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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Surpassing Overdose: Study Links Opioids to Heart-Related Deaths

 

 

The opioid epidemic has been a topic of conversation for a years now. With doctors and pharmacies being instructed to be more careful with their prescribing of the medication, and some states even asking them to look up a patient’s drug history before dispensing the drugs, it comes as no surprise that abuse and overdose are two huge issues. However, research suggests that many patients, especially those on long-term opioids, are dying not only because of overdoses, but simply because they are using them for far too long.

The study, which reviewed 45,000 patients from Tennessee from 1999 to 2012, found that those who had been prescribed opioids had a 64% increased risk of dying within 6 months of starting a regimen of the pills, compared to patients who were on other types of medications.

Although overdose and sharing medication is certainly a risk, the study claims that many doctors prescribe medication without thinking about the risk they may have for cardiovascular patients.

Patients with heart problems are the most vulnerable, as long-term opioid use can lead to slowing down of the heart, particularly when mixed with alcohol. This can lead to an accidental death. Opioids are also particularly dangerous for patients with sleep apnea, as the pills can disrupt the patients’ breathing patterns even further. This can lead to irregular heartbeat, heart attacks, and in some cases, even death.

All of the patients in this study were on Medicaid and were receiving long-term opioids for problems such as backaches, and chronic asthma and bronchitis. None had a history of abusing drugs.

Because they were on Medicaid, it is possible that they were unable to access medication that would actually treat the problem they had, thus doctors were over-prescribing opioids for temporary relief of the symptoms without curative benefits.

Dr. Magdalena Anitescu, a pain management expert at the University of Chicago, stated that there needs to be a huge change in how treatment is regulated. She states that alternative treatments can be just as effective, however, patients need to be granted access and doctors need to be educated on what else can be done besides simply prescribe opioids.

“We have a major cultural shift ahead of us,” said Dr. Chad Brummett, director of pain research at the University of Michigan Health System. (Click to Source)

The results were published in the Journal of the American Medical Association (JAMA).

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Trump administration doubles down on anti-marijuana position

TRIBUNE CONTENT AGENCY 
FEB 21, 2020  4:34 PM

 

Analysts previously predicted Donald Trump might support marijuana legalization to boost his chances of re-election this year. Instead, the opposite has happened. The Trump Administration has proposed removing medical marijuana protections in the 2021 fiscal budget and leaked audio revealed the President’s belief that smoking weed makes you dumb.

Trump has done little to reverse this appearance of an anti-marijuana sentiment building in the White House. Rather, a top Trump campaign spokesman doubled down and said marijuana should remain illegal at the federal level. During an interview with Las Vegas CBS affiliate KLAS-TV, Marc Lotter, who serves as director of strategic communications for Trump’s 2020 campaign, was asked about the President’s stance on changing federal cannabis laws.

“I think the president is looking at this from a standpoint of a parent—a parent of a young person—to make sure we keep our kids away from drugs,” Lotter said. “They need to be kept illegal. That is the federal policy.”

This complicates what Trump stated during his 2016 campaign and time in the White House. Previously, Trump supported leaving marijuana legalization to the states and voiced support for the STATES Act, bipartisan legislation that would prohibit federal prosecution for those living in states with legal cannabis.

“I think the president has been pretty clear on his views on marijuana at the federal level. I know many states have taken a different path,” Lotter said.

It could also signal a change in political strategy from the president in the upcoming election. Outside candidates Joe Biden and Mike Bloomberg, the Democratic presidential nominee will support legalizing cannabis at the federal level. Trump could see it as an advantage to position himself opposite of his eventual opponent. For now, Trump appears comfortable allowing himself being seen as someone who will uphold federal cannabis prohibition.

Said Lotter, “If he changes that, obviously that would be something I wouldn’t want to get out in front of him on that.” (Click to Source)

 

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Long-term use of depression drug may cause addiction

 

In a new study, researchers say that people who have taken antidepressants for years should consider coming off the medication.

However, these people will likely face difficult and even dangerous withdrawal symptoms due to physical dependence.

