and an ordered life that should be, but isn't, at odds with Wall's creative life work, that of a writer and writing consultant. Does the home speak more to Wall's style or her illness? Even Wall isn't sure. So much of who she is these days is related to her almost-30-year march alongside chronic fatigue syndrome.

The disease can render its sufferers virtually invisible, confined by a nebulous illness and often ignored by a public that doesn't understand or appreciate the true nature of their disease. But inside the confines of her home, Wall is very much a solid figure, in control of her environs and her life. And with her recently published book, "Encounters with the Invisible: Unseen Illness, Controversy, and Chronic Fatigue Syndrome" (Southern University Methodist Press, 352 pages), Wall is attempting to give a voice and a face to the illness.

It wasn't always so. When Wall developed the chronic disease in 1978, she had no idea what she was suffering from and neither did the doctors who treated her symptoms, lectured her about burning candles at both ends and tried to send her to therapists to deal with her "issues."

Whether they vocalized it or not, there were those who labeled Wall a malingerer. There was no cause for her illness; therefore, there was no illness.

But Wall, who jokes she was never on the forefront of a single trend until 1978, was one of the first to fall victim to what later would be called chronic fatigue syndrome.

In the late 1970s and early 1980s, hundreds of people were going to their doctors complaining of odd symptoms. Doctors at first didn't recognize the pattern; and many patients, including Wall, were told there was nothing wrong with them.

Wall was in the middle of an upheaval when she fell ill. She was a single mom going through a messy divorce and trying to rebuild her social life. She also was finishing up graduate school and working four days a week at a bookstore. She drove herself to the point that when she contracted mononucleosis, it hit her particularly hard. She now believes that might have been the trigger that soon brought on her CFS.

At first, Wall thought she was suffering a recurrence of mono. Or perhaps she'd picked up another virus or the flu. When her symptoms worsened, she saw a doctor, who prescribed antibiotics and suggested she take it easy. But weeks went by when she was too ill to function. She lived in a fog, racked with pain and with barely the energy to take care of her daughter.

One morning she awoke to realize that after two months, she genuinely felt better. The next day, she had a relapse.

"That's when I knew I had something else," Wall said. "I just didn't know what."

For the next 15 years, Walls said, she "passed." Passed for healthy, passed for normal, passed for happy. But she wasn't. Somehow she struggled through, watching as doctors scoffed at those like her and as the disease became a national joke, called the "Yuppie Flu."

But every year she grew a little stronger. She was never well, but she became less ill. And the better she felt, the more she pushed herself.

"People who cope with this illness try to cultivate the normal," Wall said, "including things in your life that normal people have - lunch with a friend, reading a book to my grandson, working. You work really hard to have those things."

But Wall pushed too hard, and in 1995, she had a complete collapse. She was unable to leave her bed for more than an hour a day, and it has taken her 10 years to get to where she is now. Wall rarely leaves her home for long and must allocate her time. She works from a home office, spending a few hours on the computer, a few on the phone.

She is like an energy miser, carefully doling out her precious coins of energy. She functions well, she said, if she stays within her "energy envelope." Venture too far outside for too long, and the price is dear.

When health experts realized they were dealing with a real disease, they began looking for a way to diagnose it. What they discovered is that while the onset of the disease might be different for some, there are three distinct symptoms that define CFS: overwhelming pain, crippling exhaustion and a brain that seems locked in a deep fog.

Early research focused on finding a single cause for the illness - a virus or pathogen, a chemical exposure, a genetic predisposition. Two decades later, researchers still have not identified the cause or a cure, but they now agree that any of those things can be a trigger that launches an attack. They've also discovered that CFS, or a type of the illness, has existed for many years, couched in euphemism of the time.

For Wall and others who have had the disease for many years, there is no expectation of a cure. They live by carefully managing their lives, monitoring their energy output and pacing themselves. Symptoms, from the pain to the occasional plunge into the cognitive fog, are treated with medications. The best they can hope for is to hold on to what they have.

