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The Justice Department Claims that Drugmaker Indivior Lied About Popular Opioid Treatment

The Justice Department Claims that Drugmaker Indivior Lied About Popular Opioid Treatment

If you’ve been following the news lately, then you’ve probably read some unsettling news. The Justice Department has recently brought charges against Indivior, the maker of Suboxone. There’s a lot of disagreements against whether Suboxone, the popular opioid treatment, actually works. This opioid treatment is currently being used by many doctors and rehab centers to treat opioid addiction. These charges come just as the government has been taking legal action against many opioid drugmakers. Many people believe that prescription opioids and opioid treatment have been driving the rise in addiction rates and have become a huge contributor to the nation’s opioid epidemic. Let’s break down what charges are being made against Indivior and the company’s statement.

“Get your loved one the help they need. Our substance use disorder program accepts many health insurance plans, this is our residential program.”

The Charges Against Indivior

On April 9, 2019, a grand jury in Virginia accused Indivior of conducting an illicit scheme to drive Suboxone sales. Prosecutors have charged Indivior with both fraud and conspiracy. They claim that the drug is prone to abuse and that Indivior not only did nothing to stop the abuse but actually misled the medical community in order to drive sales. The Department of Justice (DoJ) is currently demanding Indivior to pay up at least $3 billion in fines. This is shocking, as the company only has a market value of £202 million. This paints a bleak picture of the company’s future. According to the indictment, Indivior made numerous claims of the efficacy of Suboxone without any scientific evidence to support those claims. The DoJ has also claimed that Indivior deceived and intentionally misled health care providers into believing that Suboxone Film was a safer and less divertible option. Indivior also made it seem as if Suboxone Film was less abusable. All of these claims are false according to the prosecutors. They further claim that the company used a “Here to Help Program” to further drive up their sales. This scheme encouraged physicians to prescribe Suboxone Film. They used this program to connect patients with doctors who prescribed their product. They also encouraged physicians to prescribe a higher dose than allowed and in “suspicious circumstances”. “Indivior promoted [Suboxone] with a disregard for the truth about its safety and despite known risks of diversion and abuse.” ~ Assistant Attorney General Jody Hunt Prosecutors claim that Indivior’s malicious actions have led it to become a huge contributor to the nation’s opioid epidemic.

Brian Mann, a reporter with North Country Public Radio, has been following the opioid crisis and this case. Here’s a recording of an interview that he recently had about the situation:

Understanding the Opioid Epidemic

The Justice Department’s charges are coming at a time when the opioid epidemic has spiraled out of control. Many Americans are addicted to either prescription opioids, like Oxycodone, or illicit opioids like heroin. The opioid crisis America is facing first started off with doctors overprescribing prescription opioids. Many doctors were misled on the potential of abuse for these drugs. As more and more Americans took these opioids, they realized that these prescription medications were a lot more addictive than claimed. Those who were addicted to prescription painkillers switched to heroin when they no longer had access to the drugs that they needed. 80% of heroin users first started off abusing and misusing prescription pain pills. Nowadays, the opioid epidemic has only continued to spiral even more out of control. Here’s a look at some current statistics:

  • More than 72,000 Americans died from an opioid-related overdose in 2017. That’s more than 8 people every hour, or, basically, someone every 8 minutes. Opioid-related overdose deaths have now surpassed car accident deaths in America.
  • 6.2 billion hydrocodone pills and 5 billion oxycodone tablets were distributed in 2016. According to the International Narcotics Control Board, America consumed 99.7% of the world’s hydrocodone supply in 2015.
  • 11.4 million Americans misused and abused prescription painkillers in 2016 and 2017. About 886,000 abused heroin during this time as well.
  • Heroin overdose deaths increased by 533% between 2002 and 2016. There were only about 2,089 heroin-related overdose deaths in 2002. This number jumped to 13,219 in 2016.

It’s evident that the opioid crisis is only getting worse. Those who are addicted to opioids are not getting the help that they need. With the latest charges made against Indivior, it’s believed that opioid addiction treatment is making the situation worse.

