Perdue Pharma Will Profit From Medication-Assisted Treatment

Perdue Pharma

Perdue Pharma makes Oxycontin, one of the most addictive prescription opioid drugs on the market. They’re a subject of many lawsuits and have been under Congressional investigation for their activities promoting opioid medications to doctors and other medical professionals. Many people say their company has made hundreds of millions of dollars fueling the addiction epidemic. However, the company has now started to dig into a new way to make money from the opioid epidemic. They’ve been quietly working to patent a new form of buprenorphine, a drug that is regularly used to help people get off of opioids.

What is Perdue’s New Addiction Medication?

In the recovery community, buprenorphine better known as a medication-assisted treatment when people take these drugs to stay clean. Perdue’s version is a “fast-acting” form of buprenorphine, which helps control drug cravings, according to CBS reported. While other versions of the drug are available in either tablet or dissolving strips, the Purdue version comes in a “wafer” that dissolves in only a few seconds.

 

More PR Efforts?

Richard Sackler, a member of Purdue’s board, is listed as one of the inventors on the new drug. The Sackler family, known for their philanthropy in the art world, controls Purdue Pharma and have made hundreds of millions of dollars off of Oxycontin and other opioids.

In the past few years, while Perdue has been mired in lawsuits, the company has also been trying to salvage their name/brand. They have offered grants to various state drug treatment programs. Last week, Purdue donated $3.4 million to the developer of an over-the-counter version of naloxone, an opioid-antagonist meant to reverse fatal overdoses. And the release of buprenorphine they are developing will be offered for free to some drug treatment programs for indigent clients.

 

The Bottom Line

Perdue Pharma is fighting over 1000 lawsuits across the US. They’re under heavy scrutiny and continue to be investigated by news organizations. They’ve often lead heavy-handed PR efforts and efforts to obfuscate their efforts to push more narcotic prescriptions. While the Sackler-owned Perdue has promised to stop marketing opioids to doctors, they’ve remained silent on a second opioid manufacturing company they own – making no promises about generics at all.

In the end, it’s about the bottom line. They will do what it takes to remain profitable, it seems. Hopefully, doctors will recognize the hypocrisy and choose a different version of buprenorphine for their clients.

 

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ACLU Sues to Help Man in Maine Get Medication-Assisted Treatment in Jail

medication assisted treatment

The ACLU is assisting a man from Caribou, Manie in suing for the right to continue his addiction treatment medication while he serves his upcoming jail sentence. If the lawsuit is successful, it will create a persuasive precedent and pave the way to create fundamental changes in how jails and prisons treat inmates with substance use disorders.

Zachary Smith, 30, filed his civil rights lawsuit in federal court Thursday against the Aroostook County Sheriff’s Office and Maine Department of Corrections. The current jail policy of prevents inmates from continuing their medication-assisted treatment, such as Suboxone or methadone, while incarcerated. The assumption seems to be that while in prison drugs and alcohol are unavailable, therefore, treatment isn’t needed. Most jails allow twelve-step meetings to be brought in from the outside and allow inmates to have sponsors and participate in these meetings. In most cases, access to treatment is limited, and few inmates have constant contact with the outside world. There are still plenty of drugs smuggled into these settings, which makes temptation run high.

In most jails and prisons, prisoners are deprived of their medication-assisted treatment. If on the drug while incarcerated, inmates most often go into withdrawal, which is physically painful and sometimes medically dangerous. Withdrawal symptoms such as sweats, mood swings, vomiting, and even seizures are commonly lived out in a cell. People in withdrawal usually aren’t even allowed to go to the jail clinic – causing addicts to seek relief wherever they can get it. People deprived of their medications are also highly likely to relapse upon release.

The complaint says that Smith’s medications “will cause him physical and psychological suffering, will expose him to heightened risk for other serious medical conditions and could trigger a relapse into active addiction, potentially resulting in overdose and death.”

The U.S. Department of Justice recently launched an investigation into whether Massachusetts prison officials are violating the law by denying prisoners’ medication-assisted treatment. The outcome of that case will impact many states, including Maine.

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Lucemyra: FDA Approves New Medication-Assisted Treatment

FDA approved Lucemyra

Lucemyra has been on the market in the UK to assist with opioid withdrawal symptoms for about twenty years, but its use in the US has only just been approved. The FDA cleared the drug last Wednesday via fast-track to give American doctors another tool for fighting the opioid epidemic.

