by Justin Mckibben | Sep 6, 2018 | Drug Abuse, Fentanyl, Fentanyl, Marijuana, Medical Marijuana, Synthetic Drugs
Over a year ago, it was uncovered that a Big Pharma entity spent over $500,000 to oppose legalizing medical marijuana. This is just one example of how the pharmaceutical industry working over years to influence marijuana policy in America. What was so interesting about this company’s efforts is that their own product was a sublingual fentanyl spray.
That’s the same synthetic opioid that became a major factor in the ongoing opioid crisis in America as it was integrated into the illegal drug market.
Marijuana advocates see the move from drug makers to oppose legalization as an attempt to prevent competition. Studies show cannabis can be an effective substitute for pain treatment. Many states with medical marijuana laws acknowledge it as a means to help treat chronic pain patients.
So it became even more telling when it was revealed that the same fentanyl maker undermining medical marijuana was also developing their own synthetic THC.
Insys Therapeutics VS Cannabis
This isn’t the only time we have written about the shady dealings of Insys Therapeutics. Some may recall back in 2017 when the former CEO and founding father of the company had criminal charges brought against him, along with other company executives, for racketeering and corrupt marketing schemes.
For years, Insys has been trying to sway marijuana policy decisions. In 2011, the Big Pharma racket wrote to the DEA expressing opposition to loosening restrictions on naturally derived THC. In the letter Insys claims “the abuse potential in terms of the need to grow and cultivate substantial crops of marijuana in the United States.”
But later in 2016 the company petitioned the DEA to loosen restrictions on synthetic versions of CBD, which is another key component of the cannabis plant. Why? Because they were developing a CBD-based drug to treat pediatric epilepsy. At the time, Insys Therapeutics made a statement claiming their opposition to the marijuana legalization proposition was because, “it fails to protect the safety of Arizona’s citizens, and particularly its children.” However, the company did insist that is believed in the benefits of cannabinoids.
Now, the company accused of aggressively pushing an incredibly potent and potentially lethal opioid drug onto patients who did not need it is now working on another new racket- Syndros.
Syndros: Synthetic THC
As a chief financial backer of the opposition to medical marijuana in Arizona, Insys Therapeutics has worked hard to give itself a monopoly on the market.
Syndros is a synthetic version of the THC compound found in the cannabis plant. This is the main psychoactive component of the substance and is behind a lot of the controversy around marijuana legalization. However, Syndros was approved by the FDA to treat cancer and AIDS patients for symptoms including:
- Nausea
- Vomiting
- Weight loss
This drug is very similar to Marinol, another synthetic THC product that was already approved by the FDA to treat anorexia in cancer and AIDS patients.
Syndros and its generic variations are considered a Schedule II of the Controlled Substances Act. This acknowledges it for medical benefits, but indicates a “high potential for abuse.” So it is on the same level as prescription painkillers, morphine, and cocaine.
Meanwhile, marijuana is still a Schedule I drug, meaning the FDA still considers it more dangerous than morphine, Oxycontin and now synthetic THC.
Dronabinol Debate
Dronabinol is a synthetic THC nasal spray that was quietly granted a Schedule II classification about a year ago. The FDA allows it to be prescribed, sold and federally regulated. This is another product from Insys Therapeutics capitalizing on the components of cannabis while the company fought to smother any competition.
Ironically, in 2007 the company had admitted in a disclosure statement to the Securities and Exchange Commission (SEC) that if cannabis or synthetic cannabinoids were legal “the market for dronabinol product sales would likely be significantly reduced and our ability to generate revenue and our business prospects would be materially adversely affected.”
So in short- they adamantly opposed medical cannabis efforts for years in order to limit competition. Meanwhile, they were developing their own drugs derived from cannabis. But it was not enough for the company to oppose cannabis legalization efforts. Insys also worked to disrupt other Big Pharma companies from trying to create generic versions of its drug.
