Foyle Branch News & Research 2005
Items posted 2005
CANNABIS SPRAY IMPLICATED IN DEATH OF DIABETIC
It seldom rains but it pours - at least that seems to be the case recently with cannabis related news. Hot on the heels of the item on cannabis & schizophrenia posted here on 15/12/2005, comes disturbing media reports of the inquest into the death of Mrs Anderson, a retired supermarket supervisor, while taking part in a trial on the use of sativex spray in the treatment of diabetes. The trial was supervised by a diabetes expert who told the inquest that he was investigating whether cannabis could provide relief from severe pain experienced by some diabetic sufferers.
The family told the inquest that within hours of taking her first dose she developed disturbed behaviour, telling her family that police had planted drugs at her home and officers were circling in a helicopter. A few days later, the level of the drug was reduced after Mrs Anderson's family contacted the hospital to say she was confused and intoxicated. After taking the drug for 28 days, Mrs Anderson was admitted hospital where her physical condition dramatically deteriorated and she died.
The coroner concluded : "On the balance of probabilities, an idiosyncratic reaction to a trial drug (either alone or in combination with other medications) was at least a significant contributory factor to the initiation of this illness."
Webmaster's comment:Hopefully this was an unusual or rare reaction that is unlikely to be repeated. Nevertheless it does nothing to generate confidence in the safety of cannabis, particularly in the light of the evidence of a link between cannabis and schizophrenia reported on this page.
TopSMOKING CANNABIS & SCHIZOPHRENIA - A DISTURBING LINK
Recent studies have reported some benefits from cannabis & cannabis extracts for persons with MS and there is growing interest in these encouraging developments among the MS community. Check the cannabis & sativex spray items on this page. Persons considering the use of cannabis should be aware that there is a large body of research linking the regular smoking of cannabis with schizophrenia.
According to Schizophrenia.com, a non-profit web community, people were 4.5 times more likely to be schizophrenic at 26 if they were regular cannabis smokers at 15, compared to 1.65 times for those who did not report regular use until 18.
Recently a team from New York's Albert Einstein School of Medicine, used a new scanning technique called diffusion sensor imaging to look into the brains of adolescent cannabis smokers, schizophrenia patients and healthy non-drug users.
The team leader, Dr Manzar Ashtari, said: 'What we saw should cause alarm because the type of damage in cannabis smokers' brains was exactly the same as in those with schizophrenia and in exactly the same place in the brain. To me, this is proof of the damage cannabis can do.' The outcome was reported at a recent meeting of the Radiological Society of North America.
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OUTCOME OF FOLLOW UP STUDY OF EFFECTS OF CANNABIS EXTRACTS ON MS
Dr. J. P. Zajicek & colleagues from Peninsula Medical School in Plymouth have just reported on their follow up study of the effect of cannabis extracts & synthetic cannabinoids on MS. In the original study involving 600 persons(reported here 07/11/2003) over a 14 week period, there was some improvement in mobility & pain reduction reported by participants compared with those on a placebo. About 80% of the original group agreed to remain in the treatment for 12 months. Patient rating scales showed highly significant effects of active treatment on pain, spasms, spasticity, and sleep although only small improvements were registered in the Ashworth spasticity scale score & the Rivermead Mobility Index. Dr. Zajicek's group concluded that there is an urgent need for a long term study in progressive MS to establish whether delta-9-THC (the cannabinoid involved) has a role in long term disease treatment. Their results are reported in the December issue of the Journal of Neurology, Neurosurgery and Psychiatry.
Details of a limited UK licence to import sativex (cannabis) spray are reported on this page
TopSCIENTISTS CLAIM BREAKTHROUGH IN UNDERSTANDING MECHANISM OF NERVE SIGNAL TRANSMISSION
According to a news release from the University of Edinburgh, scientists there have made an important advance in understanding the mechanism by which signals are transmitted along nerves. The say they have identified two proteins that link the formation of the myelin sheath with the development of the nodes that facilitate the rapid movement of signals between brain and muscles. They hope that the discovery of these proteins will help them to find ways to improve nerve conduction in patients with conditions such as MS where the myelin sheath is attacked. The news release can be viewed on University of Edinburgh website
TopSTEM CELL TREATMENT CLAIM
There has been recent press & TV coverage of a person with MS who paid a substantial sum to undergo stem cell treatment at a private clinic in Rotterdam. According to reports, wheelchair bound, 19 year old Amanda Bryson, from Inverness, paid about £12000 for the treatment and claimed she felt an immediate improvement. The treatment involved injecting stem cells from an umbilical cord into the back of her neck on either side of her spine. She says she is now able to do some walking every day. The controversial treatment is not available in the UK.
