How the DEA could introduce big pharma to marijuana

http://www.marketwatch.com/story/how-the-dea-could-introduce-big-pharma-to-marijuana-2016-07-01

The U.S. could soon be one step closer to allowing marijuana sales at your local drugstore. But while that might mean good news for patients, it could also overturn 20 years of development in the medical marijuana industry.

A long-awaited decision by the Drug Enforcement Administration that could reclassify the drug’s status as a tightly regulated substance is expected this summer. That could signal a green light for the pharmaceutical industry to enter a market expected to be worth $6.7 billion in 2016, potentially leading to the development of new treatments to well-known illnesses.

But it could also shake up states where medicinal marijuana is already legal, which saw an estimated $2.4 billion in sales last year, as the standard prescription and pharmacy process replaces doctor’s recommendations and dispensaries. In short, experts say, the DEA’s decision could simultaneously legitimize medical cannabis across the U.S. and throw a still-developing market into chaos.

A change could lift a cloud over the burgeoning cannabis industry because “there’s no longer this question of…how to handle it,” said Rob Hunt, a general partner at cannabis-focused private-equity firm Tuatara Capital.

Tuatara Capital

 Rob Hunt.

But the risks to current business are substantial, experts say. “The entire medical market as we know it today could go away very quickly,” said Hunt.

The DEA treats marijuana as a Schedule I substance, marking it as unsuitable for legal medical use and having a high potential for abuse. Heroin and LSD have the same designation. But the Justice Department has essentially left states to manage marijuana enforcement, and 25 have legalized it for medical use. (Four, plus the District of Columbia, have approved it for recreational use.)

Read: The marijuana business might have a high-stakes pest problem

Market watchers have eagerly awaited the DEA’s decision. In April, the DEA said in a letter to Congress that it would decide whether to reclassify cannabis — to Schedule II, which concedes pharmaceutical uses, to even less restrictive categories — in the first half of 2016. (They could also remove it from the list of controlled substances entirely, or do nothing.) While that has passed, an agency spokesman told MarketWatch a decision could happen soon.

Most in the legal cannabis industry think a move to Schedule II is possible. A range of organizations and political figures have called for a change: The American Academy of Pediatrics, for example, advocates for a move to Schedule II to aid research into its use in treating children, according to Seth Ammerman, a member of the AAP Committee on Substance Abuse and a clinical professor of pediatrics at Stanford University.

The issue has also been raised during the presidential campaign. Democratic presidential candidate Hillary Clinton said in November that she supported moving it to Schedule II, and presumptive Republican nominee Donald Trump said in a February interview that while he was in favor of using cannabis for medical purposes he did not have a specific policy stance on legalization.

A move to Schedule II to would likely encourage pharmaceutical companies to invest in the cannabis industry, experts say, which could lead to products being available at neighborhood pharmacies rather than the dispensaries that generally distribute them today in states where they are legal.

“Schedule II substances are typically handled through pharma,” says Brett Roper, chief operating officer at Denver-based dispensary Medicine Man. “If they deploy a strict Schedule II element, typically Walgreens WBA, -0.25%  and CVS CVS, -0.77%  or another pharmacy…are going to be the places you have to buy your cannabis.”

Some worry that doing so could dismantle an industry that has been functioning since California legalized medical cannabis in 1996.

“You’d wipe out how many dollars worth of infrastructure, how many tens of thousands, hundreds of thousands of jobs, and you’d put it squarely in the hands of big pharma,” Roper says.

But others expect that if cannabis is rescheduled, businesses in states where it is already legal will be allowed to continue operations without rerouting them through pharmacies.

Either way, the pharmaceutical industry would likely have significant opportunities to develop new treatments — and to profit. Larger companies with locations in multiple states could begin clinical trials on drugs based on cannabinoids, the chemical components that make up the marijuana plant. THC produces psychoactive effects, which some contend is useful for appetite control and as a sleep aid, while cannabidiol is typically used to treat pain and other symptoms.

