Politics

FDA Committee Recommends Approval of Pharmaceutical CBD

Washington, D.C. — An advisory committee for the Food and Drug Administration (FDA) on Thursday recommended approval of the first pharmaceutical grade cannabidiol (CBD) medicine to treat severe epilepsy. In a unanimous decision, the committee voted to recommend GW Pharmaceuticals drug Epidiolex for approval.

Cannabidiol, commonly referred to as CBD, is a non-psychoactive cannabis derivative. The approval of Epidiolex would be limited to treating seizures in patients aged 2 and older caused by Lennox-Gastaut syndrome and Dravet syndrome.

“Epidiolex represents hope for the many individuals living with intractable seizures and rare epilepsies, who every day face incredible challenges and disabling seizures, and live with the continual risk of serious injury and death,” said Philip Gattone, president and CEO of the Epilepsy Foundation.

[Related: In CBD-Legal Tennessee, Cops Raid Shops Selling Non-THC CBD Gummies]

Taking a natural product such as CBD oil and turning it into a FDA approved drug has the potential to limit the avenues that people have to access the natural product. Motherboard reported last year on the drug industry lobbying for legislation that would outlaw CBD oil by turning it into a drug. South Dakota Senate Bill 95 had sought to exempt CBD from the definition of cannabis, thus taking it off Schedule I controlled substance list and becoming a Schedule IV substance.

GW Pharmaceuticals and its U.S. subsidiary, Greenwich BioSciences, lobbied for an amendment to the legislation to limit CBD rescheduling to only FDA-approved products— in other words, they wanted only CBD drugs to be legally obtainable.

A 2017 report from Motherboard explained:

Not surprisingly, GW Pharmaceuticals has just such a drug in the pipeline. Epidiolex, a ‘proprietary oral solution of pure plant-derived cannabidiol,’ has already been given to epileptic children in the U.S. as part of a federal investigative study documented recently in the New England Journal of Medicine.”

“Since no other pharmaceutical company has a CBD drug anywhere close to market, and the wide range of CBD products already available in medical marijuana states lack FDA approval, if the bill had passed with that amendment intact, patients in South Dakota would have been subjected to a virtual CBD monopoly …

More ominously, The Great CBD Battle of South Dakota appears to be but the opening salvo in a nationwide war between GW Pharmaceuticals and traditional medical cannabis providers …

[U]nder the amendment, South Dakota would … ban myriad CBD products already available in many other states. Even though they cost far less than Epidiolex, and are potentially more effective for patients, since in addition to CBD those ‘full spectrum’ cannabis extracts also contain small amounts of THC and other medicinal components of the plant.

Motherboard also noted that “corporate lobbyists in more than 20 states are currently pushing to make sure the pharmaceutical industry has the only legal supply of CBD.” Thus, it appears the big pharma takeover of CBD is underway.

“It’s incredibly important as a physician prescribing to patients that we know what we’re giving them and we know we give them one month will be the same that we give them three or six months later,” said Dr. Orrin Devinsky, director of NYU Langone Epilepsy Center, attempting to explain the importance of pharmaceutical intervention in the CBD market.

“It’s very important to highlight that the drug used in this study, cannabidiol, was derived from cannabis plants, and purified to 99 percent purity,” Devinsky told NBC News. “This is not something you can get from a dispensary today in the United States. It’s not something that you can get by smoking marijuana. It is a very specific pharmaceutical grade product derived from marijuana, but quite different than what is available anywhere else right now in the United States.”

NBC News reported that the FDA has indicated that it will likely approve Epidiolex. Although the recommended use for this particular product is very limited, doctors may prescribe it at their discretion.

“Both by Lennox-Gastaut syndrome and Dravet syndrome are rare, severe, refractory epilepsy syndromes with onset in early childhood,” the FDA stated.

“The results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome (LGS and DS),” the FDA said in briefing documents given to the advisory committee ahead of Thursday’s meeting.

“In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders.”

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Politics

Dave Rubin Accuses YouTube of Demonetizing Interview With Thomas Sowell

Political commentator and host of “The Rubin Report” Dave Rubin has claimed that YouTube demonetized a segment of his video interview with famed economist Thomas Sowell. The segment reportedly targeted is the first part of the full interview, titled “Thomas Sowell on Facts and Free Speech.”

Rubin is the host of The Rubin Report, an online talk show that covers numerous topics including social issues and politics. Rubin’s videos have also featured discussions with public figures including Philip DeFranco, Bob Saget, Jack Conte, John Kasich, Laci Green, Larry King, Roseanne Barr, Austin Petersen, and Adam Carolla.

Through a series of tweets, Rubin explained that the video was initially monetized before becoming demonetized.

YouTube eventually confirmed that “the automated system recently applied a yellow icon,” and stated that “a video’s classification may change after it’s published as our systems continue to analyze more info from the video.” YouTube added that “this video has yet to be manually reviewed, so please request one!”

Rubin replied that he had already requested a manual review and questioned how the content of the video would warrant demonetization, as well as Youtube’s protocols for reviewing video.

This is not the first incident in which Rubin has claimed that his videos were demonetized. As early as May 2017, Rubin discussed the issue and claimed that demonetization of his videos led to a decrease in revenue of 60 percent.

In January, Rubin stated that YouTube had demonetized an interview with Ben Shapiro, the Editor-in-Chief of Daily Wire. Later in the month, Rubin made another claim regarding demonetization of a video that criticized socialism.

