Ex-CEO Admits ‘I Took Money From U.S. Pain’

By Pat Anson, PNN Editor

The founder and former CEO of the U.S. Pain Foundation admitted over three months ago that he “made some big mistakes” and took money from the non-profit for his own personal use.

Paul Gileno resigned at the request of U.S. Pain’s board of directors in May, but the reasons behind his departure have only emerged in the last few days. In a statement posted Friday on the non-profit’s website, interim CEO and board chair Nicole Hemmenway publicly acknowledged for the first time that an internal audit six months ago had uncovered “financial irregularities” involving Gileno.

“The findings were clear that this individual had misused funds from the U.S. Pain Foundation,” Hemmenway wrote.

That Gileno had embezzled money from the non-profit has been known to the leadership of U.S. Pain for some time. He confessed to it in an email on September 5th. PNN has obtained a copy of the email and Gileno has acknowledged writing it.

“I am sad to say that I made some big mistakes over the past few years and took money from US Pain for my personal use. I make no excuses for this. I did take money and I will pay the ultimate price,” Gileno wrote.

“I did mismanage money and wasn’t as strict on budgets as I should have been, but it never effected what we did (nor) did it hurt our growth.”

PAUL GILENO

PAUL GILENO

Gileno sent the email to over a dozen key people at U.S. Pain, including board members Wendy Foster, Ellen Lenox Smith and Suzanne Stewart – who resigned from the board a few weeks later. Other recipients include Cindy Steinberg, National Director of Policy and Advocacy; Shaina Smith, Director of State Advocacy;  Lori Monarca, Executive Office Manager; Casey Cashman, Director of Fundraising and Emily Lemiska, Director of Communications.

U.S. Pain’s volunteers, ambassadors, and donors were left in the dark and never informed about the audit or Gileno’s confession. And the non-profit continued to solicit and accept donations as if nothing was wrong.

Only after inquiries from PNN about Gileno’s resignation and the lengthy delay in filing U.S. Pain’s tax returns did the organization release Friday’s statement. The statement offered no specifics on the financial irregularities that were found, the amount of money stolen, when the thefts occurred, or if others were involved.

‘I Never Took a Salary’

Gileno founded U.S. Pain in 2011 and it quickly grew into a nationwide patient advocacy group that received millions of dollars in mostly corporate donations.

Gileno claimed in his email that “I never took a salary… nor did I receive any benefits." But U.S. Pain’s 2015 tax return indicates Gileno was paid a salary of $403,000. The non-profit’s tax returns for 2016 and 2017 have not been filed and are delinquent, which could potentially jeopardize U.S. Pain’s tax exempt status.

In February, U.S. Pain was criticized in a congressional report for participating in a $2.5 million prescription co-pay program funded by Insys Therapeutics, an Arizona drug maker accused of bribery, fraud and other criminal charges. The co-pay program was scrapped soon after Gileno’s departure.

In his email, Gileno said he never took kickbacks from Insys or other drug makers.

“I always put the person with pain first and never accepted money from pharmaceuticals to do their bidding not once. If you are questioning this then that makes me sad because it never happened and you don't really know me,” Gileno wrote.

“I have also worked with the US Attorney in MA (Massachusetts) to deal with US Pain’s relationship with INSYS.  I cooperated with the FBI and HHS (Health and Human Services). Once again so you can feel better not one time did I take or accept money from a pharmaceutical to push a drug. They are using me to help them deal with INSYS and build whatever case they are building.” 

Last month a former Insys vice-president pleaded guilty in federal court in Boston to charges of bribing doctors to prescribe Subsys, a potent fentanyl spray made by Insys that has been blamed for the overdose deaths of hundreds of pain patients.

A spokesperson for the U.S. Attorney’s Office would not say if Gileno is a co-operating witness in the Insys case or if U.S. Pain is under investigation. “Per Department of Justice policy, we can neither confirm nor deny investigations,” said Liz McCarthy, U.S. Attorney’s Office – District of Massachusetts.

Gileno, who has two young sons, was remorseful in the email and asked for forgiveness. He anticipates serving jail time.

“My life is ruined right now because of my mistakes,” he wrote. “I am deeply truly sorry. It was selfish to take money from US Pain.

“When they finally give me charges to plead guilty to, either tax evasion or fraud or whatever they come up with, there will be a sentencing and they will need character letters or testimony of the person I am besides the taking of the money. If you reach out to me privately that you would like to stay in contact, it would mean the world to my boys and myself if you would send one in.”

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.

Subsys.png

“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.”

Report Alleges Opioid Makers Bankrolled Patient Groups

By Pat Anson, Editor

U.S. Senator Claire McCaskill (D-MO) has released a scathing report that is sharply critical of patient advocacy groups and medical pain societies for accepting money from opioid manufacturers.

