The Big Pharma industry is still in the hot seat, and this week another lawmaker is adding a new name to the roster of drug makers to be investigated for shady marketing practices. Alkermes, the company behind the opioid treatment implant Vivitrol, is now being investigated for how they market their product.
Background on Vivitrol
Vivitrol is another name given to the generic drug Naltrexone. Originally approved by the U.S. Food and Drug Administration (FDA) for the treatment of alcohol dependence in 1994, Naltrexone eventually became approved for the treatment of opioid dependence. The medications primary use appears to be blocking the opiate receptors in the brain. It’s intended so that someone using heroin or other opiate-based drugs cannot experience the drugs high.
The Vivitrol shot is made by Boston-based biotech Alkermes. This medication stood out from other Naltrexone medications because Vivitrol is an injection given every 4 weeks with a monthly doctor visit. It is time released for longer lasting relief, instead of being a pill taken once a day.
Supposedly Vivitrol is intended to further help by reducing cravings for opioids. However, Naltrexone and Vivitrol have been refuted by many for having any notable effect on opioid cravings.
Enter Senator Harris
Kamala Harris is a Democratic California Senator who has announced she will be part of launching a new investigation into the sales and marketing practices of the makers of Vivitrol. According to the senator, Alkermes allegedly worked to increase sales of their opioid treatment medication through two questionable strategies:
“Aggressively” marketing Vivitrol to officials in the criminal justice system
Senator Harris says that Alkermes pushes for judges and lawmakers to use their product. The company even provided free samples, which resulted in Vivitrol being actively implemented in 450 treatment programs across 39 states.
Lobbying efforts by federal and state lawmakers
In her statement, Harris also alleges that the company has spent millions of dollars in direct appeals to government officials. Meanwhile, they were contributing to numerous congressional campaigns.
Due to the drug companies marketing, Vivitrol raked in well over $69 million dollars in the third quarter of 2017.
In her statement Senator Harris says,
“We are at the height of a crisis, and companies are taking advantage of pain in order to profit”
“We must hold these companies accountable for their deliberate actions that magnify the opioid epidemic and drive up the cost of drugs for Americans.”
The senator even quoted the chief of addiction medicine at Stanford University School of Medicine, Dr. Anna Lembke, who said,
“Alkermes has taken unethical drug promotion to new depths by enlisting judges, law enforcement personnel, and legislators to favor Vivitrol over proven treatments. Alkermes’ actions undermine public health.”
Which seems like some pretty strong words. In the midst of the opioid crisis, it might be fair to say we should use every resource we can get. However, the Big Pharma enterprises still need to be put in check when it comes to overlooking more effective treatments.
In fact, a 2011 review of studies suggested that Naltrexone was not significantly superior to placebo, and the authors believed there was no sufficient evidence to support Naltrexone therapy for opioid dependence.
One reason Senator Harris seems to have Vivitrol in the crosshairs seems to be that the pharmaceutical company made a habit out of promoting Vivitrol as a more effective treatment than other maintenance drugs, such as Suboxone or Methadone, even though there is no substantive data to support this claim.
As part of the investigation, Harris contacted Richard Pops, the Alkermes Chairman, requesting the company provide data and communication. At the moment Alkermes is disputing the allegations. Senator Harris appears to be calling their bluff, as she was requested that Alkermes submit:
Alkermes has also been asked to turn over any materials provided to participants or speakers for Alkermes since 2010. They’re being asked to disclose amounts paid to the company by various associations, including:
American Society of Addiction Medicine
National Institute on Drug Abuse (NIDA)
Partnership for Drug-Free Kids
Any studies presented to these groups are also to be turned in.
In their own statement, Alkermes states they are “focused on ensuring that patients, healthcare professionals, and criminal justice officials are educated on Vivitrol, and believes that patients should have access to all medications.”
