Positive Sativex® Study Confirms Long Term Efficacy in MS Neuropathic Pain

08/09/2008

Results Support Designof Ongoing Phase III MS Spasticity Study

Porton Down, UK, 8 September 2008: GW Pharmaceuticals plc (GWP:AIM) announces positive results from a placebo-controlled “randomized withdrawal” study of Sativex® in patients with neuropathic pain due to Multiple Sclerosis (MS). This study design is described by regulators as being sufficient to satisfy the need for long-term efficacy data.

This randomized withdrawal study evaluated 42 MS patients with central neuropathic pain who had previously been in a Sativex Phase III MS neuropathic pain study and who continued to take Sativex on an open label basis for 12 weeks. They were then randomized to Sativex or placebo for a further 4 weeks in a double-blinded manner. During the randomized period, patients were not permitted to adjust their dose. The purpose of this blinded 4-week “randomized withdrawal” study was to assess the maintenance of pain control in patients who remain on Sativex versus those who switch to placebo.

In the patients who were randomized to Sativex pain scores remained stable. In the patients randomized to placebo, pain and sleep scores deteriorated. The prospectively defined primary efficacy endpoint of the study - the time to treatment failure - was statistically significantly in favour of Sativex (p=0.036). The difference between Sativex and placebo was also significant for mean pain score (p=0.028) and sleep quality (p=0.015). The results of all other symptom-related endpoints showed that Sativex patients maintained or improved their response whilst the symptoms of those who switched from Sativex to placebo worsened in the 4 weeks following cessation of active treatment. During the randomized withdrawal period, there were 2 patients with adverse events on Sativex, and 5 on placebo. One patient on placebo withdrew from the study. There was no evidence of any withdrawal syndrome.

Until now, all the evidence for long-term maintenance of efficacy of Sativex has come from long-term open-label exposurei. The results reported today confirm in the context of a placebo-controlled double-blind study that efficacy is indeed maintained in long-term use.

The results of this study are of further significance to GW since the design bears important similarities to the ongoing Phase III MS spasticity study requested by the UK regulator prior to granting approval for Sativex. This ongoing Phase III study involves all patients receiving Sativex for 4 weeks, following which Sativex responders are randomized to continue on Sativex or switch to placebo for a further 12 weeks. This study is due to report results in Q1 2009 with a regulatory submission targeted for H1 09.

Dr Stephen Wright, GW’s R&D Director, said: “This is the first placebo-controlled study showing that Sativex provides long term efficacy for MS patients with neuropathic pain and supplements previously published open-label studies. In addition, these results support the design of the ongoing Phase III trial in MS spasticity. It is encouraging to note that if the difference between Sativex and placebo achieved in the results today are replicated in the ongoing Phase III MS spasticity study, this Phase III study will meet its objectives.”

Enquiries:

GW Pharmaceuticals plc (Today) + 44 20 7831 3113
Dr Geoffrey Guy, Executive Chairman (Thereafter) + 44 1980 557000
Justin Gover, Managing Director

Financial Dynamics + 44 20 7831 3113
David Yates / John Dineen



Notes to Editors

About GW
GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular pain and other neurological symptoms. GW has assembled a team of over 100 scientists with extensive experience in developing both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field.

iRog DJ et al. Clinical Therapeutics. 2007; 29: 2068-2079

Can Cannabis Compounds Slow The Progression Of Multiple Sclerosis?

ScienceDaily (July 21, 2008) — The CUPID (Cannabinoid Use in Progressive Inflammatory brain Disease) study at the Peninsula Medical School in Plymouth has reached an important milestone with the news that the full cohort of 493 people with multiple sclerosis (MS) has been recruited to the study.


CUPID is a clinical trial which will evaluate whether tetrahydrocannabinol (THC), one of many compounds found in the in the cannabis plant (and the main active ingredient) is able to slow the progression of MS.

This is an important study for people with MS because current treatments either target the immune system in the early stages of MS, or are aimed at easing specific symptoms such as muscle spasms or bladder problems. At present there is no treatment which slows progression of the disease.

The CUPID trial follows an earlier study -- Cannabinoids and Multiple Sclerosis (CAMS) -- which suggested a link between THC and the slowing of MS. The CAMS trial saw participants take THC for a year -- the CUPID trial will last for longer and aims to assess the effect of THC on progressive MS.

