CEO of U.S. Pain Foundation Resigns

By Pat Anson, Editor

The founder and CEO of the U.S. Pain Foundation – an advocacy group representing chronic pain patients -- has resigned under pressure.

Paul Gileno resigned Tuesday, May 29th at the request of the foundation’s board of directors, according to a statement released on Thursday by U.S. Pain. It is highly unusual for a non-profit’s board of directors to remove its CEO. No explanation was offered for Gileno’s sudden departure

Nicole Hemmenway, U.S. Pain’s chairperson, has been appointed as interim CEO. A search for Gileno’s replacement is underway.

“The organization is stable and excited to be moving forward on its mission – to empower, educate, connect and advocate for people living with chronic conditions that cause pain,” said  board member Ellen Lenox Smith. “The Board has complete faith in Nicole and the wonderful staff that makes up our organization.”

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U.S. Pain has recently faced criticism over its relationship with Insys Therapeutics, an Arizona drug maker under investigation for its marketing of Subsys, an oral fentanyl spray blamed for hundreds of overdose deaths. Former Insys executives and sales representatives have been charged with racketeering and bribing doctors to prescribe Subsys off-label. A four day supply of Subsys can cost nearly $24,000.

In recent years, Insys has donated over $3.1 million to U.S. Pain, with most of the money going to a prescription discount program to help patients pay for Subsys and other medications prescribed for breakthrough cancer pain. Critics say the program was primarily designed to benefit Insys by allowing the company to bypass Medicare rules governing illegal kickbacks.

“Co-pay assistance programs (also called copay charities) were created to get around this restriction. Medicare allows copay charities to cover Medicare co-pays, so pharmaceutical companies funnel money through these groups to cover co-pay costs for Medicare patients while bilking Medicare, which bears the full cost of unnecessarily expensive drugs,” a group of critics said in a blog post by The Hastings Center.  

Last week Pfizer agreed to pay a $24 million fine to resolve federal charges that it used a similar co-pay assistance program to pay kickbacks to Medicare patients. “Pfizer used a third party to saddle Medicare with extra costs," said U.S. attorney Andrew Lelling.

In a statement released in February, Gileno defended U.S. Pain’s acceptance of funding from Insys for the co-pay assistance program.

"This funding, like any funding we receive, does not influence our values,” Gileno said. “The funding we receive is not used to promote one type of treatment over another.”

According to a report released by Missouri Sen. Claire McCaskill, U.S. Pain received $2.5 million from Insys in 2017 – an amount three times larger than what the non-profit received from all donors in 2015.

(Update: U.S. Pain has a statement on its website saying its copay assistance program with Insys ended “as of August 2018” and that “U.S. Pain will not accept funding from Insys going forward.”)

Gileno founded the Connecticut Pain Foundation in 2006 after a back injury forced him to abandon his catering business. In 2011, he launched U.S. Pain, which now claims to be the nation’s largest patient advocacy group. It's growth was fueled by marketing partnerships and donations from dozens of pharmaceutical companies and healthcare organizations.

In its 2016 promotional material, U.S. Pain claimed to have over 90,000 members and over 225,000 social media followers, including 59,000 followers on Twitter. However, that was reduced to less than 14,000 followers in early 2018 after Twitter purged from its system millions of fake accounts.

(Update: U.S. Pain has revised the way it counts actively “engaged members.” The organization now says its has over 15,000 members, 1,500 volunteers and a social media reach of more than 217,000 followers.)

In 2015, Gileno was paid a salary of nearly $404,000, according to U.S. Pain's tax return. Gileno says the 2015 compensation was for “back pay” from 2006 to 2012. The foundation has not publicly released its tax returns for 2016 or 2017, so we don’t know how much Gileno was paid for those years.

In a 2018 New Year’s message to U.S. Pain members, Gileno said he “would never sell out.”

“Not once has the creation of this foundation been about boosting my ego, finding public notoriety or obtaining fame. I am here to serve you. I will never jeopardize our mission or passion to gain five minutes of fame for myself," Gileno said.

