Search Results for: opioids

Justice Department Announces Global Resolution of Criminal and Civil Investigations with Opioid Manufacturer Purdue Pharma and Civil Settlement with Members of the Sackler Family

DISTRICT OF COLUMBIA: Today (10/21/2020), the Department of Justice announced a global resolution of its criminal and civil investigations into the opioid manufacturer Purdue Pharma LP (Purdue), and a civil resolution of its civil investigation into individual shareholders from the Sackler family.  The resolutions with Purdue are subject to the approval of the bankruptcy court.

“The abuse and diversion of prescription opioids has contributed to a national tragedy of addiction and deaths, in addition to those caused by illicit street opioids,” said Deputy Attorney General Jeffrey A. Rosen.  “With criminal guilty pleas, a federal settlement of more than $8 billion, and the dissolution of a company and repurposing its assets entirely for the public’s benefit, the resolution in today’s announcement re-affirms that the Department of Justice will not relent in its multi-pronged efforts to combat the opioids crisis.”

“Today’s resolution is the result of years of hard work by the FBI and its partners to combat the opioid crisis in the U.S.,” said Steven M. D’Antuono, Assistant Director in Charge of the FBI Washington Field Office.  “Purdue, through greed and violation of the law, prioritized money over the health and well-being of patients.  The FBI remains committed to holding companies accountable for their illegal and inexcusable activity and to seeking justice, on behalf of the victims, for those who contributed to the opioid crisis.”

“The opioid epidemic remains a significant public health challenge that impacts the lives of men and women across the country,” said Gary L. Cantrell Deputy Inspector General for Investigations at the U.S. Department of Health and Human Services’ Office of Inspector General.  “Unfortunately, Purdue’s reckless actions and violation of the law senselessly risked patients’ health and well-being.  With our law enforcement partners, we will continue to combat the opioid crisis, including holding the pharmaceutical industry and its executives accountable.”

“This resolution closes a particularly sad chapter in the ongoing battle against opioid addiction,” said Drug Enforcement Administration (DEA) Assistant Administrator Tim McDermott.  “Purdue Pharma actively thwarted the United States’ efforts to ensure compliance and prevent diversion.  The devastating ripple effect of Purdue’s actions left lives lost and others addicted.  DEA will continue to work tirelessly with our partners and the pharmaceutical industry to address the damage that has been done, and bring an end to this epidemic that has gripped the nation for far too long.”

Purdue Pharma has agreed to plead guilty in federal court in New Jersey to a three-count felony information charging it with one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the Federal Anti-Kickback Statute.  The criminal resolution includes the largest penalties ever levied against a pharmaceutical manufacturer, including a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture.  For the $2 billion forfeiture, the company will pay $225 million on the effective date of the bankruptcy, and, as further explained below, the department is willing to credit the value conferred by the company to State and local governments under the department’s anti-piling on and coordination policy.  Purdue has also agreed to a civil settlement in the amount of $2.8 billion to resolve its civil liability under the False Claims Act.  Separately, the Sackler family has agreed to pay $225 million in damages to resolve its civil False Claims Act liability.

The resolutions do not include the criminal release of any individuals, including members of the Sackler family, nor are any of the company’s executives or employees receiving civil releases.

While the global resolution with the company is subject to approval by the bankruptcy court in the Southern District of New York, one important condition in the resolution is that the company would cease to operate in its current form and would instead emerge from bankruptcy as a public benefit company (PBC) owned by a trust or similar entity designed for the benefit of the American public, to function entirely in the public interest.  Indeed, not only will the PBC endeavor to deliver legitimate prescription drugs in a manner as safe as possible, but it will aim to donate, or provide steep discounts for, life-saving overdose rescue drugs and medically assisted treatment medications to communities, and the proceeds of the trust will be directed toward State and local opioid abatement programs.  Based on the value that would be conferred to State and local governments through the PBC, the department is willing to credit up to $1.775 billion against the agreed $2 billion forfeiture amount.  The department looks forward to working with the creditor groups in the bankruptcy in charting the path forward for this PBC so that its public health goals can be best accomplished.

The Criminal Pleas

As part of the plea, Purdue will admit that from May 2007 through at least March 2017, Purdue conspired to defraud the United States by impeding the lawful function of the DEA by representing to the DEA that Purdue maintained an effective anti-diversion program when, in fact, Purdue continued to market its opioid products to more than 100 health care providers whom the company had good reason to believe were diverting opioids and by reporting misleading information to the DEA to boost Purdue’s manufacturing quotas.  The misleading information comprised prescription data that included prescriptions written by doctors that Purdue had good reason to believe were engaged in diversion.  The conspiracy also involved aiding and abetting violations of the Food, Drug, and Cosmetic Act by facilitating the dispensing of its opioid products, including OxyContin, without a legitimate medical purpose, and thus without lawful prescriptions.

In addition, Purdue will admit to conspiring to violate the Federal Anti-Kickback Statute.  Between June 2009 and March 2017, Purdue made payments to two doctors through Purdue’s doctor speaker program to induce those doctors to write more prescriptions of Purdue’s opioid products.  Similarly, from approximately April 2016 through December 2016, Purdue made payments to Practice Fusion Inc., an electronic health records company, in exchange for referring, recommending, and arranging for the ordering of Purdue’s extended release opioid products – OxyContin, Butrans, and Hysingla.

The Civil Settlements

The department’s civil settlements resolve the United States’ claims as to both Purdue and its individual shareholders, members of the Sackler family.

