June 05, 2018

Government Munificence: Negotiating Drug Prices in Medicare Plan D

"We've seen how monopolies - whether government granted or government 'sanctioned', through inadequate enforcement of competition laws - have built the fortunes of many of the World's wealthiest people. But there is another way to get rich. You can simply arrange for the government to hand you cash. This can happen in a myriad of ways. A little-noticed change in legislation, for example, can reap billions of dollars. This was the case when the government extended a much-needed Medicare drug benefit in 2003. A provision in the law that prohibited government from bargaining for prices on drugs was, in effect, a gift of some $50 Billion or more per year to the pharmaceutical companies."

The Price of Inequality: How Today's Divided Society Endangers Our Future by Joseph E. Stiglitz



Medicare Part D Prescription Drug Program was passed as the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003 and went into effect in 2006. The legislation establishes a voluntary program for people on Medicare for prescription drugs. The program does not allow the government to negotiate prescription drug prices yet subsidizes the variety of plans offered by private insurance companies. Instead, prices are worked out by drug companies and private insurance companies. 

This isn't about the divide between Republicans and Democrats. This is about the amount of control pharmaceutical companies and insurance companies have on the US government and how it affects the quality of the life of the individual. A Republican administration enacted legislation with this provision and Obama backed off negotiations to include it in legislation in order to get the Affordable Health Car Act passed. Trump did not include the language in his new health care reform bill. 

A Kaiser Family Foundation Poll published in August of 2015 showed 93% of Democrats and 74% of Republicans favor letting the government negotiate Part D prescription drug prices. So, a very popular idea meant to save money for seniors, people with disabilities and taxpayers is not being allowed to progress in congress because politicians are not standing up to pharmaceutical and insurance companies. 


Many bills to allow the government to negotiate drug prices have been proposed and killed in appropriations hearings since 2003. In October 2017, legislators introduced The Medicare Drug Price Negotiation Act of 2017 to direct the Secretary of the Department of Health and Human Services to negotiate lower prices for prescription drugs under Medicare Part D but the bill has stalled once again and Trump, who promised to include this in his health plan reform bill removed it just before unveiling the proposed legislation. 

By the way, the US Department of Veterans Affairs, a government agency, does negotiate the cost of pharmaceuticals for those who have served in the military. So the government demands they control negotiations on the prices of prescription medication for the military, but not US Citizens who have not served. 

So. Do You think the US Government should be negotiating prices for prescription drugs? Why or Why Not? 


The Price of Inequality

Article Reference: 

Medicare Part D Content and Appeals
Article Fact Checking on Medicare Part B
Mother Jones Article on Lobbying Efforts
Obama Back of Negotiations
Kaiser Family Foundation Poll
US Department of Veterans Affairs Drug Prices
Trump Removes Language for Government Negotiations

June 01, 2018

Medical Marijuana in Oregon: Regulation in a Direct Democracy State

Direct Democracy, or pure democracy exists where citizens write policy initiatives themselves. If activist groups collect enough signatures in the allotted time, the initiative makes it to the ballot. If voters approve the initiative, it becomes law. In representative democracy States, citizens vote for representatives who then write and implement policy based on the best interests of the citizens of that State. Currently, in the United States, California, Oregon, Colorado, Michigan, Arizona, North Dakota and Montana are direct democracy States and have been able to establish Cannabis regulation through direct voter initiatives. Oregon allows for all six forms of direct democracy. Let's examine what activist and special interest groups had to do to enact Cannabis Regulation in this State.

Oregon started its path to Cannabis regulation in 1973 becoming the first State to decriminalize Cannabis with The Oregon Decriminalization Bill abolishing criminal penalties for possessing small amounts of Cannabis. Possession of less than an ounce of Cannabis became punishable as a misdemeanor with a $500 to $1000 fine. Private use of Cannabis and public intoxication were no longer punishable offenses, however, public use and driving under the influence were punishable and continue to be to this day.

In 1998, The Oregon Medical Marijuana Act, established by Ballot Measure 67 was enacted allowing citizens with one or more of the listed qualifying conditions with a doctor's recommendation to obtain a State issued Medical Marijuana Card. This allowed the Patient possession of 1.5 pounds of Cannabis at any given time and the ability to grow 18 immature plants and 6 mature plants without the fear of citation, arrest or penalty. Patients could choose a caregiver to grow for them if they were unable and those caregivers would enjoy the same protections as the Patient. Before dispensaries were established, Patients had to grow their own or rely on a network of caregivers to produce medicine for them. Oregon became the second State in the US to enact a system of safe access for Medical Cannabis Patients following California Prop 215.

