We Need Proof on Marijuana
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We Need Proof on Marijuana
Posted by CN Staff on February 13, 2014 at 05:07:24 PT
By Orrin Devinsky and Daniel Friedman
Source: New York Times 
USA -- Many people have heard the story of Charlotte Figi, a young girl from Colorado with severe epilepsy. After her parents began giving her a marijuana strain rich in cannabidiol (CBD), the major nonpsychoactive ingredient in marijuana, Charlotte reportedly went from having hundreds of seizures per week to only two or three per month. Previously, her illness, Dravet Syndrome, was a daily torture despite multiple high doses of powerful anti-seizure drugs.
As news of Charlotte’s story moved from the Internet to a CNN story by Dr. Sanjay Gupta to Facebook pages, some families of children with similar disorders moved to Colorado, which recently legalized marijuana, to reap what they believe are the benefits of the drug.Dozens of other anecdotes of miraculous responses to marijuana treatments in children with severe epilepsy are rife on Facebook and other social media, and these reports have aroused outsize hopes and urgent demands. Based on such reports, patients and parents are finding official and backdoor ways to give marijuana to their children. But scientific studies have yet to bear out the hopes of these desperate families. The truth is we lack evidence not only for the efficacy of marijuana, but also for its safety. This concern is especially relevant in children, for whom there is good evidence that marijuana use can increase the risk of serious psychiatric disorders and long-term cognitive problems. The recent wave of state legislatures considering and often approving medical marijuana raises significant concerns. By allowing marijuana therapy for patients with diseases such as difficult-to-control epilepsy, are state legislatures endorsing the medical benefits and safety of a broad range of marijuana species and strains before they have been carefully tested and vetted? Marijuana contains around 80 cannabinoids (THC is the major psychoactive cannabinoid, largely responsible for the high) and more than 400 other compounds. The chemical composition of two genetically identical plants can vary based on growing conditions, soil content, parasites and many other factors. While the language of the legislation may be cautious, there is an implied endorsement of medical benefit for marijuana when a legislature passes a bill and a governor signs it into law, and the tremendous gaps in our knowledge are not effectively conveyed to the public.Where is the data showing that marijuana is effective for epilepsy? Although parents may report improvements in their children, it is important to remember that the placebo response is powerful, and the placebo response is greater in pediatric than adult studies.Before more children are exposed to potential risks, before more desperate families uproot themselves and spend their life savings on unproven miracle marijuana cures, we need objective data from randomized placebo-controlled trials. Based on studies showing that CBD can prevent seizures in animals and safety data from patients treated with a drug containing CBD and THC in Europe for multiple sclerosis spasms, we and other academic epilepsy centers are planning a controlled trial with pure CBD. As an initial step, we have approval from the Food and Drug Administration, the Drug Enforcement Administration and the Bureau of Narcotic Enforcement to treat children with CBD derived from marijuana plants in order to understand its safety and tolerability and potential drug interactions. This information will help us plan the placebo-controlled trials that we hope will begin in 2014 and will be completed within two years. There is no reason such studies cannot be done with other products derived from marijuana, such as the oil with high CBD and low THC sold in Colorado that was used by Charlotte Figi.Paradoxically, however, as state governments increasingly make “medical” marijuana available to parents to give to their children, the federal government continues to label the nonpsychoactive CBD — as well as THC — as Schedule 1 drugs. Such drugs are said to have “no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.” This designation hamstrings doctors from performing controlled studies. While it is possible to study Schedule 1 drugs in a controlled laboratory setting, it is extremely difficult to study these substances in patients. For our study, we keep the CBD in a 1,200-pound safe in a locked room, in a building with an alarm system. To foster research, we need to change compounds derived from marijuana from Schedule 1 to a less restrictive category. It is troubling that while few barriers exist for parents to give their children marijuana in Colorado, there are significant federal roadblocks preventing doctors from studying it in a rigorous scientific manner.When patients have not been able to get successful medical treatment, and they live in a state where the law allows medical marijuana for children — we are not suggesting they smoke the drug — compassionate use is reasonable. But for the long-term health of Charlotte and other patients like her, we urgently need valid data. Orrin Devinsky and Daniel Friedman are physicians at the NYU Comprehensive Epilepsy Center. A version of this op-ed appears in print on February 13, 2014, on page A27 of the New York edition with the headline: We Need Proof on MarijuanaSource: New York Times (NY)Author: Orrin Devinsky and Daniel FriedmanPublished: February 13, 2014Copyright: 2014 The New York Times CompanyContact: letters nytimes.comWebsite:  Medical Marijuana Archives 
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Comment #23 posted by Hope on February 22, 2014 at 17:35:43 PT
PubMed and Jpet
Storm Crow, I'd send them an email about what you've found.