It has taken two years to recruit the 493 participants who will each take part in the trial for three years, and in some cases three and a half years. After data cleaning and analysis the results should be available by spring/early summer 2012.

Professor John Zajicek from the Peninsula Medical School, who heads the team carrying out the CUPID study, said: "We are delighted to have achieved the correct number of patient participants for this trial. Patients have been recruited from 27 sites across the UK. If we are able to prove beyond reasonable doubt the link between THC and the slowing down of progressive MS, we will be able to develop an effective therapy for the many thousands of MS sufferers around the world."

The CUPID trial is funded by the Medical Research Council, the Multiple Sclerosis Society and the Multiple Sclerosis Trust.

Chris Jones, chief executive of the MS Trust, commented: "The MS Trust is delighted to be supporting this study on behalf of people with MS. The ability to halt progression in MS is what we dream of - the Holy Grail for those whose condition deteriorates year on year. This study should give us the definitive answer as to whether cannabinoids will prove to be such an agent."

Dr Laura Bell, research communications officer for the MS Society, said: "People affected by MS are keen to know whether there's any truth in the suggestion that elements of the cannabis plant can help ease the symptoms and slow down progression of the condition.

"The MS Society is supportive of safe clinical trials investigating the medicinal properties of cannabis and it's great news that this trial is going ahead. We look forward to the results of this exciting study."

Adapted from materials provided by The Peninsula College of Medicine and Dentistry, via EurekAlert!, a service of AAAS.

Marijuana ups MS problems

[Posted: Fri 15/02/2008]

People with multiple sclerosis (MS) who smoke marijuana are more likely to have emotional and memory problems, the results of a new study indicate.

Around 6,000 people in Ireland have MS, which affects the brain and the spinal cord. There is currently no cure and the condition is characterised by a slowly progressing disablement.

According to the Canadian researchers, these findings are important because a ‘significant minority’ of people with MS smoke marijuana as a treatment for the disease, ‘even though there are no scientific studies demonstrating that it is an effective treatment for emotional difficulties’.

The study involved 140 people with MS. Of these, 10 had smoked marijuana within the last month and were considered current users. They were compared to people with MS who did not smoke marijuana.

The participants were evaluated for emotional problems and psychiatric disorders, including depression and anxiety. They were also evaluated in other areas such as speed at processing information and memory.

The researchers found that marijuana smokers performed 50% slower in information processing tests, compared to MS patients who did not smoke marijuana.

There was also a significant link between smoking marijuana and emotional problems such as depression and anxiety,

“Since marijuana can induce psychosis and anxiety in healthy people, we felt it was especially important to look at its effects on people with MS. This is the first study to show that smoking marijuana can have a harmful effect on the cognitive skills of people with MS”, said lead researcher Dr Anthony Feinstein of the University of Toronto.

Details of these findings are published in the medical journal, Neurology.

Farmers Can Grow Their Own Marijuana, Says New Mexico's New Law

By Samantha Beck
Published Jul 04, 2007

New Mexico isn't the first state to allow medicinal marijuana to be legally grown on state soil-eleven other states, including Alaska, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Rhode Island, Vermont and Washington-have legalized the plant.

Although Maryland doesn't have a law that protects patients using medicinal marijuana from jail, if a judge can be convince that the defendant needed it out of medical necessity, that person will be kept out of jail. A bill regarding medical marijuana was recently vetoed by Connecticut's governor.

In all 50 states, distributing and using marijuana for recreational purposes are illegal.

New Mexico's marijuana law was passed in March and signed by Gov. Richardson, who is currently running under the Democrat ticket for the presidential nomination.

Though marijuana has been legalized for medical purposes in other states, New Mexico is the only state to officially license workers and facilities to grow marijuana.

The state will have to contact its Dept. of Health by Oct. 1 to receive official licensing to give to both marijuana farmers and in-state growing facilities and issues guidelines for a distribution system.

With that in mind, New Mexico's Attorney General Gary King was contacted by the state health department to determine whether state workers could be prosecuted under federal law for running a medicinal marijuana registry and licensing marijuana farmers and facilities.

Proceeding with care, the health department will be taking the whole process step by step as no other state that has legalized medicinal marijuana is involved in the production of it.

The main reason for legalizing the other otherwise illegal drug is to provide a safe way for ill patient to get their supply, one that doesn't involve drug dealers or growing their own.

