“THE OPIOID CRISIS IN AMERICA” – How Insys Theraputics, Inc. Sold Stock And Killed Americans At The Same Time With The Help Of Doctors

A REPORT BY MASS TORT NEXUS 

by Mark A. York ( September 26, 2017)

 

 

 

 

 

 

 

 

 

Subsys – an Insys Therapeutics, Inc. Pharmaceutical Opioid Product

      Here’s a perfect example of how corporate greed and licensed medical providers helped create the now rampant US opioid crisis– how payments to doctors and prescribers across the country caused addictive painkillers, like “Subsys” a fentanyl based opioid, to suddenly rip through our country like a flash fire.

Insys Therapeutics,a publicly traded pharmaceutical company based in Arizona, is just one small example of what Big Pharma has been doing for the last 10 years in every city and state in the United States, often increasing corporate earnings right alongside the catastrophic opioid related death rates. For Insys Theraputics executives, the sales team and its nationwide cadre of fraudulent doctors, the results have been felony indictments and long federal prison sentences, with many more to come.

INSYS EXECUTIVES INDICTED

December 2016 saw Insys Therapeutics CEO Michael Babich and five other senior executives indicted on criminal charges for paying kickbacks and bribes to medical professionals and committing fraud against insurance companies across the country for offering a highly addictive Fentanyl prescription product “Subsys” to the masses. The Insys boardroom was indicted in the US District Court of Massachusetts, where the entire team has engaged a stable of top national law firms to defend the indictments. The “Subsys” sales teams were charged in federal indictments across the country, including Arkansas, Connecticut, Alaska and New York and the indictments will only increase as those cases proceed and “cooperating witnesses” decide that prison isn’t an option.

To compound further harsh scrutiny for Insys, it’s new CEO Saeed Motahari, moved over from Purdue Pharmaceuticals, the Oxycontin maker, who’s also a major target of criminal and civil investigations across the country by local state and federal agencies. Purdue is charged with false marketing, off-label use and ignoring the Oxycontin highly addictive dangers for years, while bringing in literally billions of dollars in profits, but Purdue’s transgressions are in Part 2 of our ongoing reports on big pharma and opioid abuses.

DOCTORS FACING NUMEROUS CHARGES

Doctors and their pain clinics, medical centers and other healthcare facilities have been indicted for fraudulent prescription writing, submitting false claims to insurance companies and numerous other federal charges and all face a minimum of 20 to 50 years in federal prison. Two of the busiest “Subsys” prescription writers in the country were Alabama doctors, John Couch and Xiulu Ruan, who earned over $40 million from Insys, and were charged with running a pill mill between 2013 and 2015, have been convicted and sentenced to 20 years each in federal prison. The top “Subsys: prescriber of all, Dr. Gavin Awerbach, of Saginaw, MI pled guilty to defrauding Medicare and Blue Cross out of $3.1 million in improper Subsys prescriptions, his criminal sentence is pending. To show the far reach of Insys and it’s corporate plans to saturate the US market with opioids, in Anchorage, Alaska Dr. Mahmood Ahmad, was charged with heading a massive Subsys prescribing operation, which he denies, but immediately surrendered his Alaska medical license which the caused the revocation of his medical license in Arkansas.

INSURANCE COMPANIES FILED SUIT

Adding weight to this tragedy is Anthem Insurance — you may recognize them as Blue Cross, one of the largest insurers in the country, now setting their sights on Insys Theraputics and it’s executives.

Anthem is suing Insys Therapeutics, the maker of the powerful opioid Subsys, for allegedly lying, cheating and defrauding its way into the medicine cabinets of Anthem clients across the country. The drug according to Anthem’s complaint, was off market prescribed to thousands of patients for years. Review shows that 54% of patients who are taking Subsys don’t really have cancer — one of the requirements for prescribing the drug, Subsys was FDA approved for “treatment of pain related to cancer” and any other use is unauthorized or off-label use.

Anthem says that’s because Insys devised an elaborate scheme to get around Anthem’s system — by falsifying records and posing as medical professionals, often with the complete knowledge and cooperation of medical doctors across the country who then received thousands of dollars in kickbacks. These doctors chose to exchange high fees from Insys in exchange for writing off-label prescriptions to patients seeking pain relief for non-life threatening conditions.

Anthem claims it ultimately paid $19 million more for Subsys than it should have. “But the harm inflicted by Insys’s conduct is not merely financial in nature,” the complaint states “Insys put Anthem’s members’ health at risk.”

THE OFF LABEL CAMPAIGN

The only people who are supposed to be taking Subsys are adult cancer patients, according to the FDA “Subsys” approval files, anything other than that is an “off label” indication. Now you can take a drug to treat something off label if you want to, but you have to get your doctor to get pass a prior authorization.

Anthem alleges that Insys has an entire unit to get around this requirement — it’s titled the “reimbursement unit.” Investigative journalists exposed this fraud initially as far back as 2015 on behalf of the Southern Investigative Reporting Foundation, see Insys Therapeutics “Subsys” Off Label Rx Fraud.

