Medical Marijuana Research Act of 2017

mj_researchRepresentatives Andy Harris, M.D. (R-MD-01), Earl Blumenauer (D-OR-03), H. Morgan Griffith (R-VA-09), and Zoe Lofgren (D-CA-19) introduced H.R. 3391: The Medical Marijuana Research Act of 2017.

This Act amends the federal law to facilitate clinical investigations involving the use of cannabis and cannabis-derived products.

As you may know, there are many benefits to medical cannabis. Those suffering from PTSD, Tourette’s Syndrome, Parkinson’s Disease, and many other debilitating conditions have found relief because of medical marijuana.  

But, despite the fact that over 200 million Americans now have legal access to some form of medical marijuana, present regulations make clinical investigations involving cannabis needlessly onerous. Passage of this measure would expedite federal reviews of clinical protocols, provide greater access to scientists who wish to study the drug, and mandate an FDA review of the relevant science.

Please click HERE to contact your Representative and urge him/her to support this important measure.

 

DEA Reaffirms Stance That CBD Meets Schedule I Criteria — Reality Says Otherwise

oil_bottlesThe US Drug Enforcement Administration has publicly reiterated its position that cannabidiol, a non-psychotropic cannabinoid, is properly categorized under federal law as a schedule I controlled substance — meaning that, by definition, it possesses “a high potential for abuse,” “no currently accepted medical use in treatment in the United States,” and lacks “accepted safety … under medical supervision.”

The agency has long contended that CBD, along with all organic cannabinoids, is — by default — a schedule I controlled substance because it is a naturally occurring component of the cannabis plant. (This position is similarly held by both the NIDA and the FDA.) Nonetheless, a growing body of science undermines the notion that CBD meets any of the criteria necessary for such classification.

Specifically, clinical trial data finds that CBD is “safe,” “non-toxic,” and “well tolerated” in human volunteers. Even the director of the US National Institute on Drug Abuse acknowledges that CBD is “not mind-altering” and that it “appears to be a safe drug with no addictive effects.”

Recently conducted controlled studies also acknowledge its therapeutic efficacy, particularly the ability of CBD dosing to mitigate treatment-resistant seizures, hypertension, and psychotic symptoms in humans. Other peer-reviewed data shows that CBD therapy holds promise for the treatment of “Parkinson’s disease, Alzheimer’s disease, cerebral ischemia, diabetes, rheumatoid arthritis, other inflammatory diseases, nausea and cancer.”

That is why in addition to the thirty states that presently recognize medical cannabis, an additional 16 states also explicitly recognize the use of CBD as a viable medical treatment.

Nonetheless, it remains unlikely that the DEA is going to amend its position any time soon. Further, police in recent months have begun initiating raids of CBD retailers, such as those reported here, here, and here. That is why it is critical that members of Congress move forward with legislation to remove the cannabis plant from the Controlled Substances Act.

Presently, several pieces of federal legislation are pending to amend the federal classification of CBD as a schedule I substance. These include:

HR 2020: Passage of this act would exclude CBD from the federal definition of ‘marihuana.’

S. 1374/HR 2920: Passage of these Acts would exempt from federal prosecution those who are engaged in state-sanctioned medical cannabis activities; it would also remove CBD from the federal definition of ‘marihuana.’

HR 2273/S. 1008: Passage of these Acts would exclude CBD and CBD-rich cannabis plants from the federal definition of ‘marihuana.’

You can contact your members of Congress in support of these bills and other pending legislation by visiting NORML’s Take Action Center here.

Review Identifies 140 Controlled Clinical Trials Related to Cannabis

Marijuana researchScientists have conducted over 140 controlled clinical trials since 1975 assessing the safety and efficacy of whole-plant cannabis or specific cannabinoids, according to a new literature review published in the journal Critical Reviews in Plant Sciences.

A pair of German researchers identified 140 clinical trials involving an estimated 8,000 participants. Of these, the largest body of literature focused on the use of cannabis or cannabinoids in the treatment of chronic or neuropathic pain. Authors identified 35 controlled studies, involving 2,046 subjects, assessing the use of marijuana or cannabinoids in pain management. In January, the National Academy of Sciences acknowledged that “conclusive or substantial evidence” exists for cannabis’ efficacy in patients suffering from chronic pain.

Cannabinoids have also been well studied as anti-emetic agents and as appetite stimulants. Researchers identified 43 trials evaluating marijuana or its components for these purposes, involving total 2,498 patients. They also identified an additional 14 trials examining the role of cannabis or cannabis-derived extracts in the treatment of multiple sclerosis.