The MS Society has issued the following statement:
"The potential for stem cell therapy to repair the damage caused in multiple sclerosis is well recognised. The MS Society is already funding research in Bristol and has recently committed more than £1 million to establish a centre for myelin repair in Cambridge. Research into stem cells and MS is, however, still at an early stage. We cannot comment on the case of the lady who has been reported as receiving a form of stem cell treatment in Holland. MS is a very variable condition which affects people in different ways. In view of possible risks, we do though believe that great caution is needed when considering any unorthodox treatment which has not been subjected to rigorous trials and review."
UK PERSONS WITH MS ABLE TO GET CANNABIS SPRAY (SATIVEX)
MS patients in the UK are to be able to get a cannabis-based pain-relief drug from their doctor for the first time, it has just been announced. Sativex has already been licensed for use in Canada to relieve pain in people with MS. The Home Office has now said the drug can be imported to the UK for individual patient's use. The prescription of Sativex by a GP will require a Home Office licence. The GP will have to take responsibility for the prescription of the unlicensed drug, which will have to be imported from Canada for that particular patient. Primary care trusts could decide to fund the treatment on the NHS. Otherwise, the drug will cost patients approximately £4 a day. The government has asked a watchdog, the Commission on Human Medicines, to monitor the safety of Sativex.
Kieran Harris, Director, NI MS Society, has welcomed this development because of evidence that it helps in pain and spasticity relief for some. He confirmed that it will not be beneficial to everybody but at least there will now be an opportunity for its efficacy in individual cases to be determined.
TopCHARITABLE TRUST ESTABLISHED TO SEEK FUNDING FOR LDN RESEARCH
The LDN Research Trust is a charity which aims to raise £500,000 initially, to get low-dose naltrexone (LDN) into clinical trials. It is intended that the first trial will test the response to LDN as a treatment for Multiple Sclerosis. Further trials are planned to test the therapeutic response in certain other auto-immune connditions.
The Charity was set up by a group of people with MS who say that LDN works for them. The website declares it is non profit making and no salaries or wages are taken from the funds. Only expenses for the running of the Charity are taken and these are at the actual cost.
See the item on Low-Dose Naltrexone (LDN) & MS posted below on 31/08/2005.
TopWOULD COOLING THE BODY HELP PERSONS WITH MS EXERCISE BETTER?
Aerobic exercise is thought to help persons with multiple sclerosis fight fatigue, one of the most common symptoms of the disease. Yet MS also appears to cause the body to heat up more quickly, compromising the ability to exercise. New research at at Buffalo University in the USA will investigate if cooling the body before or during exercise allows persons with MS to exercise longer, and which method of cooling is most effective. The study also will determine the effects of a 12-week aerobic exercise program on fitness, core and skin temperature, and heat flux in MS patients.The study is funded by a $449,999 grant from the National Institute on Disability and Rehabilitation Research, U.S. Dept. of Education.
TopWHEN TO DISCLOSE A DIAGNOSIS OF MS?
According to a report in the Journal of Neurology (J Neurol. 2005 Nov 28; [Epub ahead of print]) a team from the Department of Neurology at the Patras Medical School in Greece invited 1200 MS patients to respond to a questionnaire regarding their attitudes to the timing of disclosure of the diagnosis of MS. Of 657 who responded, 91% favoured immediate disclosure. 44% reported that they had immediate disclosure, 29% were informed within 1-3 years and 27% later.
TopAWARENESS & FUNDRAISING PROGRAMME FOR SCHOOLS LAUNCHED IN NI

Popular BBC Northern Ireland presenter Donna Traynor recently launched The MS Society, NI's innovative new Awareness and Fundraising Programme for Schools.