"The work of U.S. Pain Foundation is 100% genuine. There are no strings attached or ulterior motives. All that I care about is further enhancing the lives of people suffering with pain, and we will continue to do so in a discreet and powerful manner."

PAUL GILENO

PAUL GILENO

Gileno has been criticized by some in the pain community for a passive approach to patient advocacy that avoided public controversy and protest. Some say he also has an overbearing personality that rubbed people the wrong way.

“There are so many reasons I could cite as to why it’s good to have Paul out, but I am biased because he was one of my biggest bullies and a thief to others in the chronic pain community,” a longtime patient advocate who asked to remain anonymous told PNN. “I am hoping the leadership at U.S. Pain Foundation will do better than they have in the past.”

Interim CEO Nicole Hemmenway has been a key member of U.S. Pain since its inception. She has lived with Complex Regional Pain Syndrome (CRPS) most of her life.

“We’re very focused on the future. We have a lot of wonderful programs and events coming up – a training program for chronic pain support group leaders in June; our Pain Awareness Month campaign and related activities this September; and our first retreat for pediatric patients this November,” Hemmenway said in a statement.

Doctor Arrested for Off-Label Prescribing of Subsys

By Pat Anson, Editor

A Las Vegas pain management doctor has been arrested and charged with 29 counts of healthcare fraud and unlawful distribution of fentanyl.

Steven Wolper, MD, was indicted by a federal grand jury for illegally prescribing Subsys, a fentanyl-based oral spray, to 22 patients that the doctor falsely claimed had cancer. Most of the patients were Medicare beneficiaries. One died of an overdose after self-injecting Subsys.     

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine.

The Food and Drug Administration has only approved Subsys for the treatment of breakthrough cancer pain. Although off-label prescribing of drugs is common in the medical profession, federal prosecutors maintain that “there are no off-label uses approved” for Subsys and that Holper prescribed it “without a legitimate medical purpose and outside the usual course of professional practice.”

One of Wolper’s patients – referred to as “Patient A” in the indictment -- received several prescriptions for Subsys starting in 2014. Two years later the patient died after using a syringe to inject leftover Subsys directly into their arm.

“Hundreds of Subsys canister sprays were found in and around Patient A’s bedroom, bathroom, work place, and vehicle after Patient A’s death,” the indictment says. “If Patient A had not used remaining fentanyl from the used Subsys canisters Patient A received from defendant Holper, Patient A would not have died when he/she did.”

If convicted, the 66-year old Holper faces up to 20 years in prison for illegal distribution of a controlled substance and 10 years for health care fraud.

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“Dr. Holper is charged with needlessly prescribing one of the deadliest forms of opioids and defrauding U.S. taxpayers,” said FBI Special Agent in Charge Christian Schrank. “With our law enforcement partners we will continue our fight to bring these suspected criminals to justice and protect our communities.”

Subsys has been blamed for hundreds of overdose deaths, and federal prosecutors have accused its manufacturer, Insys Therapeutics, of fraud and racketeering in promoting its use. The Arizona drug maker allegedly misled insurers into paying for Subsys and encouraged doctors to prescribe it off-label for non-cancer pain.

The government’s willingness to prosecute Dr. Holper and a handful of other doctors for the off-label prescribing of Subsys could have potentially troubling implications for Dr. Forrest Tennant, a prominent California pain physician whose home and pain clinic were raided by the DEA last November.

Tennant only treats intractable pain patients and makes no secret of the fact that he prescribed Subsys off-label to about two dozen of his patients in severe pain. He considers Subsys a useful medication to treat non-cancer patients  who would otherwise suffer without it.

“My contention is that its perfectly acceptable to prescribe (Subsys) off-label,” Tennant told PNN, adding that he has a letter from an FDA commissioner stating that fentanyl products are not prohibited from off-label use. “I think the number of doctors who prescribed Subsys off-label is up in the hundreds.”

