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HORRIFYING: Indivior Solutions Gave ADDICTIVE Opioid Drug As “Treatment” For Opioid Abuse Under FALSE CLAIM Of Drug Being A Non-Opioid Treatment For Addiction

Daily Fodder Team–July 27, 2020

Indivior Solutions today pleaded guilty to a one-count felony information and, together with its parent companies Indivior Inc. and Indivior plc, agreed to pay a total of $600 million to resolve criminal and civil liability associated with the marketing of the opioid-addiction-treatment drug Suboxone.  Together with a $1.4 billion resolution with Indivior’s former parent, Reckitt Benckiser Group PLC (RB Group), announced in 2019, and a plea agreement with Indivior plc’s former CEO, Shaun Thaxter, announced last month, the total resolution relating to the marketing of Suboxone is more than $2 billion — the largest-ever resolution in a case brought by the Department of Justice involving an opioid drug.

Suboxone is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment for opioid-use disorder.  Suboxone contains buprenorphine, a powerful opioid.

“Combatting the opioid crisis is a Department of Justice priority,” said Principal Deputy Associate Attorney General Claire M. Murray.  “Today’s announced resolution and related actions hold accountable entities and individuals that unlawfully marketed opioid-addiction products.”

“The opioid crisis is a public health emergency.  Prevention and access to effective treatments for opioid addiction are critical to fighting this epidemic,” said Deputy Assistant Attorney General Michael D. Granston for the Justice Department’s Civil Division.  “When a drug manufacturer claims to be part of a solution for opioid addicts, we expect honesty and candor to government officials, as well as to the physicians and patients making important treatment decisions based on those representations.”

Resolution of the Criminal Investigation

Indivior Solutions pleaded guilty today to a one-count felony criminal information charging false statements relating to health care matters.  In connection with its guilty plea, Indivior Solutions admitted to making false statements to promote the film version of Suboxone (Suboxone Film) to the Massachusetts Medicaid program (MassHealth) relating to the safety of Suboxone Film around children.  The resolution includes a criminal fine, forfeiture, and restitution totaling $289 million.  On June 30, 2020, Indivior plc’s former CEO Shaun Thaxter pleaded guilty to a one-count misdemeanor information related to Indivior’s false and misleading representations to MassHealth.

In 2002, Indivior Inc. received approval to market Suboxone tablets for use in the treatment of opioid addiction and dependence.  At that time, Indivior Inc. was an RB Group subsidiary known as Reckitt Benckiser Pharmaceuticals Inc.  In December 2014, RB Group spun off Indivior Inc., and the two companies are no longer affiliated.  Thereafter, Indivior Inc. became a subsidiary of Indivior plc.  On April 9, 2019, a federal grand jury sitting in Abingdon, Virginia, indicted Indivior Inc. and Indivior plc for allegedly engaging in an illicit nationwide scheme to increase prescriptions of Suboxone.

In its guilty plea today, Indivior Solutions, which employed marketing and sales personnel for the Indivior group of companies, admitted to an aspect of the scheme alleged in the indictment.  Specifically, Indivior Solutions admitted that, in October 2012, it sought to convince MassHealth to expand Medicaid coverage of Suboxone Film in Massachusetts and sent MassHealth false data indicating that Suboxone Film had the lowest rate of accidental pediatric exposure (i.e., children taking medication by accident) of all buprenorphine drugs in Massachusetts, when in fact, it did not.  Indivior Solutions further admitted that sending the false and misleading information occurred in the context of marketing and promotional efforts directed at MassHealth, which were overseen by top executives.  MassHealth announced it would provide access to Suboxone Film for patients with children under the age of six shortly after Indivior provided the false and misleading information to agency officials.

“During the nationwide opioid epidemic, Indivior Solutions made false statements about Suboxone’s safety to increase its sales.  In doing so, Indivior Solutions misled government health care officials and is being held accountable today for its felonious conduct,” said First Assistant U.S. Attorney Daniel P. Bubar of the Western District of Virginia.  “This resolution is the culmination of years of work by prosecutors and agents and demonstrates that we will continue to work tirelessly to hold pharmaceutical manufacturers responsible for illegal conduct.”

