There’s no real evidence that prescription drugs can treat chronic pain in children, but doctors prescribe them anyway

Monday, March 16, 2020 by: Isabelle Z.

(Natural News) It’s easy for adults to chalk up chronic pain to part of getting older, but for children who are otherwise healthy, it can be downright devastating. Unfortunately, when these kids are prescribed drugs to address such pain, they are taking on a host of side effects for something that hasn’t even been proven to help them feel better.

When it comes to chronic pain among children, some of the most common varieties are headaches and migraines, musculoskeletal pain, and recurrent abdominal pain. This pain can really impact their quality of life, with many children who suffer from chronic pain missing school regularly and becoming isolated from their peers. They also tend to have more depression and anxiety than children who don’t have pain, and it can adversely affect their ability to reach their full potential in life in the long term.

While drug therapy is often the first course of treatment for these kids, a recent study shows there is very little evidence supporting this option. In fact, according to the researchers from the University of Bath who led the review, there isn’t any high-quality evidence pointing to the safety or efficacy of the drugs commonly used for chronic pain in children.

The study, which was summarized in the journal PAIN, outlines the serious lack of information we have about the treatment of chronic pain in children and determines that a lot more must be done to obtain more and better evidence.

To get an idea of just how little evidence there is, consider this: More than 300,000 patients have been studied across hundreds of trials for adults with chronic pain. The number of studies that have been carried out in children, however, is just six, with 393 kids involved in total. That’s hardly enough to draw a reliable conclusion about children in general.

The researchers pointed out that it’s not very reliable to simply apply the conclusions of studies carried out in adults to children as both their biology and metabolism function differently than those of adults.

Study co-author Dr. Emma Fisher said: “Children are not just small adults, so we cannot simply extrapolate evidence acquired from adults and use it in children.”

She added that the evidence we currently have available to us is not sufficient to say with any certainty whether the drugs that are used are the right approach. However, she said that with the current rate of reporting on clinical trials of just 1 every 3.5 years, it would take more than a thousand years to accumulate an acceptable base of evidence to make informed decisions. She called for urgent attention and funding to improve the knowledge base in this regard.

One part of the problem is that there are ethical barriers to carrying out randomized control clinical trials on children, and there are also some practical barriers as well.

Alternative treatments for children with chronic pain

Why aren’t more children being given non-drug treatments to address chronic pain? There have already been studies showing that psychological therapy, such as cognitive behavioral therapy, can have some success in reducing the pain and disability in children and adolescents, as can acupuncture. Other approaches could also prove useful, such as meditation yoga, exercise, massage and music therapy.

With one out of every five children reporting experiencing chronic pain, it’s clear that a better solution is needed or we could be setting up children for a lifetime of dependence on drugs that offer very little in the way of relief in exchange for substantial risks. (Click to Source)

 Sources for this article include:

NewsWise.com

ScienceDaily.com

 

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The opioid crisis may be far worse than thought, making the epidemic harder to fight

There may be a gross underreporting of opioid-related death rates

 

As Drug Overdose Deaths Escalate, Opioids Continue to Be the Top Killer

There may be a gross underreporting of opioid-related death rates, leading to misrepresentation about the extent of the epidemic, according to a new study.

A substantial share of the documentation on fatal drug overdoses may be missing information on the specific drug that caused the overdose.

The study, published in the journal “Addiction,” looked at a total of 632,331 drug overdoses between 1999 and 2016. Of these deaths, 78.2% were drug overdoses with known drug classification and 21.8% were unclassified drug overdoses. Of the unclassified drug overdoses, further investigation revealed that 71.8% involved opioids, translating to 99,160 additional opioid-related deaths.

There were over 70,000 drug overdose deaths in 2017, according to an estimate from the Center for Disease Control and Prevention. Based on findings from the new study, over half of those deaths — about 47,000 — are suspected to have involved opioids.

An issue with documenting drug overdose deaths

“The number of deaths from opioid-related overdoses could be 28% higher than reported due to incomplete death records,” said Elaine Hill, Ph.D., an economist and assistant professor at the University of Rochester Medical Center Department of Public Health Sciences and senior author of the study.

“Other work has already exposed the ways in which coroner versus medical examiner systems undermine accuracy in death records, but the opioid crisis and our research highlights the extent of the problem,” Hill told ABC News.

Death certificates issued after fatal drug overdoses are often missing information on the specific drug involved — something that is causing the underreporting of opioid-related deaths and downplaying the extent of the opioid epidemic, the authors of the new study concluded.

“The risk of underreporting these cases is to underscore the scope of the current crisis which could lead to a slower or less intensive response in coming up with a viable solution,” says Dr. Shailinder Singh, an emergency room psychiatrist practicing in New York City.

Besides overdose deaths, there are other consequences of the opioid epidemic including increased risk of infectious disease among IV drug users, a greater number of newborns with neonatal abstinence syndrome and higher rates of emergency department visits for opioid involvement.

While the majority of overdose-related deaths in the past have involved an opioid, with illicit fentanyl as the primary driver of these deaths, however this data is likely underreported.

The rate of non-fatal overdoses has also increased and is likely underestimated. “Unless these individuals are able to receive urgent medical care and the case is reported in that manner, there is little incentive for a person to report the overdose themselves due to fear of possible litigation or stigmatization,” said Singh.

Three phases of the opioid epidemic

The opioid epidemic today progressed in three phases, according to the CDC. The first, involved deaths caused by prescription opioids, the second, an increase in heroin use, and the third, a surge in the use of synthetic opioids or fentanyl.

The United States is right in the middle of the third phase of the epidemic, due to the increasing availability of fentanyl and increasing rates of overdose deaths involving synthetic opioids.

In 2017, West Virginia, Ohio, Pennsylvania and Washington D.C., had the highest overdose death rates in the country. However, accurate data is not being collected from rural areas and therefore these areas receive significantly less federal funding to combat the crisis.

“The rates of both lethal and non-lethal overdoses have undoubtedly increased due to the addition of synthetic opioids available as pills or mixed in with heroin,” said Singh.

“Most notably, these include illegally manufactured fentanyl and carfentanil, which are 50 times and up to 5,000 times more potent than heroin, respectively.” he added.

As the U.S. faces a rise in the number of overdose deaths involving heroin and fentanyl, the federal government has readjusted its strategy to combat the epidemic. This includes expanded access to treatment medications for opioid use and to the opioid overdose antidote, naloxone.

Also crucial among those efforts is collecting accurate data. Correct data regarding deaths from opioids is critical to know when implementing policies. Federal funding is also highly dependent on accurate statistics.

“Funding from federal agencies is often tagged to areas with the highest rates of opioid mortality. If these data are inaccurate, then areas in need may receive less funding than they need to address the crisis,” said Hill. (Click to Source)

Yalda Safai, MD, MPH, is a psychiatry resident in New York City. Melanie Graber, MD, is an internal medicine resident in Connecticut. Both are contributors to the ABC Medical News Unit.