Until New Mexico has finalized their plans for producing marijuana, patients in need of the drug must get themselves. Also, the state will start collecting applications from patients whose doctors sign off on the marijuana program.

Once approved, the patients or their caretakers will receive a card certifying that they are allowed to carry up to six ounces on their persons and have four mature plants and three immature seedlings. The health department says that's enough for a three-month supply.

The new law allows the use of marijuana to quell symptoms associated with cancer, epilepsy, glaucoma, multiple sclerosis, and HIV-AIDS.

State to let patients grow their own pot

By DIANA DEL MAURO | The New Mexican
June 28, 2007

When lobbyists rallied this year at the Roundhouse to legalize medical marijuana, they distinctly said patients wouldn’t be growing this mind-altering herb. Rather, the state Health Department would create a secure production and distribution system — the first state to do so.

After years of failed attempts, the measure won approval, making New Mexico the 12th state with such a law.

Now, as the law is about to go into effect Sunday, the message has changed. In a surprise move Thursday, the Health Department unveiled a provision that allows patients to grow a limited number of marijuana plants with protection from state prosecution.

That angered the law-enforcement community. Jim Burleson, director of the state sheriffs’ and police association, said having individual growers in the state could be a big problem.

“If a person is growing their own (marijuana), there is no quality control and no quantity control — and it’s absolutely contrary to what was discussed at the (legislative) session,” he said.


Also, it “sets up” patients for a high amount of scrutiny from federal law-enforcement agencies, he added. Using or distributing marijuana is illegal under federal law, and state law cannot protect violators from federal prosecution.

The Health Department says qualified patients and caregivers may cultivate as many as four mature marijuana plants and three immature marijuana seedlings. The rule also gives the Health Department the power to audit the number of plants at a patient’s home, said Dr. Steve Jenison, the program’s medical director.

Jenison said even if a state-licensed production and distribution system is put in place, patients would still have the option to grow marijuana plants at home.

Jenison said the Health Department decided to allow patients to grow pot because a state-run system could be months in the making, if it happens at all. Under the new law, the Health Department is supposed to issue rules about developing the production and distribution system by Oct. 1.

Because of a potential conflict between state and federal law (the federal government still views marijuana as an illicit drug that has no medicinal properties), the Health Department is seeking advice from the Attorney General’s Office for the best way to carry out that aspect of the new law.

“We cannot proceed ... until we have a better understanding of the legal implications,” Jenison said.

Burleson was unaware of this development until the Health Department issued a news release about the Medical Cannabis Program on Thursday. Though the Health Department invited various law-enforcement associations to planning meetings about how to implement the new law, most refused to participate.

Burleson said the association’s lawyer warned against taking part in the planning sessions, “lest we be considered co-conspirators in distributing a controlled substance.”

Jenison said the Health Department won’t give patients information on where to obtain seeds or plants or how to grow marijuana.

But Burleson asks, “Where is the first seed or plant going to come from? That’s going to be the first illegal act.”

Patients who don’t want to grow marijuana must find a way to obtain their medicine on the black market — at least for now. Patients and caregivers on the state’s registry can possess up to 6 ounces of marijuana and be protected from state prosecution, as long as they don’t use it fraudulently.

“This program is about providing much-needed relief for New Mexicans suffering from debilitating diseases,” Dr. Alfredo Vigil, the new health secretary, said in a news release. “We will also monitor the use of medical marijuana and prevent abuse.”

The law is limited to people with conditions such as cancer, HIV-AIDS, glaucoma and multiple sclerosis.

Contact Diana Del Mauro at 986-3066 or dianadm@sfnewmexican.com.


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Copyright 2007 The New Mexican, Inc.

Medical pot bill passes; foes urge more legislation

RACHEL LA CORTE
The Associated Press

The state House late Wednesday passed a measure clarifying the state's medical marijuana law and addressing supply issues, but medical marijuana advocates and patients opposed to the measure argue it does nothing to help them.

The measure, which was passed on a 64-30 vote, requires the state Department of Health to determine the quantity of marijuana that could reasonably be considered a 60-day supply. The bill passed the Senate last month, but because it was amended in the House, it must go back to the Senate for concurrence.

Steve Sarich, executive director of CannaCare, a medical marijuana advocacy group, said that doctors - not the state - should determine the supply a patient needs.

