State Poised to Become First to Pilot Drug Injection Sites

PROVIDENCE, R.I. (AP) — Rhode Island is poised to become the first state to authorize so-called harm reduction centers where people dealing with addiction can take heroin and other illegal drugs under the supervision of medical professionals.

Legislation cleared the state General Assembly Thursday creating a two-year pilot program for the centers, which are also referred to as safe injection sites or supervised injection sites.

The Senate-approved bill now heads to Democratic Gov. Dan McKee after the state House of Representatives approved the measure earlier this week. The Democrat has said he’ll review the proposal when it reaches his desk.

“Having a place where someone can save them from an overdose and where there are people offering them the resources they need for treatment is a much better alternative to people dying alone in their homes or their cars,” state Sen. Joshua Miller, the bill’s sponsor, said in a statement.

Canada is among at least 10 countries that allow the facilities, but none exist in the U.S. Assembly leaders said their bill would make Rhode Island the first state to authorize such a pilot program.

New York, Philadelphia and Somerville, a Boston suburb, are among the American cities that have been trying to open the centers to combat the opioid crisis in recent years. Massachusetts lawmakers are also weighing a bill creating a 10-year pilot program with at least two sites.

James McDonald, the state Department of Health’s medical director, said harm reduction sites have proven effective in preventing fatal overdoses.

They’ve also proven successful in connecting people with substance abuse treatment, recovery support and other health services, added Miller.

The Cranston Democrat has cautioned the measure, if approved, could face legal challenges as the injection centers remain illegal under federal law.

Under Miller’s bill, opening a center would also require city and town approval.

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DEA: Companies Had ‘Systematic Failure’ in Monitoring Pills

A retired high-ranking official with the Drug Enforcement Administration has testified that three large opioid distributors had a “systematic failure” in monitoring suspicious pill orders.

Joe Rannazzisi, former head of the Office of Diversion Control for the DEA from 2006 to 2015, testified Tuesday in Charleston in a landmark civil case brought by Cabell County and the city of Huntington that accuses AmerisourceBergen, Cardinal Health Inc. and McKesson Corp. of fueling the U.S. opioid epidemic.

The companies say poor communication and pill quotas set by federal agents are to blame, along with a rise in prescriptions written by doctors.

Rannazzisi testified that the defendants didn’t report suspicious orders to the DEA due to a failure with their monitoring systems, The Herald-Dispatch reported. He said the DEA asked the companies in 2005 to rein in their distribution practices. A follow-up review of pill shipping data found the flow of pills was not reduced.

He testified that McKesson later told the DEA that its suspicious-pill monitoring system was not picking up generic drugs in the hydrocodone class.

The failures led to suspension orders being issued against McKesson in 2006, AmerisourceBergen in 2007 and Cardinal Health in 2007 and 2012, Rannazzisi testified.

Rannazzisi did not personally review distributors’ monitoring systems, participate in on-site visits or speak to any distributors but McKesson in 2005, McKesson attorney Paul Schmidt said.

Rannazzisi also testified that he did not know of any investigations showing the defendants had shipped orders they believed were suspicious.

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FDA OKs Higher-Dose Naloxone Nasal Spray for Opioid Overdose

The US Food and Drug Administration (FDA) has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.

When administered quickly, naloxone can counter opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option for the treatment of opioid overdoses, the FDA said in a news release.

“This approval meets another critical need in combating opioid overdose,” Patrizia Cavazzoni, MD, director, FDA Center for Drug Evaluation and Research, said in the release.

“Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most,” said Cavazzoni.

In a company news release announcing the approval, manufacturer Hikma Pharmaceuticals notes that a recent survey of community organizations in which the 4-mg naloxone nasal spray had been distributed showed that for 34% of attempted reversals, two or more doses of naloxone were used.

A separate study found that the percentage of overdose-related emergency medical service calls in the United States that led to the administration of multiple doses of naloxone increased to 21% during the period 2013–2016, which represents a 43% increase over 4 years.

“The approval of Kloxxado is an important step in providing patients, friends, and family members ― as well as the public health community ― with an important new option for treating opioid overdose,” Brian Hoffmann, president of Hikma Generics, said in the release.

The company expects Kloxxado to available in the second half of 2021.

The FDA approved Kloxxado through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

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Arrest Videos Undercut Derek Chauvin’s Murder Trial Defense, Pathologist Tells Jury

MINNEAPOLIS (Reuters) – A forensic pathologist testified on Friday that the sheer volume of videos of George Floyd’s arrest helped confirm the finding that oxygen deprivation caused his death, not an opioid overdose, as argued by lawyers for the former Minneapolis officer on trial for his murder.

Dr. Lindsey Thomas said she agreed with the findings of the Hennepin County medical examiner who ruled Floyd’s death was a homicide caused by the way Derek Chauvin and other officers pinned him to the ground on May 25, 2020.

“There’s never been case I was involved in that had videos over such a long time frame and from so many different perspectives,” she told the jury, saying the videos made it clear physical signs associated with opioid overdose were not seen in Floyd’s death.