There is no telling whether or not this investigation is going to turn into a witch hunt or if it will blow the lid off of even more bad behavior from Big Pharma. While other drug companies that can be connected to the opioid crisis are already facing lawsuits and others even criminal cases for racketeering and fraud, the Vivitrol producers might find themselves on the chopping block sooner rather than later.
There is already much disagreement about whether or not the Vivitrol treatment is really effective in the first place. Some say the medication helped save their life. Many others have horror stories of uncomfortable side-effects made worse by cravings. Either way, pharmaceutical companies still need to be held accountable for their marketing methods, especially when they seem a little suspect.
For now, this is all a request. Only Republican Senator Ron Johnson has the power to issue subpoenas on behalf of the Homeland and Governmental Affairs Committee.
When talking about the most effective treatment programs for addiction, we should also remember that maintenance drugs like Suboxone, Vivitrol and others are not exactly a solution. While they can be effective in keeping people alive and helping to overcome their sickness, the real healing does not come from magic pills or implants. The real transformation comes with developing the understand and the tools to take care of yourself. If you or someone you love is struggling, please call toll-free now.
CALL NOW 1-888-922-5398
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.
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.
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:
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.
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:
Michael L. Babich
Former CEO and President of the company from Scottsdale, Arizona
Former Vice President of Sales from Charlotte, North Carolina
Richard M. Simon
Former National Director of Sales from Seal Beach, California
Former Regional Sales Director from Bryant City, Michigan
Joseph A. Rowan
Former Regional Sales Director from Panama City, Florida
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?
For more important information on the dangers of prescription drugs, download our FREE E-BOOK “Big Secrets of Big Pharma: Why They Secretly Hope You Get Hooked”
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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
As we have seen time and time again, the opioid epidemic all across America has not been confined to one substance. It takes the shape of prescription painkillers, illicit heroin and even the more potent synthetic opioids like fentanyl. With the gradual progression of this poisonous outbreak, we have seen the stakes get higher and higher. Prescription opioids contributed to a growing population of heroin users. Dealers lacing heroin with synthetics like fentanyl led to higher overdose rates. Then the highly dangerous, frequently lethal carfentanil was added to the mix and now just being around the drugs can almost kill you.
With the addition of fentanyl and carfentanil to the illicit drug world comes a very real and potentially lethal new threat- secondary exposure overdose.
What is Secondary Exposure?
Secondary exposure is also referred to as secondary contamination or second-hand exposure. It is a term usually used with things like asbestos poisoning or mesothelioma. Sometimes it is even used to describe the effects of radiation. It is when people come into contact with gasses or substances that can be absorbed into the body and do very real damage.
The most common comparison you could make is to second-hand smoke, which is when people smoking cigarettes expose others to the toxic gas they and the cigarette release into the air. Second-hand smoke can cause very real health problems, including some cancers. The most terrible aspect of it being that the individual who gets sick doesn’t even have to smoke themselves.
With drug use secondary exposure overdose has now become a real risk thanks to synthetic opioids. Law enforcement and other officials tell us that some of these dangerous substances must be handled with the utmost caution. The news coming out of Ohio this week is just another example of how hazardous these drugs have become.
Ohio Nurses Experience Secondary Exposure Overdose
At Affinity Medical Center, a hospital in Massilion, Ohio, three nurses helped treat an overdose patient. After cleaning the room where the individual was treated, the three nurses were overcome by secondary exposure. They got sick and shortly after lost consciousness.
Detective Shaun Dadisman states,
“They were cleaning up the room and started to feel sick. And then that left them waking up in a hospital bed,”
According to the investigators in this case, the three nurses were treated with Narcan. The opioid overdose antidote Narcan is the brand name for Naloxone, which is used to reverse the effects of opioids on the respiratory system. The local law enforcement believe the substance the nurses were exposed to was fentanyl. Thankfully, all three nurses are said to have recovered.
A union representing nurses at the hospital intends to meet with hospital officials to review protocols for environmental contamination. A spokeswoman from the hospital states that the institution does have effective policies, which isn’t out of the question.
