Wednesday, December 23, 2015

DEA Eases Requirements for FDA-Approved Clinical Trials on Cannabidiol

DEC 23 - (Washington, D.C.) – The United States Drug Enforcement Administration (DEA) recently eased some of the regulatory requirements imposed by the Controlled Substances Act (CSA) for those who are conducting Food and Drug Administration-approved clinical trials on cannabidiol (CBD), an extract of the marijuana plant.  

These modifications will streamline the research process regarding CBD’s possible medicinal value and help foster ongoing scientific studies.  The DEA notified affected researchers by letter of the changes,  which take effect immediately. 

Federal Regulation 21 CFR 1301.18 requires researchers conducting CBD-based clinical trials under an FDA Investigational New Drug Application to have a DEA research registration.  This registration permits the possession of an approved amount of CBD for a specific research protocol.  Prior to now, researchers who expanded the scope of their studies and needed more CBD than they were initially approved for had to request, in writing, a modification to their DEA research registrations – potentially delaying that research while the modification underwent an approval process that includes both the DEA and the FDA.  Under these changes, a previously registered CBD clinical researcher who is granted a waiver can readily modify their protocol and continue their research seamlessly.  This waiver effectively removes a step from the approval process.
Marijuana is a Schedule I controlled substance because of the presence of tetrahydrocannabinol (THC), marijuana’s psychoactive ingredient.  Because CBD contains less than 1 percent THC and has shown some potential medicinal value, there is great interest in studying it for medical applications.  Currently, CBD is a Schedule I controlled substance as defined under the CSA. 
Though the FDA approves drugs for medical use in the United States, the DEA regulates the handling of all controlled substances, including those being used by researchers to conduct studies.

Sunday, December 20, 2015

Here's What's Happening Dumbasses! And Why You Screwed Up! Merry Christmas!

Let me begin by apologizing. That's always the best way to start. 

I am sorry for this self indulgent rant of limited scope. 

I grant myself this Indulgence free of charge as a Christmas present to myself. 

For the record, by the way, I believe in neither Santa Claus nor in any mystical, ancient myth of some creator who looks like Santa Claus only super fit, flying a magical beast-drawn vessel before the moon! 

That said, let me explain a small, but situationally relevant portion of the dumb shit you are a part of.

The People of The United States have ceded their authority, what of it they ever actually had, to various interwoven power bases...corporations, the Pentagon, and the Illuminati (this last one I'm throwing in there for the fun of it, to increase Internet search engine results and because, like I said, this is a Christmas present to myself).

It's arrogant and unproductive to be scornful of the US population for their ignorance of many matters (obviously matters of which I feel I am less ignorant than most. So, so much for avoiding my own arrogance)
The campaign against better judgement has been well funded, relentless and ingenious, whether or not it actually is a conspiracy of lizard skinned aliens.  



1: The Process
Where we are in history, as citizens of the US, for better or for worse, is part of the most successful world power ever.
Our military has dominated the last hundred years, culminating into a virtually unstoppable leviathan force which can go anywhere, anytime and do just about anything military men have ever wanted to do. Of course, once they do, they create a myriad of problems with which they are ill equipped to deal. But that's sort of the plan.
Once "the enemy" is beaten, the bureaucracy rolls in stamping sheets of paper and dividing up the spoils between contractors who will solve the problems the military is so ill equipped to deal with. The army breaks it down, then the bureaucracy hands out the pieces so the contractors can build it back up, in our image as much as possible.
At this stage of the game it really makes no difference whether or not people approve of this process. We, as in all of humanity, are knee deep into it and there is no turning back. "The West" won the World, using superb propaganda, a sustainable and viral, although inherently flawed economic model, a combined military force which, in total, has actually dominated the world for over a century, with a few punctuated fluctuations due to infighting, and with a history of dishonest or at best, unrealized treaties, including agreements with our own people.

