Feds Found ‘Staggering’ Drug Testing Fraud at Tennessee Pain Clinics

By Fred Schulte, Kaiser Health News

The Justice Department has accused a defunct chain of Tennessee-based pain clinics of cheating Medicare and other taxpayer-funded health insurers out of at least $25 million in needless urine drug tests and genetic testing.

The civil lawsuit names Comprehensive Pain Specialists, also known as Anesthesia Services Associates PLLC; four of its physician owners; and a former top executive. The doctors include Tennessee Republican State Sen. Steven Dickerson and Peter Kroll, both anesthesiologists.

At its peak, CPS ran 60 pain clinics in a dozen states and treated some 48,000 patients per month, according to the suit. It shut down abruptly last summer, leaving many chronic pain patients scrambling to find a new source of narcotic medicines.

The Justice Department fraud case centers largely on the company’s lucrative urine-testing lab in Brentwood, Tenn., which CPS financed with a $1.5 million loan. The suit also alleges overbilling from acupuncture and other services offered to patients.

CPS was the subject of a November 2017 investigation by Kaiser Health News that scrutinized Medicare billings for urine drug tests.

Medicare and other federal programs paid over $70 million from 2011 to 2018 for CPS-ordered urine tests, an amount the lawsuit called “staggering.” TennCare, the state’s Medicaid program, paid more than $9 million more during that time.

“For this reason, CPS considered [urine tests] to be ‘liquid gold’ — with revenues of tens of millions of dollars for what was largely unnecessary medical testing,” according to the suit.

The chain’s owners and then-CEO John Davis “viewed every CPS patient as an opportunity to make money, without regard to the individualized need for treatment,” the suit alleges. Davis was convicted last year in Nashville on federal criminal health care fraud charges. He has since filed a motion for a new trial.

Dan Martin, an attorney representing Kroll, said in an emailed statement: “We are aware of the allegations and very familiar with the actual facts. Dr. Kroll did not engage in any wrongdoing whatsoever, and we look forward to correcting the government’s misunderstanding of the facts.”

Dickerson’s attorney, Ed Yarbrough, also issued a statement that read: “Dr. Dickerson is an honest man. We will prove that in court.” 

$8.5 Billion Annually Spent on Drug Tests

In its investigation, KHN, with assistance from researchers at the Mayo Clinic, found that spending on urine screens and related genetic tests quadrupled from 2011 to 2014 to an estimated $8.5 billion a year — more than the entire budget of the Environmental Protection Agency. The federal government paid medical providers more to conduct urine drug tests in 2014 than it spent on the four most recommended cancer screenings combined.

CPS was among the nation’s most aggressive testers. KHN found that in 2014 five of its medical professionals stood among the nation’s top billers. Anita Bayles, a nurse practitioner working at a CPS clinic in Cleveland, Tenn., generated $1.1 million in urine-test billings that year, according to Medicare records analyzed by KHN.

The Justice Department suit says that CPS believed Bayles ordered too many urine tests and overprescribed opioids and in September 2016 decided to fire her. But the decision was reversed by CEO Davis “because of her ability to generate revenues,” according to the suit. Bayles could not be reached for comment.

IMAGE COURTESY OF MARK COLLEN AND PAIN EXHIBIT

Though CPS ran six or more urine tests a year on many patients receiving narcotics, its doctors often did not review the results to make sure patients did not abuse them, according to the suit.

Kroll, who also served as CPS’ medical director, told KHN in 2017 that the high volume of tests was justified to keep patients safe and to reduce chances of black market sales of pills.

Kroll billed Medicare $1.8 million for urine tests in 2015, the KHN analysis of Medicare billing records found.

Kroll said in a 2017 interview that he and Dickerson came up with the idea to open a high-quality pain practice over a cup of coffee at a Nashville Starbucks in 2005.

But the Justice Department alleges that CPS expanded rapidly through bilking the government, conduct that its top executives and founders “failed to take any action to stop,” according to the suit.

In what is called a “particularly egregious example of this fraudulent conduct,” the Justice Department alleged that Kroll caused over 2,500 claims to be submitted to Medicare, for which CPS was paid almost $350,000, during a 10-day period in May 2017 when Kroll was on vacation in Italy.

“Because of these fraudulent claims, Kroll’s billing privileges with Medicare have been revoked,” according to the suit.

The lawsuit states that Medicare officials began investigating overcharging for urine testing at CPS in 2014 and eventually directed the company to repay the government $27.4 million in an extrapolated penalty. But CPS aggressively appealed the decision and managed to get it overturned and stay in business.

Once among the largest pain management groups in the Southeast, CPS crumbled amid financial woes that included nearly a dozen civil suits alleging unpaid debts, as well as the criminal case against Davis. In a court filing in December, the company said that it had terminated all of its employees and that its debts “greatly exceed its assets.”

In total, Medicare paid CPS over $150 million from 2011 to 2018, a large part of which was related to urine testing, while TennCare paid CPS over $32.5 million, according to the suit.

The Justice Department complaint consolidates several whistleblower cases filed against the company by doctors and other former employees. Federal whistleblower cases seek recovery of money paid improperly and can include treble damages, or three times the amount of the original overpayment.

One of the whistleblowers said he toured the lab with CPS executives and observed an “overpowering and unpleasant smell of urine.” In response, a CPS executive said, “To me, it smells like money,” according to the whistleblower’s suit.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Teens Who Abuse Rx Opioids More Likely to Try Heroin

By Roger Chriss, PNN Columnist

A new study from the University of Southern California finds that teens who abuse prescription opioids are more likely to start using heroin by high school graduation.  

Published in JAMA Pediatrics, the study tracked nearly 3,300 students in ten public high schools in the Los Angeles area from 2013-2017. Nearly 600 of those students reported using prescription opioids to get high.

By the end of high school, a total of 70 students had started using heroin, including about 12% of those who abused opioid medication. Only 1.7% of students who did not misuse prescription opioids tried heroin.

The researchers looked closely at not only the nonmedical use of prescription opioids, but also the use of other substances. A family history of smoking, alcohol and drug problems, and interpersonal factors such as impulsiveness, anxiety, depression and delinquent behavior were also assessed.

Among all the different factors, the best predictor of heroin use was the abuse of prescription opioids. This tendency was significantly stronger than the use of alcohol, cannabis, cigarettes or other non-opioid drugs.

"Prescription opioids and heroin activate the brain's pleasure circuit in similar ways," said senior author Adam Leventhal, PhD, director of the USC Institute for Addiction Science. "Teens who enjoy the 'high' from prescription opioids could be more inclined to seek out other drugs that produce euphoria, including heroin.”

Researchers also found that students who initiated heroin use were more likely to be male, have less parental monitoring, more delinquent behavior, and impulsive personalities.

The USC study adds to previous research on the complex drug use trajectories that culminate with heroin. It has long been known that nonmedical prescription opioid use is associated with later heroin use, with some anti-opioid activists claiming that 80% of heroin addicts begin by abusing prescription opioids. That is a misleading statistic, as I discussed in a previous column.

There clearly is an association between the misuse of prescription opioids and heroin use, but as the USC researchers found, many other factors are also involved and more research is needed. Their study, for example, did not look at how teens who misused prescription opioids obtained them.  Most likely, they were obtained from friends or family members.

The USC study findings not only advance our understanding of heroin initiation, but also signal the importance of developing better policies to prevent nonmedical opioid use.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

FDA Approves First Generics for Lyrica

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved the first generic versions of Lyrica (pregabalin), a medication widely prescribed for the treatment of fibromyalgia, diabetic neuropathy and other types of chronic pain.

Lyrica has been a blockbuster drug for Pfizer since its approval in 2004, generating revenue of $4.6 billion annually. The recent expiration of Pfizer’s patent on Lyrica opened the door to much cheaper generic competitors.