Tennant has not been charged with a crime and has denied any wrongdoing. 

The grand jury indictment of Dr. Holper came one week after Attorney General Jeff Sessions said there would a be a 45-day “surge” in law enforcement efforts targeting doctors and pharmacists who prescribe and dispense high doses of opioid medication.

"Our great country has never before seen the levels of addiction and overdose deaths that we are suffering today. Sadly, some trusted medical professionals like doctors, nurses, and pharmacists have chosen to violate their oaths and exploit this crisis for cash -- with devastating consequences,” Sessions said in a news release announcing Holper’s indictment.

“Our goals at the Department of Justice for 2018 are to reduce the number of opioid prescriptions, the number of overdose deaths, and violent crime -- which is often drug-related. That's why I created the Opioid Fraud and Abuse Detection Unit and sent 12 top prosecutors to opioid hotspots around the country: to help us find the medical fraudsters who are flooding our streets with drugs. These prosecutors are already issuing indictments from Pittsburgh to Las Vegas.”

Opioid Medication Has Been a Godsend to Me

Susan Lay, Guest Columnist

I have been on pain medication for over 30 years, starting with Vicodin. My doctor at the time wasn't concerned about the hydrocodone in Vicodin as much as he was the amount of acetaminophen in it, as it could destroy my liver.

He sent me to an anesthesiologist, who has been my pain doctor for over 20 years. After all the nerve blocks, physical therapy, imagery, TENS unit, spinal cord stimulator, pain pump, etc., I was given Roxicodone. Afterwards, OxyContin was created and then time released OxyContin.

I couldn't tolerate them, so he gave me fentanyl patches (which were new on the market) with fentanyl lozenges for breakthrough pain. My insurance eventually denied the lozenges. The patches were wonderful because I had no feelings of being “high” like other drugs. They made it possible for me to continue working and have a life. I have used the patches since that first day and they've been a Godsend.

Subsys spray was prescribed for breakthrough pain about 6 years ago, but at $22,000 a month, my insurance only paid for a year.

I'm so fortunate to still have the same doctor, although he's getting older and will retire soon. My main issue has been with pharmacies. I live in a very rural area of California and about 2 years ago my regular pharmacy refused to fill any opioids due to DEA and other concerns. My doctor has continued to write scripts for me, but I found them extremely difficult to fill. All the pharmacies I tried, including Walmart, Rite Aid, Walgreens and Safeway, denied me. Some felt uneasy, would only fill a script for 2 months, or just plain would not fill them!

SUSAN LAY

SUSAN LAY

I tried mail order prescriptions, but they eventually stopped. I tried a small pharmacy 2 hours away, but had to talk the pharmacist into it, after he requested 6 months of medical records and advised me they would only fill my prescriptions every 30 days, with no early refills for vacations.

All has been good this past year, although I don't know if my insurance will continue to cover my meds. I'm 70 and on Medicare Part D. I've never increased the amount of patches or strength I use. I have Dilaudid for breakthrough pain, which doesn't help much, but some. I do what many other pain patients do to get their medication: drive for hours to my doctor once a month, undergo drug tests, sign pain contracts, and use no alcohol. I must go to office if they call for a drug count.

I discovered withdrawal from the fentanyl patches isn't as horrible for me as it is for addicts who just want to get high. I've had to go without for 5-6 days a few times, when the pharmacy was closed or I couldn't get to the doctor. My doctor explained that those in real pain are wired differently and withdrawal is usually easier. He did give me a script for methadone if I'm ever in that position again.

I feel extremely lucky to have a doctor who actually cares enough to help his patients. His contract says if any patient must go off opioids (for missing an appointment, using alcohol or whatever) he will assist us through withdrawal so we don't suffer.

It's the insurance and pharmacies that are causing us so many problems. Does anyone in other states have these issues? Marijuana is legal in California and we're a progressive state, yet even in my small rural area we're having major issues. Several pharmacies have closed, due to scrutiny by the DEA and other government involvement. It's not worth it to be constantly going through records and double-checking the way they do things.