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Comment #22 posted by Storm Crow on February 22, 2014 at 15:46:37 PT
About the discovery of THC- 
All I know is that when you run "Tetrahydrocannabinol" at PubMed, the earliest 3 studies listed (no abstract available, unfortunately) are dated 1947/1948/ 1948! And there is a 1946 study over at jpet- the Journal of Pharmacology and Experimental TherapeuticsSTUDIES ON THE PHARMACOLOGY AND ACUTE TOXICITY OF COMPOUNDS WITH MARIHUANA ACTIVITY (it has one of those huge URLs you don't like, FOM, so they can copy&paste the title to see it.) It starts out - "1. The acute toxicity of the highly marihuana-active natural charas tetrahydrocannabinol (acetate), its somewhat less active synthetic homolog, parahexyl, the feebly active hemp component cannabinol, and the inactive hemp component cannabidiol was studied in mice, rabbits, guinea pigs, cats and dogs." So what the heck is going on? PubMed and Jpet don't both publish wrong dates on studies, do they?   
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Comment #21 posted by FoM on February 20, 2014 at 05:23:35 PT
New York Times LTE: Medical Marijuana
To the Editor:Orrin Devinsky and Daniel Friedman’s Op-Ed essay, “We Need Proof on Marijuana” (Feb. 13), highlights a significant problem with current drug policy.While there is no shortage of anecdotal evidence about the medical benefits of marijuana, federal barriers prevent doctors from scientifically studying marijuana. The fact that the Controlled Substances Act lists it as a Schedule 1 substance — like heroin or LSD — is part of the problem.Researchers seeking access to it must jump through complicated bureaucratic hoops. In fact, a federal administrative law judge ruled in 2007 that researchers had been denied adequate access to marijuana.That is part of the reason that I, joined by 17 of my House colleagues, have formally requested that President Obama reschedule marijuana from Schedule 1 to a less restrictive classification.More than one million people legally use medical marijuana in 20 states and the District of Columbia. It’s time the federal government caught up with the rest of America.EARL BLUMENAUER
 Washington, Feb. 14, 2014The writer, a Democrat, represents the Third District of Oregon. A version of this letter appears in print on February 20, 2014, on page A20 of the New York edition with the headline: Medical Marijuana
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Comment #20 posted by Hope on February 17, 2014 at 18:56:33 PT
Comment 18
Sharp eye, Afterburner. You're right.
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Comment #19 posted by Oleg the Tumor on February 17, 2014 at 07:21:42 PT:
#14 - Thank You Storm Crow!
Fascinating how this tidbit of medical evidence "went to prison" before I was born. By the time I started to have the full "shake and bake" experience in 1979, they could have developed some better meds. Phenobarb causes too much impairment for most people (me included). Tegretol vacuums sodium from the body and landed me in the hospital for my birthday a few years ago.Dilantin is a safe drug and works well as does Keppra. Cannabis is the safest, most theraputic natural substance in the healers arsenal. Unfortuately, MJ stood in the way of those monied interests hell-bent on a eugenics crusade to "improve society for the sake of posterity". This meant forced sterilizations, prison and extermination according to a full list of BS specifications.And these Gilded Age types in their top hats and tails ran about, urgently proclaiming how it is up to the Captains of Industry to maintain that "Purity of Essence" (made so famous by General Ripper in the film "Dr. Strangelove")They continue today, reaching in to control with cash what cannot be controlled with spin, omission and obfuscation. And now the Ignoid ray gun no longer works. The battery is dead. The "salt of the Earth" have caught up with the "yeast of the Pharasees"! This is a good age to be alive.Somebody pinch me! Is this "Age of Singularity" really upon us? If so now, it is by default. The "Age of Plurality" is quite likely, over, for now. This means when it comes to the Truth, you're own your own. Everyone has to decide for themselves and themselves only. The whole world is about to wake up to see who the criminals really are!SOON, THE LAST MJ BUST WILL OCCUR!(Hopefully it has already)
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Comment #18 posted by afterburner on February 17, 2014 at 06:50:11 PT
something doesn't add up
StormCrow 14THC in 1947, 1949?THC discovered in 1964! See "The Man Who Discovered THC."
