by Justin Mckibben | Nov 2, 2017 | Maintenance Drugs, Methadone, Naloxone, News, Prescription Drugs, Suboxone, Vivitrol
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:
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Headache
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Constipation
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Nausea
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Injection site pruritus
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Vomiting
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Insomnia
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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
by Justin Mckibben | Oct 30, 2017 | Drug Abuse, Fentanyl, Fentanyl, News, Prescription Drugs, Synthetic Drugs
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:
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.
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.
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:
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New York
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Michigan
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Florida
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Kansas
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New Hampshire
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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:
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Michael L. Babich
Former CEO and President of the company from Scottsdale, Arizona
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Alec Burlakoff
Former Vice President of Sales from Charlotte, North Carolina
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Richard M. Simon
Former National Director of Sales from Seal Beach, California
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Sunrise Lee
Former Regional Sales Director from Bryant City, Michigan
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Joseph A. Rowan
Former Regional Sales Director from Panama City, Florida
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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
by Justin Mckibben | Oct 17, 2017 | Drug Policy, News, Opioids, Prescription Drugs, Recovery, Stigma
Back in August, the Commission on Combating Drug Addiction and the Opioid Crisis began urging President Trump to declare a national public health emergency to combat the opioid crisis that has crippled countless communities around America. While the President did soon enough say that he believed the opioid epidemic was indeed a national emergency, the actual official process has yet to begin. However, just this week news broke that President Trump will soon formally declare the “national emergency” status of the opioid crisis.
Reports indicate President Trump plans to make the official declaration next week. It seems appropriate following the explosive exposé following the story on ’60 Minutes’ of former DEA agent Joe Rannazzisi pointing a finger at Big Pharma companies, Congress, and lobbyists for fueling the opioid epidemic.
In fact, Republican Representative Tom Marino, who was the top pick for the Trump administrations Drug Czar, was name-dropped in a less than flattering light in the ’60 Minutes’ piece. Reports today now show Marino has withdrawn from consideration following the story.
So what does this newest revelation mean for combatting the opioid crisis?
Raising Awareness
One of the initial reasons for declaring a national emergency is pretty straight-forward; raising awareness. Not that we don’t see enough shocking news stories or warnings from local officials being issued in various states, but more attention on the issue will help channel more resources into actually helping address it.
As the commission states in their report:
“It would also awaken every American to this simple fact: if this scourge has not found you or your family yet, without bold action by everyone, it soon will,”
“You, Mr. President, are the only person who can bring this type of intensity to the emergency, and we believe you have the will to do so and to do so immediately.”
When the President of the United States says something is a priority, people take notice. Regardless of whether people always agree on politics, when we can all get behind a major issue and put effort into a more inclusive conversation, there is a better chance more can be done.
Overcoming Addiction Stigma
One of the most important aspects of fighting addiction is overcoming the addiction stigma itself. Many people who are suffering do not get the help they need because they are afraid of the stereotypes associated with drug abuse. A lot of people still doubt what the majority of the medical and scientific communities have adopted as fact; that addiction is a health issue, not a moral failing.
By declaring the opioid crisis a national emergency, President Trump has an opportunity to promote education along with public awareness. The more we can help people to understand how addiction affects the mind and body, the better odds we have of supporting those struggling with compassionate and effective treatment options.
Funding for Fighting Opioids
Perhaps one of the biggest hopes for many addiction recovery advocates is that by President Trump declaring the opioid crisis a national emergency he will influence lawmakers to allocate more funding to resources combatting addiction.
A federal declaration would also allow the government to pull funding from other areas as well, such as funding used for the Public Health Emergency Fund, or even the federal Disaster Relief Fund. So while America has been struck pretty hard by hurricanes and natural disasters, some of this same funding may end up going toward creating addiction resources.
One thing many are hoping is that these new funds will also go to promoting more addiction treatment options across the country. Some states may pursue incentives for performance-based enhanced care management (ECM) program, like one recently implemented in New Jersey. Others may put those resources into prevention and education initiatives.
One thing should seem pretty clear; treatment options should be a priority. We already know we cannot arrest our way out of this problem. The War on Drugs did not work, and many do not expect it will now either. With President Trump declaring the national emergency, hopefully, the new effort will go into protecting mental health and substance abuse parity with healthcare and insurance providers. If we have more ways to help those already desperately in need, we could see a better chance for a way out.
With the CDC stating an estimated 91 Americans dying every single day from opioid-related death, which many experts believe is grossly underreported, helping more people fighting opioid addiction find a way out is crucial. However, we should not wait on politicians, health officials or anyone else to fix it. Recovery takes action. If you or someone you love is struggling, please call toll-free now. We want to help.
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