Researchers also identified several additional trials evaluating the use of cannabis or cannabinoids for Crohn’s disease, Tourette’s syndrome, Parkinson’s disease, glaucoma, epilepsy, and various other indications.

A 2014 study published in the Journal of the American Medical Association reported that new drugs typically gain FDA approval on the basis of one or two pivotal clinical trials.

Full text of the study, “Medicinal uses of marijuana and cannabinoids,” appears online here.

DEA Reaffirms ‘Flat Earth’ Position With Regard To Scheduling Marijuana

imgresThe United States Drug Enforcement Administration has rejected a pair of administrative petitions that sought to initiate rulemaking proceedings to reschedule marijuana under federal law.

Although the DEA’s ruling continues to classify marijuana in the same category as heroin, the agency also announced in a separate decision that it is adopting policy changes designed to expand the production of research-grade cannabis for FDA-approved clinical studies.

Presently, any clinical trial involving cannabis must access source material cultivated at the University of Mississippi — a prohibition that is not in place for other controlled substances. Today, the agency announced for the first time that it will be seeking applications from multiple parties, including potentially from private entities, to produce marijuana for FDA-approved research protocols as well as for “commercial product development.” This change was initially recommended by the DEA’s own administrative law judge in 2007, but her decision was ultimately rejected by the agency in 2011.

Below is a statement from NORML Deputy Director Paul Armentano regarding the DEA’s decisions:

For far too long, federal regulations have made clinical investigations involving cannabis needlessly onerous and have placed unnecessary and arbitrary restrictions on marijuana that do not exist for other controlled substances, including some other schedule I controlled substances.

While this announcement is a significant step toward better facilitating and expanding clinical investigations into cannabis’ therapeutic efficacy, ample scientific evidence already exists to remove cannabis from its schedule I classification and to acknowledge its relative safety compared to other scheduled substances, like opioids, and unscheduled substances, such as alcohol. Ultimately, the federal government ought to remove cannabis from the Controlled Substances Act altogether in a manner similar to alcohol and tobacco, thus providing states the power to establish their own marijuana regulatory policies free from federal intrusion.

Since the DEA has failed to take such action, then it is incumbent that members of Congress act swiftly to amend cannabis’ criminal status in a way that comports with both public and scientific opinion. Failure to do so continues the federal government’s ‘Flat Earth’ position; it willfully ignores the well-established therapeutic properties associated with the plant and it ignores the laws in 26 states recognizing marijuana’s therapeutic efficacy.

Under the U.S. Controlled Substances Act of 1970, the cannabis plant and its organic cannabinoids are classified as Schedule I prohibited substances — the most restrictive category available under the law. By definition, substances in this category must meet three specific inclusion criteria:

The substance must possess “a high potential for abuse”; it must have “no currently accepted medical use” in the United States; and, the substance must lack “accepted safety for use … under medical supervision.”

Substances that do not meet these criteria must, by law, be categorized in less restrictive federal schedules (Schedules II through V) and are legally regulated accordingly. Alcohol and tobacco, two substances widely acknowledged to possess far greater dangers to health than does cannabis, are not classified under the Controlled Substances Act.

A recent review of FDA-approved clinical studies evaluating the safety and efficacy of herbal cannabis concluded: “Based on evidence currently available the Schedule I classification is not tenable; it is not accurate that cannabis has no medical value, or that Information on safety is lacking.”

Added Armentano: “The DEA’s decision is strictly a political one. There is nothing scientific about willful ignorance.”

The DEA has previously rejected several other rescheduling petitions, including a 2002 petition filed by a coalition of marijuana law reform and health advocacy organizations, and a 1972 petition filed by NORML. The petitions that triggered this latest DEA action were filed in 2009 by a nurse practitioner and 011 by then-Govs. Christine Gregoire of Washington and Lincoln Chafee of Rhode Island.

Variation in medical marijuana program regulations impacts enrollment

A new study found that while 14 of the nation’s 24 medical marijuana programs were essentially nonmedical in practice, they enrolled more than 99 percent of overall participants. Fewer than one percent were enrolled in ‘medicalized’ programs that adhere to accepted professional standards in medicine. The study analyzed the extent to which medical marijuana laws and program regulations incorporate accepted medical practice, good pharmaceutical manufacturing practices as established by the FDA, and restrictions on controlled substances.