A one year supply of Lyrica currently costs about $2,800 in the United States, according to Healthcare Bluebook, while a similar dose of pregabalin under the UK’s National Health Service costs about $74.

“Today’s approval of the first generics for pregabalin, a widely-used medication, is another example of the FDA’s longstanding commitment to advance patient access to lower cost, high-quality generic medicines,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“The FDA requires that generic drugs meet rigorous scientific and quality standards. Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA.”

The FDA granted approvals for generic pregabalin to 9 drug makers: Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.

Pfizer’s patent for Lyrica CR — an extended released version of Lyrica — remains in effect until April, 2021.

Side Effects

The most common side effects for Lyrica are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain and difficulty concentrating. Lyrica’s warning label also cautions users that the drug may cause suicidal thoughts in about 1 in 500 people.

Pregabalin is classified as Schedule V controlled substance in the U.S., which means it has a low potential for abuse. In recent years, however, there is growing concern that pregabalin and its sister drug gabapentin (Neurontin) are being abused and overprescribed. The drugs were recently classified as controlled substances in the UK.

Pregabalin and gabapentin were originally developed to prevent epileptic seizures, but their use has tripled over the past 15 years as more doctors prescribed them off-label as “safer” alternatives to opioids.

A recent study in the British Medical Journal found the drugs increase the risk of suicide, overdose and traffic accidents in younger people. The risks were strongest for those taking pregabalin and were most pronounced among adolescents and young adults aged 15 to 24. Patients aged 55 and older taking gabapentinoids were not at greater risk.

Pharmacists and Rx Wholesalers Charged with Drug Trafficking

By Pat Anson, PNN Editor

Major pharmaceutical companies like Purdue Pharma, Mallinckrodt and Johnson & Johnson are often singled out for their role in the nation’s opioid crisis. But wholesalers, pharmacies and other parts of the drug distribution system are also coming under scrutiny.

This week the former president and former compliance officer for an Ohio drug distributor and two West Virginia pharmacists were arrested after being indicted for conspiring to distribute controlled substances.

The company, Miami-Luken, supplied drugs to over 200 pharmacies in Ohio, West Virginia, Indiana and Tennessee, generating over $173 million in sales annually.

Prosecutors say Miami-Luken distributed opioid pain medication “outside the scope of professional practice and not for a legitimate medical purpose.”

Between 2011 and 2015, the company allegedly ignored “obvious signs of abuse” by distributing more than 2.3 million oxycodone pills and 2.6 million hydrocodone pills to a pharmacy in Oceana, West Virginia, a town of less than 1,400 people.

From 2008 to 2011, over 3.7 million hydrocodone pills were supplied by Miami-Luken to a pharmacy in Kermit, West Virginia, which has about 400 people.

Criminal Charges Rare

According to CNN, it’s only the second time a drug distributor has been criminally charged with illegally distributing opioid painkillers. In April, two former executives of the Rochester Drug Co-Operative in upstate New York were charged with drug trafficking for failing the stop suspicious orders for opioids.

In previous cases, wholesalers, pharmacies and even hospitals paid heavy fines for not being alert to suspicious activity. Last year, for example, Effingham Health System of Georgia agreed to pay a $4.1 million settlement after the DEA uncovered the diversion of tens of thousands of oxycodone tablets from its hospital.

In 2017, CVS Health agreed to pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of hydrocodone. In 2015, CVS paid a $22 million fine because two of its Florida pharmacies filled bogus prescriptions for opioids.  

Cardinal Health, one of the nation’s largest drug wholesalers, was fined $34 million by the DEA in 2012 after it failed to report suspicious orders for hydrocodone at a Florida distribution facility.

The list goes on and on. The point is that no one went to prison or was criminally charged in any of these cases. Which may be about to change. The four defendants in the Miami-Luken case face up to 20 years in prison. 

“Today’s arrests should be a wakeup call to distributors and pharmacists who are allowing opioid prescription pills to be illegally sold and dispensed from their facilities,” said DEA Assistant Administrator John Martin. “These actions will not be tolerated by the DEA, and they will be brought to justice.”

Patients Caught in the Middle

Big fines and prison terms may be appropriate, but not if they result in legitimate patients with legitimate prescriptions being denied access to opioids.  That’s what happened in April to a California woman with Stage 4 terminal breast cancer, who couldn’t get a prescription filled for Norco at her local Rite Aid pharmacy.  

April Doyle’s tearful, 6-minute video about her experience went viral online, and she wound up getting apologies from a Rite Aid vice-president, the store manager and even the pharmacist who sent her away without pain medication.

Rite-Aid’s caution in filling opioid prescriptions may have stemmed from being added a few months earlier as a defendant in New York City’s opioid lawsuit (along with CVS, Walgreens and Walmart) by the law firm of Simmons Hanly Conroy.  

“Many plaintiffs in opioid lawsuits are amending their complaints to include these retailers because they failed to monitor the drugs sold out of their pharmacy windows,” Simmons Hanly said in a statement.

The Washington Post released a report this week on how drug companies, wholesalers and pharmacies “saturated the country” with 76 billion oxycodone and hydrocodone pills from 2006 through 2012. Those pills, according to the Post, “fueled the prescription opioid epidemic” and resulted in nearly 100,000 deaths.

But as Jeffrey Singer points out in Cato at Liberty, the Post is contributing to a false narrative about the opioid crisis by pinning the blame on prescription opioids, while largely ignoring the fact that most deaths are caused by illicit drugs such as heroin and illicit fentanyl.

“The overdose problem has never been a product of doctors treating patients for pain. It has always been a product of (a growing population of) nonmedical users accessing drugs in a dangerous black market fueled by drug prohibition,” Singer wrote.  “The continued obsession about the number of pain pills being prescribed causes patients to go undertreated for their pain and will not make one IV drug user pull the needle out of their arm.”

Closing Arguments in Oklahoma Opioid Trial

By Jackie Fortier, StateImpact Oklahoma

A global megacorporation best known for Band-Aids and baby powder may have to pay billions for its alleged role in the opioid crisis. Johnson & Johnson was the sole defendant in a closely watched trial that wrapped up in Oklahoma state court this week, with a decision expected later this summer.

The ruling in the civil case could be the first that would hold a pharmaceutical company responsible for one of the worst drug epidemics in American history.

Oklahoma Attorney General Mike Hunter’s lawsuit alleges Johnson & Johnson and its subsidiary Janssen Pharmaceuticals helped ignite the opioid crisis with overly aggressive marketing, leading to thousands of overdose deaths over the past decade in Oklahoma alone.

The trial took place over seven weeks in the college town of Norman. Instead of a jury, a state judge heard the case. During closing arguments Monday, Hunter called the company the “kingpin” of the opioid crisis.

“What is truly unprecedented here is the conduct of these defendants on embarking on a cunning, cynical and deceitful scheme to create the need for opioids,” Hunter said.

The state urged Judge Thad Balkman, who presided over the civil trial, to find Johnson & Johnson liable for creating a “public nuisance” and force the company to pay more than $17 billion over 30 years to abate the public health crisis in the state.

Driving the opioid crisis home has been a cornerstone of Oklahoma’s lawsuit. In closing arguments Monday, one of the state’s attorneys, Brad Beckworth, cited staggering prescribing statistics in the county where the trial took place.

“What we do have in Cleveland County is 135 prescription opioids for every adult,” Beckworth said. “Those didn’t get here from drug cartels. They got here from one cartel: the pharmaceutical industry cartel. And the kingpin of it all is Johnson & Johnson.”

Johnson & Johnson’s attorney Larry Ottaway, rejected that idea in his closing argument, saying the company’s products, which had included the fentanyl patch Duragesic and the opioid-based pill Nucynta, were minimally used in Oklahoma.

He scoffed at the idea that physicians in the state were convinced to unnecessarily prescribe opioids due to the company’s marketing tactics.

“The FDA label clearly set forth the risk of addiction, abuse and misuse that could lead to overdose and death. Don’t tell me that doctors weren’t aware of the risks,” Ottaway said.