 

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Man high on ‘zombie drug’ Spice saws off own leg and is left with bloodied stump

GRAPHIC CONTENT: The man, who had taken the synthetic substance, had to be rushed into intensive care while doctors battled to stop him bleeding to death from his gaping wound

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By Anna Savva
  • 14:07, 21 FEB 2020
  • UPDATED14:22, 21 FEB 2020

A man reportedly sawed off his own leg while off his head on the “zombie drug” Spice.

Shocking pictures appear to show the man with a tourniquet wrapped around a bloody stump after he reportedly cut his left leg off above the knee.

The bizarre scene unfolded took place in the western Russian city of Prokopyevsk in the Kemerovo Oblast region.

Pictures shared shared on media show the man as he lies on a hospital gurney after doctors apparently battled to stem the blood and save his life.

According to the reports, the man carried out the self-amputation after consuming Spice along with a cocktail of painkillers.

It is not known how the unidentified man managed to make his way to the hospital.

Local media report the man was initially been rushed into intensive care and medics battled to save his life.

These images were reportedly taken when the man was being moved to a general ward.

Spice is a popular synthetic drug which can leave users in a crazed “zombie-like” state. It has achieved notoriety in Britain and elsewhere in recent years.

It is usually made up of herbs or shredded plant material, with man-made chemicals added which mimic cannabinoids, found in cannabis.

People took to social media to comment on the graphic scenes.

‘Motors’ said: “They eat dangerous and unidentified drugs and so they even cut off their own legs.”

‘Marina Gerasimova’ said: “Once I was walking down the street and a jerk like this was consuming stuff right at the entrance of a school! I’m raising a daughter… this is so scary…”

Meanwhile, other internet users bemoaned the fact that the man will now receive disability benefits from the Russian state for the self-inflicted wound. (Click to Source)

 

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Opioid vending machine opens in Vancouver

MySafe scheme for addicts aims to help reduce overdose deaths in Canadian city

 

A vending machine for powerful opioids has opened in Canada as part of a project to help fight the Canadian city’s overdose crisis.

The MySafe project, which resembles a cash machine, gives addicts access to a prescribed amount of medical quality hydromorphone, a drug about twice as powerful as heroin.

Dr Mark Tyndall, a professor of epidemiology at the University of British Columbia, came up with the project as part of an attempt to reduce the number of overdose deaths in the city, which reached 395 last year.

“I think ethically we need to offer people a safer source,” he said. “So basically the idea is that instead of buying unknown fentanyl from an alley, we can get people pharmaceutical-grade drugs.”

Don Durban, a social worker from Vancouver, is one of 14 opioid addicts using the MySafe vending machine. After being prescribed opioid-based painkillers in the early 2000s, the father of two developed an addiction and now feels unable to cope without a daily dose of hydromorphone.

Unlike most addicts, Durban, 66, does not have to break the law by sourcing his fix through drug dealers. Instead he is prescribed Dilaudid – the brand name for hydromorphone – and, for the past couple of weeks, has been able to collect his pills from a vending machine near his home in Eastside, a rundown neighbourhood with a large homeless community.

“This is a godsend,” he told the Guardian during one of his visits to the machine. After verifying his identity with a biometric fingerprint scan, the machine dispensed Durban with three pills for each of his four daily visits, in line with his prescription.

“It means I don’t have to go and buy iffy dope,” he said. “I have a clean supply. I don’t have to deal with other people so much. You’re treated like an adult, not some kind of demonic dope fiend. We’re just people with mental health issues.”

Vancouver already has several schemes in place to accommodate for its large community of drug addicts. A pioneer of so-called harm reduction techniques, Vancouver was the first North American city to introduce a supervised injection site – where users can administer drugs in front of medical professionals – in 2003, and there are now several in the area. There are also programmes allowing users to access prescribed Dilaudid or pharmaceutical heroin.

Tyndall believes his scheme, which he hopes to roll out in other cities, will help addicts by giving them more autonomy – allowing them to pick up supplies at their convenience without having to visit pharmacies at specific times.

However, the MySafe project and Vancouver’s other harm-reduction techniques are not universally popular.

Dr Mark Ujjainwalla, an addictions doctor who runs Recovery Ottawa in eastern Canada, says users of illegal drugs need treatment for their conditions rather than easier access to substances. He argues such schemes are in effect ushering users towards death, rather than treating curable conditions.

“If you were a patient addicted to fentanyl [and you came to me], I would say: ‘OK, I will put you in a treatment centre for one to three months, get you off the fentanyl, get you stable, get your life back together and then you’ll be fine.’ Why would I want to give you free heroin and tell you to go to a trailer and inject?

“I’ve got people here who have changed their lives. They were in jail, prostituting, and they came to my clinic, we put them on methadone, they got their lives back, they’re working again. Isn’t that a better story?”

Ujjainwalla also fears drugs distributed from machines such as MySafe could end up on the black market.

Dr Ricky Bluthenthal, a professor of preventive medicine at the University of Southern California, disagrees. “It’s always better for someone to use licitly produced, safe medication rather than illicitly produced or illicitly distributed substance, which often have contaminants and other things that are unhealthy for people,” he said.

Durban also believes the machine will help him back to good health. “My long-term aim is to get off of [these drugs],” he said. “What I’ll do is try to get down to a minimal dose and then if it starts acting up again, I’ll see Mark and ask him to bring it up again.” (Click to Source)

 

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Meth is back and flooding the streets of Ohio and Kentucky, and it’s uglier than ever

Terry DeMio, Cincinnati EnquirerPublished 8:14 a.m. ET Feb. 13, 2020

The floor seemed filthy and she could not get rid of the grime. Amie Detzel frantically scrubbed that nursing home floor with cleaning supplies she’d found when no one was looking. On hands and knees, dragging her IV pole with her, the gravely sick woman incessantly scrubbed.

Meth had found its way into the nursing home. She was suffering from addiction. So she used it.

The psychotic episode happened after Detzel had spent days (and nights) of pushing the drug into the intravenous catheter that her caregivers were using to infuse antibiotics into her infected heart. The infection had come from a contaminated needle.

That catheter, the pathway for lifesaving antibiotics, became just another way to get a drug into Detzel’s body to alter her brain.

This was not heroin, which she’d been through. This was not fentanyl, the deadly synthetic opiate that had rushed into Cincinnati several years ago. This was methamphetamine, the primary drug now flooding the streets of Greater Cincinnati and Northern Kentucky and other communities across the country. It’s a psychostimulant. It can induce psychosis.

That explains the scrubbing.

This new wave of meth is causing police and parents of users and even government officials to shift their focus from opioids to this stimulant – a drug that used to be common, then faded, but is resurging. This time, with much more purity, coming directly from Mexico, not backyard cookeries or houses or sheds.

The fresh attention to meth matters. After all, the rise in meth tested at law enforcement crime laboratories across Ohio and Kentucky is staggering.

Just one example of that rise: The 23 drug task forces (including Northern Kentucky’s) that are funded through the Ohio High-Intensity Drug Trafficking Area agency saw a 1,600% jump in meth seized from 2015 to 2019 (and the 2019 numbers are incomplete).