It wasn't easy to push this initiative through the legislative process through to implementation. First, activists had to write the initiative and gather signatures in the statutory time frame. After the vote, they had to ensure the Legislators followed through to implement the program and ensure law enforcement wasn't targeting Medical Patients in the program illegally.

Oregon is a direct democracy State allowing for a law to be citizen enacted by initiating a State Statute where special interest groups collect a certain amount of signatures for placement on the voter ballot. The first step in this process is providing the technical language for the law. In Oregon, the Ballot Measure 67 was authored by a small town member of the American College of Physicians, Dr. Rick Bayer, MD, Geoff Sugerman, a lobbyist for medical Cannabis Growers, activist John Sajo, attorney Leland Burger, ACLU Oregon executive director Dave Fidanque, and David Smigelski of advocacy group Oregonians for Medical Rights. The language in the law provided qualifying Medical Patients arrest and other protections from prosecution, created a patient registry, defined the Patient / Caregiver relationship and possession limits.

The second step in the process is collecting signatures. The Campaign for Ballot Measure 67 was run and managed by the Sugerman Group, co-petitioner Geoff Sugerman. By February of 1998, the group was established and solicits George Soros, Chairman of Soros Fund Management for money to hire signature gatherers to begin collecting the 73,000 signatures needed. George, partnering with Ethan Nadelmann of Drug Policy Alliance with contributions from individual donors paid for political ads and payroll for signature gatherers.

The Ballot Measure Campaign already had an audience through several well established media outlets. Paul Stanford of THCF Clinics, Madeline Martinez of the World Famous Cannabis Cafe and Director of OR NORML with local patient advocacy groups were producing Hempstalk bringing thousands of registered voters together in the same space as signature gatherers. The main stage speakers and panels filled with experts in drug law reform, hemp production and cannabis science educated the voters, compelling them to add their signature to the measure.

Paul Stanford also produced a TV Show running weekly on cable access Portland called Cannabis Common Sense. Every Friday night Local Doctors, Campaign advocates and special guests would speak about the economic, scientific, environmental and medical benefits of both Cannabis and Agricultural Hemp. The general tone of the conversation with average voters had already shifted towards regulation.

All of these factors together contributed to a solid defense against opposition groups including Oregon Against Dangerous Drugs and The Christian Coalition. The loudest speaker in the group of opposing parties was Multnomah County Sheriff Dan Noelle. His talking points were centered around Marijuana as an illegal drug degrading the youth who would have access to it leading to lawlessness. Since this campaign, the Sheriff has switched his views on medical cannabis.

After the bill was passed, it took some time for the Oregon State Judicial Branch to conform to the conditions of the new law. At first, legitimate Patients continued to be targeted for prosecution. It took a concentrated effort from attorney Lee Berger accompanied by key witness, Dr. Rick Bayer and a small army of court supporters to stop the effort. Mr. Berger had to convince the defendants in these cases not to take the plea deal, but to exercise their right to a fair trial. One by one, these cases were acquitted when taken to trial.

Kyllo v United States was a Federal win for Oregon growers decided 4 years prior to the passing of the medical bill. The decision using thermal imaging, or FLIR devices outside the home does not show just cause for a search within the home under the Fourth Amendment set the stage for legal language in Oregon law.

Today's Oregon Cannabis market is the culmination of 20 years of implementations, where businesses have been allowed to establish themselves and enjoy the benefits of sustainable economic growth. This would not have been a possibility without a savvy new generation of key players. These attorneys, business associations and individuals remained in the State Government buildings the whole time, driving the conversation as their initiatives were being amended each legislative session. These individuals provide sustainable business support to those looking to invest in Oregon's burgeoning markets now through trade business conferences, with legal representation and other services available to ensure success.

The International Cannabis Business EXPO began as a forum for Oregon businesses as the Oregon Marijuana Business EXPO before expanding into an international conference series, produced by Alex Rogers and Dean Arbit. These conferences combine business planning, politics and culture to educate the average business investor giving a clear and tangible path to establishing and sustaining every level of Cannabis businesses.

Portland was blessed with husband and wife team, Anthony Johnson and Sarah Duff who have lead the way for cannabis law reform activists since moving there in 2004. They have co-authored initiatives, petitioned for dispensaries and remained active throughout implementation of both medical and recreational businesses. Working with attorneys like Rachal Kurt, Business Development Manager at the National Cannabis Industry Association to establish a legal framework for business structure and representation, Oregon has maintained strong industry standards.