Ottaway played video testimony from earlier in the trial, showing Oklahoma doctors who said they were not misled about the drugs’ risks before prescribing them.

“Only a company that believes its innocence would come in and defend itself against a state, but we take the challenge on because we believe we are right,” Ottaway argued.

Initially, Hunter’s lawsuit included Purdue Pharma, the maker of OxyContin. In March, Purdue Pharma settled with the state for $270 million. Soon after, Hunter dropped all but one of the civil claims, including fraud, against the two remaining defendants.

Just two days before the trial began, another defendant, Teva Pharmaceuticals of Jerusalem, announced an $85 million settlement with the state. The money will be used for litigation costs and an undisclosed amount will be allocated “to abate the opioid crisis in Oklahoma,” according to a press release from Hunter’s office.

Both companies deny any wrongdoing.

The Legal Liability of ‘Public Nuisance’

Most states and more than 1,600 local and tribal governments are suing drugmakers who manufactured various kinds of opioid medications, and drug distributors. They are trying to recoup billions of dollars spent addressing the human costs of opioid addiction.

“Everyone is looking to see what’s going to happen with this case, whether it is going to be tobacco all over again, or whether it’s going to go the way the litigation against the gun-makers went,” says University of Georgia law professor Elizabeth Burch.

But the legal strategy is complicated. Unlike the tobacco industry, from which states won a landmark settlement, the makers of prescription opioids manufacture a product that serves a legitimate medical purpose, and is prescribed by highly trained physicians — a point that Johnson & Johnson’s lawyers made numerous times during the trial.

Oklahoma’s legal team based its entire case on a claim of public nuisance, which refers to actions that harm members of the public, including injury to public health. Burch says each state has its own public nuisance statute, and Oklahoma’s is very broad.

“Johnson & Johnson, in some ways, is right to raise the question: If we’re going to apply public nuisance to us, under these circumstances, what are the limits?” Burch said. “If the judge or an appellate court sides with the state, they are going to have to write a very specific ruling on why public nuisance applies to this case.”

Burch said the challenge for Oklahoma has been to tie one opioid manufacturer to all of the harms caused by the ongoing public health crisis, which includes people struggling with addiction to prescription drugs, but also those harmed by illegal street opioids, such as heroin.

University of Kentucky law professor Richard Ausness agreed that it’s difficult to pin all the problems on just one company.

“Companies do unethical or immoral things all the time, but that doesn’t make it illegal,” Ausness said.

If the judge rules against Johnson & Johnson, Ausness said, it could compel other drug companies facing litigation to settle out of court. Conversely, a victory for the drug giant could embolden the industry in the other cases.

Oklahoma’s Paid Expert Witness

Earlier in the trial, the state’s paid expert witness, Dr. Andrew Kolodny, testified that Johnson & Johnson did more than push its own pills — until 2016, it also profited by manufacturing raw ingredients for opioids and then selling them to other companies, including Purdue, which makes Oxycontin.

“Purdue Pharma and the Sacklers have been stealing the spotlight, but Johnson & Johnson in some ways, has been even worse,” said Kolodny, who indicated he would be paid upwards of $500,000 for his testimony.

Kolodny said that’s why the company downplayed to doctors the risks of opioids as a general class of drugs, knowing that almost any opioid prescription would benefit its bottom line.

The state’s case also focused on the role of drug sales representatives. Drue Diesselhorst was one of Johnson & Johnson’s busiest drug reps in Oklahoma. Records discussed during the trial showed she continued to call on Oklahoma doctors who had been disciplined by the state for overprescribing opioids. She even continued to meet with doctors who had patients who died from overdoses.

DR. ANDREW KOLODNY

But Diesselhorst testified she didn’t know about the deaths, and no one ever instructed her to stop targeting those high-prescribing physicians.

“My job was to be a sales rep. My job was not to figure out the red flags,” she said on the witness stand.

Johnson & Johnson’s Defense

Throughout the trial, Johnson & Johnson’s defense team avoided many of the broader accusations made by the state, instead focusing on the question of whether the specific opioids manufactured by the company could have caused Oklahoma’s high rates of addiction and deaths from overdose.

Johnson & Johnson’s lawyer, Larry Ottaway, argued the company’s opioid products had a smaller market share in the state compared to other pharmaceutical companies, and he stressed that the company made every effort when the drugs were tested to prevent abuse.

He also pointed out that the sale of both the raw ingredients and prescription opioids themselves are heavily regulated.

“This is not a free market,” he said. “The supply is regulated by the government.”

Ottaway maintained the company was addressing the desperate medical need of people suffering from debilitating, chronic pain — using medicines regulated by the Food and Drug Administration and the Drug Enforcement Administration. Even Oklahoma purchases these drugs, for use in state health care services.

Judge Thad Balkman is expected to announce a verdict in August.

If the state’s claim prevails, Johnson & Johnson could, ultimately, have to spend billions of dollars in Oklahoma helping to ease the epidemic. State attorneys are asking that the company pay $17.5 billion over 30 years, to help abate the crisis in the state.

Balkman could choose to award the full amount, or just some portion of it, if he agrees with the state’s claim.

“You know, in some ways I think it’s the right strategy to go for the $17 billion,” Burch, the law professor, said. “[The state is saying] look, the statute doesn’t limit it for us, so we’re going to ask for everything we possibly can.”

In the case of a loss, Johnson & Johnson is widely expected to appeal the verdict. If Oklahoma loses, the state will appeal, Attorney General Mike Hunter said Monday.

This story is part of a partnership that includes StateImpact Oklahoma, NPR and Kaiser Health News. KHN is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

WHO Criticized for Withdrawing Opioid Guidelines

By Pat Anson, PNN Editor

A coalition of international palliative care organizations is protesting a decision by the World Health Organization (WHO) to withdraw two guidelines for treating pain with opioid pain medication.

“We are extremely concerned that the withdrawal of these guidance documents will lead to confusion and possible extreme measures that will hinder access to patients with legitimate medical needs,” the coalition said in a joint statement released this week.

The guidelines were withdrawn after two U.S. congressmen released a report that accused WHO of being “corruptly influenced” by Purdue Pharma and other opioid manufactures when it developed the guidelines in 2011 and 2012. The guidelines for treating pain in adults and children state that opioids “are known to be safe and there is no need to fear accidental death or dependence.”

Reps. Katherine Clark (D-MA) and Hal Rogers (R-KY) said the WHO guidelines served as “marketing materials” for Purdue, the maker of OxyContin.

“We are highly troubled that, after igniting the opioid epidemic that cost the United States 50,000 lives in 2017 alone… Purdue is deliberately using the same playbook on an international scale,” the report said. “If the recommendations in these WHO guidelines are followed, there is significant risk of sparking a worldwide public health crisis.”

WHO withdrew the guidelines a month after the report was released, citing “new scientific evidence” that emerged since their publication.

WHO’s decision to withdraw the guidelines gave credibility to a congressional report based largely on innuendo, according to the statement released by over a hundred palliative care organizations, including the American Academy of Hospice and Palliative Medicine and the UK-based International Observatory on End of Life Care.

“The report contains serious factual inaccuracies and draws inaccurate and unfair conclusions. It includes misleading information, and by making false accusations of existing collaborations and alliances to advance pain relief and palliative care, concludes that there was corruption within WHO,” the coalition said. “No staff member of the offices of the U.S. representatives contacted any of the organizations or individuals mentioned in the document to seek our responses to the allegations made in the report.”

According to the coalition, the withdrawal of the guidelines could further impede the availability of pain medication in third world countries, where less than 2% of palliative care patients have access to opioids.

“Under-treatment of severe pain is reported in more than 150 countries,” the coalition said. “At least 5 billion people live in countries affected by the crisis of under-consumption, and more than 18 million annually die with untreated, excruciating pain.”