(I will often use "The West" and "The US" interchangeably, as they are in fact reflections at times, of the same entities, where the US is the dominant internal force of the Liberalized West. None of my opinions about the morality, ethics, or quality of outcome should be interpreted as inherently anti Western. In fact, I am guilty of believing in many of the ideals of both modern and classical Liberalism, viewing the world as a dangerous place which has always had brutal wars, despots, abominable human rights, disdain for the individual, be they man, woman, or child, and constant conflict for resources. The fact that Western countries have rolled the current ball is merely a pin point in the history of humanity. My own opinions lean in the direction that Democracy, when properly realized and protected from corruption, is the best answer for human governance. And Capitalism, well, some form of free trade, also protected from corruption I might add, is necessary and expected in the free human soul. The prettier, nicer sister of Capitalism, free and fair trade combine into one wholesome spirit, which is the one we, as a self respecting humanity, should ultimately marry.)

2: Victory 
The US has been compared by many to the ancient Roman Empire, of course, some with a positive spin, others a negative bent. Either way, although somewhat comparable, it might be better to relax the lines a bit and realize the powers in control of resources, including corporate and military ventures are somewhat amorphous at times, and somewhat stratigraphic as opposed to geographic, as has been the case throughout Western history. Royal families, manipulating regional conflicts like players of some board game gave way to the empowerment of the Lords, then the Landed Gentry, the Merchant Class, then morphing into mist like, ghost powers flowing through mutated corporate charters feeding "fiduciary responsibilities." The outcome is similar perhaps. World domination. 
Regardless of whether or not one believes the amorphous ideas of the West have a positive or negative influence on the outcome of humanity, it can't be denied that those ideas and values have won the day, if for no other reason than they now control, at the least, the questions, if not always the answers. Those who refuse to ask the questions and seek the answers laid out by Western values, well, those elements are annihilated.
An argument for another day is the progression of the power base. Will the people as a whole ever actually wrest control from the higher strata of the Western economies?  Given that this outcome is in fact dependent on changing demographics and the currently rapidly shifting sands of populations in flux, only time will tell.
But defining exactly what we are, or divining exactly where we are going from here is not a prerequisite component of our need to understand that the West is currently and for the foreseeable future, "the victor" in world affairs. Given the ideals of Democracy and the control through the power of the voting booth, either actual or perceived, the force of progression is in the hands of Western populations who either feel as if they are in control of their governments or are in control, the latter being a sentiment that seems less prevalent today.
This control, again, whether actual or perceived, is the element against which those cultural forces not in line with the prescribed Westernization strike out. Terrorist attacks, although not understood by most Western citizens, are in fact the hopeless attempts of dying regimes and ideas lashing out with their last breath at the only thing they can reach. You and me. 
They cannot hope, as I might add neither can you or I at this point, to sway the progression of the leviathan or the following horde of culture. Their world is dying and it results in three very natural and predictable outcomes, submission, fight, or flight.
Thus, we have created, through our success, our problems, and theirs. This is Victory.
3: Arrogance
Arrogance and intolerance go together like ebony and ivory, only less melodic and more... what's the word? ...Evil.
The modern power of the West lies more in ideas, and in ideals than in tanks and bombs. In fact, though the tanks and bombs have in some instances opened up the way for our cultural manipulations and infiltration, the organic spread of Western ideas is by far the more potent and sustainable force for globalization.
Again, the fact that Western cultural ideas have so readily spread across the globe is a sign of their strength. The West, in many instances it must be recognized, in no way invented much of the ideals to which we as a culture subscribe. And we do not often fully adhere to these ideals. The main component of the power of Western thought, in fact, has been the adherence to inclusiveness. Of course this statement only relates to a post World War II West, and only in as much as we have glorified our own successes at human rights and minimized our multitude of abominable failures. This doesn't mean the culmination of the ideals we now hold are inferior, simply that, in their current form are still in infancy, as well as the reflection of ideas reincarnate from other struggles throughout history. This is why the tune resonates with so many. Though the current song is new, the notes are old, and beloved by any good person.