Insurers and pharmacists have more power than doctors. Even with an honest and necessary prescription, they continue to over-ride doctors’ decisions. Pharmacists refuse to fill for quantities doctors have written, even when insurance agrees with that quantity. When a doctor speaks to the pharmacist, it makes no difference. When did pharmacists become doctors? The same goes for insurance companies that now refuse to pay for prescriptions they've covered for years.

I just don't get it. I'll do anything I can to fight FOR chronic pain patients and AGAINST those who don't give a damn about us and think if you use opioids you're a drug addict!

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Susan Lay is a retired nurse and day care operator. She lives with chronic shoulder and knee pain.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Tennant Patients Say DEA ‘Attacked a Good Man’

By Pat Anson, Editor

Ryle Holder wants the DEA to know that he’s not a drug dealer or a money launderer.

And he’s doesn’t think his physician, Dr. Forrest Tennant, is one either.

“They’ve gone and attacked a good man. He’s such an empathetic person for so many people. You just can’t find doctors that care like he does,” says Holder.

As PNN has reported, Tennant’s home and pain clinic in West Covina, California were raided last week by DEA agents, after a judge signed off on a search warrant that alleges Tennant is part of a drug trafficking organization and running a pill mill.

The raid stunned the pain community nationwide, because the 76-year old Tennant is widely known and respected for his willingness to see intractable pain patients who can’t find effective treatment elsewhere.  

“It’s not like he’s just giving out high doses of medication and running a pill mill, like they said. That to me was the most asinine statement in that whole search warrant,” says Holder.

FOREST TENNANT, MD

FOREST TENNANT, MD

Like many of Tennant’s patients, Holder suffers from adhesive arachnoiditis and Reflex Sympathetic Dystrophy (RSD), two chronic and painful conditions that are considered incurable.  For the last three years, the 48-year old Georgia man has been flying to California every few months to see Tennant.

Although Holder is not identified by name in the search warrant, it strongly implies that he and a handful of other patients were selling the opioid pain medication that Tennant prescribed and diverting the profits back to Tennant.

“For them to even remotely think I’m out on the streets selling this stuff is a joke. It makes me angry,” says Holder, who is a licensed pharmacist. “I’ve got a license to protect. That’s the last thing I’d do.

“It’s like everything else they do. They don’t talk to any patients. They don’t talk to any doctors. They just go and throw all this stuff out there and making all these incriminations against people. They don’t have any evidence that I’ve sold anything. It’s just ludicrous.”

Also named in the search warrant is United Pharmacy of Los Angeles and pharmacist Farid Pourmorady of Beverly Hills, the owner of United. Click here to see a copy of the search warrant.

“Investigators believe that United, Tennant, and various medical practitioners are profiting from the illicit diversion of controlled substances, including the powerful narcotic fentanyl, which are prescribed and dispensed other than for a legitimate medical purpose,” DEA investigator Stephanie Kolb states in lengthy affidavit.

stephanie kolb

stephanie kolb

Although Tennant has been under investigation for nearly three years, much of the evidence against him appears circumstantial. Kolb and medical consultants hired by the DEA identified “very suspicious prescribing patterns” that include high doses of opioids that were regularly prescribed to patients who live out-of-state.

“My review of the data shows what I recognize to be red flags reflecting the illicit diversion of controlled substances,” said Kolb, who according to her LinkedIn profile was self employed as a dog walker and pet groomer before she started working for the DEA in 2012.

“Many patients are traveling long distances to see Dr. Tennant, some as far away as Maryland and Louisiana,” Dr. Timothy Munzing says in the affidavit. "These prescribing patterns are highly suspicious for medication abuse and/or diversion. If the patients are actually using all the medications prescribed, they are at very high risk of addiction, overdose, and death.”