The coalition cited the case of a cancer patient in New Delhi, India, who wanted to die until she was able to obtain opioids through a CanSupport palliative care program.  

“I am a functioning human being in charge of my life once again. This has been made possible thanks to the oral morphine that I now take.”

— Cancer patient in New Delhi, India

“I was a human wreck. My family was at their wits end as to how to help me. Because of my excruciating pain, I could not sit, sleep, eat or drink, let alone speak or think. When the team first met me my first request to them was for an injection that would put me out of my misery,” the patient said.

“Today, I am a functioning human being in charge of my life once again. This has been made possible thanks to the oral morphine that I now take on a regular basis.”

The palliative care coalition said it was unfair to deny opioids to patients in third world countries because of abuse and addiction problems in the U.S. and other developed nations.  The coalition called on WHO to update and revise the guidelines “with all deliberate speed” and to reinstate them until the revisions are made.

‘Trapped in a Bottle’ Billboard Misses the Mark

By Dr. Lynn Webster, PNN Columnist

The mission of The Partnership for a Drug-Free New Jersey (PDFNJ) is to reduce substance use and misuse in New Jersey. The non-profit has received more than 200 advertising and public relations awards for its public service campaigns.

Much of the organization’s work is laudable, but their new "Trapped in a Bottle" campaign spreads misleading and harmful information about opioid medication.

Digital billboards of a man or woman trapped in a prescription bottle appeared in Times Square and on mass transit. The billboards end with a warning: “In just 5 days, opioid dependency can begin.”

Physical Dependence vs. Addiction

The ad talks about dependency, but it conflates dependency with addiction.

Physical dependence is a process that starts with exposure to the first pill. Discontinuance of an opioid may lead to withdrawal — but the hyperbolic ad can easily be mistaken to be about addiction rather than dependency.

Dependency is a normal neuroadaptation that takes place when certain brain receptors are exposed to drugs, including opioids. These drugs change the structure and function of a receptor with continual exposure, and that can result in physical dependence. If the drugs are abruptly stopped, that can cause withdrawal.

Using opioid medication for as little as five days will almost never induce withdrawal. And even if withdrawal occurs after taking a short course of opioids, it does not mean the person is addicted or has an opioid-use disorder.

The "5 days" concept is meaningless because it spreads unhelpful myths about opioids. I have prescribed opioids to thousands of patients and have never seen a patient experience withdrawal when stopping within a week or even two. Managed properly, the overwhelming majority of patients experience no negative effects from dependency.

Addiction, on the other hand, requires much more than simply ingesting a pill, and it does not occur in any specific number of days. The development of this disease is a process that involves multiple factors and occurs over time.

It is important to remember that addiction is not resident in the drug, but rather in human biology. Exposure to an opioid is a necessary, but by itself is insufficient to cause the disease.

For people who develop an addiction, opioids provide a reward, and the brain seeks to repeat the pleasurable experience. For a vulnerable person, one pill can be so rewarding that it drives pleasure-seeking behavior that can lead to addiction. But that does not happen in five days or on any other timetable.

This is not the first time PDFNJ has created over-the-top digital billboards to scare people away from using prescription opioids.

A 2016 billboard intended to frighten parents asked: "Would you give your child HEROIN to remove a wisdom tooth?"

This melodramatic question was followed with: “Ask your dentist how prescription drugs can lead to heroin abuse." The innuendo is neither educational nor informative.

It's understandable that an advertising agency would have trouble accurately conveying the problems of drug dependence and addiction when the news media also has difficulty communicating the facts.

Inaccurate Portrayal of the Opioid Crisis

In a recent WPIX article describing the “Trapped in a Bottle” campaign, Mary Murphy wrote that “drug overdoses killed more than 72,000 people in the United States in 2017, a new record driven by the deadly opioid crisis.”

Murphy used the statistic to help illustrate the harm of prescription opioids. But prescription opioids were involved in less than 20,000 of those drug deaths. If Murphy wanted to use a large number, she should have said there were 150,000 deaths from substance abuse in 2018. This would include alcohol-related deaths. Of course, alcohol delivers its poison in a bottle, too.

Murphy writes that a large percentage of drug overdoses can be attributed to heroin or fentanyl. Indeed, these are major sources of opioid deaths, but she fails to point out that neither heroin or illicit fentanyl are prescription opioids. Nor are they commonly found in a bottle. Again, her implication is that prescription opioids are at the heart of this crisis.

Concepts Video Productions, which is based in Towaco, New Jersey, produced the digital billboard. “Each year, we select a pro-bono project that will impact the world,” said Collette Liantonio, creative director of the production company.

The “Trapped in a Bottle” billboard, however, may do nothing for the world besides demonstrate how imperfectly most people understand the reason for the drug crisis and reinforce prevalent myths about it.

Perhaps Concepts Video Productions should consider creating a billboard that shows someone who is unable to find a job that pays a decent wage, and seeks to escape poverty and hopelessness with drugs. Economic and social woes, rather than prescription drugs, are at the core of our country's drug crisis.

Or perhaps Concepts Video Productions should create a giant digital billboard full of people with chronic pain who can’t get out of bed because their doctors refuse to prescribe the medication they need.

Using fear to solve the drug crisis will never be successful.

Moreover, knowing a drug's potential to lead to physical dependence or addiction will not prevent anyone from seeking a psychological experience to escape painful life experiences. The answer is to address the emotional and physical needs that create dependency or addiction in the first place.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. Lynn is a former president of the American Academy of Pain Medicine, author of the award-winning book “The Painful Truth” and co-producer of the documentary “It Hurts Until You Die.”

You can find him on Twitter: @LynnRWebsterMD.

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.

Study: 40% of Primary Care Clinics Refuse to See Pain Patients

By Pat Anson, PNN Editor

Many chronic pain patients know firsthand how difficult it can be to find a new doctor. In PNN’s recent survey of nearly 6,000 patients, almost three out of four (72%) said it is harder to find a doctor willing to treat their chronic pain.

“Two doctors refused to see me. I have no quality of life and I'm confined to bed. No one will help me,” one patient told us.

“It's to the point mentioning you need pain relief makes health care professionals look at you as an addict. Hell, when I have tried to get help for my pain and told the doctor I don't want opioids, I still get a suspicious look,” another patient said.

Over a third of patients (34%) in our survey said they’ve been abandoned by doctors and 15 percent said they haven’t been able to find a doctor at all.

A novel study by researchers at the University of Michigan confirms many of our findings. Using a "secret shopper" method, researchers posing as the adult children of patients taking the opioid Percocet called primary care clinics in Michigan to see if they could schedule an appointment for their parent. The callers also said their "parent" was taking medications for high blood pressure and high cholesterol.

79 of the 194 clinics that were called – about 40 percent -- said they would not accept a new patient who was taking opioids, no matter what kind of health insurance they had.

Less than half of the clinics (41%) were willing to schedule an initial appointment and 17 percent said they needed more information before making a decision.

"We were hearing about patients with chronic pain becoming 'pain refugees', being abruptly tapered from their opioids or having their current physician stop refilling their prescription, leaving them to search for pain relief elsewhere," said lead researcher Pooja Lagisetty, MD, who published her findings in JAMA Network Open.

"However, there have been no studies to quantify the extent of the problem. These findings are concerning because it demonstrates just how difficult it may be for a patient with chronic pain searching for a primary care physician."

Lagisetty and her team did find that larger clinics and community health centers were more likely to accept new patients taking opioids, perhaps because they have more resources available to treat such patients.

Still, the overall findings are concerning because they mean many patients who need medical care -- not just for pain but for high blood pressure, diabetes and other common conditions -- are being turned away because of the stigma associated with opioids.

Without access to medical care, researchers say patients may turn to other means of obtaining opioids or to illicit substances. 

“Our results suggest that there are significant barriers in accessing primary care for patients taking opioids for chronic pain.”