Police Officer Needs Narcan after Secondary Exposure Overdose
Just this summer, a police officer in a very similar situation almost died from an accidental overdose due to secondary exposure. Officer Chris Green was responding to a drug call when the incident occurred. The drug he came in contact with at the time was so powerful that even though officer Green said he was wearing gloves and a mask as he searched a suspect’s car, he still ended up being severely impacted by the substance. Merely by ending up with a white substance on his shirt officer Green needed to be revived with not just one, but multiple doses of Narcan.
How Does Secondary Exposure Overdose Happen?
Detective Shaun Dadisman spoke more about the dangers of opioid overdose through secondary exposure. Dadisman states,
“It shuts down your breathing. It shuts down your system so you get to the point where you’re not breathing on your own. And you need that boost and that Narcan is what takes that away so it helps you to recover quickly,”
Fentanyl and other opioids like carfentanil present a whole new level of danger concerning secondary exposure. The drugs are so intoxicating that law enforcement and medical personnel are now forced to come up with new policies and protocols just to handle an individual who may be overdosing on these drugs to protect themselves and others. Dadisman stated,
“I was actually stuck by a needle from an individual on a heroin overdose, so I had to run through all of the testing myself,”
The opioid epidemic now doesn’t just present an elevate risk of death to those who are using these drugs. Opioid abuse now poses a very real and deadly danger to those who work to save the lives of users every day. The greatest danger some of these drugs prevent is that of the unknown. As Dadisman points out,
“I think there will be continued changes – gloves, masks. And the problem with our first responders, police officers and our nurses and stuff, is you don’t know immediately what you’re dealing with. After the fact, you may know, but it may be too late.”
So now every day these synthetic opioid drugs don’t just threaten the lives of people who consume them, whether knowingly or not, but also the people closest to them.
So what can be said about secondary exposure overdose? Well, it is safe to say that with some of the most powerful drugs that are out there simply getting some on your skin or breathing it in, even on accident, can cause life-threatening illness. While hopefully this concept does not start a panic, it is a reality that more people should probably be aware of. Whether people are leaving the drug around others, consuming the drug in public places or being revived by loved ones and first responders, the fact is the drugs are stronger and more life-threatening than ever. The fact that a dose of Narcan might not save someone on the first shot should be enough to push for more awareness and more focus on finding a way to fight back.
So, what more can be done about the possibility of secondary exposure overdose?
If you or someone you love is struggling with opioids do not hesitate to get help. The rates for overdoses and opioid-related deaths are far too high to keep gambling with your life. Protect your loved ones and your future. If you or someone you love is struggling, please call toll-free now. We want to help.
CALL NOW 1-888-922-5398
If you believe you or someone else is experiencing fentanyl overdose symptoms, please call 911 right away. Fentanyl is an extremely potent potentially fatal drug and should not be underestimated.
Fentanyl, also known as fentanil, is an incredibly potent synthetic opioid pain medication with a rapid onset and short duration of action. This drug is considered to be around 50 to 100 times more potent than morphine, while some fentanyl analogues such as carfentali, which are designed to mimic the pharmacological effects of the original drug, may be as much as 10,000 times more potent than morphine. Fentanyl brand names include:
Individuals who abuse opioids, particularly heroin, are more likely to ingest fentanyl, knowingly or unintentionally. This puts them at an even higher risk of overdose.
In 2015 alone, 33,091 people died due to overdose on opioids like fentanyl.
Learning how to recognize the indications of a fentanyl overdose and getting professional substance abuse treatment may save a life.
Fentanyl Overdose Symptoms: Side Effects of Fentanyl
As an extremely potent opioid drug, fentanyl is very carefully prescribed and dosed by medical professionals. Those who abuse fentanyl may use the drug outside of prescription guidelines or without a prescription altogether, which can drastically increase their risk of lethal overdose.