"Does the state determine how many birth control pills you take, or how much Percocet you need?" he asked.

Initiative 692 passed with 59 percent voter approval in 1998. It gives doctors the right to recommend - but not prescribe - marijuana for people suffering from cancer, AIDS, multiple sclerosis, glaucoma and other conditions that cause "intractable pain."

But state law limits the amount of marijuana an individual can possess for medical use to a 60-day supply. People found with marijuana still can be arrested, but if they prove it's for medical purposes they can avoid being charged with a crime in the state system. That does not protect them from federal prosecution, however.

But Sarich said the bill is lacking.

"This bill provides no significant protection for patients whatsoever," he said.

The measure also would require the Health Department to come up with recommendations on how the state can provide safe access to marijuana for patients and present those suggestions to the Legislature in July 2008.

Sarich said he and others were upset that key elements of the original bill were removed in the Senate, including a provision that would have allowed cooperative growing operations. Senate Bill 6032

New Mexico approves medical use of marijuana

Mon Apr 2, 2007 7:22PM EDT

ALBUQUERQUE, New Mexico (Reuters) - New Mexico doctors are allowed to prescribe marijuana to help some seriously ill patients manage symptoms including pain and nausea under a bill signed into law by Gov. Bill Richardson on Monday.

"This law will provide much-needed relief for New Mexicans suffering from debilitating diseases," Richardson said at the signing ceremony. "It is the right thing to do."

The southwestern state is the 12th in the United States to endorse the use of marijuana for medical uses. New Mexico's state legislature is the fourth in the country to enact such a measure.


The law allows marijuana use by patients suffering from several conditions, such as HIV/AIDS, cancer, glaucoma, and multiple sclerosis and epilepsy, according to a news release from Richardson's office.

Californians voted to allow use of medical marijuana in 1996. In 1978, New Mexico began allowing very limited use of marijuana, or its active ingredient, THC, to help control cancer patients' nausea and vomiting caused by chemotherapy, but only when other nausea-control drugs failed.

The law creates a panel of eight expert physicians and other health care workers to supervise the program. Qualified patients must be under a doctor's care and supervision, the news release said.

"I would like to thank the governor for ... giving me another shot at life," said Essie DeBone, who suffers from advanced complications from HIV/AIDS.


© Reuters 2007. All rights reserved.

New Mexico Medical Marijuana Law Sets Stage for Drive in Congress

Presidential Candidate Richardson Signs 12th Medical Marijuana Law

WASHINGTON, D.C. — Today's signing of the nation's 12th state medical marijuana law by New Mexico Gov. Bill Richardson (D) will jump-start efforts to reform federal policy on medical marijuana, advocates said today. The signing comes in the wake of new research further documenting marijuana's medical value.

New Mexico now joins Alaska, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Rhode Island, Vermont and Washington in protecting medical marijuana patients from arrest. Richardson, a candidate for the Democratic presidential nomination, actively lobbied for the bill's passage.

"Governor Richardson's action is the clearest sign yet that the politicians are finally catching up with the people on the issue of medical marijuana," said Aaron Houston, director of government relations for the Marijuana Policy Project (MPP) in Washington, D.C. "Support for medical marijuana is overwhelming — 78 percent in a national Gallup poll — and backing from the medical community is solidifying as new research continues to document marijuana's medical benefits. Support in Congress keeps growing, and this could be the year the federal government finally ends its cruel attacks on the sick in states where medical marijuana is legal."

MPP is working closely with other organizations and supportive members of Congress to pass an amendment to end federal medical marijuana raids in states with medical marijuana laws. Former Republican Congressman Bob Barr of Georgia recently joined MPP's lobbying effort.

A University of California study published in the Feb. 13 issue of the journal Neurology found that marijuana effectively relieved a type of severe nerve pain that afflicts hundreds of thousands with HIV/AIDS, and is similar to the type of pain experienced by many patients suffering from multiple sclerosis, diabetes, and other illnesses. A wide variety of medical and health organizations support legal access to medical marijuana, including the American Public Health Association, American Nurses Association, American Academy of HIV Medicine, and Lymphoma Foundation of America.