The civil settlement with Purdue provides the United States with an allowed, unsubordinated, general unsecured bankruptcy claim for recovery of $2.8 billion.   This settlement resolves allegations that from 2010 to 2018, Purdue caused false claims to be submitted to federal health care programs, specifically Medicare, Medicaid, TRICARE, the Federal Employees Health Benefits Program, and the Indian Health Service.  The government alleged that Purdue promoted its opioid drugs to health care providers it knew were prescribing opioids for uses that were unsafe, ineffective, and medically unnecessary, and that often led to abuse and diversion.  For example, Purdue learned that one doctor was known by patients as “the Candyman” and was prescribing “crazy dosing of OxyContin,” yet Purdue had sales representatives meet with the doctor more than 300 times.  It also resolves the government’s allegations that Purdue engaged in three different kickback schemes to induce prescriptions of its opioids.  First, Purdue paid certain doctors ostensibly to provide educational talks to other health care professionals and serve as consultants, but in reality to induce them to prescribe more OxyContin.  Second, Purdue paid kickbacks to Practice Fusion, as described above.  Third, Purdue entered into contracts with certain specialty pharmacies to fill prescriptions for Purdue’s opioid drugs that other pharmacies had rejected as potentially lacking medical necessity.

Under a separate civil settlement, individual members of the Sackler family will pay the United States $225 million arising from the alleged conduct of Dr. Richard Sackler, David Sackler, Mortimer D.A. Sackler, Dr. Kathe Sackler, and Jonathan Sackler (the Named Sacklers).  This settlement resolves allegations that, in 2012, the Named Sacklers knew that the legitimate market for Purdue’s opioids had contracted.  Nevertheless, they requested that Purdue executives recapture lost sales and increase Purdue’s share of the opioid market.  The Named Sacklers then approved a new marketing program beginning in 2013 called “Evolve to Excellence,” through which Purdue sales representatives intensified their marketing of OxyContin to extreme, high-volume prescribers who were already writing “25 times as many OxyContin scripts” as their peers, causing health care providers to prescribe opioids for uses that were unsafe, ineffective, and medically unnecessary, and that often led to abuse and diversion.

The civil settlement also resolves the government’s allegations that from approximately 2008 to 2018, at the Named Sacklers’ request, Purdue transferred assets into Sackler family holding companies and trusts that were made to hinder future creditors, and/or were otherwise voidable as fraudulent transfers.

Today’s resolution does not resolve claims that states may have against Purdue or members of the Sackler family, nor does it impede the debtors’ ability to recover any fraudulent transfers.

Today’s announcement was made by Deputy Attorney General Jeffrey A. Rosen; Acting Assistant Attorney General of the Civil Division Jeffrey Clark; U.S. Attorney for the District of Vermont Christina Nolan; and First Assistant U.S. Attorney for the District of New Jersey Rachael Honig.  The criminal investigation was conducted by the U.S. Attorney’s Offices for the Districts of New Jersey and Vermont, the Consumer Protection Branch of the Department of Justice’s Civil Division, and the FBI’s Washington, D.C. and Newark Field Offices, with assistance by DEA.  The civil settlements were handled by the Fraud Section of the Commercial Litigation Branch of the Department of Justice’s Civil Division, and the U.S. Attorney’s Offices for the Districts of New Jersey and Vermont, with assistance from the Department of Health and Human Services, Office of General Counsel and Office of Counsel to the Inspector General; the Defense Health Agency; and the Office of Personnel Management.  The Purdue bankruptcy matter is being handled by the U.S. Attorney’s Office for the Southern District of New York and the Civil Division’s Commercial Litigation Branch, Corporate/Finance Section.

Except to the extent of Purdue’s admissions as part of its criminal resolution, the claims resolved by the civil settlements are allegations only.  There has been no determination of liability in the civil matters.

CANADA: Cannalogue Introduces COVID-19 Compassionate Care Program For Medical Cannabis

Physician-led online marketplace offers discount of 20-50% on select products for frontline workers, seniors and financially strained

CANADA: In response to the closure of storefront retailers due to COVID-19, online marketplace Cannalogue announced today a new Compassionate Care Program that seeks to provide better access to medical cannabis for all Canadians. 

Qualified candidates including first responders, seniors, nurses, teachers, and those facing financial strain due to work shortage/layoffs can enroll in the program to receive selected products at a discount of 20-50%.  The doctor-recommended, Health Canada approved products include oils, capsules, and dried flowers from as low as $3.50/gram.  As the most inclusive program in Canada, Cannalogue’s Compassionate Care Program is also available to veterans, individuals currently enrolled in a disability, federal or provincial assistance program and Indigenous peoples.

“COVID-19 has had a devastating effect on all Canadians” says President and CEO, Dr. Mohan Cooray. “As a result, we’ve seen an upsurge in cannabis use among patients managing symptoms such as pain, anxiety, difficulty sleeping, and stress – especially from symptoms related to COVID-19 isolation.  Cannabis is a natural plant medicine that can be used safely to manage mental health issues without the dependency effects we see from alcohol, opioids or narcotics.  During this unprecedented time and without access to storefront retailers, we want to help Canadians receive the products they need,” he says.

Additionally, with limited access to doctors or pharmacists during self-isolation, Cannalogue’s medical staff can assess and provide dosage recommendations over the phone.  “Cannalogue is an essential national medical service that Health Canada has confirmed will be fully available to patients during the pandemic. No matter how long we face the challenges of COVID-19, Cannalogue will be here to help,” says Dr. Cooray.

FDA Warns Consumers To Protect Themselves By Avoiding Tetrahydrocannabinol (THC)-Containing Vaping Products

FDA Warning

The FDA is providing consumers information to help protect themselves while health officials investigate recent illnesses following the use of vaping products.

DISTRICT OF COLUMBIA: Consumers are likely aware of the recent reports of respiratory illnesses — including some resulting in deaths – following the use of vaping products. The U.S. Food and Drug Administration (FDA) remains deeply concerned about these incidents and is working closely with the U.S. Centers for Disease Control and Prevention (CDC), as well as state and local public health partners to investigate them as quickly as possible.

While the work by federal and state health officials to identify more information about the products used, where they were obtained and what substances they contain is ongoing, the FDA is providing consumers with some information to help protect themselves.

In particular, many of the samples tested by the states or by the FDA as part of this ongoing investigation have been identified as vaping products containing tetrahydrocannabinol (or THC, a psychoactive component of the marijuana plant) and further, most of those samples with THC tested also contained significant amounts of Vitamin E acetate. Vitamin E acetate is a substance present in topical consumer products or dietary supplements, but data are limited about its effects after inhalation.