The programme, entitled 'Titan's Leaps and Bounds Champion Challenge', aims to encourage primary school children across Northern Ireland to 'hop, skip and jump' to help those affected by MS in their local community.
Commenting on her new role as Patron of 'Titan's Leaps and Bounds Champion Challenge', Donna said "I am proud to be working with The MS Society, NI, on this exciting new venture which encourages children to exercise and keep fit while having fun and helping people who are living with MS."
The MS Society, NI, is now hoping that primary schools in the Derry area will be ready and roaring to accept Titan's Challenge. Commenting on behalf of the Foyle branch of the MS Society, NI, Terry McNamee, Schools Link Officer for the area said "We believe we have developed a programme which will capture the imagination of children across Northern Ireland whilst being teacher friendly and fitting in with the school curriculum. We hope that schools will be willing to lend us their much valued and much needed support." 'Titan's Leaps & Bounds Champion Challenge' is an awareness/fundraising programme aimed at encouraging primary school children to engage in some form of sponsored physical activity ie dancing, swimming, skipping etc.
If you are interested in finding out more about how to become involved in Titan's Leaps and Bounds Champion Challenge, please contact the Foyle Branch of the MS Society, NI, (028 71 360831).
Photograph at launch on Activities & Events 2005 page
TopLOW-DOSE NALTREXONE (LDN) & MS
The use of LDN as a treatment for multiple sclerosis has been widely publicised on the internet.
Naltrexone is licensed in the UK as a treatment for people addicted to opiates, such as heroin. It blocks the access of opiates in the brain, thereby reducing or eliminating the pleasurable feelings associated with these drugs. It is only available under supervision in specialised clinics and doses range from 50 to 150mg a day for three days a week. Those promoting its use in MS recommend much lower doses of 3 to 4.5mg, where it is referred to as low-dose naltrexone.
There has not been any clinical assessment of its use in MS either on its own or in combination with other treatments & reports of beneficial effects are purely anecdotal.
The MS Society UK website has an excellent article written by Dr. Alasdair Coles after a meeting in Cambridge on the 27th May 2004 with Dr. M.R. (Bob) Lawrence, a retired GP who is the leading advocate of LDN use in the UK for people with MS. This article can be viewed at Dr Coles' article
Webmaster's comment: Apparently some persons have been prescribed LDN by their GPs but others have bought it over the internet. Members are strongly advised not to self-prescribe but to discuss it with their GP or neurologist. Dr Coles points out that some neurologists have expressed concern about a possible conflict with standard treatments because naltrexone is believed to act by boosting the function of the immune system whilst the standard approach to the treatment of MS is to suppress the immune system as the disease is believed to be due to excessive and inappropriate immune activity.
TopPREGNANCY OUTCOMES DURING TREATMENT WITH BETA INTERFERON IN WOMEN WITH MS
Patients are advised to stop interferon-beta when planning pregnancy, but some patients have become pregnant on the drug. A study by Dr. Sandberg-Wollheim, University Hospital, Lund, Sweden; Serono, Inc., Drs. Lopez-Bresnahan, Chang, and Francis, D. Frank, Rockland, MA; Serono , M. Stam-Moraga, Geneva, Switzerland, (Dr. Goodwin, Department of Obstetrics and Gynecology, University of Southern California; and Dr. Giesser, Department of Neurology, University of California, Los Angeles examined individual patient data from eight clinical trials with IFNbeta-1a.
Of 3,361 women in the studies, 69 pregnancies were reported, of which 41 were patients receiving (or who had stopped receiving within 2 weeks prior to conception) IFNbeta-1a. The 41 pregnancies resulted in 20 healthy full-term infants, one healthy premature infant, nine induced abortions, eight spontaneous abortions, one fetal death, and one congenital anomaly (hydrocephalus). The rate of miscarriage was marginally higher than in the general population, but these results were not statistically significant and larger studies are needed to explore this question further.
Until more exposure data become available, patients remain advised to stop IFNbeta therapy before becoming pregnant.
(Neurology. 2005 Aug 10; [Epub ahead of print])
TopIS THIS BETTER NEWS FOR TYSABRI?