With more than 21,000 members and 100,000 e-mail subscribers nationwide, the Marijuana Policy Project is the largest marijuana policy reform organization in the United States. MPP believes that the best way to minimize the harm associated with marijuana is to regulate marijuana in a manner similar to alcohol. For more information, please visit www.MarijuanaPolicy.org.

Date: 4/2/2007

House rejects bill to legalize medical use of marijuana

Barry Massey | The Associated Press
March 9, 2007

A proposal to legalize the medical use of marijuana failed Thursday in the House, dashing hopes of advocates who had picked up the support of Gov. Bill Richardson for the measure.

The Senate previously had approved the proposal, and it would have gone to the governor had it cleared the House. Richardson had said he would sign the proposal into law.

But the House narrowly rejected the bill, with 36 voting against it and 33 supporting it.

Opponents disputed that marijuana was an effective medicine. "Medically it just really has no value. For us to approve a drug like this tells our children and tells the rest of the people in this state that we, somehow as leaders, give tacit approval to the use of this drug," said Rep. John Heaton, D-Carlsbad and a pharmacist. "That is absolutely wrong for us to do."

He described marijuana as "the No. 1 gateway drug to abusing other drugs in our society."




The proposal would have allowed the use of marijuana for pain or other symptoms of debilitating illnesses such as cancer, glaucoma, epilepsy, multiple sclerosis, HIV-AIDS and certain spinal-cord injuries.

Supporters said marijuana could help patients who don't respond to other treatment, such as an individual who suffers from nausea because of treatments for cancer.

"If it offers one person ... the pain relief or the help they need, who are we in this body to say no?" said House Republican Whip Dan Foley of Roswell.

Under the legislation, the Health Department would establish a system for patients to obtain marijuana.

A doctor or other health-care provider would certify to the agency that someone suffers from a qualifying illness.

Patients could not grow marijuana, as in some states that have legalized medical marijuana.

The department would have been responsible for licensing marijuana providers who would produce it in "facilities within New Mexico housed on secured grounds."

Opponents of the bill said marijuana remains illegal under federal law, and patients in New Mexico could be subject to potential federal prosecution.

But Rep. Antonio "Moe" Maestas, D-Albuquerque, said it was the legal responsibility of the state to regulate the practice of medicine within its boundaries. "I think these issues are better left to local practitioners and ill patients than federal bureaucrats," he said.

Initially, the bill failed on a 33-33 tie vote. However, lawmakers immediately reconsidered, and then the measure failed 33-36.

Despite the House vote, advocates vowed to continue their efforts.

"We'll try it till it gets through. We're not going to give up on the state's patient community," said Erin Armstrong, a 25-year-old cancer victim after whom the legislation was named.

"This is a matter of compassion. It's a very personal matter," said Patty Jennings, the wife of Sen. Tim Jennings, D-Roswell.

She is battling cancer and taking morphine, which she said is much more powerful and dangerous than marijuana would be. "People who are not there don't always understand that we're asking ... to have all the options available to us."

Unless states are willing to step forward and challenge the federal government on the issue, the federal policy will never be changed, she said.

The medical marijuana bill is Senate Bill 238.

Cannabis Based Medicine (Sativex®) Relieves Spasms And Stiffness In People With Multiple Sclerosis

Today, a leading neurology journal - European Journal of Neurology (EJN) reports a study1 which shows that Sativex, a cannabis based medicine, significantly reduces intractable spasms and stiffness (spasticity) in people with Multiple Sclerosis (MS).

Spasticity is one of the most common symptoms of MS, occurring in up to 84% of patients1. Spasticity can severely impact quality of life and is one of the most difficult symptoms of MS to treat1.

The study, a randomised, double-blind trial, led by Professor Christine Collin from the Royal Berkshire and Battle NHS Trust, Reading, UK, saw Sativex or placebo added to existing anti-spasticity medication. Sativex demonstrated significant superiority to placebo in reducing spasticity (p<0.05). Further, the addition of Sativex produced a more than 30% improvement in spasticity in 40% of the people treated1.

Fern Andrews, a person with MS who has participated in clinical trials with Sativex, commented: "Spasticity can make the simple daily activities that most people take for granted, seem daunting. Just dressing and moving around the home can be difficult and I often have to rely on a carer for support. With Sativex, I'm able to choose how much I take depending on how bad my symptoms are - which is a real benefit".