In addition to its financial aspects, the agreement with Indivior Inc. includes novel provisions that:

  • Require Indivior Inc. to disband its Suboxone sales force and not reinstate it;
  • Require Indivior Inc.’s CEO to personally certify, under penalty of perjury, on an annual basis that during the prior year (a) Indivior was in compliance with the Food Drug and Cosmetic Act and did not commit health care fraud or (b) list all non-compliant activity and the steps taken by Indivior to remedy these acts;
  • Prohibit Indivior Inc. from using data obtained from surveys of health care providers for marketing, sales, and promotional purposes;
  • Require Indivior Inc. to remove health care providers from their promotional programs who are at a high risk of inappropriate prescribing; and
  • Make Indivior subject to contempt sanctions by the court and reinstatement of the dismissed charges if it violates the agreement.

“The opioid crisis has devastated families and communities across the Commonwealth and drug manufacturers must be held accountable for their role in creating and prolonging this crisis,” said Virginia Attorney General Mark R. Herring.  “I want to thank my Medicaid Fraud Control Unit for their work on this important case, as well as our local, state and federal partners for their continued collaboration.  My team and I will continue to do everything in our power to hold pharmaceutical companies accountable for their role in the opioid crisis and help to ensure justice for those families who have been effected by the opioid crisis.”

“Parties that contract with the government will be held to the letter of the contract,” said Kenneth Cleevely, Special Agent in Charge of the Eastern Field Office for the U.S. Postal Service Office of Inspector General.  “The U.S. Postal Service spends billions of dollars per year in workers compensation-related costs, most of which are legitimate.  However, when medical providers or companies choose to flout the rules and profit illegally, special agents with the USPS OIG will work with our law enforcement partners to hold them responsible.  To report fraud or other criminal activity involving the Postal Service, contact USPS OIG special agents at www.uspsoig.gov or 888-USPS-OIG.”

U.S. District Judge James P. Jones accepted the guilty plea but deferred acceptance of the plea agreement until after the preparation of a presentence report.  He scheduled sentencing for Oct. 20, 2020 at the U.S. Courthouse in Abingdon, Virginia.

The Civil Settlement

Under the civil settlement, Indivior Inc. and Indivior plc have agreed to pay a total of $300 million to resolve claims that the marketing of Suboxone caused false claims to be submitted to government health care programs.  The $300 million settlement amount includes approximately $209.3 million to the federal government and $90.7 million to states that opt to participate in the agreement.

The civil settlement resolves allegations by the United States that, from 2010 through 2015, Indivior companies knowingly (a) promoted the sale and use of Suboxone to physicians who were writing prescriptions that were not for a medically accepted indication and that lacked a legitimate medical purpose, were issued without any counseling or psychosocial support, were for uses that were unsafe, ineffective, and medically unnecessary, and were often diverted; (b) promoted the sale or use of Suboxone Film to physicians and state Medicaid agencies using false and misleading claims that Suboxone Film was less susceptible to diversion and abuse than other buprenorphine products and that Suboxone Film was less susceptible to accidental pediatric exposure than tablets; and (c) submitted a petition to the Food and Drug Administration on Sept. 25, 2012, claiming that Suboxone Tablet had been discontinued “due to safety concerns” about the tablet formulation of the drug and took other steps to delay the entry of generic competition for Suboxone to improperly control pricing of Suboxone, including pricing to federal healthcare programs.

“Prescription opioids are both addictive and dangerous when diverted for improper use or prescribed without accurate information about the risks that they pose,” said U.S. Attorney Craig Carpenito for the District of New Jersey.  “This resolution holds Indivior to account for placing profit above patient and community safety.”

The civil settlement resolves claims against Indivior in six lawsuits pending in federal court in the Western District of Virginia and the District of New Jersey under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery.  The False Claims Act also permits the government to intervene in such actions, as the government previously did in the three lawsuits pending in the Western District of Virginia.  The whistleblower share to be awarded in this case has not yet been determined.

