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Cardiac arrest deaths are rising — and the culprit may be "stealth" opioid overdoses

Cardiac arrest–related deaths have risen precipitously during the pandemic — and the reason may have to do with a mystery of coronavirus, an increase in drug overdoses, or both.

Indeed, those are two main theories explicating the rise in cardiac arrests, both compelling. First, because SARS-CoV-2 infects blood vessels, at least some of the cardiac arrest deaths may be from coronavirus infection. A second, equally sinister suspicion is that a percentage of the cardiac arrests over the past twelve months could have been "occult" opioid overdoses — a medical term that means that the drug-related cause of cardiac arrest was not recorded nor discernible. Even before the pandemic, researchers suspected opioid overdoses were being "disguised" as cardiac arrests. Earlier this month, researchers published a paper in the journal Resuscitation that found 10 percent of out-of-hospital cardiac arrests from February 2011 through December 2017 in San Francisco were actually occult opioid overdoses. The paper adds on to ongoing evidence that opioid overdoses are being masqueraded as cardiac arrests is prevalent across the country.

Indeed, since the pandemic, opioid overdoses have increased along with cardiac arrests. That's led some to wonder whether opioid overdoses are being reported as cardiac arrests.

"The way to think of it is that paramedics will arrive on scene, they called for cardiac arrests and will start resuscitating the patient, using protocols that are directed at resuscitating the heart," said Dr. Robert Rodriguez, who is the author of the study and a professor of emergency medicine at the University of California, San Francisco, in an interview. "So what we have shown is a certain percentage of those patients that they assume that they're assuming are cardiac arrests turned out to be narcotic overdoses."

At the beginning of the pandemic, one-third of the country's "excess deaths" were not directly due to COVID-19, according to an analysis in the Journal of the American College of Cardiology. Public health experts define excess deaths as the difference between the actual number of deaths in a specific time period and the expected numbers based on historic trends. Specifically, comparing data from January 1 to June 2, 2020, with the same timeframe from 2019, showed that deaths by ischemic heart disease increased across the country after the onset of the pandemic.

Certainly, the pandemic has been a stressful time and is affecting everyday health in a myriad of ways—especially those in low-income and marginalized communities. As Bob Hennelly reported for Salon in April, EMS workers noted that before the pandemic they would see one or two cardiac arrest calls per shift. In the beginning of the pandemic, they were attending to as many as thirteen cardiac arrest calls per shift. At the time, they suspected it was COVID-19 related. But could those deaths be related to something else — perhaps a concurrent crisis of opioid overdoses during the pandemic. The Centers for Disease Control and Prevention reports that more than 81,000 deaths between June 2019 and May 2020 were linked to drug overdoses — an 18 percent jump compared to the previous 12-month period. But when first responders attend to what is initially believed to be a cardiac arrest, the protocol doesn't include administering Naloxone, which can rapidly reverse an opioid overdose. Rarely do people die immediately over an opioid overdose, as it often takes hours.

Rodriguez said if EMS responds to 350,000 adult cardiac arrests cases in the United States a year then, assuming 10 percent of those are opioid overdoses, 35,000 lives could be saved by administering Naloxone. That's an optimistic estimate; Rodriguez's more conservative numbers suggests 1,750 lives would be saved if the Naloxone doesn't work on everyone.

Rodriguez is hoping that his paper will help inspire first responders to cardiac arrests to include Naloxone in the resuscitation protocol. There is no risk to administering it, even if a person isn't having a heart attack. CLICK FOR COMPLETE ARTICLE

THC microdosing reduces chronic pain in world-first clinical trial

By Rich Haridy
A clinical trial found single small THC doses did reduce acute sensations of pain compared to placebo

New research published in the European Journal of Pain is offering some of the first clinical trial insights into the efficacy of microdosing THC to treat chronic pain. The results of the small trial suggest minute doses of THC may confer clinically apparent reductions in pain sensation without inducing psychoactive side effects.