Read that again: 1,600%.

But as shocking as that number is, some addiction experts say that we are missing the point behind the new meth wave.

The point: Addiction. The United States has an addiction crisis.

“We just simply move like a herd of locusts from one drug to another,” said Dr. Mina “Mike” Kalfas, a certified addiction expert in Northern Kentucky. “Meth is the replacement for the crack of old. We go from opioid (pain pills) to opioid (heroin) to opioid (fentanyl) to stimulant (meth).

“We try to get them off of the drug they’re on,” Kalfas said. “What we need to do is, treat the addiction. They’re using (a) drug as a coping mechanism.”

Addiction, which has been with us forever, is what needs to be fixed. With evidence-based treatment. The American Society of Addiction Medicine is still clamoring for more doctors to learn about such treatment and to attend to the problem as a disease.

Historically, the medical system largely ignored addiction, allowing the criminal justice system and treatment programs outside of the health-care system to deal with it, said Lindsey Vuolo, director of Health Law and Policy for and public affairs for the science-based nonprofit Center on Addiction in New York City.

The grudging change started with the opioid epidemic. As overdose death tolls soared, the mantra became: Treat addiction. Save lives. Keep people safe if they use drugs. Carry the opioid-overdose antidote naloxone. Provide more needle exchanges to prevent the spread of diseases such as hepatitis and HIV. Continue treatment for this chronic disease.

Those who ignore the advice put us at our own peril, experts say.

“If we don’t start to effectively and efficiently address addiction like the public health issue that it is, we will continue to see drug epidemic after drug epidemic,” said Courtney Hunter, director of advocacy at the Center on Addiction.

So why meth? Why now?

For starters, those who are addicted to opiates are hearing others talk about a new high, cheap and easy to get, and safer than fentanyl.

They are people with addiction, after all, and most people who suffer from addiction will reach for drugs other than the one they primarily use.

Meth is an alternative. But it’s sneaky.

Kalfas calls the current meth problem a new tentacle of the opioid epidemic, noting that most patients he’s seeing who switch from heroin to meth don’t give up opioids for long.

“They perceive (meth) as different, sometimes even lesser somehow, which is how they underestimate it. But when their batteries are dry, they need to ‘come down,’ what will they turn to? The opiate-addicted turns to opiates.”

Brittany Christian, 32, of Walnut Hills, who’s in recovery, said she learned about meth while she was in treatment for heroin addiction in Louisville.

“Everybody had done it and I hadn’t done it, and I really wanted to try it,” she said. She added: “I did not want to go through the heroin withdrawal again.”

Six months after she left that rehab, in May 2017, she decided to find meth.

“It’s just as easy as getting cigarettes at the gas station,” Christian said.

And cheap. In southwest Ohio, a gram of meth can go for as little as $4.50 per gram (and up to $25 a gram), said Ohio Bureau of Criminal Investigation Assistant Superintendent Heinz Von Eckartsberg.

For Detzel, the woman who fell into obsessive floor-scrubbing, drugs were a way to cope with living, she says. Now 35 and in recovery for a year, Detzel was 13 when she was led into a sex-for-drugs trafficking situation orchestrated by someone close to her family.

She did drugs, she said, because it seemed normal.

“I never knew the proper way, you know, to get help,” she said. “All I knew was to use because that’s what I’d seen … at a young age.”

She was vulnerable to anything that took her away from her real life.

“I just wanted to try anything. Anything that I thought would take me to another level.”

And by the time she was 30, meth was simply there for her to try, she said. “Somebody was selling it.”

Like they had sold her.

But Detzel rallied. She was able to maintain sobriety after her stint in the nursing home. She had been prescribed Suboxone for her opioid addiction and had to steer clear of drug use for six months before she could have heart surgery. She learned coping mechanisms, learned she’d been trafficked through no fault of her own and turned to God for help. She celebrated one year in recovery in January.

No such help with meth

Both Detzel and Christian had been introduced to medical help for their initial addictions.

There is no medication-assisted treatment available for meth addiction, as there is for opioid addiction.

That lack will become more obvious every day.

“It looks to me that a supply of stimulants will gradually increase in the U.S., as it has been seen in other parts of the world,” said Dr. Adam Bisaga, an addiction research scientist who is a professor of psychiatry at Columbia University Medical Center. While he doesn’t believe people using opioids will easily switch to stimulants, he’s certain there will be more who use both types of drugs.

Bisaga said it appears the best treatment will be an extension of what’s beginning to happen in the United States with opioid use disorder: Medical intervention treating addiction as a chronic disease, treating both addictions “under one roof.”

The best treatment right now for meth addiction is psycho-social therapy, addiction experts say. The method can include talk therapy, learning about the illness and a rehabilitation regimen that helps people develop social and emotional skills they can employ to live a healthy life. Some sufferers are prescribed anti-anxiety or sleep-help drugs or other medications while they detox from meth.

Like with other addictions, “You have to look at the underlying issues and really make a treatment plan that’s individualized for the person,” said Kat Engel, vice president of nursing services for the Center of Addiction Treatment in the West End. “Are they self-medicating?”

As is usual with treatment, not enough are getting it. Meth-related deaths are rising. The latest figures from the U.S. Centers for Disease Control and Prevention show that, from 2012 to 2018, the rate of drug overdose deaths involving methamphetamine and other “psychostimulants with abuse potential” was up almost fivefold.

Christian, who has been in recovery for a year-and-a-half, said that, “absolutely,” treating drug use has to include treating the individual’s trauma.

“What’s causing someone to use? What issues are they going through? You know, I think a lot of it is underneath that needs to be brought up.”

In her case, it was sexual abuse she’d endured as a child.

With meth, says, she was paralyzed, hyper-focused on a single task. Sometimes, she felt empty. She scratched and picked sores onto her body and face. Once, she piloted her car to a hospital, expecting to be locked in a psych ward. But she was discharged.

For her, the confines and rules of the Center for Addiction Treatment saved her, she said. She found sobriety by following the rules, then looking into her own traumatic past.

“If they told me I could not have a pair of leggings, oh well, I can’t have a pair of leggings. If they told me to go to group therapy three times a day, I did that. My counselor, when she told me to journal, I journaled.”

Both she and Detzel believe their continued success has at least something to do with their work.

Christian is an admissions specialist for the Center for Addiction Treatment. She loves her job, saying, “Somebody did it for me.”

Detzel, now living in Cheviot, works at the YWCA downtown in Cincinnati helping domestic violence and rape victims as well as people with developmental disabilities who struggle with addiction. She’s been in recovery for just more than a year.

The lessons they learned about their own addictions and how to treat them are holding. But they see the avalanche of meth on the streets now. They know the attraction among opioid users to this drug is real.

In Hamilton County, Dr. Lakshmi Sammarco, the county coroner, said the crime lab’s meth caseload leaped from a little more than 600 in 2016 to 3,600-plus cases in 2019 – “a sixfold increase.”

In Kentucky, the amount of meth seized and tested at the Kentucky State Police Crime Laboratories rose by 77% in just two years, from 2016 to 2018.