While the FDA does not have enough data presently to conclude that Vitamin E acetate is the cause of the lung injury in these cases, the agency believes it is prudent to avoid inhaling this substance. Because consumers cannot be sure whether any THC vaping products may contain Vitamin E acetate, consumers are urged to avoid buying vaping products on the street, and to refrain from using THC oil or modifying/adding any substances to products purchased in stores. Additionally, no youth should be using any vaping product, regardless of the substance.

At least one of the associated deaths that has been publicly disclosed External Link Disclaimer appears to have been related to illicit THC vaping products. In many cases of illness reported by the states, patients have acknowledged recent use of THC-containing vaping products while speaking to healthcare personnel, or in follow-up interviews by health department staff.

It’s important to note that more information is needed to better understand whether there’s a relationship between any specific products or substances and the reported illnesses. To help gather and analyze as much information as possible, the FDA’s laboratory is working closely with our federal and state partners to identify the products or substances that may be causing the illnesses.

The FDA is analyzing samples submitted by a number of states for the presence of a broad range of chemicals, including nicotine, THC and other cannabinoids along with cutting agents/diluents and other additives, pesticides, opioids, poisons, heavy metals and toxins.

No one substance has been identified in all of the samples tested. Importantly, identifying any compounds that are present in the samples will be one piece of the puzzle but will not necessarily answer questions about what is causing these illnesses.

Federal and state partners are following any potential leads, including the presence of Vitamin E acetate found in many of the samples containing THC. The FDA is committed to taking appropriate actions as the facts emerge and keeping the public informed as we have more information to share.

However, in the interim, we encourage consumers to help protect themselves and avoid buying vaping products of any kind on the street, and to refrain from using THC oil or modifying/adding any substances to products purchased in stores. If you continue to use these THC-containing vaping products, monitor yourself for symptoms (e.g., cough, shortness of breath, chest pain) and promptly seek medical attention if you have concerns about your health. If you are concerned about your health after using a vaping product, contact your health care provider, or you can also call your local poison control center at 1-800-222-1222. Health care providers also can contact their local poison control center.

CDC and the FDA encourage the public to submit detailed reports of any unexpected tobacco- or e-cigarette-related health or product issues to the FDA via the online Safety Reporting Portal.

LTC(R) Todd Scattini- “The Hemp Colonel” Remarks At Emerald Science Conference

Thanks to the Emerald Sciences Conference team— Jules Sinclair, Ken Snoke, Wes Burk, and Cliff Beneventi, and Dr. John Abrams

I am so grateful for this platform. I am humbled to have the opportunity to kick off this important conference focused on the science of cannabis and the technology to facilitate its research. I’m honored to address you, the leaders in the field on this occasion.

CALIFORNIA

I love coming back to my home state of California and seeing how the bravery of activists changed cannabis policy here in 1996, which began a policy evolution across the United States and around the world. For example, it was the bravery of gay activists in California, like Denis Peron, Harvey Milk, and Richard Eastman, teaming up with Jack Herer responding to suffering brought on by the AIDS epidemic that inspired their movement. The loss and suffering of their friends was too much to bear, and they risked their freedom and reputations to come to the rescue of their comrades.

Todd Scattini on Stage

In many ways, my own life has followed the arc of cannabis policy.

I was born in 1970, the same year that Richard Nixon—another Californian—created the “war on drugs.” I was raised in the “Just Say No” generation in a law enforcement household. And in 1996, the same year that I graduated from West Point, CA was the first state to take the brave step forward to legalize medical cannabis.

And then on January 1st, 2018, I was officially retired from the Army, and my home state of CA legalized the adult use of cannabis. I now call Kansas City, MO home, and I’m proud to say that I was part of legalizing medical cannabis there, which passed by a vast majority during the November 2018 election.

As you’ve likely concluded from my bio, I’m not a scientist. I’m not a doctor. I am now just an old soldier. At West Point, I was trained under the banner of DUTY, HONOR, COUNTRY and inspired to a lifetime of service to the Nation. Much like many of you, I feel like working in the medical cannabis industry is my calling. I consider this how I continue to serve, today. Given my experiences in the Army and my understanding of the power of the cannabis plant, I believe that I have a voice to lend to this discussion and a duty to pursue safer and more effective methods of treating veterans and military personnel who suffer from wounds both visible and invisible.

As a Veteran now, I find myself part of a population in the midst of a health crisis marked by elevated levels of suicide, mental health concerns, substance abuse issues, and addiction. I cannot purport to speak for all veterans, but today I will attempt to describe the view from my foxhole.

VCP

But first, I also want to thank Doug Distaso for the great introduction, and congratulate him for being named the new Executive Director of the Veterans Cannabis Project, where I’m proud to serve as a board member and the director of the Midwest region. Doug is a 1996 USAFA graduate who served our Nation as a special operator for many years. He is now working tirelessly to bring about policy changes every day by waving our flag in Washington D.C., providing leaders with a great reason to say yes to increased research and access to medical cannabis for veterans. The VCP was founded by Nick Etten, a Naval Academy grad, and The VCP is turning out to be incredibly influential instrument in cannabis policy at the federal level. I believe it is because the creation of the VCP and the execution of what we do come from a place of great PURPOSE for us and a sense of DUTY, because we feel like we’re doing what we were trained to do—protect and care for those who have served. And because of our time as leaders in the military, we also care deeply about the families of those who serve; keeping in mind the often serious cascading effects of pain and trauma experienced in veterans’ families and the communities in which they live.

Todd at Emerald Science ConferenceCOMMANDER IN CHIEF’S TROPHY:

I’d be remiss if I didn’t mention that West Point owns—for the second year in a row—the Commander-in-Chief’s trophy. This means that Army beat both the Naval Academy and the Air Force Academy this year in football. I bring this up not only to gloat but also to bring us to the football field. Part of our training at the military academies is participation in athletics. This instills in all of us a sense of the interconnectedness between competitive athletics and military action–these are ideas of struggle, tactics, and strategic engagement. And football of course has a long tradition at the academies—the Army-Navy game, first played in 1890, is one of the most traditional, enduring rivalries in college football.