As recreational markets are opening, Oregon is experiencing normal, but extreme market fluctuations with a 40% surplus of last harvest. Businesses face traditional and non traditional market risks including regulation deterrents, lack of Government Compliance Systems (seed to sale), the need to utilize hard money lending solutions due to Federal Banking Restrictions, the presence of a necessary black market and vertical integration restrictions. The World is watching to see how Oregon businesses continue to thrive, grow and fail for the purpose of structuring legislature and developing implementation strategies in their local communities.

April 27, 2018

Cannabis in Michigan: The Economic Microcosm

From the 1970's to present day shifting marijuana legislation, Michigan has had some of the most lenient laws on possession in the United States in college town Ann Arbor. A 1974 voter referendum made possession of small amounts of marijuana a mere infraction punishable by a small fine. Ann Arbor also passed a local voter referendum for medical marijuana for residents of the City in 2004. The Annual Hash Bash, established since 1972 features political speakers, live music, street vending and good old fashioned civil disobedience on the University of Michigan campus. Today the event attracts 20,000 attendees. The Cannabis history is Ann Arbor is a snapshot showing how cannabis regulation in Michigan is fought most strategically through local municipalities. 

The Rainbow Farm was established in 1993 and began producing events, Memorial Day's 'HempAid' and Labor Day's 'Roach Roast' with vendors, music stages and pro cannabis, drug policy reformists on the same panels as celebrities like Tommy Chong and Merle Haggard. High Times editors, NORML Board Members, Celebrity Activists like Jack Herer and Ed Rosenthal along with local advocacy groups discussed how the prohibition of cannabis laws could be broken down and rewritten. High Times ran an article listing Rainbow Farm as one of the top twenty five stoner travel spots in the World coming in at 17, making the annual events the center point for Marijuana Activism in Michigan. 

The conversation at the time centered around responsible adult use and decriminalizing possession. The network of growers resembled the farms established in Northern California at the time, remote, locked down outdoor cannabis farms with a lot of acreage essentially run by survivalists. Rainbow Farm owners Tom Crosslin and Rolland "Rollie" Rohm were killed in a Police Standoff September 3, 2001 after being served a warrant for tax evasion. Law enforcement found 200 plants on the property. Before the stand off was over, Tom and Rollie were dead, shot down by helicopter as they tried to flee on foot and every building structure on the campground property was burned to the ground. 

The Michigan Compassionate Care Initiative established a medical cannabis program for terminally ill patients in 2008, but was not acted upon and defaulted as a public initiative willing 63% of the vote in the November electoral season. The bill allowed patient to grow up to 12 plants or designate a caretaker to grow and process cannabis medicines for them. A designated caregiver could provide medicine for 5 patients with medical marijuana cards. 


These caretakers would move on to band together to open dispensaries (now Provisioning Centers) in municipalities willing to defend them from State closure and prosecution. They became the processors making concentrates and medicated edibles for their patient networks. This allowed the development of healthy economic microcosms throughout the State with a lot of working gray area in between. Those businesses who chose to open in municipalities where law enforcement opposed Cannabis in any form were often harassed and faced potential prosecution. 

The bills Governor Ricked Snyder signed into law in September 2016 were House Bill 4209 or Public Act 281 creating the Marihuana Facilities Licensing Act to regulate the growth, processing, transport and provisioning of Medical Marijuana, House Bill 4210 or Public Act 282 allowing the manufacture of marijuana infused products by qualified patients and House Bill 4827 or Public Act 283 to create the Marihuana Tracking Act and a seed to sale tracking system for all medical marijuana. More than a year and a half later, the State begins the process of application review. 

Because of the language of the law, the program allowed the growers to be established as caregivers who could grow for up 5 patients. These caregivers also served as processors and transporters. The 5 Licences available in the new legislation are Provision Centers serving as retailers, Marijuana Cultivators for growers, Marijuana Processors for the production of concentrates and cannabis infused food products, Marijuana Testing Facilities for Analytic Companies and Marijuana Transporters. The Cultivators Licenses are broken down to three classes setting legal plant limits: Class A - Up to 500 Plants, Class B - Up to 1000 Plants, Class C - Up to 1,500 Plants. Application fees are assessed on a local level up to $5,000 and can vary. The State's application fee is $6,000. The Regulatory assessment fee, based on the number of licenses issued, is currently set at $48,000 per application for the first year of implementation. 

Before this bill was signed into law , hundreds of dispensaries had established themselves in local communities all loosely regulated in the grey area of municipal law in receptive communities. These business owners participated in the establishment of the regulatory language in the law throughout the process, maintaining control of the legislative conversation. As these bills move forward, these businesses are slowly moving through the application process. 

