The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) was established in 1993. It is one of the EU’s decentralised agencies.

The EMCDDA exists to facilitate a more evidence-informed understanding of issues that are important for developing better drug-related policies and actions across Europe. In a new series of reports, it turns its attention to cannabis, a substance with a long history of use that has recently emerged as a controversial and challenging issue in both European and wider international drug policy debates.

Cannabis is the most commonly used illicit drug in Europe. It is also the drug about which both public attitudes and the political debate are most polarized. Interest in this area is rapidly growing, prompted by some quite dramatic international developments in the ways in which some countries and jurisdictions are now regulating this substance.

In this report, EMCDDA examined the evidence for, and practice of, making cannabis or cannabis-based medicines available for therapeutic purposes. The new 48 page EMCDDA report concluded that the evidence is still thin on the medical use of cannabis. The Lisbon-based EMCDDA said in its first report on the topic that so far there were “important gaps in the evidence“.

One of the most commonly reported reasons patients use cannabis for medical purposes in the United States is to treat chronic pain that is not caused by cancer (chronic non-cancer pain, CNCP). This includes neuropathic pain, arthritis, back pain, neck and shoulder pain, and headaches.

A review of studies on the effects of cannibis on CNCP showed a “Small (but statistically significant) effect compared with placebo.” Other areas of medical use were also reviewed. For example, other medical uses, such as sleep disorders, anxiety disorders, depression, degenerative neurological disorders, and inflammatory bowel disease the evidence was rated as “insufficient.”

The short-term adverse effects of medical cannabinoids and cannabis have been evaluated in the clinical trials reported in this study. In general, the short-term adverse events reported were similar to those of other commonly used medicines and related to symptoms such as dizziness, dry mouth, disorientation, nausea, euphoria, confusion and somnolence. Serious adverse events were rare.

There is less evidence about the risks of long-term medical use of cannabinoids, but in general those reported are similar to those reported for short-term use. Over time, more people report adverse events, but these are generally mild to moderate.

A handful of regulated pharmaceuticals use chemicals derived from cannabis, such as GW Pharmaceuticals’ Sativex which is approved for treating symptoms of multiple sclerosis. But cannabis itself and most products made from it are governed by countries’ individual criminal laws on illegal drugs, which may or may not allow medicinal use.

Eight medical device makers, including a California startup that uses virtual reality to treat chronic pain, topped an innovation contest aimed at addressing the opioid crisis, the U.S. Food and Drug Administration said on Friday.

As part of the FDA’s ongoing commitment to address the opioid crisis, the FDA’s Center for Devices and Radiological Health (CDRH) launched an Innovation Challenge in May 2018. The challenge was intended to spur the development of medical devices, including digital health technologies and diagnostic tests, that could provide new solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.

The goal was to provide additional incentives for medical device developers to invest in products that can address the addiction crisis and advance the development of innovative, safe and effective technologies. We received more than 250 applications from medical device developers.

Silicon Valley-based startup CognifiSense, which is developing the virtual reality therapy, and iPill Dispenser, which uses a biometrically controlled mobile app that aims to cut overconsumption by dispensing pills based on prescriptions, were among the winners of the FDA’s contest.

The company is developing VR Neuropsychological Therapy or VRNT, a proprietary VR software platform that provides psychological and experiential training to chronic pain patients to normalize their pain perception.

VR distraction therapy utilizes the immersive power of VR to create high cognitive load. It consists of entertaining games or experiences which focus the user on another task and away from the pain. Distraction therapy has been shown to be effective in providing short-term relief in acute pain. Immersive video games that shift the user’s focus from the pain are known as “distraction therapy”.

VRNT differs from distraction therapy in that it specifically targets the brain’s “neuroplasticity”, or ability to change over time.