For years we have admonished and implored those in the world who were not singing, "Join our song! Join our chorus." And now, with victory at hand, this has begun. China, though still, and certainly always to be unique, has Westernized its architecture, clothing, culture, military, economy, you name it. Though Asia is growing, Asia is trending, it is all part and parcel of the greater trend of Westernization. We have shown that we will brook no peers to our military might. Yet, in this mimicry of Western strategy and tactics, that is exactly what China is becoming. This is in fact...submission.
The hold outs of the entrenched Middle Eastern, Arab countries are even falling into the flow. And there lies the current rub. With the complete and utter, and fairly mismanaged, destruction of the old power bases of the Middle East, those strident hold outs, still adherent to the old paradigm have entrenched themselves and their antiquated, near dead ideas and bodies to repel the uncompromising, unstoppable onslaught of the coming finalization of Westernization. Mayhem and destruction rule in the final days of the old order of repression and theocratic narcissism. But those innocent victims, those fleeing families and needy Western converts who would so love to have TVs and microwaves, clean water and the vote, come streaming out of these fallen countries, come running to the light. And what do we do? We turn them back.
This is the arrogance of which I speak. The power of "Liberator" vs the arrogance of "Invader" or "Occupier." No one can deny the West has won. In fact...people are flocking to enjoy our freedoms, our quality of life.
Controlling the flow is crucial, of course. Controlling the terrorist agendas of some violent extremists hiding in the flock of their victims...of course that is crucial too. But if we follow the commentary of the American Exceptionalism expressed in so many negative comments and inflammatory rhetoric directed at the very people we claim to be helping then our presence becomes more a product of forcing assimilation than assisting in liberation.
People from all over the world have been sold an idea, including citizens of Western countries, about Western ideals, from which support has been garnered. We must follow through on these ideals.
When individuals bring their cultural influences into Western countries it has been almost entirely for the benefit of our culture. So the idea that others are invading, or stealing our resources or culture, which is espoused by many to incite a fear response in the electorate, is just too far from the truth. Of course we need to isolate the violent, anti-democratic elements, even so far as to influence the effective reach of newcomers' political participation in Western governmental affairs. We don't have to let people in and immediately give them voting rights or 40 acres and a mule. But we need to allow only strategies on the side of assistance and welcoming. The positive side of that line can and will be rife with details, debate, fine tuning and mistakes. But it is the only moral approach to the new world.
4: Secularism 
If nothing else, the current crises and the involvement of and positioning in religious dogma fully highlights the need for only secular governments.
Secular Governments by their very nature are far more capable of protecting the rights of religious diversity than any theocracy could ever hope. Abuses of power, corruption, manipulation all seem to constantly creep into politics at any level. Religion has no place in that mix for so many reasons.
Some people who have enjoyed the prosperity and relative freedom from repression offered by the predominately secular Western governments often decry the lack of God in their Parliaments and Houses. But the very right to speak out is protected by these same "Godless" institutions. Attempting at every turn to slip some element of religion back into our government, many people fail to realize the damage that would cause and what temporary good it would do even their limited agendas.
Just look at the infighting among the nations who do lean heavily on their religious scriptures and theocratic governments. There is constant turmoil in an attempt to right ancient wrongs, interpret different passages, protect imagined sanctities. At the very least, providing some unspecific tribute to some potential deity could be tolerated. But in fact, without direct severance of government affiliation with religious agendas there will never be true religious freedom. If history, and the current crises around the world have taught us one thing, it is that change and control is never a one way street. Religious influence on Governments equals Government influence on religion. And then we have to ask...which religion wins, which denomination? 
Embracing differences is very gratifying when one opens their mind to the positive influences available through inclusiveness. Other cultures share with us their food, their songs, their dances, their stories and their blood when necessary. They arrive, become, and fight along side of us. That is the real story of immigration. 