What Will Compensation Go Towards?

The DoJ is asking for $3 billion in compensation from Indivior. That’s a fairly large sum of money. However, it may not even come close to combatting the large economic costs that come with the opioid crisis. This compensation will largely go towards things like:

  • Ensuring that current addicts have access to the addiction treatment that they need. Many opioid detox and rehab programs offered by addiction treatment centers have fairly high success rates. These programs not only use opioid addiction treatment to help ease withdrawal symptoms, but they also offer other evidence-based treatment approaches that help treat psychological symptoms and underlying issues as well.
  • Researching further ways to combat the opioid epidemic. This includes different medications that may actually work, as well as the type of therapies that have the largest success. Knowing what works and what doesn’t is key to overcoming the nation’s addiction to opioids.
  • Looking into other options for prescription opioids. It’s important for health care providers to come up with other solutions for relieving pain. If we continue to prescribe prescription opioids and opiates, the situation will not get better.
  • Raising awareness. In order for people to understand the dangers of opioids and opiates, the government must create campaigns that raise awareness of this issue. Drug education is vital.
  • Creating preventative campaigns and programs. Preventing people from getting addicted will also help lower opioid addiction rates.

The compensation can go towards many different initiatives and campaigns. Unfortunately, the economic burden of prescription opioid misuse is approximately $78.5 billion each year. The $3 billion in compensation that the DoJ is asking for is merely a drop in the bucket.

A Look at Indivior

Indivior calls itself a world leader in addiction treatment. It has over 20 years of experience in this area and is mainly a drugmaker of Suboxone Film. This company is listed in London, but its headquarters are located in the US. The company claims that it first started off by trying to understand the journey of substance abusers. Their goal is to remove any stereotype or negative stigma that comes with getting help. Since its inception, Indivior has actively sought out partnerships with healthcare professionals and policymakers. They want to humanize people suffering from addiction and want to revolutionize the way that the medical community treats addicts. Nowadays, Indivior has expanded into more than 40 countries. Before the market collapse, Indivior generated £1.01 billion in revenue each year. It had a market capitalization of approximately £257.19 million. Indivior actually branched away from Reckitt Benckiser in 2014. Founded in 1999, Reckitt Benckiser is a British multinational consumer goods company that produces health, hygiene, and home products. Its headquarter is located in Slough England. There’s a good chance that Reckitt Benckiser will also face some financial losses from this lawsuit.

Indivior’s Global Presence

Indivior mainly produces four products: Suboxone Film, Suboxone tablet, Subutex tablet, and Sublocade injection. It has a global presence. All four products are not distributed and sold in America. In fact, Indivior only sells Suboxone Film and Sublocade Injection in the US. Sublocade Injections were approved by the FDA on November 30, 2017, while Suboxone Film was approved by the FDA in August 2010.

Indivior’s Statement and Rebuttal

“We are extremely disappointed in this action by the Justice Department, which is wholly unsupported by either the facts or the law. Key allegations made by the Justice Department are contradicted by the government’s own scientific agencies, they are almost exclusively based on years-old events from before Indivior became an independent company in 2014, and they are wrong. The department has apparently decided it would rather pursue self-serving headlines on a matter of national significance than achieve an appropriate resolution, but we will contest this case vigorously and we look forward to the full facts coming out in court.” Indivior has not sat quietly on the sidelines while these charges were laid against them. On the same day, Indivior released an 8-page rebuttal to defend its actions. Indivior claims that its top priority has always been to treat patients struggling with opioid use disorders (OUD). The rebuttal also further claims that Indivior:

  • Does not make pain pills in the US, and is not a contributor to the nation’s rising opioid crisis
  • Conducts around 75% of all private research into opioid addiction, and has done more than any other company in fighting the opioid crisis
  • Has never deliberately diverted is products and have even designed a process to identify concerning prescribers, which is going beyond what the law requires
  • Engaged in extensive education campaigns to teach doctors about Suboxone dosing limits and patient caps
  • Has reported the conduct of multiple doctors to the appropriate authorities even when it has no legal obligation to do so; the Drug Enforcement Agency (DEA) informed the company’s risk manager that they would not be taking any action against these health care providers
  • Creates packages and dosing methods that are difficult to abuse
  • Has lowered pediatric exposure by 65% by using unit-dose packaging
  • Has cooperated extensively with the Department of Justice over many years
  • Has set a maintenance dose from 4 mg to 24 mg of buprenorphine a day with a recommended target dose of 16mg despite the Substance Abuse and Mental Health Services Administration (SAMHSA) advising prescribers to offer a dose up to 32 mg
  • Has conducted extensive research that proves that a dose of less than 16 mg a day may not stop opioid cravings for some patients

Indivior claims that it has a lot of evidence supporting its claims. Its rebuttal outlines many studies and research that back up their mission.

The Aftermath of these Charges

Regardless of who is right and who is wrong, the aftermath of these claims has caused Indivior to lose quite a lot of support. Their stocks have spiraled in the past couple of days and have lost approximately 70% in value. As of April 13, 2019, Indivior (INDV:LN) is worth about £35.23. This is a far cry from the £106 that it was worth less than 4 days ago on April 9, 2019. So, what does this mean for Indivior and its future? If you’ve followed Purdue Pharma’s lawsuits and recent $270 million settlement, then you know that this huge company is already publicly discussing the option of bankruptcy. Many people believe that Indivior is also heading towards this route. At the very least, the company’s financial state is now muddled. The company value has dropped to £202 million. Public confidence in Indivior has crashed, and not many people are willing to invest in or believe in the company any longer. It has taken a huge hit, and it will likely be difficult for Indivior to recover from this loss.

About Suboxone Film

Suboxone Film is a prescription opioid addiction treatment that contains both buprenorphine and naloxone. This medication can be used to treat an addiction to both opioids and opiates. It should be used as part of a complete treatment plan. A comprehensive treatment program should include psychosocial support, counseling, drug education, behavioral therapy and other types of therapies. Suboxone Film use should only be initiated by licensed health care providers. The treatment should only begin under the supervision of a licensed provider. Patients should also have follow-up visits at reasonable intervals if they continue treatment at home.

How Is Suboxone Film Administered? And, How Does It Work?

Unlike Suboxone tablets, Suboxone Film is intended for administration under the tongue or inside the cheek. This medication comes in four different dosage strengths. The film will dissolve and the buprenorphine will travel through the bloodstream to the brain. There, it will attach to mu opioid receptors. As Suboxone has a stronger affinity to these receptors that full opioid agonists, like morphine, heroin, and hydrocodone, it will bind first and stay there. This way, other opioids cannot and will not have an effect on the body.

“We treat both addiction and co-occurring disorders and accept many health insurance plans. Take a look at our inpatient program.”

A More In-Depth Look at the Ingredients

Suboxone contains both buprenorphine and naloxone. If you’ve been following the opioid crisis, you’re probably already familiar with these two ingredients. If not, let’s take a more in-depth look at them below:

  • Buprenorphine. This is a partial agonist. It is able to reduce the effects of other opioids by binding to mu opioid receptors in the central nervous system (CNS) first. Buprenorphine comes with a “ceiling effect”, which means that it will not continue to stimulate the receptors after a certain dosage. This helps reduce the potential for abuse of this substance.
  • Naloxone. This is an opioid antagonist. It’s different from an agonist, as it blocks the mu opioid receptors and prevents them from getting activated.

Both of these ingredients are potent and strong. They also come with potential side effects. Those who are interested in taking Suboxone Film must first discuss the pros and cons of this drug with their physician. Suboxone Film may not be appropriate or suitable for everyone.