Pharmaceutical companies could start developing cannabinoid-based drugs for multiple sclerosis, Parkinson’s, and “ailments that actually cause real issues that are identifiable to people,” Hunt says. “That will only happen in the pharmaceutical industry.”

Read: These parents are fighting to give pot to their kids

The pharmaceutical industry group Pharmaceutical Research and Manufacturers of America did not respond to a request for comment in time for publication. Several large drug manufacturers also did not respond to requests for comment.

Some companies, meanwhile, have been legally developing cannabis-based drugs through careful coordination with federal authorities. Those companies are watching the DEA to see if a change in the designation for cannabis might mean larger firms would seek to partner with or even acquire them.

AFP/Getty Images

 

Doylestown, Penn.-based pharmaceutical company KannaLife Sciences is developing cannabis-based products by licensing a patent, held by the National Institutes of Health, that allows the development of drugs that use cannabinoids as antioxidants and in the treatment of neurodegenerative diseases.

It is working on a treatment for hepatic encephalopathy (HE), a neurological syndrome associated with liver disease, and chronic traumatic encephalopathy, which results from repetitive brain trauma and causes memory loss, confusion, aggression, depression and dementia.

See also: Marijuana industry finds unlikely spokespeople in athletes and parents

Other companies have developed cannabis-based treatments by working directly with the DEA, which requires intensive — and expensive — oversight of the testing and development process. Marinol, a drug developed by AbbVie Inc. ABBV, +1.29% using that process, is already available. A treatment for weight loss and nausea in AIDS and chemotherapy patients, it contains synthetic THC.

And London-based GW Pharmaceuticals GWPH, +2.41% has come close to completing the FDA approval process for a CBD-derived drug after reporting positive results for a Phase 3 trial on Monday. Its drug, Epidiolex, was developed to treat Lennox Gastaut syndrome, a rare form of childhood epilepsy.

“We’ve been able to navigate very well around challenging restrictions in terms of evaluating a Schedule I product,” says Stephen Schulz, vice president of investor relations at GW. “But it’s onerous and it’s cumbersome.”

Schulz declined to say whether he thought an ease in research restrictions would attract larger pharmaceutical companies to the business. But “It’s a very attractive space,” he said.

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A few glitches as the new medical marijuana law takes effect today

http://www.bizjournals.com/seattle/blog/health-care-inc/2016/07/a-few-glitches-as-the-new-medical-marijuana-law.html

Friday marks the day when Washington’s long-time medical marijuana industry is integrated into the new, regulated, recreational industry the state has been fine-tuning since voters approved it in 2012.

All unlicensed medical marijuana dispensaries must now be closed. At the same time, 332 of the 388 licensed stores in Washington have been medically endorsed to offer medical-grade product. The Washington State Department of Health is still warning people that all the stores may not be fully prepared; patients should call before visiting.

Friday marks the day when Washington’s long-time medical marijuana industry is integrated… more

BUSINESS JOURNAL | Karen Ducey

The new law required the state to create a database of people authorized to buy medical marijuana, but announced possible delays due to software challenges on Tuesday.

The new medical marijuana law took effect Friday, and the department of health announced the database was actually operational a little after 8:30 a.m.

For medical marijuana patients to received the benifits outlined in the law, they must join this database and receive what is called a recognition card. Joining the authorization database is voluntary but is required to receive added benefits.

The benefits are:

• Purchase products sales-tax free.
• Purchase up to three times the current legal limit for recreational users.
• Purchase high-THC infused products.
• Grow more than four plants at a residence.

While registered medical marijuana users are exempt from sales tax, the 9.6 percent sales tax in Seattle for example, they are still required to pay that state’s 37 percent marijuana excise tax. The Seattle Times has reported that many believe this will lead medical users to the illicit market thought to be cheaper.