Dr. Andrew Baker, the medical examiner, is due to testify later on Friday.

Chauvin, who is white, was recorded in multiple videos kneeling for more than nine minutes on the neck of Floyd as the 46-year-old Black man, in handcuffs, begged for his life in a fading voice. The arrest sparked global protests against police brutality.

Below are some important moments from the tenth day of witness testimony:

DR. LINDSEY THOMAS, FORENSIC PATHOLOGIST

Dr. Thomas was an assistant medical examiner in the Hennepin County medical examiner’s office until she went into “semi-retirement” in 2017. She told the jury she had performed over 5,000 autopsies over her career.

While physically examining a body can be helpful in determining a cause of death, she explained to the jury that other records and inquiries could sometimes be even more illuminating.

“What was unique in this case was the volume of materials I had to review,” she told the jury, referring to videos recorded on bystanders’ cellphones and police body-worn cameras. “I never had a case like this that had such thorough documentation of the terminal events.”

She said the videos made clear that Floyd died because his body was deprived of oxygen by the way Chauvin, 45, and other officers pinned him to the ground as they arrested him on suspicion of passing a counterfeit $20 bill to buy cigarettes.

Thomas was the fourth medical expert called by the Minnesota attorney general’s office as prosecutors seek to dismantle Chauvin’s central defense, that the fentanyl found in Floyd’s blood at death killed him.

“There was nothing sudden about his death,” Thomas told the jury, challenging a defense argument that Floyd’s underlying health problems may have led to a heart attack. “Likewise, it was not the type of death that has been reported in fentanyl overdose, for example, where someone becomes very sleepy and then just sort of gradually, calmly, peacefully stops breathing.”

Jurors were handed envelopes containing photographs of Floyd’s corpse, and Thomas drew their attention to abrasions on the left side of Floyd’s face and his shoulder.

The wounds were “consistent with what it looks like on the video, that he’s struggling to push himself into a position where he can breathe,” she said.

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Opioid use is linked with other forms of substance misuse, mental health problems

Opioid use has dramatically increased in the 21st century, especially among young adults. A new study from the University of Illinois provides insights on usage patterns among Illinois high school students to help inform prevention and treatment strategies.

"The societal and personal costs of opioid misuse are massive. There's been a lot of focus on trying to understand how to combat the current epidemic. But we also need to make sure we have good data in order to know how we should apply our efforts," says Allen Barton, assistant professor in the Department of Human Development and Family Studies at U of I and lead author on the study.

The researchers based their study on information from the 2018 Illinois Youth Survey (IYS), which measures risk behaviors among high school students.

Over 230,000 students across Illinois typically participate in the biannual survey, says Doug Smith, professor of social work and director of the Center for Prevention Research and Development at U of I. Smith is co-author on the opioid study and principal investigator for the IYS.

The study focused on 18-to 19-year-olds, the beginning of a developmental stage when opioid use vulnerability is highest, Barton says.

Among the more than 26,000 respondents in this age group, 5.6% (1,468 youth) indicated they had used prescription pain medication in the past year without a prescription or differently than intended; that is, non-medical use of prescription opioids.

Another 2.6% (682 youth) reported they had used prescription painkillers to get high. This addresses motive of use, which is an important part of understanding the issue."

Allen Barton, Study Lead Author and Assistant Professor, Department of Human Development and Family Studies, University of Illinois

Finally, 0.4% of the sample (105 youth) reported they had used heroin in the past year. Heroin is another form of opioid that is not in the form of prescription medication, Barton notes.

The researchers found clear differences in characteristics of opioid users versus non-users.

"The individuals engaging in opioid use are also engaging in heightened levels of other forms of substance misuse, primarily alcohol and cannabis. They have more mental health concerns and higher suicide intent. And those who are using opioids report much lower grades and much higher levels of being victims of bullying," Barton says.

As opioid use is closely linked with other forms of substance misuse, counselors and medical practitioners should treat it as part of a pattern, Smith states.

"This contradicts the typical image of a non-substance-using youth who one day decides to use opioids and then gets progressively addicted. That doesn't typically happen. These kids are already using other substances, often at levels indicative of problematic use. It seems more like a progression of general substance use than specific opioid usage," he notes.

The researchers also analyzed the data to look for profiles among the subset of youth using opioids.

"Our findings indicated three main profiles of individuals reporting opioid use. You have one group, comprising slightly more than half of this subsample, that's using opioids, but not specifically to get high. You have another group of individuals reporting a clear motive of use to get high. And a third, small group that's just using heroin," Barton notes.

While there were many similarities among the three groups, individuals who reported using opioids to get high also reported much more problematic substance abuse overall, as well as higher suicide risk compared to people who are engaged in non-medical use of prescription opioids without such motive, Smith adds.

The researchers say their study shows opioid use is a complex issue which needs tailored approaches to treatment and prevention.

"In order to address opioid use at this developmental stage, which is a transition to adulthood, we need to realize it is indicative of a broader pattern of factors related to other substance use and mental health issues that require attention. A one-step approach to just address the opioid use may not be sufficient," Barton states.