— Pooja Lagisetty, MD, University of Michigan

“These findings may also reflect practitioners' discomfort with managing opioid therapy for chronic pain or treating patients with OUD (opioid use disorder) as a result of pressures to decrease overall opioid prescribing,” researchers found. “In addition, the findings may reflect frontline staff bias against what may be perceived as drug-seeking behavior and may not actually indicate prescriber decision-making or clinic-level policies.

“However, regardless of the reason for denial, our results suggest that there are significant barriers in accessing primary care for patients taking opioids for chronic pain.”

Lagisetty said the 2016 CDC opioid guideline – widely blamed by many patients for restricting access to opioid medication – is only part of the problem.

"States, including Michigan, have implemented many other policies that are only occasionally based on the guidelines, in an effort to restrict opioid prescribing," she said. "We hope to use this information to identify a way for us to fix the policies to have a more patient-centered approach to pain management.

"Everyone deserves equitable access to health care, irrespective of their medical conditions or what medications they may be taking."

Drug Maker Payments May Influence Gabapentinoid Prescribing

By Pat Anson, PNN Editor

There is growing attention being paid to doctors who accept money from pharmaceutical companies. A recent study, for example, found that doctors who receive direct payments from opioid manufacturers tend to prescribe more opioid medication than doctors who receive no such payments.

But another new study shows the same is true for doctors who prescribe an expensive class of non-opioid drugs that are widely used “off label” to treat chronic pain.

Researchers at Yale University and the University of Connecticut looked at Medicare Part D prescribing data for gabapentinoids from 2014 to 2016, comparing it with payments made to doctors from gabapentin manufacturers. Over the study period, about 51,000 physicians received $11.5 million from the drug makers, mostly for meals, beverages and gifts.

The researchers found that doctors who received the payments were more likely to prescribe a brand name gabapentinoid such as Lyrica (Pfizer), Gralise (Assertio) or Horizant (Arbor). These brand name drugs cost several hundred dollars for a one-month supply, compared to less than $20 for a one-month supply of a generic version. 

“Among physicians who prescribed gabapentinoids, receipt of payments from industry was associated with a higher likelihood of prescribing brand-name products than generic gabapentin,” researchers reported in JAMA Internal Medicine.

“Our findings raise concerns about the reasons some physicians prescribe brand-name gabapentinoids and not less-expensive generic alternatives.”

Generic drugs are generally just as effective as brand name drugs, but the differences in cost can be significant. For a Medicare beneficiary in 2016, about $2,500 a year was spent on a brand name gabapentin vs. just $89 for a generic version of the same drug.

“All of these studies have essentially the same finding -- that marketing to physicians is associated with increased sales of a company’s product and increased Medicare expenditures,” Robert Steinbrook, MD, UC San Francisco School of Medicine, wrote in a JAMA editorial.

“Association studies do not establish cause and effect, they do not account for other influences on prescribing, such as direct-to-consumer advertising, and they do not assess the appropriateness of prescriptions for individual patients. Nonetheless, the pattern is indisputable.”

Does your doctor accept industry payments? You can see for yourself on Medicare’s Open Payments database.

In addition to the costs involved, there is growing awareness that gabapentinoids are over-prescribed and not as effective for some chronic pain conditions.

The drugs were originally developed to prevent epileptic seizures, but their use has tripled over the past 15 years as more doctors prescribed them off label for a wide variety of pain conditions.

“Our findings raise concerns about the reasons some physicians prescribe brand-name gabapentinoids and not less-expensive generic alternatives.”

— JAMA Internal Medicine study

“Gabapentinoids have become frequent first-line alternatives in patients with chronic pain from whom opioids are being withheld or withdrawn, as well as in patients with acute pain who traditionally received short courses of low-dose opioid,” wrote Christopher Goodman, MD, and Allan Brett, MD, University of South Carolina School of Medicine, in a recent clinical review in JAMA Internal Medicine.

“The evidence to support off-label gabapentinoid use for most painful clinical conditions is limited. For some conditions, no well-performed controlled trials exist.”

Goodman and Brett said the 2016 CDC opioid guideline reinforces “an inflated view of gabapentinoid effectiveness” by asserting they are “first-line drugs” for neuropathic pain. Many patients who take gabapetinoids have side-effects such as dizziness or drowsiness, and there are increasing reports that the drugs are being abused and sold on the street.   

Opioid Addiction Rates Redux

By Roger Chriss, PNN Columnist

The Oklahoma opioid trial is garnering attention for what could be a pivotal role in determining the liability of Johnson & Johnson and other drug makers in the opioid crisis. A key point hinges on a seemingly simple question: What percentage of people on long-term opioid therapy develop addiction?

Dr. Timothy Fong, a UCLA psychiatrist and defense expert, refuted claims by prosecution witness Dr. Andrew Kolodny that people who take opioid pain medication over extended periods have a 25% chance of becoming addicted. Fong said other studies suggest that patients who take opioids over long periods might have addiction rates closer to 1 to 3 percent.  

There is an extensive literature on these estimates, including NIH studies and published research from leading experts. I covered some of them in a PNN column last year (see “How Common Is Opioid Addiction?”)

“The best and most recent estimate of the percentage of patients who will develop an addiction after being prescribed an opioid analgesic for long-term management of their chronic pain stands at around 8 percent,” NIDA director Nora Volkow, MD, told Opioid Watch.

Why are there so many different estimates? There is an important distinction between the incidence and prevalence of a medical condition. Briefly, incidence represents the probability of occurrence of a given medical condition in a population within a specified period of time. In contrast, prevalence gives the proportion of a particular population found to be affected by a medical condition.

The distinction is not just semantics and is critical in epidemiology. As explained in Physiopedia, “incidence conveys information about the risk of contracting the disease, whereas prevalence indicates how widespread the disease is.”

Besides obvious difficulties in determining incidence (the necessary clinical trials will never receive approval) and measuring prevalence (the required public health monitoring is well beyond our current capability), we instead have to rely on proxy measures derived from prescription drug databases, medical records and surveys.

We also have to make decisions about the “specified period of time” when determining incidence and the assessment of the “medical condition’ for prevalence.

There is no universally agreed upon time frame for the development of addiction or opioid use disorder after opioid initiation, whether medical or non-medical. Similarly, the definition of opioid use disorder has evolved over the years.

Further, in many cases incidence and prevalence are calculated based on assumptions made by researchers. For instance, in an Annual Review of Public Health article co-authored by Dr. Kolodny, a 2010 study is cited that found 26% of chronic pain patients met the criteria for opioid dependence and 35% met the criteria for opioid use disorder. This seems to be the source of the 25% claim used by Kolodny in the Oklahoma opioid trial.

But the 2010 study doesn’t distinguish between incidence and prevalence. It is also not clear how many of the surveyed pain patients had an opioid use disorder diagnosis before the onset of medical opioid therapy.

A similar critique can be levied against the authors of a 1980 letter in The New England Journal of Medicine that claimed opioid addiction was rare in pain patients. Some have claimed publication of the letter helped launch the opioid crisis. 

The problem with all of these studies is that they are retrospective in nature, limited to a particular patient population, and constrained by the diagnostic criteria in use at the time. And the estimates derived from such studies do not necessarily implicate or exonerate Johnson & Johnson.

Moreover, it is possible that addiction rates have varied over time and were influenced by factors that were not yet understood or even known. For example, recent research has found an association between opioid overdoses and drug diversion among family and friends, cold weather, altitude above sea level, and medical cannabis legalization.

The NIH work that Dr. Volkow refers to in her Opioid Watch interview works to account for all of these factors. So as Volkow stated last year, the “best and most recent estimate" stands at about eight percent. Improved public health surveillance, epidemiological research, and patient monitoring may shift this number up or down, and will increase confidence in the estimate.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

Canadian Doctors Prescribe Opioids to Keep Patients Off Street Drugs

By Pat Anson, PNN Editor

So-called “safe injection sites” – supervised clinics where intravenous drug users can inject themselves -- remain controversial in the U.S. Efforts to establish such sites in San Francisco and Philadelphia are mired in political and legal opposition.