The Reimbursement Unit claim was basically the company’s fraudulent  prescription approval factory, which helped participating doctors process claims (the doctors had so many they couldn’t handle them all). The unit falsified records to show patients had cancer and called insurers, pretending to be patients or other medical professionals, to facilitate approval of payment for off-label treatment.

This is the Unit’s script for obtaining off-label approval (taken from the Anthem suit):

The script read: “The physician is aware that the medication is intended for the management of breakthrough pain in cancer patients. The physician is treating the patient for their pain (or breakthrough pain, whichever is applicable).” The script deliberately omitted the word “cancer as applied to the patient treatment under discussion.”

DO STOCKS RISE AND FALL ON INDICTMENTS

 

 

 

 

 

 

 

In late 2016 the entire top level of Insys executives, including former CEO Michael Babich, and five others were indicted and charged with multiple counts of fraud and conspiracy. Since then a number of sales reps and medical practitioners have pled guilty to charges that they gave or accepted kickbacks in furtherance of the fraudulent prescription scheme. The manager of reimbursement services, Elizabeth Gurrieri, pleaded guilty to wire fraud in June. There have been numerous deaths and related overdoses attributed to the over prescribing of Subsys across the country, which to date, show most parties involved being able to avoid the scrutiny of criminal charges related to off-label marketing and prescribing. Insys has tried to re-shuffle the executive board by bringing in new members, but business as usual in the Big Pharma boardroom goes on, as they simply brought in other more experienced “opioid industry” insiders to help further the continued use of “Subsys” and purportedly the major Insys New Pharma” entry, a line of complex medical marijuana products, that may enable them to shake off the current Insys label as the United States leading “opioid abuse by boardroom design” corporation.

As part of the boardroom strategy to get doctors to prescribe Subsys, Insys spent millions paying them off through a fraudulent “speakers program” meant to educate medical professionals about the drug. The speaking engagements were a veiled attempt to cover-up the direct payment to doctors for writing prescriptions, the more prescriptions you wrote, the higher your “speaking fees” increased. There are e-mails, texts and other Insys communications from all levels of company personnel stating “if they not writing prescription, they’re off the speaking program”, this policy resulted in one Alabama sales rep being paid over $700 thousand in Subsys based Rx commissions for one year, while her base salary was $40 thousand.

“While the exact amount of those kickbacks has yet to be determined, criminal indictments of the recipients indicate that Insys paid “speaker fees” of millions, of dollars, which may result in additional criminal charges against the doctors as well as the doctors facility staff who often worked hand in hand with Insys staff.

SALES REP NATALIE REED PERHAC

In the plea, Perhacs admitted that she was hired to be the personal sales representative for one of Insys’s most important prescribers, Dr. Xiulu Ruan. Ruan is one of two Alabama doctors who picked up over $115,000 in speaker fees from 2012 to 2015, and earned in excess of $40 million in related medical earnings during the same period. Earlier this year they were sentenced to 20 years in jail each for running a “pill mill” and helping Insys sales rep Natalie Reed Perhacs sell Subsys, for which she was paid in excess of $700 thousand in commissions, see Perhac Guilty Plea in Alabama Federal Court.

Perhac Plea Excerpts:

Admision No. 78: . Perhacs admitted that her primary responsibility at Insys was to increase the volume of Subsys® prescribed by Dr. Ruan, and his partner Dr. John Patrick Couch. This… was accomplished by (1) handling prior authorizations for their patients who had been prescribed Subsys®; (2) identifying patients who had been at the same strength of Subsys® for several months and recommending that Dr. Ruan or Dr. Couch increase the patients’ prescription strength; and (3) setting up and attending paid speaker programs.

Admission No. 79:. Ms. Perhac admitted that because of her involvement in the prior authorization process, she knew that the vast majority of Dr. Ruan and Dr. Couch’s patients did not have breakthrough cancer pain.

As you can see by the Perhac admissions, numbers 78 and 79, which reflect the vast number of charges lodged against her, the federal government is cracking down on everyone involved with the “Subsys” fraud. According to confidential sources, the recent June 2017 FDA “Opioid Crisis” Conference and related strategic review of the opioid crisis, will result in many more indictments and charges against drug makers and the medical providers who’ve helped facilitate the opioid epidemic that is currently in place across the United States.

Coming in “The Opioid Crisis In America” Part 2: How Insys Therapeutics, Purdue Pharmaceuticals, Endo Health, J&J’s Janssen Pharmaceutical and other opioid manufacturers were allowed to place profits over patients for more than 15 years…

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ACTEMRA: Why Is Genentech Ignoring Wrongful Death, Heart Attack and Stroke Injuries?

ACTEMRA: Why Is Genentech-Roche Ignoring Ever Increasing Evidence Of Wrongful Deaths, Heart Attack and Stroke Injuries?