Emergency rules have allowed for businesses to operate a proposed facility if the business completed the application process by February 15, 2018. The State, in the process of reviewing the first application in the current legislative session, just issued more than 200 cease and desists letters throughout the State for those businesses who were not in compliance with the application deadlines or were not issued an operating extension under the emergency rules. 

The whole time applications were being submitted and prepared for review, local municipalities have been deciding if they will allow these businesses to operate in their Cities, Townships and Villages and if so, which zones will have parcels available for these businesses to operate. The first step in the State application is facility approval from appropriate municipalities. The number of licenses in each municipality is decided by City Councils, Statewide. 

Local Cannabis Attorneys Craigs Arronoff and Travis Copenhaver of Cannabis Legal Group produce a series of legal YouTube videos with content to help the business owners navigate the complicated waters of Michigan cannabis regulation. Traveling the State to coordinate with each local municipality, they have been greeted with a full spectrum of views on regulation from communities who opted out of the conversation to those who have or are currently initiating city ordinance to define participation. Some communities are establishing lotteries for applicants, some are reviewing each on a first come first serve policy, smaller communities are having trouble finding parcels available for development. 

It's hard to forecast the long term economic viability for these niche markets. Adding complication, an additional voter initiative was passed allowing for recreational cannabis sales to be regulated in the State. The State is attractive to investors being the second largest Cannabis market after California in the United States. But it's the same State who's legislators took almost 10 years to create a system of safe access for medical marijuana patients  and will now attempt to establish and regulate a recreational market. Michigan recreational markets may appear attractive to out of State investors and the State does allow for outside money, however it will be some time before this market shows more return and with less risk. 

April 12, 2018

The Deep State: Conflicting Meanings in Powerful Language


As a writer I understand the power of language, the power of words. So when I see words and phrases thrown around in general conversation as a means to discount another's perspective, I tend to to do the research to see where a term originated and what is its intended purpose. 

Today's phrase is 'Deep State'. Every time I see this phrase used, I get a sense of confusion. Does anyone really know what this means? Turns out there are several interpretations of this phrase. Many books have been written, but they represent varying and opposing perspectives, so let's take a look. 

My first experience with this phrase goes way back to anti war activists using the term to describe a military industrial complex gone rogue, working outside the confinements of Government. Several authors have written books about this particular use of the phrase. 

The first noted use of the term was describing a secretive Turkish Network known as Derin Devlet. Founded in 1923 by former President of Turkey Mustafa Kemal Ataturk, the group's purpose was to use nefarious acts such as coups and private assassinations of individuals seen as a threat to the establishment to preserve the Government structure, particularly the press, communists and other dissenters. At the time, the term was applied to what was happening in Turkey and Russia. 

Later, the term was used to describe the secretive activities of the military industrial complex as expressed iPresident Dwight D. Eisenhower's 1961 farewell address: "In the councils of government, we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the military-industrial complex. The potential for the disastrous rise of misplaced power exists and will persist." At the time, there was great potential for misuse and they did misuse the military often without the consent of Congress, however, in today's information society, nothing the military does is secret. When something happens with the US military, someone records it and the information is made available to global societies. The People involved in 1961 were able to hide their activities without the technology available to make the information available to everyone with internet access. 

In The Concealment of the State, Professor Jason Royce Lindsey takes this idea further to include what he describes as a fourth branch of the US Government established after the September 11 attacks on the World Trade Center to use the national security and intelligence communities to work autonomously from the Executive Branch of Government for private interests. Again, this definition is still entrenched in the military industrial complex. 

Moving forward to 2014, a new definition appears from Mike Lofgren, a former Republican US congressional aide as  "a hybrid association of elements of government and parts of top-level finance and industry that is effectively able to govern the United States without reference to the consent of the governed as expressed through the formal political process." This refers to Corporate and private interests using blackmail and payoffs as a way to influence policy through elected representatives serving these entities only and not the working for the will of the people, though they maintain the facade of being dedicated public servants. Moving out of the military industrial complex this definition focuses on the establishment or career politicians who sit in powerful positions influencing policy as Presidents come and go. This includes career military officers, but is not limited to military operations. Intellectuals remain at odds with this definition arguing there is not one entity involved in these nefarious activities, but several groups who often find themselves at odds with each other. 

The Trump Administration uses the term to describe leaks and entrenched bureaucracy being used to interfere with the President's agenda. Steve Bannon through Breitbart News pushes this theory in many ways, one such example is the belief Barack Obama is creating a deep state resistance to Trump. This has been proven to have no basis in reality as have other such conspiracy theories coming from the alt-right media. Alex Jones uses this term to describe anything from alien invasions to weather modification to resistance to Trump's political agenda. 