Lucemyra alone is not to be considered treatment for opioid use disorder, the FDA says. However, clinical trials prove that it can reduce the severity of withdrawal symptoms that patients experience when they cease opioid use completely. This can give a person with an opioid use disorder a lifeline to help them get clean once and for all. Combined with therapy, 12-step programs and other tools, Lucemyra can help people find their way to recovery without the torment of many withdrawal symptoms.

FDA Commissioner Dr. Scott Gottlieb says that this makes the drug an important tool that warranted quick approval. “The physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction,” he said in a press release. “The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms.”

What is Opioid Withdrawal Like?

Opioid withdrawal can be intense and vary. People just getting off of opioids, when withdrawing rapidly, can be anxious, agitate, and experience a variety of mood swings. Physical symptoms include muscle aches, runny nose, sweating, nausea, vomiting, diarrhea. A person with an opioid use disorder will also experience strong cravings for their drug of choice.

For people who have merely been on opioids for a while, but not abusing their medication, doctors help them create a plan for tapering and lowing the amount of drug taken. However, this is dangerous in more than one way for a person with an opioid use disorder, and temptation is the major worry.

Clinical studies will be required to evaluate the safety of Lucemyra. Right now, the FDA only recommends that people take thedrug for a maximum of 14 days.

Are There Any Side Effects?

All drugs have potential side effects, and it’s up to you and your doctor to weigh the pros and cons of any medication-assisted treatment.

According to the FDA, Lucemyra can cause low blood pressure, slow heart rate, sleepiness, sedation and dizziness. There is a risk of abnormal heart rythmns. Some people have fainted when taking Lucemyra. Lucemyra has not been established in children or adolescents less than 17 years of age.

 

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Purdue Pharma “Fights Opioid Epidemic” – Too Little, Too Late?

Perdue pharma

Purdue Pharma is one of the largest opioid makers in the country and the subject of countless lawsuits in the past few years. They’ve received scrutiny over their choices to market and push Oxycontin on the doctors, and in February, they promised to stop actively marketing the drug. Now, this opioid maker is making efforts to help the people that are now addicted to their drugs. But is it just another PR campaign to mitigate the company’s bad reputation?

 

Critics say that all of this is “too little, too late.” Thousands have died from what even lawmakers say are irresponsible and maybe even illegal practices to push the drug. However, the dire consequences of opioid addiction make it so many localities can’t discriminate between funds. For many people addicted to opioids across the US, there simply isn’t enough help available. The federal government’s Opioid Commission is considered pretty much a “bust”, with lots of recommendations and few monetary resources to implement them. Many states are spending too much money simply on saving lives with tools such as the opioid-antagonist Naloxone. Budgets are tight in areas where the most vulnerable are finding addiction pervasive.

 

What Purdue Has Done to Help Fight Addiction

 

·      Purdue has partnered with the National Sheriffs’ Association to give free naloxone overdose-antidote kits and training to front-line officers. Total, the second phase of this program will allow total funding of the program up to $850,000 since its inception. 

 

·      They have funded pill disposal boxes in pharmacies, clinics and police stations in various states, including North Caroline.

 

·      They have run a radio campaign in Connecticut warning of the dangers of opioid abuse.

 

·      Lawsuits they have lost have inadvertently funded treatment for addiction in places like West Virginia, where the opioid epidemic is still raging. (This is inadvertant funding, but the settlements for lawsuits still help cities and states.)

 

Why People Aren’t Buying it

 

·      OxyContin sales dropped in recent years, from $2.8 billion in 2012 to $1.7 billion in 2017, with many competitive drugs on the market, especially generic drugs.

 

·      Purdue almost exclusively sells and manufactures various opioid drugs. They have only promised to quit marketing Oxycontin.

 

·      Alongside running ads warning about opioid abuse, they also have been marketing a new medicine to treat opioid-induced constipation, which is just another drug in their line of products.

 

·      In 2007, Purdue Pharma pleaded guilty in federal court to misleading doctors and patients about OxyContin’s risk of addiction and potential for abuse. They agreed to pay $600 million in fines, but did not stop marketing the drug until there was a nationwide outcry as the opioid crisis progressed.