The outcomes of all this meth is yet to be seen.

Bisaga has this prediction for those who use such stimulants along with opioids:

“The mixed stimulant-opioid addiction is a different one,” Bisaga said. “We do not have a strategy to treat it, and many programs will be taken by surprise.

“The number of overdoses and adverse medical outcomes in people using both will increase, and this will be a fourth wave of the opioid epidemic.” (Click to Source)

 

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MONTANA SUES DRUG DISTRIBUTORS OVER OPIOID SHIPMENTS

February 03, 2020 at 6:54 pm | By AMY BETH HANSON

HELENA, Mont. (AP) — Montana has filed a lawsuit against the two leading drug distributors in the state, saying they failed to monitor and report excessive opioid shipments to Montana pharmacies, worsening the opioid epidemic.

Attorney General Tim Fox announced Monday the state was suing McKesson Corporation and Cardinal Health Inc., alleging they breached their legal duties under Montana’s Controlled Substances Act. The state is seeking damages to help pay for treatment, emergency response and public education programs it created to respond to the epidemic.

Between 2011 and 2013, prescription drug overdoses were responsible for at least 369 deaths in Montana, state officials said.

Montana law requires wholesale distributors to stop shipments of suspiciously large or increasingly frequent orders and report them to state and federal authorities. The lawsuit argues the companies failed to do so while shipping drugs Montana pharmacies from 2006 to 2014 — the most recent date for which information is available. During that time frame, McKesson supplied more than 48% and Cardinal supplied more than 15% of the opioid doses in Montana.

Together, they distributed the equivalent of over 432 million 10 milligram opioid doses in Montana between 2006 and 2014 — more than 400 pills for every resident of the state, the attorney general’s office said.

“As the two largest wholesale opioid distributors in the state, McKesson and Cardinal played a key role in fueling this devastation,” Fox asserted.

Media contacts with Cardinal Health did not immediately return an after-hours message seeking comment.

“Our company plays an important but limited role in the pharmaceutical supply chain, and any suggestion that McKesson drove demand for opioids in this country reflects a fundamental misunderstanding and mischaracterization of our role as a distributor,” a McKesson spokeswoman said in a statement. “We will continue to fight that mischaracterization and defend ourselves in the litigation.”

Several other states, including Washington, Arkansas and Vermont, have also sued McKesson and Cardinal Health.

McKesson has paid $163 million in federal civil penalties while Cardinal Health has paid $78 million in federal civil penalties and paid $20 million to resolve a civil lawsuit in West Virginia. (Click to Source)

 

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New, deadly drug called ‘gray death’ found in Louisiana; officials say just touching it could kill you

by: Britt Lofaso – Posted:  Updated: 

FRANKLIN, La. (KLFY)- A new, deadly drug is being found in Louisiana for the first time.

Officials say the drug is so powerful, just touching it could kill you.

They’re calling this super drug “gray death.”

“The public recognizes a lot of the drugs that we deal with. This is a new one,” David Spencer, spokesperson for the St. Mary Parish Sheriff’s Office said.

“Gray death” is heroin that has been cut with Fentanyl, according to Spencer, and it is deadly.

“Be aware of the color. It looks like chunks of concrete,” Spencer warned.

“Gray death” first started appearing in Alabama and Georgia in 2017. It then moved to Ohio and Pennsylvania.

Now, deputies say it’s here in Louisiana.

“You don’t want to touch this. If it all possible, you don’t even want to put it on your hands,” Spencer said.

The drug is reportedly 10,000 times more potent than morphine. Just touching the drug could kill you.

“You would really hate to see somebody innocent touch this not knowing what it is or a child touch that now knowing what it is,” Spencer added. “We just definitely just want to educate the public so they know, hey, this is a new thing.”

Officials say if you come across this drug, you should not pick it up or even touch it. Instead, you should report it to authorities.

The first sample of “gray death” in Louisiana was recently recovered from suspects from the Lake Charles area who were traveling through St. Mary Parish. (Click to Source)

Copyright 2020 Nexstar Broadcasting, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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Marketing Psychiatric Drugs to Jailers and Judges

Drug companies are courting jails and judges through sophisticated marketing efforts.

 
On a rainy Monday morning in April, more than a hundred sheriffs, doctors, nurses, and jail guards from around the country sat in a ballroom on the outskirts of Nashville, sipping on coffees and listening to Daniel Potenza, a psychiatrist from New Hampshire, describe one of their most vexing problems: treating schizophrenia.

The conference, on medical care inside America’s jails and prisons, had been put on by an organization that sets standards for treatment in correctional facilities. Potenza paced the stage, talking animatedly about a national mental-health epidemic that had burdened jails and prisons. He flipped to a presentation slide showing that nearly half of all inmates diagnosed with schizophrenia were “non-adherent,” meaning that they weren’t taking their daily medications as prescribed.

Then, Potenza suggested a solution: a single shot of long-acting antipsychotic medicine, whose effects last for as long as three months, administered to patients while they’re still incarcerated. To show how this might help, Potenza presented a hypothetical scenario in which an inmate with schizophrenia becomes eligible for release but is denied parole because a medical provider describes the person as non-adherent. Parole-board members might be willing to reconsider if they could ensure that the person would receive his or her medications as prescribed ahead of release. In some cases, a “treatment resistant” patient who is simply forgetful might agree to the shot. However, in some cases, a judge might order a shot to be administered without the patient’s permission.

Potenza didn’t recommend a specific drug, and he was presenting at the conference at his employer’s expense, having been invited by its organizers.  But if you looked inside the conference program, you would learn that the keynote address on schizophrenia had been underwritten by Alkermes, an Irish company that manufactures one of the long-acting medicines, Aristada. If you walked through the exhibit hall, you would see Alkermes banners hanging from the rafters, along with a booth of salespeople expounding on the benefits of the antipsychotic drug. An Aristada flyer they passed out featured two buildings—a guard tower surrounded by a razor-wire fence, and a community health center—with the slogan “Transition of care takes time.”

For most of the twentieth century, pharmaceutical companies expressed little interest in inmates. People in need of mental-health treatment often received it at state-run psychiatric hospitals. But in the 1950s and ’60s, states began shuttering many of America’s psychiatric hospitals, pushing patients toward treatment in their communities. Then, in the 1980s and ’90s, lawmakers passed “tough on crime” policies that dramatically expanded the nation’s corrections population. Taken together, those developments had the unintended consequence of turning jails and prisons into warehouses for the mentally ill. By 2005, more than a million adults behind bars had some form of mental illness, according to the Bureau of Justice Statistics.

The dramatic shift in American mental-health care presented new opportunities for pharmaceutical companies. Correctional officials are required by law to provide adequate health care, including prescription drugs, to inmates. They also have an imperative to try to make sure people have enough medication when they are released to tide them over until they can seek care on their own. Federal researchers have found that releasing inmates with a supply of medication, and connecting them to community-based treatment, has lowered the odds of recidivism. But by the turn of the millennium, psychiatric-drug prices were rising. As early as the 2000s, to help mitigate costs, local officials in some states, including Washington and Ohio, sought free samples of antipsychotic medications from pharmaceutical companies.