Dr. Munzing is a family practice physician who has worked as a medical consultant for the DEA since 2014. Munzing doesn't hide his strong feelings about opioids and says in his Medscape profile that he wants to be "involved with law enforcement in trying to attack the opioid crisis."

Munzing has established a lucrative business for himself as a consultant for the federal government. According to GovTribe, a website that tracks payments to federal contractors, Munzing is paid $300 an hour by the DEA to testify as an expert witness and reviewing patient records. Munzing was paid about $45,000 by the DEA during the period Tennant's prescribing records were under review.   

timothy munzing, md

timothy munzing, md

"Many well-meaning physicians prescribed high-dose opioids because of a lack of, or erroneous, education and experience, being naïve or exceedingly busy, or not recognizing the dangers that existed," Munzing wrote in a recently published paper. "This resulted in drug overdoses and death. A very small proportion of patients began selling their prescribed opioid medications for profit."

No Patients Harmed

Unmentioned anywhere in the affidavit is that it is common for Dr. Tennant to prescribe high doses of  medication to his patients because most are in extreme pain and some are dying.  Many travel from out-of-state simply because Tennant is the only doctor willing to see them.  Also unmentioned is any evidence that a patient overdosed or was harmed while under Tennant’s care.  Nor is any evidence presented that a patient sold their medication.

The omission of those important details from Kolb’s affidavit – whether by design or ignorance -- may have influenced Judge Alicia Rosenberg’s decision to sign the search warrant on the afternoon of November 13. Coincidentally, that was the same day Tennant was testifying 1,200 miles away in Montana as a defense witness in the trial of Dr. Chris Christensen, another doctor accused by the DEA of prescribing too many opioids.

Tennant and his wife Miriam returned home the next evening to find the front door of their house had been kicked in by DEA agents.

“We can’t tell you how very sorry we are that you are a new DEA target! We feel somewhat responsible for this travesty, since they obviously knew you were in Montana on our behalf,” Dr. Christensen and his wife wrote in an open letter to Tennant posted on Facebook.

“It’s our very firm belief that the DEA’s course is to attack all those practitioners, who stand in opposition to their intrusion into the practice of medicine.  It is my contention that the DEA will spare no effort to conceal its catastrophic failure to interdict the flow of counterfeit pharmaceuticals into the United States over the past decade. Therein lies the true cause of increasingly severe opioid addiction and opioid related deaths.”

The DEA raids on Tennant's home and pain clinic were widely publicized in Montana after his testimony, just as a jury was about to begin deliberations in the Christensen case. Yesterday the jury found Christensen guilty of negligent homicide in the deaths of two patients.

Subsys Connection  

A major part of the DEA’s case against Tennant hinges on nearly $127,000 in speaking fees that he was paid by Insys Therapeutics, a controversial Arizona drug maker that makes a potent fentanyl spray called Subsys.

Several company officials have been indicted on federal charges that they bribed doctors with kickbacks and lucrative speaking fees to get them to promote Subsys, which has been implicated in hundreds of overdose deaths.  

Tennant says he stopped taking payments from Insys in 2015 and was dropped from the company’s speaker’s bureau last year.

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“What money we did make, we put in the clinic and used it to support the patients,” he told PNN.

Subsys is only approved by the FDA for the treatment of cancer pain, but Insys aggressively marketed the spray to have it prescribed “off label” to treat other pain conditions. It’s perfectly legal for physicians to prescribe a drug off-label – in fact it’s a common practice – but Tennant drew additional scrutiny because he prescribed Subsys to several of his non-cancer pain patients.

Subsys is an extremely expensive drug – a single prescription for one of Tennant’s patients cost over $21,000. According to the DEA, nearly $2 million in prescriptions for Subsys were written by Tennant for just five patients. One of them was Ryle Holder.

“It did help a little bit, but it wasn’t doing anything more than what I was already taking,” says Holder, who stopped using Subsys after six months. He was shocked to discover how much his insurance was billed for Subsys.

