SACRAMENTO, Calif. – The first U.S. clinical trials in more than two decades on the medical benefits of marijuana confirm pot is effective in reducing muscle spasms associated with multiple sclerosis and pain caused by certain neurological
injuries or illnesses, according to a report issued Wednesday.

Igor Grant, a psychiatrist who directs the Center for Medicinal Cannabis Research at the University of California, San Diego, said five studies funded by the state involved volunteers who were randomly given real marijuana or placebos to
determine if the herb provided relief not seen from traditional medicines.

“There is good evidence now that cannabinoids may be either an adjunct or a first-line treatment,” Grant said at a news conference where he presented the findings.

The California Legislature established the research center in 2000 to examine whether the
therapeutic claims of medical marijuana advocates could withstand scientific scrutiny. In 1996, state voters became the first in the nation to pass a law approving pot use for medical purposes.

Thirteen other states have followed suit, but California is the only one so far to sponsor
medical marijuana research. After 10 years and nearly $9 million, the Center for Medicinal
Cannabis Research is preparing to wrap up its work next year.

Along with the studies on muscle spasms and pain associated with spinal cord injuries and AIDS, the center also has funded research on how marijuana effects sleep and driving, limb pain due to diabetes, and whether inhaling vaporized cannabis is as effective as smoking it.

A laboratory study supported by the center examined if pot could be helpful in treating
migraine headaches and facial pain. In that study, rats given a cannabis-like drug exhibited reduced activity of nerve cells that transmit pain.

State Sen. Mark Leno, a San Francisco Democrat who chairs a budget subcommittee on health and human services and supports medical marijuana, said he doubted there would be more financial support for the center, given California’s ongoing budget crisis.

The federal government classifies marijuana as an illicit drug with no medical use but produces the only pot legally available for scientific research under a contract with the University of Mississippi.

Grant said obtaining some of the Mississippi crop and meeting the complex security regulations required by the Drug Enforcement Agency and other federal agencies was time-consuming and cumbersome.

Grant, however, had no problem with the quality of the government’s supply. Its consistency was helpful in determining that patients who smoked less-potent marijuana enjoyed the same amount of pain relief but less mental confusion than those
who inhaled a more powerful strain, he said. Such quality control is notably absent from the marijuana that patients with a doctor’s recommendation can legally obtain in California through hundreds of cooperatives and storefront dispensaries, Grant said.

He said more research was needed on how pot works and its side effects.

“Because we don’t know the composition of the strains that are on the street, we don’t know what patients really are getting,” he said. “As a doctor I feel some discomfort when someone says take X or Y pill or herb because we think that might be helpful.”

Since its founding, the center has approved 15 research studies, but five had to be discontinued because there were not enough volunteers willing or able to meet the criteria for participating.

One proposed study on the effectiveness of marijuana in reducing chemotherapy-related nausea was canceled because researchers could not recruit enough cancer patients who weren’t already treating their symptoms effectively with anti-nausea medications.

In the 24-page report submitted Wednesday to the Legislature, Grant said research protocols had been rigorous, with six studies published or accepted for publication in peer-reviewed science journals.

In four studies, participants suffering from multiple sclerosis, AIDS or diabetes, along with
healthy volunteers injected with a chili pepper substance to induce pain, were randomly assigned to receive cigarettes filled with marijuana. Half had the active ingredient
delta-9-tetrahydrocannabinol, or THC, removed.

Not every patient who smoked the real marijuana reported improvement. But the percentage who did was comparable to those who said they experienced relief from antidepressants and other medications commonly prescribed for neuropathic pain, the
study said.

We are reporting improvement of symptoms of schizophrenia in a small group of patients who received the cannabinoid agonist dronabinol (synthetic Delta-9-tetrahydrocannabinol). Before this report, cannabinoids had usually been associated with worsening of psychotic symptoms. In a heuristic, compassionate use study, we found that 4 of 6 treatment-refractory patients with severe chronic schizophrenia but who
had a self-reported history of improving with marijuana abuse improved with dronabinol. This improvement seems to have been a reduction of core psychotic symptoms in 3 of the 4 responders and not just nonspecific calming. There were no clinically significant adverse
effects. These results complement the recent finding that the cannabinoid blocker rimonabant does not improve schizophrenic symptoms and suggest that the role of cannabinoids in psychosis may be more complex than previously thought. They open a possible new role for cannabinoids in the treatment of schizophrenia.
PMID: 19440079 [PubMed - in process]

Researchers found that a chemical called cannabidiol (CBD) affects the
activity of a gene known as Id-1 in patients with hormone-independent
breast cancer. In embryos, Id-1 is responsible for helping cells grow and
spread, but is supposed to remain inactive in adults. In human adults, it
is found only in metastatic cancer cells, or cancer cells that are
spreading throughout the body.

“When [the Id-1 genes] wake up, they are very bad,” said senior researcher
Pierre Yves-Desprez. “They push the cells to behave like embryonic cells
and grow. They go crazy, they proliferate, they migrate.”

According to Desprez, shutting off the activity of Id-1 can make cancer
far less lethal. Tumors, Desprez says, can be “removed easily by surgery,”
but if the cancer is spreading then the disease becomes much more
difficult to contain.

“[Id-1 is like] an [orchestra] conductor,” Desprez said. “If you shoot the
violinist, the orchestra just continues to play.”

“In this case, you shoot the conductor, and the whole orchestra is going
to stop,” he said.

Because CBD occurs in only very small quantities in the cannabis plant,
the researchers do not recommend smoking marijuana as a cancer treatment.
To be effective, CBD will either have to be artificially synthesized or
extracted and concentrated.