The Dangers of Suboxone

Even before this lawsuit was laid against Indivior, there has been a lot of concern surrounding this drug. The National Pain Report has previously claimed that Suboxone is also a frequently abused prescription drug. These reports claim that Suboxone only further spirals the opioid epidemic by allowing addicts to use Suboxone to ease withdrawal symptoms between periods of abuse. This allows opioid abusers to take breaks from their addiction without experiencing any physical consequences associated with withdrawal. These reports also claim that some people take higher doses of Suboxone in order to get high. This significantly increases their risk of overdose. These reports claim that the statistics match up with their theories, as Suboxone sales continue to climb. The Center for Substance Abuse Research (CESAR) found that Suboxone sales grew 10 times from 2006 to 2012. Suboxone is not only sold in pharmacies. Many people are also finding this drug on the black market. Many drug dealers now give their clients an option between heroin and Suboxone.

Overdose Deaths Caused by Suboxone

Suboxone is not as safe as most people would like to believe. This prescription drug is, in fact, responsible for a fair amount of overdose deaths. In 2011, 27 people in Florida died from buprenorphine use. This number is incredibly high, especially when you consider the fact that only 62 people died from heroin use. This number also outlines an alarming upward overdose trend, as only 6 people died from a buprenorphine overdose in 2009. Many experts have also noted that these numbers may not be entirely accurate. They may underestimate the actual toll that buprenorphine has on the community. This is because most medical examiners do not routinely test for this drug. Due to this reason, not many people know the exact impact that this drug has on the community.

Other Opioid Addiction Treatment Medications

Fortunately, there are other opioid addiction treatment medications that can be used to treat an addiction to opioids and opiates. Some other popular types of medication-assisted treatment for opioid addictions include:

  • Methadone. This is a full opioid agonist, so it works in the same way as heroin and other strong opioids. This medication stimulates opioid receptors, so the intensity of withdrawal symptoms are greatly reduced. The only issue with methadone is that it has a high potential for abuse as well. It’s easy to develop a secondary addiction to this drug.
  • Vivitrol or naltrexone. This is an opioid antagonist, which means that it blocks opioid receptors and prevents them from being simulated. This medication is administered as a once-a-month injection, so it is difficult to abuse. Vivitrol is neither a narcotic nor an addictive substance. The only issue is that addicts must be free of opioids or alcohol for at least 7 days before they can take this medication.
  • Lofexidine, also known as Lucemyra. This is a new type of opioid addiction treatment medication. It is a non-opioid and it is also not addictive. There is a lot of hype surrounding this medication. Many people believe that this medication will be a turning point in the opioid epidemic. It treats opioid withdrawal symptoms without any side effects.

Medical detox programs may use a large assortment of medications. Some addiction treatment centers may use benzodiazepines or over-the-counter medications to ease specific withdrawal symptoms. It all depends on the patient, as well as the intensity and severity of his or her withdrawal symptoms. Each patient will need something different.

“We accept many health insurance plans. Get your life back in order, take a look at our residential program.”

How to Treat an Addiction to Suboxone

Let’s say that your opioid addiction has now become an addiction to Suboxone. What do you do when you become addicted to your treatment? Fortunately, there are drug addiction treatment programs out there that deal with Suboxone abuse and addiction. These substance abuse treatment programs usually include evidence-based treatment approaches like:

  • Detox. This usually means that patients will slowly taper off Suboxone in a controlled and comfortable environment. They may receive certain medications to fend off intense withdrawal symptoms.
  • Therapy. Both behavioral and emotional counseling are key to learning more about each patient’s triggers. Patients will also take this opportunity to explore their motivations for getting sober.
  • Peer support groups and recovery meetings. Studies show that going to support groups can help many patients stick with their treatment plan. Recovery meetings keep patients accountable for their own actions and allow them to receive further guidance from other people who have been in their shoes.
  • Continuing care. Relapse prevention plans encourage abstinence. They also keep patients motivated.

Those who are addicted to Suboxone will need to acquire an arsenal of tools and skills that prevent them from relapsing. Recovery is possible with the right motivation and help.

What Are Your Thoughts?

As of right now, both sides are arguing back and forth. The Justice Department claims that Indivior lied and claims that they have proof. On the other hand, Indivior claims that they have solid evidence backing their claims as well. No one really knows how this lawsuit is going to turn out.

What are your thoughts on the matter? Has Suboxone helped you overcome an opioid addiction? Or, has it made your condition worse? Let us know in the comments below!