Since then, the relationship between drug companies and the criminal-justice system seems to have intensified: free samples to detention facilities; comped lunches during which jail and prison doctors learn about medications; and payments to physicians to tout certain medications at conferences for criminal-justice professionals, including those without health-care licenses such as sheriffs and drug-court judges. At recent conferences about correctional health care, Merck, Gilead, AbbVie, and other big pharmaceutical companies have staged “product theaters” or “education luncheons” that show how their products could help treat inmates. The criminal-justice system isn’t just a lucrative market because of current inmates; it also introduces incarcerated people to medication that they might continue using after they’re released. (The full cash price of Aristada is about $1,300 for a four-week shot. The drug is covered by Medicaid and Medicare but can still require hefty copays.)

Dr. Joseph Penn, the director of mental-health services for the Correctional Managed Care division of the University of Texas Medical Branch, which oversees treatment in many of the state’s jails and prisons, says drug companies have awakened to the potential market behind bars. “No other country incarcerates as many people as we do, and they realized, ‘Hey, that’s a whole market we haven’t tapped,’” Penn said.

Long-acting schizophrenia drugs, in particular, can be an effective medication for inmates who might otherwise resist treatment, potentially leading to a safer and more predictable environment for them and for the correctional officers on shift. Potenza, the doctor who presented at the Tennessee conference, told me that meetings with drug companies allow doctors like him “to understand the benefits, despite the amplification”—of a particular drug’s merits—“from the company reps.” And free samples of these drugs can make them more accessible.

But despite having benefits for detention facilities and prisoners—free drugs, more information about new treatments—these marketing efforts have raised worries among criminal-justice advocates that drug companies could influence both the prescribing habits of correctional doctors and the choices of non-health-care professionals such as sheriffs and drug-court judges. A recent ProPublica analysis found that doctors who accepted money from pharmaceutical companies for top brand-name drugs were more likely to prescribe those companies’ medicines than doctors who did not. And Dominic Sisti, a medical-ethics professor at the University of Pennsylvania, worries that nonmedical professionals might not be able to analyze drug companies’ marketing messages the way doctors can. “It’s a sales pitch,” Sisti said.

Potenza said that audiences should “apply a keen eye as to anything that is biased.” Dr. Brent Gibson, the chief health officer for the National Commission on Correctional Health Care, which organized the conference at which Potenza presented, said in an email that Alkermes and other sponsoring companies do not have input into presentations like Potenza’s. “We do reserve the right to not accept financial support from a corporate entity that is in conflict with our mission, but we do not feel that is the case with pharmaceutical companies that offer medications that can be useful in the correctional setting,” he wrote.

While drug companies have long marketed to people in a position to help patients make decisions, critics say their efforts in the criminal-justice sphere are particularly troubling because the patients involved, being incarcerated, may not feel that they have as much of a say in their own health-care decisions.

John Snook, the executive director of the Treatment Advocacy Center, a group that calls for better mental-health treatment, said, “If you’re a jailer, and someone says, ‘We’re going to provide you with a solution that gets regular levels of therapeutic medicine to a population that’s difficult for you to control’”—in the form of samples of psychiatric drugs—“that’s going to be extremely attractive.”

But David Fathi, director of the ACLU’s National Prison Project, expressed concern about whether this kind of marketing, aimed at jailers and judges rather than incarcerated people themselves, further diminishes the agency of prisoners, who are disempowered in nearly every facet of life behind bars. Even in cases where incarcerated patients elect to take a psychiatric drug, he said, it may be a choice made under duress, knowing that they may be medicated against their will if they refuse. “If you know you can be forcibly medicated, can you really make a free and noncoercive choice about medication?” he said.

Geoff Mogilner, a spokesman for Alkermes, said, “We expect healthcare professionals to utilize their independent clinical judgment to continually assess, with their patient’s input, how a medication is working and to recommend the medication that works best.”

Alkermes, which manufactures drugs for conditions that are disproportionately found behind bars—such as schizophrenia and alcohol and opioid addiction—is among several companies that have embraced the criminal-justice system as a source of customers. Starting in the early 2010s, Alkermes promoted Vivitrol, a treatment for opioid-use disorder, to correctional facilities. The treatment, generically known as naltrexone, had previously been used for alcohol-use disorder, but the drug floundered. When Alkermes recast it as a solution to the opioid epidemic, the company directly lobbied jailers and judges on the shot’s merits, selling the promise of the drug despite scant evidence of its effectiveness compared to competing treatments like buprenorphine, one of the active ingredients in the brand-name drug Suboxone. In closed-door meetings, Alkermes disparaged Suboxone as a “black market” drug that was illegally abused inside correctional facilities, according to a report from The New York Times. The company’s marketing practices received blowback. (Alkermes has pointed to studies it says offer further evidence for Vivitrol’s effectiveness. In some cases, the company has pushed back against criticisms. Earlier this month, in response to a warning letter from the Food and Drug Administration, the company responded that it was taking steps to be “fully compliant” with federal regulations.) Alkermes accomplished its goal: People received Vivitrol while behind bars, and kept using it once they were released. Today Vivitrol is widely available in treatment facilities across the country, in part thanks to this early push.

Drugmakers introduced long-acting schizophrenia shots more than 50 years ago as a way to infuse consistency into psychosis treatment. But some psychiatrists and mental-health advocates were skeptical because of concerns about extended exposure to side effects such as sleepiness and low blood pressure, and because the shots seemed like “an attempt by psychiatrists to impose their will on patients,” according to a paper by Ahsan Khan, a psychiatrist at Saint Louis University, and colleagues.

As long-acting antipsychotic drugs improved, along with their public image, drug companies thought they could reinvigorate the market. In July 2009, the Food and Drug Administration approved Invega Sustenna, a long-acting, injectable form of an earlier antipsychotic pill made by Johnson & Johnson’s Janssen brand. Abilify Maintena, from a Japanese company called Otsuka Pharmaceutical, followed four years later. Then came Aristada, green-lit in 2015.

Within the multibillion-dollar schizophrenia-drug market, the makers of all three drugs are seeking to cast long-acting injections as the future of schizophrenia treatment. A 2015 study by the University of California, Los Angeles, found that patients who were given such injections were more likely to adhere to treatment and see reduced symptoms over a 12-month period, compared to those taking the same medication orally. But there’s also a chance that side effects will last longer than with the pill form, and that’s one of the key reasons some psychiatrists still start with the pill.

Recognizing the importance of detention facilities in the mental-health market—approximately 15 percent of state prisoners experience serious mental illness, more than three times the rate found in the total U.S. adult population—drugmakers are, to varying degrees, marketing the long-acting drugs to criminal-justice audiences.

Janssen, whose schizophrenia drug leads the market, offers free samples and financially supports advocacy groups aimed at keeping individuals with mental illnesses out of jails. Last year, the company won approval from the FDA to market Invega Sustenna as a treatment that can keep schizophrenic patients out of jail. Before then, Janssen could market the drug’s ability to treat schizophrenia but not make further claims about how it might help incarcerated populations.

