Minnesota: Congressman Peterson Joins Smith, Craig and McCollum To Urge Federal Agencies To Clarify Hemp Rules

MINNESOTA: Representative Collin Peterson today jointed U.S. Senator Tina Smith (D-Minn.) and U.S. Representatives Angie Craig (D-MN 2), and Betty McCollum (D-MN 4) in calling on the leaders of four federal agencies to streamline hemp rules. Currently, contradictory federal guidelines are leading to uncertainty in the market and preventing Minnesota farmers and Tribes from fully reaping the economic benefits of growing hemp.

“The bipartisan 2018 Farm Bill legalized hemp in order to create economic opportunities for farmers. Minnesota farmers appreciate the United States Department of Agriculture’s (USDA) efforts in implementing the Interim Rule on Establishment of a Domestic Hemp Production Program. However, despite the Interim Rule there are still hurdles in place for Minnesota farmers to fully realize the economic benefits of growing hemp,” wrote the lawmakers in their letter to the United States Department of Agriculture (USDA), the Office of Management and Budget (OMB), the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).

Sen. Smith and Reps. Craig, McCollum and Peterson go on to identify some of the inconsistencies that need to be addressed: “The federal regulatory framework has proven to be inconsistent. For example, the USDA’s rule stated that farmers will be held accountable – facing possible revoking of their licenses – if their crops test above a .5 percent THC level three times in a five year period. Despite this somewhat onerous and arbitrary level, the Drug Enforcement Agency (DEA) instituted their own rule saying that exceeding .3 percent THC level deems the crop a controlled substance.

The burdensome competing rules don’t allow for remediation if the crop tests above the deemed inappropriate levels. Farmers should not be penalized for plants that they intended to grow as hemp, but for any number of reasons, the final THC numbers exceeded the arbitrary 0.3% THC level.  At the same time, the Food and Drug Administration (FDA) guidance on CBD is still pending at the Office of Management and Budget (OMB), which adds even more uncertainty to the marketplace.”

Premier Biotech’s Oral Fluid Drug Testing Device Granted FDA Clearance

MINNESOTA: On February 2, 2018, Premier Biotech Inc. was granted a coveted 510(k) clearance for the following drugs Amphetamine, Cocaine, Marijuana, Methamphetamine, Opiates and Phencyclidine from the Food and Drug Administration (FDA) for OralTox, its flagship, patented rapid oral fluid drug screen device. A FDA 510(k) clearance is a significant achievement as it paves the way for distribution and utilization in clinical markets and allows for further expansion in the employment sector.

The Minnesota-based manufacturer of rapid drug testing devices designed, developed and manufactures the OralTox screening device. OralTox can simultaneously detect up to 12 drugs. The use of oral fluid as a testing matrix offers numerous benefits over urine testing: the process is less invasive, the collection can be fully observed without privacy concerns, tests can be administered without the need for specialized collection facilities and, most significantly, is resistant to adulteration. Premier Biotech’s laboratory is uniquely positioned to offer LC-MS/MS confirmations of presumptive positive results as well as a comprehensive test panel.

Premier Biotech has extensive experience working with corporate workplace customers and government agencies to expedite their drug screening processes with fast, accurate drug tests. After rigorous precision, safety, and efficacy review, the FDA’s 510(k) clearance of OralTox enables the implementation of a rapid oral fluid drug test in the clinical market. OralTox is the only FDA-cleared, rapid oral fluid drug test capable of being sent to a lab for confirmation. OralTox can help medical professionals including treatment providers, behavioral health centers, and pain clinics test for illicit substance use and medication compliance. OralTox also equips corporations throughout the United States to make immediate hiring decisions and facilitates expedited client interactions in the criminal justice industry.

Todd Bailey, CEO, states, “Premier Biotech was founded with the goal of designing, developing and commercializing drug testing devices that represent the highest quality and most reliable results. With the clearance of OralTox, we can offer expertise in oral fluid drug testing, giving corporations and clinical groups alike an effective way to quickly screen and identify illicit substance use or monitoring the utilization of prescribed medications.”