“Opioid addiction and abuse is an immense public health crisis and taking steps to address it is one of the FDA’s highest priorities,” said FDA Commissioner Stephen M. Hahn, M.D.  “Medication-assisted treatments incorporating drugs like Indivior’s Suboxone, in combination with counseling and behavioral therapy, are an important tool in combating opioid use disorder but can quickly become part of the problem if not used responsibly.  When companies encourage the use of powerful drugs where not medically necessary and provide misleading information about relative product benefits, they can ultimately risk more misuse, abuse, diversion, and accidental exposure to opioid drugs as well as make treatment more difficult to obtain for those suffering from this crisis.  We will continue to work with the Department of Justice to investigate and hold accountable those who devise and participate in schemes to the detriment of the public health.”

Non-monetary Provisions of the Corporate Integrity Agreement

In addition to the criminal and civil resolutions, Indivior executed a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG).  The CIA requires that Indivior implement numerous accountability and auditing provisions.  On an annual basis, top executives and the Board of Directors must certify about compliance, Indivior must conduct annual risk assessments and other monitoring, and an independent review organization will conduct multi-faceted audits.

“Addressing the opioid crisis is a top priority for OIG, and we will continue to work closely with the Department of Justice to hold corporations and individuals accountable when they use illegal tactics to promote and sell opioids,” said Gregory E. Demske, Chief Counsel to the Inspector General, HHS-OIG.  “Among other things, our CIA with Indivior imposes accountability on the Board and top executives, subjects the company to internal and external auditing, and ensures that the company will separate itself from its prior top leadership.”

“The opioid epidemic has ravaged this nation,” said Elton Malone, Assistant Inspector General for Investigations with the Office of Inspector General of the U.S. Department of Health and Human Services.  “This resolution, along with our law enforcement partners’ work, should serve as a warning that large companies will face prosecution if they break the law.”

FTC Resolution

Under a separate agreement with the Federal Trade Commission (FTC), Indivior has agreed to pay $10 million to resolve claims that it engaged in unfair methods of competition in violation of the Federal Trade Commission Act, 15 U.S.C. § 53(b).  The FTC filed a complaint in the U.S. District Court for the Western District of Virginia alleging anticompetitive activities by Indivior designed to impede competition from generic equivalents of Suboxone.  As part of a consent decree, Indivior agreed that it would notify the FTC if it filed a Citizen Petition with the FDA in connection with a drug product, it would simultaneously disclose to both the FDA and the FTC all studies and data relevant to that Citizen Petition.  Indivior further agreed not to withdraw a drug from the market or otherwise disadvantage a drug after obtaining approval to market another drug containing the same active ingredient.

“As alleged in the FTC’s complaint, in the midst of the nation’s opioid crisis, a critical opioid-addiction treatment was about to become more affordable,” said Gail Levine, a Deputy Director of the FTC’s Bureau of Competition.  “But Indivior prevented that.  It kept its drug prices high by unlawfully impeding generic manufacturers from competing effectively.”

A Multilateral Effort

The criminal case against Indivior was prosecuted by Randy Ramseyer of the U.S. Attorney’s Office for the Western District of Virginia, Albert P. Mayer and Carol Wallack of the Department of Justice Civil Division’s Commercial Litigation Branch, Charles J. Biro and Matthew J. Lash of the Department of Justice Civil Division’s Consumer Protection Branch, Kristin L. Gray, Joseph S. Hall and Janine M. Myatt of the Virginia Medicaid Fraud Control Unit of the Office of the Virginia Attorney General, and Garth W. Huston of the Federal Trade Commission.  This matter was investigated by the Virginia Attorney General’s Medicaid Fraud Control Unit; FDA – Office of Criminal Investigation; United States Postal Service – Office of Inspector General; and Department of Health and Human Services – Office of Inspector General.