By Mark A. York

Mass Tort Nexus (September 26, 2017)

 

 

 

 

 

 

 

 

 

 

Many newer rheumatoid arthritis drugs have strong warnings known as black box warnings, dictated by FDA guidelines, which warn of the risk of heart attack, stroke, heart failure, lung disease, and other injuries, but Actemra warnings were not issued by the drug maker when the medication was introduced.

Actemra, a rheumatoid arthritis medication by Roche-Genentech, has now been linked to increased heart attacks, stroke and lung interstitial disease among other side effects that the maker, Genentech did not warn the public about.

Blockbuster Drug

Actemra is a humanized interleukin-6 (IL-6) receptor antagonist approved for treatment of adults with moderately to severely active rheumatoid arthritis. It was approved in 2010 and has been prescribed to more than 760,000 patients. The drug was responsible for $1.7 billion in revenue for Genentech and Roche last year and considered a blockbuster.

Actemra Wrongful Death

Actemra has been found to be the cause of thousands of deaths and critical illnesses, according to recent reports, it’s now documented that hundreds of patients taking the RA drug died from cardiovascular and pulmonary complications – medical issues not usually known to be  associated with the drug. According to the investigation, Actemra did not carry warning labels about the possible side effects, unlike many competing RA drugs. Stat said it investigated more than 500,000 side effect reports for RA drugs and “found clear evidence” that the risks of the side effects, such as heart attack or stroke, “were as high or higher for Actemra patients than for patients taking some competing drugs.” The difference Stat stressed is that Actemra, unlike the other RA drugs, does not carry a warning label for those side effects.

What is Actemra?

Actemra (tocilizumab) is Genentech’s newest blockbuster rheumatoid arthritis drug introduced by parent company Roche in 2010. It is given to patients as an intravenous infusion on a monthly basis or as a subcutaneous (under the skin) injection on a weekly or bi-weekly basis.

Actemra is a monoclonal antibody drug, approved by the FDA to treat autoimmune disorders including Rheumatoid Arthritis (RA), Polyarticular Juvenile Idiopathic Arthritis (PJIA), and Systemic Juvenile Idiopathic Arthritis (SJIA) and was recently approved for the treatment of Giant Cell Arteritis (GCA).

In autoimmune disorders like RA, the immune system begins to attack and destroy the body’s own joint or other tissue. Actemra works to suppress the immune system by blocking interleukin-6, an immune messenger.

Actemra is Genentech’s Poster Drug?

Roche-Genentech touted their new rheumatoid arthritis drug as a “unique” breakthrough treatment, and it has since become a blockbuster drug, generating $1.6 billion in sales in 2016. Actemra competes with other popular and widely used rheumatoid arthritis drugs already on the market, including Enbrel, Humira, and Remicade.

Actemra Has Caused Serious Heart and Lung Injuries

 

Competitor RA drugs Enbrel, Humira and Remicade contained strong warnings about the heart risks and other serious health problems, but Actemra warnings did not indicate that patients may develop heart attacks, stroke, heart failure, lung disease, pancreatitis or other serious side effects.

Unfortunately, many doctors and patients were falsely led to believe that Actemra was safer, and Actemra may have actually caused these same, or even increased a greater risk of heart problems, lung complications, and other injuries.

Report Highlights Failure to Warn About Actemra Risks

In June 2017, the national publication STATNews.com released a detailed review of adverse event reports submitted to the FDA involving Actemra problems. The report raised a serious question about the failure to warn about the risk of cardiovascular problems, pancreatitis, lung disease and other injuries that have been experienced by users nationwide.

STAT News researchers examined thousands of serious adverse event reports filed with the FDA and found that 1,128 cardiac and respiratory deaths in Actemra patients had been reported to the FDA, along with thousands of other serious adverse events including heart attack, stroke, interstitial lung disease, gastrointestinal perforation and others.

STAT identified at least 13,500 reports of issues following an Actemra infusion or injection, which were submitted to the FDA between 2010 and 2016.

Actemra was linked to a higher-than-expected number of serious adverse event reports when compared with the more widely used drugs Humira, Remicade and Enbrel, which each have warnings about risks that users may face.

Actemra Serious Adverse Events

Actemra patients were more likely to have a lung disease event than patients taking Remicade and just as likely as those using Humira.

Actemra patients were 1.5 times more likely to experience a heart attack or stroke as those using Enbrel.

Will Actemra Be The Next MDL?

According to law firm and other third party investigations reviewing the Actemra drug for potential legal action against Roche and Genentech, the drug maker placed their desire for profits before patient safety by withholding important warnings about the risk of heart attacks, strokes, heart failure, lung disease, pancreatitis and other harmful side effects. When the catastrophic adverse events started to be known to the company, a boardroom decision was made to disregard the ever increasing adverse events, including those of patients dying after taking the drug. Where the Actemra investigations lead to will be known later in 2017, as determinations on taking legal action are made.

 

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