Fentanyl’s most common side effects of Fentanyl use include
- Dry mouth
Some of the less common side effects of Fentanyl use include:
- Abdominal pain
- Anorexia and weight loss
- Flu-like symptoms
- Dyspnea (shortness of breath)
- Urinary retention abuse
Fentanyl Overdose Symptoms: Risks of abuse
With a powerful drug like fentanyl the risk of abuse is exceedingly high, especially considering the drug’s medical use is so limited to treating extreme cases. So when people take fentanyl in higher doses or more frequently than prescribed it of course elevates their risk for serious side effects and experiencing fentanyl overdose symptoms.
As far as recreational use, fentanyl is extremely dangerous. Using this drug in any way other than intended, such as snorting or injecting it, is not only illicit abuse of the chemical, but potentially life-threatening. In recent years drug dealers have been mixing fentanyl powder with heroin to increase potency or compensate for low-quality heroin. This illegally manufactured, non-pharmaceutical fentanyl cut into other substances caused an outbreak of overdose deaths in the United States and Canada over the past several years.
Combining fentanyl with other drugs can have effects that either compound the already severe side effects of fentanyl or contradict the effect and cause more chaos in the body. Using fentanyl with other substances is very hazardous, especially with drugs such as:
- Antidepressant medication
The Center for Disease Control and Prevention (CDC) conducted a study recently that showed:
- 82% of fentanyl overdose deaths involved illegally manufactured fentanyl
- Only 4% were suspected to originate from a prescription
National Forensic Laboratory Information System reported:
- 942 fentanyl seizures in 2013
- 3,344 fentanyl seizures in 2014
Fentanyl Overdose Symptoms: Signs to Look For
Being able to address a possible overdose means being able to recognize and understand some of the possible fentanyl overdose symptoms. While one of these may not be a definite indication, noticing a combination of symptoms may be a more serious issue.
A person experiencing fentanyl overdose symptoms may present with the following overdose signs:
- Pinpoint pupils
- Pale skin
- Choking sounds or gurgling/snoring noises
- Weak muscles
- Extreme sleepiness
- Very low blood pressure
- Dangerously slowed or stopped breathing
- Blue skin tinge nails and lips
- Loss of consciousness
- Intensely slowed heart beat
The effects of fentanyl overdose symptoms on an individual’s respiratory system and heart rate are the most serious relating to risk of death or permanent damage. Not only can this lead to coma or death, but even after surviving the overdose there can still be complications.
If not treated immediately, the impact of fentanyl overdose symptoms on the heart and respiratory system may cause residual problems such as permanent brain damage.
Fentanyl Overdose Symptoms: How Much Is Too Much?
It is difficult to determine the exact dose it would take for someone to experience fentanyl overdose symptoms. According to some medical professionals, 250 micograms of fentanyl might represent a lethal dose of fentanyl. However, most individual’s using heroin and other drugs are unaware that they have ingested the drug at all, let alone know how much fentanyl is in the doses.
At the end of the day, fentanyl overdose symptoms can vary depending on the individual, and the amount it takes to overdose will vary to. Some elements that impact the odds of overdosing includes:
- Other drugs taken
- Physical condition
In the event of an overdose of fentanyl you should seek immediate emergency medical assistance. Some cases require several doses of Narcan (Naloxone), the opioid overdose antidote, to stabilize the individual suffering from an overdose. Even if you have access to Narcan or Naloxone yourself, always contact emergency medical services to get assistance, because when the antidote wears off the overdose could return, or there may be other severe complications.
Opiate medications and street drugs have done a great deal of damage these past few years. Synthetic opioids like fentanyl have raised the risks and increased the death rates in a big way. Far too many lives are ruined, or brought to an abrupt end, because of overdoses when there is real help out there. Don’t wait until after an overdose. If you or someone you love is struggling with substance abuse or addiction, please call toll-free now.
CALL NOW 1-888-922-5398