Research undermines medical marijuana claims

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You'd think that Cobra03 would be in favor of mj. As a hardcore conservative one would think (he?) would be against government control of what plants can and can't grow. Furthermore, the idea that government can control what an individual puts in their own body smells heavily extreme liberal principles. It's very confusing to understand unless it's a personal matter that hasn't resolved.
 

wrenhal

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You'd think that Cobra03 would be in favor of mj. As a hardcore conservative one would think (he?) would be against government control of what plants can and can't grow. Furthermore, the idea that government can control what an individual puts in their own body smells heavily extreme liberal principles. It's very confusing to understand unless it's a personal matter that hasn't resolved.
As with an argument with someone on abortion, everyone has their line in the sand, it's just different. I think abortion is murder, another doesn't call it murder until the kid takes a breath. Lines drawn. You think the government should regulate mj as medicine or for recreational use and at least tax it, I think the government should not allow it. Lines drawn. Just in different places.

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okstate987

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The point of the quote was simply:
Everything, here and everywhere else for that matter, about the discussion on mj is based on ignorance, we cannot know what we don't know (and regarding this discussion we are all ignorant some to a lesser degree and others like myself to a greater degree) regardless of how long or where you or anyone else studied, it wasn't directed at you, if you took it that way I'm sorry you took it that way. but that was your choice.

The only position I can take with certainty is that the Constitution does not grant the right to the federal gvt to determine what I can and cannot ingest, regardless of whether said substance is good or bad for me, that's entirely a man made directive to gain power (taxes commercial success etc...) over others.

Finally, the guy who ran our 6 sigma program, and our Malcolm Baldridge applications, was a Stanford PHD statistical scientist he was at the forefront of the big data movement some 30 years ago, he told some of us that science opens up a world of possibility because it is never right and never wrong, it is not binary nor final, only math /logic are binary and final.
Science is beautiful because it proves nothing, what it does is look at all possibilities and narrow your choices and then causes you to think about what and why you think the way you do, while urging you to continue to explore possibilities.
Having a pharmacy degree does not mean that a person is well read on herbs/supplements or marijuana. It just means they understand mechanism of action, side effects, interacions and efficacy of FDA approved medicines. They have the potential of understanding herbs and supplements well beyond the average person, but it requires them to spend time doing the research. Outside of a few popular herbs/supplements that interact with medicines (usually due to inducing/inhibiting cytocrome p450 enzymes that break down pharmaceuticals), that usually is the extent of their knowledge unless they have a personal interest in herbs and supplements.

There is also the appeal to authority issue that you went into.
 

ksupoke

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Having a pharmacy degree does not mean that a person is well read on herbs/supplements or marijuana. It just means they understand mechanism of action, side effects, interacions and efficacy of FDA approved medicines. They have the potential of understanding herbs and supplements well beyond the average person, but it requires them to spend time doing the research. Outside of a few popular herbs/supplements that interact with medicines (usually due to inducing/inhibiting cytocrome p450 enzymes that break down pharmaceuticals), that usually is the extent of their knowledge unless they have a personal interest in herbs and supplements.

There is also the appeal to authority issue that you went into.
Here’s a good read if you’re interested and haven’t already read it.

https://www.vox.com/cards/marijuana-legalization/where-is-marijuana-legal
 

RxCowboy

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I've always heard that we can't have real trials because it's classified as a schedule 1 drug at the federal level as well. But the truth is I don't know much about this stuff. I appreciate the knowledge. I know this type of thing is in your wheelhouse.

In your opinion, when will we have a solid amount of data to determine the short & long term side effects of marijuana? Or do we already have enough data to make those determinations?
It just isn't true, it's propaganda.

As far as data, are you talking about recreational or medicinal use, because the two are very different?
 

RxCowboy

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I don’t know why you replied like this, that wasn’t directed at anyone in particular, I would have replied directly to you if that was the intent.
BTW other people have studied other subjects and you don’t seem to want to acknowledge their expertise.
You had just said the following:
You’re straining at a gnat to swallow a camel here
Then you posted the meme. Now you pretend like they had nothing to do with each other.
 
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It just isn't true, it's propaganda.

