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Is Indivior Drug a Revolutionary Opioid Treatment or the Next Suboxone?

Is Indivior Drug a Revolutionary Opioid Treatment or the Next Suboxone?

While the nation is still struggling to find the right strategy to climb out of the opioid crisis in U.S. it seems many are holding onto the idea that Big Pharma is going to save us from the destruction they helped create. While we can agree that evidence-based medical assistance in recovery is a useful tool, some seem to think that the only fix for a pill problem is more pills, or in this case, more needles.

Just recently, after President Trump declared the opioid crisis a “National Health Emergency”, the advisory committee to the U.S. Food and Drug Administration (FDA) voted 18-1 that a new injectable drug called RBP-6000 could benefit addicts and the lower of two doses studied had an “acceptable” safety profile.

So what does this mean for the opioid epidemic efforts? Is Indivior a miracle injection that is going to make the epidemic more manageable, or is it another kind of Methadone or Suboxone that is just keeping people hooked?

What is RBP-6000?

For a little background, RBP-6000 is an experimental drug designed to help fight America’s growing opioid addiction crisis. It is described as a sustained-release buprenorphine. It is designed to be delivered once a month as a subcutaneous injection. The compound solidified once in contact with bodily fluids and releases buprenorphine over time.

If approved, it will be the first monthly injectable buprenorphine treatment. When creating the drug the manufacturers studied two dosing regimens.

In one, 300 milligrams were given once a month for six months.

In the other, two doses of 300 milligrams were followed by four doses of 100 milligrams.

According to reports, there was only a minute difference in effectiveness between the two doses, and they drug company acknowledge that the higher dose of RBP-6000 caused more side effects. Looking closely into some of the reports from the research, some side-effects include:

  • Headache

  • Constipation

  • Nausea

  • Injection site pruritus

  • Vomiting

  • Insomnia

  • Upper respiratory tract infection

While these side effects were not noted in an extremely high percentage of those tested, they are still relevant to consider until there is more extensive data available. So far, the report says the safety profile is consistent with that of Suboxone.

So RBP-6000 is like Suboxone using the delivery of Vivitrol; another injectable drug used to try and block the effects of opioids.

Big Pharma Making Big Moves

This is one sign of how Big Pharma is stepping in to make a buck off of the opioid epidemic yet again.

Indivior is the company behind RBP-6000. It was originally part of Reckitt Benckiser as the Buprenorphine division but has since split off to be a specialty pharmaceutical company. Indivior already sells Suboxone Film, a product which combines buprenorphine and naloxone. Suboxone is a maintenance drug widely used in America to try and curb the effects of opioid addiction and withdrawal, but Suboxone is known to have its own side-effects and withdrawals. Some even attest that Suboxone is itself addictive and very difficult to get off of.

Two months ago the share prices for Indivior took a deep hit after a U.S. court ruling clearing the way for a generic rival to Suboxone Film. So, with new competition on the way in the Suboxone market, Indivior put a renewed focus on another maintenance drug to bring to market.

Some analysts already expect that RBP-6000 could capture around 30% of the broader buprenorphine market. Some believe this new form of injectable buprenorphine could generate annual sales of around $700 million by 2021.

Jefferies sees potential sales of $1.3 billion by 2025.

So now the push for this new drug is boosting its sales prospects as competitors threaten revenues from Suboxone sales.

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Waiting for FDA Final Ruling

This endorsement on behalf of RBP-6000 comes less than a week after FDA Commissioner Scott Gottlieb announced the agency’s plans to promote extensive use among opioid addicts of less harmful opioids such as methadone and buprenorphine, the active ingredient in RBP-6000.

However, some of the FDA panelists still would like to see more data about which patients should be given the higher dose. Other panelists say they would like to have it available, even though they lack of data supporting any additional benefit of higher doses. So even though the drug is shown to have side-effects in higher doses, and there is limited information on how these side-effects impact the individual, the FDA is considering to let this drug pass the grade.

The FDA’s decision is set to be made by November 30th, although typically the agency follows the recommendations of its advisory panels. So it may very well already be a done deal.

Why It Matters

Again, with respect to the importance of offering alternatives to particularly dangerous opioids like heroin or fentanyl. It is important to have resources for the purpose of preserving of life. Keeping people alive long enough to get help is crucial. But we also have to see that this is not a miracle cure.