So much fear surrounds the potential failure of the American way of life. But, in fact, that is the American way of life. We learn, live, succeed and fail together. These are the strengths of inclusiveness that have allowed us to become the dominant force for almost everything in the world today. If we give that up, we have lost. To not be the us that is and has become the US through trial, and error, and sacrifice and bleeding... That would be something other than what we are, which would mean we no longer are. 

It's time we honestly admit that we are an imperial force in the world, that our ideas and culture have spread and infiltrated almost every other corner of the globe, and therefore we have a responsibility to follow through. There can be no doubt that this follow through must contain honest, straight forward, constructive dealings, which have been the hallmark of any positive advances made since World War II. Just look to the strong ties of the former enemies of that conflict, who came together to be part of the democratized world and major driving forces of the global economy.

America is in charge of the skies and the seas. OK. Let's admit what the rest of the world knows. Now let's stick to the power, that gave us that power. That is the power of fairness, inclusivity and human rights. This paved the way for our success and will provide for all future success and sustainability. 

None of the rhetoric I hear today bothers to paint a clear and full picture. Too much pandering and posturing. Too much pulling for, or to, one side or the other. We need to mature as a country. We need to admit as a country. We need to commit as a country.

Yes! We have screwed the pooch on many issues. But until we pull together and stop responding to politicians who divide us into childish groups, sitting at different tables, whining and bitching like infants, we will continue to cause them to do that very thing. They respond to our responses. It is a ridiculous cycle.

Perhaps that is just the kind of divisiveness that the Illuminati wishes to instill in their subjects. It will make it easier for them to hide their lizard skin if we are too distracted to notice. 


By the way...Merry Christmas!      

(PS. If this was not adequately specific or you cannot glean from it the subtle inference of answers please remember it was primarily a rant and you're dumb.)  

Monday, December 7, 2015

Facing 'Keep it in the Ground' Protest, Feds Halt Fossil Fuel Auction Coinciding With Paris Climate Talks

Second Auction Halted in a Month Following Growing Protests
 
WASHINGTON— Facing a climate protest from a growing “Keep It in the Ground” movement, the Bureau of Land Management today halted an oil and gas auction scheduled for Thursday in Washington, D.C. The auction was scheduled as the Obama administration negotiates a climate deal in Paris this week.
 
Keep It in the Ground
Photo by Suchat Pederson.
“If the administration can’t handle the optics of auctioning fossil fuels while negotiating a climate deal in Paris, it shouldn’t be auctioning off fossil fuels at all,” said Taylor McKinnon of the Center for Biological Diversity. “It’s time to end the federal fossil fuel leasing program to align public lands management with our climate goals and keep as much as 450 billion tons of carbon pollution in the ground.”
In November, facing a previous “Keep It in the Ground” protest, the BLM halted another oil and gas auction in Utah. Auctions in Wyoming and Colorado were similarly protested this fall, with another slated for Reno, Nev., on Tuesday.

The protests are part of a rapidly growing “Keep It in the Ground” movement of local and national groups calling on President Obama to define his climate legacy by stopping new federal fossil fuel leases on public lands and oceans — a step that would keep as much as 450 billion tons of carbon pollution from escaping into the atmosphere.

The auctions highlight a significant conflict between the Obama administration’s climate goals and its “all-of-the-above” energy policy by leasing federal fossil fuels that should be considered “unburnable” in the context of global carbon budgets. Federal fossil fuels — those that the president controls — should be the first taken off the table to fight climate change.

“The ‘Keep It in the Ground’ movement is only getting stronger, and the Obama administration is going to face more and larger protests for auctioning off federal fossil fuels to the highest bidder,” said McKinnon.

Background
 
The American public owns nearly 650 million acres of federal public land, as well as more than 1.7 billion acres of the Outer Continental Shelf — and the fossil fuels beneath them. The federal public lands include national parks, national forests and wildlife refuges that make up about a third of the U.S. land area — and oceans such as Alaska’s Chukchi Sea, the Gulf of Mexico and the Eastern Seaboard. These places and fossil fuels are held in trust for the public by the federal government; federal fossil fuel leasing is administered by the Department of the Interior. 


The potential greenhouse gas emissions of unleased federal fossil fuels — including unleased oil and gas in Nevada — is incompatible with any U.S. share of global carbon limits to avoid dangerous warming. By ending new leasing, the president can remove as much as 450 billion tons of potential greenhouse gas emissions from the global pool. 

More than 400 organizations and leaders in September called on Obama to end federal fossil fuel leasing. They included Bill McKibben, Winona LaDuke, Robert F. Kennedy Jr., Dr. Noam Chomsky, Dr. Michael Mann, Tim DeChristopher, Dr. Stuart Pimm, Dr. Michael Soule, United Auto Workers Union, Unitarian Universalist Association, Physicians for Social Responsibility, Protect Our Winters, 350.org, Center for Biological Diversity, Environment America, Friends of the Earth, Food & Water Watch, Indigenous Environmental Network, Oil Change International, Greenpeace, Rainforest Action Network, REDOIL, Sierra Club, Great Old Broads for Wilderness, Waterkeeper Alliance, WildEarth Guardians and hundreds of others. 

On Nov. 4 Sens. Jeff Merkley (D-Ore.), Bernie Sanders (I-Vt.) and others introduced legislation to end new federal fossil fuel leases and cancel nonproducing federal fossil fuel leases. Days later Obama canceled the Keystone XL tar sands pipeline, saying, “Because ultimately, if we’re going to prevent large parts of this Earth from becoming not only inhospitable but uninhabitable in our lifetimes, we’re going to have to keep some fossil fuels in the ground rather than burn them and release more dangerous pollution into the sky.” 