“I was absolutely blown away. I’ve never in my life as a pharmacist seen anything price-wise even remotely like that. I don’t know if that’s the true price or not, or if they were inflating the price. Who knows? I was shocked when I got it and saw that’s what they had billed,” Holder said.

“I certainly had no comprehension of how expensive this thing had become,” said Tennant, who bristles at the notion that Subsys should be limited to patients with cancer pain.

“It was an excellent product. It still is, for some people it’s just essential,” says Tennant. “Every doctor in the country should be disturbed about this. Are they saying off label use is now a crime?”    

Patients Support Tennant

Tennant has not been charged with a crime and can still practice medicine. But he’s been informed by the DEA that medical records seized from his pain clinic will not be returned directly to him. Patients must request a copy of their records from the DEA if they wish to continue seeing Tennant.

Many are vowing to do just that.

“Before seeing Dr. Tennant I was in and out of the emergency room constantly. I had no idea what was wrong with me at the time and it was not only extremely painful, but I really just wanted to die,” says Dawn Erwin, who Tennant diagnosed with arachnoiditis.

courtesy montana public radio

courtesy montana public radio

“He took time to explain it. He told me he could help get it under control. And he has! Not by opiates, but by anti-inflammatory meds, magnets, copper, vitamins, hormones. This has all been life changing for me. I no longer am in the emergency room. I no longer wish to die. I have some of my life back and I have Dr. Tennant to thank. This man has literally saved my life.”

“I remember the first time I told my doctor I felt like I had bugs crawling under my skin. He looked at me like I was crazy, but not Dr. Tennant. He said yes that is all part of the adhesive arachnoiditis and we can see what we can do to help with that,” says Candy Eller. “The creams he recommended, the blood work and hormones he prescribed, the magnet therapy and light therapy, and exercises that he prescribed have helped so much with getting my pain under control.”

“Dr. Tennant is the only doctor that I have found that is willing to treat my rare, complex, incurable medical issues,” says Erin Taylor, who lives with Ehlers-Danlos Syndrome and an autoimmune disease. “I saw over 20 doctors, tried over 15 different invasive treatments, and tried well over 40 different medications in an effort to improve my quality of life. I was most often met with doctors that had no interest in working with such a complicated case.

“To restrict Dr. Tennant’s ability to practice would have a devastating impact on my life, my family’s life, and lives of many more.  Please know that if you chose to eliminate the one doctor that is working to help my debilitating illness, you will be taking away my ability to be mother, wife, daughter, friend, and functioning member of society. I will be bed bound, just a shell of who I use to be.”

For the record, Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.  

Former Insys Executives Arrested for Bribing Doctors

By Pat Anson, Editor

The former CEO of Insys Therapeutics and five other former company executives have been arrested on federal charges of racketeering and bribing doctors to prescribe a potent painkiller off-label.

The arrests culminate a lengthy investigation into the Arizona drug maker, which has been accused of sordid sales practices that led to the overdose deaths of hundreds of pain patients.  

The fentanyl-based painkiller, called Subsys, has FDA approval for breakthrough cancer pain. The Insys executives allegedly bribed and gave kickbacks to doctors to prescribe the oral spray off-label for patients suffering from conditions such as joint pain and post-traumatic stress disorder.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine.

“Patient safety is paramount and prescriptions for these highly addictive drugs, especially fentanyl, which is among the most potent and addictive opioids, should be prescribed without the influence of corporate money,” U.S. Attorney Carmen Ortiz said in a statement. 

Former CEO Michael Babich and the other Insys executives are also charged with misleading and defrauding insurance companies that were reluctant to approve payments for Subsys when it was prescribed for non-cancer patients. The company created a special “reimbursement unit” that was dedicated to obtaining prior authorization from insurers, often by falsely claiming they were for patients with medically urgent cancer diagnoses.