General Douglas MacArthur, himself a superb athlete, while serving as Superintendent of West Point identified so clearly the relationship between competition on  the football field and combat on the battlefield. He said, “On the fields of friendly strife are sown the seeds that on other days, on other fields will bear the fruits of victory.”

In no other forum is there a clearer representation of today’s modern gladiators and warriors.

On the second Saturday every of every December, the football field is where gladiators from both Army and Navy engage in competition that will translate one day to the battlefield, where they will serve as warriors. It’s also the field where men engage in competition that is a multi-billion dollar “entertainment” industry. Professional athletes, our modern Gladiators on the football field risk their health, and arguably their lives in the long term, for our entertainment. And warriors on the battlefield do our nation’s bidding, by putting their lives on the line as part of duty to our country. Both of these populations are at high risk for suffering from long-term health issues, including chronic pain, PTSD, TBI, and CTE, just to name a few. These populations are also at extremely high risk of becoming addicted to opioids and other frequently prescribed drugs. These populations should have access to medical cannabis as an option.

I believe that we are in a position to change the lives of veterans, football players, men and women affected by

these debilitating medical conditions. And indeed we have an ethical duty to do so.

So, How does an Army Colonel get involved in cannabis?

In Afghanistan, I served  on the Commander’s Initiatives Group, which is an interdisciplinary team comprised of diplomats, military personnel, and civilians tasked with providing strategic advice to the Coalition Commander.

Among many other things, we were asked to develop innovative solutions to transform the Afghan economy using the country’s available natural resources. I proposed the use of hemp as an element of the Afghan economy to provide a replacement to the widespread cultivation of opium. An additional benefit of this plan would have been the cross-pollination of hemp and cannabis, thereby reducing the amount of THC in the hashish crops they grew to sell in prohibition markets for exorbitant profits. My recommendation fell on deaf ears, because, although I served for incredibly intelligent and talented leaders, this was still a bit “out there.”

But it was there, in Afghanistan, where I became so interested in everything revolving around cannabis. I had never found a subject more fascinating on so many levels. Its history in the United States charts a path beginning with the devastating Social Justice implications of our prohibition of this plant rooted in racism, greed, and often illogical, fear-mongering, and uninformed political arguments.

The social justice impacts alone, coupled with the  potential health impacts on our society, merit focus and the concentrated efforts of the entire global community. This includes international organizations, federal, state and local governments, as well as academic institutions. Our future must focus on the as-yet untapped transformative possibilities that this plant has to offer.

As states begin to legalize adult use of marijuana, we’re beginning to see positive outcomes in Job Creation, Revenue Generation, and increased Research opportunities. We are building an industry from the underground up. It is amazing to watch, as many of you are already doing, what it looks like when we apply modern scientific tools and techniques to a plant we’ve been unable to study for far too long. So, I am very excited to hear many of your findings over the next two days.

Today, we find ourselves in a position to facilitate meaningful research and then to amplify the medical outcomes of cannabis. By creating opportunities for interdisciplinary, multinational collaborative groups, we can synchronize research agendas. And with the support of powerful partners in the federal arena, including but not limited to the DoD, and in national, influential institutions like the NFL, we can make visible the results of this research.

And I believe that this conference, with the incredible roster of scientists leading sessions on significant topics such as cannabis genomics and chemotyping, genetic sequencing, standards and practices, pharmacological strategies, cultivation, extraction, and processing, and emerging research trends and findings, to name just a few, , are so vital to forward progress and to what I see as our ethical responsibility, our DUTY, to our planet and our fellow human beings.

Before I left the military, I struggled, at first, to see how my skill sets might translate to the industry. But I realize that the skill sets that I am deploying in the cannabis space were the same ones that were developed in me in the military. While serving, I was trained to lead soldiers in combat, and I was trained in the art of diplomacy. In the military we have been told that our only limit was our imagination and that we have to think critically about complex issues and develop creative solutions to apply to them.

There are few issues facing our country that are more complex than that of veteran suicide and our Nation’s opioid crisis. The two combined result in the death of nearly 12,000 veterans annually. Beyond that, opioid overdoses cost the lives of almost 70,000 American civilians last year, resulting for the third year in a row, in a decline in the life expectancy of American citizens.

Now, THAT is a national emergency. Cannabis can help reverse this situation. This is no longer an assumption. This is what we know from experience in 33 states that have legalized cannabis for medical purposes.

Even the FDA holds several patents on cannabinoids as a neuroprotectant, anti-inflammatory, and antioxidant. This triad comprises, ironically, the three things that would be most useful to combat Traumatic Brain Injuries, what the Defense Advanced Research Projects Agency (or DARPA) has called “The Signature Wound of the Iraq and Afghanistan Wars.”

My passion project is The Athena Protocol.

I’ve named this project after the Greek goddess, Athena, who is the goddess of military victory, knowledge, and good counsel. And, her helmet is prominently displayed on the crest of the United States Military Academy at West Point.

Athena Protocol

The Athena Protocol is a four-phased, multi-disciplinary strategy designed to mitigate and treat traumatic brain injury (TBI). And, we believe it may have the same application to prevent and treat chronic traumatic encephalopathy (CTE). The Protocol seeks to harness the neuroprotective, anti-oxidative, and anti-inflammatory properties of non-impairing cannabinoids administered as a prophylaxis and a treatment through a phased program prior to and following a brain injury, which would include administration on the battlefield immediately following a suspected TBI, at the point of injury.

The development of this Protocol was inspired by the loss of one of my Lieutenants who had served under my command.

Captain Andrew Houghton, from Houston, Texas was an exceptional young officer and a fellow graduate of West Point (Class of 2001). Andy threw his hat in the air on the field at Michigan Stadium just months before the attacks of 9/11 on our Nation that thrust us into what is our country’s longest conflict. I last saw Andy at the Walter Reed Army Medical Center, where I met his parents. We pinned a purple heart on his chest, and the following day he succumbed to his traumatic brain injury sustained while serving in Iraq. My hope is that The Athena Protocol might be able to prevent or reduce the severity of TBIs, and perhaps increase the survivability of soldiers in combat. It is scientists and researchers like you who fill this room and the technology that we are all working to bring to bear on the cannabis plant that might help move research like this forward.