As far as data, are you talking about recreational or medicinal use, because the two are very different?
A long time ago I talked to some of my family in California about medical marijuana. They said that just about anyone who wanted it would go to their doctor and tell them they wanted a prescription for it because they had back pain or headaches. Because of this, I've always viewed medical MJ as an excuse for recreational use and I don't really separate the two uses.

I heard a doctor on the radio today talking about SQ 788. He said that we still lack adequate trial data because MJ is still classified as a schedule 1 drug on the federal level. I did a little digging and I found out that schedule 1 drugs can in fact be studied, but the rules are really stringent and access to the drugs are extremely limited. So it's very difficult to do studies on schedule 1 drugs.

It kind of blows me away that MJ is classified as a schedule 1 drug while cocaine & meth are classified as schedule 2.
 

okstate987

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A long time ago I talked to some of my family in California about medical marijuana. They said that just about anyone who wanted it would go to their doctor and tell them they wanted a prescription for it because they had back pain or headaches. Because of this, I've always viewed medical MJ as an excuse for recreational use and I don't really separate the two uses.

I heard a doctor on the radio today talking about SQ 788. He said that we still lack adequate trial data because MJ is still classified as a schedule 1 drug on the federal level. I did a little digging and I found out that schedule 1 drugs can in fact be studied, but the rules are really stringent and access to the drugs are extremely limited. So it's very difficult to do studies on schedule 1 drugs.

It kind of blows me away that MJ is classified as a schedule 1 drug while cocaine & meth are classified as schedule 2.
Meth (Desoxyn) is still perscribed for treatment resistant ADHD which is why it is schedule 2. I agree that having Marijuana as a schedule 1 drug is a joke and does limit the number of studies one can do on it, but in the last few years, the DEA has allowed more studies. MDMA and Psilocybin are both in or have completed phase 2 clinical trials so it is possible, just expensive and difficult.
 

StillwaterTownie

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As with an argument with someone on abortion, everyone has their line in the sand, it's just different. I think abortion is murder, another doesn't call it murder until the kid takes a breath. Lines drawn. You think the government should regulate mj as medicine or for recreational use and at least tax it, I think the government should not allow it. Lines drawn. Just in different places.

Sent from my Moto G Play using Tapatalk
In other words, American public safety is best served keeping sales of marijuana underground and out of sight. God forbid that marijuana stores become as common as liquor stores to remind people every day that marijuana is freely available and for sale. Another thing about keeping marijuana banned is that the drug peddlers don't have to pay income tax, so you have more money from them flowing to the economy, rather than the government.
 
Last edited:

StillwaterTownie

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Marijuana addiction is real, and rising

SAN RAFAEL, Calif. - For as long as most residents can remember, smoking marijuana has been a part of life here. The fact that California legalized the practice in January went practically unnoticed in this quiet town a half-hour's drive north of San Francisco, where some say the normalization of America's marijuana culture got its start.

For Quintin Pohl and other teenagers before him, smoking pot was a rite of passage. It was a diversion from the loneliness he felt at home when his parents were splitting up and a salve for middle-school angst. It was his entire social life in seventh and eighth grades, he said, when social life is everything.

Even though nearly all his friends were using marijuana and seeming to enjoy it, Pohl said, at some point his marijuana use took a turn he never saw coming: He became addicted.

Many people are unaware of marijuana addiction. But in the public health and medical communities, it is a well-defined disorder that includes physical withdrawal symptoms, cravings and psychological dependence. Many say it is on the rise, perhaps because of the increasing potency of genetically engineered plants and the use of concentrated products, or because more users are partaking multiple times a day.

(Excerpt) Read more at sfgate.com ...
The story only spoke of what happens when high school kids use marijuana. Their school may grades go down. So no wonder in legal rec states users must be at least 21. High school kids are going to get addicted to marijuana whether it's legal or not. Parents need to do a better job of taking care of their kids. Alcohol and cigarettes are another matter.
 

StillwaterTownie

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A long time ago I talked to some of my family in California about medical marijuana. They said that just about anyone who wanted it would go to their doctor and tell them they wanted a prescription for it because they had back pain or headaches. Because of this, I've always viewed medical MJ as an excuse for recreational use and I don't really separate the two uses.

