Medical Marijuana Research Reports

Low doses of cannabis can relieve severe pain for people with multiple sclerosis and spinal cord injuries, the largest clinical trial into the drug has found.

Tests on three medicines derived from the plant helped 28 out of 34 patients.

GW Pharmaceuticals, the company given a licence by the Government to grow cannabis in Britain and run clinical trials, said none of the patients had responded well to conventional drugs.

Dr Willy Notcutt, of the James Paget Hospital, Great Yarmouth, who is running the trial, said: "Patients in this trial are suffering from severe pain. It dominates their lives.

"Given the previously intractable nature of their pain symptoms, the improvements provided by cannabis-based medicines are all the more remarkable.

"Many of those with chronic pain also suffer from a poor quality of sleep which over time can have profoundly negative effects on them and their families. By bringing about improvements in their sleep regime, as well as their pain, we can have a major positive impact on their quality of life."

Patients were given three drugs containing cannabinoids, the active ingredients in the cannabis plant. One spray contained the cannabinoid CBD, another THC and a third an equal amount of both.

Cannabis-based drugs worked better than a dummy placebo for 28 of the patients, all of whom asked to continue on the drug. Twenty-five are still on the trial and have been taking the drugs for two years. Only six felt no benefit.

The drugs are administered with an inhaler under the tongue at low levels designed to avoid intoxicating effects. Dr Geoffrey Guy, of GW Pharmaceuticals, said: "We believe there will be a market for all three medicines in pain treatment."

The company will announce preliminary results from a bigger trial in November involving 400 people. If cannabis derived drugs get approval, they will be delivered by a smart inhaler which stops patients getting too high a dose.

The world's oldest euphoric drug is poised to make a return to the medicine cabinet. Cannabis, reputedly taken by Queen Victoria to quell her period pains but banished from Britain's schedule of medicinal drugs in 1971, is on the point of winning scientific backing for its role in easing the symptoms of chronic disease.

This week the Medical Research Council is due to announce that it has recruited the last of 660 patients to a UKP1.2m trial of cannabis-based medicines in the treatment of multiple sclerosis, the largest in the world. Most of the patients recruited over the past two years have already completed the 15-week trial, in 30 centres round the UK.

Although final results will not be available until next summer, researchers are optimistic. Dr John Zajicek, consultant neurologist at Derriford Hospital, Plymouth, who is leading the research, said: "I'm fairly confident we are going to find an effect in reducing spasticity, or muscle spasms, and it is also going to have an effect on bladder control.

"Anecdotally some patients have had tremendous benefit from it. One or two who couldn't walk or go to the loo found they were able to when they were on the drug. There have been some whose lives have changed dramatically."

Next month, a venture capital firm, GW Pharmaceuticals, is due to report preliminary results from its own Phase III trials of cannabis-based medicines in patients with multiple sclerosis, spinal cord injury and other conditions. Phase III trials are the largest and most rigorous, and must show positive results before a drug can be licensed.

Last week the company published results from an earlier, smaller Phase II trial which showed that 28 out of 34 patients suffering severe pain benefited from the medicines and had elected to continue on the trial. Geoffrey Guy, GW's executive chairman, said: "One can be confident the Phase III trials are going to yield results reflective of Phase II."

If such hopes are fulfilled, cannabis-based medicines could be on the market in two to three years. The National Institute for Clinical Excellence, the government watchdog on new medicines, has been alerted by its horizon scanning unit in Birmingham, whose job is to spot drugs in development before they hit the NHS.

The medicinal benefits of cannabis have been known for at least 2,000 years. Its analgesic properties were described by the British herbalist Nicholas Culpepper in 1653. Two drugs based on the active constituent tetrahydrocannabinol ( THC ) have been used in the UK for over 30 years to treat nausea in cancer patients undergoing chemotherapy, although their use has declined as better anti-emetics have been developed.

Medicines derived from the cannabis plant are being tested by drug companies around the world as treatments for pain, stiffness, tremor, weak bladder, loss of appetite and high blood pressure. It is being tested in people with behavioural disturbance caused by Alzheimer's and in sufferers from Parkinson's disease.

Research is also going on into its role in stimulating appetite in cancer and Aids patients ? cannabis has long been known to give users the "munchies".