The civil settlement was handled by Edward Crooke of the Civil Division’s Commercial Litigation Branch, Sara Bugbee Winn of the U.S. Attorney’s Office for the Western District of Virginia, and Andrew A. Caffrey III of the U.S. Attorney’s Office for the District of New Jersey.  Assistance was provided by representatives of the HHS Office of Counsel to the Inspector General; the HHS Office of the General Counsel, CMS Division; FDA’s Office of Chief Counsel; the U.S. Attorney’s Office for the Eastern District of Virginia; the U.S. Department of Agriculture Office of the General Counsel; the National Association of Medicaid Fraud Control Units; the Defense Criminal Investigative Service; the Office of Personnel Management – Office of Inspector General; the Department of Veterans’ Affairs Office of Inspector General; the Department of Labor – Office of Inspector General; and TRICARE Program Integrity.

The joint effort advances the goals of the Department’s Prescription Interdiction & Litigation (PIL) Task Force to deploy all available criminal, civil, and regulatory tools to hold opioid manufacturers accountable for unlawful practices and to ensure that prescription opioid products are marketed truthfully.

Except to the extent admitted as part of the criminal resolution, the claims resolved by the civil settlement are allegations only.  There has been no determination of liability in the civil case. (Click to Source)

For more information about the U.S. Attorney’s Office for the Western District of Virginia, visit its website at https://www.justice.gov/usao-wdva.  Additional information about the Consumer Protection Branch and the Civil Fraud Section and their enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch and http://www. justice.gov/civil/fraud-section.  Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).

 

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Chemicals supplied by China play a big role in America’s illegal drug trade

Thursday, June 11, 2020 by: Isabelle Z.

(Natural News) Coronavirus isn’t the only deadly epidemic that can be traced to China; factories in the country have also been involved in supplying huge amounts of precursor chemicals to Mexican super labs to produce methamphetamines and other drugs that end up on American streets.

Precursor chemicals are used for the illegal manufacture of narcotics and psychoactive substances. However, they also have legitimate commercial applications and are used legally in consumer products such as medicines and fragrances, as well as for industrial processes. One example of this is phenylacetic acid, which is legally used to produce penicillin and cleaning solutions but can also be used to illegally manufacture methamphetamines.

A former special agent for the DEA, Derek Maltz, told One News Now that China’s participation in the drug crisis that is killing people around world, particularly in America, is an “underreported story” that has been going on for many years.

He said that while the DEA did a great job of stunting the ability of what he termed “mom and pop” labs in the U.S. to make meth, drug kingpins in Mexico spotted an opportunity to make a lot of money, so they began bringing significant quantities of precursor chemicals from China and other Asian countries into Mexican ports, from which point they went on to be used to make street drugs in labs around the country.

“Cartels started dominating the methamphetamine production business inside of Mexico,” he said. “Cartels like the Sinaloa Cartel and the Jalisco Cartel built super-labs in Mexico to produce massive amounts of methamphetamines, up to seven tons of meth every three days.”

The synthetic drug market is highly profitable for them, he says, pointing out that China is home to more than 150,000 chemical companies and that the country is earning millions of dollars by selling “these poisons.”

They are also making a lot of money by selling massive amounts of fentanyl to Mexican cartels, and some Americans are even managing to buy some of these chemicals from websites in China and having them shipped directly to their homes.

In addition, the Chinese are helping the money laundering for these cartels in the U.S. as law enforcement has a far more difficult time penetrating ethnic Chinese groups than the Mexican ones, given the high number of Spanish-speaking informants used by law enforcement.

Maltz believes that money may not be the only motivation behind China’s actions, saying: “America is a big adversary to China, so it’s not far-fetched to think the Chinese are purposely killing Americans and making millions of dollars while doing it.”

Coronavirus crisis in Wuhan disrupted the drug trade

Wuhan will forever be associated with coronavirus, but prior to the pandemic, it was known for producing the chemicals that are needed for fentanyl and other opioids. According to the L.A. Times, Mexican drug cartels were their biggest customers.