Given the confusion surrounding the meaning of this term, polls were conducted in 2017 where as 48% of people polled believed there is a deep state entity in the US Government with the purpose of secretly manipulation and policy influence. In 2018 a similar poll was conducted with 63% of the individuals polled showing unfamiliarity with the term, but believing it was possible for something to like it to exist in modern geopolitical situations. 

As one can see, this is a term which has many interpretations and issues surrounding the term are quite convoluted, but at the same time offer a space for constructive ideas to form a potential consensus on the use of the words. What does Deep State mean to You? 


March 26, 2018

Why I Believe Sex Workers


Since the beginning of Human Politics, Men have been sending sex workers over to their opponents chambers to get secrets out of them for the purpose of winning wars and gaining power. Servant girls were used to get secrets from Kings, the local brothel was a hot bed of espionage. Cambridge Analyica's CEO Alexander Nix was caught on tape selling this as a service to undercover investigators just recently. Honey Traps (AKA Honey Pots) have been the preferred method for spies to gain secrets forever, it seems. So much so, You would think people in power were keep their DNA to themselves just so they wouldn't be caught in the trap, but sadly, they don't. 


Trump has been officially been spreading his seed since He hit puberty. EWWWW.... 

Stormy Daniels is a very successful sex worker. She is not shy about it. She isn't just in front of the camera. She produces, writes and stars in porn videos. Her continuously expanding network is quite large. I consider her an extremely savvy business woman in her trade. In her 60 minutes interview she reiterates, she is not a victim, the sex was consensual. Hey, much respect. The bigger issue with Stormy Daniels is intimidation, illegal use of campaign funds and thuggish behavior by people in power. This is why we will see more of Stormy Daniels and why Trump hasn't tweeted her name with a cute little insult about looks or intelligence. It's also why Trump spent Saturday night with his attorney Michael Cohen at Mar-A- Largo discussing strategy. 


I have way more respect for Stormy than Karen McDougal who was stupid enough to think Trump loved her just because he said so. He offered her money, she turned it down and feels SO guilty for having the affair because Trump was married at the time. She called Trump a 'sweet man'. Whatever. 

The more important story to Me is Russian Sex Worker Anastasia Vashukevich who claims to have 16 hours of video and audio proving collusion with Russia. In 2016, Anastasia or Nastya Rybka, spent time on a yacht with Russian Oligarch Oleg Deripaska and Deputy Prime Minister Sergy Prikhodko. Deripaska is known for creating a back channel to the Trump campaign through Paul Manafort. 

So, Anastasia leaves Russia and ends up in Thailand working with a group of sex workers running sex training sessions without a work visa. She ends up in a Bankok prison awaiting trial and extradition back to Russia where she will most likely be tortured, poisoned or whatever they do in Russia to people who know too much. 

She reaches out to CNN to try to exchange the 16 hours of evidence for asylum. Now, let's be clear. I do not think she will get assistance from the US Government. I'm not sure Mueller can or will save her. It appears Mueller's case is pretty rock solid with 5 American Guilty Pleas, 1 Russian and counting. 

My point in all of this is sex workers have been used since the beginning of time as weapons of espionage, so Yes... I believe the sex workers. I believe Stormy Daniels. I believe Anastasia Vashukevich. I could care less about doey eyed Karen McDougal or her stupid guilt... Stop wasting our time. 

Live Tweeting the Stormy interview last night was spectacular! So many funny tweets. My favorite? This gem from @wmbienes: 
'Who among us hasn't had unprotected intercourse with a porn star & playmate while wife #3 (the one you had intercourse with while still married to wife #2, the woman you slept with while still married to wife #1) was home nursing child number five? #StormyDanielsDay"

This is our President. This is the man all of the evangelicals follow as if he were the next messiah coming to lead them all to redemption in the promised land. It seems to me all of these powerful men need to keep their DNA to themselves as a matter of national security.. before someone gets impeached or poisoned. 

Does anyone else miss the days when The President of the United States didn't have any sex scandals? OBAMA....



So. What did We learn here today? Sex Workers are spies, Politicians need to keep their DNA to themselves and if a sociopath tells you he loves you, he doesn't. None of this has ANY place in American Politics. That's how I really feel. 