In February, he again publicly called out YouTube for demonetizing a video interview with Shapiro and Jordan Peterson while showing ads on the video in question. In that incident, The Daily Caller reported that when it had asked for an explanation from YouTube, a spokesperson “blamed the original demonetization on the platform’s algorithms.”

In March, Ben Swann published a Reality Check that explored the topic of tech giants censoring certain content, noting that targets are often content creators that are “not part of the establishment structure.”

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Politics

WATCH: Pink Floyd’s Roger Waters Calls White Helmets a “Fake Organization”

Barcelona, Spain – Pink Floyd’s Roger Waters, during a recent solo concert in Barcelona, stopped mid-concert to address the recent bombing of Syria – under pretense of retaliation for an alleged chemical attack – and called out the White Helmets as a “fake organization that exists only to create propaganda for jihadists and terrorists.”

Waters said he had been approached by a man prior to the concert who wanted to get onstage to speak on behalf of the White Helmets regarding the alleged chemical attack in Douma, but instead chose educate the crowd himself. Although well intentioned, Waters said he believed the person had simply been misled about the White Helmets.

“The White Helmets is a fake organization that exists only to create propaganda for jihadists and terrorists,” Waters said. “That’s my belief. We have opposing beliefs. If we were to listen to the propaganda of the White Helmets and others, we would be encouraged to encourage our governments to start dropping bombs on people in Syria. This would be a mistake of monumental proportions for us as human beings.”

Officially known as Syria Civil Defense, the White Helmets were founded in 2013 by James Le Mesurier, a former British military intelligence officer and private security specialist, and are largely funded by the U.S. and UK governments. Investigative reporter James Corbett delved into the White Helmets as a western propaganda construct in a video earlier this year.

Waters went on to say that individuals should “persuade our governments not to go and drop bombs on people,” going on to imply that a rush to judgement based on propaganda isn’t a substitute research, likely in direct reference to the US-led attack on Syria, based on the Douma chemical allegations.

“What we should do is go and persuade our governments not to go and drop bombs on people. And certainly not until we have done all the research that is necessary so that we would have a clear idea of what is really going on. Because we live in the world where propaganda seems to be more important than the reality of what is really going on,” he added.

Waters has been a staunch anti-war activist throughout his career and has never shied away from controversial stances. For instance, in 2016, he explained that the entertainment industry discourages individuals from calling out the atrocities committed by the Israeli military, and how the “boycott, divestment and sanctions” (BDS) campaign was targeted:

The only response to BDS is that it is anti-Semitic, I know this because I have been accused of being a Nazi and an anti-Semite for the past 10 years. My industry has been particularly recalcitrant in even raising a voice [against Israel]. There’s me and Elvis Costello, Brian Eno, Manic Street Preachers, one or two others, but there’s nobody in the United States where I live. I’ve talked to a lot of them, and they are scared s***less.

“If they say something in public they will no longer have a career. They will be destroyed. I’m hoping to encourage some of them to stop being frightened and to stand up and be counted because we need them. We need them desperately in this conversation in the same way we needed musicians to join protesters over Vietnam,” he added.

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Politics

Chuck Schumer wants to legalize it

Top Senate Dem. announces marijuana legislation on 4/20

Senate minority leader Chuck Schumer (D., N.Y.) on Friday morning announced his intention to introduce legislation to decriminalize marijuana federally.

“Today, I am formally announcing my plan to decriminalize marijuana at the federal level. It’s time we allow states, once and for all, to have the power to decide what works best for them,” Schumer wrote on Twitter.

Schumer’s official announcement followed a Thursday night interview with Vice News, in which he discussed his legalization agenda. The sexagenarian Senator also signed a bong for the news site, which has attained a marijuana-laced reputation with articles like “The Best Weed Strains for Mind-Blowing Sex.”

Via Free Beacon
Featured Image: Sen. Chuck Shumer (NY-D) (Morning Joe/Flickr)

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Democratic Party files suit alleging Russia, the Trump campaign, and WikiLeaks conspired to disrupt the 2016 election

Intellihub editor’s note: The Democrats along with deep state operatives are making a last ditch effort to thwart the latest push by key Republicans who plan to prosecute Hillary Clinton and others for colluding with the Russian government in various uranium deals and more. Looks the the Dems are squirming.

  • The Democratic National Committee sued the Trump campaign, the Russian government, Wikileaks on Friday, accusing them of conspiring to disrupt the 2016 presidential election.

  • President Donald Trump’s son Donald Trump Jr. and son-in-law Jared Kushner are among the defendants.

  • The DNC says Russia found a “willing and active partner” in the Trump campaign to attack American democracy and defeat Hillary Clinton.

The Democratic Party on Friday sued President Donald Trump’s presidential campaign, the Russian government and the Wikileaks group, claiming a broad illegal conspiracy to help Trump win the 2016 election.

The multi-million-dollar lawsuit filed in Manhattan federal court says that “In the Trump campaign, Russia found a willing and active partner in this effort” to mount “a brazen attack on American Democracy,” which included Russian infiltration of the Democratic Party computer network.

The Trump campaign, according to the lawsuit, “gleefully welcomed Russia’s help.”

The suit says that “preexisting relationships with Russia and Russian oligarchs” with Trump and Trump associates “provided fertile ground for [the] Russia-Trump conspiracy.”

Via CNBC
Featured Image: Matt Wade/Flickr

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