The report found that Purdue Pharma, Janssen Pharmaceuticals, Mylan, Depomed and Insys Therapeutics provided nearly $9 million to over a dozen non-profits and medical societies from 2012 to 2017.  In many cases, the amount of the donations was not fully disclosed by the recipients.

“These financial relationships were insidious, lacked transparency, and are one of the many factors that have resulted in arguably the most deadly drug epidemic in American history,” McCaskill's report alleges.

    Opioid Maker Payments to Advocacy Groups

  • Purdue Pharma              $4,153,000
  • Insys Therapeutics         $3,146,000
  • Depomed                        $1,071,000
  • Janssen                             $465,000
  • Mylan                                  $20,250

Over the same five year period, physicians affiliated with the advocacy groups and medical societies accepted more than $1.6 million in payments from the opioid manufacturers.  

bigstock-Pills-669040.jpg

McCaskill, who is the top-ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, has long been critical of opioid prescribing practices and the role they played in fueling the so-called opioid epidemic.  Her report suggests that advocacy groups that criticized the CDC’s 2016 opioid prescribing guidelines did so to curry favor with drug makers -- not because of the well-documented harm the guidelines were causing pain patients.  

“Initiatives from the groups in this report often echoed and amplified messages favorable to increased opioid use — and ultimately, the financial interests of opioid manufacturers. These groups have issued guidelines and policies minimizing the risk of opioid addiction and promoting opioids for chronic pain, lobbied to change laws directed at curbing opioid use, and argued against accountability for physicians and industry executives responsible for overprescription and misbranding,” the report found.

"The fact that these same manufacturers provided millions of dollars to the groups described below suggests, at the very least, a direct link between corporate donations and the advancement of opioids friendly messaging. By aligning medical culture with industry goals in this way, many of the groups described in this report may have played a significant role in creating the necessary conditions for the U.S. opioids epidemic."   

Top 10 Recipients of Funding from Opioid Makers

  1. U.S. Pain Foundation                                                      $2.922,000
  2. American Academy of Integrative Pain Management     $1,265,000
  3. American Academy of Pain Medicine                              $1,199,000
  4. American Pain Society                                                       $962,000
  5. National Pain Foundation                                                   $562,000
  6. Washington Legal Foundation                                           $500,000
  7. American Chronic Pain Association                                   $417,000
  8. American Society of Pain Management Nursing                $323,000
  9. AAPM Foundation                                                              $304,000
  10. Center for Practical Bioethics                                             $163,000

"Sen. McCaskill and the others haven’t spent the necessary time talking to us to understand how we do things and what we have to offer," Bob Twillman, PhD, Executive Director of the American Academy of Integrative Pain Management said in a statement. "It appears that they’ve simply looked at how much money we got from a set of pharma companies, constructed a narrative about what that means, and published it."

Perhaps the most surprising detail in the report is the amount of money Insys Therapeutics gave to the U.S. Pain Foundation – over $3.1 million --- with $2.5 million paid in 2017 alone. Insys is the manufacturer of Subsys, a potent fentanyl-based spray that has been 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 to non-cancer patients. The Arizona drug maker has also been accused of misleading and defrauding insurance companies to pay for Subsys, which can cost tens of thousands of dollars for each 30-day prescription.

U.S. Pain founder and president Paul Gileno released a statement defending his non-profit's acceptance of the Insys money. He said the funds were used by the organization to fund a co-pay assistance program for cancer patients.   

"This funding, like any funding we receive, does not influence our values. When it comes to opioids, we believe both that people with legitimate pain have a right to effective care and that systematic changes must be made to address the ongoing opioid crisis," Gileno said.

McCaskill’s report makes no mention of the increasing role played by illegal opioids, such as heroin and illicit fentanyl, in fueling the opioid epidemic. A recent CDC report blamed illicit fentanyl for over half of the overdoses in ten states -- including McCaskill's home state of Missouri.  

Law Firms Major Donors to McCaskill Campaign

According to OpenSecrets.org, McCaskill has received over $6 million in campaign donations from law firms since 2005, including some currently involved in litigation against opioid manufacturers. Contributors affiliated with the law firm of Simmons Hanly Conroy have donated over $300,000 to McCaskill, who is running for re-election this year.

Simmons Hanly Conroy represents dozens of states, counties and cities that are suing Purdue Pharma and other drug makers over their marketing of opioids, and would pocket one-third of the proceeds from any settlement, according to reports.

A statement on the Simmons Hanly Conroy website claims the law firm "effectively invented large-scale, multi-defendant opioid litigation" and is a "trusted ally to local and state governments who seek justice and reprieve from the often debilitating costs associated with fighting the opioid crisis."