March 23, 2018

How Russia Hacked the DNC Emails

We begin this sordid tale in June of 2016 when a hacker going by the handle Guccifer 2.0 hacked into the Democratic National Convention's database and stole "emails". In his first blog post Guccifer claims he is a lone romanian hacker hell bent on exposing "The Illuminati" Yes... This set the conspiracy theorists all up in a frenzy. I don't know if the Illuminati exists. I do know Russia exists.... So....
Anyway, back to 2016... The buzzword highlighted in everyone's talking points were emails. It's a little more than emails, Kids. That data contained candidate assessments with strengths and weaknesses relevant to swing States like Pennsylvania and Florida, analysis of demographics and campaign recruit material, among others.


Guccifer sent the data to Assange... Assange began leaking emails to discredit the democratic national party. Assange wasn't the only person to receive the data. People like GOP political operative in Florida, Aaron Nevins also received a database. He proceeded to use this information to target swing voters in Florida.
Meanwhile, Roger Stone or "The Penguin" (that's the costume he chooses at Halloween each year) kept on his media campaign to assure everyone Guccifer was a lone hacker, not a Russian. You may have remembered seeing him on EVERY news channel spewing these lies.
Meanwhile, on the campaign trail, Trump uses the leaked 'emails' against Hilary, invites Russian hackers to find the missing emails... he believes they will be rewarded greatly by the US Fake News media. Sigh.
Now. Flash Forward to the shit show We are experiencing today: Just recently Guccifer failed to activate the VPN client before logging in, so he was able to be traced to the Russian Foreign Military Intelligence Agency - GRU AKA Main Directorate of the General Staff of the Russian Armed Forces office on Grizodubovoy St in Moscow. Where is Moscow, Kids? Say it with Me... RUSSIA!
***Please don't ask me what a VPN does... I don't know. Go have coffee with your favorite tech geek and have them bot-splain it to you. All I know is the exit was in France. Good Luck****
So this week, Mueller has now taken over the Guccifer investigation and folded it into the Russia investigation. Will we get Guccifer? Probably not. He never left Russia. I'm sure they killed him for screwing up and now knowing too much. My guess is that guy was tortured or gassed or poisoned or whatever they do over there to people who make mistakes. And now you know why Roger Stone just looks really, really sad all of the time and has stopped speaking with the press.
As for Assange... That mother fu**** needs to come on out of that embassy and take in the ass like a MAN.
And that's I really feel. Namaste!
Source disclaimer... This shit is all over the newswires, so pick an outlet. I chose Tech Crunch because it's an industry publication like Marketwatch... I figure they know.... So. There. S

https://techcrunch.com/2018/03/22/more-evidence-ties-guccifer-2-0-to-russian-intelligence/

January 31, 2018

The Future of CBD Oil after DEA and FDA Move to Enforce more Stringent Regulation

The United States Department of Health and Human services has owned the patent to use cannabinoids as nueroprotectants and antioxidants since October 2003. Scientists from the National Institute for Mental Health (NIMH), a smaller division of The National Institute of Health (NIH) applied for the patent 4 years prior for the purpose of awarding exclusive rights to create a new class of antioxidants significant for the role cannabinoids serve as nueroprotectants. 

Patent #6,630,507 excludesTetrahydrocannabidiol (THC) as a qualifying cannabinoid citing the medicinal benefits of Cannabidiol (CBD) with no psychotropic effects allowing patients to ingest high doses with "no toxicity or side effects."  It is important to consider this patent when analyzing recent actions taken by the FDA and DEA with regards to clarifying CBD Oil extracts being introduced in emerging medical and recreational markets.  

The two Federal Regulatory agencies working to regulate Hemp and Marijuana are the Food and Drug Agency (FDA) and the Drug Enforcement Administration (DEA). The purpose of the FDA is to promote public health by regulating food, dietary supplements,  over the counter medications not prescribed by a doctor and vaccines among others. The purpose of the DEA is to classify and enforce laws for substances considered to have a potential for abuse,  medical or pharmaceutical benefit or pose risk to the general public in accordance with the Controlled Substances Act of 1970. Both agencies are extensions of the US Department of Health and Human Services.  

Agricultural Hemp Foods and Extracts containing only trace amounts of THC are regulated by the FDA after a concerted effort on the part of the Hemp Industries Association (HIA),  the Organic Consumers Association (OCA) and several Hemp food and body product companies who spent more than $200,000 fighting the DEA to exempt these products from definition in the Controlled Substances Act and won in 2004. Hemp CBD Oil was not an issue during this time as these products were marketed as food items and were not tested for the cannabinoid, only for THC.  Hemp producers wouldn't realize their products contained high amounts of CBD until many years later when analytical testing became available in emerging State regulated Medical Marijuana Markets.  