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Yes, Assessing Pain Is Vital

http://www.painmedicinenews.com/Commentary/Article/07-16/Yes-Assessing-Pain-Is-Vital/36824/ses=ogst

I wrote in a blog last year that efforts to roll back pain as the fifth vital sign are likely to gain traction, despite inaccuracies and flawed thinking. That is precisely what has happened. A recent Medpage Today article titled “Opioid Crisis: Scrap Pain as 5th Vital Sign?” lays out similar flawed arguments touted by Physicians for Responsible Opioid Prescribing (PROP). At press time, the American Medical Association had been petitioned by its Illinois delegates to remove pain’s fifth-vital-sign status.

What are these flawed arguments? One is to falsely equate the Joint Commission standard to assess pain with a mandate to prescribe opioids. If anyone believes that administering opioids is the sole and automatic response to managing high pain levels, that in itself demonstrates a lack of education, knowledge and understanding. Such a perceived mandate would be a terrible misapplication.

The problem is not the Joint Commission standard but what happens afterward. This is where the system is failing with inadequate education about assessing and managing pain. Clinicians should assess and treat underlying disorders that cause pain, and they should work to eliminate the pain, but they should also understand that, for some patients with some types of pain, eradicating all underlying causes or the pain itself may not be possible. Yet pain must be prioritized and addressed. To do otherwise puts patients at risk for a host of complications, the most serious of which is the progression to pain as a chronic destructive pathology.

So, is pain, after all, a vital sign? I have argued in the past that it is. But the main point is that assessing pain is indeed vital, whether or not pain is a vital sign. Furthermore, assessing pain as often as vital signs are assessed would seem appropriate. We assess cognitive function, reflexes and laboratory values, none of which are vital signs but are clinically important signs nevertheless. Pain is a symptom; however, it can become a disease when the nervous system changes as a result of it, as the 2011 report on pain in America from the Institute of Medicine, now the Health and Medicine Division (HMD) of the National Academies of Sciences, Engineering, and Medicine, clearly indicates (“Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.” Washington, D.C.: National Academies Press; 2011). It is better to assess pain often and regularly and treat it adequately while it is still a symptom, and before it can progress to the point of disease, at which point it will demand chronic management, much like diabetes.

Another flawed argument is that we as health care professionals would not use dangerous methods to treat pain if only we could remain ignorant that the pain exists. Incredible as it seems, this is indeed the argument. In a letter dated March 28, 2016, the American College of Emergency Physicians (ACEP) wrote to the secretary of the Department of Health and Human Services to claim that asking patients about their pain care could lead to opioid overprescribing. The fear, also expressed by the members of PROP, is that patients who seek opioids will give poor marks to hospitals that do not provide the drugs, thus driving down financial reimbursement through the Centers for Medicare & Medicaid Services (CMS). Like PROP, the ACEP asked the department to remove questions pertaining to pain control from the 32-question survey known as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS).

But increased reimbursement for improved health care results in a hospital is appropriate, and CMS should not deviate from the objective of creating incentives for better outcomes, particularly quality of pain control. The HCAHPS questions pertain to how often pain was well controlled and whether hospital staff did everything possible to help control the pain. These are quality improvement measures, and pain control is an important part of quality improvement.

The HMD report addressed evidence of poorly managed pain by calling for more comprehensive assessment, and this is the direction in which medicine should move. Health care providers have a professional and ethical obligation to assess and reassess the pain of their patients, not to decide that assessing pain levels should no longer be part of routine care because CMS ties a small part of hospital payments to patient evaluations of how well their pain was treated. Patients often demand unnecessary antibiotics, but ethical physicians must learn when and how to refuse them, informed by the ethics of good care, not maximum reimbursement. Ethical, informed clinicians do not prescribe unnecessary medication for the sole purpose of gaining a high patient satisfaction rating.