"The good news in this data is that opioid use rates are very low for this demographic across the state. However, for a subset of youth who do use, it appears to be making a difficult situation all the more challenging."

Barton and Smith say the correlation with other forms of substance misuse can help identify opioid use at an early stage.

"For any youth who is getting treatment for another substance, we need to be screening for whether they're using opioids, and we need to have a prevention program within a treatment program," Smith says.

Source:

University of Illinois College of Agricultural, Consumer and Environmental Sciences (ACES)

Journal reference:

Barton, A. W., et al. (2021) Opioid use at the transition to emerging adulthood: A latent class analysis of non-medical use of prescription opioids and heroin use. Addictive Behaviors. doi.org/10.1016/j.addbeh.2020.106757.

Posted in: Healthcare News

Tags: Alcohol, Bullying, Cannabis, Heroin, Mental Health, Opioids, Pain, Research, students, Substance Abuse

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Three decades-old antibiotics could offer an alternative to opioid-based painkillers

Three decades-old antibiotics administered together can block a type of pain triggered by nerve damage in an animal model, UT Southwestern researchers report. The finding, published online today in PNAS, could offer an alternative to opioid-based painkillers, addictive prescription medications that are responsible for an epidemic of abuse in the U.S.

Over 100 million Americans are affected by chronic pain, and a quarter of these experience pain on a daily basis, a burden that costs an estimated $600 billion in lost wages and medical expenses each year. For many of these patients – those with cancer, diabetes, or trauma, for example – their pain is neuropathic, meaning it's caused by damage to pain-sensing nerves.

To treat chronic pain, prescriptions for opioid painkillers have increased exponentially since the late 1990s, leading to a rise in abuse and overdoses. Despite the desperate need for safer pain medications, development of a new prescription drug typically takes over a decade and more than $2 billion according to a study by the Tufts Center for the Study of Drug Development, explains study leader Enas S. Kandil, M.D., associate professor of anesthesiology and pain management at UTSW.

Seeking an alternative to opioids, Kandil and her UT Southwestern colleagues – including Hesham A. Sadek, M.D., Ph.D., professor of internal medicine, molecular biology, and biophysics; Mark Henkemeyer, Ph.D., professor of neuroscience; Mahmoud S. Ahmed, Ph.D., instructor of internal medicine; and Ping Wang, Ph.D., a postdoctoral researcher – explored the potential of drugs already approved by the Food and Drug Administration (FDA).

The team focused on EphB1, a protein found on the surface of nerve cells, which Henkemeyer and his colleagues discovered during his postdoctoral training nearly three decades ago. Research has shown that this protein is key for producing neuropathic pain. Mice genetically altered to remove all EphB1 don't feel neuropathic pain, he explains. Even mice with half the usual amount of this protein are resistant to neuropathic pain, suggesting EphB1's promise as a target for pain-relieving drugs. Unfortunately, no known drugs inactivate EphB1.

Exploring this angle further, Ahmed used computer modeling to scan a library of FDA-approved drugs, testing if their molecular structures had the right shape and chemistry to bind to EphB1. Their search turned up three tetracyclines, members of a family of antibiotics used since the 1970s. These drugs – demeclocycline, chlortetracycline, and minocycline – have a long history of safe use and minimal side effects, Ahmed says.

To investigate whether these drugs could bind to and inactivate EphB1, the team combined the protein and these drugs in petri dishes and measured EphB1's activity. Sure enough, each of these drugs inhibited the protein at relatively low doses. Using X-ray crystallography, Wang imaged the structure of EphB1 with chlortetracycline, showing that the drug fits neatly into a pocket in the protein's catalytic domain, a key portion necessary for EphB1 to function.

In three different mouse models of neuropathic pain, injections of these three drugs in combination significantly blunted reactions to painful stimuli such as heat or pressure, with the triplet achieving a greater effect at lower doses than each drug individually. When the researchers examined the brains and spinal cords of these animals, they confirmed that EphB1 on the cells of these tissues had been inactivated, the probable cause for their pain resistance. A combination of these drugs might be able to blunt pain in humans too, the next stage for this research, says Kandil.

Unless we find alternatives to opioids for chronic pain, we will continue to see a spiral in the opioid epidemic. This study shows what can happen if you bring together scientists and physicians with different experience from different backgrounds. We're opening the window to something new."

Enas S. Kandil, M.D., Associate Professor, Anesthesiology and Pain Management, UT Southwestern

Source:

UT Southwestern Medical Center

Posted in: Medical Science News | Medical Research News | Pharmaceutical News

Tags: Anesthesiology, Animal Model, Antibiotic, Cancer, Cardiology, Chronic, Chronic Pain, Crystallography, Diabetes, Drugs, Education, heat, Medicine, Minocycline, Molecular Biology, Nerve, Neuropathic Pain, Neuroscience, Opioids, Pain, Pain Management, pH, Prescription Drug, Protein, Receptor, Research, Tetracycline, Trauma, X-Ray

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