Flat-D Innovations Introduces the 420Stealth Bag

Honolulu, Hawaii (PRWEB) September 1, 2010

From the inventors of the Flatulence Deodorizer comes the revolutionary new product: The 420Stealth bag. A small, lightweight bag made out of a high quality activated charcoal cloth. The 420Stealth significantly reduces the odor of its contents to the point that virtually no human nose can detect what is inside. This material is so effective that specially trained canines also find it extremely difficult to identify the inner contents of the bag. This product is perfect for medical marijuana users who don?t want the odor of marijuana emanating out of their pockets or handbag, when in a public area.

Made from a more enhanced version of the doctor approved Flat-D products, the 420Stealth is fabricated with the new MEGA-420 material, the strongest in Flat-D Innovations arsenal. The 420Stealth will be available in three sizes: Small, Medium, and Large. The small, at the size of a coin purse, is the perfect size for carrying some papers, a lighter, and a couple of grams in one?s jeans? pocket. The Medium is large enough for a pipe, lighter, and up to half an ounce, making it ideal for a backpack or purse. The Large is just right for holding up to an ounce, making it the perfect bag for stopping by the local dispensary and holding it at home. With all three sizes coming with a double Velcro seal and an overlapping flap to ensure the peace of mind of the user, the 420Stealth is the future in carrying medical marijuana, hassle free.

Testimonial -

For years, everyone I know has used every kind of container to carry their stash. From zip seal bags, candy boxes, and prescription bottles, somehow the smell still permeates through, someone catches the scent and medical or not you feel the need to explain. This has proven to be very embarrassing and very uncomfortable for me. Your containment bag has saved me alot of grief. This sleek looking bag not only works, its simple size, shape, color and style is discreet (I’m a girl so things have to look good as well).

Thank you again,

H.I.

The 420Stealth will be sold both online at http://www.420Stealth.com and in stores nationwide, and can be bought in a discounted variety pack containing all three sizes. For more information on The 420Stealth, orders and user testimonials please refer to our website @ http://www.420Stealth.com.

Flat-D Innovations, http://www.flat-d.com an FDA registered and Better Business Bureau Accredited company, is the market leader for over 8 years in flatulence/personal odor control products, feminine odors, and clothes odor. Founded in 2002, the company’s patented products feature activated charcoal cloth that has improved the quality of life for people in over 50 countries worldwide.

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Journey Healing Centers Votes No on Medical Marijuana Abuse and Addiction

Scottsdale, AZ (PRWEB) October 6, 2010

Journey Healing Centers (AZ and UT drug and alcohol treatment centers) urges voters to Vote No on Prop 203 (Arizona) and Prop 19 (California) to reduce marijuana abuse, health risks and family heartache when dealing with a loved one fighting addictions. According to a SAMHSA report, Initiation of Marijuana Use: Trends, Patterns and Implications, “the younger children are when they first use marijuana, the more likely they are to use cocaine and heroin and become dependent on drugs as adults.” According to Zack, a 21-yr-old and former Journey Healing Centers client, “If I could go back and tell my 12-yr-old self anything, it would be to not start smoking marijuana. It led me to other harder drugs and treatment by age 20. I know first-hand that marijuana is a gateway drug. I have lost 13 friends to addiction related deaths, and most of them started by smoking marijuana.”

Many don’t realize that smoking marijuana can be much more dangerous than smoking tobacco and cause cancer. If Prop 203 passes, Arizona citizens (including teens under 18) with a medical marijuana card can get two and a half ounces of pot every 14 days, which is about 10 joints a day. The National Institutes of Health estimate that smoking 5 marijuana cigarettes per week has the same health affects as smoking a full pack of tobacco cigarettes every day. “Smoked marijuana damages the brain, heart, lungs, and immune system. It impairs learning and interferes with memory, perception, and judgment. Smoked marijuana contains cancer-causing compounds and has been implicated in a high percentage of automobile crashes and workplace accidents,” explains John Walters, Director, Office of National Drug Control Policy.

One of the main drivers behind the marijuana movement is revenue, and eventually making it legal for recreational use. In San Diego, California, only 2 percent of the people getting “medicalmarijuana have HIV, cancer or glaucoma, while 98 percent have no serious illness (Billings Gazette). The profit takers who will truly benefit from marijuana legalization are the pot farms, dispensaries, and the doctors. There is no requirement that a 420 (medical marijuana) “doctor” be an M.D. to give out a recommendation, and there are no FDA approvals for marijuana. Almost anyone can get a recommendation with a headache and $ 150. Not only will it be easy to obtain a medical marijuana card, but teens will start taking marijuana out of their parent’s medicine cabinets, adding to the current prescription drug abuse epidemic in the U.S.