According to a survey of over 3,100 patients by Pain News Network and the International Pain Foundation, the CDC guidelines have reduced access to pain care, harmed many patients and caused some to consider suicide. Over 70 percent said their opioid medication had been reduced or cutoff by doctors, and 11 percent said they had obtained opioids illegally for pain relief since the guidelines came out. 

DEA Gives Final Approval to Synthetic Marijuana Drug

By Pat Anson, Editor

The U.S. Drug Enforcement Administration has approved a synthetic form of THC (tetrahydrocannabinol) – the active ingredient in marijuana that makes people “high” – as a Schedule II controlled substance. The move is the final regulatory hurdle for dronabinol (Syndros), an oral solution already being prescribed for the treatment of nausea and vomiting in chemotherapy patients, and as an appetite stimulant for AIDS patients.

Schedule II substances include oxycodone, hydrocodone and other drugs that have an accepted medical use, but a high abuse potential.  

The DEA announced the scheduling of dronabinol in a notice quietly published in the Federal Register the day before Thanksgiving. The agency adopted an interim rule classifying dronabinol as a Schedule II substance in March, and the Food and Drug Administration approved a new drug application for dronabinol in July, recommending that DEA make its rule final.

This week’s action was not unexpected, but is weirdly ironic on several levels.

The classification of dronabinal as a Schedule II substance means that a synthetic version of marijuana can be legally prescribed throughout the country, while real marijuana is still classified as a dangerous Schedule I substance and remains illegal under federal law – except in the 29 states and the District of Columbia where medical cannabis is legal.

Dronabinol is sold under the brand named Syndros by Insys Therapeutics, a controversial Arizona drug maker beset by allegations that another one of its products – a potent fentanyl spray called Subsys – is responsible for hundreds of overdose deaths.

The DEA has been aggressively going after doctors who prescribed Subsys and accepted speaking fees from Insys, and several company officials have been indicted on fraud, racketeering and kickback charges.

Snydros is similar to Marinol, another medication derived from marijuana that comes in pill form.

insys therapeutics photo

insys therapeutics photo

The DEA's action is also notable because it gives Insys the exclusive right to manufacture and sell its liquid formulation of dronabinol without having to worry about competition. Any other synthetic version not sold as Syndros will still be considered a Schedule I substance, on par with LSD, heroin and marijuana.

 “It should be noted as a preliminary matter that any form of dronabinol other than in an FDA-approved drug product remains a schedule I controlled substance, and those who handle such material remain subject to the regulatory controls, and administrative, civil, and criminal sanctions, applicable to schedule I controlled substances set forth in the CSA (Controlled Substance Act) and DEA regulations,” the DEA said.

According to Healthcare Bluebook, a one-month supply of Syndros will cost about $2,000 at major pharmacy chains. A "fair price" for Syndros is listed as $1,000.

Insys Thereapeutics drew the ire of marijuana advocates last year when it donated $500,000 to a campaign against the legalization of marijuana in Arizona.

The company is worried about the medical use of “natural cannabis,” but has petitioned the DEA to reschedule another synthetic cannabidiol (CBD) that is derived from marijuana from Schedule I to Schedule IV.

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.

cancer-pain-5.png

“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.  

I Would Not Be Alive Without Dr. Tennant

(Editor’s note: As PNN has reported, last week the DEA raided the home and offices of Dr. Forest Tennant, a prominent pain physician in California.  The DEA search warrant alleges that Dr. Tennant is part of a “drug trafficking organization” and prescribes excessive amounts of opioid pain medication. Dr. Tennant treats about 120 patients with intractable chronic pain, including many from out-of-state who can’t get effective treatment elsewhere. Kimberley Comfort is one of them.)  

By Kimberley Comfort, Guest Columnist

My Dad searched the country for help for me, as I have spent my life since September 2010 in 24/7 intractable pain. I ended up having two major surgeries trying to help. None helped with the severe intractable pain.

My Dad finally found Dr. Tennant and flew me on three plane seats, while he sat in another row, so I could remain laying down to reach California in January 2014.

Dr. Tennant saw me for over 12 hours in two hour sections in the morning and afternoon. He was essentially a charity. It was 12 hours of full one-on-one attention for $100. He did extensive examinations, blood tests, a genetic test, and trying out different very mild exercises once he diagnosed my adhesive arachnoiditis. He explained some treatments that might help if I ever had my spinal cord stimulator removed.

KIMBERLEY COMFORT

KIMBERLEY COMFORT

Dr. Tennant did prescribe me some additional opioid medication, while awaiting the results from genetic testing, along with vitamins, minerals, anti-inflammatory drugs, and a water reduction pill that mainly concentrated on the spine.