2017 Outlook for Cannabis in Minnesota

EXCLUSIVE TO MJNewsNetwork!

By Rachelle G

MINNESOTA: Often considered one of the more liberal states in the Midwest, Minnesota is fragmented —  a sea of blue centered around the Minneapolis/Saint Paul metro area surrounded by red rural areas. In terms of cannabis law, Minnesota is a bit ahead of other Midwest states but not by much. Adult recreational cannabis use remains illegal, but being caught with less than an ounce and a half will only result in a small, traffic-ticket like fine.

Medical marijuana was approved for a small list of ailments in 2014, and Minnesota’s program is considered one of the most restrictive in the country. MMJ Patients cannot smoke actual cannabis flower, but instead must vaporize oils or take capsules. Qualifying conditions include cancer, HIV/AIDS, seizure disorders, MS, glaucoma, ALS, Tourette’s syndrome, Crohn’s disease, and other terminal illness. Intractable pain and PTSD were approved as qualifying conditions in 2016; pain patients were able to join the medical marijuana program in August of that year, while PTSD patients will be able to join starting August 1st of 2017.

So what’s on deck for cannabis in Minnesota in 2017? For activists, it appears that raising awareness of drug policy issues and the right for patients to access medical cannabis are on the top of the list.

“Minnesota has a strong history of cannabis activism, but our activists are spread out among many different groups and organizations with different means to reach the same end goal,” explained Gunnar Aas, president of the Hamline University chapter of Students for Sensible Drug Policy (SSDP) in Saint Paul. “We’re devoting the majority of our efforts as a chapter towards continuing to build a coalition of activists, politicians, volunteers, and concerned citizens beyond campus to create the legislative changes necessary to bring sensible drug policies to our state.”

Aas added that the Hamline chapter is planning a trip to Portland, Oregon over spring break to attend the 2017 Students for Sensible Drug Policy Conference. “We’re excited to take the skills we develop in Oregon back home, where we can share what we learned with our peers and allies in an effort build the world we dream of.”

No new cannabis legislation is expected in 2017, and until the 2018 election brings a new chief executive to replace Minnesota Governor Mark Dayton, who opposes cannabis reform, little more is expected to happen legislatively.

“We will spend most of this year training and preparing supporters for the 2018 elections, so we are organized and ready to address the question of who we would like to see elected governor,” stated Michael Ford, director of the Minnesota chapter of NORML. “The governor has been our biggest roadblock these past few years in reforming marijuana laws here in Minnesota.”

Rep. Matt Dean (R-Dellwood) introduced a bill to disallow the program head (currently Ed Ehlinger, the commissioner of health) to add qualifying conditions. Dean was vehemently opposed to legalizing medical marijuana when legislation passed, believing it’s a “slippery slope.”

Dr. Kyle Kingsley, CEO of MinnMed (one of two approved producers of medical cannabis programs), is not concerned about potential back-peddling on marijuana issues – either at the state or federal level.

“We’re really excited about what’s to come in 2017,” he explained. “Price reductions have lead to a dramatic increase in patient volume in our dispensaries, and the addition of chronic pain and PTSD was a real shot in the arm.”

Kingsley added that topicals were recently approved for medical marijuana patients, which will bring much-needed relief to those who cannot vaporizer or have issues swallowing capsules. He believes that a pragmatic approach to reform will ensure the best results.

“This is no longer a bipartisan issue. I am calling on all pragmatic members of Congress to take a look at this and find some solutions. 1 in 3 people have chronic pain of some type – it would be great to come up with practical ways for patients to gain access to this medicine.”

LeafLine Labs Begins Offering Care To Minnesota Patients Suffering From Intractable Pain

MINNESOTA: As of August 1st, LeafLine Labs, the physician-founded and patient-focused organization formed to cultivate, process and distribute medical cannabis in Minnesota, will be able to dispense medical cannabis to patients suffering from intractable pain.

Intractable pain was added to the list of qualifying conditions for medical cannabis earlier this year by the Minnesota Department of Health. July 1 was the first day health care practitioners were able to certify patients with chronic pain in the state’s medical cannabis program and August 1 is the first day this medicine is available for patients at distribution locations—including four LeafLine Care Centers in St. PaulEagan,Hibbing, and St. Cloud.