Safety on the roads is another concern. An attorney recently called Journey Healing Centers free addiction helpline (1-866-774-5119) to ask for advice because their client was just arrested for driving under the influence of drugs and marijuana possession. This attorney admitted that he told his client to hurry up and get a medical marijuana card. The San Diego Union Tribune reported that a 24-year-old Temecula, CA, man with a medical marijuana prescription caused thirteen car accidents last March, and presented his medical marijuana card as an explanation for his erratic behavior.

What the Medical Marijuana Project fails to mention is that addiction will be around whether Prop 203 and Prop 19 pass or not. Many also don’t realize that THC (Tetrahydracanabinol) potency is almost ten times higher today than it was in the 1960s, which makes it even more addictive. With an FDA drug already approved called Marinol as a synthetic form of THC, there is no need to invite more drug abuse, health risks, and family heartache from increased addictions by legalizing medical marijuana. Vote No on Prop 203, Vote No on Prop 19, and Vote No on Medical Marijuana Abuse and Addiction.

Background:

Journey Healing Centers operates drug and alcohol rehabilitation centers in Arizona and Utah, and specializes in holistic healing programs, family treatment and has a Sobriety for Life Program. Their work and success stories have been featured on MTV’s Gone Too Far, PBS, ABC News 15 Phoenix, Fox 10 Phoenix, ABC 4 Salt Lake City, USAToday.com, Psychology Today and in People Magazine. Journey Healing Centers has supported thousands dealing with addictions through Residential Treatment Programs, Intensive Outpatient Programs (IOP), Sober Living Homes, Aftercare and a Free 24-Hour Hotline with Addiction Specialists: 1-866-774-5119.

http://journeyrecoverycenters.com

Media contact:

Liz Brown

310-795-1485

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Find More Medical Marijuana Doctors Press Releases

Journey Healing Centers Sends Voters a Medical Marijuana Video Wake-up Call

Scottsdale, AZ (PRWEB) October 28, 2010

While many Prop 203 (AZ medical marijuana) and Prop 19 (CA legalization) advocates think “It’s Only Marijuana,” many Journey Healing Centers clients who enter drug abuse treatment addicted to cocaine, heroin, marijuana and meth often say, “If only I hadn’t started smoking marijuana.” After working in Law Enforcement and Night Clubs in Las Vegas, the Co-Founders are passionate about educating and assisting families in overcoming addiction and bringing to light the massive abuse, which is why Journey Healing Centers is releasing this Venice Beach, CA Video where dispensaries actively solicit new clients, 420 Doctors give out medical marijuana cards for any pain, and smoking lounges are making this beach town look more like Amsterdam.

Vote No on Prop 203 and Medical Marijuana Abuse

http://www.youtube.com/watch?v=rNIPicdL5M4

As seen in the Venice Beach video, these propositions are about much more than medical marijuana. The solicitors are not looking for critically ill patients and instead announce to people walking by, “Walk-ins welcome everybody,” “Get just what the doctor ordered,” “Hash bars, smoking lounges, dispensaries upstairs,” and “You can get medical marijuana, right now.”

Journey Healing Centers is one of the only Addiction Centers publically opposing Prop 203 and Prop 19 because the propositions are misleading and will increase addiction. While these Addiction Experts support medical marijuana use for critically ill patients, the reality is that only 2% of the current patients use it for serious illnesses (Billings Gazzette). And there is already an FDA approved drug on the market for this purpose, Marinol. The Medical Marijuana Project (MPP) is misleading the public by saying Prop 203 was written to help people with HIV, Cancer and Glaucoma (MPP’s website clearly states that their goal is to legalize marijuana, which seems more about money versus helping sick people.) If the MPP goal is to legalize marijuana, why not come out and state that big objective and offer to educate the public about the risks of smoking marijuana? Pro marijuana groups and individuals say that treatment centers are opposed because they will lose clients if it passes. The exact opposite is true, it will increase those addicted to substances, yet Journey Healing Centers still opposes because of the misleading prop and the lack of education the MPP is providing on the subject.