But one hurdle remains to be overcome. Scientists have not so far succeeded in isolating cannabis's medicinal properties from its euphoria-inducing ones. Although patients in both trials have not got high, that is believed to be because they were taking low doses.

"Most of the active ingredients of cannabis can give a high. What the Government wants is a drug that can be used without being abused," Dr Zajicek said.

In the 1970s, researchers discovered morphine-like opioid receptors in the spinal cord that led to the development of epidural painkillers, which did not have the psychoactive effects of morphine. They are now widely used in childbirth, after surgery, and increasingly for intractable pain such as that caused by cancer.

Similar receptors for cannabinoids have been identified in the spinal cord, and the hope is that cannabis-based drugs can be developed to target them which would have a painkilling effect without a psychoactive one.

With scientists confident that they can harness some of the 60 active constituents of cannabis to alleviate a range of symptoms, millions of pounds are being invested by drug companies in developing unique combinations of the constituents or finding a unique means of delivering them to the body, which would be patentable. As cannabis is a natural plant, neither it nor the oil produced from it can be patented.

In the MRC trial, patients were given either THC - cannabis oil derived from the whole plant - or a placebo in a capsule to be swallowed. The THC was manufactured in California and the cannabis oil was derived from plants grown in Switzerland and processed in Germany.

One drawback of using an oral drug is that there is great variation between patients in the dose needed to produce an effect. Patients in the MRC trial were started on a target dose based on their weight, which was adjusted over the first five weeks, depending on side effects.

GW Pharmaceuticals have developed an under-the-tongue spray which they claim is absorbed more quickly, making dose adjustment simpler. Their patients received THC or cannabidiol, either alone or in combination, manufactured from cannabis plants grown in a secret location under tight security in southern England.

The Multiple Sclerosis Society has taken a close interest in the research, but has declined to fund patients who wished to continue on the drug after the end of the MRC trial ? to the anger of some of its members.

A spokesman said: "There is a tremendous amount of anecdotal evidence that cannabis in various forms can be helpful in alleviating some of the most unpleasant symptoms of MS.

"But we also know that there have been people with MS who have had very bad experiences. So the main concern is whether the substance is safe in the long term, because people with MS have a condition that is going to last the rest of their life."

'It Was Brilliant Just To Be Able To Stand'

The pills Hazel Walker swallowed as part of the Medical Research Council's ( MRC ) cannabis trial helped her get out of her wheelchair and walk. She took them for 15 weeks last year and the effect was dramatic.

"I could walk a couple of lengths of the hallway and do simple things that other people take for granted. It was brilliant, really brilliant," she said.

She still doesn't know what was in the pills because the trial was "double blind" to prevent both the patients and their doctors knowing who was taking the active ingredient and who was taking the placebo.

But the improvement in her condition was so striking that after a fortnight's break at the end of the trial she elected to go back on the pills for another year and continued to reap the benefits.

"The first week after I came off the pills I really went downhill. I tried to do things I had got used to and I found I couldn't. When I went back on them I noticed a change again - more mobility and fewer spasms. It is very hard to stand at the sink and wash the dishes if you have got spasms in your legs."

Her love life improved, too. "It was brilliant to be able to stand up. It is difficult to get passionate stuck in a wheelchair."

Aged 47, she has had multiple sclerosis for seven years. She is confined to a wheelchair and when her husband, a fisherman, is away, she needs two carers to get her up and dressed in the morning and put her to bed at night at their home in Plymouth.

The only drugs that have helped during those seven years have been steroids, but they have damaging effects if taken long-term. Medicines based on cannabis are her only hope but now they, too, have been taken away.

Funding was only available to provide one year's supply of pills. For Hazel, they ran out this summer. The MRC's researchers applied to the Multiple Sclerosis Society for financial help to continue supplying the drugs, but the society declined.

Hazel said: "I was left in limbo. I was annoyed, to be honest. The MS Society says it won't fund the drug, yet it gives benefits to people with MS. It's frustrating."

She experimented with herbal cannabis for a while: "I tried it for a fortnight. I sat watching telly and started laughing. I don't know whether it helped because I was giggling all the time."

"I didn't fancy going out if I was going to be in the street giggling. People already think if you are in a wheelchair you are practically braindead and if they saw me giggling they would probably think I had lost it altogether. You need your wits about you. My hope now is that the trial is successful, the drug is licensed and I can start taking it again."