So, where are we now?

I’d say that we are in The Adaptive Space. This is a concept we train our officers on at the Command and General Staff College in Ft. Leavenworth, Kansas. It’s based on Michael Arena’s groundbreaking work that leads organizations to become more agile and to embrace disruptive forces as positive accelerators. Cannabis is that disruptive force.

The Adaptive Space exists in between and intersecting the Entrepreneurial and the Operational realms of leadership. In short, the Adaptive Space is the space that exists between the prohibition period, where research was stifled (an understatement) to a place where cannabinoid medicines can be prescribed with predictable outcomes. It is the place where we will soon get to apply the most complex plant that we know of at some of the worlds most complex health issues.  In this space–if people collaborate freely with parallel objectives–real growth happens and true organic innovation emerges.

In order to develop a deeper understanding of how cannabinoid medicine might be applied to some of the most complex medical conditions of our time, we need to:

  • Reduce barriers to research
  • Develop clear protocols for cannabis
  • Create an environment to conduct research on the predictability of cannabis’ effects on the prevention and treatment of injury, illness, and disease.
  • Conduct research on dosing, which the Emerald Sciences Team is currently working toward.
  • Furthermore, we should demand that medical schools train their students on the endocannabinoid system and the most current science on cannabis.
  • Finally, I believe that the DoD is uniquely positioned as the ideal organization to lean into medical cannabis research. The veteran community represents the largest patient population in the United States. The DoD has over 1,200 health care facilities nationwide, including 170 VA Medical Centers, and over 1,000 outpatient sites of care. These serve over 9 Million enrolled veterans annually. 75% of that population have made it known that they would welcome cannabis as a treatment option.  The two largest VSOs (VFW and AL) have made demands for increased cannabis research part of their national platforms.
  • It makes sense that the military would lead this effort

The military has a long history of driving medical advances, including the discovery of penicillin, the development of plastic surgery, and the treatment of amputation. These advances were realized in response to necessity. We’re now in a moment of necessity. And we need the DoD to STEP UP, get past the stigma, and look at medical cannabis as a way to address the veterans health crisis that we’re in today. I’m confident that cannabis would become an effective tool for the military medical community to address veterans health issues, if they were to commit to understanding the full potential this plant possesses. And, I believe that we would reduce healthcare costs for our nation, as a whole.

If we focus science, technology, and minds with clear vision and purpose, we can maximize innovations in this Adaptive Space. And this must happen NOW. In the military, we spend a lot of time learning about revolutions in military affairs. That is to say how small changes or inventions change warfare. These include the advent of the stirrup that made it possible for warfare to be conducted while mounted on a horse. It is the advent of the rail lines to speed military transport. It is the invention of the computer…of the satellite. These all add to revolutions in military affairs.

Today, we are on the precipice of an authentic paradigm shift that will be seen as a true revolution in medical affairs. Even today, medical cannabis is saving people’s lives and improving the health and well-being of their families and communities. It is my goal to ensure that this happens within the veteran community, as well.

We are so lucky to be operating within the cannabis industry today, in whatever role you might be playing. While the rest of the world gets to watch the shifting of a paradigm, we get to actually guide it, shape it, direct it. We get to make it in the form of something that we can be really proud of. We can set the example for other industries to follow.

My final thought

We spend a lot of time discussing this plant, and that is for good reason. For many of us, we consider that this plant has saved our lives or the lives of someone close to us. Most of us are inspired by this plant for the bounty we believe it possesses and because we believe that it can revolutionize the way we treat patients and how it might improve the health and well-being of our species. What will make this all possible are the People. And, that is why we are gathered here, to interact with one another, and to create connections that might help us advance medical science and deepen our understanding of the cannabis plant and how to deploy it. We are here to promote collaboration among Nations, institutions, and people. I’m sure many of you have experienced the deep friendships that develop around the study of this plant…some of it even owed to the mutual communion around the cannabis plant.

One particular individual that I would like to mention was a dear friend and colleague, Steve Baugh. He spoke here last year and was a member of the Harvest 360 Team. Steve passed away suddenly just ten days ago. He was an accomplished chemist and inventor who held several patents. He was a husband and father with a genius mind. But most of all, he was our friend and a valued teammate. His passing is a great loss to the scientific community. We will miss him dearly and offer condolences to his family.

My goal for this address was to inspire this crowd by pointing out the need for greater research of cannabis and perhaps introduce you to the struggles of a the veteran population so desperately in need of safer and more effective treatments for the wounds of war. But, I believe you already know this. I think we are all well aware of the potential for cannabis to serve as a life saving medicine. We wouldn’t be here if we didn’t.

In the end, I believe what I am trying to do is to inspire our country to significantly reduce the barriers to research of cannabis. I think that access to this medicine and the ability of scientists to research it should be considered a human right, and that it is our DUTY to explore it.

During a recent trip to Washington DC with the VCP, I visited the American Academy of Sciences. I went there to pick up a copy of their recent publication: The Health Effects of Cannabis and Cannabinoids The Current State of Evidence and Recommendations for Research. This report provides a broad set of evidence-based research conclusions on the health effects of cannabis and cannabinoids and puts forth recommendations to help advance the research field and better inform public health decisions.

As I entered the building, I was immediately struck by Albert Einstein’s words that guard the entrance to the building.

He was quoted as saying:

“The right to search for truth implies also a duty;

One must not conceal any part of what one has recognized to be true.”

In this, Einstein is challenging all of us to search for truth with integrity and purpose and to share that truth for the greater good.

I feel that Einstein’s quote was an appropriate way to open our proceedings this week, and I hope to harness or enlist the intellectual power and the scientific capabilities represented in this room to that end.

I cannot wait to search for truth with you and share it with the world.