Overall eight submissions were selected. The following selected proposals include therapeutic and diagnostic medical devices intended to treat opioid use disorder, detect and treat overdose, dispense medication and treat pain:

– Brainsway, Ltd (Brainsway Deep Transcrainal Magnetic Stimulation (DTMS) Device)
– Avanos (Pain therapy Device)
– iPill Dispenser (iPill Dispenser)
– Masimo Corporation (Overdose Detection Device)
– ThermoTek, Inc. (NanoThermTM and VascuTherm TM Systems)
– Milliman (Opioid Prediction Service)
– Algomet Rx, Inc. (Rapid Drug Screen)
– CognifiSense, Inc. (Virtual Reality Neuropsychological Therapy)

The FDA received over 250 applications for the innovation challenge, which seeks to prioritize the approval of novel medical devices including digital health technologies such as mobile medical apps.

Christine McKellar began her 16-year employment with Cedars-Sinai Medical Center in 2000. Cedars-Sinai terminated her employment in April 2016.

Before she was terminated, several of McKellar’s physicians authored a number of “to whom it may concern” letters sent to Cedars-Sinai attempting to excuse her from work for unspecified medical reasons. Several of them were written by Gayle K. Windman, Ph.D. from the office Dr. Thomas Curtis claiming she was disabled for “emotional stress complications.”One of them said she was disabled because of “EMOTIONAL STRESS COMP.”

Because none of the notes sent on McKellar’s behalf contained sufficient information to satisfy Cedars-Sinai’s leave policies, Cedars-Sinai sent McKellar a series of letters detailing the specific information it needed from her to process her request for leave.

McKellar received all of Cedars-Sinai’s letters, but never opened, read, or responded to any of them. McKellar requested no form of accommodation from Cedars-Sinai between her cessation of work on January 6, 2016 and her termination on April 20.

Ultimately Cedars-Sinai sent her a letter explaining that she had been “separated from employment.”

McKellar alleged in six causes of action that Cedars-Sinai retaliated against her for filing a workers’ compensation claim and discriminated against her based on her claimed disability.

Cedars-Sinai filed a motion for summary judgment, arguing, among other things, that it had a legitimate non-pretextual reason to terminate McKellar’s employment. The trial court granted the motion. McKellar appealed and the court of appeal affirmed in the unpublished case of McKellar v. Cedars-Sinai Medical Center

To avoid summary judgment based on her proffered theory, McKellar needed to produce admissible evidence in the trial court that the decisions leading to McKellar’s termination were made on the basis of her disability or workers’ compensation claim.

The evidence McKellar relies on is that Cedars-Sinai sent five letters to a post office box. The necessary implication is that Cedars-Sinai should have attempted to contact McKellar some other way. The record, however, establishes that Cedars-Sinai did attempt to contact McKellar by telephone. McKellar had changed her telephone number because, she said, she did not want anyone at Cedars-Sinai to be able to contact her.

Cedars-Sinai had no obligation to reach out to someone other than its employee to determine whether that employee intended to comply with the company’s leave policy. McKellar’s argument assumes that McKellar could unilaterally require Cedars-Sinai to engage in the FEHA “interactive process” to determine effective reasonable accommodations with a representative McKellar designated without notifying Cedars-Sinai. That assumption is incorrect for a variety of reasons.

Janak K.. Mehtani, M.D. was issued a physician and surgeons certificate by the California Medical Board in 1978. He specialized in psychiatry with an office located at 2951 Fulton avenue in Sacramento. He practiced in an office clinic under the business name of Fair Oaks Psychiatric Associates. He is also listed by the DWC as a QME in psychiatry at that same address.

The current QME Disciplined Physicians List shows that his QME certification has been evoked with revocation stayed, and he was placed on probation through October 11, 2019 concurrent with Medical Board probation.

The Medical Board filed an Accusation against Mehtani accusing him of “grossly negligent acts in his care and treatment of Patients” three of whom were identified only by their initials. All three were being treated for the effects of workers’ compensation injuries.