A Norfolk-based trial of cannabis-based medicines has produced powerful evidence of their painkilling potential, say scientists.

The Government has given a special license to firm GW Pharmaceuticals to carry out tests on a range of cannabis-based prescription medicines.

The latest research has been carried out by Dr Willy Notcutt at his pain clinic at the James Paget Hospital, in Gorleston.

It focused on 34 patients - with multiple sclerosis, spinal cord injury and other severe conditions causing severe pain - who had not responded well to current medications.

When they were treated with the cannabis-based medication, 28 said it had reduced pain and helped them sleep better.

Each patient was treated with three different types of medication, containing different levels of the active ingredients of cannabis.

All out-performed a dummy medication.

Dr Notcutt said: "Patients in this trial are suffering from severe pain - it dominates their lives.

"Given the previously intractable nature of their pain symptom,s. the improvements provided by cannabis-based medicines are all the more remarkable.

"Many of those with chronic pain also suffer from a poor quality of sleep, which - over time - can have profoundly negative effects on them and their families."

The trial is on pilot scale and more extensive research is needed before cannabis-based medications are made widely available.

But Dr Geoffrey Guy, GW executive chairman, said: "We are delighted with the results of this study in patients with severe pain.

"The data shows improvements with all three of our cannabis-based medicines and we therefore believe that there will be a market for all three medicines in pain treatment in due course."

The Medicinal Cannabis Research Foundation ( MCRF ) welcomes the results.

Its lead trustee Lord Rea said: "We are encouraged that patients in this study have gained significant benefit and that the medicines appear to be well tolerated."

UK: MS Cannabis Trial At Ipswich Hospital
Pubdate: Thu, 04 Jul 2002
Source: Evening Star, The (UK)
Copyright: 2002sEastern Counties Newspapers Group Ltd
Contact: nigel.pickover@ecng.co.uk
Website: http://www.eveningstar.co.uk/Content/news/news_home.asp
Author: Jessica Nicholls, Health Reporter

A CONSULTANT at Ipswich Hospital is involved in groundbreaking new trials to see if cannabis really does relieve the symptoms of multiple sclerosis.

Trials are being conducted nationally by the Medical Research Council into the use of cannabis as a prescribed drug.

Sufferers of the disease have been campaigning for several years for the trials and some have even been taken to court for using the drug which they claim relieves the debilitating symptoms they suffer.

But MS sufferer, Stephen Williams, of St Peters Road, Stowmarket, treated the news with some caution. He was diagnosed 16 years ago and said during that time his hopes had been raised too often only to be dashed when the treatment proved too expensive.

The 52-year-old said: "The frustrating thing is being told that there is a major breakthrough but it has to go through five years of trials.

"So you sit and wait patiently and then you find you can't have it after all because it is too expensive."

Mr Williams has been closely following tests of cannabis and spoke out in the Evening Star in September for the cannabis law to be reformed so he could use it to relieve the pain wracking his body.

He said: "I have been checking the website of a pharmaceutical company ( which is running trials ) and they said that in most incidences they have had good results.

"Although there are still a lot of people that it does not help, it is helping more than they thought".

"When I was first diagnosed in 1986 the doctors told me not to worry and that there would be a cure by the end of the century" that has been and gone.

"I am wary of it but now it is in Ipswich I will ask my GP if I can get involved."

Bob Wake from Stradbroke, near Eye, was diagnosed with MS 14 years ago. At that time he said he never believed medical research would advance this far.

He said: "I never thought I would see this".

"We always hoped that it would and various things have come up during that time".

"When I was diagnosed I did not think there would be anything for me and cannabis may not be the one but at least we can try."

Mr Wake, 67, is involved in the East Anglian Branch of the Multiple Sclerosis Society and often gives talks to both sufferers and non-sufferers.

He said: "From what I know, cannabis does not seem to be doing much harm".

"If you have MS you are willing to have a go at absolutely anything you don't know when you wake up each morning which part of you is never going to work again".

"When I have been to meetings and talked to people they have said that as long as there would not be any terrible side effects they would try anything" even if there was only a one in a thousand chance it would work.

"No two patients are the same and MS affects random sections of the brain.

"One person could be helped in a different way to another."