The Medical Marijuana Project (MPP) is also misleading the public with stories about the importance of keeping people out of jail who need medical marijuana for critical illnesses and that legalizing it will reduce crime. The reality is that out of the half a million people serving time in prison for drug offenses, less than 1 percent are in prison for possession of marijuana (Chicago Tribune). The other 99% are serving time for drug dealing and distributing. Dispensaries also attract criminal activity, including drug trafficking, money laundering, assaults, burglaries, armed robberies, gang activity, home invasions and even murders (as seen in Los Angeles.) In Colorado Springs (where medical marijuana is legal), a new Police Department is being formed just to keep watch over the industry (The Gazette.)

Have the marijuana advocates thought about the consequences if marijuana passes for recreational use, as California is proposing in Prop 19? Marijuana is still illegal on a federal level, and the FDA has never approved a medical drug to be smoked. Eric Holder, US Attorney General, sent a letter to the DEA, stating, “If passed, this legislation will greatly complicate federal drug enforcement efforts to the detriment of our citizens” (New York Times.) The DEA has already raided medical marijuana clinics in Las Vegas, where medical marijuana is state approved, and took the patients records. It’s time for Voters to wake-up and Vote No on Prop 203, Vote No on Prop 19, and Vote No on Marijuana Abuse because It’s Not Only Marijuana.

Background:

Journey Healing Centers operates drug and alcohol rehabilitation centers in Arizona and Utah, and specializes in holistic healing programs, family treatment and has a Sobriety for Life Program. Their work and success stories have been featured on MTV’s Gone Too Far, PBS, ABC News 15 Phoenix, Fox 10 Phoenix, ABC 4 Salt Lake City, KUAT PBS Tucson, USAToday.com, Psychology Today and in People Magazine. Journey Healing Centers has supported thousands dealing with addictions through Residential Treatment Programs, Intensive Outpatient Programs (IOP), Sober Living Homes, Aftercare and a Free 24-Hour Hotline with Addiction Specialists: 1-866-774-5119.

http://journeyrecoverycenters.com

Media contact:

Liz Brown

310-795-1485

References

New York Times

http://www.nytimes.com/2010/10/16/us/16pot.html

Chicago Tribune

http://articles.chicagotribune.com/2010-10-15/news/chi-101015bensinger_briefs_1_prison-for-drug-offenses-drug-cartels-peter-bensinger

Pot Cops a possible side effect of medical marijuana (Colorado Gazzette)

http://www.gazette.com/articles/marijuana-106837-medical-possible.html

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Find More Medical Marijuana Doctors Press Releases

Study: Vaporized, Low-Potency Cannabis Mitigates Neuropathic Pain

The administration of vaporized, low THC cannabis is associated with reduced pain in subjects with neuropathy, according to clinical trial data published online by The Journal of Pain.

Investigators at the University of California, Davis Medical Center conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic efficacy of vaporized cannabis in 39 subjects, the majority of whom were experiencing neuropathic pain despite traditional treatment. Subjects inhaled cannabis of either moderate THC (3.53 percent), low dose THC (1.29 percent), or zero THC (placebo). Subjects continued to take all other concurrent medications as per their normal routine during the 3- to 4-week study period. Spontaneous pain relief, the primary outcome variable, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).

Researchers reported: “Both the low and medium doses proved to be salutary analgesics for the heterogeneous collection of neuropathic pain conditions studied. Both active study medications provided statistically significant 30% reductions in pain intensity when compared to placebo.”

They concluded: “Both the 1.29% and 3.53% vaporized THC study medications produced equal antinociception at every time point. … [T]he use of low doses could potentially be prescribed by physicians interested in helping patients use cannabis effectively while minimizing cognitive and psychological side effects. Viewed with this in mind, the present study adds to a growing body of literature supporting the use of cannabis for the treatment of neuropathic pain. It provides additional evidence of the efficacy of vaporized cannabis as well as establishes low-dose cannabis (1.29%) as having a favorable risk-benefit ratio.”

Previous clinical trials have indicated that inhaled cannabis can safety and effectively relieve various types of pain, particularly neuropathy — a hard-to-treat nerve condition often associated with cancer, HIV, spinal cord injury, diabetes, multiple sclerosis, and other conditions. These include the following double-blind, placebo-controlled (FDA gold-standard) studies:

Ware et al. 2010. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial. CMAJ 182: 694-701.

Wilsey et al. 2008. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. Journal of Pain 9: 506-521.

Ellis et al. 2008. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology 34: 672-80.

Abrams et al. 2007. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology 68: 515-521.

Wallace et al. 2007. Dose-dependent Effects of Smoked Cannabis on Capsaicin-induced Pain and Hyperalgesia in Healthy Volunteers Anesthesiology 107: 785-796.