After the virus emerged and disrupted the fentanyl supply chain, however, Mexican drug traffickers saw their profits take a huge hit, and street drug prices across America started climbing. Lockdowns, travel bans, and other types of virus containment efforts have crippled the narcotics trade, and the Mexican production of meth and fentanyl was particularly hard hit as they were unable to get the precursor chemicals that usually arrive via plane or cargo ship from China.

In addition, new restrictions on entering the U.S. have been another big roadblock for the Mexican drug cartels, and the resulting loss of income is said to be contributing to escalating violence in Mexico, where the monthly homicide figures reached a two-year high in March. As pandemic-related lockdowns start being lifted, however, the illegal drug trade will soon be in full swing once again. (Click to Source)

Sources for this article include:

BigLeaguePolitics.com

OneNewsNow.com

LATimes.com

 

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Aldous Huxley In 1958 – Pharmacology And Propaganda Will Make The Masses Love Their Slavery

 

As the world is forced into accepting greater and greater levels of government control in all areas of life, remember that nothing in politics happens by chance. There is a science to creating empires. Tomes have been written on the techniques of controlling masses of people.

Three important axioms stand out: people are much easier to control when they love their slavery, people in fear are very easy to control, and individualism is dangerous to the state.

During a prophetic interview with journalist Bill Wallace in 1958, Aldous Huxley commented on what he foresaw as a potential future for the United States and the world.

Huxley’s classic dystopian novel, Brave New World, was written almost 90 years ago in 1931, prior to World War II, and his insight is still highly relevant today. We are seeing in real-time the emergence of a global, technocratic super state, of which pharmaceutical companies play a critically important role, and terrorism is always a lurking background threat.

Huxley, as introduced by Wallace:

A man haunted by a vision of hell on earth. A searing social critic, Mr. Huxley 27 years ago wrote Brave New World, a novel that predicted that someday the entire world would live under a frightful dictatorship. Today Mr. Huxley says that his fictional world of horror is probably just around the corner for all of us. ~Mike Wallace (1958)

If Huxley was able to see all of this coming almost 90 years ago and describe it so well in Brave New World, what are we missing?

He was able to make these predictions because he understood that mass control is the most studied science of the world’s wealthiest and powerful people. He also understood human nature and the nature of government.

…obviously the passion for power is one of the most moving passions that exists in man; and after all, all democracies are based on the proposition that power is very dangerous and that it is extremely important not to let any one man or any one small group have too much power for too long a time.

After all what are the British and American Constitution except devices for limiting power, and all these new devices are extremely efficient instruments for the imposition of power by small groups over larger masses. ~Aldous Huxley

Today, over 40 million Americans regularly take antidepressants, a testament to the omnipresence of the pharmacological state. Huxley foresaw this being a critical tenet of control, for people need to love their slavery, and new drugs can really help with that.

To Wallace, he states:

In this book of mine, Brave New World, I postulated a substance called Soma, which was a very versatile drug. It would make people feel happy in small doses, it would make them see visions in medium doses, and it would send them to sleep in large doses.

…this is the pharmacological revolution which is taking place, that we have now powerful mind-changing drugs, which physiologically speaking are almost costless.

…if you want to preserve your power indefinitely, you have to get the consent of the ruled, and this they will do partly by drugs as I foresaw in Brave New World… ~Aldous Huxley

Furthermore, he spoke about the need to disrupt the natural thought process of human beings, accessing their subconscious minds, so that their emotions instead of logic will lead them. Huxley foresaw advanced forms of propaganda being used to hack the mind’s of the masses.

[They will do it]… partly by these new techniques of propaganda.

They will do it by bypassing the sort of rational side of man and appealing to his subconscious and his deeper emotions, and his physiology even, and so, making him actually love his slavery.

I mean, I think, this is the danger that actually people may be, in some ways, happy under the new regime, but that they will be happy in situations where they oughtn’t to be happy.

…We know, there is enough evidence now for us to be able, on the basis of this evidence and using certain amount of creative imagination, to foresee the kind of uses which could be made by people of bad will with these things and to attempt to forestall this… ~Aldous Huxley

With the state of national media and the clear biases they project onto the population, it’s hard to imagine a more propagandized environment in America; however, the rise of internet censorship foreshadows an even darker future for free thought and free speech.