“As alleged, top executives of Insys Therapeutics, Inc. paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression,” said Harold Shaw, Special Agent in Charge of the FBI’s Boston Field Division.  “In doing so, they contributed to the growing opioid epidemic and placed profit before patient safety."

The Southern Investigative Reporting Foundation released a report last year, headlined “Murder Incorporated,”  that blamed aggressive sales practices at Insys for the overdose deaths of hundreds of pain patients.  CNBC also accused the company of “putting profits before patients as it makes millions off your pain.”

In June, federal agents arrested two Insys sales representatives for bribing doctors to prescribe Subsys. Some physicians were wined and dined at upscale restaurants in New York City, while others were taken to private tables at a strip club and given free drinks. According to the indictment, the salesmen were instructed to "expect and demand" that doctors hired by Insys to speak at promotional events prescribe "large quantities" of Subsys. The doctors obliged, prescribing over $5 million worth of Subsys in 2014, much of it billed to private insurers or Medicare.

Doctors are allowed to prescribe drugs for conditions not approved by the FDA, a practice known as off-label prescribing, but drug makers are not permitted to market or promote medications for off-label use.

According to Open Payments, a government website that tracks industry payments to doctors, Insys paid over $6 million to nearly 7,800 doctors last year for food, beverages, travel, lodging and speaker fees. The payments were 30 times more than what the company reported spending on research.

Subsys is a lucrative product for Insys and its biggest moneymaker. According to the Healthcare Bluebook, 30 spray bottles of Subsys currently cost about $5,600.

Sales Reps Charged in Fentanyl Kickback Scheme

By Pat Anson, Editor

We’ve been reporting recently about illicit fentanyl and how drug dealers were using the potent painkiller to make counterfeit pain medication and selling it on the street, resulting in dozens of overdose deaths.

But drug dealers aren’t the only ones peddling fentanyl illegally and killing people in the process.

Federal prosecutors say two sales reps for Insys Therapeutics broke the law by paying doctors to prescribe Subsys, an oral fentanyl spray sold by the Arizona drug maker. Some doctors were wined and dined at upscale restaurants in New York City, while others were taken to private tables at a strip club, given free booze, and who knows what else.

The sordid details were revealed in a federal indictment handed down last week, which resulted in the arrests of Jonathan Roper and Fernando Serrano.

It’s not the first and probably not the last time Insys has come under scrutiny for unscrupulous marketing tactics or for putting profits ahead of patients. Another former Insys sales representative pleaded guilty to federal kickback charges in February, and the company is under federal and state investigations in Oregon, California, Massachusetts, Connecticut, Arizona and Illinois.

Subsys was approved by the FDA for breakthrough cancer pain, but Insys allegedly pressured its sales representatives to woo or bribe doctors into prescribing Subsys off-label for conditions such as joint pain and post-traumatic stress disorder.

The spray is a lucrative product for Insys and it's biggest moneymaker. According to the Healthcare Bluebook, 30 spray bottles of Subsys cost about $7,300.

“This case should be something the medical industry and the general public should pay close attention to because it’s one of the reasons we’re experiencing an epidemic of overdoses and deaths in this country,” said FBI Assistant Director Diego Rodriguez.

“Not only did the defendants in this case allegedly bully sales reps into pushing this highly addictive drug, they paid doctors to prescribe it to patients.  The more prescriptions written, the more money the doctors made.  Instead of seeing a way to help people who are dealing with extreme pain, they allegedly saw a huge payday that potentially put people’s lives in danger.”

Since Subsys was introduced in 2012, the FDA’s Adverse Events Reporting System lists over 200 deaths linked to Subsys as the probable cause of an adverse reaction.

According to prosecutors, Roper and Serrano paid two unnamed doctors hundreds of thousands of dollars to make “educational presentations” to other physicians about Subsys. Many of the presentations were nothing more than “social gatherings at high-end restaurants in Manhattan” and some of the physicians were later taken to a strip club, according to prosecutors. Sign in sheets for the presentations were frequently forged to make them appear legitimate

According to the indictment, Serrano was instructed by his sales manager to "expect and demand" that the two doctors hired as speakers prescribe "large quantities" of Subsys. The doctors apparently obliged, prescribing over $5 million worth of Subsys in 2014, much of it billed to private insurers or Medicare.