The best process is to follow a tapering schedule while consulting with a physician. Stopping medication outright is almost never advisable.

The research was conducted by a team at Midwestern University Chicago.

The team says many people feel safe in that their depression or anxiety is continuously managed by medication.

However, these are mind-altering drugs and were never intended as a permanent solution.

Once the patient’s depression or anxiety has been resolved, the physician should guide them toward discontinuation, while providing non-pharmacologic treatments to help them maintain their mental health.

In the study, the team found patients who stop taking their medication often experience Antidepressant Discontinuation Syndrome (ADS), which includes flu-like symptoms, insomnia, nausea, imbalance, sensory disturbances often described as electric shocks or “brain zaps”, and hyperarousal.

Older, first-generation antidepressants often come with additional risks for more severe symptoms, including aggressiveness, catatonia, cognitive impairment, and psychosis.

Discontinuing any antidepressant also carries a risk for gradual worsening or relapsing of depression and anxiety, as well as suicidal thoughts.

A recent report from the CDC said a quarter of people taking antidepressants had been using them for a decade or more.

The team says this data makes the case that patients and physicians are overly reliant on medication without concern for long-term consequences.

While relatively safe, antidepressants still carry side effects, including weight gain, sexual dysfunction and emotional numbing.

The team also urges caution as the evidence for antidepressant risk factors is based on short-term usage and says there are no sufficient longitudinal studies on the neurologic impact of taking antidepressants for decades.

The lead author of the study is Mireille Rizkalla, Ph.D., Assistant Professor, Department of Clinical Integration. (Click to Source)

The study is published in The Journal of the American Osteopathic Association.

Copyright © 2019 Knowridge Science Report. All rights reserved.

 

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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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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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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

today

 

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.”

___

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

___

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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Drug companies reach settlement in opioid litigation: Report

Published October 21

Four drug companies reached a settlement to avoid going to trial that sought to blame them for stoking the nationwide opioid crisis, according to The Wall Street Journal.

The Journal reported Monday, citing people familiar with the matter, that McKesson Corp., Cardinal Health Inc., AmerisourceBergen Corp., and Teva Pharmaceuticals Ltd agreed to a deal. It is unclear, at this time, if Walgreens will continue on as the lone remaining defendant at the trial.

Ticker Security Last Change Change %
MCK MCKESSON CORPORATION 144.64 -1.24 -0.85%
CAH CARDINAL HEALTH 55.03 -0.19 -0.34%
ABC AMERISOURCEBERGEN CORPORATION 87.91 -0.60 -0.68%
TEVA TEVA PHARMACEUTICALS INDUSTRIES LTD. 10.42 -0.03 -0.29%

Settlement talks — reportedly for nearly $50 billion dollars — had fallen through over the weekend. In the last 20 years, an estimated 400,000 deaths are blamed on opioids, both legal and illegal.

The stakes of the case were expected to be significant and far-reaching, as a bellwether for how future cases are handled. There have been 2,600 lawsuits filed against various pharmaceutical-related companies — that make, sell or distribute the drugs — in an effort to recover some of the cost to opioid-ravaged communities.

In the case at hand, two Ohio counties — Cuyahoga and Summit — were suing companies that either make, sell, or distribute opioids. The counties were looking for money to help them fight and fix the epidemic, while families who lost loved ones to overdoses are seeking justice. The companies, meanwhile, say they followed the law and aren’t to blame for the crisis.

“This is not your typical tort product liability case. It’s really about an epidemic,” Carl Tobias, a professor in the law school at the University of Richmond, said. “There are so many different motivations among so many different players, it’s virtually impossible to know what would be good.”

“The distributors’ role is to help ensure that medicines prescribed by licensed doctors are delivered to licensed pharmacies, so they are available for patients who need them, when they need them, where they need them,” the three large distributors said in a joint statement issued after settlement negotiations hit an impasse on Friday. “We have to balance our mission to deliver medicines to pharmacies and hospitals when and where they need them against our important efforts to prevent and detect illegal diversion of those drugs.” (Click to Source)

The Associated Press contributed to this report.

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