He agreed that I try a drug combination from a doctor in France that my Dad had researched and spoken with. Opioids were Dr. Tennant's last choice and high dose opioids were for those who metabolized the opioids much too fast.

Dr. Tennant thought I should return monthly, but we explained that the flight was just way too much for me to handle. So Dr. Tennant explained that palliative care was all that remained. He wrote letters to my pharmacy in Florida explaining my disease and why I was requiring such high amounts of opioids. He wrote my primary care provider and explained everything to him, offering to help in any way he could.

Dr. Tennant had recommended injectable Dilaudid, but my doctor would not give me that. Instead, it took him another 15 months and 4 different opioids to get me to a point where I was not in intractable pain 24/7.

I would not be alive today if it were not for Dr. Tennant. There is no way I could or would survive the pain I have without my high dosage of opioids. The genetic test showed I was a very fast metabolizer of opioids.

I have suffered with pain since I was a teenager.  Even back then, I was given opioids with Valium. My primary care provider still gives them to me today. If a doctor told me my liver was dying and they needed to cut back on my opioids, my answer would be the same now at age 52, as it was at 16.  I would much prefer a shortened life with manageable pain than to live a long torturous life with intractable pain. Frankly, I believe my heart would give out if I faced intractable pain again 24/7.

The opioid doses that the CDC recommends are far less then I have been on since the day adhesive arachnoiditis hit me like a Mack truck.

As for the money Dr. Tennant received from Insys Therapeutics, it is very little compared to some doctors. Doctors often get paid for speaking, get free lunches for the staff and themselves, and airfare to conferences where they will speak. Dr. Tennant is far from the only doctor to do this.

One can go online to ProPublica’s Dollars for Docs and see how much your internist, orthopedic surgeon, neurologist, etc. got from pharmaceutical and medical device companies. It shows that from 2013 to 2015, Dr. Tennant received $127,000.

Compare that to the highest paid doctor. Dr. Roger Jackson, an orthopedic spine surgeon, was paid $54,100,000 during that same time period.

DR. FOREST TENNANT

DR. FOREST TENNANT

Dr. Tennant basically works for nothing. You should see how hard and long he works, speaks to educate doctors, and does research to help those of us who would very likely be dead if not for him. To me, Dr. Tennant is a saint!

The DEA should be going to Dr. Tennant, not to raid his offices, but to learn from him. My understanding of U.S. medicine is that a doctor had to be a Doctor of Public Health (DPH), as Dr. Tennant is, to have prescribed pain medication back in the 1960’s. Dr. Tennant was sent the worst of the worst pain patients back then, when “learning to live with it” was impossible for severely injured patients. Pain patients from all walks of life were referred to him for help that the other doctors could not give.

Dr. Tennant is far more educated than most any doctor left today, except perhaps other DPH doctors who have kept up with the times. In my Dad’s research, we found no other doctor specializing in intractable pain. Dr. Tennant has more than 35 years of prescribing pain medication under his belt. He knows what works and what doesn’t. He is the doctor the DEA and the Department of Justice should be calling as an expert witness in the treatment of pain, not going after.

This is nothing more than a smear campaign to try to ruin Dr. Tennant. All these government agencies, Physicians for Responsible Opioid Prescribing (PROP), and the news media have mixed up illicit drug use with needed intractable and chronic pain relief. They are mixing apples with oranges. Pain patients do NOT get a high from opioids. If we are lucky, we get some relief. Some get more relief than others and can go back to living a fairly normal life with opioids.

The crackdown on pain medication isn’t going to stop an addict from looking for that next high. Overdoses will continue even if the DEA, FDA, CDC and DOJ totally eliminate opioid medication. People will find something else to get high with and we will still have overdoses.

The intractable pain patient who has followed the law and their prescription directions will never get high and will, if they’re lucky, be able to have some semblance of a life. Take away their opioid medication and you will murder these people by forcing them to take their own life or waiting until their body fails from the extreme stress of the pain. Our blood will be forever on your hands.

You are trying so hard to take down any doctor who follows the Hippocratic Oath they took to render care to those who need it. You are too ignorant to not recognize the bad science used by the greedy doctors trying to get more money for rehabilitating illicit drug users. You fail to listen to the experts in the treatment of pain and instead only care about the treatment of addicts.

We, the intractable and chronic pain patients, need and depend on the assistance of the few remaining doctors willing to help. Let Dr. Tennant continue to be the highly educated pain doctor he is. Let him continue to help us stay alive and be with our loved ones.

We all are suffering, some worse than others. Without Dr. Tennant and those good doctors you have already tossed to the curb or worse, you will be responsible for our screams of pain and our forced intentional suicides. It will be murder by proxy.

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Kimberly Comfort lives in Florida.

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.

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