According to Open Payments, a government website that tracks industry payments to doctors, Insys paid over $7 million to doctors in 2014 for food, beverages, travel, lodging and speaker fees; over ten times what the company reported spending on research.  You can see if your doctor took money from Insys and how much by clicking here.

“Jonathan Roper and Fernando Serrano corruptly induced doctors to prescribe millions of dollars’ worth of Fentanyl through thousands of dollars in kickbacks disguised as phony educational programs.  As alleged, Roper and Serrano helped feed this devastating surge of opioid addictions by tapping into another age-old addiction, greed,” said U.S. Attorney Preet Bharara.

Roper and Serrano are each charged with one count of conspiracy to violate the federal Anti-Kickback Statute and one count of violating the Anti-Kickback Statute.  Each of the two counts carries a maximum term of five years in prison. 

Cancer Painkiller Blamed for Hundreds of Deaths

By Pat Anson, Editor

An Arizona drug maker that developed a powerful painkiller for cancer patients falsified records so the drug would be prescribed to non-cancer pain patients, possibly resulting in hundreds of overdose deaths, according to a new report by the Southern Investigative Reporting Foundation.

Subsys has FDA approval for breakthrough cancer pain, but Insys Therapeutics allegedly misled insurers into paying for the drug and encouraged off-label prescribing for patients suffering from conditions such as joint pain and post-traumatic stress disorder.

Subsys is a fentanyl based spray-on painkiller, said to be 100 times stronger than morphine.

The new report, headlined “Murder Incorporated,”  adds to the growing body of evidence and critical media reports about the aggressive business tactics of Insys Therapeutics. Last month CNBC accused the company of “putting profits before patients as it makes millions off your pain.”

"I've been investigating drug cases for about 15 years now, and the conduct that we saw in this case was among the most unconscionable that I've seen," Oregon Assistant Attorney General told CNBC. "There was harm done to patients on a level I'm not used to seeing."

image courtesy of insys therapeutics

image courtesy of insys therapeutics

Insys is under federal and state investigations in Oregon, California, Massachusetts, Connecticut, Arizona and Illinois. The company has settled a class action lawsuit in Oregon for $1.1 million and another in Arizona for $6.1 million.

The Southern Investigative Reporting Foundation has spent the past year investigating Insys and its business practices. It reported the company set up a special unit to help patients get prior authorization for Subsys prescriptions, often by falsely claiming they were medically urgent cancer diagnoses.

“Our findings suggest that the federal prosecutors are on to something. The prior authorization unit was set up to assist patients with complex insurance paperwork. Its value proposition was simplicity itself: the patient signs a few forms and Insys handles the messy paperwork. Patients would get the medicine, prescribers wouldn't have to scramble for a replacement and Insys would book thousands of dollars in revenue per prescription,” the report says.

Since Subsys was introduced in 2012, the FDAs Adverse Events Reporting System lists 203 deaths where Subsys was listed as the probable cause for triggering an adverse reaction. The pace of Subsys-related deaths is accelerating, with 52 deaths in the second quarter of this year alone.

“Depending on the dosage, one package of 30 Subsys sprays can cost between $900 and $3,000. Insys generates almost all of its revenue from Subsys. Last month the company reported over $91 million in revenue during the third quarter, beating estimates.

CEO Mike Babich resigned the day before earnings were released, saying he wanted to spend more time with his family.

“Insys is committed to developing products for the supportive care of patients through the use of its drug delivery technologies.  Insys takes patient safety very seriously and is committed to working with the health care community,” the company said in a statement. “Based on its interactions with patients and prescribers, Insys believes that the success of Subsys is directly attributable to the clinical benefits of its product.”