Once it got the additional approval, Janssen rolled out video testimonials of formerly incarcerated individuals receiving injections, including a 31-year-old woman identified only as “Tanara” who was incarcerated after a fight with a neighbor. Tanara explained that the injection allowed her to not worry about missing daily pills for schizophrenia and helped her get a steady job as a peer-support specialist after she was released.

Kaitlin Meiser, a Janssen spokeswoman, said free samples allow doctors to “familiarize themselves with the medicine and for patients to try the medicine and determine if it is the right fit for them.” But she noted that the company does not have any “concerted” efforts to specifically educate correctional doctors through the use of paid speakers or free meals.

Otsuka’s criminal-justice efforts appear more limited. Public records show that psychiatrists who have worked in corrections have received payments or perks from Otsuka, but Robert Murphy, a spokesman, said the company’s marketing does not specifically target the criminal-justice system. It has offered free samples of Abilify Maintena to just one correctional system, in Maricopa County, Arizona—and that was on request. He also said that Otsuka has not made “any payments for meals or speaking fees at any meetings or conferences where the audience was doctors or individuals who work with jails, prisons, or courts.”

Aristada, a relative newcomer in the antipsychotic-injection sector, trails behind Invega Sustenna and Abilify Maintena. As Alkermes seeks to catch up, it has provided the treatment in 40 correctional facilities in 18 states, offering free samples to many of them. And it has paid doctors to speak at criminal-justice conferences about its potential, as well as designing advertisements that depict people reentering society thanks to the shot. Two doctors told me Alkermes paid them to participate in focus-group panels where they were asked by company representatives about how to market the shot to criminal-justice officials.

Mogilner, the Alkermes spokesman, did not answer specific questions about the company’s marketing and sales tactics but noted that they are, to a large degree, no different from other companies’ efforts. He wrote in an email that Aristada can offer people leaving prison or jail “consistent and sustained” treatment during “the often-challenging transition back to the community.”

Corrections officials don’t have to exclusively prescribe Aristada in exchange for free samples, Mogilner added, or continue prescribing the shot after the samples run out. “We work to educate healthcare professionals and other stakeholders with whom they work about the treatment of schizophrenia in diverse settings of care, including criminal justice healthcare settings, community mental health centers, and hospitals,” he wrote. “No one medicine is right for every patient.”

Several health-care officials and practitioners told me that free samples of long-acting antipsychotic shots have helped their patients in the criminal-justice system access helpful drugs that would otherwise be too expensive for them to offer. “Funding is always an issue,” Rachel Waddell, a nurse practitioner who treats inmates in a 662-bed jail in Rapid City, South Dakota, told me. The jail has provided samples of Aristada to 10 inmates but hasn’t accepted payments from drug companies, or perks such as free lunches. “With Alkermes, we don’t have to jump through hoops.”

Officials in Maricopa County, Arizona, have not taken perks or payments from drug companies, but they have accepted free samples of long-acting shots from Janssen, Otsuka, and Alkermes. Grant Phillips, the medical director of Maricopa County’s correctional-health services, said that nearly 120 inmates are on long-acting shots and that they work well. More than half of those are ordered by judges, he said, but judges leave it up to doctors to decide which product is best for their patients. The medication consumes a fifth of the total pharmacy budget for a jail population of about 7,500.

While some jail officials see mostly an upside in drug companies’ marketing efforts, others say it’s more complicated. Jeff Gromer, the former warden of the Minnehaha County Jail in Sioux Falls, South Dakota, said he hasn’t accepted perks or consulting payments, but he has given samples of Aristada to 16 patients since 2018; their symptoms stabilized while on the drug. “When you put someone with anxiety and paranoia in [a jail] environment, it gets hard for them to cope,” Gromer said. “When they can’t cope, there’s behavioral problems such as self-harm or aggression toward inmates or staff, or hiding in their cell.” Still, he’s wary of Alkermes’s efforts to reach patients by marketing to criminal-justice officials overseeing them. “Alkermes’s hope is that the prescription is continued once they’re out of custody, and they’re going to get paid for that,” he said. (Alkermes didn’t comment on Gromer’s characterization.)

Penn, the doctor working with Texas prisons, said his system does not accept samples from drug companies at all and restricts the perks or payments doctors receive. While patients in Texas prisons are sometimes prescribed long-acting antipsychotic drugs—typically as a last resort—Penn expressed concern, noting that “there’s not much literature” on them yet. Though more company-funded studies are emerging, he hasn’t seen enough “good head-to-head studies of the medications,” he said.

Alkermes and other drug companies have marketed not only to jailers but to judges as well. Earlier this year, at a conference for drug- and mental-health-court professionals in Maryland, Alkermes sponsored a closed-door promotional session about using long-acting shots in a court setting. Featured at the session was Richard Jackson, a former psychiatrist at the Women’s Huron Valley Correctional Facility in Ypsilanti, Michigan, and Ernie Glenn, a magistrate in Bexar County, Texas, who had helped defendants in his court get access to long-acting antipsychotic shots. While Glenn had received no payments from Alkermes, the company had paid Jackson more than $250,000 between 2015 and 2018 for speeches, travel and lodging, and meals, according to the Centers for Medicare and Medicaid Services’s open payments database. (Jackson also received $252,608 in payments from Otsuka from 2015 to 2018, and said he has continued receiving payments from drug companies in 2019; it wasn’t immediately clear whether Alkermes was one of them.) The conference program, as in the conference in Nashville, directed people to learn about Aristada at Alkermes’s exhibit booth. “It wouldn’t matter to me if the info was sponsored by one company or all the companies, so long as the info about the medication gets out to the public,” Glenn later told me.

“A lot of people in corrections … they’re not even aware,” Jackson said of long-acting injections. “If you’re not getting educated, you’re not using them, there’s no way it’ll ever be afforded to those prisoners.”

Judge Robin Faber, who presides over a Miami-Dade County court division that aims to divert inmates into mental-health treatment, has not been the target of marketing by Alkermes or any other pharmaceutical firm but said he sees the potential of long-acting drugs in his sixth-floor courtroom. One sweltering afternoon in early September, a young man named Chris Sellers took off his orange cap and slouched into the back of Faber’s courtroom. (Sellers’s name has been changed; Faber, Sellers’s lawyer, and Sellers allowed The Atlantic to sit in the courtroom, which isn’t open to the public, on the condition that his real name not be used.) Faber was reviewing Sellers’s medical records.

“You look good,” Faber said. The first time Faber had met Sellers, several months earlier, Sellers had recently been arrested for stealing a $20 T-shirt. Having looked at his records, along with his initial health assessment from a doctor, Faber felt Sellers’s nonviolent offenses were linked to untreated mental illness, and decided to require treatment instead of incarceration. At the time, to ensure that Sellers received his medication, Faber ordered an involuntary shot for his schizophrenia. Faber believed that Sellers would reoffend without it—and hoped that it would break his cycle of incarceration. As Faber continued reviewing the records, he noticed that Sellers had since received another long-acting shot. “That’s probably helping a lot,” Faber said, agreeing to keep Sellers on the treatment regimen instead of sending him to the Dade County Jail.