A microdose is generally known as a subtherapeutic dose of a drug, and the term has more recently become synonymous with tiny, regular dosing of psychedelics such as LSD. The practice has been anecdotally popular, however, little research has been conducted to rigorously test how useful these imperceptible doses of psychedelic drugs actually can be.

So, an Israeli pharma-tech company named Syqe Medical set out to try to answer the THC microdose question, and solve the problem of imprecise cannabis dosing. The Syqe Inhaler is a first-of-its-kind product that reportedly enables precise dosing of low-levels of THC.

A randomized, double‐blinded, and placebo‐controlled trial recruited a cohort of 27 subjects with chronic neuropathic pain. Across three separate test days each subject received one inhaled dose, containing either 500 micrograms (0.5 mg) of THC, 1,000 micrograms (1 mg) of THC, or a placebo.

“Both doses, but not the placebo, demonstrated a significant reduction in pain intensity compared with baseline and remained stable for 150‐min,” the researchers write in the published study. “The 1‐mg dose showed a significant pain decrease compared to the placebo.” CLICK FOR COMPLETE ARTICLE

LSD microdose trial for acute pain relief reports “remarkable” results

By Rich Haridy Researchers report 20 micrograms of LSD delivers similar analgesic results to opioids such as oxycodone and morphine in an acute pain test
Researchers report 20 micrograms of LSD delivers similar analgesic results to opioids such as oxycodone and morphine in an acute pain test.

An incredible, first-of-its-kind trial testing the pain-killing properties of LSD microdoses has delivered the compelling suggestion that tiny, non-psychedelic doses of this infamous drug could serve as an effective analgesic.

Back in the 1960s, during the original heyday of psychedelic science, one of the more fascinating research areas for LSD was its unexpected efficacy as an analgesic. Researcher Eric Kast was one of the pioneer investigators on the topic, publishing over a dozen key papers exploring the ways pain perception is influenced by LSD.

Decades later, as the freeze on psychedelic research begins to thaw, the idea of LSD as a pain-reliever still sits on the fringes of psychedelic science. No modern clinical researcher has returned to Kast’s ideas, however, anecdotal cases have begun to emerge highlighting some people self-medicating with LSD microdoses to treat chronic pain.

This new study, led by researchers from Maastricht University with assistance from the Beckley Foundation, is the first clinical trial to revisit this topic in more than 50 years. Unlike Kast’s prior work, this new research focused on microdoses of LSD rather than larger, actively psychedelic doses. CLICK FOR COMPLETE STORY

New York Gov. Cuomo files fraud claim against Johnson & Johnson for opioid crisis

FEATURED
BY LIZ CAREY | SEPTEMBER 21, 2020
New York Gov. Andrew Cuomo announced Thursday his administration’s Department of Financial Services (DFS) had filed a fraud claim against Johnson & Johnson for its part in the opioid epidemic.

Johnson & Johnson is the fourth company DFS has gone after in New York as part of its ongoing investigation into responsibility for the opioid crisis in the state.

DFS filed charges and started administrative proceedings against Johnson & Johnson and its subsidiaries Janssen Pharmaceutica, Inc., Janssen Pharmaceuticals, Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc. – collectively, “Johnson & Johnson.”

In court documents, the department said Johnson & Johnson misrepresented the safety of its opioid products and played a key role in creating the market for chronic pain treatment. DFS alleges that Johnson & Johnson marketed its Duragesic opioid medication specifically to elderly patients, while minimizing the risks; fraudulently characterized opioid addiction as “pseudoaddiction” that could be cured by even more opioid medication; ignored multiple warnings from the U.S. Food and Drug Administration that the company was misrepresenting the addictive nature of Duragesic in its marketing; and developed a poppy in the 1990s that would become a key ingredient in oxycodone.

“To do so, among many other things, the entities and individuals misrepresented the safety and efficacy of their drugs in marketing materials and in communications to healthcare professionals,” DFS said in court records. “They downplayed the addictive nature of their products and actively promoted a discredited theory of ‘pseudoaddiction.’ They paid prominent doctors, advocacy groups, and professional associations vast sums of money to promote the use of opioids in areas that were not medically responsible. Moreover, they chose to look the other way when faced with blatant signs of over-prescription, abuse, and illegal diversion.”