I implore this group to join me and so many other veterans who are working toward this end to find solutions to address the healthcare crisis we are in today. I invite the Department of Defense and others to join us in helping facilitate research.\

I believe it is our duty to do so.

I believe we have WE HAVE SKIN IN THE GAME!

Cresco Labs Continues Its Illinois Expansion With Regulatory Approval For Three Dispensaries

ILLINOIS: Cresco Labs Inc., one of the largest vertically integrated multi-state cannabis operators in the United States, today announced that it received approval from the Illinois Department of Financial and Professional Regulation (IDFPR) for Cresco’s previously announced acquisitions of licensed medical cannabis dispensaries MedMar Rockford and MedMar Lakeview, located in the popular Wrigleyville neighborhood of Chicago. The IDFPR also approved Cresco’s acquisition of PDI Medical, a medical cannabis dispensary located in Buffalo Grove, Illinois, which was purchased by the Company in November 2018. The MedMar dispensaries are Cresco Labs’ fourth and fifth dispensary acquisitions in Illinois bringing the Company’s footprint to five dispensaries in its home state.

“Illinois is at the forefront of our nation’s evolution of the cannabis industry, and with these three dispensary approvals, Cresco has reached the maximum level of dispensaries any single company can own and operate in our home state,” said CEO & Co-Founder Charlie Bachtell. “We have already achieved the highest market share of any operator in Illinois and our prospects for accelerated growth are promising with the recent implementation of the Alternatives to Opioids program that began on February 1st. Illinois has opened access for patients by eliminating the three-month waiting period as well as requirements for fingerprinting and background checks for all patients with any qualifying condition. With a doctor’s approval, a patient can now receive a medical-use cannabis card in just one day.”

In addition to its five dispensaries in Illinois, Cresco operates three cultivation and processing facilities across the state.

Acreage Holdings Appoints Corey Burchman, MD As Chief Medical Officer

Former Geisel School of Medicine at Dartmouth Clinician and Researcher Brings Expertise in Clinical Cannabinoid Therapeutics to Guide Multi-State Cannabis Operator

Acreage-HoldingsNEW YORK: Acreage Holdings,  announced the appointment of Corey Burchman, MD as Chief Medical Officer. Dr. Burchman will oversee development of an Acreage medical advisory board, assist in developing patient outreach programs, and serve as medical risk mitigator to the company’s product development and innovation. Additionally, Corey will cultivate important relationships with regulatory partners and patient advocacy groups, and drive medical education and engagement throughout the company. Dr. Burchman will report to Chief Operating Officer, Bob Daino.

“Corey is a nationally recognized expert on clinical cannabinoid therapeutics and has chaired multiple national and international conferences on the use of medical cannabis for therapeutic purposes. He is the perfect fit for this critical position and will play an instrumental role in helping Acreage deliver on our mission of bringing safe, affordable cannabis to anyone who needs it,” said Acreage Chairman and CEO, Kevin Murphy

Prior to joining Acreage, Dr. Burchman served as Assistant Professor of Anesthesiology and Pain Medicine at the Geisel School of Medicine at Dartmouth, in Lebanon, NH. At Dartmouth-Hitchcock Medical Center, he directed the Section on Neuroanesthesia, the Post Anesthesia Care Unit, and the Same Day Surgical Program. Additionally, he was an Attending Physician on the Acute Pain Service. Dr. Burchman also served as Medical Advisor to the Board at Prime Alternative Treatment Center of New Hampshire, a therapeutic cannabis dispensary.

Dr. Burchman is an author of a May 2017 study that found a significant reduction in use of opioids, antidepressants and alcohol for pain, anxiety and sleep among medical cannabis patients in New England. Published in the Journal of Psychopharmacology, it remains one of the largest studies of its kind.

On joining Acreage Dr. Burchman said, “In my role as Chief Medical Officer, I hope to bring my experience in clinical cannabinoid therapeutics as the basis for developing strong patient outreach programs, and building relationships with advocacy groups and partners. Working with Acreage allows me to further a theme that has anchored my entire career—patient safety—in an industry that has the capacity to change lives for the better across the country.”

Dr. Burchman received his medical degree from George Washington University School of Medicine and his residency and fellowship training at Harvard Medical School, the Massachusetts General Hospital and the Brigham and Women’s Hospital. He has been actively involved in teaching medical residents, medical research, and administering clinical care for over 33 years. He is a US Navy veteran of 13 years.

8 Best Complementary Health Approaches For Chronic Pain

Complementary and integrative medicine, otherwise known as CIM, encompasses both Western medicine and complementary health approaches as a new combined strategy to treat many clinical conditions.

Chronic pain is, in fact, the leading indication for the use of CIM. According to the National Center for Complementary and Integrative Health (NCCIH), about 33% of adults and 12% of children in the US have used CIM in this context.

“All of us that are thinking about the management of chronic pain are aware that, alongside the use of pharmaceuticals, we need other approaches,” said Josephine Briggs, the head of NCCIH.

Pain has both physical and mental components, which is why most types of chronic pain could be managed through approaches that are medication-free and have very few negative side effects.

Some of the strategies that seem to offer the best results for those with chronic pain include mindful meditation, CBT, acupuncture, deep breathing exercises, use of CBD oil, and so on. Continue reading to learn more about the said practices for treating chronic pain.

Mind over Matter

Mind Over Matter

Mindfulness is a modern complementary health approach for pain originated from ancient Eastern philosophy.

“It’s a practice designed to cultivate the cognitive state of mindfulness that is premised on nonjudgmental awareness of the present situation,” said Fadel Zeidan, a mindfulness and pain researcher at Wake Forest School of Medicine in Winston-Salem, North Carolina, US.

Over the past few decades, thousands of studies have investigated the effects of mindfulness on both mental and physical health. A 1985 study showed that about a 10-week of mindfulness training gave significant benefits to patients with chronic pain, including lowering the amount of medication they took.

However, a recent analysis of studies showed evidence that mindfulness treatments can improve pain in people with a variety of conditions.

Mindful meditation focuses mainly on the present and emphasizes acceptance instead of focusing on the past or future. When it comes to meditating, a person will usually focus on a particular word, object, or breathing pattern.