After Sellers’s hearing, Faber told me he defers to doctors regarding which medications patients should get. Ernesto Grenier, a psychiatrist at Jackson Health, the medical provider for three of Miami-Dade County’s jails, is often the one choosing those drugs.

When I spoke with Grenier, he told me that Jackson Health prohibits free samples from pharmaceutical companies. But, on occasion, Grenier has listened to pitches from Otsuka, Janssen, and Alkermes. From 2016 to 2018, he accepted food or drinks from the three companies 22 times, for a total of $949.92. He said he does not typically prescribe Aristada—which he considers less proven than some other drugs because it is newer—and dismissed the notion that free lunches or drinks from any drugmaker might have influenced his care. “They all say theirs is the best,” Grenier said. “We choose medication based on the patient.” (Click to Source)


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VIDEO: America collapses into a pharma state; just like a “narco state” but run by prescription drug cartels

12/02/2019 / By Mike Adams

A “narco state” is a nation where nearly every aspect of society — politics, law enforcement, media, etc. — is controlled by narcotics traffickers. Mexico is a modern-day narco state.

America has collapsed into a pharma state, where all the most powerful corporations, regulators and government entities are beholden to pharmaceutical interests.

  • The establishment media is largely funded by Big Pharma and uses its influence to promote pharmaceuticals while attacking nutrition and natural supplements.
  • Federal regulators like the FDA and CDC function as little more than pharmaceutical cheerleading squads that hype the benefits of prescription medications (and vaccines) and protect Big Pharma’s profits through regulatory monopoly enforcement.
  • The techno fascists like Google, Facebook and Amazon are all-in for Big Pharma, promoting prescription drugs by censoring natural health information while pursuing their own for-profit medication and vaccine retailing operations.
  • Law enforcement is entirely controlled by Big Pharma, which is why the CEOs of powerful drug companies like GlaxoSmithKline are never indicted, even when that company admitted to running a nationwide bribery campaign involving 44,000 doctors. Instead of going to jail, they paid a fine to the DOJ and continue to conduct business as usual in the United States.
  • The judicial system is overtly rigged in favor of Big Pharma, too. The vaccine has absolute legal immunity against lawsuits stemming from the millions of children who are harmed (and in some cases killed) each year by faulty vaccines made with toxic, dangerous ingredients. In America, no parent can due a vaccine manufacturer for the damage caused to their child by childhood immunization vaccines.
  • The institution of “science” is totally corrupted by Big Pharma, and medical journals are almost entirely funded by pharmaceutical interests. Med schools teach doctors how to be little more than pharmaceutical vending machines, and even the “science” entries in Wikipedia are almost entirely engineered by Big Pharma sock puppets that pretend to be unbiased “editors.”
  • Lawmakers in Washington D.C. are bought and “owned” by Big Pharma campaign donations and well-funded lobbyists. The pharmaceutical industry has more paid lobbyists in D.C. than even the weapons manufacturing industry or the oil industry.
  • Even veterinary medicine is now totally corrupted by Big Pharma, to the point where vets largely just push vaccines and medications onto dogs, cats and even horses.
  • These same pharmaceutical giants are pushing the FDA to outlaw CBD products and criminalize even non-THC cannabis as a form of natural medicine. This is being done, of course, to protect the monopoly profits of the opioid manufacturers that are killing tens of thousands of Americans each year while raking in billions in profits.

Watch this powerful mini-documentary, below, to learn more about how America has collapsed into a “pharma state.” Share the video everywhere to help spread the word. Big Pharma is as grave a danger to the United States as the narcotics cartels are to Mexico. If we don’t end this pharmaceutical tyranny over America, this nation will collapse from runaway “health care” spending and pension payouts to the pharmaceutical giants.

Oh yeah, and Elizabeth Warren wants to pump another $51 trillion in Big Pharma’s pockets by unleashing “Medicare for All” which is nothing more than a massive taxpayer-funded windfall of profits for the drug companies and cancer centers that keep people sick and medicated.

https://www.brighteon.com/a0006c0a-e398-40dd-bad2-f9569916c690


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Purdue Pharma’s foreign affiliate now selling overdose cure

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The gleaming white booth towered over the medical conference in Italy in October, advertising a new brand of antidote for opioid overdoses. “Be prepared. Get naloxone. Save a life,” the slogan on its walls said.

Some conference attendees were stunned when they saw the company logo: Mundipharma, the international affiliate of Purdue Pharma — the maker of the blockbuster opioid, OxyContin, widely blamed for unleashing the American overdose epidemic.

Here they were cashing in on a cure.

“You’re in the business of selling medicine that causes addiction and overdoses, and now you’re in the business of selling medicine that treats addiction and overdoses?” asked Dr. Andrew Kolodny, an outspoken critic of Purdue who has testified against the company in court. “That’s pretty clever, isn’t it?”

As Purdue Pharma buckles under a mountain of litigation and public protest in the United States, its foreign affiliate, Mundipharma, has expanded abroad, using some of the same tactics to sell the addictive opioids that made its owners, the Sackler family, among the richest in the world. Mundipharma is also pushing another strategy globally: From Europe to Australia, it is working to dominate the market for opioid overdose treatment.

“The way that they’ve pushed their opioids initially and now coming up with the expensive kind of antidote — it’s something that just strikes me as deeply, deeply cynical,” said Ross Bell, executive director of the New Zealand Drug Foundation and a longtime advocate of greater naloxone availability. “You’ve got families devastated by this, and a company who sees dollar signs flashing.”

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This story was produced with support from the Pulitzer Center on Crisis Reporting.

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Mundipharma’s antidote, a naloxone nasal spray called Nyxoid, was recently approved in New Zealand, Europe and Australia. Mundipharma defended it as a tool to help those whose lives are at risk, and even experts who criticize the company say that antidotes to opioid overdoses are badly needed. Patrice Grand, a spokesman for Mundipharma Europe, said in a statement that heroin is the leading cause of overdose death in European countries and nasal naloxone is an important treatment option.

Injectable naloxone has long been available; it is generic and cheap. But Mundipharma’s Nyxoid is the first in many countries that comes pre-packaged as a nasal spray — an easier, less threatening way for those who witness an overdose to intervene. Nyxoid, which isn’t sold in the U.S., is more expensive than injectable naloxone, running more than $50 a dose in some European countries. A similar product manufactured by another pharmaceutical company has been available for years in the U.S. under the brand name Narcan.

Critics say Nyxoid’s price is excessive, particularly when inexpensive naloxone products already exist. Grand declined to say how much Nyxoid costs Mundipharma to manufacture or how profitable it has been.

The Sackler family’s pharmaceutical empire has long considered whether it might make money treating addiction, according to lawsuits filed against Purdue and the family. In the U.S., Purdue Pharma called its secret proposal Project Tango, the attorneys general of Massachusetts and New York have alleged, and discussed it in a September 2014 conference call that included family member Kathe Sackler.