Christine Jones, Chief Executive of the MS Trust said, "Effective relief of spasticity is extremely important to people with MS. Spasticity and muscle spasms are not only distressing and painful, they can have a negative impact on quality of life. The results of this study add to the growing body of evidence that cannabis-based medicines can be effective in helping to relieve this common symptom of MS."

About the study published in the European Journal of Neurology:

The six week study was conducted in 189 MS patients, all of whom were experiencing significant levels of spasticity and had failed to gain adequate relief from currently available anti-spasticity medications. Patients enrolled in the study continued to take their existing medication throughout the trial1.

Sativex®:

Sativex (THC:CBD), an endocannabinoid system modulator, is derived from whole plant extracts of two specifically bred cannabis plant varieties. The extracts are combined to produce a standardised formulation containing two major components of cannabis, the cannabinoids D9-tetrahydrocannabinol (THC) and cannabidiol (CBD).

Sativex is formulated into a pump action oromucosal (mouth) spray designed for self-administration by the patient This formulation allows for flexible dosing, ideal for the variable nature of MS. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD. Sativex was generally well tolerated in the study.

Sativex has been developed by UK-based GW Pharmaceuticals plc. It is approved as a prescription medicine in Canada for the symptomatic relief of neuropathic pain in adults with MS. Sativex is currently being reviewed by European regulatory authorities for the symptomatic relief of spasticity in MS and, on approval, will be exclusively marketed by Bayer HealthCare in the UK.

Spasticity:

Spasticity results from more than one group of muscles contracting incorrectly, causing spasms or stiffness. Spasms are uncontrollable muscle contractions and can be painful. They can be a particular problem at night causing disruption of sleep. Limbs may shoot away or bend upwards towards the body and severe spasms may make the back arch off the bed or chair.

Stiffness of the limbs is common and can make it difficult to perform normal activities, particularly delicate movements of the hand and fingers. If the leg muscles are affected it can make walking difficult. Pain can be associated with spasticity. Current treatments are often only partially helpful.

About Bayer HealthCare:

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The Pharmaceuticals division, Bayer Schering Pharma AG, comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology, Primary Care, and Oncology. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases. http://www.bayerhealthcare.com

About GW Pharmaceuticals plc:

GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop non-smoked cannabis-based prescription medicines. GW's shares are publicly traded on AiM, a market on the London Stock Exchange.

GW's clinical research program is being carried out by a team of pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems. http://www.gwpharm.com

References:

1. Collin C et al. Randomised controlled trial of cannabis based medicine in spasticity caused by Multiple Sclerosis. European Journal of Neurology, March 07

Group sues feds over medical marijuana claims

LISA LEFF
Associated Press

OAKLAND, Calif. - Armed with a new study that showed smoking marijuana eased pain in some HIV patients, medical marijuana advocates sued the federal government Wednesday over its claim that pot has no accepted medical benefits.

The lawsuit filed in U.S. District Court by Americans for Safe Access accuses the U.S. Department of Health and Human Services of engaging in "arbitrary and unlawful behavior" that prevents "sick and dying persons from seeking to obtain medicine that could provide them needed, and often lifesaving relief."

The Oakland-based advocacy group wants a judge to force the department and the Food and Drug Administration to stop giving out information that casts doubt on the efficacy of marijuana in treating various illnesses.

"The FDA position on medical cannabis is incorrect, dishonest and a flagrant violation of laws requiring the government to base policy on sound science," Joe Elford, chief counsel for Americans for Safe Access, said in a statement.

California is one of 11 states where marijuana use is legal for people with a doctor's recommendation, but because the U.S. government does not recognize pot's medical benefits patients can still be arrested and prosecuted by federal authorities.

Last week, researchers from the University of California, San Francisco reported in the journal Neurology that a test involving 50 HIV patients showed that those who smoked pot experienced much less pain than those given placebos.

Americans for Safe Access said in the lawsuit that Health and Human Services has rejected its requests to retract the assertion that cannabis "has no currently accepted medical use in treatment in the United States," a position the agency has advertised since 2000.

Countering that statement by petitioning the government and distributing evidence that marijuana eases the symptoms of cancer, multiple sclerosis, HIV and other conditions has cost Americans for Safe Access more than $100,000, the group said in its suit.

The Department of Health and Human Services did not immediately have a response to the lawsuit.

ON THE NET

http://www.safeaccessnow.org