Methadone, Suboxone, and Vivitrol may serve a purpose for some in a certain capacity. However, these drugs are not an adequate substitute for comprehensive addiction treatment. Each one of these methods should be accompanied by a holistic treatment plan that addresses all aspect of addiction, including emotional and mental health.

Drugs like RBP-6000 may help subdue the more serious symptoms from the physical side of addiction, but they can also present their own risks.

It is important to offer safe medical assistance, but we have to remember that these Big Pharma companies are not selling us instant cures to opioid addiction. This isn’t even the first time we have seen a new drug come out to try and treat the opioid problem from companies that are closely related or directly responsible for narcotic medications that helped fuel the issue.

Remember, there is not a quick fix for this problem. We cannot prescribe our way out of the problem. It is going to take better treatment resources beyond more medications.

Drugs like RBP-6000 from Indivior are not necessarily a bad thing, but they also may not be the kind of treatment people should focus on. Instead, there are safe medical treatment options that offer holistic resources and mental health services. A lasting recovery begins with effective treatment. If you or someone you love is struggling, please call toll-free now.

 CALL NOW 1-888-922-5398

Racketeering for Fentanyl: Opioid Maker Insys Founder Arrested for Bribes

Big Pharma Founder of Insys Arrested on Racketeering for Fentanyl

In December of 2016, the Palm Partners Recovery Center blog covered a story about how federal prosecutors were bringing racketeering charges against several employees of Insys Therapeutics Inc. The initial report and the controversy that followed was a profound moment considering criminal charges are rarely ever brought against pharmaceutical companies. Now it seems that even more the corporate drug dealers who helped create the opioid crisis in America are going to be finding themselves under serious scrutiny for their unethical practices.

Last week President Trump declared the opioid epidemic a public health emergency. That very same day, as if to accent the severity of the crisis and the unignorable need for change, the co-founder of Insys Therapeutics Inc. himself was arrested on fraud and racketeering charges.

Insys Therapeutics CEO Taking a Fall

John Kapoor is the former CEO of Insys Therapeutics; a founding father of one of the most prominent opioid manufacturing companies in America. As of last week, Kapoor is reported to be charged with conspiring to push the company’s signature drug for unacceptable uses through a series of bribes and kickbacks.

The drug Kapoor and his company are accused of pushing just happens to be one of the most dangerous opioids on the market, which has contributed to countless deaths across the country over the years- fentanyl.

The brand name for the product made by Insys Therapeutics Inc is Subsys. This extremely potent compound transmits the synthetic opioid fentanyl in spray form. As an opioid analgesic, people use Subsys by spraying it under the tongue for quick absorption of potent fentanyl. Technically, this drug is supposed to only be used for treating cancer patients suffering from severe pain. But according to prosecutors that is very far from the sales strategy Kapoor and his executives were using.

With recent reports showing that approximately 64,000 Americans died last year from drug overdose, and an estimated 20,100 overdose deaths linked to synthetic opioids like fentanyl, how many of those lives were impacted by the drug Insys forced onto the market with bribes?

According to the prosecution, Kapoor and several other former high-ranking executives at the company colluded to bribe doctors to write-

“- large numbers of prescriptions for the patients, most of whom were not diagnosed with cancer.”

They also allegedly-

“- conspired to mislead and defraud health insurance providers who were reluctant to approve payment for the drug when it was prescribed for non-cancer patients.”

How did they do all this?

The Insidious Work of  Insys Therapeutics Inc

Back in 2016, there was the discussion of six former executives and sales-managers from Insys Therapeutics Inc. being arrested. The charges, according to the Justice Department, included:

  • Conspiring to defraud health insurers
  • Conspiring to bribe doctors into needlessly prescribing Subsys, the company’s fentanyl painkiller

The scam is allegedly a long list of kickback schemes, sham speaking programs, and illegitimate gifts or services.

Sham Speaking

Allegedly, doctors and nurses were paid to attend dinners at high-end restaurants. These dinners were disguised as ‘speaker programs’ that were actually described as gatherings of friends and co-workers who had no power to prescribe medications. Supposed ‘speakers’ were paid fees of up to several thousand dollars for attending these exclusive outings.

One healthcare provider reportedly received an illegal kickback to the tune of $83,000!

All of this money to bribe doctors and other healthcare professionals to prescribe Subsys, even when inappropriate. So not only were they pressuring doctors to use their product over alternatives, but also to prescribe a dangerous and potentially fatal opioid to people who didn’t even need it.