In internal documents, the lawsuits allege, Purdue illustrated the connection they had publicly denied between opioids and addiction with a graphic of a blue funnel. The top end was labeled “Pain treatment.” The bottom: “opioid addiction treatment.” The slideshow said they had an opportunity to become an “end-to-end provider” — opioids on the front end, and addiction treatment on the back end.

“It is an attractive market,” the staff wrote, according to the Massachusetts complaint. “Large unmet need for vulnerable, underserved and stigmatized patient population suffering from substance abuse, dependence and addiction.”

In its response to the court, the family’s lawyers wrote that the plan was put forward by a third-party private equity fund as a potential joint venture and “at the very most, Project Tango was mentioned in passing on a few occasions and the proposal was subsequently abandoned.” A press release issued by the Sacklers said no member of the family or board had an active role in the presentations or supported the proposal, and called the lawsuits “sensationalized” and “misleading.” Purdue declined to comment.

New York’s lawsuit alleges that in 2015, Project Tango was presented to Purdue’s board as a joint venture to sell the addiction medication suboxone that could become the “market lead in the addiction medicine space.” The presentation highlighted the sales opportunity in opioid addiction: 40 to 60 percent who went through treatment would relapse and need it again.

Project Tango stalled. It was revised the next year with a new plan to sell naloxone, the lawsuits allege.

Publicly, Purdue was denying that its painkillers caused the addiction epidemic. But in internal communications, the company described naloxone as a “strategic fit” and a “complementary” product to the prescription opioids they were already selling, the Massachusetts attorney general said. Purdue calculated that the need for overdose reversal medication was increasing so rapidly, potential revenue could triple from 2016 to 2018.

The lawsuit alleges that Purdue identified its own painkiller patients as a target market for naloxone — and that it could use its sales force already visiting doctors to promote opioids to also promote overdose reversal medication. They saw potential profits in government efforts to expand access to naloxone to stem the tide of overdose deaths, a toll that has soared to 400,000 since the American epidemic began.

Project Tango fizzled in the U.S.; the family’s press release said Purdue’s board rejected it.

But half a world away, in Australia, Mundipharma embarked on an effort to promote naloxone that was sweeping and effective.

As part of an Australian coroner’s investigation last year into six fatal opioid overdoses in New South Wales state, Mundipharma submitted a 15-page document touting the benefits of naloxone. If people around the overdose victims had had access to naloxone, the company wrote, many of those deaths may have been avoided. At the same time, Mundipharma was registering Nyxoid in Australia, a fact it acknowledged within its submission.

In the document, the company suggested that officials change the country’s laws to allow for easier access to naloxone, get naloxone into needle exchange programs, detox centers and supervised injecting clinics, and establish a national, free take-home naloxone program.

“The Coroner should consider what is needed to realise the full public health benefits of this essential medicine,” Mundipharma wrote.

During the coroner’s inquest, Mundipharma sent a staffer to court to testify about the benefits of naloxone nasal spray. According to a transcript, Mundipharma’s Medical Affairs Director, Brian Muller, came to court with samples of naloxone products, including Nyxoid.

Health and addiction experts also praised the drug’s life-saving potential. In her written findings delivered in March, Coroner Harriet Grahame agreed that naloxone should be more widely distributed and Nyxoid given to the state’s paramedics, police agencies, doctors and hospital emergency departments.

Mundipharma also paid for a drug policy institute’s study on naloxone that the federal government ultimately used as a blueprint for a 10 million Australian dollar ($6.8 million) pilot program to distribute naloxone, including Nyxoid. And in October, Australian Health Minister Greg Hunt announced that Australia’s government would subsidize Nyxoid prescriptions, meaning it costs Australians as little as AU$6.50 ($4.50) per pack, versus around AU$50 without the subsidy.

Asked in an interview whether the government had any concerns about following the recommendations of a Mundipharma-funded report that stood to benefit the company financially, Hunt replied: “All of the advice is that this is a product that will save lives and protect lives and our approach is to be fearless of the source of the product.”

In a statement, Mundipharma Australia denied its Nyxoid push in the country had any connection to, or was influenced in any way, by Purdue’s Project Tango.

“Mundipharma Australia and Purdue Pharma are independent companies,” the Australian company wrote. “Mundipharma Australia introduced Nyxoid to help meet a clear clinical need.”

Grand, the spokesman for Mundipharma Europe, also rejected any link between the company’s Nyxoid strategy and Project Tango, saying that the European company and Purdue have separate managements, boards and strategies.

In some countries, including Norway, Nyxoid is the only nasal naloxone product approved, said Thomas Clausen, a professor at the University of Oslo in Norway who runs the nation’s naloxone program. Clausen is happy that Nyxoid is available, but not that a company profiting from mass marketing opioids is now trying to profit again off opioid addiction.

“It’s kind of a paradox,” he said.

Clausen said he hopes other companies will enter the market, and that competition will drive down cost. In its basic, generic form, Clausen said, naloxone is so cheap that the United Nations launched a pilot program in central Asian countries providing injectable naloxone at a cost of around $1 per kit.

Some critics argue that Mundipharma should be providing a cheaper — or even free — naloxone product, although Nyxoid’s cost is not remarkable when compared to the exorbitant price of many prescription drugs in the U.S. The most common nasal antidote in the U.S. retails for more than $100, double what most Europeans pay for Nyxoid.

Still, in some countries, Nyxoid’s price could prove problematic.

Pernilla Isendahl runs a naloxone distribution program in a county in south Sweden that began in June 2018, when Nyxoid came onto the market. Each kit costs the government 450 Swedish Krona ($47.)

The project is expected to run for at least three years, and she hopes after that the county will continue to pay for the medication, despite budget constraints.

“I can’t really see how it would be financed by the people themselves, at the price it is now,” she said.

In the United Kingdom, Nyxoid is being distributed by a handful of charities, said Peter Furlong, coordinator of British charity Change Grow Live’s Nyxoid distribution pilot program in Manchester. Furlong is pleased more people now have access to the medicine, but it still costs more than injectable naloxone. Furlong said he asked Mundipharma if they could reduce the drug’s price for the charity’s pilot, which began in August, but Mundipharma told him it was too early to talk discounts.

Grand, the spokesman for Mundipharma Europe, said the company was working closely with charities and addiction organizations to identify the best ways to make the drug available to those who may benefit from it. Nyxoid’s price reflects the company’s investment, manufacturing cost and the value of the technology, while recognizing the “prevailing financial pressures that exist within care sectors,” he said.

Stephen Wood, a fellow at the Harvard Medical School Center for Bioethics who studied how pharmaceutical companies in the U.S. raised prices on naloxone products as the addiction epidemic intensified, says that Sackler-owned companies manufacturing naloxone have an ethical duty to make it widely available.

“If they were trying to find a solution, they would just distribute naloxone for free,” he said. “They could use all that money they made off opioids to help support a program where they are giving away this life-saving medication.” (Click to Source)

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The Global Opioids project can be seen here: https://www.apnews.com/GlobalOpioids


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