Shutting Out Competition
Now, according to publicly available documents, Insys has tried to extend its monopoly over its oral dronabinol product. In October 2017, Insys Therapeutics requested that the FDA decline applications from competitors seeking to produce generic versions of Syndros. They’ve already sued two such drug companies:
- Par Pharmaceuticals
- Alkem Laboratories
Each had submitted Abbreviated New Drug Applications (ANDA). And ANDA is the first step in the process of gaining approval for generic versions of existing drugs. The request from Insys consisted of two parts:
- It asked the FDA to decline to “receive or approve” any ANDA applications that didn’t establish “in vivo bioequivalence” to its drug.
- Asked that ANDA applications for its drug “include fed and fasted state bioequivalence studies.”
Essentially, Insys was claiming that Dronabinol was too complex to be replicated by generic competitors.
However, the FDA eventually denied the company’s petition.
Robin Feldman is a professor of law and director of the Institute for Innovation Law at UC Hastings College of the Law in San Francisco. She literally wrote the book on all the ways mainstream pharmaceutical companies try to subvert generic competition. When discussing the language used in Insys petition to the FDA, she states:
“Companies pile these exclusivities on one after another to keep generic competitors off the market as long as possible. So the reason I laughed is what you are seeing is a multipronged effort by the brand company to stave off generic entry as long as possible.”
Insys has been able to enjoy some time cornering the market on synthetic THC products. But apparently, it is very likely that more companies will be able to get in on the racket pretty soon.
The Other Synthetic Marijuana
Then there is the other synthetic marijuana sold on the streets, which is very different and extremely dangerous.
Meanwhile, we have seen countless stories in recent years of the synthetic THC products made on the streets for recreational use and how these chemical compounds have resulted in outbreaks of overdoses. Infamous brands like Spice and K2 are designed to mimic the properties of natural marijuana. However, these synthetic cannabinoids can cause a range of adverse side effects, including:
- Seizures
- Psychosis
- Cardiac arrest
These are the more dangerous synthetics made in unregulated labs with chemical cocktails that are unpredictable and frequently toxic. Thousands of people have been hospitalized over the years due to the synthetic THC on the street. There are even dozens of fatalities attributed to illicit synthetic THC products.
Again, these are two different variations of synthetic THC. Synthetics like Spice or K2 are not quite the same thing as medications produced by companies like Insys. However, it should at least give some pause to consider that they are being created with the same intention- to artificially manufacture the effects of cannabis.
Drug Makers Want Marijuana Monopoly
Officials all over America are calling out Big Pharma companies for pushing to stop cannabis legalization efforts. Some say many of these drug companies are just trying to sell more drugs that addict patients. Essentially, the argument is that pharmaceutical companies are actively making a profit from drugs containing marijuana constituents while lobbying to prevent medicinal cannabis growth and development.
So do companies like Insys have the best interest of the patient in mind? Can a company accused of questionable tactics and supposedly illegal kickbacks be trusted with a monopoly on synthetic THC? Or are they just want a monopoly on marijuana-derived substances?
And if opioid makers get to dominate the market on synthetic THC products, will they be willing to put more people at risk of drug abuse and addiction in order to maintain their dominance?
Whether it’s natural cannabis, illicit synthetic marijuana, or medical synthetic THC, the risk for substance abuse should be taken seriously. Marijuana use disorder is a real issue that affects a lot of people across the country every day. If medical marijuana products are going to continue to evolve, our treatment of marijuana use disorder has to evolve with it. Innovative and holistic treatment options can make all the difference.
Marijuana use disorder is a very real issue that people struggle with all over America. If you or someone you love is struggling with a substance use disorder, such as chemical dependency or addiction, please call toll-free now to speak with a specialist today. We want to help.
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:
-
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:
-
Michael L. Babich
Former CEO and President of the company from Scottsdale, Arizona
-
Alec Burlakoff
Former Vice President of Sales from Charlotte, North Carolina
-
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?
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