Biogen & Elan have announced (9 August 2005) the findings of their safety evaluation of Tysabri. The companies had previously reported 3 confirmed cases of PML, 2 of which were fatal. Almost 2000 patients from the clinical trials participated in the evaluation. No new cases of PML were detected.
Whaijen Soo, MD, PhD, senior vice president, Medical Research, Biogen Idec. Is quoted as saying, "Our ongoing TYSABRI safety evaluation is a rigorous medical and scientific undertaking that has been led by some of the world's leading experts in neurology and neuroradiology. Given the high unmet medical need in MS and the therapeutic benefit we have seen with TYSABRI, we are encouraged by these safety findings."
Lars Ekman, MD, PhD, executive vice president and president, Research and Development, Elan said, "The findings announced today are an important milestone in understanding the appropriate benefit-risk profile for TYSABRI. Patient safety remains our top priority. We are committed to finalizing the safety evaluation for Crohn's disease and rheumatoid arthritis, which is progressing well and on track to be completed by the end of the summer. We look forward to working with regulatory authorities to determine the path forward for TYSABRI.
There is some guarded speculation that limited approval of Tysabri for severe MS patients in the US could be granted during 2006. Further information on this page at Tysabri (Antegren)Shock Withdrawal
TopCIGARETTE SMOKING AND PROGRESSION OF MS
Some studies have reported an increased risk of MS among smokers. (Read an item posted here on 07/11/2003 Smoking increases risk of MS )
A research team from the Department of Epidemiology, Harvard School of Public Health, Boston, has now studied the association between smoking and progression of multiple sclerosis. The outcome was reported online by the journal Brain in March 2005. To assess the association between smoking and progression of multiple sclerosis, they carried out a study of 201 multiple sclerosis cases with a relapsing-remitting onset and 1913 controls. They report that the results support the hypothesis that cigarette smoking is associated with an increased risk of multiple sclerosis and suggest that smoking may be a risk factor for transforming a relapsing-remitting clinical course into a secondary progressive course.
TopSPOUSES LIVING WITH MS
The spouse of a person with MS often assumes the carer's role. An interesting report of research to investigate the experiences of persons whose spouses have MS has recently been published in the Journal of Neuroscience Nursing (J Neurosci Nurs. 2005; 37 (1): 20-27. ©2005 American Association of Neuroscience Nurses).
The study was carried out under the supervision of an associate professor and chair of the adult health department at the University of North Carolina-Greensboro School of Nursing. The data were collected by nurse counselors and a senior nursing student research assistant. The university's institutional review board approved the research. 8 men and 4 women carers participated in a 2-hour focus group. The husbands' average age was 50 and the wives 55. The length of time since diagnosis ranged from 2 to13 years.
The researchers report that 4 major themes emerged: caregiver roles, need for information, relationship changes, and barriers. The researchers found that there were gender differences in how the participants experienced their roles and expressed their feelings. The men acted as protectors of their wives' time, energy, and employment opportunities and were angry at those who did not understand the effects of MS on its sufferers. They demonstrated their support by assuming more responsibility for household management, participating in giving injections, and going with their spouses to see their physicians. The women described with great feeling major lifestyle changes and role reversals. They became advocates to help their husbands maintain independence and existing roles.
This was a small study that provides an important insight into the experiences of carers whose spouses have MS. The very detailed and interesting report can be read in full at the Medscape Website
TopSINGLE GENE LINKING MS, RHEUMATISM & HEART DISEASE DISCOVERED
Researchers in the fields of MS, rheumatism and cardiovascular (heart and blood vessel) disease in Sweden have identified a single gene variant linking these conditions. It is the first identified gene to link autoimmune diseases with cardiovascular diseases. An estimated 20-25 per cent of the population carry this variant of the gene. The researchers discovered that people with the variant ran a 20-40 per cent greater risk of developing rheumatism, MS or a myocardial infarction (destruction of heart tissue resulting from obstruction of the blood supply to the heart muscle). A spokesperson for the researchers believes that this gene variant may be one of the single largest genetic causes of complex diseases with inflammatory components such as MS.
Statins, a relatively new group of drugs used to lower blood cholesterol levels, have been shown to reduce activity in this gene and thus produce anti-inflammatory effects. Statins have been tested on MS patients and have been demonstrated to be beneficial in this very way. See the item on statins on this page This discovery provides a pointer to how they may work.