Currently Marijuana is considered a Schedule 1 substance in the DEA's Drug Diversion Program considered harmful to society and highly addictive with no medicinal benefit in spite of scientific research depicting the opposite.  Extracts from the marijuana plant, like Charlottes Web falls under the regulation of the DEA. The Controlled Substance Act of 1970 defines Marijuana as, "all parts of the plant Cannabis Sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound,  manufacture,  salt, derivative,  mixture,  or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant,  fiber produced from such stalks, oil or cake made from the seeds of such plant,  any other compound,  manufacture,  salt,  derivative,  mixture or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, cake, or the sterilized seed of such a plant which is incapable of germination." Resins and oils from the Marijuana plant had always been included in the definition of Marijuana in the Drug Diversion Program if they were derived from the flowers of a mature plant.   


In 2017 the DEA created a new drug code for Marijuana extracts to better comply with the United Nations Convention on Narcotic Drugs enacted in 1961. Drug Code 7350 Marihuana Extract defines oil extracts as such: "Meaning an extract containing one or more of the cannabinoids that has been from derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant." This new drug code goes into effect January 13, 2018. The intent behind this action is for the DEA to better track extracts derived from the Marijuana plant,  however,  this same action caused confusion and misunderstanding with leaders in both medical marijuana and agricultural hemp communities. 

Back in 2004, the technical act achieved by HIA allowing for Agricultural Hemp Foods and body products to be sold in stores was exempting Agricultural Hemp Products with only trace amounts of THC from the definition of Marijuana in the Controlled Substance Act. That was before Hemp Processors understood their products contain high levels of CBD and therefore could be used as medicine just like oils and resins extracted from the Marijuana plant.  Very quickly, CBD Hemp Oils began flooding National Markets with online sales and appeared on the shelves of several health food stores claiming the oil helps alleviate medical problems,  not just provide nutritional benefits.  

This began the concerted effort on the parts of both agencies to quickly clarify. As the DEA's new drug code goes into effect,  the FDA is sending warning letters to online distributors of CBD Hemp Oil Companies who claim their products are medicinal for the nueroprotectant and antioxidant qualities of the CBD's contained.  Meanwhile,  the DEA issued a clarifying statement ensuring Hemp food and body products are still exempt from inclusion in the definition of Marijuana in the Controlled Substance Act. 

One such letter was sent to That's Natural! Marketing and Consulting in Pueblo, CO. Specific products referenced in the letter were CBD All Natural Hemp Oil, Bosom Lotion Potion and CBD Rich Healing Creme sold on the Company's website www.cbdoil.life. The letter informed the Company the aforementioned products are classified as a drug and not a dietary supplement according to the Federal Food, Drug and Cosmetics Act because product claims on the website show intent for use in the diagnosis, cure, mitigation, treatment or prevention of disease.  Referenced from the Company's Website, the FDA listed claims the products "kill cancer cells" and "provide a protective coating around our brain cells" among others as violations. The Company Website also made claims the products are anti-tumor, effective against MRSA (antibiotic- resistant bug), lowers blood sugar,  regulates blood pressure and heart rate and alleviates cancer related pain, among others.  The FDA gave the Company 15 days to respond to the letter with actions taken to correct violations. 

In spite of the DEA's actions to move CBD Oil into classification with Marijuana CBD Oil,  grocery stores and independent health food stores are pushing the conversation by stocking CBD Oil products on their shelves.  Kroger backed Lucky's Market announced plans in October 2017 to offer these products to their customers, the first National brand to do so.  Independent health food stores like Corner Store Apothocary in Grand Rapids, IA, know they are operating in a legal gray area,  but are willing to assume the risk.  Without clarification in the Federal Laws, these businesses are most certainly assuming great risk. 

In December of 2017, The United States Patent and Trademark Office revised its stance announcing patent and trademark applications involving CBD products would no longer be accepted and pending applications would be rejected based on the Office's Lawful Use Rule.  This rule applies after the DEA'S new drug code categorizes CBD Oil derived from the tops of flowering plants as a schedule 1 drug and therefore its use considered unlawful.  Prominent attorneys in the industry are advising their clients they can no longer expect protection from the trademark office,  at least not while the DEA's new drug code remains in place.  Theories on the purpose and status of patent #6,630,507 for the use of Cannabinoids as antioxidants and nueroprotectants owned by the US Department of Health and Human Services are speculative.  

The Hemp Industries Association (HIA), along with two other parties responded in January of 2017 moving to block implementation of the DEA's Drug Code filing a lawsuit in the 9th District Court questioning the legality of the code. Attorneys involved in the case claim products derived from Hemp lawfully under section 7606 of the Agricultural Act of 2014 (farm bill) remain exempt from the definition of Marijuana in the Controlled Substances Act.