The chemical’s major advantage, according to the researchers, is its
apparent non-toxicity.

“Right now we have a limited range of options in treating aggressive forms
of cancer,” co-author Sean D. McAllister said. “Those treatments, such as
chemotherapy, can be effective but they can also be extremely toxic and
difficult for patients. This compound offers the hope of a non-toxic
therapy that could achieve the same results without any of the painful
side effects.”

The researchers also expressed hope that CBD will also prove effective
against other cancers that rely on Id-1, including brain, colon and
prostate cancer.

FOR IMMEDIATE RELEASE

CONTACT: Jag Davies — 786-393-8100, jag.davies@gmail.com
or Lady Amanda Feilding — amanda@beckleyfoundation.org

VIENNA, Austria – The Beckley Foundation, a U.N.-accredited NGO,
joined with a diverse coalition of eminent scientists, other NGOs and
political leaders to propose a paradigm shift in cannabis policy as
the U.N. Commission on Narcotic Drugs held a high-level meeting from
March 11-20 to review the past decade of international drug policy
and recommend strategies for future decades.

The Beckley Foundation’s Global Cannabis Commission, comprised of an
international team of leading public health policy experts, presented
the findings of their Report at several meetings in Vienna. The
Conclusions & Recommendations of the Report map out solutions to
break the current stalemate, including a new draft Framework
Convention on Cannabis Control. The Report provides a review of the
issues that must be considered by policymakers in developing
evidence-based cannabis policies that minimize the harms associated
with its use and control. Among its recommendations, the Commission
suggests allowing individual countries the leeway to implement
differing systems of regulation that best suit their individual
needs–even to the point of state production and licensed sale.

As documented in the Cannabis Commission’s Report, cannabis is the
mainstay of the global War on Drugs. The U.N. has estimated that
cannabis is used regularly by 166 million people–4% of the global
adult population, compared to 1% for all other illegal drugs
combined. In the U.S., where 42% of the adult population has used
cannabis, three-quarters of a million citizens are arrested every
year for simple possession. Additionally, in certain producer/transit
countries such as Mexico, where cannabis comprises half of the drug
trafficking market, prohibitionist policies have led to a grim and
growing war.

A decade ago the U.N. issued a declaration outlining its 10-year
global strategy to “eliminate or significantly reduce” all illicit
coca, cannabis, and opium plants from the earth under the motto, “A
drug free world  we can do it!” Yet, the global experience of the
past 10 years has demonstrated that current drug policies have
exacerbated–not abated–violence and health epidemics, while also
causing massive civil and human rights violations. Under current
international norms, anyone who possesses an illegal drug such as
cannabis is treated as a serious criminal–subject to the possibility
of arrest, property seizure, imprisonment, denial of access to public
benefits, such as financial aid for college or welfare, potential
loss of child custody and the ability to get a job. Still, despite
these harsh punishments and a spectacular increase in government drug
control expenditures, drug production and consumption have risen
while drug violence and health epidemics have worsened.

Increasingly, however, members of the international community are
acknowledging the failure of U.S.-style drug prohibition as a model
for global drug policy and have turned toward health-based approaches
more in line with the U.N.’s health and human rights mandates. In the
U.S., alternatives to cannabis prohibition are increasingly becoming
politically viable–three-quarters of citizens think that the drug
war is a failure, thirteen states have passed laws to protect
patients who use medical marijuana, several states have introduced
legislation to follow Massachusetts’ lead by decriminalizing
marijuana, and public support for marijuana legalization is polling
higher than ever.

Although signatories of the international drug control treaties are
formally required to criminalize the production, distribution, sale,
use and possession of cannabis, a number of countries have de facto
adopted less punitive policies. As documented in the Report, reforms
reducing or removing criminal sanctions for the use and possession of
cannabis have been shown not to lead to an increase in the prevalence
of use or harms. Enforcement of such regimes is also vastly more
cost-effective, enabling society to address other pressing issues
more effectively.

“The Report of the Global Cannabis Commission convened by the Beckley
Foundation is a valuable contribution to our thinking on the thorny
subject of illicit drugs … The failure of the ‘War on Drugs’
strategy is quite evident around the world, but the alternatives are
not easy to grasp. We need to change our way of thinking and acting
on this matter. New policies must be based on empirical data, not on
ideological assumptions and dogmas,” said former President of Brazil
Fernando Henrique Cardoso, who has endorsed the Report. Influenced by
the Beckley Foundation Report, last month, Cardoso, along with the
former Presidents of Mexico and Colombia and 17 delegates from nine
Latin American nations, called for a “paradigm shift” in
international drug policy that includes the decriminalization of cannabis.

Although delegates from several countries, in addition to the press
(such as the cover story of last week’s Economist), agree with the
approach of the Beckley Foundation’s Report, the Political
Declaration adopted by U.N. member states earlier this week failed to
even mention cannabis. In addition, to the dissatisfaction of many
countries, the Declaration adopted in Vienna earlier this week
omitted any emphasis on “harm reduction” approaches to the control
and regulation of drugs.

The Global Cannabis Commission Report will be co-published with
Oxford University Press in Spring, 2009. The text of the Report and
new draft Framework Convention on Cannabis Control, as well as
additional background information, are available at:
http://www.beckleyfoundation.org/policy/cannabis_commission.html

Jun 9 2010

Patricia F. Dimond, Ph.D.

http://www.genengnews.com/analysis-and-insight/medical-uses-for-marijuana-no-longer-in-the-weeds/77899328/

In one of the only U.S. clinical trials testing the medicinal properties of inhaled Cannabis sativa, results confirmed that pot was effective in reducing muscle spasms associated with multiple sclerosis and pain caused by certain neurological injuries or illnesses. The trial, sponsored by the California-funded Center for Medical Cannabis Research at the University of California, San Diego (http://www.cmcr.ucsd.edu/), enrolled participants
suffering from multiple sclerosis, AIDS, or diabetes along with healthy volunteers injected with a chili pepper substance to induce pain. They were randomly assigned to receive cigarettes filled with marijuana.