The drive to end pain control assessment appears to come from the belief that people with substance abuse problems will complain if a practitioner fails to give them the drugs they seek. Thus, ignorance is deemed a better alternative to appropriate clinical judgment. But supporting evidence for this belief is lacking, as a top CMS official recently wrote in JAMA (2016 Mar 10. [Epub ahead of print]): “It has been alleged that, in pursuit of better patient responses and higher reimbursement, HCAHPS compels clinicians to prescribe prescription opioids. However, there is no empirical evidence that failing to prescribe opioids lowers a hospital’s HCAHPS scores. … On the other hand, good nurse and physician communication are strongly associated with better HCAHPS scores.”

Advocates in favor of eliminating pain assessments are attempting to benefit patients and society at large. The principles that not all pain can be relieved and that opioids are not always the answer are good and deserve wider dissemination. But there is nothing in assessing the quality of pain relief or in patient satisfaction surveys that says opioids must be administered, and if such is automatically happening, then education on pain assessment needs improvement. Pain treatment has never been, nor should it ever be, synonymous with opioid therapy. In its zeal to eliminate problems with opioids, society must not dismiss pain, whether that pain is a symptom or a disease.

Sadly, because of today’s opioid crisis, many patients are being denied humane treatment of their pain. There is no rational argument that appropriate in-hospital pain control contributes to the opioid crisis in our communities. This attack on our most vulnerable patients must stop. The problem isn’t that we ask our patients too many bothersome (to the clinician) questions. Neither does the solution to the opioid crisis lie in denying the majority of patients compassionate pain control.

Lynn R. Webster, MD, is a past president of the American Academy of Pain Medicine and author of “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.” Visit www.thepainfultruthbook.com. He also is a member of the Pain Medicine News editorial advisory board. He lives in Salt Lake City.

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Former suspects sue over DEA raid

http://www.indystar.com/story/news/local/hamilton-county/2016/06/30/former-suspects-sue-over-dea-raid/86529042/

INDIANAPOLIS — Former employees of medical clinics in Central Indiana that were raided two years ago by the Drug Enforcement Administration filed a lawsuit Wednesday alleging unlawful arrest.

In July 2014, local police and federal agents with the DEA arrested doctors and staff affiliated with the Drug Opiate Recovery Network (DORN) on charges of selling prescription painkillers to their patients, calling the operation a pill mill.

INDIANAPOLIS STAR

DEA raids clinics, arrests four doctors

 

The defendants have maintained their innocence and questioned the validity of the accusations. Charges have since been dismissed against nine of the 12 suspects — everyone but three doctors.

In the lawsuit filed in U.S. District Court in Indianapolis, the former DORN staff members are seeking unspecified monetary damages from drug agents, police agencies and cities involved in the arrest. The former employees are Cassy Bratcher, Carmel; Jessica Callahan, Muncie; Andrew Dollard, Noblesville; Eric Ley, Noblesville; Joeseph Mackey, Howard County; Yvonne Morgan, Eaton, Ohio; Felicia Reid, Carmel; and Derek Tislow, Avon.

Many of the staff members, the lawsuit says, lost jobs, spent significant savings on legal defenses and bail, and are no longer employable due to the criminal charges and subsequent publicity.

The lawsuit alleges that DEA agents Gary Whisenand and Dennis Wichern, Hamilton County Drug Task Force Maj. Aaron Deitz, the Carmel Police Department, the Hendricks County Sheriff’s Office, the Johnson County Sheriff’s Office, the Howard County Sheriff’s Department, the city of Kokomo and the town of Cumberland performed false arrests and took part in malicious prosecution, negligence and defamation.

Carmel, Johnson County and the DEA had no comment on ongoing litigation. None of the other defendants could be reached Wednesday.

The lawsuit, filed by attorney Jeffrey S. McQuary of the firm Brown, Tompkins, Lory & Mastrian, based in Indianapolis, alleges the employees were not responsible for prescribing medication and were merely performing their jobs.