 

·      The company press releases never use the words “addicted” or “addictive” in any statements or literature, preferring to use the words “use” and “abuse”, which minimizes the opioid crisis.

 

 

Purdue is far from the only bad actor in the addiction crisis, but they are certainly the most well-known and litigated against. There are lawsuits on the state level, county level, and city level across the country. Most recently, last week, Greenville County, South Carolina filed suit against several opioid manufacturers, including Perdue. The lawsuit accuses pharmaceutical manufacturers and distributors of participating in a “scheme to change prescriber habits and public perception.”

 

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Dr. Phil’s Addicted Guests Allegedly Exploited

Dr. Phil at the 1st Annual Merv Griffen/Beverly Hills Country Club Celebrity Tennis Classic to benefit ChildHelp USA, Beverly Hills Country Club, Beverly Hills, CA 09-21-02

Dr. Phil at the 1st Annual Merv Griffen/Beverly Hills Country Club Celebrity Tennis Classic to benefit ChildHelp USA, Beverly Hills Country Club, Beverly Hills, CA 09-21-02 via Yayimages.com

A little over a week ago, revelations that Dr. Phil exploited people with addiction disorders made its way all over the news, shocking addiction recovery advocates and dismaying many of the treatment centers and interventionists he frequently works with when staging interventions.

Several guests appearing on Phil McGraw’s talk show told of temptation in their green rooms, and drug offerings such as pills that “calm nerves,” casting doubt on his good intentions.

Guests that have appeared on his show are often left without a support system in place as they wait for their turn on the recorded show. For some, this means they are required to “detox” alone in a hotel room, without medical intervention, for up to 48 hours. By the time they arrive at the studio, many of them are physically and emotionally exhausted.

Experts say that this is because the show has partnerships with treatment centers in other states, who are not licensed to provide assistance in the state where Dr. Phil’s show is taped for television.

People coming to get help on the show don’t expect to find alcohol in their “green room” when they arrive, but, of course, it happens. In fact, one guest with an opioid use disorder described bringing his heroin, with the consent of Dr. Phil’s staff, according to a family member who spoke with reporters.

Another guest, who became a “frequent flyer” through Dr. Phil’s show, described how he compulsively downed a bottle of liquor once he landed comfortably in the green room. (The room came equipped with more than just a mini-bar, there were bottles of several favorite liquors for those who liked to drink.) Unfortunately, for this particular guest, alcohol was his drug of choice. He got wasted and later told friends and family he didn’t remember anything about the show itself.

The Real Issue is Addiction Treatment Access

For many people, desperation is what drove them to Dr. Phil’s shows in the first place. They were promised free drug treatment (if they agreed to go) at some of the most reputable (and expensive) treatment centers in the US.

One man with an alcohol use disorder went on the show three times– knowing that he would suffer from humiliation but also knowing that he just couldn’t afford treatment at all.

Addiction treatment centers are woefully underfunded, and there are few beds for people who don’t have the money or insurance to help pay. Funding is such an essential issue for addiction treatment advocates to continue to pursue in 2018 and beyond.

Dr. Phil’s show is just a symptom of what goes on when the government fails to address a public health crisis like the current opioid addiction crisis. Address the problem at the roots, and branches like the exploitation on television shows will fail to grow.

Treatment — especially quality, evidence-based addiction medicine is not accessible for many people, especially those who are vulnerable and come from the middle to lower-class households. Television has always proven itself to be a platform willing to exploit

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Sublocade, New Med FDA-Approved for Opioid Abuse Disorder

Subclocade once a month

Last week, the FDA announced approval of a once-a-month drug, Sublocade, for individuals with an opioid use disorder who need drug-assisted treatment to get and stay clean.

For people suffering from the opiate-related disorders, there are just a few options for drug-related therapy to help them reduce cravings and stay clean. Suboxone and methadone have been the most available forms, but each has its drawbacks, including the fact that methadone is regulated in a way that means it must usually be dispensed just a dosage at a time. Missing a dosage can cause awful withdrawal symptoms and cravings. Even something as simple as inclement weather such as snow can make it difficult for drug treatment clients to get the medication they need.

Suboxone has become popular because it has fewer drawbacks, with one of the main complaints being that a person prescribed the pill must be consistent with its dosage, taking it once a day, at the same time every day. This is why Sublocade, just approved by the FDA last week, offers hope to some addiction recovery professionals. It can help fill a treatment void for those who need it.