The results were comparable to the percentage of people who experience relief after taking other pain medications. “This is the first step in approaching the [FDA], which has invested absolutely nothing in providing scientific data to resolve the debate,” said state Senator Mark Leno (D. San Francisco).

The U.S. Government spent heavily on the first approved cannabis-based drug, Marinol®, back in 1985. The drug was developed by Unimed, now a subsidiary of Solvay Pharmaceuticals. FDA also approved Valeant Pharmaceuticals’ Cesamet the same year. Both drugs, however, are synthetic versions of one active marijuana constituent, delta-9-tetrahydrocannabinol (ΔTHC.)

The FDA sanctioned Marinol to treat nausea and vomiting associated with chemotherapy in patients who do not respond adequately to conventional medications as well as appetite loss associated with weight loss in AIDS patients. Cesamet, developed as an antiemetic and an adjunct analgesic for neuropathic pain, was not marketed in the U.S. until 2006. It is also approved for use in treatment of anorexia and weight loss in patients with
AIDS.

The distinction between inhaled Cannabis sativa and an approved pharmaceutical hinged, at the time of the drugs’ approval, on separating the psychoactive properties of some of marijuana’s constituents and the medicinal properties of others. A 1999 report commissioned by the The White House Office of National Drug Control stated that “marijuana is not a completely benign substance. It is a powerful drug with a variety of
effects.”

“However, the harmful effects to individuals from the perspective of possible medical use of marijuana are not necessarily the same as the harmful physical effects of drug abuse. Although marijuana smoke delivers THC and other cannabinoids to the body, it also delivers harmful substances, including most of those found in tobacco smoke. In addition, plants contain a variable mixture of biologically active compounds and cannot be expected
to provide a precisely defined drug effect.”

The report went on to conclude that “the future of cannabinoid drugs lies not in smoked marijuana but in chemically defined drugs that act on the cannabinoid systems that are a natural component of human physiology.” The White House commissioned the 267-page report shortly after voters in California passed the Compassionate Use Act of 1996, which legalized the medical use of cannabis under state law.

And on March 18 of this year, GW Pharmaceuticals said that Sativex, its oral mucosal cannabinoid spray, should be approved in the U.K. and Spain soon. Both countries concluded that there are no major quality, safety, or efficacy issues remaining to be resolved. Details about final wording on the patient information leaflet is reportedly all that is left to be ironed out.

A few days later, the company announced Phase IIb results of Sativex in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy. The trial recruited a total of 360 patients in 14 countries in North America, Europe, Latin America, and South Africa and evaluated three dose ranges. Sativex produced statistically significant differences from placebo in pain scores, supporting advancement into Phase III, according to the company.

Beyond Pharmaceuticalization

The emergence of public companies pursuing the development of legalized cannabis products may provide a new crop of useful drugs. On March 24, 2009, Medical Marijuana became the first public corporation solely based on medical marijuana. Bruce Perlowin, the company’s CEO, established the firm as a step toward legitimizing the industry after decades of advocating the benefits of legalizing medical marijuana.

Richard Cowan, Cannabis Science’s CFO, noted that the segment got another boost on May 24 of this year when 15 members of Congress led by U.S. Representative Barney Frank (D. MA) urged the Treasury Department to set rules that encourage banks to provide financial services to medical marijuana clinics, which they consider lawful businesses. “This is just one more important step toward a realistic federal policy on medical marijuana,”
Cowan noted.

A policy that would assure banks that they won’t be targeted for doing business with companies that distribute medical marijuana, would definitely benefit Cannabis Sciences as it buys up experienced growers. On May 24, the company acquired RockBrook, a fully licensed dispensary providing patients in Colorado with medical marijuana as well an experienced grower of medical cannabis in accordance with state laws.

Cannabis Science used to be Gulf Onshore and changed its name after acquiring Cannex Therapeutics. The company is developing products both with and without psychoactive properties to treat disease and the symptoms of disease as well as for general health maintenance. It is looking to partner IND filing and clinical development.

Cannabis Science plans to develop a whole cannabis extract lozenge as its first pharmaceutical product. Initial findings from informal human trials using the whole-cannabis extract demonstrated that it has the capacity to enhance rapid onset pain relief through oral mucosal absorption. The lozenge is a part of the assets and know-how acquired through Cannex.

On June 1, the company said that it was working toward picking up a private company that owned complementary patented intellectual property for specific clinical-stage cannabinoid products and uses.

“It seems inevitable that at least for some period of time there will co-exist two distribution pathways for this medicine,” noted Lester Grinspoon, M.D., emeritus professor of psychiatry at Harvard and long-time advocate for the legalization of marijuana, “first, the conventional model of modern allopathic medicine through pharmacy-filled prescriptions for FDA-approved medicines, and second, a model closer to the distribution of alternative and herbal medicines, where there is little if any quality or
quantity control. Either way, growing numbers of people will become familiar with cannabis and its derivative products.”

As individual U.S. states move toward either legalization of marijuana or approval of its medical use, the new corporate voices are adding to the pro-pot choir. These companies can potentially help advance the political debate by providing the long-needed clinical trials to validate specific medical applications of Cannabis sativa and its constituent compounds.