TopCANADIAN APPROVAL FOR CANNABIS DERIVED SPRAY FOR MS PAIN
GW Pharmaceuticals today (19/04/2005) announced that Canadian approval with certain conditions had been granted for the marketing of Sativex, its spray derived from cannabis for relief of pain in MS. The spray is marketed in Canada by Bayer Healthcare and is administered under the tongue or to the inside of the cheek. It is designed for self administration. According to the statement, the most frequent side-effects encountered in clinical trials included nausea, fatigue, dizziness and application site reactions. These were claimed to be usually mild or moderate in severity and often resolved with down-titration or interruption of treatment. The approval is conditional on additional studies to verify the clinical benefit. Sativex is expected to be available through Canadian pharmacies by late Spring 2005.
TopGOAT SERUM (AIMSPRO) TRIAL HALTED BY DAVAL
Last month the aimspro trial at St George's Hospital was halted by Daval International. Initially the company said it was stopped because proper protocals were not being followed. It has now issued a further statement (29/03/2005) as follows:
"The trial was halted because of concerns over St Georges Hospital's pharmacy allowing the product "Aimspro" to thaw. This was in breach of all instructions given by Daval International. All other treatment programmes are completely unaffected."
This leaves the intriguing question as to whether any of the participants suffered ill effects in the trial. Apparently the trial in Oxford continues. This disappointing development comes in the wake of the very recent claim by the company that there had been very significant improvement in optic neuritis symptoms among those in the trial. See the earlier item on goat serum on this page
TopTYSABRI (ANTEGREN) SHOCK WITHDRAWAL ONLY WEEKS AFTER POSITIVE RESULTS FROM TRIAL AND MONTHS AFTER AFTER FDA APPROVAL
Biogen & Elan today announced they are withdrawing Tysabri (Antegren) from sale in the USA and ending all trials following the death of one person and the serious illness of a second. The statement was issued only two weeks after the release of very positive results from trials and three months after early approval for its use was granted by the FDA in the USA as reported in the following item on this page.
A statement from the two companies said,
"This decision is based on very recent reports of two serious adverse
events that have occurred in patients treated with TYSABRI in combination with AVONEX® (Interferon beta-1a)
in clinical trials. These events involve one fatal, confirmed case and one suspected case of progressive
multifocal leukoencephalopathy (PML), a rare and frequently fatal, demyelinating disease of the central
nervous system. Both patients received more than two years of TYSABRI therapy in combination with AVONEX.
The companies' actions have been taken in consultation with U.S. Food and Drug Administration (FDA). Worldwide
regulatory agencies are being kept informed.
The companies will work with clinical investigators to evaluate TYSABRI-treated patients and will consult with
leading experts to better understand the possible risk of PML. The outcome of these evaluations will be used
to determine possible re-initiation of dosing in clinical trials and future commercial availability."
The previously successful outcome of the trials had raised a hope that tysabri might be the world's most effective MS treatment. This hope has now been dashed at least for the present.
TopTYSABRI (ANTEGREN) TRIAL CONFIRMS EARLIER POSITIVE RESULTS
Biogen & Elan, the companies jointly conducting clinical trials of Tysabri (Antegren) (Natalizumab), today announced that their Phase III Affirm trial has confirmed the earlier reported outcome of the Phase I & Phase II trials of persons with relapsing forms of MS. They say that there was a 42% reduction in the risk of disability progression and a 67% reduction in the rate of clinical relapse over two years. The companies anticipate that two-year data from the AFFIRM trial will be presented at the American Academy of Neurology meeting in April 2005. The companies expect two-year results from the SENTINEL trial will be available mid-year. Earlier developments reported on this page at Antegren, renamed Tysabri, gets FDA approval for MS (posted:25/11/2004) and Latest on Antegren (natalizumab) Trials (posted 10/11/2004)
TopWHAT'S THIS ABOUT GOAT SERUM?
A number of people with MS have been receiving aimspro, a treatment that uses antibodies of serum of goats that have been treated with a number of vaccines to generate the antibodies. There is a considerable amount of anecdotal evidence of significant improvements although there are also some reports of no beneficial outcome.