I heard a doctor on the radio today talking about SQ 788. He said that we still lack adequate trial data because MJ is still classified as a schedule 1 drug on the federal level. I did a little digging and I found out that schedule 1 drugs can in fact be studied, but the rules are really stringent and access to the drugs are extremely limited. So it's very difficult to do studies on schedule 1 drugs.

It kind of blows me away that MJ is classified as a schedule 1 drug while cocaine & meth are classified as schedule 2.
A researcher has to get the pot from the fed's pot farm in Mississippi. Feds prefer the research study propose to discover what is bad about marijuana, not what is good.
 
Well well.

Kathy Young/AP
The Food and Drug Administration on Monday approved the country’s first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy.

The drug, GW Pharmaceuticals’ Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb said in a statement. “And, the FDA is committed to this kind of careful scientific research and drug development.”

The FDA’s decision was expected. FDA officials had indicated they supported approving Epidiolex, and an advisory panel had unanimously recommended it get the green light. There was some concern about the drug’s effects on the liver, but experts have said this risk could be addressed by doctors as they monitor their patients during treatment.

Before GW can market Epidiolex, though, the Drug Enforcement Administration will have to reclassify CBD, which in this case, because it comes from marijuana, is considered a Schedule I drug, meaning it has no medical value and a high risk of abuse. The agency is expected to do so within 90 days.

“This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine,” GW CEO Justin Gover said in a statement. “These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

A company representative said the list price for the medication had not been set yet.

Patients with Lennox-Gastaut and Dravet syndromes, which typically emerge in the first few years of life, can suffer from debilitating and recurrent seizures, sometimes dozens a day. One in five patients is estimated to die before they are 20 years old.

There are six other drugs approved to treat seizures associated with Lennox-Gastaut, but none approved for Dravet.

Although Epidiolex was only approved for the two specific conditions, analysts expect doctors to prescribe it off label for a variety of epileptic diseases. It comes from a proprietary strain of cannabis grown by GW that has been bred to have high levels of CBD and low levels of THC, the component that does make people high.

The FDA has previously approved synthetic medications that resemble or are identical to THC. The drugs are listed as Schedule II and Schedule III, meaning they have medicinal value but also potential for abuse.

Many families have moved to states where marijuana is legal medically or recreationally so they could treat their children with CBD on their own. But experts have said that having a regulated medication with standard dosing and supply is crucial for patient safety, a sentiment echoed by Gottlieb in his statement Monday.

Gottlieb also used the approval to vouch for the years-long clinical development of Epidiolex as a model for bringing products made from marijuana to the market. The FDA is willing to help companies that want to pursue such research programs, he said, but they need to prove their products work and are safe with data from clinical trials.

“This is an important medical advance,” Gottlieb said. “But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.”

Gottlieb hinted at additional enforcement actions against companies that sell unregulated CBD products with medical claims that aren’t backed up by evidence. The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer’s fighters.

“Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases,” he said.

About the Author

Andrew Joseph
General Assignment Reporter
Andrew is a general assignment reporter.
 

wrenhal

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As with an argument with someone on abortion, everyone has their line in the sand, it's just different. I think abortion is murder, another doesn't call it murder until the kid takes a breath. Lines drawn. You think the government should regulate mj as medicine or for recreational use and at least tax it, I think the government should not allow it. Lines drawn. Just in different places.

Sent from my Moto G Play using Tapatalk
In other words, American public safety is best served keeping sales of marijuana underground and out of sight. God forbid that marijuana stores become as common as liquor stores to remind people every day that marijuana is freely available and for sale. Another thing about keeping marijuana banned is that the drug peddlers don't have to pay income tax, so you have more money from them flowing to the economy, rather than the government.
So while I acknowledge people can have different opinions, you don't care about my opinion and I should shut up. Got it.

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StillwaterTownie

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So while I acknowledge people can have different opinions, you don't care about my opinion and I should shut up. Got it.

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No, I don't want you to shut up, but wish you would answer a question I keep asking on here but don't get an answer, which is, if you want more people in prison over drugs, such as marijuana, how shall we raise your taxes to provide funding to build more prisons.
 