Separating psychoactive from medicinal properties through “pharmaceuticalization” of marijuana may be unrealistic. According to NIH, Cesamet “has complex effects on the central nervous system. Its effects on the mental state (i.e., “inner mental life”) are similar to those of cannabis. Subjects given Cesamet may experience changes in mood (euphoria,
detachment, depression, anxiety, panic, paranoia), decrements in cognitive performance and memory, a decreased ability to control drives and impulses, and alterations in the experience of reality (e.g., distortions in the perception of objects and the sense of time and hallucinations.”

At least 66 other cannabinoids are also present in cannabis, including cannabidiol, cannabinol, and tetrahydrocannabivarin, which are believed to result in different effects than those of THC alone. Apart from significant difficulties associated with titrating appropriate effective doses, inhaling smoke—which can be avoided through marijuana vaporization—and psychoactive effects, the whole weed may remain the real deal.

Patricia F. Dimond, Ph.D., is a principal at BioInsight Consulting. Email:
drpdimond@genengnews.com.

http://www.genengnews.com/analysis-and-insight/medical-uses-for-marijuana-no-longer-in-the-weeds/77899328/

Volume 362:1453-1457
April 22, 2010
Number 16

Diane E. Hoffmann, J.D., and Ellen Weber, J.D.

http://content.nejm.org/cgi/content/full/362/16/1453

The U.S. legal landscape surrounding “medical marijuana” is complex and rapidly changing. Fourteen states — California, Alaska, Oregon, Washington, Maine, Hawaii, Colorado, Nevada, Vermont, Montana, Rhode Island, New Mexico, Michigan, and most recently, New Jersey — have passed laws eliminating criminal penalties for using marijuana for medical purposes, and at least a dozen others are considering such legislation.

Medical experts have also taken a fresh look at the evidence regarding the therapeutic use of marijuana and the American Medical Association (AMA) recently adopted a resolution urging review of marijuana as a Schedule I controlled substance, noting it would support rescheduling if doing so would facilitate research and development of cannabinoid-based medicine. Criticizing the patchwork of state laws as inadequate to establish clinical standards for marijuana use, the AMA has joined the Institute of Medicine, the American College of Physicians, and patient advocates in calling for changes in federal drug-enforcement policies to establish evidence-based practices in this area.

States have led the medical marijuana movement largely because federal policymakers have consistently rejected petitions to authorize the prescription of marijuana as a Schedule II controlled substance that has both a risk of abuse and accepted medical uses. Restrictive federal law and,until recently, aggressive federal law enforcement have hamstrung research and medical practice involving marijuana. The federal Controlled Substances Act (CSA) classifies marijuana as a Schedule I drug — one with a high
potential for abuse and “no currently accepted medical use” — and criminalizes the acts of prescribing, dispensing, and possessing marijuana for any purpose. Although physicians may recommend its use under First Amendment protections of physician–patient communications, as set forth in the 2002 federal appeals court decision Conant v. Walters, they violate federal law if they prescribe or dispense marijuana and may be charged with
“aiding and abetting” violation of the federal law if they advise patients about obtaining it. A 2005 Supreme Court decision (Gonzales v. Raich) made clear that regardless of state laws, federal law enforcement has the authority under the CSA to arrest and prosecute physicians who prescribe or dispense marijuana and patients who possess or cultivate it.

Nevertheless, in October 2009, the Department of Justice issued a memorandum
to U.S. Attorneys stating that federal resources should not be used to
prosecute persons whose actions comply with their states’ laws permitting
medical use of marijuana. This change in the Justice Department’s
prosecutorial stance paved the way for states to implement new
medical-marijuana laws, and states are now attempting to design laws that
balance concerns about providing access for patients who can benefit from
the drug with concerns about its abuse and diversion. Although the current
state laws facilitate access, they do little to advance the development of
standards that address the potency, quality, purity, dosing, packaging, and
labeling of marijuana.

All the state laws allow patients to use and possess small quantities of
marijuana for medical purposes without being subject to state criminal
penalties. They also allow a patient’s “caregiver” — an adult who agrees
to assist with a patient’s medical use of marijuana — to possess, but
not use, marijuana. Most laws protect “qualifying” patients, who are
variously
defined as those who have received a diagnosis of a debilitating medical
condition and have written documentation (or, in one case, an oral
recommendation) from their physician indicating that they might or would
“benefit from the medical use of marijuana” or that the “potential benefits
of medical use of marijuana would likely outweigh the health risks.”
Definitions of “debilitating medical condition” vary by state (see Table 1)
but typically include HIV–AIDS, cachexia, cancer, glaucoma, epilepsy and
other seizure disorders, severe nausea, severe and chronic pain, muscle
spasms from multiple sclerosis or Crohn’s disease, and other conditions. All
but two states allow additions to this list if approved by the state health
department.

View this table: Table 1. Diseases and Conditions for Which Medical
Marijuana Use Is Permitted According to State Laws. -
http://content.nejm.org/cgi/content-nw/full/362/16/1453/T1

State laws do not regulate marijuana’s quality or potency, and most don’t
address ways of obtaining the drug. Virtually all permit patients or
caregivers to cultivate marijuana. New Jersey’s new law prohibits such
cultivation but provides for the establishment of alternative treatment
centers that will “fill” a physician’s written instruction for a certain
quantity of marijuana. Most laws are silent on whether patients or their
caregivers may buy or sell marijuana or whether dispensaries are permitted
(see Table 2). California permits dispensing through cooperatives or
collectives, but until recently most other states did not — a situation
that is changing with the enactment of some recent laws and amendments.