Aimspro is manufactured by Daval International, a UK based company. A controlled trial (where half of the participants are receiving the treatment and half are on placebo) involving 80 participants with secondary progressive MS currently ongoing at St George's Hospital in London is expected to report in Jume 2005. Another trial in Oxford involving participants with optic neuritis is also expected to report around the same time. A third trial involving persons with acute relapses is planned.
Aimspro is administered through injection and appears to have very limited side effects. It was made available to 150 persons through their GP before the trials started. It is no longer available this way. Much of the anecdotal evidence of benefits came from these sources. Proper evaluation of its effect must await the outcome of the clinical trials.
TopWHY DO MORE WOMEN THAN MEN GET MS?
This question has long puzzled researchers and now a Mayo Clinic led team of international researchers has identified a gene difference that may help to explain it at least in part. The team studied MS populations in four countries, USA, Northern Ireland, Belgium and Italy.
Interferon gamma belongs to a group of proteins that communicate with cells. Research by scientists at the Mayo Clinic has shown that women have higner levels of naturally produced interferon gamma than men. Experiments elsewhere showed that high levels of interferon gamma could intensify the MS damage processes and make the disease worse.
The team found that fewer men than women in the populations studied had the gene that gives rise to higher levels of gamma interferon. The leading author of the report, Dr. Weinshenker of the Mayo Clinic said "Our finding isn't the whole genetic cause, but it's a helpful step that could lead us to a more complete understanding of MS -- and ultimately, effective treatment. It's also a very promising lead about gender differences that may pertain to susceptibility of other diseases, too, such as rheumatoid arthritis."
The report was published on 27 January, 2005 in the online edition of the journal, Genes & Immunity. Shirley Haggerty from the Applied Genomics Group, School of Pharmacy, Queen's University of Belfast and Stanley Hawkins of the Northern Ireland Regional Molecular Genetics Laboratory, Belfast City Hospital Trust were the Northern Ireland participants in the research.
TopDOG SUPPORT FOR WOMAN WITH MS
According to an item on the the US National Ms Society webpage, Caryn Piche has had MS for 25 years. She walks
with the aid of a crutch on her left side. Now, thanks to a partnership between the Long Island Chapter of The
MS Society, and the Canine Companions for Independence, her life has been made more manageable by a dog. She
attended a two week course at the CCFI training centre where she learned to work with a Labrador and Golden
Retriever mix named Geyser who can respond to around 40 commands including commands to turn off lights and
close doors. She will continue to receive support and training throughout the lifetime of the dog. The MS
Society Chapter will raise money to cover the cost of food and veterinary care. The dog helps her balance by
walking on her right side and eases her fatigue by picking up everything she drops during the day. Caryn is
quoted as saying that the dog enhances her life 'physically, mentally and emotionally '.
HORMONE INFLUENCES IN MS
MS affects twice as many women as men and it is significantly less active during pregnancy, suggesting hormones play a role in its development. Clinical trials of Early Pregnancy Factor( now called Cpn10) have been granted approval in Australia.
It is reported in the current issue of The Journal of Neurology, Neurosurgery and Psychiatry that researchers from University La Sapienza in Italy looked at a range of sex hormone levels in 25 men and 35 women with MS and in 36 people without the disease. None of the women had used oral contraceptives, and all had normal cycles. The average age of the participants was 32 and those with MS had their disease for an average of six years. Those with MS were also given MRI scans to monitor areas of tissue damage and inflammation.
Compared with healthy women, those with MS had lower levels of the male hormone testosterone in both phases of their menstrual cycle and those with the lowest testosterone levels also had the highest amount of inflammation in their brain tissue. Women with MS and abnormally high testosterone levels also had greater levels of brain damage and a trend towards increased disability.
Among men, there were no differences in testosterone levels between those with MS and the healthy group. But men with MS and the highest levels of the female hormone oestrogen also had the greatest degree of brain tissue damage. None of the other hormones seemed to have any influence.
The researchers concluded that oestrogens and testosterone play a role in the development of brain tissue damage in MS and proposed that the contribution of these two hormones and their types of actions and interactions deserve further analysis.