“As a caregiving organization dedicated to putting patients first, we welcome this opportunity to improve the quality of life of Minnesotans who bear the burden of chronic pain,” said LeafLine Labs co-founder and CEO Dr. Andrew Bachman. “For too long, dangerous prescription opioids have been used to treat intractable pain when the evidence suggests we should not. Now we can offer a safer alternative—a natural botanically derived medication that treats many causes of chronic pain without the same risk of deadly overdose.”

According to data from the Minnesota Department of Health, the state is experiencing a long-term trend of rising deaths due to drug overdoses, with more than half of drug-related deaths tied to prescription medications. The leading drugs responsible for overdose deaths in 2015 were opioid pain relievers. States with medical cannabis access, according to a 2014 study inJAMA Internal Medicine, have 25 percent fewer deaths from opioid overdose than states without legal medical cannabis.

A recently-published study in Health Affairs showed that patients do indeed turn away from prescription drugs when their state allows medical cannabis as an alternative. In states with legalized medical cannabis, researchers looking at data from Medicare found a decrease in prescriptions for a variety of drugs, for conditions including anxiety, depression, nausea, pain, psychosis, seizures, sleep disorders and spasticity. The drop in prescriptions wasn’t across-the-board: it only appeared for drugs where medical cannabis could feasibly be used as a replacement.

“We take our mission to provide safe, reliable medical cannabis formulations extremely seriously, and look forward to building upon our track record of success. Since medical cannabis became legal in Minnesota, 90 percent of patients have reported mild to significant benefits when surveyed by the Department of Health,” said Dr. Bachman. “Now that the state has extended access to patients with intractable pain, we hope we can save people not just from pain, but from the risks that can come with opioid use, such as accidental dependency, a mounting tolerance, and in some cases, even death.”

In order to schedule an appointment at a Care Center, patients with a qualifying medical condition who have received certification from their health care practitioners must first register with the Minnesota Department of Health’s Office of Medical Cannabis. After registering, they can consult with pharmacists and certified pharmacy technicians at LeafLine Labs to determine which specific botanically-formulated medications and recommended dosages are best for them and purchase their medical cannabis.

LeafLine Labs is one of two Minnesota organizations licensed to cultivate, process and distribute medical cannabis as part of the state’s medical cannabis program, which launched in the summer of 2015. Physician-founded and patient-care driven, LeafLine Labs delivers safe, reliable, sustainable and accessible formulations of botanically derived medication from the whole cannabis plant. We’re dedicated to providing knowledgeable, compassionate, authentic and dignified care to Minnesotans in need.

Patients in Minnesota Discuss First Months Of Medical Marijuana

MINNESOTA: Lawmakers, medical experts and law enforcement officials tracking the launch of Minnesota’s medical marijuana law got an earful Friday of the good and bad stories of the state’s new program.

Nearly three months in since medical cannabis went on sale in July, it’s a mixed bag: several parents who report their children’s lives have turned around due to the medicine after years of debilitating seizures, patients who have returned to the black market because the prices are too high and people who still can’t register due to the narrow list of qualifying conditions.

The task force overseeing the program met Friday for the first time since it launched this summer, with a sharp focus on the growing pains of Minnesota’s new medical marijuana economy — from patient’s struggles to afford the medication to the logistical hurdles that come with selling a drug that the federal government still bans.

Manny Munson-Regala, chief executive at the manufacturing company LeafLine Labs, said the federal government’s stance on marijuana — it’s classified as a Schedule I drug — has exacerbated production costs. Neither LeafLine nor Minnesota Medical Solutions can write off business expenses for tax purposes. Munson-Regala said his company pays about a 50 percent tax rate.

Some Minnesota Marijuana Patients Opting To Buy Illegally

MINNESOTA: Just two months after Minnesota launched its medical marijuana program, some patients turned off by high costs say they are back to buying the drug illegally because it’s the only way they can afford it.