RxCowboy

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From medscape.com:


www.medscape.com

FDA Approves First Cannabis Drug for Rare Forms of Epilepsy
Deborah Brauser

June 25, 2018

The US Food and Drug Administration (FDA) has given the thumbs up to a purified formulation of cannabidiol (CBD) (Epidiolex oral solution, GW Pharmaceuticals) for the treatment of seizures related to two rare forms of epilepsy in patients older than 2 years of age. The two types of epilepsy indicated are Lennox-Gastaut syndrome and Dravet syndrome.

"This is the first FDA-approved drug that contains a purified drug substance derived from marijuana," the agency announced in a press release. "It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome."

"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies," FDA Commissioner Scott Gottlieb, MD, said in the same release.

"The FDA is committed to this kind of careful scientific research and drug development," added Gottlieb.

He noted that marijuana-derived therapies are most appropriately brought to patients through strict clinical trials that assess both safety and efficacy, and then by going through the FDA's stringent drug approval process.

The current drug was evaluated in three randomized, placebo-controlled studies with a total of 516 patients evaluated — all with Dravet syndrome or Lennox-Gastaut syndrome. Results showed that add-on therapy with the CBD product was more effective than placebo in reducing seizure frequency.

Because of these "well-controlled" trials, which were published in the New England Journal of Medicine and Lancet, "prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes," said Gottlieb.

Commonly reported adverse events in patients receiving the add-on treatment included elevated liver enzymes, sedation and lethargy, sleepiness, decreased appetite, fatigue, insomnia and poor sleep quality, infections and rash, and diarrhea.

Quality-of-Life Impact
Patients with Lennox-Gastaut syndrome often have seizures that begin as early as at age 3 years. More than 75% of patients with the syndrome experience tonic seizures; most children with it develop intellectual disabilities; and many patients have motor skill impairments.

Dravel syndrome affects babies during the first year of their life and causes frequent febrile seizures. As the patient ages, other types of seizures often occur, as does status epilepticus. These children also often have language and motor skill dysfunction.

"The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life," Billy Dunn, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

"In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition," added Dunn. A patient medication guide, describing drug use and risks, will need to be included with all prescriptions.

As reported by Medscape Medical News, an FDA advisory committee voted unanimously in April to support approval of this drug.

"It's an honor to be part of a meeting that's making an important decision based on science and public input rather than a political discussion," panel member Mark W. Green, MD, professor of neurology, anesthesiology, and rehabilitation medicine at Icahn School of Medicine at Mt Sinai, New York City, said at the time.

CBD is currently classified as a Schedule I substance under the Controlled Substances Act, so the new product will need to be rescheduled before it can be made available to patients.

After evaluating a scheduled substance, the FDA provides recommendations to the US Drug Enforcement Administration (DEA). The DEA must then make a scheduling determination.

Dravet syndrome had been granted fast-track designation by the FDA, and both it and Lennox-Gastaut syndrome were indications granted orphan drug designation. Application for the current drug was granted priority review designation.

"Historic Milestone"
"Today's approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies," Justin Gover, chief executive officer of GW Pharmaceuticals, said in its own press release.

"I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD," said Orrin Devinsky, MD, New York University Langone Health's Comprehensive Epilepsy Center, in the same release. Devinsky is also lead investigator in the Epidiolex Clinical Program.

He noted his relief that he and his colleagues "will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults."

Philip Gattone, president and CEO of the Epilepsy Foundation, called the newly approved drug "a true medical advancement" in a statement.

"Clinical development for these rare and severe conditions is essential, and today's news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures," said Gattone.

After it goes through rescheduling, which the company says is expected to occur within 90 days, "Epidiolex is expected to be available to appropriate patients by Fall 2018." A decision on approval recommendation by the European Medicines Agency is expected in the first quarter of 2019.

Follow Deborah Brauser on Twitter: @MedscapeDeb . For more Medscape Neurology news, join us on Facebook and Twitter .


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Cite this article: FDA Approves First Cannabis Drug for Rare Forms of Epilepsy - Medscape - Jun 25, 2018.