View this table: Table 2. Variation among State Medical Marijuana Laws. -
http://content.nejm.org/cgi/content/full/362/16/1453/T2

Most of the statutes also limit the amount of marijuana that patients or
caretakers can possess or cultivate, although the quantities allowed are not
derived from clinical trials or pegged to a medical condition (see Table 2).
The amounts range from 1 oz and 6 plants in Alaska to 24 oz and 15 plants in
Washington, an amount that Washington considers to be a “60-day supply.”
California’s original medical-marijuana ballot initiative did not specify an
allowed quantity, instead permitting an amount reasonably related to the
patient’s medical needs. Subsequent legislation set limits, which apply to
individuals who register and thereby gain protection from arrest, but the
California Supreme Court recently struck down the limits as they apply to
unregistered patients who possess amounts of marijuana acceptable under the
original ballot initiative. Such patients can be arrested, but if prosecuted
can assert that the quantity they possess is reasonably related to their
needs. Under the New Jersey law, physicians must provide patients with
written instructions specifying the amount of marijuana to be dispensed by
legally sanctioned treatment centers, but the maximum amount for a 30-day
period is 2 oz — making a “60-day supply” in New Jersey just 4 oz, one
sixth of that in Washington, a disparity that underscores the absence of
standards.

The laws also vary in terms of whether they establish a registry and issue
identification cards for qualifying patients. Eleven of the 14 states have a
registry, and Maine and New Jersey will soon. In most states where patients
have identification cards, they are protected from arrest and prosecution.
In some states, however, registered patients with identification cards may
be arrested but can use the defense that they have a demonstrated medical
need for marijuana. And in a few states, unregistered but “qualifying”
patients who meet other requirements of the law may also use this defense.

Missing from many state laws is a requirement that physicians recommending
medical marijuana to adult patients provide the rudimentary disclosure of
risks and benefits necessary for informed consent, although such disclosure
is generally required for patients who are minors. In Canada, the first
country to decriminalize medical marijuana, regulations require that
physicians discuss the risks with their patients, yet the lack of relevant
clinical trials of smoked cannabis makes it difficult for physicians to
comply with the law.

In states debating new legislation, policymakers are grappling with
questions that only scientific research can answer: For what conditions does
marijuana provide medicinal benefits? Are there equally effective
alternatives? What are the appropriate doses for various conditions? How can
states ensure quality and purity?

Although state laws represent a political response to patients seeking
relief from debilitating symptoms, they are inadequate to advance effective
treatment. Medical experts emphasize the need to reclassify marijuana as a
Schedule II drug to facilitate rigorous scientific evaluation of the
potential therapeutic benefits of cannabinoids and to determine the optimal
dose and delivery route for conditions in which efficacy is established.2
This research could provide the basis for regulation by the Food and Drug
Administration. Current roadblocks to conducting clinical trials, however,
make this more rational route of approval unlikely and perpetuate the
development of state laws that lack consistency or consensus on basic
features of an evidence-based therapeutic program.

Reliance on state laws as the basis for access to medical marijuana also
leaves patients and physicians in a precarious legal position. Although the
current Justice Department may not prosecute patients if they use marijuana
in a manner consistent with their states’ laws, the federal law remains
unchanged, and future administrations could return to previous enforcement
practices.

Disclosure forms provided by the authors are available with the full text of
this article at NEJM.org.

Source Information

From the University of Maryland School of Law, Baltimore.

References

1. ProCon.org. 14 Legal medical marijuana states: laws, fees and
possession limits. (Accessed April 1, 2010, at
http://medicalmarijuana.procon.org/view.resource.php?resourceID=000881.)

2. Taylor T. Supporting research into the therapeutic role of marijuana.
Position paper. New York: American College of Physicians, 2008. (Accessed
April 1, 2010, at
http://proxychi.baremetal.com/csdp.org/research/medmarijuana.pdf.)

3. Use of cannabis for medicinal purposes, report 3 of the Council on
Science and Public Health (I-09). Chicago: American Medical Association,
2009. (Accessed April 1, 2010, at
http://www.ama-assn.org/ama1/pub/upload/mm/443/csaph-report3-i09.pdf.)

4. Degenhardt L, Hall WD. The adverse effects of cannabinoids:
implications for use of medical marijuana. CMAJ 2008;178:1685-1686. [Free
Full Text]

http://content.nejm.org/cgi/content/full/362/16/1453

http://www.prnewswire.com/news-releases/petition-to-reschedule-marijuana-to-recognize-medical-benefits-in-final-stages-of-review-by-dea-90957944.html

WASHINGTON, April 15 /PRNewswire-USNewswire/ — The following was released today by DrugScience.org:

As scientists and researchers from Israel, Brazil, Canada and the US participate in the Sixth National Clinical Conference on Cannabis Therapeutics, a coalition of medical marijuana advocates is calling on the Obama administration for prompt action on an eight-year-old petition to reschedule marijuana for medical use.  The petition, filed in 2002, argues that marijuana should be classified as a drug with “accepted medical use”
based on growing scientific evidence and acceptance in state law.  Since the petition was filed, even more scientific studies and state laws have recognized the medical efficacy of marijuana.

President Obama’s Administration now has the opportunity to reclassify cannabis (marijuana) under the Controlled Substances Act (CSA) to make it consistent with state medical marijuana policies and that of its own Department of Justice. After nearly eight years of agency review, including an analysis of existing scientific evidence by the Department of Health and Human Services (HHS), the petition is finally approaching its ultimate phase.