 

Why a Monthly Injection to Combat Addiction Cravings?

 

While not seen as a perfect drug, Sublocade can function as a new tool in the box for addiction professionals and medical providers to fight addiction. Patients with substance abuse disorders – as well as mental health disorders – may have difficulty with medication compliance for a number of reasons. People may think that they are “cured” or simply be too “busy” or overwhelmed in life to remember to take their pills like clockwork. And while it often goes unmentioned, this can lead to relapse when cravings set in.

Suboxone is a prescribed medicine that when used as directed can block early, mild withdrawal symptoms while blocking opiate receptors, which relieves painful opiate withdrawal symptoms. When a person misses a dose, however, they may get “sick” and experience immediate withdrawal symptoms. Some people don’t experience these symptoms immediately, but for others, the symptoms may be severe.

Sublocade is the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients. Prior to using the monthly dosage, the patient must have been on the regular Suboxone drug for 7 days without any ill effects.

Medication-assisted treatment does its job, but as the FDA has warned, it is most effective when used with other treatment modes, such as therapy and 12-step programs.

Daily Suboxone treatment, also known as buprenorphine, is usually taken as a tablet or film that dissolves in the mouth. It is also available as an implant under the brand name Probuphine.

 

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Insurance Giant Cigna to Halt Coverage for Oxycontin

Cigna health insurance, the fourth largest insurer in the US company with over 11,400,000 members, has taken what is seen as a drastic step in the fight against opioid addiction. Effective in January, the insurance giant will effectively stop covering the cost of use of the opioid OxyContin.

While many in the addiction treatment profession have lauded this change, it’s important to look more carefully at what’s really going on. At the same time that Cigna announced they would no longer be providing coverage for Oxycontin, the company also announced a contract to continue covering a competing oxycodone alternative by the name of Xtampza ER. The contract includes a financial penalty on that drug’s maker if Cigna discovers the drug is overprescribed or there are other patterns indicating the drug has become a drug of abuse. Because of this stipulation, the manufacturer also has more motivation to monitor sales and look for areas of abuse and high prescription rates.

Cigna’s announcement comes just a year after the insurer said it intended to cut opioid use among its customers by 25% by 2019. Out of 33,000 opioid-related deaths in 2015, nearly half are attributed to Oxycontin or similar formularies, according to the CDC. (The remaining are attributed to heroin or to fentanyl, a synthetic opioid)

OxyContin is the only opioid-based prescription painkiller that Cigna is removing in 2018 from its formulary. (A formulary is the list of medications that an insurer will cover for its members.) Cigna will review individual prescriptions for OxyContin on a case-by-case basis, but people with terminal diseases will be able to continue taking it.

Will Cigna’s Actions Reduce Opiate Abuse?

So while this announcement sounds like a big move in taking drugs off the market, it appears to be more of a punishment for the manufacturers. A spokesman for Purdue Pharma, the Connecticut company that makes OxyContin, says that the drugs are pretty much the same in makeup, although Jon Maesner, Cigna’s chief pharmacy officer, insists that the insurer is “not specifically singling out Oxycontin.”

However, it appears trust is a central issue. “We found a strong sense of commitment” to reducing opioid overuse from Collegium Pharmaceuticals, the maker of the oxycodone drug that Cigna plans to cover instead. Purdue Pharma is currently facing dozens of lawsuits from cities, counties, and states across the US, all of them alleging that the drug makers cared more about profits and misled users and doctors about their addictive nature.

The contract with a new manufacturer helps create a relationship that makes drug makers more accountable to others involved in pain medicine. This is a great beginning for insurers who want to protect their patients.

However, there are literally dozens of other opioid and opiate drugs on the market, and many of them have yet to answer for their own part in creating the addiction epidemic. Until all of the “shady” pharma companies are held to account, there will be more pills mills and rampant addiction waiting in the shadows of this under-regulated industry.

 

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Addiction Treatment Under AHCA

Five hundred thousand Americans have died from opioid addiction in the last 15 years According the U.S. Centers for Disease Control and Prevention (CDC). The amount of deaths is four times that of the previous fifteen years. This an American crisis of addiction to opioids and the problem is only getting worse.  Because of this increase in use of opioids the issue has made it’s way into the forefront of American policy.