Separate clinical trial data also reports that inhaled “cannabis augments the analgesic effect of opioids” and therefore “may allow for opioid treatment at lower doses with fewer side effects.”

Since 1999, US sales of opiate drugs have tripled in number and in 2010, a record-setting 254 million prescriptions for opioids were filled in the United States — enough to medicate every American adult around the clock for a month. (In particular, the manufacturing of the drug Oxycodone has increased from 8.3 tons in 1997 to 105 tons in 2011, an increase of 1,200 percent.) Overdose deaths from the use of prescription painkillers are also now at record levels, totaling some 15,000 annually — more than triple the total a decade ago.

Full text of the study, “Low-dose vaporized cannabis significantly improves neuropathic pain,” appears in The Journal of Pain.

Study: Cannabis May Mitigate Traumatic Memories In Patients With PTSD

[Editor's note: This post is excerpted from this week's forthcoming NORML weekly media advisory. To have NORML's news alerts and legislative advisories delivered straight to your in-box, sign up here.]

The use of cannabis and cannabinoids appears to mitigate symptoms associated with post-traumatic stress disorder (PTSD), according to a new review of clinical and preclinical evidence published online in the scientific journal Drug Testing and Analysis.

An international team of investigators from Germany, the United States, and the United Kingdom reported that the use of cannabis to “dramatically reduced” PTSD symptoms in a single 19-year-old male patient.

Authors reported: “In the case report presented in this review, the patient displayed a grave pathology involving anxiety, dissociation and heavy flashbacks as a consequence of PTSD. … The patient stated that he found cannabis more useful than lorazepam. … It is evident from the case history that the patient experienced reduced stress, less involvement with flashbacks and a significant decrease of anxiety.

Authors further cited “accumulating clinical and preclinical evidence that cannabinoids may mitigate some major symptoms associated with PTSD.”

They concluded: “Cannabis may dampen the strength or emotional impact of traumatic memories through synergistic mechanisms that might make it easier for people with PTSD to rest or sleep and to feel less anxious and less involved with flashback memories. … Evidence is increasingly accumulating that cannabinoids might play a role in fear extinction and anti-depressive effects. It is concluded that further studies are warranted in order to evaluate the therapeutic potential of cannabinoids in PTSD.”

Last year, administrators at the United States Department of Health and Human Services, National Institute on Drug Abuse (NIDA) blocked investigators at the University of Arizona at Phoenix from conducting an FDA-approved, placebo-controlled clinical trial to evaluate the use of cannabis in 50 patients with PTSD.

Under federal law, any clinical trial evaluations involving cannabis must receive NIDA approval because the agency is the only source of legal cannabis for FDA-approved research purposes. In 2010, a spokesperson for the agency told The New York Times: “[O]ur focus is primarily on the negative consequences of marijuana use. We generally do not fund research focused on the potential beneficial medical effects of marijuana.”

FDA Approval of Cannabis is a Red Herring (by Wayne Reiss)

The following is a guest post from longtime Stasher Wayne Reiss of Brooklyn, NY…

There is no legal, medical or ethical reason for cannabis to pass FDA approval. Like cannabis, pharmaceutical drugs such as morphine, penicillin, aspirin and several others never passed FDA approval and became part of the medical pharmacopeia based on anecdotal evidence alone. For these reasons, most politicians and some physicians argue that cannabis cannot be considered medicine (despite hundreds of peer reviewed research to the contrary) until it passes FDA approval yet they make no such claims regarding any pharmaceutical medications which meet the identical criteria. Moreover, aspirin which can cause bleeding of the stomach lining and accounts for hundreds of deaths per year would never pass FDA approval today, and none claims it should. Nor do these detractors make similar claims regarding any of the hundreds of other homeopathic medicinal herbs which physicians are free to recommend and are available at most pharmacies.

Cannabis was used medicinally in China and India for thousands of years. No medicine survives that long if it is not effective. Prior to cannabis prohibition, it was prescribed by American physicians for 100 years, it was used in 50% of all medications, and was sold by pharmaceutical companies such as Bristol Myers Squib, Merck, Parke-Davis, Eli Lilly, and Smith Bros. Before its prohibition, neither doctors nor pharmaceutical companies complained that dosage was impossible to control, nor did they argue that only chemicals, not herbs, are medicine. It was prohibited despite the objections of the AMA. During the first three years of cannabis prohibition Harry Anslinger, head of the Federal Bureau of Narcotics (FBN), prosecuted more than 3,000 AMA physicians for prescribing cannabis. The AMA relented, and in the next decade, Anslinger only prosecuted three physicians. In response to this attack on physicians, medicine and science, in 1944 Mayor LaGuardia commissioned a panel of medical experts which concluded that none of Anslinger’s concerns regarding the harms of cannabis was justified, but despite science and reason the FBN prevailed. Marijuana would be legal medicine today (without FDA approval) if it were not for this irrational war on cannabis users.