The lawsuit claims that prior to being arrested and charged, the staff members were performing often mundane clinical duties such as answering the phone, scheduling appointments, ordering drug screens, processing patients and physically handing prescriptions to patients.

“The employees had no reason to believe the doctors had done anything wrong,” McQuary said. “I don’t think the doctors did anything wrong, but even assuming for a second that a doctor was prescribing medication outside of the legitimate scope for doing so, how on earth would the employees have known that?”

The lawsuit alleges that one suspect was told by a DEA agent she was arrested in hopes she would testify against the doctors. McQuary said using the staff members for leverage in the prosecution of the doctors might be only plausible explanation for the arrest of staff members.

The drug case has stalled since authorities in a multijurisdiction drug task force announced on July 25, 2014, that they had uncovered an extensive drug ring after a nine-month investigation.

In charging documents, authorities accused the doctors of illegally providing patients prescriptions for Suboxone, a synthetic heroin substitute, in exchange for cash.

At the time, authorities said thousands of patients streamed into the clinics, and consultations would take minutes or less. Patients paid up to $160 to obtain prescriptions, authorities said, and doctors pocketed hundreds of thousands of dollars in legal fees.

Dr. Larry Ley, the former head of the clinic, faces charges in Hamilton County. Prosecutors there also are pursing charges against Dr. Ronald Vierk. Howard County is pursuing charges against Dr. Luella Bangura and Ley. Wayne County is pursuing charges against Vierk and Ley. All have maintained their innocence as the cases have progressed.

Hamilton County and Wayne County courts, however, dismissed charges against the staff members, essentially ruling staff members could not be held legally responsible for the prescriptions written by doctors.

INDIANAPOLIS STAR

Hamilton County judge dismisses 6 of 9 cases in DEA raid

 

One of the cleared suspects, Dollard, had asked the Indiana Disciplinary Commission to investigate and ultimately disbar five prosecutors for their roles in what he called one of the most corrupt, dishonest and unethical prosecutions in the history of the state.

Dollard was DORN’s attorney. He also is a former candidate for Hamilton County Council.

The commission declined to discipline any of the prosecutors.

Dollard also has filed a civil lawsuit accusing Current Publishing in Carmel of defamation for its news reporting in relation to the drug raid. A trial has been scheduled for 2017.

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CVS to pay $3.5M to settle allegations of forged prescriptions

http://www.seattletimes.com/business/cvs-to-pay-3-5m-over-allegations-of-forged-prescriptions/

Could this mean that more CVS Pharmacist “not being comfortable” filling controlled meds ?

BOSTON (AP) — CVS Pharmacy has agreed to pay $3.5 million to settle allegations that dozens of its Massachusetts pharmacies violated federal law by filling forged prescriptions for addictive painkillers and other controlled substances.

U.S. Attorney Carmen Ortiz announced the settlement with the Woonsocket, Rhode Island-based drugstore chain Thursday.

CVS says it has tightened its policies and procedures to help its pharmacists determine whether a prescription is legitimate.

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DEA: Heroin-related deaths tripled in four years

It really doesn’t matter when big business is involved.. be it for profit, non profit or governmental… You often have to wonder if what you see is the reality of it all or if there is some hidden agenda. If there is a hidden agenda, no one will every really know… unless legalities are involved and someone ends up getting caught with their hand in the cookie jar.

I have posted before about our judicial system’s apparent “addiction/dependency” on  the 51 billion dollars that flow into the judicial system  annually to fund the war on drugs.

I have posted about the fact that 43 % of the members of Congress are attorneys (170 House, 60 Senate) and how it would seem that – in general – will not do anything that will deprive the judicial system of any funding.. including failing to acknowledging what everyone considers how big a failure the war on drugs is in reality.

Sometimes, parts of a agenda can be intentionally or unintentionally hidden or can appear to have no association with the agenda at all. This is what could be happening right now. All of a sudden over the last few months there has seemingly been a “bum’s rush” to get a dose or two of Naloxone in as many pockets as possible.  There seems to be no limit to the times that a substance abuser should or should not be revived. I have reports of a single person being revived TEN TIMES in one day.