As the department has done with other pharmaceuticals, DFS alleges that Johnson & Johnson violated two state codes – one for insurance fraud and one for financial services fraud. According to the department, each prescription for opioids constitutes one violation of insurance fraud, punishable by up to $5,000, and one violation of financial services law, also punishable by a fine of up to $5,000.

In 2018, the CDC reported that NY saw 34 opioid prescriptions for every 100 of the state’s 19.53 million residents, the equivalent of roughly 6.6 million prescriptions – each of which could carry a combined penalty of $10,000.

“The opioid crisis has taken too many lives, and New York State will continue to take action against those who helped fuel this public health catastrophe and bring a measure of justice to families who have lost loved ones,” Cuomo said. “Misrepresentation of opioids to consumers for profit is inexcusable, and we will use every tool necessary to help ensure those responsible are held fully accountable.”

The hearing on the charges is scheduled for Jan. 25, 2021, at the offices of the New York State Department of Financial Services. https://healthcrisisalert.com/
FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone: Goal is to Help Reduce Opioid Overdoses and Deaths
For Immediate Release:
July 23, 2020
The U.S. Food and Drug Administration today announced it is requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder (OUD) be updated to recommend that as a routine part of prescribing these medicines, health care professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment.

Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the overdose effects, usually within minutes.

“Even during this global pandemic, we have continued to prioritize addressing the opioid crisis,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action can help further raise awareness about this potentially life-saving treatment for individuals that may be at greater risk of an overdose and those in the community most likely to observe an overdose. We will use all available tools to address this crisis, and we know efforts to increase access to naloxone have the potential to put an important medicine for combatting opioid overdose and death in the hands of those who need it most – those at increased risk of opioid overdose and their friends and family.”

The required labeling changes announced in a Drug Safety Communication recommend that health care professionals consider prescribing naloxone when they prescribe medicines to treat OUD. Additionally, the labeling changes recommend that health care professionals consider prescribing naloxone to patients being prescribed opioid pain medicines who are at increased risk of opioid overdose, including those who are also taking benzodiazepines or other medicines that depress the central nervous system; those who have a history of OUD; and those who have experienced a prior opioid overdose. A naloxone prescription should also be considered for patients prescribed opioids who have household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.

The FDA is requiring that these recommendations be added to the prescribing information for opioid pain medicines and medicines to treat OUD, including buprenorphine, methadone and naltrexone.

The FDA is working with other federal, state and local officials as well as health care professionals, patients and communities nationwide to help increase availability of naloxone and combat opioid overdoses. Patients should talk to their health care professional about how to obtain naloxone according to their state’s requirements or guidelines. The U.S. Department of Health and Human Services has ongoing efforts to fight the opioid crisis and expand the use of naloxone. This includes: better targeting of overdose reversing drugs as part of a 5-Point Strategy to Combat the Opioids Crisis.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
US Substance Abuse and Mental Health Services Administration (SAMHSA) announces
At-home treatment of opioid use disorder
https://www.medscape.com/viewarticle/927248

UPDATED March 21, 2020 // In the face of the US COVID-19 pandemic, the US Substance Abuse and Mental Health Services Administration (SAMHSA) has announced at-home treatment of opioid use disorder (OUD).

The agency issued a directive to allow some patients in opioid treatment programs (OTP) to receive a 28-day supply of take-home doses of medications such as methadone and buprenorphine, for treatment of opioid use disorder (OUD).

The agency also said states are now allowed to request up to 14 days of take-home medication for patients who are less stable but who can, in the judgement of OTP clinicians, safely handle this level of take-home medication.

An FAQ section on the SAMHSA website offers detailed, up-to-date guidance for providing methadone and buprenorphine treatment.

www.samhsa.gov

Call SAMHSA National Hotline At 1-800-662-4357
Click on findtreatment.gov for Local Crisis Services
National Suicide Hot Line 800.273.8255
Free Naloxone (Narcan) at www.nextdistro.org

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