Mindful medication doesn’t eliminate pain. But it has shown to improve the quality of life for those with chronic pain. The medication has also been found to release tension and reduce stress hormones.

Acupuncture

Long practiced in traditional Eastern medicine as a treatment; acupuncture is an alternative therapy which involves using needles to stimulate specific points on the body.

These points are said to connect with meridians – certain pathways that carry vital energy (or “chi”) throughout the body.

Blockages in the flow of chi disrupt well-being, which leads to illness. By stimulating acupuncture points, acupuncturists aim to clear up those blockages and restore the patient’s health and vitality.

Here are some of the pain conditions that showed to improve with the use of acupuncture:

  • Headaches and Migraines: A study suggests that acupuncture is more effective than medication in protecting against migraines. It’s also beneficial for those with frequent episodic or chronic tension headaches.
  • Low Back Pain: As already mentioned, acupuncture tends to focus on certain channels, some of which correspond to specific points on the body. There are a few acupuncture points — back of the knees, foot, lower back, hip, hand, and stomach — that can help you recover from lower back pain.
  • Arthritis: People with osteoarthritis can benefit from acupuncture. An intensive two- to four-week treatment regimen can offer significant short-term relief of osteoarthritis-related knee pain.

Acupuncture releases opioid-like chemicals in your body, which causes the body to release neurotransmitters that shut off your receptors to pain. It also triggers the electromagnetic impulses with the body, helping to speed up the release of endorphins. This allows your body to manage pain more easily.

Biofeedback

Biofeedback is another complementary health approach for chronic pain, such as low back pain. It involves becoming aware of physiological processes in the body and learning how to control a portion of them.

There are two common forms of biofeedback:

  • Neuromuscular biofeedback: This practice can be used to treat a variety of musculoskeletal conditions. It uses electromyography (EMG), which translates muscles contracting and relaxing on a graph or into numbers, or real-time ultrasound imaging (RTUS), which works similarly and muscles are displayed on a screen contracting and relaxing in real time.
  • Cardiovascular biofeedback: This technique involves tracking blood pressure, heart rate, and other cardiovascular functions. A therapist may often use an electrocardiogram to monitor HRV (heart rate variability), which measures the time between heartbeats. This practice usually focuses on learning to control breathing.

Biofeedback is often done in conjunction with CBT and relaxation exercises.

CBT – Cognitive Behavioral Therapy

The goal of CBT is to recognize negative thoughts and redirect them towards coping thoughts. This can ultimately make chronic pain a livable part of daily life. Generally, cognitive behavioral therapy is provided by a mind-body therapist or psychologist.

“CBT is a useful and empirically based method of treatment for pain disorders which can decrease reliance on the excessive use of opiates,” said Donna M. Sudak of Drexel University College of Medicine, Philadelphia, and Muhammad Hassan Majeed of Natchaug Hospital, Mansfield Center, Connecticut.

According to them, the use of CBT can avoid or reduce the use of opioids of chronic pain. It helps patients understand that pain is a stressor, and similar to other stressors, it is something they can adapt to and easily cope with.

Progressive Muscle Relaxation

This practice involves tensing and relaxing certain muscle groups followed by a release of muscle tension. If practiced regularly, it can teach you to be more aware of where the pain is coming from as well as help you relieve muscle tension.

Deep Breathing Exercises

Chronic pain often leads to strained breathing, including taking shallow breaths. This can cause dizziness and chest pain. By taking deep breaths over a period of time, your body will consume more oxygen, improve lung function, and ultimately enhance the overall energy levels.

Guided Imagery

This one is a rather simple yet effective method. During pain flare-ups, consider focusing on a pleasant scene or soothing image. This will help distract attention from the discomfort.

CBD Oil

CBD Oil Pix

There are different compound levels found in the natural hemp. How people breed hemp affects CBD levels. CBD oil that comes from industrial hemp usually has a higher CBD content than cannabis.

Different methods are used to extract the compound, which is then added to a carrier oil called Cannabidiol or CBD oil. It comes in many different strengths and is used in various ways.

People have been using CBD traditionally for hundreds of years to treat various types of pain. One report found that short-term use of CBD oil can reduce the levels of spasticity a person feels. The same report studied the use of CBD oil for pain, especially chronic pain.

Researchers compiled the results of several systematic reviews covering dozens of studies and trials. Their research concluded that there’s substantial evidence of cannabis being an effective treatment for chronic pain in adults.

Another study in the Journal of Experimental Medicine suggests that using CBD oil can reduce pain and inflammation, supporting the above-mentioned results.

Wrapping Up

When it comes to chronic pain, some of us reach for a pain remedy — something that is quick and easy. Well, of course, popping a pill may offer you fast relief, but other options may actually offer you long-term better health. Consider the complementary health approaches mentioned in this article to help treat your chronic pain naturally.

Representative Tulsi Gabbard To Lead Landmark Bipartisan Marijuana Reform

DISTRICT OF COLUMBIA: Rep. Tulsi Gabbard (HI-02), along with Rep. Don Young (AK-AL), NORML, and other supporters, will hold a press conference introducing two bipartisan marijuana bills.

The Ending Federal Marijuana Prohibition Act of 2019 would remove marijuana from the federal Controlled Substances list and allow states the freedom to regulate marijuana as they choose, without federal interference.

The Marijuana Data Collection Act of 2019 would study the effects of state legalized medicinal and non-medicinal marijuana programs from a variety of perspectives, including state revenues, public health, substance abuse and opioids, criminal justice, and employment.