Country-Wide Con-Artists

Other stories written about in Forbes include cases in:

  • Connecticut

In 2015 a nurse practitioner pleaded guilty to violating a federal anti-kickback statute by taking money from Insys to prescribe the drug to Medicare patients who did not have cancer.

  • Alabama

A former Insys sales representative also pleaded guilty to a conspiracy to violate the anti-kickback statute by paying two doctors to prescribe the drug.

  • Illinois

The state has filed multiple claims against Insys Therapeutics involving the pressuring prescriptions of Subsys for unapproved uses.

Doctors who have worked with the company are being investigated by states including:

  • New York

  • Michigan

  • Florida

  • Kansas

  • New Hampshire

  • Rhode Island

U.S. attorneys in the Central District of California and the District of Massachusetts are also investigating Insys Therapeutics Inc.

Shady Gifts and Services

The buck doesn’t stop there either. It wasn’t just cash gifts for unethical practices. Insys Therapeutics wanted their partners in crime to get the full effect of their illicit activities.

The company would send its own employees to work in doctor’s offices when the physician prescribed their fentanyl fuming drug to patients. They even hired the relatives of health care providers as a favor to the family for their loyalty to Subsys.

Insurance Fraud

They allegedly even set up a portion of their staff to defraud insurance companies by calling to speak with insurance representatives while posing as doctors. Some allegations state they were even misrepresenting a patients diagnosis to inflate drug sales.

A December of 2016 indictment states that Insys actively worked to defraud insurance companies by setting up the “reimbursement unit” dedicated to obtaining prior authorization from insurers and pharmacy benefit managers.

Other Insys Therapeutics Exes

Kapoor stepped down as chief executive in January. However, he is definitely not the only former Insys Therapeutics executive currently under fire. This is just the tip of a very rocky ice-berg. The indictment from 2016 included:

  1. Michael L. Babich

Former CEO and President of the company from Scottsdale, Arizona

  1. Alec Burlakoff

Former Vice President of Sales from Charlotte, North Carolina

  1. Richard M. Simon

Former National Director of Sales from Seal Beach, California

  1. Sunrise Lee

Former Regional Sales Director from Bryant City, Michigan

  1. Joseph A. Rowan

Former Regional Sales Director from Panama City, Florida

  1. Michael J. Gurry

Former Vice President of Managed Markets from Scottsdale, Arizona

On January 5, 2017, all of these defendants appeared in federal court for their initial appearance and arraignment. Each has pled not guilty and been released on conditions approved by the court.  A Status Conference hearing followed on September 12, 2017 that is the first of many to be held over several months. That day Massachusetts federal judge set a trial date for October 15, 2018, for the 6 executives.

For now, we have to wait and see if any of the dirty laundries from these alleged white-collar criminals come out in the wash.

Holding Big Pharma Accountable

For a long time, Big Pharma companies have been using unlawful and corrupt tactics for marketing and distribution, which many now see has brought with it some great devastation to communities across the nation. Now, during an opioid crisis that has claimed tens of thousands of lives a year, for several years, these discretions are finally catching up to those accused of corporate greed. The DEA, FBI and Justice Department, along with several state officials and district attorneys, are now aggressively pursuing charges against Big Pharma operators who have a connection to some of the most dangerous and widely abused narcotics on the market.

The acting U.S. Attorney William D. Weinreb said in a statement,

“In the midst of a nationwide opioid epidemic that has reached crisis proportions, Mr. Kapoor and his company stand accused of bribing doctors to overprescribe a potent opioid and committing fraud on insurance companies solely for profit.

“Today’s arrest and charges reflect our ongoing efforts to attack the opioid crisis from all angles,”

Kapoor was arrested in Arizona and his indictment was filed in federal court in Boston. Prosecutors say the charge of conspiracy to violate the anti-kickback law carries the possibility of up to five years in prison. However, the charges of conspiracy to commit racketeering and conspiracy to commit mail and wire fraud each carry a maximum sentence of up to 20 years in prison. Needless to say, Mr. Kapoor is in for a fight.

But many are still wondering if these executives will truly be held accountable? And truthfully, is it even enough at this point? Even if proven to be indirectly contributing to the opioid epidemic, how could anyone ever know how many lives were damaged or lost because the powerful played around with lethal prescription drugs to line their pockets?

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With recent reports showing that approximately 64,000 Americans died last year from drug overdose, and an estimated 20,100 overdose deaths linked to synthetic opioids like fentanyl, how many of those lives were impacted by drugs like Subsys being forced onto the market with bribes?