But supervised injection sites are already operating in several Canadian cities, where they are seen as an important resource in reducing the risk of overdose and getting drug users into treatment.

Some Canadian doctors, however, believe the injection sites leave out a key population – illicit drug users who don’t normally inject drugs. Rather than run the risk of those patients turning to risky street drugs, they are prescribing opioid medication to them.

“We have to be willing to step outside of our comfort zone and out of the medical establishment comfort zone and say that we need to keep people alive,” Dr. Andrea Sereda, a family physician at the London Intercommunity Health Centre in Ontario told Global News.

Sereda is prescribing hydromorphone tablets to about 100 patients, most of whom were homeless and using street drugs. So far there have been no fatal overdoses, half the patients have found housing, and they have regular contact with healthcare providers.

“It’s not just a prescription for pills, but it’s a relationship between myself and the patient and a commitment to make things better,” Sereda said. “That involves me taking a risk and giving them a prescription, but it also involves the patient committing to doing things that I recommend about their health and us working together.”

Sereda says her “safer supply” program is only intended for patients who have failed at addiction treatment programs where methadone or Suboxone are usually prescribed.

A similar pilot program recently began at a Vancouver clinic, where hydromorphone tablets are given to about 50 patients, who ingest them on site under staff supervision. At another clinic in Toronto, hydromorphone is prescribed to 10 patients who would normally rely on the black market, where drugs are often tainted with illicit fentanyl or its lethal chemical cousin, carfentanil.

“I’ve had people who, literally, their urine is just all carfentanil,” Dr. Nanky Rai, a physician at Parkdale Queen West Community Health Centre told Global News. “That’s really what terrified me into action.”

Other physicians are warming up to the idea. Last week over 400 healthcare providers and researchers sent an open letter to Ontario Premier Doug Ford asking that high dose injectable hydromorphone be made widely available to illicit drug users.

“We could rapidly implement hydromorphone prescribing,” Jessica Hales, a Toronto nurse practitioner, said in a statement. “Clients want this. Prescribers are eager to deliver it. But it is not covered under the Ontario Public Drug Plan, which is how almost all of my clients access prescription drugs.”

What About Pain Patients?

But patient advocates say the safe supply movement should be expanded to include pain patients who have lost access to opioid medication or had their doses drastically reduced.

“The Chronic Pain Association of Canada fully endorses the safe supply initiative, but asks why we’re helping one group while hurting the other, pointlessly. Safe supply is equally critical for the million or so unfortunate Canadians, including children, who suffer high-impact chronic pain and can no longer obtain the drugs they need,” Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, said in a statement. 

“These patients have long been sustained by the pharmaceuticals and don’t abuse them. But now they’re routinely forced down or completely off their medications, blamed for overdoses they have no part in.”

Some pain patients are turning to street drugs. In PNN’s recent survey of nearly 6,000 chronic pain patients in the United States, eight out of ten said they are being prescribed a lower dose or that their opioid prescriptions were stopped. Many are turning to other substances for pain relief. About 15 percent have obtained opioid medication from family, friends or the black market, or used street drugs such as heroin and fentanyl.

“I know seven people personally that have gone to the streets to get pain relief. Four of them died because it was mixed with fentanyl. Two committed suicide,” one patient told us.

“I have been without a prescription for two years and have been getting medication on the street. I cannot afford this and I have no criminal history whatsoever. I have tried heroin for the first time in my life, out of desperation and thank God, did not like it,” wrote another patient.

Barry Ulmer says these patients need a safe supply too.

“Prescribing opiates safely to those with addiction makes sense. But simultaneously denying legitimate pain patients their medications doesn’t. It’s pointless — and cruel. Let’s give people with pain the same respect and care we give people with addiction,” he said.

Study Finds Antidepressants Make Tramadol Less Effective for Pain Relief

By Pat Anson, PNN Editor

Common antidepressants interact with the opioid medication tramadol to make it less effective for pain relief, according to a small new study from University Hospitals (UH) in Cleveland. The findings suggest that some patients who exceed their prescribed dose of tramadol may be under-medicated and are seeking more effective pain relief.

Prescriptions for tramadol – which is sold under the brand names Ultram and ConZip – have increased in recent years because it is widely perceived as a “safer” opioid with less rick of addiction. Many patients, however, say tramadol is not as effective as hydrocodone, oxycodone and other opioids.  

UH researchers reviewed the prescription records of 152 patients who received tramadol for at least 24 hours.

Those patients who were also taking the antidepressants Prozac (fluoxetine), Paxil (paroxetine) or Wellbutrin (bupropion) required three times more tramadol per day to control their breakthrough pain, compared to patients not taking the antidepressants.

Previous studies on healthy volunteers have shown effects on blood levels when combining tramadol with those particular antidepressants. However, this was the first study to document the effects of this interaction in a real-world setting with pain patients.

"We knew that there was a theoretical problem, but we didn't know what it meant as far as what's happening to pain control for patients," said Derek Frost, PharmD, a UH pharmacist and lead author of the study, which was published in the journal Pharmacotherapy.

Frost says millions of Americans may be suffering the ill effects of this drug-to-drug interaction.

"Tramadol relies on activation of the CYP2D6 enzyme to give you that pain control," Frost said. "This enzyme can be inhibited by medications that are strong CYP2D6 inhibitors, such as fluoxetine, paroxetine and bupropion.

“Many chronic pain patients are taking antidepressants, mainly selective serotonin reuptake inhibitors (SSRIs), which many of these CYP2D6 inhibitors fit into. There are a lot of patients who experience both, unfortunately. The likelihood that somebody on one of these offending agents and tramadol is relatively high."

Frost says the problem has a relatively easy fix.

"We have a lot of other antidepressants available that are in the same class of medication that don't inhibit this particular enzyme, such as Zoloft (sertraline), (Celexa) citalopram and Lexapro (escitalopram)," he said. "You also have other options for pain control - non-opioid medications such as NSAIDs. If we need to use opioids, a scheduled morphine or a scheduled oxycodone would avoid this interaction."

Tramadol is a synthetic opioid that was rescheduled by the Drug Enforcement Administration in 2014 as a Schedule IV controlled substance, a category that means it has a low potential for abuse. That same year, hydrocodone was rescheduled as a Schedule II drug, meaning it has a high potential for abuse. Many patients who were taking hydrocodone were switched to tramadol as a result of the rescheduling.

American Pain Society Files for Bankruptcy

By Pat Anson, PNN Editor

The American Pain Society (APS) filed for bankruptcy Friday after an overwhelming vote by its members to dissolve the financially troubled medical organization. In a membership vote last month, 93% voted in favor of a recommendation by the APS board of directors to file a voluntary petition for Chapter 7 bankruptcy.

The APS is a non-profit, research-based organization that focuses on the causes and treatment of acute and chronic pain. Although many of its members are researchers and academics who are investigating non-opioid treatments for pain, the APS was targeted as a defendant by Simmons Hanly Conroy and several other law firms seeking to recover billions of dollars in damages in opioid litigation cases.

In a press release, APS said efforts to resolve the “meritless” lawsuits without lengthy and expensive litigation were unsuccessful.

“It’s the perfect storm and now pointless to continue operations just to defend against superfluous lawsuits.  Our resources are being diverted to paying staff to comply with subpoenas and other requests for information and for payment of legal fees instead of funding research grants, sponsoring pain education programs, and public policy advocacy,” APS President William Maixner, DDS, said in a statement.

“As a result, the Board of Directors no longer believes APS can continue to fulfill its mission and meet the needs of our members and the pain care community.”

Press coverage of the APS often parroted what the opioid lawsuits alleged. The Guardian, for example, called the APS a “pawn of big pharma” and claimed the organization “pushed doctors to prescribe painkillers.”