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Comment #17 posted by keninsj on February 16, 2014 at 23:57:09 PT:
Thank you Storm Crow
If I click directly on the link it works, I was trying to open in a new tab, or copy and past and that did not work.I got it though, good stuff.
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Comment #16 posted by Storm Crow on February 16, 2014 at 21:58:15 PT
I just opened it using the posted link, and it was there for me! Try copying the title and doing a search for it! It is up at a couple of sites. 
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Comment #15 posted by keninsj on February 16, 2014 at 16:23:58 PT:
Storm Crow
The link you posted does not open. I tried to find it through the site, but I am not able to. Could you repost it, or edit it? I tried with chrom and Ie
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Comment #14 posted by Storm Crow on February 16, 2014 at 15:13:47 PT
From 1949....
Anti-epileptic Action of Marijuana-Active Substances    (full - 1949) I'm 66, and I was just barely out of diapers when that 1949 study came out! So just how far back do we need to go with the evidence? It IS there if you look! My new 2014 Granny's List has 10 pages of links on epilepsy and the various cannabinoids. How much more proof do they need? 
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Comment #13 posted by keninsj on February 14, 2014 at 23:31:05 PT:
Pure CBD
"centers are planning a controlled trial with pure CBD"This part concerns me, without all the other compounds in Cannabis, how do we know if CBD is effective. We know there are relationships between CBD and THC where CBD helps to calm the effect of THC. My concern is if pure CBD without any of the other compounds may cause unforeseen problem and then cause them more fuel for their fire. I could see the prohibs using this kind of strategy. The plant is perfect the way it was created.
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Comment #12 posted by FoM on February 14, 2014 at 15:40:16 PT
It's good to see you. I hope all is well out in your neck of the woods. We have been having snow and sub zero temperatures and are looking forward to Spring.
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Comment #11 posted by museman on February 14, 2014 at 12:37:45 PT
"It is dangerous to educate a person beyond their own intelligence. It makes dumb people think they are smarter than they really are."SO profound! I will quote you and spread it around.One reason why "Scum always rises to the top." LEGALIZE FREEDOM
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Comment #10 posted by The GCW on February 14, 2014 at 09:03:27 PT
Faith At Heart Of Work By Brothers Who Developed Medical Marijuana Oil(The Stanley brothers have become famous for developing Charlotte's Web) Christians accused them of doing "Satan's work."
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Comment #9 posted by Ryannn29 on February 14, 2014 at 08:43:38 PT:
I don't get how the author can go from how kids with Epilepsy use CBD then try to explain that marijuana has over 80 chemicals. They ARE not ingesting marijuana, they are taking CBD! That's just one chemical, it's an extract! And we're well aware of its effects, which do not include getting high.
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Comment #8 posted by The GCW on February 14, 2014 at 06:47:05 PT
Safety on a Biblical scale.
"The truth is we lack evidence not only for the efficacy of marijuana, but also for its safety."-0-In over 5,000 years of documented use cannabis has not killed a single person. That's safety on a Biblical scale.If cannabis were to kill one person We would have evidence. But since it has killed nobody, WE DON'T HAVE EVIDENCE??????
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Comment #7 posted by Universer on February 13, 2014 at 18:51:34 PT
Not Just Proof That's Missing
"Where is the data showing that marijuana is effective...?"That is impossible to obtain because cannabis is impossible to test, due to its non-medical categorization by the federal government as Schedule 1.Where is the call in this opinion piece for cannabis to be re-scheduled?Unlike evidence for cannabis' efficacy, that doesn't exist.These two gentlemen are either disingenuous, ill-informed, or both.
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Comment #6 posted by Oleg the Tumor on February 13, 2014 at 16:08:55 PT:
That 2nd Debt that Dr.s Must Service! 
After their student loans, a Dr. MUST continue to service the debt owed to the Medical Profession as a whole.Observing this debt requires a physician to observe that SCIENCE always works "top down". No info from the bottom is possible. Your testimony as a patient is merely "anecdotal".If its your daughter who goes from "having hundreds of seizures per week to only two or three per month", sorry, but you are only telling an anecdote.Your witness is not valid because you are not a doctor.