For those newly diagnosed, the news is more heartening. Early treatment of symptoms and a slowdown of activity has allowed many to make a near-full recovery, although they must be forever mindful of the illness.

And more good news, Wall said, is that doctors are more knowledgeable about the disease and less likely to dismiss symptoms as "all in your head." Much work, however, is needed, she said. Of the diseases that get federal funding for research, CFS languishes at the bottom of the list.

It's not easy to live with the disease, Wall said, but it is easier than it was. The order she imposes on her life might, from the outside, make her appear as a prisoner in her home. She ventures outside little and follows a precise schedule to ensure she accomplishes what she can without pushing herself too hard.

The most difficult is accepting those limitations. The disease is with her always, but when symptoms flare, they typically focus on her throat, leaving it sore and raw and robbing her of speech. If she catches a cold, it's likely to leave her unable to speak for months at a time.

Reducing her exposure to cold viruses means reducing her contact with others, particularly her young grandson. In the winter, visits with him must take place outdoors, and she can't hold or touch him.

But when you think of Wall, don't think of her as a victim, she said. "I don't want CFS to define my life."

British Journal of Nursing - 8-page review on ME/CFS

Copy of News from The ME Association blog 3 July 2006:

MAY BE REPOSTED

The debate: Myalgic encephalomyelitis and chronic fatigue syndrome
British Journal of Nursing, 2006, vol 15 (12), pages 662 - 669

As there have been very few papers on ME/CFS published in well recognised peer-review nursing journals I recently submitted an eight page review to the British Journal of Nursing.

This has just been published in the June/July issue.

Among the issues covered are:

The debate into nomenclature and definition
Epidemiology
Predisposing, precipitating and perpetuating factors
Diagnostic and disability assessment
Drug management - including possible disease modifying drugs and drugs used for symptomatic relief
Non-pharmacological management - pacing, problems with graded exercise etc
General management issues - including alternative and complementary therapies
Prognosis

The section on causation emphasises and references the key clinical and research abnormalities relating to neurological function that the ME Association presented to the first oral hearing of the Gibson Inquiry.

Paper copies are available in UK newsagents for non-subscribers.

An electronic version can be obtained at: a payment per item service .

Please note that this is the longest and most referenced paper in this issue of the BJN. I have tried to fit in as much information as possible in the space that I was able to agree on.

Dr Charles Shepherd
posted by ME Association at 10:13 AM

Trapped in bed for 14 years with chronic fatigue

Daily Mail article by Gill Swain, Trapped in bed for 14 years with chronic fatigue - see comments by readers, 28 to date.

Dr Charles Shepherd wants information on possible morphine resistance in ME/CFS

News from The ME Association:

Information on possible morphine resistance in ME/CFS required

I have recently been discussing the cases of a small number of people with ME who form part of the database operated by the UK charity CHROME (Case History Research on ME). This small group of people appear to have a degree of resistance to morphine - a very potent analgesic that is occasionally used for the management of severe pain.

The pharmacology of morphine resistance is interesting in that the drug is broken down by enzymes in the liver into two metabolites known as morphine 3 glucuronide (M3G) and morphine 6 glucuronide (M6G).

M6G may be even more potent than the parent morphine whereas M3G antagonises the action of morphine and M6G and so is known as an anti-analgesic.

The individual response to morphine therefore depends on the balance of activity between these two metabolites with an excess of M3G producing varying degrees of morphine resistance or intolerance. This aspect of morphine pharmacology may also help to explain the presence of the paradoxical pain that people sometimes experience when given morphine.

Morphine resistance is very unusual and I have only come across one person with this reaction so far in my whole medical career - that was in hospital practice and did not involve ME/CFS.

If anyone has further information on possible morphine resistance or intolerance in ME/CFS I would be pleased to receive it.

And if morphine resistance does appear to be more common in people with ME/CFS than the normal population, then this could link in to some of the research work currently being carried out in the UK and USA into abnormal gene expression.

Please email ME Connect putting FAO Dr Shepherd in the subject line.
Dr Charles Shepherd
Medical Adviser, The ME Association.