The Guardian’s coverage was based largely on a report by Sen. Claire McCaskill (D-MO), who accepted over $400,000 in campaign donations from Simmons Hanly in her failed bid for re-election in 2018. APS is named as a defendant in several opioid lawsuits filed by Simmons Hanly, which stands to make hundreds of millions of dollars in contingency fees if the lawsuits are successful. The Guardian failed to mention any connection between Simmons Hanly and McCaskill.

The APS’ bankruptcy filing likely brings an end to its monthly publication, The Journal of Pain, which has been rated among the top five scientific journals in pain science. The current issue features research articles on diverse topics such as meditation for low back pain, diagnostic codes for fibromyalgia, whether opioids are effective for chronic noncancer pain, and the use of virtual reality to relieve arm pain.

“APS has been advocating for increased investment in research for many years, and it is particularly ironic that APS’s voice will go silent at this critical time in our history, when increased investment in pain research has finally become a reality in an effort to combat the opioid crisis,” said Roger Fillingim, PhD, an APS past president and professor of psychology at the University of Florida School of Dentistry.  

“There is a sad irony that the professional organization best poised to provide the spectrum of science to improve the prevention and treatment of pain and related substance abuse is defunct,” said APS President-elect Gary Walco, PhD, director of pain medicine at Seattle Children’s Hospital.

“Now, more than ever, our nation needs the collective efforts of leading scientists and clinicians who hold patients’ well-being at the highest premium.  The principal focus on punishing those in industry that may have contributed to the problem is shortsighted and far from sufficient.”

The APS is the second professional pain management organization to cease operations this year. In February, the Academy of Integrative Pain Management (AIPM) also shutdown. Opioid litigation has not only been costly for APS and AIPM, it has contributed to steep declines in financial support from pharmaceutical companies for other pain organizations, medical conferences and patient advocacy groups.   

How Opioid Critics and Law Firms Profit From Litigation

By Pat Anson, PNN Editor

Dr. Andrew Kolodny has long been known as one of the most strident critics of opioid prescribing. The founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP) has claimed that drug makers and a web of industry-funded groups are to blame for the nation’s addiction and overdose crisis.

Kolodny has accused the so-called “opioid lobby” of undermining the CDC opioid guideline, claimed pain patients are being “effectively manipulated” by drug makers, and called the American Cancer Society a “shady organization” because it accepts outside funding. 

Kolodny even spoke about an “opioid mafia” as he testified as an expert witness in Oklahoma’s opioid lawsuit against Johnson & Johnson.

“We’ve seen Johnson & Johnson promote opioids in this unbranded campaign, funding front groups, patient groups meant to look like grassroots organizations that promoted opioids, funding professional groups that were promoting opioids,” Kolodny testified.  

“We know that Johnson & Johnson participated in the Pain Care Forum, a group that I have referred to as the opioid mafia, working to protect their stake in the opium supply into the United States.”

Kolodny’s hyperbole is catnip to compliant reporters who can usually count on him to return their calls and provide a good quote.  A psychiatrist and former chief medical officer for the addiction treatment chain Phoenix House, Kolodny is the go-to source for many news organizations covering the opioid crisis. He now co-directs an opioid research program at Brandeis University that is funded by a federal grant.

Kolodny’s has long maintained that he is free of any conflicts of interest and that PROP has never accepted funding from the pharmaceutical industry.

“I don’t believe physicians should be helping drug companies market their products,” he testified in Oklahoma. “It’s very easy to fool yourself when it’s profitable to fool yourself.”

Lawyers for Johnson & Johnson have opened a window into a profitable sideline Kolodny has as a paid consultant and expert witness for law firms involved in opioid litigation.

Kolodny stands to make upwards of half a million dollars working for the law firm of Nix Patterson & Roach, one of three outside law firms hired by Oklahoma Attorney General Mike Hunter to handle the case against Johnson & Johnson.

“It’s very easy to fool yourself when it’s profitable to fool yourself.”

— Dr. Andrew Kolodny

Kolodny testified that he’s being paid $725 an hour by Nix Patterson and could collect up to $500,000 for his services – possibly even more, depending on the length of the Oklahoma trial. Under questioning, Kolodny also acknowledged that he was paid $725 an hour as a consultant for at least one other law firm involved in opioid litigation.

“I don’t think it should be a secret that I’m being compensated,” Koldony said, adding that he worked for Nix Patterson about ten hours a week before the trial started and 40 hours a week since it began four weeks ago. At his hourly rate, Kolodny’s weekly pay would be $29,000.

Nix Patterson can easily afford to pay Kolodny. According to the terms of their contingency agreement with Oklahoma, the three law firms stand to collect up to 25% of any damages and penalties. With $17.5 billion being sought from Johnson & Johnson, Nix Patterson’s share could theoretically add up to nearly $2.5 billion. 

Purdue Pharma and Teva Pharmaceuticals have already settled out-of-court with Oklahoma for far less — $270 million and $85 million respectively.  Nix Patterson’s share of the Purdue settlement alone was $31.6 million.

Compensation Not Disclosed

Koldony’s work as a paid witness in opioid litigation is not disclosed on Brandeis University’s website, PROP’s website or on the website of the Steve Rummler Hope Network, a non-profit that is the “fiscal sponsor” of PROP.  

A non-profit fiscal sponsorship is an IRS loophole that allows the Rummler Hope Network to collect tax deductible donations on PROP’s behalf — even though PROP is not a registered charity. The identity of PROP’s donors and the size of their donations have never been disclosed.

Kolodny serves on the medical advisory committee of the Rummler Hope Network, along with PROP President Jane Ballantyne, MD. Coincidentally, Ballantyne worked as a paid consultant for Cohen Milstein Sellers & Toll – a law firm involved in opioid litigation in New Jersey, Indiana, Vermont, California and Illinois.

Kolodny testified in the Oklahoma trial that he also did some consulting for attorney Linda Singer at Cohen Milstein, which The New York Times profiled in 2014 as a politically influential law firm that was laying the groundwork for opioid lawsuits around the country. Singer was the lead outside counsel for the City of Chicago and Santa Clara County, California, two of the first jurisdictions to file opioid lawsuits.

“The lawsuits follow a pattern: Private lawyers, who scour the news media and public records looking for potential cases in which a state or its consumers have been harmed, approach attorneys general. The attorneys general hire the private firms to do the necessary work, with the understanding that the firms will front most of the cost of the investigation and the litigation. The firms take a fee, typically 20 percent, and the state takes the rest of any money won from the defendants,” the Times reported.

Singer left Cohen Milstein in 2017 to join Motley Rice, yet another law firm that specializes in healthcare litigation. PNN was unable to verify whether Kolodny was still on the payroll of Cohen Milstein, Motley Rice or any other law firms. He refused to discuss his work in opioid litigation.

“I’m not interested in answering any questions or talking to you,” Kolodny told this reporter.

(Update: In 2022 testimony in West Virginia, Kolodny testified that he started working on opioid litigation in 2012 with Linda Singer. It’s unknown if he disclosed that relationship to the CDC when he was advising the agency during the drafting of the 2016 opioid guideline. The CDC declined to provide that information to PNN after an FOIA request.

On September 4, 2019 Kolodny changed two of his JAMA disclosure statements to include his work as a paid expert in malpractice lawsuits. “I received compensation for work as an expert in malpractice litigation involving opioid prescribing. When the articles were first published, I did not believe this work could be perceived as a potential conflict of interest. My view has since changed. In the spirit of full transparency, I am requesting a correction to my disclosure statements.”)

PharmedOUT’s Paid Expert Witness

Another vocal critic of opioid prescribing is Dr. Adriane Fugh-Berman, Director of PharmedOUT, a program at Georgetown University Medical Center that seeks to expose deceptive marketing practices in the healthcare industry.