Dr Stephen Wroe is a consultant neurologist at Ipswich Hospital and he has been involved in the trials.

He was unavailable to comment today but it is believed that around 23 patients are actually taking part.

If the trials are successful the treatment could be in place as early as 2004.

Physicians and consumers need reliable information on medical herbs. The popularity of such therapy in the US is growing rapidly but the science is not progressing as rapidly as sales. In the January 1st, 2002 Annals of Internal Medicine, Dr. Edzard Ernst (from the UK) wrote The Risk-Benefit Profile of Commonly Used Herbal Therapies: Ginkgo, St. Johns Wort, Ginseng, Echinacea, Saw Palmetto, and Kava. The Annals has a history of conservative politics (for example, they oppose the Oregon Death With Dignity Act and have written scathing half-truths about the medical use of marijuana). With those conservative politics in mind, I have provided the following review of Dr. Ernsts article.

The seven top selling legal herbal medicines are ginkgo biloba, St. Johns wort, ginseng, garlic, echinacea, saw palmetto, and kava. Dr. Ernst looked for the best scientific articles he could find and graded them as to how well they answered questions such as, Are objectives of the study clearly stated, Are the data sources stated, and Are inclusion and exclusion criteria stated?. Readers are welcome to review the scientific abstract at PubMed www.ncbi.nlm.nih.gov/entrez/.

Ginkgo is mostly used for memory impairment, dementia, tinnitus (ringing ears), and intermittent claudication (legs hurt when walking because of clogged arteries). In persons with memory impairment and dementia, ginkgo is superior to placebo but in normal persons, ginkgo does not enhance normal function. Ginkgo may help with ringing ears but there is insufficient data to make any consistent claims. Ginkgo is just as effective as the allopathic drug company competitor, pentoxifylline, for intermittent claudication but the best treatment is to stop smoking and to start walking exercise. Ginkgo is generally safe but inhibits clotting (like aspirin does) so may interact with other medicines such as warfarin blood thinners.

St. Johns wort is used almost exclusively as an herbal antidepressant. Its mechanisms of actions appear similar to drug company products like imipramine. St. Johns wort is more effective than placebo in the treatment of mild to moderate depression and is similar in effect to moderate doses of drug company products. My experience is that no antidepressant drug works all the time and that persons with severe and/or recurring depression usually benefit more from talk therapy plus chemical treatment rather than either treatment alone. St. Johns wort can cause sensitivity to sunlight and can interact with other drugs such as blood thinners and oral contraceptives. Because of drug interactions, all of your doctors should know if you are taking this herb.

Ginseng is a confusing herb looking for a home in allopathic circles. The studies are poor and conclusions are not reliable. Sold as an ergogenic (energy giving) booster or an aphrodisiac or other, the reviews do not show ginseng to enhance performance. It does interact with warfarin blood thinners.

Echinacea preparations contain many potentially active ingredients but no single active constituent has been found. The best-researched indications are prevention and treatment of uncomplicated upper respiratory infections. In prevention trials, the results were not conclusive but suggested that groups receiving echinacea received benefit compared to control groups. In treatment trials, most groups showed benefit with echinacea compared to placebo. Dr. Ernst states, Echinacea (particularly E. purpurea) may be efficacious, but the trial data are weak and inconclusive. Side effects from echinacea are rare. I use echinacea during high-risk settings (like air travel) to prevent a cold. It seems to help and there is no alternative because antibiotics are ineffective and dangerous in this setting.

Saw palmetto is almost exclusively used to treat benign prostatic hyperplasia, a condition of aging men when the prostate grows and interferes with normal urinary flow. The results show superiority of saw palmetto over placebo in terms of urination frequency and peak flow and suggest similar effectiveness to finasteride (the drug company competitor). In some European countries, saw palmetto is considered first-line therapy over finasteride. Side effects are rare but long-term studies are lacking.

Kava is mainly used for its anti-anxiety effects and short-term administration of kava appears to be effective. Unfortunately, several cases of toxic liver damage requiring liver transplants have been reported. Kava also interacts with other drugs, including alcohol, that impair the central nervous system. A skin condition can occur with long-term use of kava at high doses.

Garlic was reported on by Dr. Ernst in a prior Annals article (19 Sept 2000). Garlic was reported to be superior to placebo in decreasing cholesterol levels. However, the impact was small (around 5% compared to the drug company statins impact of about 20% or more). About 20% of garlic users complained of indigestion and odor.