Who will fund FDA approval?

Double blind control studies necessary for FDA approval cost approximately $200 million, sometimes more. Who will pay this tab? The US government? The head of the Office of National Drug Control Policy (ONDCP), Drug Czar Gil Kerlikowske, is mandated by law to oppose all efforts to legalize marijuana for any reason. The National Institute of Drug Addiction (NIDA), the sole source of government funding for cannabis research, largely because of the ONDCP mandate, denies funding any research into the medical utility of cannabis and only grants funding for research that studies the harms of cannabis. Although 70-80% of the public has supported medical marijuana for the last 20 years and according to the latest Gallup poll 50% supports recreational legalization, only one senator and less than 1% of congress support legalizing cannabis even for medical reasons. The DEA is the sole provider of legal cannabis in the U.S. They have consistently denied providing cannabis or license to grow it for research into its medical efficacy. Without this cannabis FDA approval is impossible.

The federal government actively lobbies to maintain cannabis prohibition, denies it has any medical utility, and is the primary obstacle preventing cannabis research and FDA approval.

Neither will the pharmaceutical industry fund cannabis FDA approval. Pharmaceutical companies recoup the enormous cost of FDA approval by patenting medicines and then selling them exclusively once approved, but plants cannot be patented. In addition, pharmaceutical companies benefit by keeping cannabis, a powerful competitor, illegal because it is cheap (when not prohibited) and it successfully treats many diseases and symptoms, such as glaucoma, neuropathic pain, depression, anxiety, insomnia, nausea, gastrointestinal distress, lack of appetite (aids wasting syndrome), spasticity (epilepsy, multiple sclerosis, etc.), migraine, menstrual cramps, asthma and many others. Pharmaceutical companies have many economic incentives to maintain cannabis prohibition and have no incentive to fund its FDA approval.

The legal cannabis industry also cannot fund FDA approval. Although its existence depends upon the legalization of cannabis, the legal cannabis industry is cash strapped and only provides 2% of the funding for legalization efforts. (Wealthy philanthropists supply 98% of this funding.) To the extent that some in the quasi legal cannabis industry profit from prohibition, they too oppose FDA approval.

In theory, states could provide the revenue for cannabis FDA approval, but in today’s political and economic climate, this is unrealistic. California, the only state to ever fund cannabis research, spent $9 million over three years (far from the $200 million needed for FDA approval) to fund the Center for Medical Cannabis Research. This funding has been exhausted and was not replenished. No other state has ever provided funding for cannabis research.

The claim that cannabis must pass FDA approval, unlike many lethal pharmaceutical drugs and hundreds of other medicinal herbs, is based on political agenda, not science. Most who make this disingenuous claim are aware that there is no entity capable of funding or willing to fund this effort. Cannabis would still be legal medicine as it has been for thousands of years if it were not for prohibition which has confounded science for the last 75 years and still continues to do so.

This Week in Weed: Feb. 26th – March 3rd

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This week in weed: Colorado’s legalization initiative officially qualifies for the November ballot and a new report shows how the federal government stifles research into cannabis’ medicinal applications.

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In Kansas, Eric Voth says Oregon ended workplace drug testing following medical marijuana law

Click here for more coverage of KansasReefer madness is alive and well in Kansas.  The Weed Blog picked up on a story out of Topeka, Kansas, where the legislature held a hearing to discuss medical marijuana.  Supporters outnumbered opponents by a long shot.

Dramatic testimony was given by a son whose mother died from the FDA-approved prescription arthritis drug Humira.  Esau Freeman of Wichita read a two-page list of Humira’s known side effects and asked, “I’m here to ask you if we can do better. If patients in Kansas deserve the legal right to access safe and more natural medicine. I’m asking you as responsible and caring legislators of this great state of Kansas to investigate the evidence of medical marijuana with an unbiased and open mind.”

According to the Topeka Capital-Journal, Eric Voth, the chairman of the Institute on Global Drug Policy, claimed that the state of Oregon has mostly stopped pre-employment drug screenings after medical marijuana passed in 1998 because “they had no usable work force.”  Also during testimony, Voth claimed that in California, more prescriptions (recommendations) are filled on Friday afternoons by those under 25 than at any other time by any other group.  ”It’s a scam, it’s not a prescription,” Voth said.