A final decision on the rescheduling petition will be made by the Drug Enforcement Administration (DEA), however DEA can not place marijuana in a more restrictive schedule than recommended by HHS.  Recently nominated DEA Administrator Michele Leonhart will make the decision on rescheduling marijuana at some point in the near future.

Jon Gettman, a spokesperson for The Coalition for Rescheduling Cannabis, states that, “Rescheduling marijuana is an urgent priority that needs this Administration’s immediate attention.  Medical marijuana patients have waited too long for the federal government to catch up to scientific research and state laws that recognize that the therapeutic use of cannabis is safe, effective, and most importantly not criminal activity.  We demand
that federal policymakers recognize and accept their responsibility to regulate marijuana under the provisions of the Controlled Substances Act.”

The CSA classifies marijuana and other drugs in various schedules. Marijuana is currently classified as a Schedule I substance, designating it as having a high potential for abuse, no currently accepted medical use in the United States, and a lack of accepted safety for use under medical supervision.

The CSA provides a procedure to have scheduling classifications changed in response to scientific research and other relevant factors, such as recognition of a drug’s accepted medical use and its dependence liability as compared to other controlled substances.  Schedule I substances include heroin, GHB and MDMA (ecstasy).  Cocaine and oxycodone are both Schedule II substances, which allows for severely restricted medical use while
maintaining the assertion that its abuse may lead to severe physiological
and psychological dependence.  Marinol® a synthetic form of THC (marijuana)
that is widely prescribed medically is a Schedule III substance designating that it has a currently accepted medical use in the United States and that’s its abuse may lead to only moderate or low physical dependence or high psychological dependence.

The case for rescheduling marijuana has been strengthened by several recent developments.  Fourteen states now recognize marijuana’s medical use.  The Department of Justice (DOJ) has also recognized that marijuana is used medically under these state laws and directed the DEA and US Attorneys not to prosecute individuals for such use in these states.  In addition the reclassification of marijuana under the CSA is now supported by the American Medical Association.  The Iowa Pharmacy Board, using the same criteria as the CSA, has recommended rescheduling of marijuana under state law. Furthermore, recent studies by the California Center for Medicinal Cannabis Research have documented marijuana’s effectiveness in treating a variety of ailments.  Most recently, on April 16th and 17th Patients Out of Time and the University of California San Francisco School of Medicine will hold The Sixth National Clinical Conference on Cannabis Therapeutics at the Crowne Plaza Hotel in Warwick, RI.  This accredited educational event features cannabis/cannabinoid researchers from Israel, Brazil, Canada and the US.

The members of the Coalition for Rescheduling Cannabis include the American Alliance for Medical Cannabis.  Americans for Safe Access (ASA), California NORML, the Drug Policy Forum of Texas, High  Times, Iowans for Medical Marijuana, the National Organization for the Reform of Marijuana Laws (NORML), New Mexicans for Compassionate Use, Oakland Cannabis Buyers Cooperative, and Patients Out of Time.

The petition and supporting research can be found online at
http://www.drugscience.org/index.html

Timeline of Efforts to Reschedule Marijuana

* 1995 – 2001 — Prior attempt by Jon Gettman to reschedule cannabis
ended with a rejection of the petition by then DEA head Asa Hutchinson
* 2002 — Coalition for Rescheduling files new petition to DEA to
reschedule marijuana.
* 2003 — DEA evaluates petition and sends it for review to HHS
* 2003 – 2009 — HHS reviews all science relevant and makes
recommendation to DEA
* 2009 – Present — Coalition for Rescheduling Cannabis awaits final
decision by DEA.

Related information

The Cannabis Rescheduling Petition:

http://www.drugscience.org

Department of Justice Advisory on Medical Marijuana:

http://blogs.usdoj.gov/blog/archives/192

California Center for Medicinal Cannabis:

http://www.cmcr.ucsd.edu

The Sixth National Clinical Conference on Cannabis Therapeutics:

http://www.medicalcannabis.com/Clinical-Conferences/2010-upcoming-conference

SOURCE DrugScience.org

http://www.prnewswire.com/news-releases/petition-to-reschedule-marijuana-to-recognize-medical-benefits-in-final-stages-of-review-by-dea-90957944.html

http://www.cnn.com/2010/HEALTH/02/22/medical.marijuana/

Lynda, a 48-year-old mother of three who lives in upstate New York, got a diagnosis of fibromyalgia in 2000. While there are prescription medications for fibromyalgia, she’s found one unconventional drug — marijuana — that really does the trick.

“I would use [marijuana] when the burning pains started down my spine or my right arm, and shortly after, I found I could continue with housework and actually get more done,” says Lynda.

Fibromyalgia is notoriously difficult to treat and only 35 percent – 40 percent of people with the chronic pain condition get relief from the available medications. Although there are strong opinions surrounding its use, some patients are trying marijuana — legally or illegally — and finding it can help fibromyalgia pain.

“My patients are asking me all the time about it,” says Stuart Silverman, M.D., a rheumatologist at Cedars-Sinai Medical Center, in Los Angeles. “Historically and anecdotally, marijuana has been used as a painkiller.”

Why marijuana sometimes helps

Our bodies naturally make pain relievers called endorphins, but they also make other substances that can trigger pain relief in the so-called endocannabinoid system. This system seems to play a key role in many processes in the body, including modulating how we feel pain. Marijuana contains cannabinoids very similar to those that occur in the body
naturally.

Fibromyalgia patients typically experience bodywide pain, but they must often take multiple drugs for other symptoms, which can include difficulty sleeping, restless legs syndrome, depression, and anxiety. However, marijuana may treat multiple symptoms, and some patients are seeing results.