State officials and the companies hired to make marijuana products trumpeted the program’s medical approach — pills and oils, no leaf products — when it launched in July. But some patients say the highly restricted and regulated system is costing them hundreds or even thousands of dollars a month– none of it covered by insurance.

Company executives defend their prices — a small vial of marijuana extract can run nearly $130 in Minnesota, more than double the cost of a similar product in Colorado, where recreational marijuana is legal and they’ve sold it medically for more than a decade — and say costs will fall over time. But they’re also taking steps to help some buyers, including raising money to cut the price for lower-income patients.

Minnesota Woman Asks Court To Allow Marijuana Use Per Indiana Church Beliefs

MINNESOTA: A Minnesota woman accused of violating probation says she should be able to use marijuana for religious reasons because she belongs to a pot-smoking church based in Indiana.

The Minneapolis Star Tribune reports 31-year-old Ashley Firnschild argues to the Hennepin County District Court that marijuana laws place an “undue burden” on her beliefs as a First Church of Cannabis member. The Golden Valley woman is accused of smoking marijuana and violating her probation on a drug charge.

Hennepin County Attorney Mike Freeman said in a statement that the First Amendment doesn’t protect possessing or smoking marijuana.

The church was established earlier this year in a test of Indiana’s new religious objections law. It has sued the city of Indianapolis and state of Indiana, claiming laws against possessing and using marijuana infringe on its religious beliefs.

A Month In, Medical Marijuana Yields Mixed Results

MINNESOTA:  Patrick McClellan’s first batch of medical marijuana, via vaporizer, worked like a charm, curbing the pain and muscle spasms that come with his muscular dystrophy and supplanting a combination of prescription medications that doctors say could kill him.

But the first and second rounds of cannabis oil missed the mark for treating 18-year-old Scott Rapp’s seizures. With the high costs and the hoops the Rapp family had to jump through just to get signed up, mother Shelly Rapp said they’re considering a move back to California, where the medicine was cheaper and worked better.

The story of Minnesota’s first month of medical marijuana is one of triumphs, disappointments and everything in between — a trial-and-error process that manufacturers expected and many patients hoped to avoid. For some in both camps, it’s breaking the bank.

Officials from the two companies cultivating and selling the cannabis pills and oils said they cautioned patients from the start: It’s a matter of finding the right dosage and strain to nail down an effective treatment. The state hopes to build off that learning curve by tracking patient results, filling a void of research for which cannabis-based medications work best for different ailments.

Price Hike Adds To Sticker Shock For Medical Marijuana

MINNESOTA:  One of Minnesota’s medical marijuana manufacturers has raised its prices substantially after less than a month in business, adding to a cost that many patients are already struggling to cover.

Dr. Kyle Kingsley of Minnesota Medical Solutions told the Associated Press Thursday that the company raised prices on its pills, vapors and liquids by 15 percent to 20 percent last week. The company also reduced the size of a discount for low-income Minnesota residents, he said.

“That’s not something we do lightly. The reality is, it’s very expensive to do this,” he said.

Kingsley said the price changes were driven largely by an unexpected influx of patients who qualified for the low-income discount. And low enrollment since medical marijuana sales began July 1 has kept savings from producing in mass quantities out of reach. Just 220 patients were registered to buy medical marijuana with the state as of July 23.

 

Medical Marijuana, Now Legal, Still Not Easy To Get For Some

MINNESOTA:  It’s a 400-mile, seven-hour, $100 or more journey from Maria Botker’s home in tiny Clinton to the nearest clinic where she can buy medical marijuana – the only drug that does the trick for her daughter’s rare and aggressive seizure disorder.

In addition to the medicine’s high cost, the short list of qualifying conditions and the difficulty in getting a doctor’s approval to sign up, there’s one more thing making the program difficult for Minnesota patients. Some have to come an awfully long way to get it, with only two of eight dispensaries opening since the July 1 launch.

The law doesn’t require all eight to be open until July 2016. A third location is slated to open Thursday in Rochester. A Bemidji clinic for the northeast corner of the state likely won’t be running until sometime next year.

And even after all eight facilities open, Botker and others from southwestern Minnesota will still face five-hour trips or longer.