Rep. Trimmer noted that few of the people testifying offered much in the way of scientific citation for cannabis’ proven medicinal benefits.  ”Do we have any evidence on either side from sources like the National Cancer Institute, the American Medical Association, the New England Journal of Medicine, the American Opthamological Association Journal?” Trimmer asked. “I would hope that we have something in the medical profession that tells us whether these things work or not. I like to base policy on sound research.”

OK, then…

National Cancer Institute:  The potential benefits of medicinal Cannabis for people living with cancer include antiemetic effects, appetite stimulation, pain relief, and improved sleep. Although few relevant surveys of practice patterns exist, it appears that physicians caring for cancer patients in the United States who recommend medicinal Cannabis predominantly do so for symptom management.

American Medical Association:  Results of short term controlled trials indicate that smoked cannabis reduces neuropathic pain, improves appetite and caloric intake especially in patients with reduced muscle mass, and may relieve spasticity and pain in patients with multiple sclerosis.

New England Journal of Medicine:  Federal authorities should rescind their prohibition of the medical use of marijuana for seriously ill patients and allow physicians to decide which patients to treat. The government should change marijuana’s status from that of a Schedule I drug … to that of a Schedule II drug … and regulate it accordingly.

American Academy of Ophthalmology:  …no scientific evidence has been found that demonstrates increased benefits and/or diminished risks of marijuana use to treat glaucoma compared with the wide variety of pharmaceutical agents now available. [This lady would beg to differ...]

The chairwoman, Rep. Brenda Landwehr, wasn’t buying any of the testimony from patients who told how cannabis had helped them medically.  ”I think that, if there was a huge benefit for those folks, the FDA would have already stepped in,” Landwehr said.

So once again we have opponents of medical cannabis use retreating to the tautological safety of the FDA excuse:

  1. Cannabis is not a medicine because it is not FDA approved;
  2. The FDA can’t study cannabis, because it is in Schedule I;
  3. Cannabis is in Schedule I because it is not a medicine.
  4. Return to Point 1.

The fact is the FDA can never approve cannabis as a medicine because that would be like asking you to define exactly what a dog looks like.  The FDA is set up to evaluate the beneficial and harmful effects of a certain amount of an exact molecule given consistently to test subjects.  The FDA can – and has – evaluated THC molecules in synthetic form and approved their medical benefits.

But evaluating whole plant cannabis involves too many variables, just as defining a dog runs the gamut from chihuahua and pug to St. Bernard and greyhound.  Sure, they all have four legs, tails, two eyes, etc., but some are short, tall, thick, thin, long snouts, flat faces, fast, slow, friendly, aggressive, and so on.  A dog that would serve well for an elderly woman in a city apartment might not work for a middle-aged man who likes hunting ducks.

The same applies to cannabis.  Even different buds picked from the same plant can have variance in their constituent cannabinoids.  Varieties that work great for aiding my creativity might not be beneficial for treating my co-host’s chronic pain.  One grower may cultivate that variety I like with better results.  Some days, I may want a different variety that eases my stress.

The main point is this: FDA approval of cannabis is unnecessary.  The whole point of the FDA’s creation was to protect us from the patent medicine manufacturers of the early 20th Century that were selling us “snake oil” of dubious value, elixirs that were sometimes harmful to health.  It continues to evaluate the new patent medicines devised by the chemistry of man to ensure their safety and efficacy.  Cannabis has 5,000 years of history of safe, effective use in humans.  It is not a new chemical substance whose effects and dangers are unknown; it is a plant as old as history.  Retreating to the FDA excuse or claiming there’s not enough scientific research is the last resort of the frustrated prohibitionist.

Marijuana-Based Mouth Spray Asks For Approval of FDA as A Painkiller

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A marijuana-based mouth spray may obtain approval of the United States Food and Drug Administration (FDA) before 2013 – that is what GW Pharma, a British manufacturer, expects. GW Pharma is in progressive clinical tests on the primary pharmaceutical in the world produced from

Marijuana-Based Painkiller Seeks FDA Approval

A quarter-century after the U.S. Food and Drug Administration approved the first prescription drugs based on the main psychoactive ingredient in marijuana, additional medicines derived from or inspired by the cannabis plant itself could soon be making their way to pharmacy shelves, according to drug companies, small biotech firms and university scientists.

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