In a recent column in STAT News, Fugh-Berman and two of her grad students echoed many of Kolodony’s complaints about opioid manufacturers — claiming that “industry-funded attacks” on the CDC guideline by physician and patient advocacy groups were eroding public health.   

“The eerily similar attacks on the guideline… raise the question of whether this is a coordinated attempt by opioid manufacturers to use third parties to undermine, discredit, and smear the guideline,” they wrote. “There’s certainly a credible motive for opioid manufacturers to do this: The CDC guideline is an effective, evidence-based tool that has helped decrease inappropriate and dangerous prescribing of opioids for chronic pain patients.”

DR. ADRIANE FUGH-BERMAN

Unlike Kolodny, Fugh-Berman does disclose on PharmedOUT’s website that she is “a paid expert witness.” It is not disclosed, however, which law firms Fugh-Berman works for, what cases she is working on, or how much she is paid.

After initially agreeing to a telephone interview with PNN, Fugh-Berman abruptly cancelled. She did answer a few questions by email.

“I am a paid expert witness at the request of plaintiffs in litigation regarding pharmaceutical and medical device marketing practices, including litigation brought by several states and cities against opioid manufacturers.  My expert witness work has been disclosed to Georgetown, in my publications, and on our website,” Fugh-Berman wrote.

(Update: In testimony in California on August 15, 2019, Fugh-Berman said she billed $500 an hour for her testimony in a pelvic mesh liability trial of Johnson & Johnson. She received about $120,000 for her work on the case to date.)

Like PROP, PharmedOUT does not disclose it donors, which Fugh-Berman calls “a common practice.”

“(We) are funded primarily by individual donations, mostly small donations but we have several major donors. We do not provide the names of our individual donors,” she said.

Fugh-Berman did disclose that Kaiser Permanente sponsored PharmedOUT’s recent opioid conference, which featured a speech by Kolodny entitled “How the Opioid Lobby Protected the Status Quo” and a talk by a Kaiser doctor on “How Kaiser Permanente Promotes Rational Prescribing.”  

Lobbying and Campaign Donations

Law firms involved in opioid litigation have played a significant role in some political campaigns and in shaping news coverage of the opioid crisis. The national firm of Simmons Hanly Conroy — which claims to have “effectively invented large-scale, multi-defendant opioid litigation” — represents dozens of states, counties and cities that are suing drug companies. According to reports, Simmons Hanly’s contingency fee will be as high as one-third of the proceeds from opioid settlements.

In the 2018 congressional election, Simmons Hanly spent nearly $1.2 million on lobbying and donated over $1 million to candidates, according to OpenSecrets.org. Missouri Sen. Claire McCaskill (D) received five times more than any other candidate — nearly $410,000 — from donors affiliated with Simmons Hanly.

In February of that year, McCaskill released a report that was sharply critical of physician and patient advocacy groups for accepting money from opioid manufacturers. At least two organizations cited in the McCaskill report — the American Academy of Pain Medicine and the American Pain Society (APS) — are named as defendants in opioid lawsuits filed by Simmons Hanly. The APS recently filed for bankruptcy, citing the high cost of defending itself against “meritless” law suits.

The report made headlines for McCaskill, who ultimately lost her bid for re-election, but continues to make news today — most recently in the STAT news column written by paid expert witness Dr. Fugh-Berman.

With the Oklahoma trial now heading into its fifth week, enormous amounts of money are at stake. A verdict against Johnson & Johnson could lead to a cascade of settlements in hundreds of other opioid lawsuits that could cost the pharmaceutical industry up to $50 billion. States, cities and counties would certainly benefit from a settlement of that size. So would the law firms that represent them – and their paid witnesses.

U.S. Pain Foundation Founder Pleads Guilty to Fraud and Tax Evasion

By Pat Anson, PNN Editor

Paul Gileno, the former CEO and founder of the U.S. Pain Foundation, has pleaded guilty to fraud and tax evasion charges stemming from his misuse of funds from the Connecticut-based non-profit.

Gileno, 46, waived his right to be indicted and pleaded guilty Monday before U.S. District Judge Victor Bolden in Bridgeport, Connecticut. He faces up to 25 years in prison, but as part of the plea agreement prosecutors agreed to ask for a lesser sentence because of Gileno’s “prompt recognition and affirmative acceptance of personal responsibility.” A sentencing date has not been set.

According to court documents, Gileno embezzled nearly $1.6 million from the foundation from 2015 to 2017 and failed to report the income on his personal tax returns. For that, he owes an unpaid federal tax of over $532,000. Gileno must also pay a fine and make full restitution to the foundation and Internal Revenue Service, as well as tax penalties and interest.

Prosecutors say Gileno used the foundation’s bank account to write checks to himself and issued payments to other people for his own benefit. The money was used to pay for personal expenses, such as Gileno’s mortgage, car payments and a $3,600 visit to Universal Studios in Orlando, Florida. The misuse of funds went undetected for three years.

“Gileno failed to maintain accurate books and records of the United States Pain Foundation and in a number of instances, made false and fraudulent representations to the Board regarding the expenditures,” prosecutors said.

PAUL GILENO

“I hope your readers realize I did make mistakes but that should not take away from all the good work I did and the organization I created,” Gileno said in an email to PNN. “The board has been the same for the past 9 years and I hope they continue to help people with pain and use the programs we created together."

As he awaits sentencing, Gileno said he was “trying to focus my life on my two boys who are 5 and 4 and need their dad."

Acting CEO Nicole Hemmenway did not respond to a request for comment on Gileno’s guilty plea, but the foundation released a statement.

“While the last year has been difficult, the organization has never lost sight of its guiding mission to educate, empower, support, and advocate for the 50 million Americans living with chronic pain,” the foundation said. “We are thankful that resolution of these issues is coming to an end, and are committed to continuing to serve people with pain, stronger than ever.”

As PNN has reported, Gileno was forced to resign in May, 2018 after “financial irregularities” were finally discovered by the board. A few months later, Gileno confessed in an email to misusing charitable funds.

“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.

According to an audit released last month and U.S. Pain’s 2018 tax return, Gileno misappropriated over $2,055,000 from the charity from 2016 to 2018. The misused funds were reported to the IRS as “excess benefit transactions,” a broad category that includes unauthorized compensation, reimbursement for personal expenses, and payments to Gileno’s family members.

In addition to the $32,537 that Gileno was paid for roughly five months of work in 2018, he collected over $166,000 in excess benefits. The latter amount includes a $36,000 payment to an unidentified company owned by Gileno. It is not clear what the payment was for.

Gileno’s wife, sister and step-daughter were paid nearly $71,000 in wages in 2018. It is not clear what work they did. Gileno’s sister also received an unspecified amount of severance pay and maternity leave.

The auditor also reported that U.S. Pain has been unable to recover any money from a $100,000 investment in SMJ Homes, a real estate business owned by Gileno’s brothers. A promissory note from the company was due in February 2019, but has not be repaid, according to the audit.  

Gileno disputes the auditor’s finding and says most of the money was paid back.

“U.S. Pain has failed to tell you that the investment that was made with my brothers have been mostly paid back and they were paid 4 years of interest at 6 percent a year which was paid monthly and was deposited by people from U.S. Pain. It was never a surprise U.S. Pain cashed all the checks,” Gileno wrote. 

The foundation at one time claimed to be the nation’s largest non-profit patient advocacy group. While it’s unclear how many members U.S. Pain actually has, it remains well-funded. Major corporate donors to U.S. Pain include Abbvie, Amgen, Lilly, Sanofi, Novartis, Teva, Abbott, Pfizer and other pharmaceutical companies.   

After Gileno’s departure, the board scrapped a $2.5 million prescription co-pay program with Insys Therapeutics, a controversial drug maker whose founder and four former executives were recently convicted of racketeering.

U.S. Pain says it has implemented new policies, oversight measures and a system of checks and balances to ensure that only appropriate expenses are paid by the foundation.