It seems logical — why shouldn’t fibromyalgia sufferers try marijuana for their symptoms, if they live in a state where medical marijuana is legal?

But there are two problems with herbal cannabis, Silverman and other critics say: It’s a complex natural substance that contains about 60 different compounds with potentially medicinal effects, some of which may interact with one another. The other problem is that the amount of these various compounds may vary by batch, as marijuana is not synthesized but grown.

While Silverman says he has great hopes that synthetic medicines based on individual compounds in cannabis may one day help fibromyalgia patients (after appropriate randomized controlled clinical trials have been done), he argues that the real thing today is just too inconsistent.

“We think that there’s probably a role for that class of compounds, the cannabinoids in general, and it’s just a question of working out how that’s going to be put into practice,” says Mark Ware, M.D., an assistant professor in family medicine and anesthesia at McGill University, in Montreal, and the executive director of the Canadian Consortium for the Investigation of Cannabinoids.

Drugs derived from marijuana

Ware recently published a study showing that one such compound, nabilone (Cesamet), helped fibromyalgia patients sleep better. It was more effective than amitriptyline, a tricyclic antidepressant often prescribed to fibromyalgia patients to ease pain and improve sleep. And a study published a couple of years ago found nabilone helped lessen pain and anxiety in fibromyalgia patients.

Nabilone is a synthetic analog of delta-9 tetrahydrocannabinol — THC for short — often thought of as the active ingredient of cannabis. The U.S. Food and Drug Administration (FDA) approved the drug back in 1985 for treating nausea in cancer patients undergoing chemotherapy.

The only other cannabis-based drug now on the market in the U.S. is dronabinol, which is sold as Marinol in the U.S. and is FDA-approved for treating chemo-related nausea and vomiting. It hasn’t been tested formally in fibromyalgia patients, although Lynda received a prescription for Marinol in 2006.

“The drug makes me more tired and doesn’t last long enough in my system, but I’ve stuck with it since then for two basic reasons — I do supplement with marijuana, just not as many times per day,” she says. “There are times that I don’t use all day or week or month.”

A third cannabis-based medicine, Sativex, is now in clinical trials in the United States for treating cancer pain.

The drug is sprayed under the tongue or into the cheek, and contains THC and cannabidiol, a non-psychoactive compound found in cannabis that eases inflammation and pain and may also reduce the side effects of THC (like anxiety, hunger production, and some of the intoxicating properties), as well as a number of other compounds (other cannabinoids and terpenoids, which are analgesics in their own rights).

But do they help?

“It is quite possible that cannabis-based medicines could be helpful for sufferers of fibromyalgia based on available science,” says Ethan Russo, M.D., who is senior medical advisor to GW Pharmaceuticals, which makes Sativex, and a study physician for the U.S. clinical trials now underway for cancer treatment.

Russo says he’s hopeful Sativex will get FDA approval for treating cancer pain in 2013. “While a theoretical basis for Sativex potentially helping benefit fibromyalgia symptoms is quite strong, and we know it has been very helpful with neuropathic pain and sleep disturbance in many other conditions,” he adds, “it’s ultimate utility in fibromyalgia can only be proven in a meaningful, practical fashion through formal randomized clinical
trials.”

For now, Ware says, patients with fibromyalgia who aren’t being helped by their existing treatment might want to discuss nabilone with their physician. “A lot of doctors just don’t know that these prescription cannabinoids exist,” he says.

However, these drugs have side effects too. “The most typical side effects are what I call the three D’s: drowsiness, dizziness, and dry mouth. It’s not euphoria as such,” he adds.

In Canada, federal law allows patients to use medical marijuana with a doctor’s support (they can’t prescribe marijuana because it’s not approved as a drug in Canada) of the patient’s application to possess; the drug is delivered directly to the patient, and grown under controlled conditions by the government.

“I have patients with a range of pain syndromes who have failed all their other treatments and for whom herbal cannabis has been the only reasonable option that they have that controls their symptoms,” Ware says. In such cases, he adds, he will help the patient obtain the card they need to authorize them to possess the drug.

But in the U.S., the legality of medical marijuana is determined state-by-state (it’s now legal in 14 states), and rules and regulations vary widely.

And while Attorney General Eric Holder said last year that he would no longer go after people who were selling or using medical marijuana legally, many users — and potential users — are fearful of the legal risks they may be taking.

“Licensed for use or not, it’s still a federal crime, says Dee, a 52-year-old medical assistant with fibromyalgia, who lives in Colorado, which passed a law allowing medical marijuana in 2000. While visiting a wellness center for therapeutic massages, staffers suggested she try marijuana for her symptoms.

After getting her doctor’s approval, “I tried a little of this and a little of that. I would say that most of the time my pain was not relieved,” although she did sleep better and had a better appetite. “I did find one plant that really did help, but it was hard to get, and you only get so much grown per plant for year.”

So when the time came for Dee to get her state license to use medical marijuana (Colorado gives people 90 days), at a cost of $90 every year, “I let the ball drop.”

While Dee says she has no problem with medical marijuana, she is concerned about the increase of dispensaries across the state. “There are more places to purchase medical marijuana than banks or Mexican restaurants now,” she says.

In New York, the state assembly has approved medical marijuana legislation, and Lynda says she is working to support legalization efforts there. For now, legal or not, she is continuing to use marijuana.

“I would suggest to any ‘fibromyalgiac’ to try marijuana if they are open to it,” says Lynda.