Aldous Huxley’s Brave New World is emerging all around us. Are you paying attention? (Click to Source)

Watch the full interview, here:

 

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‘Young people drop like flies’ Overdoses spike as fake pills go around Tennessee county

by Kaylin Jorge –

GRUNDY COUNTY, Tenn. (WZTV) — A small Middle Tennessee county is dealing with a crises on top of the coronavirus pandemic right now: fake pills and drugs laced with fentanyl claiming the lives of young residents.

Grundy County Sheriff Clint Shrum said there were eight overdoses reported in 10 days – and three of those were fatal.

Sheriff Shrum said his department has confirmed the substance in fake Xanax and Roxicet pills is fentanyl, a deadly substance 25-50 times more potent than heroin. He also suspects fentanyl is being mixed with heroin and methamphetamine.

Fake Xanax (DEA)

 

The victims? All in their 30s or younger.

“When you start having young people drop like flies it becomes very, very concerning,” Sheriff Shrum said in one of his Facebook updates on the overdose investigation.

Sheriff Shrum says his agency is small and only has two investigators who are working 16 to 18 hour days following leads in the overdose investigations. Tackling this new crises is taking investigators off other cases that need to be worked.

And right now, Sheriff Shrum said while they’ve made substantial progress in the cases – investigators are still hitting roadblocks.

“Because of this code that people live by, ‘we can’t tell,’ more people are going to die,” Shrum said on Facebook. “It’s going to get worse before it gets better.”

Sheriff Shrum is reaching out to the community, urging people with information to come forward.

“The life you save may be your own,” Sheriff Shrum said. “Without communication from the community we’re not going to solve this.”

Sheriff Shrum said he’s also concerned about the COVID-19 virus, overdoses and protecting his staff.

“We are using precautions working these cases to limit exposure to our people because of COVID-19,” Sheriff Shrum said. “As the virus decreases it will open up new avenues for us to dive deeper.”

Sheriff Shrum says these overdoses are happening in young people – and it’s hitting the community hard.

“Those people who are drug addicts belong to somebody, they are mothers, fathers, sons, daughters,” Sheriff Shrum said. “They belong to somebody. Because they are dealing with addiction doesn’t mean we just mark it up and move on.”

He shared a message directly to those who need help.

“If you’re listening to me and you’re a user, it’s dangerous territory right now,” Sheriff Shrum said. “You don’t know what you’re getting. Seek help if you have a loved one who needs help, talk to them and try to convince them it’s a dangerous thing going on right now.” (Click to Source)

 

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Study: Overdose risk doubles for young people with family on opioids

By Brian P. Dunleavy

March 27 (UPI) — Adolescents and young adults with family members on prescription opioids are more than twice as likely as others to overdose on the pain medications, a new study has found.

In results published Friday by JAMA Network Open, researchers note that young people who have access to these drugs from family members may misuse them, perhaps in unsafe amounts.

Additionally, young people prescribed opioids themselves were six times more likely to overdose on the drugs than those administered to them by a medical professional, the study authors report.

“Prescription opioids are potent medicines that can pose serious health risk to children and teens, if taken accidentally or misused on purpose,” study co-author Dr. Anh P. Nguyen, a research post-doctoral fellow at Kaiser Permanente Colorado’s Institute for Health Research, told UPI. “Parents should control access to these medications in the home.”

According to the U.S. Centers for Disease Control and Prevention, roughly 170 million prescriptions for opioid-based pain relievers were written in 2018. Opioids have been found to be highly addictive, and the medications have fueled an “epidemic” of abuse and misuse — as well as overdose deaths — across the United States over the past 20 years.

For the research, Nguyen and his colleagues reviewed health data from more than 45,000 families in a Kaiser Permanente Colorado health plan from 2006 and through 2018. These families included more than 72,000 adolescents and young adults between 11 and 26 years of age.