Financial Dilemma

Meanwhile, with the growing number of addicts, the availability of resources for recovery become less attainable and more costly. This creates a new financial dilemma that is hanging over the heads of the addicts in our communities and puts  pressure onto the policy makers in government.

Lack of Coverage

The severity of these issues then brings into question the Trump Era’s health care policies and his team’s ability to confront this epidemic. The forecast is grim considering this new administration’s policy towards the healthcare of Americans. There is a substantial lack of coverage for people with pre-existing conditions and many addicts will fall into this category.

Losing Obamacare

The new policy has yet to be made into law as it still needs senate approval. Addicts most likely will fall under pre-existing condition clauses and will not be afforded the addiction recovery resources as was seen under Obamacare.  Treatment for this epidemic will dwindle leaving tens of thousands of American opioid dependent people untreated and the death toll will continue to go up.

Donald Trump has acknowledged America’s problem with opioids and hired New Jersey’s Governor Chris Christie to lead a commission on the opioid problem in the US.  However this appointment does very little to ease the concerns of the medical community.

How the insurers will approach the new system of healthcare is the big question. It is important to have a clear understanding of the actual monetary costs required for the the treatment of opioid addiction.

Estimated Cost for Treatment 2017

  • Methadone            $600 to $800       annually
  • Buorenorphine     $400 to $600       annually
  • Vivitrol                   $1000                     monthly
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Pros and Cons of Bunavail Approved by FDA

Pros

  •  Twice the bioavailability of Suboxone

    teen on pills then heroin

    Pills Lead to Heroin All Too Often

  •  Promising alternative to methadone
  •  Treatment includes psychiatric therapy

Cons

  • Causes respiratory issues
  • Can cause death

Bio Delivery Sciences International’s new drug application has reached the final phase of approval by the FDA. Their supplemental application (sNDA) for Bunavail can step out of the management phase for opioid addiction patients and begin the use of the drug for treatment of opioid addiction.

Bunavail has twice the bioavailability of Suboxone film, which has increased it’s marketability ten fold and and therefore an attractive alternative for bottom line of the manufactures.

 

Bioavailability –  the proportion of a drug or other substance that enters the circulation when introduced into the body. When a drug is injected it has 100% bioavailability. Other means of administration have less than 100% bioavailability such as oral methods.

Bunavail will be administered to patients that are just beginning recovery from opioid dependency. This is a major step in the right direction for the addicts who seek a break from dependency that may have otherwise not found relief from transitional drugs like Methadone.

The company offers a comprehensive package of recovery support through counselling and psychiatric therapy along with administering of Bunavail.  The advantages are promising for the recovering addicts  and it will be a shift in the methods used by the pharmaceutical community via the melding of medication and hands on personal analysis.

Some Drawbacks

There are still drawbacks of Bunavail, which as promising as it could be it has stirred some speculation.  It has been shown to affect respiratory function and in some cases death by overdose through the synergistic effects when combined with benzodiazepines, various tranquillizers and or alcohol.  As well withdrawal symptoms similar to that of heroin are seen with the decreasing dose.

Withdrawal issues are not unfamiliar to this family of drugs and can be controlled through proper dose. The most common of the side effects are the withdrawal symptoms in the form of headaches, fatigue and inability to sleep.  Sweating and constipation have both been noted in the studies and do raise concerns when considering the cost benefit analysis of Bunavail.

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Narcan (Naloxone) Becoming a Life Saving Option for Police to Use

While calling Narcan (the brand name for active ingredient naloxone) an “antidote” to heroin isn’t quite accurate, the reality that the drug can be dispensed via a nasal spray in order to revive a drug user who is dying of overdose certainly give the impression that it is a miracle elixir out of a movie.

Recent articles from The Greenville Sun and and the Idaho Press highlight how police officers in Tusculum (Tennessee) and Nampa (Idaho) have been trained in administering the potentially life saving concoction.

This is emblematic of the full blown health crisis that opiate addiction and overdose now represents in the United States.

The United states contains 5% of the total world population yet consumes 80% of the world’s narcotic medications. The Center for Disease Control (CDC) has gone on record as describing the opiate addiction and overdose epidemic as a “full blown health crisis.”

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