“I swore when I became a parent I would not touch weed again (ah, youth), but times have changed, and I was desperate to find something for the burning pain so I could function. I’m glad that I made this decision because it works for me.”

http://www.cnn.com/2010/HEALTH/02/22/medical.marijuana/

Date:  February 17, 2010

UC Studies Show Marijuana Has Therapeutic Value, Reports to Legislature

First results in United States in 20 years from clinical trials of smoked cannabis

Researchers from the University of Californiaís Center for Medicinal Cannabis Research (CMCR) have found ìreasonable evidence that cannabis is a promising treatmentî for some specific, pain-related medical conditions. Their findings, presented today to the California legislature and public, are included in a report available on the CMCR web site at
http://www.cmcr.ucsd.edu.

“We focused on illnesses where current medical treatment does not provide adequate relief or coverage of symptoms,” explained CMCR director, Igor Grant, MD, Executive Vice-Chair of the Department of Psychiatry at the UCSD School of Medicine.  “These findings provide a strong, science-based context in which policy makers and the public can begin discussing the place of cannabis in medical care.”

Researchers have completed five scientific clinical trials, with more in progress.  These studies showed that cannabis can be helpful in easing pain in selected syndromes caused by injury or diseases of the nervous system and possibly for painful muscle spasms due to multiple sclerosis.

“These scientists created an unparalleled program of systematic research, focused on science-based answers rather than political or social beliefs,” said Senator John Vasconcellos, original author of The Medical Marijuana Research Act of 1999 (SB847) which led to the creation of the CMCR.

Study results have been published in high-impact medical journals, garnering national and international attention which prompted leading experts to come together and foster scientific dialog on the possible uses of cannabis as a therapeutic agent.  More study will be necessary to figure out the mechanisms of action and the full therapeutic potential of cannabinoid compounds, according to the UC researchers.

About The Center for Medicinal Cannabis Research:

The CMCR was created in 2000 (through the passage of SB847) to conduct clinical and pre-clinical trials of cannabinoids, including smoked marijuana, to provide evidence, one way or the other, to answer the question “Does marijuana have therapeutic value?”  The program’s purpose is to oversee objective, high-quality, medical research that would enhance understanding of the efficacy and adverse effects of marijuana as a
pharmacological agent.  The project was never to be construed as encouraging or sanctioning the social or recreational use of marijuana.
http://www.cmcr.ucsd.edu

Released: 1/6/2010 3:00 PM EST

Embargo expired: 1/11/2010 12:05 AM EST

Source: California Pacific Medical Center

Newswise — Combining the two most common cannabinoid compounds in Cannabis may boost the effectiveness of treatments to inhibit the growth of brain cancer cells and increase the number of brain cancer cells that die off. That’s the finding of a new study published in the latest issue of the journal Molecular Cancer Therapeutics.

Researchers at the California Pacific Medical Center Research Institute (CPMCRI) combined the non-psychoactive Cannabis compound, cannabidiol (CBD), with Δ9-tetrahyrdocannabinol (Δ9-THC), the primary psychoactive active ingredient in Cannabis. They found the combination boosts the inhibitory effects of Δ9-THC on glioblastoma, the most common and aggressive form of brain tumor and the cancer that claimed the life of Sen. Ted Kennedy last year.

“Our study not only suggests that combining these two compounds creates a synergistic effect,” says Sean McAllister, Ph.D., a scientist at CPMCRI and the lead author of the study. “but it also helps identify molecular mechanisms at work here, and that may lead to more effective treatments for glioblastoma and potentially other aggressive cancers.”

Previous studies had shown that Δ9-THC was effective in inhibiting brain cancer growth in cell cultures and in animal models and prompted a small clinical trial in Spain. There is also evidence that other compounds in Cannabis might prove effective against tumors, but limited scientific evidence is available. The CPMCRI researchers screened a number of different cannabis-based compounds before settling on CBD as the most active one.

“Compared to using Δ9-THC alone against glioblastoma cell lines, the combination therapy of Δ9-THC and CBD showed a significant improvement in activity, both in slowing down the growth of those cells and also, and perhaps more importantly, in doubling the number of cancer cells which underwent apoptosis or programmed cell death,” says Dr. McAllister.

The next step in the research is to carry out similar studies in animal models of aggressive brain cancer. Even if the synergistic effect is not evident in those studies, the combination treatments may allow for stronger doses to be given to patients due to non-overlapping toxicities and decrease development of resistance to the activity of Δ9-THC or CBD alone.

Despite the promising findings of the study the researchers point out that they are not a recommendation for people with brain cancer to smoke marijuana. They say it is highly unlikely that effective concentrations of either Δ9-THC or CBD could be reached by smoking cannabis.

The study was funded by the National Institute of Health and the SETH group.

California Pacific Medical Center. Beyond Medicine.

At San Francisco’s California Pacific Medical Center, we believe in the power of medicine. We research the most up-to-date treatments, hire the most qualified individuals, and practice the most modern, innovative medicine available. We deliver the highest quality expert care, with kindness and compassion, in acute, post-acute and outpatient services, as well as preventive and complementary medicine. But we also believe that medicine
alone is only part of the solution. That’s why we look intently at each individual case and treat the whole person, not just the illness. It’s why we go beyond medical care and provide our patients with things like disease counseling, family support and wellness treatments. As one of California’s largest private, community-based, not-for-profit, teaching medical centers, and a Sutter Health affiliate, we are able to reach deep into our community
to provide education, screening and financial support in some of the city’s most underserved neighborhoods. Medicine can transform a body. But going beyond medicine can transform a life. www.cpmc.org

http://www.newswise.com/articles/combining-components-of-marijuana-enhances-inhibitory-effects-on-brain-cancer