In general, young people were more commonly exposed to opioids dispensed to a family member than they were to have their own prescription. Nearly 48,000, or 66 percent, of the adolescents and young adults included in the study had at least one family member with an opioid prescription, while just over 26,000, or 37 percent, were prescribed the drugs themselves.

The risk for overdose doubled for young people with family members on prescription opioids, and increased six-fold for those on the drugs themselves. Risk for overdose increased 13-fold for those who were prescribed opioids themselves and had a family member taking the drugs.

“There are several measures that families can take,” Nguyen said. “Opioid medications should be stored securely in a place out of reach. Unused and no longer needed medications should be disposed of properly, such as through a medicine take-back program.”

“Controlling access to prescription opioids is just one of several efforts needed to address the opioid crisis,” Nguyen added. “It should be paired with strategies to increase screening and access to treatment for substance use disorder.” (Click to Source)

 

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High-dose opioids – five factors that increase the risk of harm

March 30, 2020 11.44am EDT

Sean Jennings started taking opioids in 1993 following a complication from a hernia operation that left him in debilitating pain. His GP initially prescribed codeine combined with paracetamol, but the pain persisted. Every day Sean took more and more pills. His GP eventually prescribed stronger opioids than codeine – tramadol, at first, and then morphine. Twenty-five years on, Sean was taking 160mg of morphine every day – a very high dose – but he was still in pain. He was also at high risk of overdosing.

To find out how many people there are like Sean, we conducted a study, synthesising all the published research on high-dose opioids. We found that of 4.2 million people taking prescription opioids in Australia, the UK and the US, over 154,000 were taking high doses. We also found five factors linked to the use of high-dose opioids: being prescribed benzodiazepines (such as Valium), increased visits to emergency departments, depression, unemployment and being male.

Of these factors, the combined use of high-dose opioids with benzodiazepines is the most worrying. Benzodiazepines, also called “benzos”, are sedative drugs that are prescribed for anxiety and poor sleep – common in people with chronic pain. But people taking high-dose opioids plus a benzodiazepine have a tenfold greater risk of unintended overdose than people taking opioids alone.

Sean Jennings’ story.

Gradual process

High doses of opioids aren’t used at the start of treatment. The escalation in dose is usually a gradual process, occurring over many years. While high doses are necessary for people receiving palliative care and cancer treatment, no clinical trials of the benefits and harms of using opioids in high doses for chronic pain have been conducted. Despite this, prescriptions of high-dose opioids have increased in Australia, Canada, England and the US.

Reducing the amount of high-dose opioid prescriptions can benefit stretched healthcare budgets and systems. In England, if GPs reduced the number of high-dose opioid prescriptions, £24.8 million could be saved in six months. And visits to the emergency department would be reduced too.

But there is a critical gap in our understanding of this problem as most studies were from the US, with one from Australia and one from the UK. This is because access to electronic patient records is very limited globally, and not much research has evaluated the prescribing of high-dose opioids. Data on the number of prescriptions is more readily available, but to understand what dose people are prescribed, we need patient-level data.

Through self-management with exercise, mindfulness and group therapy, Sean has been opioid-free for two years and is “thriving”, although he is still in pain. He is living proof that life without high-dose opioids is possible. Sean says that social prescribing, where GPs refer patients to a local community group or social activity, such as art classes, in addition to standard clinical care, is the way forward.

We must rethink the prescribing of high-dose opioids for people with chronic pain. There are many unanswered questions, but turning to the prescription pad will not solve the problem. Lower doses of opioids are safer, will benefit strained healthcare budgets and reduce the burden on healthcare systems globally. Sean is proof that there is another way. (Click to Source)

 

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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

By Dr. Yalda Safai and Dr. Melanie Graber – February 27, 2020, 1:20 PM – 6 min read

 

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

BY SETH POLLARD
POSTED ON MAY 3, 2019

 

 

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).

Sources:

Claims Journal

CBS News

 

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Trump administration doubles down on anti-marijuana position

By BRENDAN BURES, THE FRESH TOAST
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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