You are not qualified to influence a true professionals judgement.You are a patient, know your place!And they wonder why we walk away.
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Comment #5 posted by Swazi-X on February 13, 2014 at 14:13:00 PT
that this article is calling for proof of safety in using cannabis, especially with children, then continues to say the authors (who stand to benefit financially in this area) have the ok from the FDA, DEA and others to go ahead and administer this unproven, possibly dangerous substance TO CHILDREN.Kids are not guinea-pigs, and if these clowns truly are concerned about cannabis' safety why are they using real children as testing platforms for the basic safety they claim is as of now unknown? Apparently they're unconcerned that they might be causing "...serious psychiatric disorders and long-term cognitive problems." in their test subjects. How is that ethical? Why shouldn't they be investigated for risking the long term health of the very children they say they're concerned about?With all the technology and science and education these shlubs of physicians have at their disposal, and with their dismal track record of actually curing the causes of epilepsy, not to mention the debilitating side effects of the brutal chemicals that are their only tools, of course they'll throw aspersions on something so cheap, so effective, and so powerful and especially so safe (if you believe over 10,000 years of anecdotal evidence). This "devil weed" strikes fear into the heart of greedy doctors all over the world.This lowly plant will humble the AMA - if that's even possible - and cut Big Pharma down to size once the benefits are more widely known. Those using it in MMJ states already know - which is why this is spreading like wildfire across the country. We can now grow our own cure for most of the hugely-profitable chronic diseases that sap our finances and fatten physicians and chemical/pharmaceutical companies worldwide, but always be aware of the profit driven excuses for "caution" and "more studies" thrown in the road to delay the inevitable loss of income by those who bank on our continued ill-health.
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Comment #4 posted by schmeff on February 13, 2014 at 10:07:14 PT
The Med/Pharma Empire Strikes Back!
Doctor Desperate: "Long ago, in a USA far, far away, we knew cannabis was medicine. But it was more profitable to claim it was not, and prohibit the herb so as to sell the people corporate medz. But for seven decades, our massively funded war and propaganda campaign has failed to quell the Resistance, and battle by battle, we lose the war of misinformation. Too many people have rediscovered that cannabis is not toxic like corporate medz. Where safety leads, profits follow.""With the Empire in jeopardy, we must again pivot our strategy and acknowledge - rediscover, if you will - that cannabis is medz. And there is the brilliance of our plan!
Medz. Never herb. For God's sake don't say 'herb'. Medz can be derived from herbs, but only for profit by the Empire.Medz belong to the Empire. Only we, who have all the $cientists and huge budget$ can prove the $afety of medz. We must always emphasize that medz can be dangerous if not properly magicated by the Empire. I'm considering this for the press release, what do you think?""For our study, we keep the CBD in a 1,200-pound safe in a locked room, in a building with an alarm system."
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Comment #3 posted by runruff on February 13, 2014 at 07:59:18 PT
Kaleidoscope brains
It becomes obvious to me that some people are educated beyond their own ability to comprehend what they have learned.Too much knowledge stored in a brain of limited intellect is only confusing and knowledge becomes a kaleidoscope of swirling images, theories and possibilities.It is dangerous to educate a person beyond their own intelligence. It makes dumb people think they are smarter than they really are.
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Comment #2 posted by Sam Adams on February 13, 2014 at 07:35:33 PT
who's "we" sucka?
Wow, just when you think the NY Times can't more elitist - it does! who's "We" exactly? The Deep State billionaires? Big Pharma? The Kennedy family?  Rockefellers?I thought the USA was founded on the values of self-reliance and freedom. No "we" necessary to treat your family with herbs and medicine. 
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Comment #1 posted by The GCW on February 13, 2014 at 06:45:28 PT
Proof there for people with eyes and brains.
"Charlotte reportedly went from having hundreds of seizures per week to only two or three per month." There are many other similar findings with children having seizures experiencing results. And lately, I've learned there are a lot of children in America having seizures often.How is going from hundreds of seizures per week to almost nothing, NOT PROOF?-0-"We Need Proof on Marijuana""The truth is we lack evidence"-0-So now Americans are witnessing a problem where because of lack of "proof" prohibitionists want to prohibit using a substance proven to work, WHICH HAS BEEN BANNED FROM MAKING PROOF AVAILABLE.And now citizens are not about to wait on the IGNOIDS who created the problem and perpetuate the problem any more.
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