There was a recent DEA report that opiate OD deaths have TRIPLED in FOUR YEARS.. There has been reports that acetylfentanyl from Mexico and China have been added/mixed with Heroin and since acetylfentanyl is 25 -40 times more potent than Heroin.. and as a result many people are dying from a overdose.

There has also been reports for tablets showing up on the west coast .. looking like Narco 10 (Hydrocodone/Acetaminophen 10/325) but in reality it is acetylfentanyl from Mexico or China or some mixture of Heroin and acetylfentanyl.. and more people are dying… Also reported that there has been tablets that appear to be Xanax (Alprazolam ) 2mg showing up on the west coast of Florida but also containing acetylfentanyl and/or mixed with Heroin and again people are dying.

Since the Harrison Narcotic Act of 1914 there has been an estimated 1%-2% of our population abusing some substance other than Alcohol and Nicotine.. the population of the USA back then was around 100 million as opposed to 330 million today..  It is now estimated that there are some 1.9-2.1 million serious substance abusers.. percent of the population has dropped dramatically since 1914 < 0.7 % and with the increased deaths from the acetylfentanyl and Heroin.. is the DEA/judicial system frighten that the serious substance abuser population could be dwindling ?

Does this help explain the “bum’s rush” to get a dose or two of Naloxone in as many pockets as possible ? Could this explain the change in the mindset of the politicians/bureaucrats that substance abuse is a “mental health issue” ? Could this explain the change in the nomenclature .. no more addicts.. no more junkies…just people who take opiates for whatever reason – both legal & illegal – are now being labeled as having a “opiate use disorder” ?  And we no longer have accidental/unintentional drug OD’s… now we have deaths that are just a “opiate related death”.  Doesn’t matter if their is a lethal amount of opiates in the toxicology report… any amount showing is enough to classify the death as “opiate related”

Then there is the CDC guidelines… wanting no one taking opiates longer than 90 days… with the estimated 106 million chronic pain pts.. there are going to be untold numbers – perhaps millions – that will be forced to go to “the street” to seek whatever pain relief that they can get.

Then there are proposed rule changes that will raise the number of Suboxone pts that a single prescriber can manage at any one time from 100 to 500.

Is it just me… or does it look like all those parties that are addict to the “war on drugs” money… are laying the ground work to make sure that the “substance abusers population” at least stays the same and possibly grows ?

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Top 26 marijuana opponents in the U.S. Senate

http://extract.suntimes.com/news/10/153/20480/top-marijuana-opponents-united-states-senate

12 Senate seats currently occupied by Senators that are “hard-headed” opposed to the legalization/decriminalization of MJ.. ARE UP FOR RE-ELECTION this fall !

At least 26 U.S. Senators are still dedicated to marijuana prohibition.

A fair amount of attention has been paid to presidential candidates’ positions on marijuana legalization this election cycle. However, United States Congress member stances have received far less coverage.

Considering Congress can amend federal marijuana laws and block executive action in many cases, their positions on marijuana and drug policy will play significantly into the outcomes of reform efforts.

Recognizing this, the National Organization for the Reform of Marijuana Laws (NORML) has gathered Congressional voting records and relevant member statements and compiled “Scorecards” that assign letter grades “A” through “F” to all Congress members.

Twenty-six serving U.S. Senators received failing grades from NORML this year.

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“Guest Speaker, Ed Coghlan from the National Pain Report on Wednesday, June 29th, 2016 at 9:00 PM EDT

Live interview with Ed Coghlan from the National Pain Report on June 29th, 2016 at 9:00 PM EDT.

During this special event, we will be discussing a wide range of topics, followed by a question and answer segment where you will be able to ask questions directly to Ed.

Goto https://www.livesupportgroup.com/ to register for the live webinar

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