"The DEA's attempt to regulate hemp-derived products containing cannabinoids lawfully sourced under the CSA, and farmed and produced under the Farm Bill in States like Kentucky and Colorado,  is not only outside the scope of their power,  it's an attempt to rob us of hemp' s economic opportunity, " said Colleen Keahy,  executive director of HIA, in a statement.  Oral arguments in the case are scheduled to be heard in February of 2018. The DEA's Drug Code went into effect mid January,  2018. 

Attorneys, Activist Organizations and Industry Business Leaders make up the think tank around all of these issues. Course of action proposals vary greatly and often cause discourse in the grassroots movement to regulate Cannabis in all forms.  Most agree the fundamentals of the laws are intricately integrated in the language used to market products vs. the language in the law,  whether it's food or medicine.  Below are listed some of the more prominent theories.  

Rescheduling

Currently,  Marijuana is classified as a Schedule 1 substance, considered to have no medicinal value, a high potential for abuse and harmful to society along with heroin, LSD, ecstasy, methaqualone and peyote. Some believe placing Marijuana in a less stringent category would open the doors for research and development of Cannabinoids as medicine.  Opinions on which category Marijuana should be placed vary greatly in the community.  It is important to note the drugs falling into these categories must be obtained by a prescription from a doctor or are illegal under Federal Law. Anything outside of these schedules but still considered medicinal are regulated by the FDA as an over the counter drug.  

Schedule ll drugs have a high potential for abuse and are considered dangerous,  but also have applied medical applications.  Drugs in this category include Vicodin, Dilauded, oxycodone (Oxicotin), Fentanyl, Adderall and Ritalin, to name a few.  More illicit drugs in this category are cocaine and methamphetamine.  Most of the groups pushing for this category are connected to pharmaceutical companies with patents pending for use of cannabinoids as medicine.  Opposing groups believe this move will push out the small business farmer considered to be the very backbone of the medical cannabis movement.  

Schedule lll contains drugs with a moderate to low potential of abuse.  Drugs in this category include Tylenol with Codeine, steroids, testosterone, ketamine and anabolic steroids. 

Schedule lV drugs are considered to have a lower potential for abuse or risk of dependence than Schedule lll and include Xanax, Soma, Darvon, Valium and Ambien to name a few.  

Schedule V drugs have low potential for abuse,  but also contain limited amounts of narcotics and are generally used for antidiarrheal, antitusive and analgesic purposes like cough medicine with Codeine. Lyrica and Motofen are also included in this category.  

The conversation surrounding scheduling is controversial to say the least.  Some activists believe Schedule lll to be destructive to local medical cannabis markets and would like to see Marijuana fall into Schedule lV or V believing small farmers could exist in a competitive environment with pharmaceutical companies.  Many take the whole plant approach believing all of the cannabinoids in the plant work together to produce medicinal effects and isolating cannabinoids while adding terpenes back in makes the plant less effective.  They believe allowing patents for these procedures to be issued would also be devastating to everyone involved,  grower to patient. 

Descheduling

Removing Marijuana from the Controlled Substance Act, thereby descheduling it altogether is another proposal for Federal clarification.  These activists believe Marijuana to be a plant, not a drug and would like products derived from the plant to be considered a nuetracuetical.  Nuetracueticals are loosely regulated by the FDA which doesn't interfere in research and production,  however products must be labeled as not intended for medicinal use.  Nuetracueticals exist because there is currently no official definition in current law unlike Marijuana, defined by the Controlled Substance Act,  however as recent as January 2018, the FDA launched an effort to impose more stringent regulations for homeopathic products.  

Announcing a new "risk based enforcement approach" the FDA declared any and all homeopathic medicines currently on the market as being sold illegally and any drug which has not been considered "generally recognized as safe and effective" to be classified as a "new drug" and go through the FDA Approval Process. Products intended to be used for the prevention or treatment of serious life threatening illnesses were specifically listed, which makes CBD Oil as a target for enforcement.  

No matter where one falls on the spectrum of belief,  everyone having the conversation agrees action to counteract the US Department of Health and Human Services must be well thought out and presented as a United Front.  Attorneys and organizations are preparing themselves for an extensive, very expensive legal battle to protect well established businesses and communities.  Anyone inspired to join the conversation can find activist groups representing all aspects of the spectrum who desperately need time and financial support from volunteers and businesses. It's time to advance to conversation if the movement wants to maintain their voice in the legal and political battles ahead.