On Friday, May 3, Dr. Esther Fride from Israel reviewed the molecular biology of cannabinoids and how they work in the body. She explained how cannabinoids and opioid pain medicine (like morphine) work together in a synergistic fashion. New research shows there are at least three different endogenous cannabinoids. One of these has been shown to be essential for suckling in newborn rat pups. If the action of the cannabinoid is blocked with an antagonist drug, the newborn pups do not suckle and thus die. Therefore, not only is the internal cannabinoid system important for pain control but it also regulates important appetite areas in the brain that are essential for life in newborn mammals.

Later in the morning, Dr. David Bearman provided a historical review of medical cannabis that has been used as medicine for thousands of years. Dr. Rick Musty reviewed the studies that showed pain relief with cannabinoids in patients with multiple sclerosis. Dr. Juan Sanchez-Ramos talked about how cannabinoids might help some persons with movement disorders such as Parkinsons disease.

Dr. Donald Abrams discussed his odyssey of having to spend years trying to study cannabis in persons with AIDS/HIV. The federal government blocked his study on the possible benefit of cannabis until he changed his study around to look for the bad effects rather than the good effects of cannabis. In spite of this federal stonewalling that lasted for years, Dr. Abrams finally completed a study and published it last year showing that smoking cannabis has no negative effect on the immune system of persons with AIDS and actually helps patients improve appetite and gain weight. He is looking forward to more clinical studies to include using cannabis for pain management in persons with prostate cancer and breast cancer whose cancer has spread to the bones.

Dr. Stuart Rosenblum, the director of the Legacy Emanuel Pain Clinic in Portland, reviewed clinical case studies from Oregonians who are participating in the Oregon Medical Marijuana Act (OMMA) and who volunteered to fill out questionnaires and pain diaries. Dr. Rosenblum reported, Patient comments emphasize efficacy and functional improvement. Dr. Wenner from Hawaii also discussed positive clinical experience with more than 250 patients in Hawaii.

At lunch, Oregon State Health Officer, Dr. Grant Higginson, discussed The Oregon Medical Marijuana ActThree Years of Experience. He reported there are currently some 3003 patients and 628 doctors participating in the OMMA. The average age of the patients is 46 years old and most are men. The most common reason for using cannabis in Oregon is to control pain.

In the afternoon, the editor of Journal of Cannabis Therapeutics, Dr. Ethan Russo, and other researchers discussed a study in which they looked at the effects of cannabis on four patients who have been using cannabis daily for many years under the now-discontinued federal Investigational New Drug (IND) trials. Three of the four patients attended the conference and told their stories. One of the patients has smoked 10 joints (7 to 9 grams of cannabis) daily for 31 years and the other two have used cannabis medically for nearly as long. Sadly, George Bush (the elder) shut the program down to new applicants in 1992 because there were too many applicants. Dr. Russos conclusion is that cannabis works for pain, spasms, and reducing eye pressure while the major risk is some inflammation of the airways. No evidence of liver damage, kidney damage, brain damage, or malignancy has been found. The authors strongly encouraged our federal government to re-open the IND program for sick and dying persons.

On Saturday May 4, persons from Hawaii, California, and Colorado discussed the state programs. The Hawaii program is the only program in the country that was created by the legislature and governor and it was modeled after the OMMA. Like Oregon, all the other states with medical marijuana programs had to bypass an ignorant or uncompassionate legislature and governor who forced the citizens to seek justice through the Initiative process.

Oregon patients under the OMMA told their stories at the conference reporting on the benefit they receive and the improvement they seek in the laws. Medical cannabis providers from Oregon, Washington, California, and British Columbia also spoke on issues of access to medical cannabis for patients. Interestingly, the Americans uniformly described our federal government as the major obstacle for patient access to medical cannabis; while the speaker from British Columbia praised her federal government and said that in Canada, it is the doctors who slow down federal political gains. Dr. Mark Ware from Quebec discussed Canadian clinical trials of Cannabis for chronic pain. He confirmed that by the time that patients got to pain clinics a significant percentage have already tried cannabis. Doctors are taught that cannabis is not medicine so tend not to ask if the patient is using cannabis to control pain. Our medical educators need to get with the program. He also confirmed that there is no causal relationship between cannabis smoking and the development of head and neck cancer. The positive image of the Canadian federal government depicted by its citizens contrasted dramatically with the endless condemnation of the US drug policy by all American participants.