More needs to be done to stop Big Pharma companies like Insys Therapeutics Inc from exploiting the system and putting the lives of millions of Americans at risk. And not just the middle-men should be accountable, but also those sitting comfortably at the top these industries. At least this is a start. But for the individual, it all starts with taking action. Getting safe and effective treatment can not just save a life, but help someone build a foundation for a better one. If you or someone you love is struggling, please call toll-free now. We want to help. 

 CALL NOW 1-888-922-5398

Addictive Opana Pulled From Market After FDA Confronts Abuse

Addictive Opana Pulled From Market After FDA Confronts Abuse

Oxymorphone is a powerful semi-synthetic opioid analgesic developed in Germany back in 1914. Since the painkiller’s introduction into the medical world it has gone by many brand names, such as:

  • Numorphan (suppository and injectable solution)

  • Opana ER (extended-release tablet)

  • Opana IR (immediate-release tablet)

  • O-Morphon in Bangladesh by Ziska pharmaceutical ltd

In the midst of the opioid epidemic in America many pharmaceutical drugs are now under close scrutiny for their addictive potential. Now, a public announcement has come to light explaining that in June of 2017, the U.S. Food and Drug Administration asked the manufacturer of Opana ER, a Oxymorphone medication, to remove the product from the market.

What is Opana?

Opana or Oxymorphone is meant for use as:

  • Moderate to severe pain relief
  • Preoperative medication to alleviate apprehension
  • Medication to maintain anaesthesia
  • As a obstetric analgesic

Oxymorphone extended-release tablets are designated for managing chronic pain. These tablets are also only for people already on a regular schedule of strong opioids for an extended time.

Oxymorphone immediate-release tablets are recommended for breakthrough pain for people on the extended-release version.

Endo International PLC is the Big Pharma empire based in Dublin, Ireland that manufactures Opana.

  • 2006- Opana approved for use in the United States
  • 2012- Endo changed the drug’s formulation to try to make it harder to abuse. The FDA approved sales of the new version, however the FDA prohibited Endo International from marketing Opana as abuse deterrent.
  • 2013- the Centers for Disease Control and Prevention (CDC) reported an illness associated with intravenous abuse of oral Opana ER in Tennessee.
  • 2015- Reports in Austin, Indiana indicated an outbreak of HIV was caused by recreational injection of Opana

Endo primarily makes generic medicines, as well as a number of brand-name specialty drugs. Endo reported that Opana ER last year posted net sales of $159 million.

Opana ER Abuse

The FDA has taken a revolutionary stance after deciding that the risks greatly outweighed the benefits of Opana use.

In a statement on Thursday Endo International PLC said it will voluntarily stop selling the pills. However, the drug-maker does not necessarily agree with the conclusion made by the FDA, adding in their statement that the extended-release opioid is safe and effective when used as intended, and that Endo still believes Opana ER’s benefits outweigh its risks.

And yet, FDA advisers are firm after reviewing the safety of Opana ER and voting 18-8 against keeping it on the market.

The agency said it had perceived a “significant shift” from individuals abusing the drug recreationally by crushing and snorting the pill to injecting it instead. Besides the stories in Indiana and Tennessee, Opana was also called out for contributing to the rising rates of drug overdose and overdose deaths.

According to the FDA there were no generic versions of the reformulated Opana ER on the market, as of June. However, there are two generics of earlier versions of Opana on sale, called Oxymorphone.

The Big News For Big Pharma

The big news here is that this is the first time the U.S. Food and Drug Administration has actively taken steps to remove a currently marketed opioid pain medication from sale due to the drugs abuse and the related public health consequences!

Some see this as a major move in the fight toward overcoming the opioid addiction problem gripping the nation.

Thus, Endo International PLC has committed to working with the FDA to try to minimize disruption for patients relying on the drug for pain relief. Of course those prescribed to the drug for medical reasons will also need to be provided with alternative treatments.

But the FDA isn’t done yet. The U.S. Food and Drug Administration claims that its agencies will be reviewing other opioid painkillers and could take further action to regulate or even eliminate dangerous opioid medications like Opana ER.

Taking steps to reduce the impact of this epidemic is a step in the right direction. Big Pharma might be in for a bit of a shakedown from the FDA as they attempt to reduce the amount of dependence on opioids. If you or someone you love is struggling, please call toll-free now.

CALL NOW 1-888-922-5398

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