Details:

Day-of Contact: Lauren McIlvaine: (202) 713-6040

Thursday, March 7, 2019:

Who:

  • Rep. Tulsi Gabbard (HI-02)
  • Rep. Don Young (AK-AL)
  • Erik Altieri, Executive Director, National Organization for the Reform of Marijuana Laws (NORML)

When: 11:00 AM ET

Where: House Triangle, U.S. Capitol

 

MedMen’s New Commercial Chronicles The History of American Cannabis From Counterculture To Just Culture

MedMen’s The New Normal Taps Acclaimed Filmmaker Spike Jonze and Actor/Activist Jesse Williams to Normalize Cannabis

CALIFORNIA: MedMen Enterprises rewrote history yesterday with the debut of a disruptive new commercial that chronicles the American history of cannabis. Supported by the most expansive integrated marketing campaign the company has executed to date, The New Normal is directed by Academy Award-winning storyteller Spike Jonze and features actor Jesse Williams, best known for his longstanding activism and starring role in Grey’s Anatomy. The ad furthers MedMen’s vision where legalized and regulated cannabis creates a safer, healthier and happier world. Founded in 2010, MedMen is known for its disruptive advertising campaigns, innovative approach to cannabis retail and progressive legalization efforts.

The diverse creative team behind the project includes actor Jesse Williams, director Spike Jonze, Academy-Award nominated cinematographer Bradford Young and production designer James Chinlund, who is currently working on the upcoming Lion King movie.

MedMen launched a 360-degree approach to The New Normal campaign, which includes spots on connected TV networks (including Bravo, CBS Sports Network, Oxygen, MSNBC, Lifetime and Food Network), 80+ out of home assets, print ads (including national ad placements in Rolling Stone and US Weekly), Sirius XM, native integrations with Complex, podcasts and terrestrial radio, digital, pre-roll and programmatic ads. MedMen will also be advertising for the first time in hundreds of movie theaters across California, Nevada, and Michigan.

The commercial chronicles society’s evolving perceptions of the plant, from pre-prohibition to the modern industry of today. While looking back through America’s history, from George Washington’s hemp farm, to Reefer Madness propaganda, The New Normal takes the audience on a journey through the injustices of the past and a hopeful view for the future. Jonze and Williams collaborated to ensure that much of the commercial’s cast and crew had a personal real-life connection to the plant. Those individuals included military veterans who use cannabis to treat their PTSD, a former NFL football player who uses it as a substitute for opioids, victims of racial profiling and those who work in the emerging industry.

Jesse Williams, who also co-wrote the film with Jonze, will appear on the cover of EMBER volume 4, MedMen’s in-house magazine. The magazine will be free with purchase at every MedMen store beginning February 25, 2019. It will also be distributed at Barnes & Noble bookstores nationwide and select boutiques, hotels and restaurants.

In addition to the commercial, Spike Jonze is creating a short documentary with filmmaker Molly Schiot that was shot on set and explores the themes of the short film in more detail. It was important to all involved to tell the stories of cast members who all have their own relationships with cannabis, including: veterans who have found cannabis as a way to treat themselves, former law enforcement, formerly incarcerated drug offenders and young entrepreneurs in the cannabis industry.

All of this content as well as a brief history of cannabis and more is available on www.medmen.com.

Jesse Williams commented, “The highly selective criminalization of one plant, with flagrantly harsher punishments for one community, must be acknowledged and left behind for something more reasonable, realistic and fair. It’s pretty clear that Americans are ready to exist beyond a few inherited hypocrisies. We deserve the opportunity to make this right. We can do, and feel, better.”

When I read the premise about telling the story of the history of cannabis and our country, there was something that moved me about it. I apologize for using such a 2010’s word, but it felt healing to me. I didn’t know much about the specifics of the history, but as I learned about it, I felt like it was a story of a very dysfunctional couple. The relationship started in such a healthy place, with even our Founding Fathers having hemp farms, but it got so tragically messed up in the 80 years of prohibition that we couldn’t see straight. It was shocking to just sit in all the stories of so many people and so many lives that were unfairly hurt by the prohibition and the fear that was stoked by it, especially people of color. And it wasn’t just their lives, it was their families, too. And now we are starting to come out of it. We are at that point in a relationship where a couple is calming down after a fight and realizing how irrational they were and trying to make amends. I’ve never been into pot much or a huge advocate for legalization, but I’ve always supported it because it seemed absurd for the reasons we all know. And it always felt inevitable. But getting to do this, I got to learn the bigger picture of the whole story. I feel so hopeful, but the thing that sticks with me and upsets me is that there are still so many people that are still locked up for this plant that is now legal in so many places. That doesn’t make sense,” Spike Jonze stated.

“Cannabis is part of our country’s history. We’ve moved away from the propaganda of the past and into a world where cannabis is the new normal. We want this commercial to educate and embolden in equal measures. This is our opportunity to make a statement on a national stage,” said Adam Bierman, MedMen’s CEO & Co-Founder.

 

Study: Majority Of Medical Cannabis Patients Are Seeking Pain Relief

MICHIGAN: Most US patients registered to access medical cannabis cite chronic pain as their primary qualifying condition, according to data published in the journal Health Affairs.

Investigators from the University of Michigan, Ann Arbor reviewed patient registration data from the majority of states that provide medical cannabis access. (Some states, notably California and Maine, possess voluntary registries and therefore do not compile patient profile data.)

They reported that in 2016, chronic pain was the most common qualifying condition reported by patients (65 percent). They added, “Of all patient-reported qualifying conditions, 85 percent had either substantial or conclusive evidence of therapeutic efficacy,” as defined by the 2017 report published by the National Academy of Sciences, Engineering, and Medicine. The authors of that report concluded that there exists conclusive or substantial evidence for the effectiveness of cannabis in the treatment of chronic pain, nausea and vomiting, and spasticity.

Separate studies indicate that legal cannabis access is typically associated with reduced rates of opioid use and abuse. Studies have also identified a reduction in the prevalence of opioid-related mortality following statewide marijuana access.

Authors concluded: “[O]ur data show that the number of medical cannabis patients has risen dramatically over time as more states have legalized medical cannabis. … [W]e believe not only that it is inappropriate for cannabis to remain a Schedule I substance, but also that state and federal policy makers should begin evaluating evidence-based ways for safely integrating cannabis research and products into the health care system.”


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Qualifying conditions of medical cannabis license holders in the United States,” appears in Health Affairs. Additional information is available in NORML’s fact-sheet, “Relationship Between Marijuana and Opioids.”