Dr. Geoffrey Guy, founder of GW Pharmaceuticals in the UK, spoke on matching medicinal cannabis strains with symptoms. His company is testing cannabis extracts that are higher in THC and lower in cannabidiol versus extracts that are lower in THC and higher in cannabidiol versus extracts that have an equal THC to cannabidiol ratio. This is some of the most exciting research headed our way because under-the-tongue spray preparations are currently undergoing clinical trials in the UK and may be on the market next year, plus GW Pharmaceuticals is committed to using a whole plant extract rather than synthetic products.

I have concerns that if the only products available to patients are synthetics then there may be an escalation of the War on Drugs aimed at cannabis, sick patients and their doctors (see my article in the Fall 2000 issue of Alternatives)

Using medical herbs as an alternative to medical pharmaceuticals must be a patients choice. Having many preparations of therapeutic agents to tailor therapy is good but patients should not be arrested for using the politically incorrect medi-cine. Right now, in spite of polls showing that most Americans support allowing patients medical access to cannabis, the major health risk of using marijuana in the US is being arrested. This is inhumane in a civilized society. Period.

Dr. Audra Stinchcomb from the University of Kentucky shared interesting research on the transdermal (skin) patch. The good news is that the American Cancer Society funded her study to deliver a cannabinoid through a patch but the bad news is the research has just started on lab animals and human trials may be years away.

Dr. Sumner Burstein, from the University of Massachusetts, discussed very early research on a synthetic cannabinoid called ajulemic acid or CT3. He has removed the section of the THC molecule that causes psychoactivity (the high). His reports in mice indicate it is equivalent to morphine in pain control but has no psychoactive effects and it is equally effective as the potent anti-inflammatory medicine, indomethacin (Indocin). To have a drug that would control pain like morphine, cool off joints without the bleeding risk of most anti-inflammatory drugs, and still allow one to drive a car or work crossword puzzles sounds almost too good to be true. My recommendation is to be cautiously optimistic and stay tuned.

Finally, Professor Mathre moderated a panel for questions and answers.

This conference shows what can happen when health care professionals and others apply the same risk-benefit analysis to cannabis and cannabinoids that we apply to other medicines, whether complex herbs or space-age designer drugs. Ideally, if everyone was in the same business to practice safe medicine and protect consumers/patients, we could use science to break through the bigotry and propaganda that clouds all herbal drug discussion but especially the medical use of the ancient herb cannabis.

There will never be enough information to satisfy some people. Some persons will always oppose medical access to cannabis for reasons unrelated to science. This includes those who are committing senseless violations of constitutional rights while enriching the huge drug testing industry. This includes most law enforcement and the prison industrial complex, which has become a major political force and needs a steady stream of customers (prisoners) to satisfy its profit quota driven by shareholder expectations. Private industry entering the prison business is especially scary.

But most of all, this includes the barbarians in the current Bush Administration such as Attorney General Ashcroft and his cronies at the Drug Enforcement Administration (DEA) and the Office of National Drug Control Policy (ONDCP). Doesnt US Justice, DEA, and ONDCP have better things to do than raid medical cannabis clubs in California, take medicine from dying and suffering patients, block medical research, convolute administrative rules concerning controlled drugs and threaten doctors? Their War on Drugs is a war on good American citizens whose crime is illness and it must stop. Americans must stand up for our fellow citizens who are chronically and terminally ill. This is an issue of personal choice for them and, after all, we may be sick someday and want the same choices available to us. In spite of the harsh reality of the War on Drugs and the War to Make Money, common sense must prevail and patient advocacy must come first.

Dr. Bayer is board-certified in internal medicine, a fellow in the American College of Physicians American Society of Internal Medicine, and practiced in Lake Oswego for many years. He is co-author of Is Marijuana the Right Medicine For You? A Factual Guide to Medical Uses of Marijuana. He was a chief petitioner for the Oregon Medical Marijuana Act in 1998 and manages the website www.omma1998.org that includes a medical bibliography with referenced scientific books and articles on medical use of cannabis and cannabinoids.

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