Download the letter urging President Obama to cancel Thursday’s oil and gas lease sale here

Download the September “Keep It in the Ground” letter to Obama here

Download Grounded: The President’s Power to Fight Climate Change, Protect Public Lands by Keeping Publicly Owned Fossil Fuels in the Ground here (this report details the legal authorities with which a president can halt new federal fossil fuel leases). 

Download The Potential Greenhouse Gas Emissions of U.S. Federal Fossil Fuels here (this report quantifies the volume and potential greenhouse gas emissions of remaining federal fossil fuels). 

Download The Potential Greenhouse Gas Emissions factsheet here

Download Public Lands, Private Profits here (this report details the corporations profiting from climate-destroying fossil fuel extraction on public lands).

Wednesday, December 2, 2015

New Report: Airplane Pollution Jeopardizes Paris Climate Goals

PARIS— Airplanes could generate 43 gigatonnes of planet-warming pollution through 2050, consuming almost 5 percent of the world’s remaining carbon budget, according to a new Center for Biological Diversity report.
Up in the Air
Yet the Center’s analysis also finds that negotiators at the Paris climate conference are considering a draft agreement that, in its current form, is unlikely to create measurable effects on aviation pollution. (A Paris panel will address this issue Dec 3: details here.)
“A Paris climate deal that doesn’t address airplane pollution would represent a drastic failure to protect our planet,” said Vera Pardee, senior counsel at the Center. “The aviation pollution problem is too big and growing too quickly to be ignored. U.S. negotiators must back strong action in Paris to confront this jet-powered threat to our climate.”
The Center’s report finds that global greenhouse gas emissions from aircraft are a surprisingly large and fast-growing contributor to the climate crisis. If global aircraft emissions were compared to the greenhouse gas pollution of individual countries, they would rank seventh, just behind Germany and ahead of some 150 other countries.
U.S. airplanes have released 1.6 gigatonnes of carbon dioxide since 2007, when the Center and others first petitioned the U.S. Environmental Protection Agency to begin regulating aviation emissions. That’s equivalent to the CO2 emissions in 2014 from the entire U.S. electricity generation sector attributed to burning coal.
Without regulation, the Center’s report says, global aviation emissions will triple by mid-century. In 2050 aviation alone could emit more than 3 gigatonnes of carbon annually under a high-growth, business-as-usual scenario. By comparison Germany, the sixth-largest emission source by country, currently emits 0.84 gigatonnes per year.
Paris negotiators hope to produce an agreement that will help keep the global temperature rise below 1.5 to 2 degrees Celsius. But language folding aviation emissions into this goal was recently deleted from the Paris negotiating text and replaced by vague text that makes no mention of a temperature cap.
The International Energy Agency projects that the world’s estimated remaining carbon budget, consistent with a 50 percent chance of keeping temperature rises below 2 degrees Celsius, will be consumed by 2040 without aggressive international carbon emission cuts.
Airplane pollution could be reduced dramatically. A recent International Council on Clean Transportation report showed that some of the top 20 transatlantic air carriers can drive down greenhouse emissions by as much as 51 percent using existing technology and operational improvements.
But the aviation industry has fought measures to curb its carbon pollution for nearly two decades. It now supports standards under discussion by the International Civil Aviation Organization (ICAO) that would cover just 5 percent of the existing airplane fleet by 2030 and barely bend the curve of the industry’s steeply rising greenhouse gas pollution. 
The U.S. EPA issued a proposed rulemaking earlier this year finding that greenhouse gas pollution from America’s aircraft fleet harms the climate and endangers human health and welfare. Once the “endangerment finding” becomes final, U.S. law mandates that standards be set. The standards now under discussion at ICAO do not meet U.S. legal requirements.
“The Obama administration's climate legacy is at stake on the issue of aircraft emissions,” Pardee said. “Airlines’ denial and delay must not stop America and the international community from reining in the aviation industry’s skyrocketing pollution.”
The Center for Biological Diversity is a national, nonprofit conservation organization with more than 900,000 members and online activists dedicated to the protection of endangered species and wild places.