One of them identified by the initials GC was a 47 year old female who was employed at a warehouse where she was injured on a number of different occasions and has had cumulative injuries since then. The first injury was in 2003 and she was first seen by Mehtani in 2008.

The Medical Board reviewed his clinical notes, and noted many medical errors and historical inconsistencies in his treatment of this patient. For example, with respect to patient GC, the Board alleged that he “prescribed atypical antipsychotics without clear indication for their necessity.” and he “inappropriately prescribed antipsychotics to Patient GC who has diabetes, to treat problems for sleep, depression and anxiety.”

GC was not proficient in English. The Board noted that Mehtani used his medical assistant to act as translator, and as a result he “failed to provide an interpreter in order for Patient GC to freely share her feelings and be open to psychotherapeutic interventions.”

The Board noted that he “also documented a global statement without providing any clinical justification or explanation. Respondent noted that ‘She remains disabled from gainful employment’ without explaining and documenting exactly what was Patient GC’s disability, how the disability affects her life and what are the barriers for progress.”

The Board also listed allegation against Mehtani for his treatment of Patient JC is a 59-year-old male who experienced a work related injury in 1989. And a third persons, Patient RW, a 48-year-old, male who was seriously injured during the course of his employment while on his way to a service call, He sustained a serious head injury and has been totally and permanently disabled ever since.

Mehtani signed a Stipulated Settlement and Disciplinary Order with the consent of his attorney. The Stipulation was the basis of the Medical Board and subsequent DWC probation orders.

A former opioid sales executive has admitted to participating in a conspiracy to bribe doctors to prescribe a highly addictive fentanyl spray.

Alec Burlakoff changed his plea to guilty on November 28, 2018 in a Boston federal courtroom. Prosecutors say the former vice president of sales for Insys Therapeutics has agreed to cooperate with them in the closely-watched case targeting executives at the Chandler, Arizona company, including billionaire founder John Kapoor. His sentencing will occur at a later date.

On December 6, 2016, the defendants, former executives and managers of Insys Therapeutics Inc., were charged by indictment by the United States Attorney’s Office for the District of Massachusetts with conspiracy to commit racketeering, mail and wire fraud, and conspiracy to violate the anti-kickback law in relation to a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud payers of the medication, including insurers.

The Insys executives are accused of paying kickbacks to doctors willing to write large numbers of prescriptions for the powerful medication Subsys, which is meant for cancer patients with severe pain. Prosecutors say the kickbacks were disguised as speaking fees for events billed as opportunities for other doctors to learn about the drug.

The indictment alleges that Michael L. Babich, 40, of Scottsdale, Ariz., the former CEO and President of the company; Alec Burlakoff, 42, of Charlotte, N.C., former Vice President of Sales; Richard M. Simon, 46, of Seal Beach, Calif., former National Director of Sales; former Regional Sales Directors, Sunrise Lee, 36, of Bryant City, Mich. and Joseph A. Rowan, 43, of Panama City, Fla.; and former Vice President of Managed Markets, Michael J. Gurry, 53, of Scottsdale, Ariz., conspired to bribe practitioners in various states, many of whom operated pain clinics, in order to get them to prescribe a fentanyl-based pain medication, called Subsys.

Subsys is a powerful narcotic intended to treat cancer patients suffering intense episodes of breakthrough pain. In exchange for bribes and kickbacks, the practitioners wrote large numbers of prescriptions for the patients, most of whom were not diagnosed with cancer.

A status hearing has been scheduled for December 6, 2018, 03:30 PM for the remaining defendants. A pretrial motion hearing has been scheduled for defendant John Kapoor December 6, 2018, 03:30 PM at Courtroom 14, John Joseph Moakley Courthouse, 1 Courthouse Way, Boston, MA for defendant(s) John N. Kapoor before Judge Jennifer Boal.

Trial is scheduled to begin January 28, 2019 09:00 AM in Courtroom 17 before Judge Allison D. Burroughs